Food and Drug Administration, HHS Pt. 878

table. Prior to treatment, the urinary 878.3800 External aesthetic restoration pros- stone is targeted using either an inte- thesis. gral or stand-alone localization/imag- 878.3900 Inflatable extremity splint. ing system. Shock waves are typically 878.3910 Noninflatable extremity splint. 878.3925 Plastic surgery kit and accessories. generated using electrostatic spark dis- charge (spark gap), electromagneti- Subpart E—Surgical Devices cally repelled membranes, or piezo- electric crystal arrays, and focused 878.4010 Tissue adhesive. onto the stone with either a specially 878.4011 Tissue adhesive with adjunct wound designed reflector, dish, or acoustic closure device for topical approximation of skin. lens. The shock waves are created 878.4014 Nonresorbable gauze/sponge for ex- under water within the shock wave ternal use. generator, and are transferred to the 878.4015 Wound dressing with poly (diallyl patient’s body using an appropriate dimethyl ammonium chloride) acoustic interface. After the stone has (pDADMAC) additive. been fragmented by the focused shock 878.4018 Hydrophilic wound dressing. waves, the fragments pass out of the 878.4020 Occlusive wound dressing. body with the patient’s urine. 878.4022 Hydrogel wound dressing and burn dressing. (b) Classification. Class II (special 878.4025 Silicone sheeting. controls) (FDA guidance document: 878.4040 Surgical apparel. ‘‘Guidance for the Content of Pre- 878.4100 Organ bag. market Notifications (510(k)’s) for 878.4160 Surgical camera and accessories. Extracorporeal Shock Wave 878.4165 Wound autofluorescence imaging Lithotripters Indicated for the Frag- device. mentation of Kidney and Ureteral 878.4200 Introduction/drainage catheter and Calculi.’’) accessories. 878.4300 Implantable clip. [65 FR 48612, Aug. 9, 2000] 878.4320 Removable skin clip. 878.4340 Contact cooling system for aes- thetic use. PART 878—GENERAL AND PLASTIC 878.4350 Cryosurgical unit and accessories. SURGERY DEVICES 878.4360 Scalp cooling system to reduce the likelihood of chemotherapy-induced alo- Subpart A—General Provisions pecia. 878.4370 Surgical drape and drape acces- Sec. sories. 878.1 Scope. 878.4371 Irrigating wound retractor device. 878.3 Effective dates of requirement for pre- 878.4380 Drape adhesive. market approval. 878.4400 Electrosurgical cutting and coagu- 878.9 Limitations of exemptions from sec- lation device and accessories. tion 510(k) of the Federal Food, Drug, 878.4410 Low energy ultrasound wound and Cosmetic Act (the act). cleaner. 878.4420 Electrosurgical device for over-the- Subpart B—Diagnostic Devices counter aesthetic use. 878.4430 Microneedling device for aesthetic 878.1800 Speculum and accessories. use. 878.4440 Eye pad. Subpart C [Reserved] 878.4450 Nonabsorbable gauze for internal use. Subpart D—Prosthetic Devices 878.4452 Nonabsorbable expandable hemo- 878.3250 External facial fracture fixation ap- static sponge for temporary internal use. pliance. 878.4454 Non-absorbable, hemostatic gauze 878.3300 Surgical mesh. for temporary internal use. 878.3500 Polytetrafluoroethylene with car- 878.4456 Hemostatic device for intraluminal bon fibers composite implant material. gastrointestinal use. 878.3530 Silicone inflatable breast pros- 878.4460 Non-powdered surgeon’s glove. thesis. 878.4470 Surgeon’s gloving cream. 878.3540 Silicone gel-filled breast prosthesis. 878.4490 Absorbable hemostatic agent and 878.3550 Chin prosthesis. dressing. 878.3590 Ear prosthesis. 878.4493 Absorbable poly(glycolide/l-lactide) 878.3610 Esophageal prosthesis. surgical suture. 878.3680 Nose prosthesis. 878.4494 Absorbable poly(hydroxybutyrate) 878.3720 Tracheal prosthesls. surgical suture produced by recombinant 878.3750 External prosthesis adhesive. DNA technology.

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878.4495 Stainless steel suture. 878.5080 Air-handling apparatus accessory. 878.4520 Polytetrafluoroethylene injectable. 878.5350 Needle-type epilator. 878.4580 Surgical lamp. 878.5360 Tweezer-type epilator. 878.4590 Focused ultrasound stimulator sys- 878.5400 Low level laser system for aesthetic tem for aesthetic use. use 878.4630 Ultraviolet lamp for dermatologic 878.5650 Topical oxygen chamber for ex- disorders. tremities. 878.4635 Sunlamp products and ultraviolet lamps intended for use in sunlamp prod- 878.5900 Nonpneumatic tourniquet. ucts. 878.5910 Pneumatic tourniquet. 878.4660 Skin marker. AUTHORITY: 21 U.S.C. 351, 360, 360c, 360e, 878.4670 Internal tissue marker. 360j, 360l, 371. 878.4680 Nonpowered, single patient, port- able suction apparatus. SOURCE: 53 FR 23872, June 24, 1988, unless 878.4683 Non-Powered suction apparatus de- otherwise noted. vice intended for negative pressure wound therapy. EDITORIAL NOTE: Nomenclature changes to 878.4685 Extracorporeal shock wave device part 878 appear at 73 FR 35341, June 23, 2008. for treatment of chronic wounds. 878.4700 Surgical microscope and acces- Subpart A—General Provisions sories. 878.4730 Surgical skin degreaser or adhesive tape solvent. § 878.1 Scope. 878.4750 Implantable staple. (a) This part sets forth the classifica- 878.4755 Absorbable lung biopsy plug. tion of general and plastic surgery de- 878.4760 Removable skin staple. vices intended for human use that are 878.4780 Powered suction pump. 878.4790 Powered surgical instrument for in commercial distribution. improvement in the appearance of (b) The identification of a device in a cellulite. regulation in this part is not a precise 878.4800 Manual surgical instrument for description of every device that is, or general use. will be, subject to the regulation. A 878.4810 Laser surgical instrument for use in general and plastic surgery and in der- manufacturer who submits a pre- matology. market notification submission for a 878.4815 Magnetic surgical instrument sys- device under part 807 cannot show tem. merely that the device is accurately 878.4820 Surgical instrument motors and ac- described by the section title and iden- cessories/attachments. 878.4830 Absorbable surgical gut suture. tification provision of a regulation in 878.4840 Absorbable polydioxanone surgical this part, but shall state why the de- suture. vice is substantially equivalent to 878.4860 Light based energy source device other devices, as required by § 807.87 of for topical application. this chapter. 878.4930 Suture retention device. (c) To avoid duplicative listings, a 878.4950 Manual operating table and acces- sories and manual operating chair and general and plastic surgery device that accessories. has two or more types of uses (e.g., 878.4960 Operating tables and accessories used both as a diagnostic device and as and operating chairs and accessories. a therapeutic device) is listed in one 878.5000 Nonabsorbable poly(ethylene subpart only. terephthalate) surgical suture. 878.5010 Nonabsorbable polypropylene sur- (d) References in this part to regu- gical suture. latory sections of the Code of Federal 878.5020 Nonabsorbable polyamide surgical Regulations are to chapter I of title 21 suture. unless otherwise noted. 878.5030 Natural nonabsorbable silk surgical (e) Guidance documents referenced in suture. 878.5035 Nonabsorbable expanded polytetra- this part are available on the Internet fluoroethylene surgical suture. at http://www.fda.gov/MedicalDevices/ 878.5040 Suction lipoplasty system. DeviceRegulationandGuidance/ 878.5050 Surgical smoke precipitator. GuidanceDocuments/default.htm.. Subpart F—Therapeutic Devices [53 FR 23872, June 24, 1988, as amended at 67 FR 77676, Dec. 19, 2002; 78 FR 18233, Mar. 26, 878.5070 Air-handling apparatus for a sur- 2013] gical operating room.

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§ 878.3 Effective dates of requirement tributed unless it is reclassified. If for premarket approval. FDA knows that a device being com- A device included in this part that is mercially distributed may be a ‘‘new’’ classified into class III (premarket ap- device as defined in this section be- proval) shall not be commercially dis- cause of any new intended use or other tributed after the date shown in the reasons, FDA may codify the statutory regulation classifying the device unless classification of the device into class the manufacturer has an approval III for such new use. Accordingly, the under section 515 of the act (unless an regulation for such a class III device exemption has been granted under sec- states that as of the enactment date of tion 520(g)(2) of the act). An approval the amendments, May 28, 1976, the de- under section 515 of the act consists of vice must have an approval under sec- FDA’s issuance of an order approving tion 515 of the act before commercial an application for premarket approval distribution. (PMA) for the device or declaring com- (c) A device identified in a regulation pleted a product development protocol in this part that is classified into class (PDP) for the device. III and that is subject to the transi- (a) Before FDA requires that a device tional provisions of section 520(l) of the commercially distributed before the act is automatically classified by stat- enactment date of the amendments, or ute into class III and must have an ap- a device that has been found substan- proval under section 515 of the act be- tially equivalent to such a device, has fore being commercially distributed. an approval under section 515 of the Accordingly, the regulation for such a act, FDA must promulgate a regula- class III transitional device states that tion under section 515(b) of the act re- as of the enactment date of the amend- quiring such approval, except as pro- ments, May 28, 1976, the device must vided in paragraphs (b) and (c) of this have an approval under section 515 of section. Such a regulation under sec- the act before commercial distribution. tion 515(b) of the act shall not be effec- tive during the grace period ending on § 878.9 Limitations of exemptions from the 90th day after its promulgation or section 510(k) of the Federal Food, on the last day of the 30th full calendar Drug, and Cosmetic Act (the act). month after the regulation that classi- The exemption from the requirement fies the device into class III is effec- of premarket notification (section tive, whichever is later. See section 510(k) of the act) for a generic type of 501(f)(2)(B) of the act. Accordingly, un- class I or II device is only to the extent less an effective date of the require- that the device has existing or reason- ment for premarket approval is shown ably foreseeable characteristics of in the regulation for a device classified commercially distributed devices with- into class III in this part, the device in that generic type or, in the case of may be commercially distributed with- in vitro diagnostic devices, only to the out FDA’s issuance of an order approv- extent that misdiagnosis as a result of ing a PMA or declaring completed a using the device would not be associ- PDP for the device. If FDA promul- ated with high morbidity or mortality. gates a regulation under section 515(b) Accordingly, manufacturers of any of the act requiring premarket ap- commercially distributed class I or II proval for a device, section 501(f)(1)(A) device for which FDA has granted an of the act applies to the device. exemption from the requirement of (b) Any new, not substantially equiv- premarket notification must still sub- alent, device introduced into commer- mit a premarket notification to FDA cial distribution on or after May 28, before introducing or delivering for in- 1976, including a device formerly mar- troduction into interstate commerce keted that has been substantially al- for commercial distribution the device tered, is classified by statute (section when: 513(f) of the act) into class III without (a) The device is intended for a use any grace period and FDA must have different from the intended use of a le- issued an order approving a PMA or de- gally marketed device in that generic claring completed a PDP for the device type of device; e.g., the device is in- before the device is commercially dis- tended for a different medical purpose,

