Food and Drug Administration, HHS Pt. 878

generated using electrostatic spark dis- 878.3925 Plastic surgery kit and accessories. charge (spark gap), electromagneti- cally repelled membranes, or piezo- Subpart E—Surgical Devices 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 lens. The shock waves are created of skin. under water within the shock wave 878.4014 Nonresorbable gauze/sponge for ex- generator, and are transferred to the ternal use. 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 (b) Classification. Class II (special dressing. controls) (FDA guidance document: 878.4025 Silicone sheeting. ‘‘Guidance for the Content of Pre- 878.4040 Surgical apparel. 878.4100 Organ bag. market Notifications (510(k)’s) for 878.4160 Surgical camera and accessories. Extracorporeal Shock Wave 878.4200 Introduction/drainage catheter and Lithotripters Indicated for the Frag- accessories. mentation of Kidney and Ureteral 878.4300 Implantable clip. Calculi.’’) 878.4320 Removable skin clip. 878.4340 Contact cooling system for aes- [65 FR 48612, Aug. 9, 2000] thetic use. 878.4350 Cryosurgical unit and accessories. PART 878—GENERAL AND PLASTIC 878.4360 Scalp cooling system to reduce the likelihood of chemotherapy-induced alo- SURGERY DEVICES pecia. 878.4370 Surgical drape and drape acces- Subpart A—General Provisions sories. 878.4371 Irrigating wound retractor device. Sec. 878.4380 Drape adhesive. 878.1 Scope. 878.4400 Electrosurgical cutting and coagu- 878.3 Effective dates of requirement for pre- lation device and accessories. market approval. 878.4410 Low energy ultrasound wound 878.9 Limitations of exemptions from sec- cleaner. tion 510(k) of the Federal Food, Drug, 878.4420 Electrosurgical device for over-the- and Cosmetic Act (the act). counter aesthetic use. 878.4440 Eye pad. Subpart B—Diagnostic Devices 878.4450 Nonabsorbable gauze for internal 878.1800 Speculum and accessories. use. 878.4452 Nonabsorbable expandable hemo- Subpart C [Reserved] static sponge for temporary internal use. 878.4454 Non-absorbable, hemostatic gauze Subpart D—Prosthetic Devices for temporary internal use. 878.4460 Non-powdered surgeon’s glove. 878.3250 External facial fracture fixation ap- 878.4470 Surgeon’s gloving cream. pliance. 878.4490 Absorbable hemostatic agent and 878.3300 Surgical mesh. dressing. 878.3500 Polytetrafluoroethylene with car- 878.4493 Absorbable poly(glycolide/l-lactide) bon fibers composite implant material. surgical suture. 878.3530 Silicone inflatable breast pros- 878.4494 Absorbable poly(hydroxybutyrate) thesis. surgical suture produced by recombinant 878.3540 Silicone gel-filled breast prosthesis. DNA technology. 878.3550 Chin prosthesis. 878.4495 Stainless steel suture. 878.3590 Ear prosthesis. 878.4520 Polytetrafluoroethylene injectable. 878.3610 Esophageal prosthesis. 878.4580 Surgical lamp. 878.3680 Nose prosthesis. 878.4590 Focused ultrasound stimulator sys- 878.3720 Tracheal prosthesls. tem for aesthetic use. 878.3750 External prosthesis adhesive. 878.4630 Ultraviolet lamp for dermatologic 878.3800 External aesthetic restoration pros- disorders. thesis. 878.4635 Sunlamp products and ultraviolet 878.3900 Inflatable extremity splint. lamps intended for use in sunlamp prod- 878.3910 Noninflatable extremity splint. ucts.

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878.4660 Skin marker. SOURCE: 53 FR 23872, June 24, 1988, unless 878.4670 Internal tissue marker. otherwise noted. 878.4680 Nonpowered, single patient, port- EDITORIAL NOTE: Nomenclature changes to able suction apparatus. part 878 appear at 73 FR 35341, June 23, 2008. 878.4683 Non-Powered suction apparatus de- vice intended for negative pressure wound therapy. Subpart A—General Provisions 878.4685 Extracorporeal shock wave device for treatment of chronic wounds. § 878.1 Scope. 878.4700 Surgical microscope and acces- (a) This part sets forth the classifica- sories. tion of general and plastic surgery de- 878.4730 Surgical skin degreaser or adhesive vices intended for human use that are tape solvent. in commercial distribution. 878.4750 Implantable staple. (b) The identification of a device in a 878.4755 Absorbable lung biopsy plug. 878.4760 Removable skin staple. regulation in this part is not a precise 878.4780 Powered suction pump. description of every device that is, or 878.4790 Powered surgical instrument for will be, subject to the regulation. A improvement in the appearance of manufacturer who submits a pre- cellulite. market notification submission for a 878.4800 Manual surgical instrument for device under part 807 cannot show general use. merely that the device is accurately 878.4810 Laser surgical instrument for use in described by the section title and iden- general and plastic surgery and in der- tification provision of a regulation in matology. this part, but shall state why the de- 878.4815 Magnetic surgical instrument sys- vice is substantially equivalent to tem. 878.4820 Surgical instrument motors and ac- other devices, as required by § 807.87 of cessories/attachments. this chapter. 878.4830 Absorbable surgical gut suture. (c) To avoid duplicative listings, a 878.4840 Absorbable polydioxanone surgical general and plastic surgery device that suture. has two or more types of uses (e.g., 878.4930 Suture retention device. used both as a diagnostic device and as 878.4950 Manual operating table and acces- a therapeutic device) is listed in one sories and manual operating chair and subpart only. accessories. (d) References in this part to regu- 878.4960 Operating tables and accessories latory sections of the Code of Federal and operating chairs and accessories. Regulations are to chapter I of title 21 878.5000 Nonabsorbable poly(ethylene terephthalate) surgical suture. unless otherwise noted. 878.5010 Nonabsorbable polypropylene sur- (e) Guidance documents referenced in gical suture. this part are available on the Internet 878.5020 Nonabsorbable polyamide surgical at http://www.fda.gov/MedicalDevices/ suture. DeviceRegulationandGuidance/ 878.5030 Natural nonabsorbable silk surgical GuidanceDocuments/default.htm.. suture. 878.5035 Nonabsorbable expanded polytetra- [53 FR 23872, June 24, 1988, as amended at 67 fluoroethylene surgical suture. FR 77676, Dec. 19, 2002; 78 FR 18233, Mar. 26, 878.5040 Suction lipoplasty system. 2013] 878.5050 Surgical smoke precipitator. § 878.3 Effective dates of requirement Subpart F—Therapeutic Devices for premarket approval. A device included in this part that is 878.5070 Air-handling apparatus for a sur- classified into class III (premarket ap- gical operating room. proval) shall not be commercially dis- 878.5350 Needle-type epilator. 878.5360 Tweezer-type epilator. tributed after the date shown in the 878.5400 Low level laser system for aesthetic regulation classifying the device unless use the manufacturer has an approval 878.5650 Topical oxygen chamber for ex- under section 515 of the act (unless an tremities. exemption has been granted under sec- 878.5900 Nonpneumatic tourniquet. tion 520(g)(2) of the act). An approval 878.5910 Pneumatic tourniquet. under section 515 of the act consists of AUTHORITY: 21 U.S.C. 351, 360, 360c, 360e, FDA’s issuance of an order approving 360j, 360l, 371. an application for premarket approval