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or the device is intended for lay use nonilluminated or illuminated and where the former intended use was by may have various accessories. health care professionals only; (b) Classification. Class I (general con- (b) The modified device operates trols). The device is exempt from the using a different fundamental sci- premarket notification procedures in entific technology than a legally mar- subpart E of part 807 of this chapter, keted device in that generic type of de- subject to the limitations in § 878.9. vice; e.g., a surgical instrument cuts tissue with a laser beam rather than [53 FR 23872, June 24, 1988, as amended at 54 FR 13827, Apr. 5, 1989; 59 FR 63010, Dec. 7, with a sharpened metal blade, or an in 1994; 66 FR 38802, July 25, 2001] vitro diagnostic device detects or iden- tifies infectious agents by using deoxyribonucleic acid (DNA) probe or Subpart C [Reserved] nucleic acid hybridization technology rather than culture or immunoassay Subpart D—Prosthetic Devices technology; or (c) The device is an in vitro device § 878.3250 External facial fracture fixa- that is intended: tion appliance. (1) For use in the diagnosis, moni- (a) Identification. An external facial toring, or screening of neoplastic dis- fracture fixation appliance is a metal eases with the exception of apparatus intended to be used during immunohistochemical devices; surgical reconstruction and repair to (2) For use in screening or diagnosis immobilize maxillofacial bone frag- of familial or acquired genetic dis- ments in their proper facial relation- orders, including inborn errors of me- ship. tabolism; (b) Classification. Class I (general con- (3) For measuring an analyte that trols). The device is exempt from the serves as a surrogate marker for premarket notification procedures in screening, diagnosis, or monitoring subpart E of part 807 of this chapter life-threatening diseases such as ac- subject to § 878.9. quired immune deficiency syndrome (AIDS), chronic or active hepatitis, tu- [53 FR 23872, June 24, 1988, as amended at 54 FR 13827, Apr. 5, 1989; 65 FR 2317, Jan. 14, berculosis, or myocardial infarction or 2000] to monitor therapy; (4) For assessing the risk of cardio- § 878.3300 Surgical mesh. vascular diseases; (5) For use in diabetes management; (a) Identification. Surgical mesh is a (6) For identifying or inferring the metallic or polymeric screen intended identity of a microorganism directly to be implanted to reinforce soft tissue from clinical material; or bone where weakness exists. Exam- (7) For detection of antibodies to ples of surgical mesh are metallic and microorganisms other than polymeric mesh for hernia repair, and immunoglobulin G (IgG) or IgG assays acetabular and cement restrictor mesh when the results are not qualitative, or used during orthopedic surgery. are used to determine immunity, or the (b) Classification. Class II. assay is intended for use in matrices § 878.3500 Polytetrafluoroethylene other than serum or plasma; with carbon fibers composite im- (8) For noninvasive testing as defined plant material. in § 812.3(k) of this chapter; and (9) For near patient testing (point of (a) Identification. A polytetrafluoro- care). ethylene with carbon fibers composite implant material is a porous device [65 FR 2317, Jan. 14, 2000] material intended to be implanted dur- ing surgery of the chin, jaw, nose, or Subpart B—Diagnostic Devices bones or tissue near the eye or ear. The device material serves as a space-occu- § 878.1800 Speculum and accessories. pying substance and is shaped and (a) Identification. A speculum is a de- formed by the surgeon to conform to vice intended to be inserted into a body the patient’s need. cavity to aid observation. It is either (b) Classification. Class II.

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§ 878.3530 Silicone inflatable breast stabilizers. The outer shell is inflated prosthesis. to the desired size with sterile isotonic (a) Identification. A silicone inflatable saline before or after implantation. breast prosthesis is a silicone rubber The device is intended to be implanted shell made of polysiloxane(s), such as to augment or reconstruct the female polydimethylsiloxane and breast. polydiphenylsiloxane, that is inflated (3) Polyurethane covered silicone gel- to the desired size with sterile isotonic filled breast prosthesis. A polyurethane saline before or after implantation. covered silicone gel-filled breast pros- The device is intended to be implanted thesis is an inner silicone rubber shell to augment or reconstruct the female made of polysiloxane(s), such as breast. polydimethylsiloxane and (b) Classification. Class III. polydiphenylsiloxane, with an outer (c) Date PMA or notice of completion of silicone adhesive layer and an outer a PDP is required. A PMA or a notice of covering of polyurethane; contained completion of a PDP is required to be within the inner shell is a fixed amount filed with the Food and Drug Adminis- of cross-linked polymerized silicone tration on or before November 17, 1999, gel, fillers, and stabilizers and an inert for any silicone inflatable breast pros- support structure compartmentalizing thesis that was in commercial distribu- the silicone gel. The device is intended tion before May 28, 1976, or that has, on to be implanted to augment or recon- or before November 17, 1999, been found struct the female breast. to be substantially equivalent to a sili- (b) Classification. Class III. cone inflatable breast prosthesis that (c) Date premarket approval application was in commercial distribution before (PMA) is required. A PMA is required to May 28, 1976. Any other silicone inflat- be filed with the Food and Drug Ad- able breast prosthesis shall have an ap- ministration on or before July 9, 1991 proved PMA or a declared completed for any silicone gel-filled breast pros- PDP in effect before being placed in thesis that was in commercial distribu- commercial distribution. tion before May 28, 1976, or that has on or before July 9, 1991 been found to be [53 FR 23872, June 24, 1988, as amended at 64 substantially equivalent to a silicone FR 45161, Aug. 19, 1999] gel-filled breast prosthesis that was in commercial distribution before May 28, § 878.3540 Silicone gel-filled breast prosthesis. 1976. Any other silicone gel-filled breast prosthesis shall have an ap- (a) Identification—(1) Single-lumen sili- proved PMA in effect before being cone gel-filled breast prosthesis. A single- placed in commercial distribution. lumen silicone gel-filled breast pros- thesis is a silicone rubber shell made of [53 FR 23872, June 24, 1988, as amended at 56 polysiloxane(s), such as FR 14627, Apr. 10, 1991] polydimethylsiloxane and § 878.3550 Chin prosthesis. polydiphenylsiloxane. The shell either contains a fixed amount cross-linked (a) Identification. A chin prosthesis is polymerized silicone gel, filler, and sta- a silicone rubber solid device intended bilizers or is filled to the desired size to be implanted to augment or recon- with injectable silicone gel at time of struct the chin. implantation. The device is intended to (b) Classification. Class II. be implanted to augment or recon- struct the female breast. § 878.3590 Ear prosthesis. (2) Double-lumen silicone gel-filled (a) Identification. An ear prosthesis is breast prosthesis. A double lumen sili- a silicone rubber solid device intended cone gel-filled breast prosthesis is a sil- to be implanted to reconstruct the ex- icone rubber inner shell and a silicone ternal ear. rubber outer shell, both shells made of (b) Classification. Class II. polysiloxane(s), such as polydimethylsiloxane and § 878.3610 Esophageal prosthesis. polydiphenylsiloxane. The inner shell (a) Identification. An esophageal pros- contains fixed amounts of cross-linked thesis is a rigid, flexible, or expandable polymerized silicone gel, fillers, and tubular device made of a plastic,

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metal, or polymeric material that is § 878.3800 External aesthetic restora- intended to be implanted to restore the tion prosthesis. structure and/or function of the esoph- (a) Identification. An external aes- agus. The metal esophageal prosthesis thetic restoration prosthesis is a device may be uncovered or covered with a intended to be used to construct an ex- polymeric material. This device may ternal artificial body structure, such as also include a device delivery system. an ear, breast, or nose. Usually the de- (b) Classification. Class II. The special vice is made of silicone rubber and it control for this device is FDA’s ‘‘Guid- may be fastened to the body with an ance for the Content of Premarket No- external prosthesis adhesive. The de- tification Submissions for Esophageal vice is not intended to be implanted. and Tracheal Prostheses.’’ (b) Classification. Class I (general con- [65 FR 17145, Mar. 31, 2000] trols). The device is exempt from the premarket notification procedures in § 878.3680 Nose prosthesis. subpart E of part 807 of this chapter, (a) Identification. A nose prosthesis is subject to the limitations in § 878.9. If a silicone rubber solid device intended the device is intended for use without to be implanted to augment or recon- an external prosthesis adhesive to fas- struct the nasal dorsum. ten it to the body, the device is exempt (b) Classification. Class II. from the current good manufacturing practice requirements of the quality § 878.3720 Tracheal prosthesis. system regulation in part 820 of this (a) Identification. The tracheal pros- chapter, with the exception of § 820.180, thesis is a rigid, flexible, or expandable with respect to general requirements tubular device made of a silicone, concerning records, and § 820.198, with metal, or polymeric material that is respect to complaint files. intended to be implanted to restore the [53 FR 23872, June 24, 1988, as amended at 59 structure and/or function of the tra- FR 63010, Dec. 7, 1994; 66 FR 38802, July 25, chea or trachealbronchial tree. It may 2001] be unbranched or contain one or two branches. The metal tracheal pros- § 878.3900 Inflatable extremity splint. thesis may be uncovered or covered (a) Identification. An inflatable ex- with a polymeric material. This device tremity splint is a device intended to may also include a device delivery sys- be inflated to immobilize a limb or an tem. extremity. (b) Classification. Class II. The special (b) Classification. Class I (general con- control for this device is FDA’s ‘‘Guid- trols). The device is exempt from the ance for the Content of Premarket No- premarket notification procedures in tification Submissions for Esophageal subpart E of part 807 of this chapter, and Tracheal Prostheses.’’ subject to the limitations in § 878.9. [65 FR 17146, Mar. 31, 2000] [53 FR 23872, June 24, 1988, as amended at 59 FR 63010, Dec. 7, 1994; 66 FR 38802, July 25, § 878.3750 External prosthesis adhe- 2001] sive. (a) Identification. An external pros- § 878.3910 Noninflatable extremity thesis adhesive is a silicone-type adhe- splint. sive intended to be used to fasten to (a) Identification. A noninflatable ex- the body an external aesthetic restora- tremity splint is a device intended to tion prosthesis, such as an artificial immobilize a limb or an extremity. It nose. is not inflatable. (b) Classification. Class I (general con- (b) Classification. Class I (general con- trols). The device is exempt from the trols). The device is exempt from the premarket notification procedures in premarket notification procedures in subpart E of part 807 of this chapter, subpart E of part 807 of this chapter subject to the limitations in § 878.9. subject to § 878.9. If the device is not la- [53 FR 23872, June 24, 1988, as amended at 59 beled or otherwise represented as ster- FR 63010, Dec. 7, 1994; 66 FR 38802, July 25, ile, it is exempt from the current good 2001] manufacturing practice requirements

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of the quality system regulation in vice used for adhesion of internal tis- part 820 of this chapter, with the excep- sues and vessels. tion of § 820.180 of this chapter, with re- (2) Classification. Class III (premarket spect to general requirements con- approval). As of May 28, 1976, an ap- cerning records, and § 820.198 of this proval under section 515 of the act is chapter, with respect to complaint required before this device may be files. commercially distributed. See § 878.3 of [53 FR 23872, June 24, 1988, as amended at 54 this chapter. FR 13827, Apr. 5, 1989; 65 FR 2317, Jan. 14, [73 FR 31033, May 30, 2008] 2000] § 878.4011 Tissue adhesive with ad- § 878.3925 Plastic surgery kit and ac- junct wound closure device for top- cessories. ical approximation of skin. (a) Identification. A plastic surgery (a) Identification. A tissue adhesive kit and accessories is a device intended with adjunct wound closure device in- to be used to reconstruct maxillofacial tended for the topical approximation of deficiencies. The kit contains surgical skin is a device indicated for topical instruments and materials used to application only to hold closed easily make maxillofacial impressions before approximated skin edges of wounds molding an external prosthesis. from surgical incisions, including (b) Classification. Class I (general con- punctures from minimally invasive trols). The device is exempt from the premarket notification procedures in surgery, and simple, thoroughly subpart E of part 807 of this chapter cleansed, trauma-induced lacerations. subject to § 878.9. It may be used in conjunction with, but not in place of, deep dermal stitches. [53 FR 23872, June 24, 1988, as amended at 54 Additionally, the adjunct wound clo- FR 13827, Apr. 5, 1989; 65 FR 2317, Jan. 14, sure device component maintains tem- 2000] porary skin edge alignment along the length of wound during application of Subpart E—Surgical Devices the liquid adhesive. (b) Classification. Class II (special § 878.4010 Tissue adhesive. controls). The special control for this (a) Tissue adhesive for the topical ap- device is FDA’s ‘‘Guidance for Industry proximation of skin—(1) Identification. A and FDA Staff; Class II Special Con- tissue adhesive for the topical approxi- trols Guidance Document: Tissue Adhe- mation of skin is a device intended for sive with Adjunct Wound Closure De- topical closure of surgical incisions, in- vice Intended for the Topical Approxi- cluding laparoscopic incisions, and mation of Skin.’’ See § 878.1(e) for the simple traumatic lacerations that have availability of this guidance document. easily approximated skin edges. Tissue adhesives for the topical approxima- [75 FR 68794, Nov. 10, 2010] tion of skin may be used in conjunction with, but not in place of, deep dermal § 878.4014 Nonresorbable gauze/sponge for external use. stitches. (2) Classification. Class II (special con- (a) Identification. A nonresorbable trols). The special control for this de- gauze/sponge for external use is a ster- vice is FDA’s ‘‘Class II Special Controls ile or nonsterile device intended for Guidance Document: ‘‘Tissue Adhesive medical purposes, such as to be placed for the Topical Approximation of directly on a patient’s wound to absorb Skin.’’ See § 878.1(e) of this chapter for exudate. It consists of a strip, piece, or the availability of this guidance docu- pad made from open woven or ment. nonwoven mesh cotton cellulose or a (b) Tissue adhesive for non-topical simple chemical derivative of cellulose. use—(1) Identification. A tissue adhesive This classification does not include a for non-topical use, including adhesives nonresorbable gauze/sponge for exter- intended for use in the embolization of nal use that contains added drugs such brain arteriovenous malformation or as antimicrobial agents, added bio- for use in ophthalmic surgery, is a de- logics such as growth factors, or is

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composed of materials derived from wound environment, and to allow the animal sources. exchange of gases such as oxygen and (b) Classification. Class I (general con- water vapor through the device. It con- trols). The device is exempt from the sists of a piece of synthetic polymeric premarket notification procedures in material, such as polyurethane, with or part 807, subpart E of this chapter sub- without an adhesive backing. This clas- ject to the limitations in § 878.9. sification does not include an occlusive [64 FR 53929, Oct. 5, 1999] wound dressing that contains added drugs such as antimicrobial agents, § 878.4015 Wound dressing with poly added biologics such as growth factors, (diallyl dimethyl ammonium chlo- or is composed of materials derived ride) (pDADMAC) additive. from animal sources. (a) Identification. A wound dressing (b) Classification. Class I (general con- with pDADMAC additive is intended trols). The device is exempt from the for use as a primary dressing for exud- premarket notification procedures in ing wounds, 1st and 2d degree burns, part 807, subpart E of this chapter sub- and surgical wounds, to secure and pre- ject to the limitations in § 878.9. vent movement of a primary dressing, and as a wound packing. [64 FR 53929, Oct. 5, 1999] (b) Classification. Class II (special controls). The special control is: the § 878.4022 Hydrogel wound dressing FDA guidance document entitled and burn dressing. ‘‘Class II Special Controls Guidance (a) Identification. A hydrogel wound Document: Wound Dressing With Poly dressing is a sterile or non-sterile de- (Diallyl Dimethyl Ammonium Chlo- vice intended to cover a wound, to ab- ride) (pDADMAC) Additive.’’ See sorb wound exudate, to control bleed- § 878.1(e) for availability of this guid- ing or fluid loss, and to protect against ance document. abrasion, friction, desiccation, and con- [74 FR 53167, Oct. 16, 2009] tamination. It consists of a nonresorbable matrix made of hydro- § 878.4018 Hydrophilic wound dress- philic polymers or other material in ing. combination with water (at least 50 (a) Identification. A hydrophilic percent) and capable of absorbing wound dressing is a sterile or non-ster- exudate. This classification does not ile device intended to cover a wound include a hydrogel wound dressing that and to absorb exudate. It consists of contains added drugs such as anti- nonresorbable materials with hydro- microbial agents, added biologics such philic properties that are capable of ab- as growth factors, or is composed of sorbing exudate (e.g., cotton, cotton materials derived from animal sources. derivatives, alginates, dextran, and (b) Classification. Class I (general con- rayon). This classification does not in- trols). The device is exempt from the clude a hydrophilic wound dressing premarket notification procedures in that contains added drugs such as anti- part 807, subpart E of this chapter sub- microbial agents, added biologics such ject to the limitations in § 878.9. as growth factors, or is composed of [64 FR 53929, Oct. 5, 1999] materials derived from animal sources. (b) Classification. Class I (general con- § 878.4025 Silicone sheeting. trols). The device is exempt from the premarket notification procedures in (a) Identification. Silicone sheeting is part 807, subpart E of this chapter sub- intended for use in the management of ject to the limitations in § 878.9. closed hyperproliferative (hypertrophic and keloid) scars. [64 FR 53929, Oct. 5, 1999] (b) Classification. Class I (general con- § 878.4020 Occlusive wound dressing. trols). The device is exempt from the premarket notification procedures in (a) Identification. An occlusive wound subpart E of part 807 of this chapter dressing is a nonresorbable, sterile or subject to the limitations in § 878.9. non-sterile device intended to cover a wound, to provide or support a moist [69 FR 48148, Aug. 9, 2004]

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§ 878.4040 Surgical apparel. § 878.4100 Organ bag. (a) Identification. Surgical apparel are (a) Identification. An organ bag is a devices that are intended to be worn by device that is a flexible plastic bag in- operating room personnel during sur- tended to be used as a temporary recep- gical procedures to protect both the tacle for an organ during surgical pro- surgical patient and the operating cedures to prevent moisture loss. room personnel from transfer of micro- (b) Classification. Class I (general con- organisms, body fluids, and particulate trols). The device is exempt from the material. Examples include surgical premarket notification procedures in caps, hoods, masks, gowns, operating subpart E of part 807 of this chapter room shoes and shoe covers, and isola- subject to § 878.9. tion masks and gowns. Surgical suits [53 FR 23872, June 24, 1988, as amended at 59 and dresses, commonly known as scrub FR 63010, Dec. 7, 1994; 65 FR 2318, Jan. 14, suits, are excluded. 2000] (b) Classification. (1) Class II (special controls) for surgical gowns and sur- § 878.4160 Surgical camera and acces- gical masks. A surgical N95 respirator sories. or N95 filtering facepiece respirator is (a) Identification. A surgical camera not exempt if it is intended to prevent and accessories is a device intended to specific diseases or infections, or it is be used to record operative procedures. labeled or otherwise represented as fil- (b) Classification. Class I (general con- tering surgical smoke or plumes, fil- trols). The device is exempt from the tering specific amounts of viruses or premarket notification procedures in bacteria, reducing the amount of and/ subpart E of part 807 of this chapter, or killing viruses, bacteria, or fungi, or subject to the limitations in § 878.9. affecting allergenicity, or it contains coating technologies unrelated to fil- [53 FR 23872, June 24, 1988, as amended at 54 tration (e.g., to reduce and or kill FR 13827, Apr. 5, 1989; 66 FR 38802, July 25, microorganisms). Surgical N95 res- 2001] pirators and N95 filtering facepiece res- § 878.4165 Wound autofluorescence im- pirators are exempt from the pre- aging device. market notification procedures in sub- part E of part 807 of this chapter sub- (a) Identification. A wound ject to § 878.9, and the following condi- autofluorescence imaging device is a tions for exemption: tool to view autofluorescence images (i) The user contacting components from skin wounds that are exposed to of the device must be demonstrated to an excitation light. The device is not be biocompatible. intended to provide quantitative or di- (ii) Analysis and nonclinical testing agnostic information. must: (b) Classification. Class I (general con- (A) Characterize flammability and be trols). The device is exempt from the demonstrated to be appropriate for the premarket notification procedures in intended environment of use; and subpart E of part 807 of this chapter, (B) Demonstrate the ability of the subject to the limitations in § 878.9. device to resist penetration by fluids, [83 FR 52968, Oct. 19, 2018] such as blood and body fluids, at a ve- locity consistent with the intended use § 878.4200 Introduction/drainage cath- of the device. eter and accessories. (iii) NIOSH approved under its regu- (a) Identification. An introduction/ lation. drainage catheter is a device that is a (2) Class I (general controls) for sur- flexible single or multilumen tube in- gical apparel other than surgical gowns tended to be used to introduce nondrug and surgical masks. The class I device fluids into body cavities other than is exempt from the premarket notifica- blood vessels, drain fluids from body tion procedures in subpart E of part 807 cavities, or evaluate certain physio- of this chapter subject to § 878.9. logic conditions. Examples include irri- [53 FR 23872, June 24, 1988, as amended at 65 gation and drainage catheters, pedi- FR 2317, Jan. 14, 2000; 83 FR 22848, May 17, atric catheters, peritoneal catheters 2018] (including dialysis), and other general

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surgical catheters. An introduction/ with a liquid nitrogen cooled cryoprobe drainage catheter accessory is intended and accessories is a device intended to to aid in the manipulation of or inser- destroy tissue during surgical proce- tion of the device into the body. Exam- dures by applying extreme cold. ples of accessories include adaptors, (2) Cryosurgical unit with a nitrous connectors, and catheter needles. oxide cooled cryoprobe and accessories. A (b) Classification. Class I (general con- cryosurgical unit with a nitrous oxide trols). The device is exempt from the cooled cryoprobe and accessories is a premarket notification procedures in device intended to destroy tissue dur- subpart E of part 807 of this chapter ing surgical procedures, including subject to § 878.9. urological applications, by applying ex- [53 FR 23872, June 24, 1988, as amended at 65 treme cold. FR 2318, Jan. 14, 2000] (3) Cryosurgical unit with a carbon di- oxide cooled cryoprobe or a carbon dioxide § 878.4300 Implantable clip. dry ice applicator and accessories. A (a) Identification. An implantable clip cryosurgical unit with a carbon dioxide is a clip-like device intended to con- cooled cryoprobe or a carbon dioxide nect internal tissues to aid healing. It dry ice applicator and accessories is a is not absorbable. device intended to destroy tissue dur- (b) Classification. Class II. ing surgical procedures by applying ex- treme cold. The device is intended to § 878.4320 Removable skin clip. treat disease conditions such as tu- (a) Identification. A removable skin mors, skin cancers, acne scars, or clip is a clip-like device intended to hemangiomas (benign tumors con- connect skin tissues temporarily to aid sisting of newly formed blood vessels) healing. It is not absorbable. and various benign or malignant gyne- (b) Classification. Class I (general con- cological conditions affecting vulvar, trols). The device is exempt from the vaginal, or cervical tissue. The device premarket notification procedures in is not intended for urological applica- subpart E of part 807 of this chapter tions. subject to § 878.9. (b) Classification. Class II. [53 FR 23872, June 24, 1988, as amended at 65 FR 2318, Jan. 14, 2000] § 878.4360 Scalp cooling system to re- duce the likelihood of chemo- § 878.4340 Contact cooling system for therapy-induced alopecia. aesthetic use. (a) Identification. A scalp cooling sys- (a) Identification. A contact cooling tem to reduce the likelihood of chemo- system for aesthetic use is a device therapy-induced alopecia is a prescrip- that is a combination of a cooling pad tion device intended to reduce the fre- associated with a vacuum or mechan- quency and severity of alopecia during ical massager intended for the disrup- chemotherapy in which alopecia-induc- tion of adipocyte cells intended for ing chemotherapeutic agents are used. non-invasive aesthetic use. (b) Classification—Class II (special (b) Classification. Class II (special controls). The special controls for this controls). The special controls for this device are: device is FDA’s ‘‘Guidance for Industry (1) Non-clinical performance testing and FDA Staff; Class II Special Con- must demonstrate that the device trols Guidance Document: Contact meets all design specifications and per- Cooling System for Aesthetic Use.’’ See formance requirements, and that the § 878.1(e) for the availability of this device performs as intended under an- guidance document. ticipated conditions of use. This infor- [76 FR 6553, Feb. 7, 2011] mation must include testing to dem- onstrate accuracy of the temperature § 878.4350 Cryosurgical unit and acces- control mechanism. sories. (2) Performance testing must dem- (a) Identification—(1) Cryosurgical unit onstrate the electromagnetic compat- with a liquid nitrogen cooled cryoprobe ibility and electrical safety of the de- and accessories. A cryosurgical unit vice.