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(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, tributed unless it is reclassified. If or the device is intended for lay use FDA knows that a device being com- where the former intended use was by mercially distributed may be a ‘‘new’’ health care professionals only; device as defined in this section be- (b) The modified device operates cause of any new intended use or other using a different fundamental sci- reasons, FDA may codify the statutory entific technology than a legally mar- classification of the device into class keted device in that generic type of de- III for such new use. Accordingly, the vice; e.g., a surgical instrument cuts regulation for such a class III device tissue with a laser beam rather than states that as of the enactment date of with a sharpened metal blade, or an in the amendments, May 28, 1976, the de- vitro diagnostic device detects or iden- vice must have an approval under sec- tifies infectious agents by using tion 515 of the act before commercial deoxyribonucleic acid (DNA) probe or distribution. nucleic acid hybridization technology

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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 [53 FR 23872, June 24, 1988, as amended at 54 (AIDS), chronic or active hepatitis, tu- 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; (a) Identification. Surgical mesh is a (5) For use in diabetes management; metallic or polymeric screen intended (6) For identifying or inferring the to be implanted to reinforce soft tissue identity of a microorganism directly or bone where weakness exists. Exam- from clinical material; ples of surgical mesh are metallic and (7) For detection of antibodies to polymeric mesh for hernia repair, and microorganisms other than acetabular and cement restrictor mesh immunoglobulin G (IgG) or IgG assays used during orthopedic surgery. when the results are not qualitative, or (b) Classification. Class II. are used to determine immunity, or the assay is intended for use in matrices § 878.3500 Polytetrafluoroethylene other than serum or plasma; with carbon fibers composite im- plant material. (8) For noninvasive testing as defined in § 812.3(k) of this chapter; and (a) Identification. A polytetrafluoro- (9) For near patient testing (point of ethylene with carbon fibers composite care). implant material is a porous device material intended to be implanted dur- [65 FR 2317, Jan. 14, 2000] ing surgery of the chin, jaw, nose, or bones or tissue near the eye or ear. The Subpart B—Diagnostic Devices device material serves as a space-occu- pying substance and is shaped and § 878.1800 Speculum and accessories. formed by the surgeon to conform to (a) Identification. A speculum is a de- the patient’s need. vice intended to be inserted into a body (b) Classification. Class II. cavity to aid observation. It is either § 878.3530 Silicone inflatable breast nonilluminated or illuminated and prosthesis. may have various accessories. (a) A silicone inflatable (b) Classification. Class I (general con- Identification. trols). The device is exempt from the breast prosthesis is a silicone rubber premarket notification procedures in shell made of polysiloxane(s), such as subpart E of part 807 of this chapter, polydimethylsiloxane and subject to the limitations in § 878.9. polydiphenylsiloxane, that is inflated to the desired size with sterile isotonic [53 FR 23872, June 24, 1988, as amended at 54 saline before or after implantation. FR 13827, Apr. 5, 1989; 59 FR 63010, Dec. 7, The device is intended to be implanted 1994; 66 FR 38802, July 25, 2001] to augment or reconstruct the female breast. Subpart C [Reserved] (b) Classification. Class III. 490

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

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

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chapter, with respect to complaint required before this device may be files. commercially distributed. See § 878.3 of this chapter. [53 FR 23872, June 24, 1988, as amended at 54 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 surgery, and simple, thoroughly premarket notification procedures in cleansed, trauma-induced lacerations. subpart E of part 807 of this chapter It may be used in conjunction with, but subject to § 878.9. 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 § 878.4014 Nonresorbable gauze/sponge with, but not in place of, deep dermal 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 vice used for adhesion of internal tis- composed of materials derived from sues and vessels. animal sources. (2) Classification. Class III (premarket (b) Classification. Class I (general con- approval). As of May 28, 1976, an ap- trols). The device is exempt from the proval under section 515 of the act is premarket notification procedures in

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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 wound dressing that contains added [64 FR 53929, Oct. 5, 1999] 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, [64 FR 53929, Oct. 5, 1999] and as a wound packing. (b) Classification. Class II (special § 878.4022 Hydrogel wound dressing controls). The special control is: the and burn dressing. FDA guidance document entitled (a) Identification. A hydrogel wound ‘‘Class II Special Controls Guidance dressing is a sterile or non-sterile de- Document: Wound Dressing With Poly vice intended to cover a wound, to ab- (Diallyl Dimethyl Ammonium Chlo- sorb wound exudate, to control bleed- ride) (pDADMAC) Additive.’’ See ing or fluid loss, and to protect against § 878.1(e) for availability of this guid- abrasion, friction, desiccation, and con- ance document. tamination. It consists of a nonresorbable matrix made of hydro- [74 FR 53167, Oct. 16, 2009] philic polymers or other material in § 878.4018 Hydrophilic wound dress- combination with water (at least 50 ing. percent) and capable of absorbing (a) Identification. A hydrophilic exudate. This classification does not wound dressing is a sterile or non-ster- include a hydrogel wound dressing that contains added drugs such as anti- ile device intended to cover a wound microbial agents, added biologics such and to absorb exudate. It consists of as growth factors, or is composed of nonresorbable materials with hydro- materials derived from animal sources. philic properties that are capable of ab- (b) Classification. Class I (general con- sorbing exudate (e.g., cotton, cotton trols). The device is exempt from the derivatives, alginates, dextran, and premarket notification procedures in rayon). This classification does not in- part 807, subpart E of this chapter sub- clude a hydrophilic wound dressing ject to the limitations in § 878.9. that contains added drugs such as anti- microbial agents, added biologics such [64 FR 53929, Oct. 5, 1999] as growth factors, or is composed of materials derived from animal sources. § 878.4025 Silicone sheeting. (b) Classification. Class I (general con- (a) Identification. Silicone sheeting is trols). The device is exempt from the intended for use in the management of premarket notification procedures in closed hyperproliferative (hypertrophic part 807, subpart E of this chapter sub- and keloid) scars. ject to the limitations in § 878.9. (b) Classification. Class I (general con- trols). The device is exempt from the [64 FR 53929, Oct. 5, 1999] premarket notification procedures in § 878.4020 Occlusive wound dressing. subpart E of part 807 of this chapter subject to the limitations in § 878.9. (a) Identification. An occlusive wound dressing is a nonresorbable, sterile or [69 FR 48148, Aug. 9, 2004] non-sterile device intended to cover a wound, to provide or support a moist § 878.4040 Surgical apparel. wound environment, and to allow the (a) Identification. Surgical apparel are exchange of gases such as oxygen and devices that are intended to be worn by water vapor through the device. It con- operating room personnel during sur- sists of a piece of synthetic polymeric gical procedures to protect both the material, such as polyurethane, with or surgical patient and the operating