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(3) Software verification, validation, to cover its exposed edges, and a latex and hazard analysis must be performed. drape with a self-retaining finger cot (4) The patient contacting compo- that is intended to allow repeated in- nents of the device must be dem- sertion of the surgeon’s finger into the onstrated to be biocompatible. Mate- rectum during performance of a rial names must be provided. transurethral prostatectomy. (5) Labeling must include the fol- (b) Classification. Class II (special lowing: controls). The device, when it is an ear, (i) A statement describing the poten- nose, and throat surgical drape, a latex tial risk of developing scalp metas- sheet drape with self-retaining finger tasis. cot, a disposable urological drape, a (ii) Information on the patient popu- Kelly pad, an ophthalmic patient lation and chemotherapeutic agents/ drape, an ophthalmic microscope regimen for which the device has been drape, an internal drape retention ring demonstrated to be effective. (wound protector), or a surgical drape (iii) A summary of the non-clinical that does not include an antimicrobial and/or clinical testing pertinent to use agent, is exempt from the premarket of the device. notification procedures in subpart E of (iv) A summary of the device tech- part 807 of this chapter subject to the nical parameters, including tempera- limitations in § 878.9. ture cooling range and duration of [53 FR 23872, June 24, 1988, as amended at 84 cooling. FR 71814, Dec. 30, 2019] (v) A summary of the device- and pro- cedure-related adverse events pertinent § 878.4371 Irrigating wound retractor to use of the device. device. (vi) Information on how the device (a) Identification. An irrigating wound operates and the typical course of retractor device is a prescription de- treatment. vice intended to be used by a surgeon (6) Patient labeling must be provided to retract the surgical incision, to pro- and must include: vide access to the surgical wound, to (i) Relevant contraindications, warn- protect and irrigate the surgical ings, precautions, and adverse effects/ wound, and to serve as a conduit for re- complications. moval of fluid from the surgical wound. (ii) Information on how the device (b) Classification. Class II (special operates and the typical course of controls). The special controls for this treatment. device are: (iii) Information on the patient popu- (1) The patient-contacting compo- lation for which there is clinical evi- nents of the device must be dem- dence of effectiveness. onstrated to be biocompatible and (iv) The potential risks and benefits evaluated for particulate matter. associated with use of the device. (2) Performance data must dem- (v) Postoperative care instructions. onstrate the sterility and pyrogenicity (vi) A statement describing the po- of the patient-contacting components tential risk of developing scalp metas- of the device. tasis. (3) Performance data must support [81 FR 7453, Feb. 12, 2016] shelf life by demonstrating continued functionality and sterility of the de- § 878.4370 Surgical drape and drape vice over the identified shelf life. accessories. (4) Non-clinical performance testing (a) Identification. A surgical drape must demonstrate that the device per- and drape accessories is a device made forms as intended under anticipated of natural or synthetic materials in- conditions of use. Performance testing tended to be used as a protective pa- must: tient covering, such as to isolate a site (i) Characterize the tear resistance, of surgical incision from microbial and tensile strength, and elongation prop- other contamination. The device in- erties of the barrier material; cludes a plastic wound protector that (ii) Demonstrate that the liquid bar- may adhere to the skin around a sur- rier material is resistant to penetra- gical incision or be placed in a wound tion by blood, and is non-flammable;

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(iii) Characterize the forces required (b) Classification. Class II (special to deploy the device; controls). The special control is FDA’s (iv) Characterize the device’s ranges guidance document entitled ‘‘Class II of operation, including flow rates and Special Controls Guidance Document: maximum suction pressures; Low Energy Ultrasound Wound Clean- (v) Demonstrate the ability of the de- er.’’ See § 878.1(e) for the availability of vice irrigation apparatus to maintain a this guidance document. user defined or preset flow rate to the [70 FR 67355, Nov. 7, 2005] surgical wound; and (vi) Demonstrate the ability of the § 878.4420 Electrosurgical device for device to maintain user defined or pre- over-the-counter aesthetic use. set removal rates of fluid from the sur- (a) Identification. An electrosurgical gical wound. device for over-the-counter aesthetic (5) The labeling must include or state use is a device using radiofrequency en- the following information: ergy to produce localized heating with- (i) Device size or incision length in tissues for non-invasive aesthetic range; use. (ii) Method of sterilization; (b) Classification. Class II (special (iii) Flammability classification; controls). The special controls for this (iv) Non-pyrogenic; device are: (v) Shelf life; and (1) Non-clinical performance data (vi) Maximum flow rate and suction must demonstrate that the device pressure. meets all design specifications and per- formance requirements. The following [83 FR 24, Jan. 2, 2018] performance characteristics must be § 878.4380 Drape adhesive. tested: Over-heating, power accuracy radiofrequency, pulse cycle, waveform, (a) Identification. A drape adhesive is pulse duration, and device character- a device intended to be placed on the ization parameters. skin to attach a surgical drape. (2) Label comprehension and self-se- (b) Classification. Class I (general con- lection performance evaluation must trols). The device is exempt from the demonstrate that the intended over- premarket notification procedures in the-counter users can understand the subpart E of part 807 of this chapter, package labeling and correctly choose subject to the limitations in § 878.9. the device for the indicated aesthetic [53 FR 23872, June 24, 1988, as amended at 59 use. FR 63010, Dec. 7, 1994; 66 FR 38802, July 25, (3) Usability performance evaluation 2001] must demonstrate that the over-the- counter user can correctly use the de- § 878.4400 Electrosurgical cutting and vice, based solely on reading the direc- coagulation device and accessories. tions for use, to treat the indicated (a) Identification. An electrosurgical aesthetic use. cutting and coagulation device and ac- (4) Clinical performance evaluation cessories is a device intended to re- must demonstrate that the device per- move tissue and control bleeding by forms as intended under anticipated use of high-frequency electrical cur- conditions of use to achieve the in- rent. tended aesthetic results. (b) Classification. Class II. (5) The patient-contacting compo- nents of the device must be dem- § 878.4410 Low energy ultrasound onstrated to be biocompatible. wound cleaner. (6) Instructions for cleaning the de- (a) Identification. A low energy vice must be validated. ultrasound wound cleaner is a device (7) Performance data must be pro- that uses ultrasound energy to vapor- vided to demonstrate the electro- ize a solution and generate a mist that magnetic compatibility and electrical is used for the cleaning and mainte- safety, including the mechanical integ- nance debridement of wounds. Low lev- rity, of the device. els of ultrasound energy may be carried (8) Software verification, validation, to the wound by the saline mist. and hazard analysis must be performed.

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(9) Labeling must include: (5) Performance data must dem- (i) Warnings, precautions, and con- onstrate the electrical safety and elec- traindications to ensure the safe use of tromagnetic compatibility (EMC) of all the device for the over-the-counter electrical components of the device. users. (6) Software verification, validation, (ii) A statement that the safety and and hazard analysis must be performed effectiveness of the device’s use for for all software components of the de- uses other than the indicated aesthetic vice. use are not known. (7) The patient-contacting compo- (iii) A summary of the clinical infor- nents of the device must be dem- mation used to establish effectiveness onstrated to be biocompatible. for each indicated aesthetic usage and (8) Performance data must validate observed adverse events. the cleaning and disinfection instruc- tions for reusable components of the [81 FR 42244, June 29, 2016] device. (9) Labeling must include the fol- § 878.4430 Microneedling device for lowing: aesthetic use. (i) Information on how to operate the (a) Identification. A microneedling de- device and its components and the typ- vice for aesthetic use is a device using ical course of treatment; one or more needles to mechanically (ii) A summary of the device tech- puncture and injure skin tissue for aes- nical parameters, including needle thetic use. This classification does not length, needle geometry, maximum include devices intended for penetration depth, and puncture rate; transdermal delivery of topical prod- (iii) Validated methods and instruc- ucts such as cosmetics, drugs, or bio- tions for reprocessing of any reusable logics. components; (b) Classification. Class II (special (iv) Disposal instructions; and controls). The special controls for this (v) A shelf life. device are: (10) Patient labeling must be pro- (1) The technical specifications and vided and must include: needle characteristics must be identi- (i) Information on how the device op- fied, including needle length, geom- erates and the typical course of treat- etry, maximum penetration depth, and ment; puncture rate. (ii) The probable risks and benefits (2) Non-clinical performance data associated with use of the device; and must demonstrate that the device per- (iii) Postoperative care instructions. forms as intended under anticipated [83 FR 26577, June 8, 2018] conditions of use. The following per- formance characteristics must be test- § 878.4440 Eye pad. ed: (a) Identification. An eye pad is a de- (i) Accuracy of needle penetration vice that consists of a pad made of var- depth and puncture rate; ious materials, such as gauze and cot- (ii) Safety features built into the de- ton, intended for use as a bandage over vice to protect against cross-contami- the eye for protection or absorption of nation, including fluid ingress protec- secretions. tion; and (b) Classification. Class I (general con- (iii) Identification of the maximum trols). The device is exempt from the safe needle penetration depth for the premarket notification procedures in device for the labeled indications for subpart E of part 807 of this chapter, use. subject to the limitations in § 878.9. (3) Performance data must dem- [53 FR 23872, June 24, 1988, as amended at 59 onstrate the sterility of the patient- FR 63010, Dec. 7, 1994; 66 FR 38803, July 25, contacting components of the device. 2001] (4) Performance data must support the shelf life of the device by dem- § 878.4450 Nonabsorbable gauze for in- onstrating continued sterility, package ternal use. integrity, and device functionality (a) Identification. Nonabsorbable over the intended shelf life. gauze for internal use is a device made

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of an open mesh fabric intended to be safety under anticipated conditions of used inside the body or a surgical inci- use. Assessments must include the fol- sion or applied to internal organs or lowing: structures, to control bleeding, absorb (i) Material specifications. fluid, or protect organs or structures (ii) Immunogenicity. from abrasion, drying, or contamina- (iii) Viral inactivation for animal-de- tion. The device is woven from mate- rived materials. rial made of not less than 50 percent by (5) Non-clinical performance data mass cotton, cellulose, or a simple must demonstrate that the device per- chemical derivative of cellulose, and forms as intended under anticipated contains x-ray detectable elements. conditions of use. The following per- (b) Classification. Class I (general con- formance characteristics must be test- trols). The device is exempt from the ed: premarket notification procedures in (i) Absorption capacity. subpart E of part 807 of this chapter, (ii) Extent of swelling. subject to the limitations in § 878.9. (iii) Mechanical properties. [53 FR 23872, June 24, 1988, as amended at 61 (iv) Expansion force/pressure. FR 1123, Jan. 16, 1996; 66 FR 38803, July 25, (v) Radiopacity. 2001] (vi) Deployment/applicator functionality. § 878.4452 Nonabsorbable expandable hemostatic sponge for temporary (6) In vivo performance data must internal use. demonstrate safe and effective use by verifying that the device performs as (a) Identification. A nonabsorbable ex- intended under anticipated conditions pandable hemostatic sponge for tem- of use. Appropriate analysis/testing porary internal use is a prescription must demonstrate that the product: device intended to be placed tempo- Controls bleeding, does not promote rarily into junctional, non-compress- adverse local or systemic effects, and ible wounds, which are not amenable to can be completely removed from the tourniquet use, to control bleeding wound. The following performance until surgical care is acquired. The characteristics must be tested: sponges expand upon contact with (i) Deployment. blood to fill the wound cavity and pro- (ii) Control of bleeding. vide a physical barrier and pressure that facilitates formation of a clot. (iii) Radiopacity. The device consists of sterile, non- (iv) Retrieval. absorbable radiopaque compressed (v) Assessment of local and systemic sponges and may include an applicator effects. to facilitate delivery into a wound. (7) Human factors testing and anal- (b) Classification. Class II (special ysis must validate that the device de- controls). The special controls for this sign and labeling are sufficient for ap- device are: propriate use by emergency responders (1) Performance data must dem- deploying the device as well as sur- onstrate the biocompatibility of pa- geons retrieving the device from tient-contacting components. wounds. (2) Performance data must dem- (8) Labeling must include: onstrate the sterility of patient-con- (i) Specific instructions for deploy- tacting components including ment by emergency responders and re- endotoxin and pyrogenicity assess- trieval by surgeons. ments. (ii) Warnings, cautions, and limita- (3) Performance data must support tions needed for safe use of the device. device stability by demonstrating con- (iii) Information on how the device tinued sterility of the patient-con- operates and the typical course of tacting components of the device, treatment. package integrity, and device (iv) A detailed summary of the in functionality over the requested shelf vivo and human factors testing perti- life. nent to use of the device. (4) Assessment of material character- (v) Appropriate imaging information istics must be sufficient to support to ensure complete retrieval of device.

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(vi) An expiration date/shelf life. (i) Instructions for use, including an instruction to remove all visible device [79 FR 34224, June 16, 2014] components by irrigation; (ii) The maximum amount of time § 878.4454 Non-absorbable, hemostatic gauze for temporary internal use. the device may be left within the body; (iii) A shelf life; (a) Identification. A non-absorbable, (iv) A contraindication for hemostatic gauze for temporary inter- intravascular use of the device; and nal use is a prescription device in- (v) A warning regarding the potential tended to be placed temporarily for for adhesion formation. control of severely bleeding wounds such as surgical wounds and traumatic [83 FR 6794, Feb. 15, 2018] injuries. The gauze is coated or impreg- § 878.4456 Hemostatic device for nated with a hemostatic material intraluminal gastrointestinal use. which may enhance hemostasis by (a) Identification. A hemostatic device physical means. The device is intended for intraluminal gastrointestinal use is to be removed once the patient is sta- a prescription device that is bilized. endoscopically applied to the upper (b) Classification. Class II (special and/or lower gastrointestinal tract and controls). The special controls for this is intended to produce hemostasis via device are: absorption of fluid or by other physical (1) Animal performance testing must means. demonstrate that the device performs (b) Classification. Class II (special as intended under anticipated condi- controls). The special controls for this tions of use. Specifically testing must: device are: (i) Demonstrate that the device is (1) The device must be demonstrated able to achieve hemostasis; to be biocompatible. (ii) Demonstrate that the device can (2) Performance data must support be radiographically detected; and the sterility and pyrogenicity of the (iii) Assess pertinent safety device. endpoints including vascular obstruc- (3) Performance data must support tion and adhesion formation. the shelf life of the device by dem- (2) The device must be demonstrated onstrating continued sterility, package to be biocompatible. integrity, and device functionality (3) Non-clinical performance data over the identified shelf life. must demonstrate that the device per- (4) In vivo performance testing must forms as intended under anticipated demonstrate that the device performs conditions of use. The following tests as intended under anticipated condi- must be performed: tions of use. The testing must evaluate (i) In vitro clot assessment; the following: (ii) Particulate release testing; (i) The ability to deliver the hemo- (iii) Physical characterization, in- static material to the bleeding site; (ii) The ability to achieve hemostasis cluding swelling percent and particu- in a clinically relevant model of gas- late size; trointestinal bleeding; and (iv) Chemical characterization; (iii) Safety endpoints, including (v) Radiopacity testing; and thromboembolic events, local and sys- (vi) Mechanical integrity testing, in- temic toxicity, tissue trauma, gastro- cluding tensile strength and tear intestinal tract obstruction, and bowel strength. distension and perforation. (4) Performance data must dem- (5) Non-clinical performance testing onstrate the sterility of the device. must demonstrate that the device per- (5) Performance data must support forms as intended under anticipated the shelf life of the device by dem- conditions of use. The following per- onstrating continued sterility, package formance characteristics must be eval- integrity, and device functionality uated: over the identified shelf life. (i) Materials characterization of all (6) Labeling must include the fol- components must demonstrate the de- lowing: vice meets established specifications,

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which must include compositional (c) Date PMA or notice of completion of identity and purity, characterization of a PDP is required. As of May 28, 1976, an impurities, physical characteristics, approval under section 515 of the act is and reactivity with fluids. required before this device may be (ii) Performance testing must dem- commercially distributed. See § 878.3. onstrate the mechanical integrity and functionality of the system used to de- § 878.4493 Absorbable poly(glycolide/l- liver the device and demonstrate the lactide) surgical suture. device meets established specifications, (a) Identification. An absorbable including output pressure for propel- poly(glycolide/l-lactide) surgical suture lant-based systems. (PGL suture) is an absorbable sterile, (6) Labeling must include: flexible strand as prepared and syn- (i) Information identifying and ex- plaining how to use the device and its thesized from homopolymers of components; and glycolide and copolymers made from 90 (ii) A shelf life. percent glycolide and 10 percent l- lactide, and is indicated for use in soft [83 FR 52971, Oct. 19, 2018] tissue approximation. A PGL suture meets United States Pharmacopeia § 878.4460 Non-powdered surgeon’s glove. (U.S.P.) requirements as described in the U.S.P. ‘‘Monograph for Absorbable (a) Identification. A non-powdered sur- Surgical Sutures;’’ it may be geon’s glove is a device intended to be monofilament or multifilament (braid- worn on the hands of operating room personnel to protect a surgical wound ed) in form; it may be uncoated or from contamination. A non-powdered coated; and it may be undyed or dyed surgeon’s glove does not incorporate with an FDA-approved color additive. powder for purposes other than manu- Also, the suture may be provided with facturing. The final finished glove in- or without a standard needle attached. cludes only residual powder from man- (b) Classification. Class II (special ufacturing. controls). The special control for this (b) Classification. Class I (general con- device is FDA’s ‘‘Class II Special Con- trols). trols Guidance Document: Surgical Su- tures; Guidance for Industry and [53 FR 23872, June 24, 1988, as amended at 66 FR 46952, Sept. 10, 2001; 81 FR 91730, Dec. 19, FDA.’’ See § 878.1(e) for the availability 2016] of this guidance document.

§ 878.4470 Surgeon’s gloving cream. [56 FR 47151, Sept. 18, 1991, as amended at 68 FR 32984, June 3, 2003] (a) Identification. Surgeon’s gloving cream is an ointment intended to be § 878.4494 Absorbable used to lubricate the user’s hand before poly(hydroxybutyrate) surgical su- putting on a surgeon’s glove. ture produced by recombinant DNA (b) Classification. Class I (general con- technology. trols). The device is exempt from the (a) Identification. An absorbable premarket notification procedures in poly(hydroxybutyrate) surgical suture subpart E of part 807 of this chapter, is an absorbable surgical suture made subject to the limitations in § 878.9. of material isolated from prokaryotic [53 FR 23872, June 24, 1988, as amended at 59 cells produced by recombinant FR 63010, Dec. 7, 1994; 66 FR 38803, July 25, deoxyribonucleic acid (DNA) tech- 2001] nology. The device is intended for use § 878.4490 Absorbable hemostatic in general soft tissue approximation agent and dressing. and ligation. (b) Classification. Class II (special (a) Identification. An absorbable he- mostatic agent or dressing is a device controls). The special control for this intended to produce hemostasis by ac- device is the FDA guidance document celerating the clotting process of entitled ‘‘Class II Special Controls blood. It is absorbable. Guidance Document: Absorbable (b) Classification. Class III. Poly(hydroxybutyrate) Surgical Suture

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Produced by Recombinant DNA Tech- mounted surgical light, a surgical light nology.’’ For the availability of this carrier, surgical light accessories, a guidance document see § 878.1(e). surgical lamp, a remote illuminator, or an incandescent surgical lamp, is ex- [72 FR 43146, Aug. 3, 2007] empt from the premarket notification § 878.4495 Stainless steel suture. procedures in subpart E of part 807 of this chapter subject to the limitations (a) Identification. A stainless steel su- in § 878.9. ture is a needled or unneedled non- absorbable surgical suture composed of [53 FR 23872, June 24, 1988, as amended at 84 316L stainless steel, in USP sizes 12–0 FR 71814, Dec. 30, 2019] through 10, or a substantially equiva- lent stainless steel suture, intended for § 878.4590 Focused ultrasound stimu- lator system for aesthetic use. use in abdominal wound closure, intes- tinal anastomosis, hernia repair, and (a) Identification. A Focused sternal closure. Ultrasound Stimulator System for Aes- (b) Classification. Class II (special thetic Use is a device using focused controls). The device, when it is a steel ultrasound to produce localized, me- monofilament suture that is uncoated chanical motion within tissues and and does not incorporate barbs, is ex- cells for the purpose of producing ei- empt from the premarket notification ther localized heating for tissue coagu- procedures in subpart E of part 807 of lation or for mechanical cellular mem- this chapter subject to the limitations brane disruption intended for in § 878.9. The special control for this noninvasive aesthetic use. device is FDA’s ‘‘Class II Special Con- (b) Classification. Class II (special trols Guidance Document: Surgical Su- controls). The special control for this tures; Guidance for Industry and device is FDA’s ‘‘Class II Special Con- FDA.’’ See § 878.1(e) for the availability trols Guidance Document: Focused of this guidance document. Ultrasound Stimulator System for Aes- thetic Use.’’ See § 878.1(e) for the avail- [65 FR 19836, Apr. 13, 2000, as amended at 68 ability of this guidance document. FR 32984, June 3, 2003; 84 FR 71814, Dec. 30, 2019] [76 FR 43121, July 20, 2011]

§ 878.4520 Polytetrafluoroethylene § 878.4630 Ultraviolet lamp for der- injectable. matologic disorders. (a) Identification. Polytetrafluoro- (a) Identification. An ultraviolet lamp ethylene injectable is an injectable for dermatologic disorders is a device paste prosthetic device composed of (including a fixture) intended to pro- polytetrafluoroethylene intended to be vide ultraviolet radiation of the body used to augment or reconstruct a vocal to photoactivate a drug in the treat- cord. ment of a dermatologic disorder if the (b) Classification. Class III. labeling of the drug intended for use (c) Date PMA or notice of completion of with the device bears adequate direc- a PDP is required. As of May 28, 1976, an tions for the device’s use with that approval under section 515 of the act is drug. required before this device may be (b) Classification. Class II. commercially distributed. See § 878.3. § 878.4635 Sunlamp products and ul- § 878.4580 Surgical lamp. traviolet lamps intended for use in (a) Identification. A surgical lamp (in- sunlamp products. cluding a fixture) is a device intended (a) Identification. A sunlamp product to be used to provide visible illumina- is any device designed to incorporate tion of the surgical field or the patient. one or more ultraviolet (UV) lamps in- (b) Classification. Class II (special tended for irradiation of any part of controls). The device, when it is an op- the living human body, by UV radi- erating room lamp, a surgical instru- ation with wavelengths in air between ment light, a surgical floor standing 200 and 400 nanometers, to induce skin light, an endoscopic surgical light, a tanning. This definition includes tan- surgical light connector, a ceiling ning beds and tanning booths. A UV