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room personnel from transfer of micro- logic conditions. Examples include irri- organisms, body fluids, and particulate gation and drainage catheters, pedi- material. Examples include surgical atric catheters, peritoneal catheters caps, hoods, masks, gowns, operating (including dialysis), and other general room shoes and shoe covers, and isola- surgical catheters. An introduction/ tion masks and gowns. Surgical suits drainage catheter accessory is intended and dresses, commonly known as scrub to aid in the manipulation of or inser- suits, are excluded. tion of the device into the body. Exam- (b) Classification. (1) Class II (special ples of accessories include adaptors, controls) for surgical gowns and sur- connectors, and catheter needles. gical masks. (b) Classification. Class I (general con- (2) Class I (general controls) for sur- trols). The device is exempt from the gical apparel other than surgical gowns premarket notification procedures in and surgical masks. The class I device subpart E of part 807 of this chapter is exempt from the premarket notifica- subject to § 878.9. tion procedures in subpart E of part 807 of this chapter subject to § 878.9. [53 FR 23872, June 24, 1988, as amended at 65 FR 2318, Jan. 14, 2000] [53 FR 23872, June 24, 1988, as amended at 65 FR 2317, Jan. 14, 2000] § 878.4300 Implantable clip. § 878.4100 Organ bag. (a) Identification. An implantable clip is a clip-like device intended to con- (a) Identification. An organ bag is a nect internal tissues to aid healing. It device that is a flexible plastic bag in- tended to be used as a temporary recep- is not absorbable. tacle for an organ during surgical pro- (b) Classification. Class II. cedures to prevent moisture loss. (b) Classification. Class I (general con- § 878.4320 Removable skin clip. trols). The device is exempt from the (a) Identification. A removable skin premarket notification procedures in clip is a clip-like device intended to subpart E of part 807 of this chapter connect skin tissues temporarily to aid subject to § 878.9. healing. It is not absorbable. [53 FR 23872, June 24, 1988, as amended at 59 (b) Classification. Class I (general con- FR 63010, Dec. 7, 1994; 65 FR 2318, Jan. 14, trols). The device is exempt from the 2000] premarket notification procedures in subpart E of part 807 of this chapter § 878.4160 Surgical camera and acces- subject to § 878.9. sories. [53 FR 23872, June 24, 1988, as amended at 65 (a) Identification. A surgical camera FR 2318, Jan. 14, 2000] and accessories is a device intended to be used to record operative procedures. § 878.4340 Contact cooling system for (b) Classification. Class I (general con- aesthetic use. trols). The device is exempt from the (a) Identification. A contact cooling premarket notification procedures in system for aesthetic use is a device subpart E of part 807 of this chapter, that is a combination of a cooling pad subject to the limitations in § 878.9. associated with a vacuum or mechan- [53 FR 23872, June 24, 1988, as amended at 54 ical massager intended for the disrup- FR 13827, Apr. 5, 1989; 66 FR 38802, July 25, tion of adipocyte cells intended for 2001] non-invasive aesthetic use. § 878.4200 Introduction/drainage cath- (b) Classification. Class II (special eter and accessories. controls). The special controls for this device is FDA’s ‘‘Guidance for Industry (a) Identification. An introduction/ and FDA Staff; Class II Special Con- drainage catheter is a device that is a trols Guidance Document: Contact flexible single or multilumen tube in- Cooling System for Aesthetic Use.’’ See tended to be used to introduce nondrug § 878.1(e) for the availability of this fluids into body cavities other than guidance document. blood vessels, drain fluids from body cavities, or evaluate certain physio- [76 FR 6553, Feb. 7, 2011]

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§ 878.4350 Cryosurgical unit and acces- (2) Performance testing must dem- sories. onstrate the electromagnetic compat- (a) Identification—(1) Cryosurgical unit ibility and electrical safety of the de- with a liquid nitrogen cooled cryoprobe vice. and accessories. A cryosurgical unit (3) Software verification, validation, with a liquid nitrogen cooled cryoprobe and hazard analysis must be performed. and accessories is a device intended to (4) The patient contacting compo- destroy tissue during surgical proce- nents of the device must be dem- dures by applying extreme cold. onstrated to be biocompatible. Mate- (2) Cryosurgical unit with a nitrous rial names must be provided. oxide cooled cryoprobe and accessories. A (5) Labeling must include the fol- cryosurgical unit with a nitrous oxide lowing: cooled cryoprobe and accessories is a (i) A statement describing the poten- device intended to destroy tissue dur- tial risk of developing scalp metas- ing surgical procedures, including tasis. urological applications, by applying ex- (ii) Information on the patient popu- treme cold. lation and chemotherapeutic agents/ (3) Cryosurgical unit with a carbon di- regimen for which the device has been oxide cooled cryoprobe or a carbon dioxide demonstrated to be effective. dry ice applicator and accessories. A (iii) A summary of the non-clinical cryosurgical unit with a carbon dioxide and/or clinical testing pertinent to use cooled cryoprobe or a carbon dioxide of the device. dry ice applicator and accessories is a (iv) A summary of the device tech- device intended to destroy tissue dur- nical parameters, including tempera- ing surgical procedures by applying ex- ture cooling range and duration of treme cold. The device is intended to cooling. treat disease conditions such as tu- (v) A summary of the device- and pro- mors, skin cancers, acne scars, or cedure-related adverse events pertinent hemangiomas (benign tumors con- to use of the device. sisting of newly formed blood vessels) (vi) Information on how the device and various benign or malignant gyne- operates and the typical course of cological conditions affecting vulvar, treatment. (6) Patient labeling must be provided vaginal, or cervical tissue. The device and must include: is not intended for urological applica- (i) Relevant contraindications, warn- tions. ings, precautions, and adverse effects/ (b) Classification. Class II. complications. § 878.4360 Scalp cooling system to re- (ii) Information on how the device duce the likelihood of chemo- operates and the typical course of therapy-induced alopecia. treatment. (a) Identification. A scalp cooling sys- (iii) Information on the patient popu- tem to reduce the likelihood of chemo- lation for which there is clinical evi- therapy-induced alopecia is a prescrip- dence of effectiveness. tion device intended to reduce the fre- (iv) The potential risks and benefits quency and severity of alopecia during associated with use of the device. chemotherapy in which alopecia-induc- (v) Postoperative care instructions. ing chemotherapeutic agents are used. (vi) A statement describing the po- (b) Classification—Class II (special tential risk of developing scalp metas- controls). The special controls for this tasis. device are: [81 FR 7453, Feb. 12, 2016] (1) Non-clinical performance testing must demonstrate that the device § 878.4370 Surgical drape and drape meets all design specifications and per- accessories. formance requirements, and that the (a) Identification. A surgical drape device performs as intended under an- and drape accessories is a device made ticipated conditions of use. This infor- of natural or synthetic materials in- mation must include testing to dem- tended to be used as a protective pa- onstrate accuracy of the temperature tient covering, such as to isolate a site control mechanism. of surgical incision from microbial and

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other contamination. The device in- set removal rates of fluid from the sur- cludes a plastic wound protector that gical wound. may adhere to the skin around a sur- (5) The labeling must include or state gical incision or be placed in a wound the following information: to cover its exposed edges, and a latex (i) Device size or incision length drape with a self-retaining finger cot range; that is intended to allow repeated in- (ii) Method of sterilization; sertion of the surgeon’s finger into the (iii) Flammability classification; rectum during performance of a transurethral prostatectomy. (iv) Non-pyrogenic; (b) Classification. Class II. (v) Shelf life; and (vi) Maximum flow rate and suction § 878.4371 Irrigating wound retractor pressure. device. [83 FR 24, Jan. 2, 2018] (a) Identification. An irrigating wound retractor device is a prescription de- § 878.4380 Drape adhesive. vice intended to be used by a surgeon to retract the surgical incision, to pro- (a) Identification. A drape adhesive is vide access to the surgical wound, to a device intended to be placed on the protect and irrigate the surgical skin to attach a surgical drape. wound, and to serve as a conduit for re- (b) Classification. Class I (general con- moval of fluid from the surgical wound. trols). The device is exempt from the (b) Classification. Class II (special premarket notification procedures in controls). The special controls for this subpart E of part 807 of this chapter, device are: subject to the limitations in § 878.9. (1) The patient-contacting compo- [53 FR 23872, June 24, 1988, as amended at 59 nents of the device must be dem- FR 63010, Dec. 7, 1994; 66 FR 38802, July 25, onstrated to be biocompatible and 2001] evaluated for particulate matter. (2) Performance data must dem- § 878.4400 Electrosurgical cutting and onstrate the sterility and pyrogenicity coagulation device and accessories. of the patient-contacting components (a) Identification. An electrosurgical of the device. cutting and coagulation device and ac- (3) Performance data must support cessories is a device intended to re- shelf life by demonstrating continued functionality and sterility of the de- move tissue and control bleeding by vice over the identified shelf life. use of high-frequency electrical cur- (4) Non-clinical performance testing rent. must demonstrate that the device per- (b) Classification. Class II. forms as intended under anticipated conditions of use. Performance testing § 878.4410 Low energy ultrasound must: wound cleaner. (i) Characterize the tear resistance, (a) Identification. A low energy tensile strength, and elongation prop- ultrasound wound cleaner is a device erties of the barrier material; that uses ultrasound energy to vapor- (ii) Demonstrate that the liquid bar- ize a solution and generate a mist that rier material is resistant to penetra- is used for the cleaning and mainte- tion by blood, and is non-flammable; nance debridement of wounds. Low lev- (iii) Characterize the forces required els of ultrasound energy may be carried to deploy the device; to the wound by the saline mist. (iv) Characterize the device’s ranges (b) Classification. Class II (special of operation, including flow rates and controls). The special control is FDA’s maximum suction pressures; guidance document entitled ‘‘Class II (v) Demonstrate the ability of the de- Special Controls Guidance Document: vice irrigation apparatus to maintain a Low Energy Ultrasound Wound Clean- user defined or preset flow rate to the er.’’ See § 878.1(e) for the availability of surgical wound; and this guidance document. (vi) Demonstrate the ability of the device to maintain user defined or pre- [70 FR 67355, Nov. 7, 2005]