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lamp intended for use in sunlamp prod- (ii) Sunlamp products and UV lamps in- ucts is any lamp that produces UV ra- tended for use in sunlamp products. Man- diation in the wavelength interval of ufacturers of sunlamp products and UV 200 to 400 nanometers in air. lamps intended for use in sunlamp (b) Classification. Class II (special products shall provide or cause to be controls). The special controls for sun- provided in the user instructions, as lamp products and UV lamps intended well as all consumer-directed catalogs, for use in sunlamp products are: specification sheets, descriptive bro- (1) Conduct performance testing that chures, and Web pages in which sun- demonstrates the following: lamp products or UV lamps intended (i) Device meets appropriate output for use in sunlamp products are offered performance specifications such as for sale, the following contraindication wavelengths, energy density, and lamp and warning statements: life; and (A) ‘‘Contraindication: This product (ii) Device’s safety features, such as is contraindicated for use on persons timers to limit UV exposure and under the age of 18 years.’’ alarms, function properly. (B) ‘‘Contraindication: This product (2) Demonstrate that device is me- must not be used if skin lesions or open chanically safe to prevent user injury. (3) Demonstrate software wounds are present.’’ verification, validation, and hazard (C) ‘‘Warning: This product should analysis. not be used on individuals who have (4) Demonstrate that device is bio- had skin cancer or have a family his- compatible. tory of skin cancer.’’ (5) Demonstrate that device is elec- (D) ‘‘Warning: Persons repeatedly ex- trically safe and electromagnetically posed to UV radiation should be regu- compatible in its intended use environ- larly evaluated for skin cancer.’’ ment. (c) Performance standard. Sunlamp (6) Labeling—(i) Sunlamp products. (A) products and UV lamps intended for The warning statement below must ap- use in sunlamp products are subject to pear on all sunlamp products and must the electronic product performance be placed in a black box. This state- standard at § 1040.20 of this chapter. ment must be permanently affixed or inscribed on the product when fully as- [79 FR 31213, June 2, 2014] sembled for use so as to be legible and § 878.4660 Skin marker. readily accessible to view by the person who will be exposed to UV radiation (a) Identification. A skin marker is a immediately before the use of the prod- pen-like device intended to be used to uct. It shall be of sufficient durability write on the patient’s skin, e.g., to out- to remain legible throughout the ex- line surgical incision sites or mark an- pected lifetime of the product. It shall atomical sites for accurate blood pres- appear on a part or panel displayed sure measurement. prominently under normal conditions (b) Classification. Class I (general con- of use so that it is readily accessible to trols). The device is exempt from the view whether the tanning bed canopy premarket notification procedures in (or tanning booth door) is open or subpart E of part 807 of this chapter, closed when the person who will be ex- subject to the limitations in § 878.9. posed approaches the equipment and the text shall be at least 10 millimeters [53 FR 23872, June 24, 1988, as amended at 59 (height). Labeling on the device must FR 63010, Dec. 7, 1994; 66 FR 38803, July 25, 2001] include the following statement: § 878.4670 Internal tissue marker. Attention: This sunlamp product should not be used on persons under the age of 18 years. (a) Identification. An internal tissue marker is a prescription use device (B) Manufacturers shall provide vali- that is intended for use prior to or dur- dated instructions on cleaning and dis- ing general surgical procedures to de- infection of sunlamp products between marcate selected sites on internal tis- uses in the user instructions. sues.

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(b) Classification. Class II (special device is FDA’s ‘‘Class II Special Con- controls). The special controls for this trols Guidance Document: Non-powered device are: Suction Apparatus Device Intended for (1) The device must be demonstrated Negative Pressure Wound Therapy to be biocompatible. Material names (NPWT).’’ See § 878.1(e) for the avail- and specific designation numbers must ability of this guidance document. be provided. (2) Performance testing must dem- [75 FR 70114, Nov. 17, 2010] onstrate that the device performs as § 878.4685 Extracorporeal shock wave intended to mark the tissue for which device for treatment of chronic it is indicated. wounds. (3) Performance data must dem- (a) Identification. An extracorporeal onstrate the sterility of the device. shock wave device for treatment of (4) Performance data must support chronic wounds is a prescription device the shelf life of the device by dem- that focuses acoustic shock waves onto onstrating sterility, package integrity, the dermal tissue. The shock waves are device functionality, and material sta- generated inside the device and trans- bility over the requested shelf life. ferred to the body using an acoustic (5) Labeling must include: interface. (i) A warning that the device must (b) Classification. Class II (special not be used on a non-sterile surface controls). The special controls for this prior to use internally. (ii) An expiration date/shelf life. device are: (iii) Single use only labeling must be (1) Non-clinical performance testing labeled directly on the device. must be conducted to demonstrate that the system produces anticipated and [80 FR 46486, Aug. 5, 2015] reproducible acoustic pressure shock waves. § 878.4680 Nonpowered, single patient, (2) The patient-contacting compo- portable suction apparatus. nents of the device must be dem- (a) Identification. A nonpowered, sin- onstrated to be biocompatible. gle patient, portable suction apparatus (3) Performance data must dem- is a device that consists of a manually onstrate that the reusable components operated plastic, disposable evacuation of the device can be reprocessed for system intended to provide a vacuum subsequent use. for suction drainage of surgical (4) Performance data must be pro- wounds. vided to demonstrate the electro- (b) Classification. Class I (general con- magnetic compatibility and electrical trols). The device is exempt from the safety of the device. premarket notification procedures in (5) Software verification, validation, subpart E of part 807 of this chapter and hazard analysis must be performed. subject to § 878.9. (6) Performance data must support [53 FR 23872, June 24, 1988, as amended at 65 the use life of the system by dem- FR 2318, Jan. 14, 2000] onstrating continued system functionality over the labeled use life. § 878.4683 Non-Powered suction appa- (7) Physician labeling must include: ratus device intended for negative (i) Information on how the device op- pressure wound therapy. erates and the typical course of treat- (a) Identification. A non-powered suc- ment; tion apparatus device intended for neg- (ii) A detailed summary of the de- ative pressure wound therapy is a de- vice’s technical parameters; vice that is indicated for wound man- (iii) Validated methods and instruc- agement via application of negative tions for reprocessing of any reusable pressure to the wound for removal of components; and fluids, including wound exudate, irriga- (iv) Instructions for preventing hear- tion fluids, and infectious materials. It ing loss by use of hearing protection. is further indicated for management of (8) Patient labeling must include: wounds, burns, flaps, and grafts. (i) Relevant contraindications, warn- (b) Classification. Class II (special ings, precautions, adverse effects, and controls). The special control for this complications;

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(ii) Information on how the device ization during surgical resection and operates and the typical course of closure of pleural punctures associated treatment; with percutaneous, transthoracic nee- (iii) The probable risks and benefits dle lung biopsies. Upon deployment associated with the use of the device; into the biopsy tract, the plug expands (iv) Post-procedure care instructions; to fill the biopsy void and remains in and place until resorbed. (v) Alternative treatments. (b) Classification. Class II (special controls). The special controls for this [83 FR 9699, Mar. 7, 2018] device are: § 878.4700 Surgical microscope and ac- (1) The design characteristics of the cessories. device must ensure that the geometry (a) Identification. A surgical micro- and material composition are con- scope and accessories is an AC-powered sistent with the intended use. device intended for use during surgery (2) Performance testing must dem- to provide a magnified view of the sur- onstrate deployment as indicated in gical field. the accompanying labeling, including (b) Classification. Class I (general con- the indicated introducer needles, and trols). The device is exempt from the demonstrate expansion and resorption premarket notification procedures in characteristics in a clinically relevant subpart E of part 807 of this chapter, environment. subject to the limitations in § 878.9. (3) In vivo evaluation must dem- onstrate performance characteristics [55 FR 48440, Nov. 20, 1990, as amended at 59 of the device, including the ability of FR 63010, Dec. 7, 1994; 66 FR 38803, July 25, the plug to not prematurely resorb or 2001] migrate and the rate of pneumothorax. § 878.4730 Surgical skin degreaser or (4) Sterility testing must dem- adhesive tape solvent. onstrate the sterility of the device and the effects of the sterilization process (a) Identification. A surgical skin on the physical characteristics of the degreaser or an adhesive tape solvent is plug. a device that consists of a liquid such (5) Shelf-life testing must dem- as 1,1,2-trichloro-1,2,2-trifluoroethane; onstrate the shelf-life of the device in- 1,1,1-trichloroethane; and 1,1,1-tri- cluding the physical characteristics of chloroethane with mineral spirits in- the plug. tended to be used to dissolve surface (6) The device must be demonstrated skin oil or adhesive tape. to be biocompatible. (b) Classification. Class I (general con- (7) Labeling must include a detailed trols). The device is exempt from the summary of the device-related and pro- premarket notification procedures in cedure-related complications pertinent subpart E of part 807 of this chapter, to the use of the device and appropriate subject to the limitations in § 878.9. warnings. Labeling must include iden- [53 FR 23872, June 24, 1988, as amended at 59 tification of compatible introducer FR 63010, Dec. 7, 1994; 66 FR 38803, July 25, needles. 2001] [79 FR 13219, Mar. 10, 2014] § 878.4750 Implantable staple. § 878.4760 Removable skin staple. (a) Identification. An implantable sta- ple is a staple-like device intended to (a) Identification. A removable skin connect internal tissues to aid healing. staple is a staple-like device intended It is not absorbable. to connect external tissues temporarily (b) Classification. Class II. to aid healing. It is not absorbable. (b) Classification. Class I (general con- § 878.4755 Absorbable lung biopsy trols). The device is exempt from the plug. premarket notification procedures in (a) Identification. A preformed (po- subpart E of part 807 of this chapter lymerized) absorbable lung biopsy plug subject to § 878.9. is intended to provide accuracy in [53 FR 23872, June 24, 1988, as amended at 65 marking a biopsy location for visual- FR 2318, Jan. 14, 2000]