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§ 878.4420 Electrosurgical device for (iii) A summary of the clinical infor- over-the-counter aesthetic use. mation used to establish effectiveness (a) Identification. An electrosurgical for each indicated aesthetic usage and device for over-the-counter aesthetic observed adverse events. use is a device using radiofrequency en- [81 FR 42244, June 29, 2016] ergy to produce localized heating with- in tissues for non-invasive aesthetic § 878.4440 Eye pad. use. (a) Identification. An eye pad is a de- (b) Classification. Class II (special vice that consists of a pad made of var- controls). The special controls for this ious materials, such as gauze and cot- device are: ton, intended for use as a bandage over (1) Non-clinical performance data the eye for protection or absorption of must demonstrate that the device secretions. meets all design specifications and per- (b) Classification. Class I (general con- formance requirements. The following trols). The device is exempt from the performance characteristics must be premarket notification procedures in tested: Over-heating, power accuracy subpart E of part 807 of this chapter, radiofrequency, pulse cycle, waveform, subject to the limitations in § 878.9. pulse duration, and device character- ization parameters. [53 FR 23872, June 24, 1988, as amended at 59 (2) Label comprehension and self-se- FR 63010, Dec. 7, 1994; 66 FR 38803, July 25, lection performance evaluation must 2001] demonstrate that the intended over- § 878.4450 Nonabsorbable gauze for in- the-counter users can understand the ternal use. package labeling and correctly choose the device for the indicated aesthetic (a) Identification. Nonabsorbable use. gauze for internal use is a device made (3) Usability performance evaluation of an open mesh fabric intended to be must demonstrate that the over-the- used inside the body or a surgical inci- counter user can correctly use the de- sion or applied to internal organs or vice, based solely on reading the direc- structures, to control bleeding, absorb tions for use, to treat the indicated fluid, or protect organs or structures aesthetic use. from abrasion, drying, or contamina- (4) Clinical performance evaluation tion. The device is woven from mate- must demonstrate that the device per- rial made of not less than 50 percent by forms as intended under anticipated mass cotton, cellulose, or a simple conditions of use to achieve the in- chemical derivative of cellulose, and tended aesthetic results. contains x-ray detectable elements. (5) The patient-contacting compo- (b) Classification. Class I (general con- nents of the device must be dem- trols). The device is exempt from the onstrated to be biocompatible. premarket notification procedures in (6) Instructions for cleaning the de- subpart E of part 807 of this chapter, vice must be validated. subject to the limitations in § 878.9. (7) Performance data must be pro- [53 FR 23872, June 24, 1988, as amended at 61 vided to demonstrate the electro- FR 1123, Jan. 16, 1996; 66 FR 38803, July 25, magnetic compatibility and electrical 2001] safety, including the mechanical integ- rity, of the device. § 878.4452 Nonabsorbable expandable (8) Software verification, validation, hemostatic sponge for temporary and hazard analysis must be performed. internal use. (9) Labeling must include: (a) Identification. A nonabsorbable ex- (i) Warnings, precautions, and con- pandable hemostatic sponge for tem- traindications to ensure the safe use of porary internal use is a prescription the device for the over-the-counter device intended to be placed tempo- users. rarily into junctional, non-compress- (ii) A statement that the safety and ible wounds, which are not amenable to effectiveness of the device’s use for tourniquet use, to control bleeding uses other than the indicated aesthetic until surgical care is acquired. The use are not known. sponges expand upon contact with

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blood to fill the wound cavity and pro- (ii) Control of bleeding. vide a physical barrier and pressure (iii) Radiopacity. that facilitates formation of a clot. (iv) Retrieval. The device consists of sterile, non- (v) Assessment of local and systemic absorbable radiopaque compressed effects. sponges and may include an applicator (7) Human factors testing and anal- to facilitate delivery into a wound. ysis must validate that the device de- (b) Classification. Class II (special sign and labeling are sufficient for ap- controls). The special controls for this propriate use by emergency responders device are: deploying the device as well as sur- (1) Performance data must dem- geons retrieving the device from onstrate the biocompatibility of pa- wounds. tient-contacting components. (8) Labeling must include: (2) Performance data must dem- (i) Specific instructions for deploy- onstrate the sterility of patient-con- ment by emergency responders and re- tacting components including trieval by surgeons. endotoxin and pyrogenicity assess- (ii) Warnings, cautions, and limita- ments. tions needed for safe use of the device. (3) Performance data must support (iii) Information on how the device device stability by demonstrating con- operates and the typical course of tinued sterility of the patient-con- treatment. tacting components of the device, (iv) A detailed summary of the in package integrity, and device vivo and human factors testing perti- functionality over the requested shelf nent to use of the device. life. (v) Appropriate imaging information (4) Assessment of material character- to ensure complete retrieval of device. istics must be sufficient to support (vi) An expiration date/shelf life. safety under anticipated conditions of [79 FR 34224, June 16, 2014] use. Assessments must include the fol- lowing: § 878.4454 Non-absorbable, hemostatic (i) Material specifications. gauze for temporary internal use. (ii) Immunogenicity. (a) Identification. A non-absorbable, (iii) Viral inactivation for animal-de- hemostatic gauze for temporary inter- rived materials. nal use is a prescription device in- (5) Non-clinical performance data tended to be placed temporarily for must demonstrate that the device per- control of severely bleeding wounds forms as intended under anticipated such as surgical wounds and traumatic conditions of use. The following per- injuries. The gauze is coated or impreg- formance characteristics must be test- nated with a hemostatic material ed: which may enhance hemostasis by (i) Absorption capacity. physical means. The device is intended (ii) Extent of swelling. to be removed once the patient is sta- (iii) Mechanical properties. bilized. (iv) Expansion force/pressure. (b) Classification. Class II (special (v) Radiopacity. controls). The special controls for this (vi) Deployment/applicator device are: functionality. (1) Animal performance testing must (6) In vivo performance data must demonstrate that the device performs demonstrate safe and effective use by as intended under anticipated condi- verifying that the device performs as tions of use. Specifically testing must: intended under anticipated conditions (i) Demonstrate that the device is of use. Appropriate analysis/testing able to achieve hemostasis; must demonstrate that the product: (ii) Demonstrate that the device can Controls bleeding, does not promote be radiographically detected; and adverse local or systemic effects, and (iii) Assess pertinent safety can be completely removed from the endpoints including vascular obstruc- wound. The following performance tion and adhesion formation. characteristics must be tested: (2) The device must be demonstrated (i) Deployment. to be biocompatible.

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(3) Non-clinical performance data (b) Classification. Class I (general con- must demonstrate that the device per- trols). The device is exempt from the forms as intended under anticipated premarket notification procedures in conditions of use. The following tests subpart E of part 807 of this chapter, must be performed: subject to the limitations in § 878.9. (i) In vitro clot assessment; (ii) Particulate release testing; [53 FR 23872, June 24, 1988, as amended at 59 (iii) Physical characterization, in- FR 63010, Dec. 7, 1994; 66 FR 38803, July 25, cluding swelling percent and particu- 2001] late size; (iv) Chemical characterization; § 878.4490 Absorbable hemostatic (v) Radiopacity testing; and agent and dressing. (vi) Mechanical integrity testing, in- (a) Identification. An absorbable he- cluding tensile strength and tear mostatic agent or dressing is a device strength. intended to produce hemostasis by ac- (4) Performance data must dem- celerating the clotting process of onstrate the sterility of the device. blood. It is absorbable. (5) Performance data must support (b) Classification. Class III. the shelf life of the device by dem- (c) Date PMA or notice of completion of onstrating continued sterility, package a PDP is required. As of May 28, 1976, an integrity, and device functionality over the identified shelf life. approval under section 515 of the act is (6) Labeling must include the fol- required before this device may be lowing: commercially distributed. See § 878.3. (i) Instructions for use, including an instruction to remove all visible device § 878.4493 Absorbable poly(glycolide/l- components by irrigation; lactide) surgical suture. (ii) The maximum amount of time (a) Identification. An absorbable the device may be left within the body; poly(glycolide/l-lactide) surgical suture (iii) A shelf life; (PGL suture) is an absorbable sterile, (iv) A contraindication for flexible strand as prepared and syn- intravascular use of the device; and thesized from homopolymers of (v) A warning regarding the potential glycolide and copolymers made from 90 for adhesion formation. percent glycolide and 10 percent l- [83 FR 6794, Feb. 15, 2018] lactide, and is indicated for use in soft tissue approximation. A PGL suture § 878.4460 Non-powdered surgeon’s meets United States Pharmacopeia glove. (U.S.P.) requirements as described in (a) Identification. A non-powdered sur- the U.S.P. ‘‘Monograph for Absorbable geon’s glove is a device intended to be Surgical Sutures;’’ it may be worn on the hands of operating room monofilament or multifilament (braid- 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- cludes only residual powder from man- or without a standard needle attached. ufacturing. (b) Classification. Class II (special (b) Classification. Class I (general con- controls). The special control for this trols). device is FDA’s ‘‘Class II Special Con- trols Guidance Document: Surgical Su- [53 FR 23872, June 24, 1988, as amended at 66 tures; Guidance for Industry and FR 46952, Sept. 10, 2001; 81 FR 91730, Dec. 19, 2016] FDA.’’ See § 878.1(e) for the availability of this guidance document. § 878.4470 Surgeon’s gloving cream. [56 FR 47151, Sept. 18, 1991, as amended at 68 (a) Identification. Surgeon’s gloving FR 32984, June 3, 2003] cream is an ointment intended to be used to lubricate the user’s hand before putting on a surgeon’s glove.

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§ 878.4494 Absorbable § 878.4580 Surgical lamp. poly(hydroxybutyrate) surgical su- (a) Identification. A surgical lamp (in- ture produced by recombinant DNA technology. cluding a fixture) is a device intended to be used to provide visible illumina- (a) Identification. An absorbable tion of the surgical field or the patient. poly(hydroxybutyrate) surgical suture (b) Classification. Class II. is an absorbable surgical suture made of material isolated from prokaryotic § 878.4590 Focused ultrasound stimu- cells produced by recombinant lator system for aesthetic use. deoxyribonucleic acid (DNA) tech- (a) Identification. A Focused nology. The device is intended for use Ultrasound Stimulator System for Aes- in general soft tissue approximation thetic Use is a device using focused and ligation. ultrasound to produce localized, me- (b) Classification. Class II (special chanical motion within tissues and controls). The special control for this cells for the purpose of producing ei- device is the FDA guidance document ther localized heating for tissue coagu- entitled ‘‘Class II Special Controls lation or for mechanical cellular mem- Guidance Document: Absorbable brane disruption intended for Poly(hydroxybutyrate) Surgical Suture noninvasive aesthetic use. Produced by Recombinant DNA Tech- (b) Classification. Class II (special nology.’’ For the availability of this controls). The special control for this guidance document see § 878.1(e). device is FDA’s ‘‘Class II Special Con- [72 FR 43146, Aug. 3, 2007] trols Guidance Document: Focused Ultrasound Stimulator System for Aes- § 878.4495 Stainless steel suture. thetic Use.’’ See § 878.1(e) for the avail- (a) Identification. A stainless steel su- ability of this guidance document. ture is a needled or unneedled non- [76 FR 43121, July 20, 2011] absorbable surgical suture composed of 316L stainless steel, in USP sizes 12–0 § 878.4630 Ultraviolet lamp for der- through 10, or a substantially equiva- matologic disorders. lent stainless steel suture, intended for (a) Identification. An ultraviolet lamp use in abdominal wound closure, intes- for dermatologic disorders is a device tinal anastomosis, hernia repair, and (including a fixture) intended to pro- sternal closure. vide ultraviolet radiation of the body (b) Classification. Class II (special to photoactivate a drug in the treat- controls). The special control for this ment of a dermatologic disorder if the device is FDA’s ‘‘Class II Special Con- labeling of the drug intended for use trols Guidance Document: Surgical Su- with the device bears adequate direc- tures; Guidance for Industry and tions for the device’s use with that FDA.’’ See § 878.1(e) for the availability drug. of this guidance document. (b) Classification. Class II. [65 FR 19836, Apr. 13, 2000, as amended at 68 FR 32984, June 3, 2003] § 878.4635 Sunlamp products and ul- traviolet lamps intended for use in § 878.4520 Polytetrafluoroethylene sunlamp products. injectable. (a) Identification. A sunlamp product (a) Identification. Polytetrafluoro- is any device designed to incorporate ethylene injectable is an injectable one or more ultraviolet (UV) lamps in- paste prosthetic device composed of tended for irradiation of any part of polytetrafluoroethylene intended to be the living human body, by UV radi- used to augment or reconstruct a vocal ation with wavelengths in air between cord. 200 and 400 nanometers, to induce skin (b) Classification. Class III. tanning. This definition includes tan- (c) Date PMA or notice of completion of ning beds and tanning booths. A UV a PDP is required. As of May 28, 1976, an lamp intended for use in sunlamp prod- approval under section 515 of the act is ucts is any lamp that produces UV ra- required before this device may be diation in the wavelength interval of commercially distributed. See § 878.3. 200 to 400 nanometers in air.

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(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. wounds are present.’’ (3) Demonstrate software (C) ‘‘Warning: This product should verification, validation, and hazard not be used on individuals who have analysis. had skin cancer or have a family his- (4) Demonstrate that device is bio- tory of skin cancer.’’ compatible. (D) ‘‘Warning: Persons repeatedly ex- (5) Demonstrate that device is elec- posed to UV radiation should be regu- trically safe and electromagnetically larly evaluated for skin cancer.’’ compatible in its intended use environ- (c) Performance standard. Sunlamp ment. products and UV lamps intended for (6) Labeling—(i) Sunlamp products. (A) use in sunlamp products are subject to The warning statement below must ap- the electronic product performance pear on all sunlamp products and must standard at § 1040.20 of this chapter. be placed in a black box. This state- ment must be permanently affixed or [79 FR 31213, June 2, 2014] inscribed on the product when fully as- sembled for use so as to be legible and § 878.4660 Skin marker. readily accessible to view by the person (a) Identification. A skin marker is a who will be exposed to UV radiation pen-like device intended to be used to immediately before the use of the prod- write on the patient’s skin, e.g., to out- uct. It shall be of sufficient durability line surgical incision sites or mark an- to remain legible throughout the ex- atomical sites for accurate blood pres- pected lifetime of the product. It shall sure measurement. appear on a part or panel displayed (b) Classification. Class I (general con- prominently under normal conditions trols). The device is exempt from the of use so that it is readily accessible to premarket notification procedures in view whether the tanning bed canopy subpart E of part 807 of this chapter, (or tanning booth door) is open or subject to the limitations in § 878.9. closed when the person who will be ex- posed approaches the equipment and [53 FR 23872, June 24, 1988, as amended at 59 the text shall be at least 10 millimeters FR 63010, Dec. 7, 1994; 66 FR 38803, July 25, 2001] (height). Labeling on the device must include the following statement: § 878.4670 Internal tissue marker.