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§ 878.4780 Powered suction pump. § 878.4800 Manual surgical instrument (a) Identification. A powered suction for general use. pump is a portable, AC-powered or (a) Identification. A manual surgical compressed air-powered device in- instrument for general use is a non- tended to be used to remove infectious powered, hand-held, or hand-manipu- materials from wounds or fluids from a lated device, either reusable or dispos- patient’s airway or respiratory support able, intended to be used in various system. The device may be used during general surgical procedures. The device surgery in the operating room or at the includes the applicator, clip applier, bi- patient’s bedside. The device may in- opsy brush, manual dermabrasion clude a microbial filter. brush, scrub brush, cannula, ligature (b) Classification. Class II. carrier, chisel, clamp, contractor, cu- rette, cutter, dissector, elevator, skin § 878.4790 Powered surgical instru- graft expander, file, forceps, gouge, in- ment for improvement in the ap- strument guide, needle guide, hammer, pearance of cellulite. hemostat, amputation hook, ligature (a) Identification. A powered surgical passing and knot-tying instrument, instrument for improvement in the ap- knife, blood lancet, mallet, disposable pearance of cellulite is a prescription or reusable aspiration and injection device that is used for the controlled needle, disposable or reusable suturing release of subcutaneous tissue for im- needle, osteotome, pliers, rasp, re- provement in the appearance of tainer, retractor, saw, scalpel blade, cellulite. The device consists of a cut- scalpel handle, one-piece scalpel, snare, ting tool powered by a motor and a spatula, stapler, disposable or reusable means for instrument guidance to con- stripper, stylet, suturing apparatus for trol the areas of subcutaneous tissue the stomach and intestine, measuring cutting underneath the cellulite de- tape, and calipers. A surgical instru- pressions or dimples. ment that has specialized uses in a spe- (b) Classification. Class II (special cific medical specialty is classified in controls). The special controls for this separate regulations in parts 868 device are: through 892. (1) Non-clinical testing must be per- (b) Classification. Class I (general con- formed to demonstrate that the device trols). The device is exempt from the meets all design specifications and per- premarket notification procedures in formance requirements, and to dem- subpart E of part 807 of this chapter, onstrate durability and mechanical in- subject to the limitations in § 878.9. tegrity of the device. [53 FR 23872, June 24, 1988, as amended at 54 (2) In vivo evaluation of the device FR 13828, Apr. 5, 1989; 59 FR 63010, Dec. 7, must demonstrate device performance, 1994; 66 FR 38803, July 25, 2001] including the safety of the release methodology and blood loss at the § 878.4810 Laser surgical instrument treatment sites. for use in general and plastic sur- (3) All elements of the device that gery and in dermatology. may contact the patient must be dem- (a) Identification. (1) A carbon dioxide onstrated to be biocompatible. laser for use in general surgery and in (4) Electrical safety and electro- dermatology is a laser device intended magnetic compatibility of the device to cut, destroy, or remove tissue by must be demonstrated. light energy emitted by carbon dioxide. (5) The labeling must include a sum- (2) An argon laser for use in derma- mary of in vivo evaluation data and all tology is a laser device intended to de- the device specific warnings, pre- stroy or coagulate tissue by light en- cautions, and/or contraindications. ergy emitted by argon. (6) Sterility and shelf-life testing for (b) Classification. (1) Class II. the device must demonstrate the ste- (2) Class I for special laser gas mix- rility of patient contacting compo- tures used as a lasing medium for this nents and the shelf life of these compo- class of lasers. The devices subject to nents. this paragraph (b)(2) are exempt from [79 FR 31861, June 3, 2014] the premarket notification procedures

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in subpart E of part 807 of this chapter, (6) Performance data must support subject to the limitations in § 878.9. shelf life by demonstrating continued sterility of the device or the sterile [53 FR 23872, June 24, 1988, as amended at 61 components and device functionality FR 1123, Jan. 16, 1996; 66 FR 38803, July 25, 2001] over the labeled shelf life. (7) Training must be developed and § 878.4815 Magnetic surgical instru- validated by human factors testing and ment system. analysis to ensure users can follow the instructions for use to allow safe use of (a) Identification. A magnetic surgical the device. instrument system is a prescription de- (8) Labeling must include: vice used in laparoscopic surgical pro- (i) Magnetic field safe zones. cedures consisting of several compo- (ii) Instructions for proper device nents, such as surgical instruments, use. and a magnetic controller. The mag- (iii) A screening checklist to ensure netic controller is provided separately that all patients and operating staff from the surgical instrument and is are screened from bringing ferromag- used outside the patient. The external netic implants, devices, or objects near magnetic controller is magnetically the external magnet. coupled with the internal surgical in- (iv) Reprocessing instructions for any strument(s) at the surgical site to reusable components. grasp, hold, retract, mobilize, or ma- (v) Shelf life. nipulate soft tissue and organs. (vi) Use life. (b) Classification. Class II (special controls). The special controls for this [81 FR 64763, Sept. 21, 2016] device are: § 878.4820 Surgical instrument motors (1) In vivo performance data must and accessories/attachments. demonstrate that the device performs (a) Identification. Surgical instrument as intended under anticipated condi- motors and accessories are AC-pow- tions of use. Testing must demonstrate ered, battery-powered, or air-powered the ability of the device to grasp, hold, devices intended for use during surgical retract, mobilize, or manipulate soft procedures to provide power to operate tissue and organs. various accessories or attachments to (2) Non-clinical performance data cut hard tissue or bone and soft tissue. must demonstrate that the system per- Accessories or attachments may in- forms as intended under anticipated clude a bur, chisel (osteotome), conditions of use. The following per- dermabrasion brush, dermatome, drill formance characteristics must be test- bit, hammerhead, pin driver, and saw ed: blade. (i) Magnetic field strength testing (b) Classification. Class I (general con- characterization to identify the dis- trols). The device is exempt from the tances from the magnet that are safe premarket notification procedures in for patients and users with ferromag- subpart E of part 807 of this chapter netic implants, devices, or objects. subject to § 878.9. (ii) Ability of the internal surgical [55 FR 48440, Nov. 20, 1990, as amended at 65 instrument(s) to be coupled, de-cou- FR 2318, 2000] pled, and re-coupled with the external magnet over the external magnet use § 878.4830 Absorbable surgical gut su- life. ture. (3) The patient-contacting compo- (a) Identification. An absorbable sur- nents of the device must be dem- gical gut suture, both plain and chro- onstrated to be biocompatible. mic, is an absorbable, sterile, flexible (4) Performance data must dem- thread prepared from either the serosal onstrate the sterility of the device connective tissue layer of beef (bovine) components that are patient-con- or the submucosal fibrous tissue of tacting. sheep (ovine) intestine, and is intended (5) Methods and instructions for re- for use in soft tissue approximation. processing reusable components must (b) Classification. Class II (special be validated. controls). The special control for this

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device is FDA’s ‘‘Class II Special Con- MedWatch if they experience any ad- trols Guidance Document: Surgical Su- verse events when using this device. tures; Guidance for Industry and (6) Labeling must include specific in- FDA.’’ See § 878.1(e) for the availability formation pertinent to use of the de- of this guidance document. vice by the intended patient population and the treatment regimen. [54 FR 50738, Dec. 11, 1989, as amended at 68 (7) Simulated use testing must in- FR 32984, June 3, 2003] clude information from a usability, § 878.4840 Absorbable polydioxanone label comprehension and self-selection surgical suture. study to demonstrate that the device can be used by the intended patient (a) Identification. An absorbable population without any assistance. polydioxanone surgical suture is an ab- (8) Clinical data must show adequate sorbable, flexible, sterile, reduction in time to healing and assess monofilament thread prepared from risks of redness, discomfort, burns, and polyester polymer poly (p-dioxanone) blisters. and is intended for use in soft tissue approximation, including pediatric car- [83 FR 52969, Oct. 19, 2018] diovascular tissue where growth is ex- pected to occur, and ophthalmic sur- § 878.4930 Suture retention device. gery. It may be coated or uncoated, (a) Identification. A suture retention undyed or dyed, and with or without a device is a device, such as a retention standard needle attached. bridge, a surgical button, or a suture (b) Classification. Class II (special bolster, intended to aid wound healing controls). The special control for the by distributing suture tension over a device is FDA’s ‘‘Class II Special Con- larger area in the patient. trols Guidance Document: Surgical Su- (b) Classification. Class I (general con- tures; Guidance for Industry and trols). The device is exempt from the FDA.’’ See § 878.1(e) for the availability premarket notification procedures in of this guidance document. subpart E of part 807 of this chapter, subject to the limitations in § 878.9. [67 FR 77676, Dec. 19, 2002] [53 FR 23872, June 24, 1988, as amended at 59 § 878.4860 Light based energy source FR 63010, Dec. 7, 1994; 66 FR 38803, July 25, device for topical application. 2001] (a) Identification. The device emits § 878.4950 Manual operating table and light energy at near infrared spectrum accessories and manual operating and is applied externally to the surface chair and accessories. of herpes simplex labialis lesions on or (a) Identification. A manual operating around the lips. table and accessories and a manual op- (b) Classification. Class II (special erating chair and accessories are non- controls). The special controls for this powered devices, usually with movable device are: components, intended to be used to (1) The technical parameters of the support a patient during diagnostic ex- device, including wavelength, treat- aminations or surgical procedures. ment time, treatment area, energy (b) Classification. Class I (general con- density, spot size, and power, must be trols). The device is exempt from the characterized. premarket notification procedures in (2) The cleaning and disinfection in- subpart E of part 807 of this chapter, structions for the device must be vali- subject to the limitations in § 878.9. dated. [53 FR 23872, June 24, 1988, as amended at 54 (3) The device must be demonstrated FR 13828, Apr. 5, 1989; 59 FR 63010, Dec. 7, to be biocompatible. 1994; 66 FR 38803, July 25, 2001] (4) Performance testing must vali- date electromagnetic compatibility § 878.4960 Operating tables and acces- (EMC), ocular safety, and electrical sories and operating chairs and ac- safety of the device. cessories. (5) Labeling must direct end-users to (a) Identification. Operating tables contact the device manufacturer and and accessories and operating chairs

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and accessories are AC-powered or air- an FDA approved color additive; and powered devices, usually with movable the suture may be provided with or components, intended for use during di- without a standard needle attached. agnostic examinations or surgical pro- (b) Classification. Class II (special cedures to support and position a pa- controls). The special control for this tient. device is FDA’s ‘‘Class II Special Con- (b) Classification. Class I (general con- trols Guidance Document: Surgical Su- trols). The device is exempt from the tures; Guidance for Industry and premarket notification procedures in FDA.’’ See § 878.1(e) for the availability subpart E of part 807 of this chapter of this guidance document. subject to § 878.9. [56 FR 24685, May 31, 1991, as amended at 68 [55 FR 48440, Nov. 20, 1990, as amended at 65 FR 32984, June 3, 2003] FR 2318, Jan. 14, 2000] § 878.5020 Nonabsorbable polyamide § 878.5000 Nonabsorbable surgical suture. poly(ethylene terephthalate) sur- (a) Identification. Nonabsorbable poly- gical suture. amide surgical suture is a nonabsorb- (a) Identification. Nonabsorbable able, sterile, flexible thread prepared poly(ethylene terephthalate) surgical from long-chain aliphatic polymers suture is a multifilament, nonabsorb- Nylon 6 and Nylon 6,6 and is indicated able, sterile, flexible thread prepared for use in soft tissue approximation. from fibers of high molecular weight, The polyamide surgical suture meets long-chain, linear polyesters having re- United States Pharmacopeia (U.S.P.) current aromatic rings as an integral requirements as described in the U.S.P. component and is indicated for use in monograph for nonabsorbable surgical soft tissue approximation. The sutures; it may be monofilament or poly(ethylene terephthalate) surgical multifilament in form; it may be pro- suture meets U.S.P. requirements as vided uncoated or coated; and it may described in the U.S.P. Monograph for be undyed or dyed with an appropriate Nonabsorbable Surgical Sutures; it FDA listed color additive. Also, the su- may be provided uncoated or coated; ture may be provided with or without a and it may be undyed or dyed with an standard needle attached. appropriate FDA listed color additive. (b) Classification. Class II (special Also, the suture may be provided with controls). The special control for this or without a standard needle attached. device is FDA’s ‘‘Class II Special Con- (b) Classification. Class II (special trols Guidance Document: Surgical Su- controls). The special control for this tures; Guidance for Industry and device is FDA’s ‘‘Class II Special Con- FDA.’’ See § 878.1(e) for the availability trols Guidance Document: Surgical Su- of this guidance document. tures; Guidance for Industry and FDA.’’ See § 878.1(e) for the availability [56 FR 24685, May 31, 1991, as amended at 68 FR 32985, June 3, 2003] of this guidance document. [56 FR 24685, May 31, 1991, as amended at 68 § 878.5030 Natural nonabsorbable silk FR 32984, June 3, 2003] surgical suture. (a) Identification. Natural nonabsorb- § 878.5010 Nonabsorbable poly- able silk surgical suture is a non- propylene surgical suture. absorbable, sterile, flexible multifila- (a) Identification. Nonabsorbable poly- ment thread composed of an organic propylene surgical suture is a protein called fibroin. This protein is monofilament, nonabsorbable, sterile, derived from the domesticated species flexible thread prepared from long- Bombyx mori (B. mori) of the family chain polyolefin polymer known as Bombycidae. Natural nonabsorbable silk polypropylene and is indicated for use surgical suture is indicated for use in in soft tissue approximation. The poly- soft tissue approximation. Natural propylene surgical suture meets United nonabsorbable silk surgical suture States Pharmacopeia (U.S.P.) require- meets the United States Pharmacopeia ments as described in the U.S.P. Mono- (U.S.P.) monograph requirements for graph for Nonabsorbable Surgical Su- Nonabsorbable Surgical Suture (class tures; it may be undyed or dyed with I). Natural nonabsorbable silk surgical