Attention: This sunlamp product should not be (a) Identification. An internal tissue used on persons under the age of 18 years. marker is a prescription use device that is intended for use prior to or dur- (B) Manufacturers shall provide vali- ing general surgical procedures to de- dated instructions on cleaning and dis- marcate selected sites on internal tis- infection of sunlamp products between sues. uses in the user instructions. (b) Classification. Class II (special (ii) Sunlamp products and UV lamps in- controls). The special controls for this tended for use in sunlamp products. Man- device are: ufacturers of sunlamp products and UV (1) The device must be demonstrated lamps intended for use in sunlamp to be biocompatible. Material names

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

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(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 [83 FR 9699, Mar. 7, 2018] controls). The special controls for this 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- [55 FR 48440, Nov. 20, 1990, as amended at 59 onstrate performance characteristics FR 63010, Dec. 7, 1994; 66 FR 38803, July 25, of the device, including the ability of 2001] the plug to not prematurely resorb or § 878.4730 Surgical skin degreaser or migrate and the rate of pneumothorax. adhesive tape solvent. (4) Sterility testing must dem- (a) Identification. A surgical skin onstrate the sterility of the device and degreaser or an adhesive tape solvent is the effects of the sterilization process a device that consists of a liquid such on the physical characteristics of the as 1,1,2-trichloro-1,2,2-trifluoroethane; plug. 1,1,1-trichloroethane; and 1,1,1-tri- (5) Shelf-life testing must dem- chloroethane with mineral spirits in- onstrate the shelf-life of the device in- tended to be used to dissolve surface cluding the physical characteristics of skin oil or adhesive tape. the plug. (b) Classification. Class I (general con- (6) The device must be demonstrated trols). The device is exempt from the to be biocompatible. premarket notification procedures in (7) Labeling must include a detailed subpart E of part 807 of this chapter, summary of the device-related and pro- subject to the limitations in § 878.9. cedure-related complications pertinent [53 FR 23872, June 24, 1988, as amended at 59 to the use of the device and appropriate FR 63010, Dec. 7, 1994; 66 FR 38803, July 25, warnings. Labeling must include iden- 2001] tification of compatible introducer needles. § 878.4750 Implantable staple. (a) Identification. An implantable sta- [79 FR 13219, Mar. 10, 2014] ple is a staple-like device intended to connect internal tissues to aid healing. § 878.4760 Removable skin staple. It is not absorbable. (a) Identification. A removable skin (b) Classification. Class II. staple is a staple-like device intended to connect external tissues temporarily § 878.4755 Absorbable lung biopsy to aid healing. It is not absorbable. plug. (b) Classification. Class I (general con- (a) Identification. A preformed (po- trols). The device is exempt from the lymerized) absorbable lung biopsy plug premarket notification procedures in is intended to provide accuracy in subpart E of part 807 of this chapter marking a biopsy location for visual- subject to § 878.9. ization during surgical resection and closure of pleural punctures associated [53 FR 23872, June 24, 1988, as amended at 65 with percutaneous, transthoracic nee- 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- (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 the limitations in § 878.9. [54 FR 50738, Dec. 11, 1989, as amended at 68 [53 FR 23872, June 24, 1988, as amended at 54 FR 32984, June 3, 2003] FR 13828, Apr. 5, 1989; 59 FR 63010, Dec. 7, 1994; 66 FR 38803, July 25, 2001] § 878.4840 Absorbable polydioxanone surgical suture. § 878.4960 Operating tables and acces- sories and operating chairs and ac- (a) Identification. An absorbable cessories. polydioxanone surgical suture is an ab- sorbable, flexible, sterile, (a) Identification. Operating tables monofilament thread prepared from and accessories and operating chairs polyester polymer poly (p-dioxanone) and accessories are AC-powered or air- and is intended for use in soft tissue powered devices, usually with movable approximation, including pediatric car- components, intended for use during di- diovascular tissue where growth is ex- agnostic examinations or surgical pro- pected to occur, and ophthalmic sur- cedures to support and position a pa- gery. It may be coated or uncoated, tient. undyed or dyed, and with or without a (b) Classification. Class I (general con- standard needle attached. trols). The device is exempt from the (b) Classification. Class II (special premarket notification procedures in controls). The special control for the subpart E of part 807 of this chapter device is FDA’s ‘‘Class II Special Con- subject to § 878.9. trols Guidance Document: Surgical Su- [55 FR 48440, Nov. 20, 1990, as amended at 65 tures; Guidance for Industry and FR 2318, Jan. 14, 2000] FDA.’’ See § 878.1(e) for the availability of this guidance document. § 878.5000 Nonabsorbable poly(ethylene terephthalate) sur- [67 FR 77676, Dec. 19, 2002] gical suture. (a) Identification. Nonabsorbable § 878.4930 Suture retention device. poly(ethylene terephthalate) surgical (a) Identification. A suture retention suture is a multifilament, nonabsorb- device is a device, such as a retention able, sterile, flexible thread prepared bridge, a surgical button, or a suture from fibers of high molecular weight, bolster, intended to aid wound healing long-chain, linear polyesters having re- by distributing suture tension over a current aromatic rings as an integral larger area in the patient. component and is indicated for use in (b) Classification. Class I (general con- soft tissue approximation. The trols). The device is exempt from the poly(ethylene terephthalate) surgical premarket notification procedures in suture meets U.S.P. requirements as subpart E of part 807 of this chapter, described in the U.S.P. Monograph for subject to the limitations in § 878.9. Nonabsorbable Surgical Sutures; it may be provided uncoated or coated; [53 FR 23872, June 24, 1988, as amended at 59 and it may be undyed or dyed with an FR 63010, Dec. 7, 1994; 66 FR 38803, July 25, 2001] appropriate FDA listed color additive. Also, the suture may be provided with § 878.4950 Manual operating table and or without a standard needle attached. accessories and manual operating (b) Classification. Class II (special chair and accessories. controls). The special control for this (a) Identification. A manual operating device is FDA’s ‘‘Class II Special Con- table and accessories and a manual op- trols Guidance Document: Surgical Su- erating chair and accessories are non- tures; Guidance for Industry and powered devices, usually with movable FDA.’’ See § 878.1(e) for the availability components, intended to be used to of this guidance document. support a patient during diagnostic ex- [56 FR 24685, May 31, 1991, as amended at 68 aminations or surgical procedures. FR 32984, June 3, 2003]