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suture may be braided or twisted; it diaphragm, a single or double piston, may be provided uncoated or coated; and a safety trap. and it may be undyed or dyed with an (b) Classification. Class II (special FDA listed color additive. controls). Consensus standards and la- (b) Classification. Class II (special beling restrictions. controls). The special control for this [63 FR 7705, Feb. 17, 1998] device is FDA’s ‘‘Class II Special Con- trols Guidance Document: Surgical Su- § 878.5050 Surgical smoke precipitator. tures; Guidance for Industry and (a) Identification. A surgical smoke FDA.’’ See § 878.1(e) for the availability precipitator is a prescription device in- of this guidance document. tended for clearance of the visual field [58 FR 57558, Oct. 26, 1993, as amended at 68 by precipitation of surgical smoke and FR 32985, June 3, 2003] other aerosolized particulate matter created during laparoscopic surgery. § 878.5035 Nonabsorbable expanded (b) Classification. Class II (special polytetrafluoroethylene surgical su- ture. controls). The special controls for this device are: (a) Identification. Nonabsorbable ex- (1) Adverse tissue reaction must be panded polytetrafluoroethylene mitigated through the following: (ePTFE) surgical suture is a (i) Chemical characterization and monofilament, nonabsorbable, sterile, toxicological risk assessment of the flexible thread prepared from ePTFE treated surgical smoke. and is intended for use in soft tissue (ii) Demonstration that the elements approximation and ligation, including of the device that may contact the pa- cardiovascular surgery. It may be tient are biocompatible. undyed or dyed with an approved color (2) Electrical safety and electro- additive and may be provided with or magnetic compatibility testing must without an attached needle(s). demonstrate that the device performs (b) Classification. Class II (special as intended. controls). The special control for this (3) Software verification, validation, device is FDA’s ‘‘Class II Special Con- and hazard analysis must be performed. trols Guidance Document: Surgical Su- (4) Performance data must dem- tures; Guidance for Industry and onstrate the sterility of the patient FDA.’’ See § 878.1(e) for the availability contacting components of the device. of this guidance document. (5) Performance data must support [65 FR 20735, Apr. 18, 2000, as amended at 68 the shelf life of the sterile components FR 32985, June 3, 2003] of the device by demonstrating contin- ued functionality, sterility, and pack- § 878.5040 Suction lipoplasty system. age integrity over the identified shelf (a) Identification. A suction lipoplasty life. system is a device intended for aes- (6) Animal simulated-use testing thetic body contouring. The device must demonstrate that the device per- consists of a powered suction pump forms as intended under anticipated (containing a microbial filter on the conditions of use. The following per- exhaust and a microbial in-line filter formance characteristics must be test- in the connecting tubing between the ed: collection bottle and the safety trap), (i) Device must be demonstrated to collection bottle, cannula, and con- be effectively inserted, positioned, and necting tube. The microbial filters, removed from the site of use. tubing, collection bottle, and cannula (ii) Device must be demonstrated to must be capable of being changed be- precipitate surgical smoke particulates tween patients. The powered suction to clear the visual field for pump has a motor with a minimum of laparoscopic surgeries. 1⁄3 horsepower, a variable vacuum range (iii) Device must be demonstrated to from 0 to 29.9 inches of mercury, vacu- be non-damaging to the site of use and um control valves to regulate the vacu- animal subject. um with accompanying vacuum (7) Labeling must identify the fol- gauges, a single or double rotary vane lowing: (with or without oil), a single or double (i) Detailed instructions for use.

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(ii) Electrical safety and electro- high-frequency AC combined with DC magnetic compatibility information. current, or DC current only. (iii) A shelf life. (b) Classification. Class I (general con- trols). The device is exempt from the [83 FR 4143, Jan. 30, 2018] premarket notification procedures in subpart E of part 807 of this chapter, Subpart F—Therapeutic Devices subject to the limitations in § 878.9. § 878.5070 Air-handling apparatus for [53 FR 23872, June 24, 1988, as amended at 61 a surgical operating room. FR 1123, Jan. 16, 1996; 66 FR 38803, July 25, (a) Identification. Air-handling appa- 2001] ratus for a surgical operating room is a § 878.5360 Tweezer-type epilator. device intended to produce a directed, nonturbulent flow of air that has been (a) Identification. The tweezer-type filtered to remove particulate matter epilator is an electrical device intended and microorganisms to provide an area to remove hair. The energy provided at free of contaminants to reduce the pos- the tip of the tweezer used to remove sibility of infection in the patient. hair may be radio frequency, galvanic (b) Classification. Class II (special (direct current), or a combination of controls). The device, when it is an air radio frequency and galvanic energy. handling bench apparatus, an air han- (b) Classification. Class I (general con- dling room apparatus, or an air han- trols). The device is exempt from pre- dling enclosure apparatus, is exempt market notification procedures in sub- from the premarket notification proce- part E of part 807 of this chapter sub- dures in subpart E of part 807 of this ject to § 878.9. chapter subject to the limitations in [63 FR 57060, Oct. 26, 1998] § 878.9. [53 FR 23872, June 24, 1988, as amended at 84 § 878.5400 Low level laser system for FR 71814, Dec. 30, 2019] aesthetic use (a) Identification. A Low Level Laser § 878.5080 Air-handling apparatus ac- System for Aesthetic Use is a device cessory. using low level laser energy for the dis- (a) Identification. An air-handling ap- ruption of adipocyte cells within the paratus accessory is a supplementary fat layer for the release of fat and device that is intended to be used with lipids from these cells for noninvasive an air-handling apparatus for a sur- aesthetic use. gical operating room. This device pro- (b) Classification. Class II (special vides an interface between the compo- controls). The special control for this nents of the device or can be used to device is the FDA guidance document switch electrical power. This generic entitled ‘‘Guidance for Industry and type of device includes fittings, adapt- Food and Drug Administration Staff; ers, couplers, remote switches, and Class II Special Controls Guidance footswitches. Document: Low Level Laser System for (b) Classification. Class I (general con- Aesthetic Use.’’ See § 878.1(e) for the trols). The device is exempt from the availability of this guidance document. premarket notification procedures in subpart E of part 807 of this chapter [76 FR 20842, Apr. 14, 2011] subject to the limitations in § 878.9. § 878.5650 Topical oxygen chamber for [84 FR 14870, Apr. 12, 2019] extremities. (a) Identification. A topical oxygen § 878.5350 Needle-type epilator. chamber for extremities is a device (a) Identification. A needle-type epila- that is intended to surround a patient’s tor is a device intended to destroy the limb and apply humidified oxygen topi- dermal papilla of a hair by applying cally at a pressure slightly greater electric current at the tip of a fine nee- than atmospheric pressure to aid heal- dle that has been inserted close to the ing of chronic skin ulcers such as bed- hair shaft, under the skin, and into the sores. dermal papilla. The electric current (b) Classification. Class II (special may be high-frequency AC current, controls). The special control for this

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device is FDA’s ‘‘Class II Special Con- 880.2400 Bed-patient monitor. trols Guidance: Topical Oxygen Cham- 880.2420 Electronic monitor for gravity flow ber for Extremities.’’ See § 878.1(e) for infusion systems. the availability of this guidance docu- 880.2460 Electrically powered spinal fluid pressure monitor. ment. 880.2500 Spinal fluid manometer. [76 FR 22807, Apr. 25, 2011] 880.2700 Stand-on patient scale. 880.2720 Patient scale. § 878.5900 Nonpneumatic tourniquet. 880.2740 Surgical sponge scale. 880.2750 Image processing device for esti- (a) Identification. A nonpneumatic mation of external blood loss. tourniquet is a device consisting of a 880.2800 Sterilization process indicator. strap or tubing intended to be wrapped 880.2900 Clinical color change thermometer. around a patient’s limb and tightened 880.2910 Clinical electronic thermometer. to reduce circulation. 880.2920 Clinical mercury thermometer. (b) Classification. Class I (general con- 880.2930 Apgar timer. trols). The device is exempt from the Subparts D–E [Reserved] premarket notification procedures in subpart E of part 807 of this chapter, Subpart F—General Hospital and Personal subject to the limitations in § 878.9. Use Therapeutic Devices [53 FR 23872, June 24, 1988, as amended at 54 880.5025 I.V. container. FR 13828, Apr. 5, 1989; 59 FR 63010, Dec. 7, 880.5045 Medical recirculating air cleaner. 1994; 66 FR 38803, July 25, 2001] 880.5075 Elastic bandage. 880.5090 Liquid bandage. § 878.5910 Pneumatic tourniquet. 880.5100 AC-powered adjustable hospital bed. (a) Identification. A pneumatic tour- 880.5110 Hydraulic adjustable hospital bed. niquet is an air-powered device con- 880.5120 Manual adjustable hospital bed. sisting of a pressure-regulating unit, 880.5130 Infant radiant warmer. 880.5140 Pediatric medical crib. connecting tubing, and an inflatable 880.5145 Medical bassinet. cuff. The cuff is intended to be wrapped 880.5150 Nonpowered flotation therapy mat- around a patient’s limb and inflated to tress. reduce or totally occlude circulation 880.5160 Therapeutic medical binder. during surgery. 880.5180 Burn sheet. (b) Classification. Class I (general con- 880.5200 Intravascular catheter. trols). The device is exempt from the 880.5210 Intravascular catheter securement device. premarket notification procedures in 880.5240 Medical adhesive tape and adhesive subpart E of part 807 of this chapter, bandage. subject to the limitations in § 878.9. 880.5270 Neonatal eye pad. [53 FR 23872, June 24, 1988, as amended at 61 880.5300 Medical absorbent fiber. FR 1123, Jan. 16, 1996; 66 FR 38803, July 25, 880.5400 Neonatal incubator. 880.5410 Neonatal transport incubator. 2001] 880.5420 Pressure infusor for an I.V. bag. 880.5430 Nonelectrically powered fluid injec- PART 880—GENERAL HOSPITAL tor. AND PERSONAL USE DEVICES 880.5440 Intravascular administration set. 880.5445 Intravascular administration set, Subpart A—General Provisions automated air removal system. 880.5450 Patient care reverse isolation Sec. chamber. 880.1 Scope. 880.5475 Jet lavage. 880.3 Effective dates of requirement for pre- 880.5500 AC-powered patient lift. market approval. 880.5510 Non-AC-powered patient lift. 880.9 Limitations of exemptions from sec- 880.5550 Alternating pressure air flotation tion 510(k) of the Federal Food, Drug, mattress. and Cosmetic Act (the act). 880.5560 Temperature regulated water mat- tress. Subpart B [Reserved] 880.5570 Hypodermic single lumen needle. 880.5580 Acupuncture needle. Subpart C—General Hospital and Personal 880.5630 Nipple shield. Use Monitoring Devices 880.5640 Lamb feeding nipple. 880.5680 Pediatric position holder. 880.2200 Liquid crystal forehead tempera- 880.5700 Neonatal phototherapy unit. ture strip. 880.5725 Infusion pump.

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