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§ 878.5010 Nonabsorbable poly- § 878.5030 Natural nonabsorbable silk propylene surgical suture. surgical suture. (a) Identification. Nonabsorbable poly- (a) Identification. Natural nonabsorb- propylene surgical suture is a able silk surgical suture is a non- monofilament, nonabsorbable, sterile, absorbable, sterile, flexible multifila- flexible thread prepared from long- ment thread composed of an organic chain polyolefin polymer known as protein called fibroin. This protein is polypropylene and is indicated for use derived from the domesticated species in soft tissue approximation. The poly- Bombyx mori (B. mori) of the family propylene surgical suture meets United Bombycidae. Natural nonabsorbable silk States Pharmacopeia (U.S.P.) require- surgical suture is indicated for use in ments as described in the U.S.P. Mono- soft tissue approximation. Natural graph for Nonabsorbable Surgical Su- nonabsorbable silk surgical suture tures; it may be undyed or dyed with meets the United States Pharmacopeia an FDA approved color additive; and (U.S.P.) monograph requirements for the suture may be provided with or Nonabsorbable Surgical Suture (class without a standard needle attached. I). Natural nonabsorbable silk surgical (b) Classification. Class II (special suture may be braided or twisted; it controls). The special control for this may be provided uncoated or coated; device is FDA’s ‘‘Class II Special Con- and it may be undyed or dyed with an trols Guidance Document: Surgical Su- FDA listed color additive. tures; Guidance for Industry and (b) Classification. Class II (special FDA.’’ See § 878.1(e) for the availability controls). The special control for this of this guidance document. device is FDA’s ‘‘Class II Special Con- trols Guidance Document: Surgical Su- [56 FR 24685, May 31, 1991, as amended at 68 FR 32984, June 3, 2003] tures; Guidance for Industry and FDA.’’ See § 878.1(e) for the availability § 878.5020 Nonabsorbable polyamide of this guidance document. surgical suture. [58 FR 57558, Oct. 26, 1993, as amended at 68 (a) Identification. Nonabsorbable poly- FR 32985, June 3, 2003] amide surgical suture is a nonabsorb- able, sterile, flexible thread prepared § 878.5035 Nonabsorbable expanded from long-chain aliphatic polymers polytetrafluoroethylene surgical su- Nylon 6 and Nylon 6,6 and is indicated ture. for use in soft tissue approximation. (a) Identification. Nonabsorbable ex- The polyamide surgical suture meets panded polytetrafluoroethylene United States Pharmacopeia (U.S.P.) (ePTFE) surgical suture is a requirements as described in the U.S.P. monofilament, nonabsorbable, sterile, monograph for nonabsorbable surgical flexible thread prepared from ePTFE sutures; it may be monofilament or and is intended for use in soft tissue multifilament in form; it may be pro- approximation and ligation, including vided uncoated or coated; and it may cardiovascular surgery. It may be be undyed or dyed with an appropriate undyed or dyed with an approved color FDA listed color additive. Also, the su- additive and may be provided with or ture may be provided with or without a without an attached needle(s). standard needle attached. (b) Classification. Class II (special (b) Classification. Class II (special controls). The special control for this controls). The special control for this device is FDA’s ‘‘Class II Special Con- device is FDA’s ‘‘Class II Special Con- trols Guidance Document: Surgical Su- trols Guidance Document: Surgical Su- tures; Guidance for Industry and tures; Guidance for Industry and FDA.’’ See § 878.1(e) for the availability FDA.’’ See § 878.1(e) for the availability of this guidance document. of this guidance document. [65 FR 20735, Apr. 18, 2000, as amended at 68 [56 FR 24685, May 31, 1991, as amended at 68 FR 32985, June 3, 2003] FR 32985, June 3, 2003]

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§ 878.5040 Suction lipoplasty system. ued functionality, sterility, and pack- (a) Identification. A suction lipoplasty age integrity over the identified shelf system is a device intended for aes- life. thetic body contouring. The device (6) Animal simulated-use testing consists of a powered suction pump must demonstrate that the device per- (containing a microbial filter on the forms as intended under anticipated exhaust and a microbial in-line filter conditions of use. The following per- in the connecting tubing between the formance characteristics must be test- collection bottle and the safety trap), ed: collection bottle, cannula, and con- (i) Device must be demonstrated to necting tube. The microbial filters, be effectively inserted, positioned, and tubing, collection bottle, and cannula removed from the site of use. must be capable of being changed be- (ii) Device must be demonstrated to tween patients. The powered suction precipitate surgical smoke particulates pump has a motor with a minimum of to clear the visual field for 1 ⁄3 horsepower, a variable vacuum range laparoscopic surgeries. from 0 to 29.9 inches of mercury, vacu- (iii) Device must be demonstrated to um control valves to regulate the vacu- be non-damaging to the site of use and um with accompanying vacuum animal subject. gauges, a single or double rotary vane (with or without oil), a single or double (7) Labeling must identify the fol- diaphragm, a single or double piston, lowing: and a safety trap. (i) Detailed instructions for use. (b) Classification. Class II (special (ii) Electrical safety and electro- controls). Consensus standards and la- magnetic compatibility information. beling restrictions. (iii) A shelf life. [63 FR 7705, Feb. 17, 1998] [83 FR 4143, Jan. 30, 2018]

§ 878.5050 Surgical smoke precipitator. Subpart F—Therapeutic Devices (a) Identification. A surgical smoke precipitator is a prescription device in- § 878.5070 Air-handling apparatus for tended for clearance of the visual field a surgical operating room. by precipitation of surgical smoke and (a) Identification. Air-handling appa- other aerosolized particulate matter ratus for a surgical operating room is a created during laparoscopic surgery. (b) Classification. Class II (special device intended to produce a directed, controls). The special controls for this nonturbulent flow of air that has been device are: filtered to remove particulate matter (1) Adverse tissue reaction must be and microorganisms to provide an area mitigated through the following: free of contaminants to reduce the pos- (i) Chemical characterization and sibility of infection in the patient. toxicological risk assessment of the (b) Classification. Class II. treated surgical smoke. (ii) Demonstration that the elements § 878.5350 Needle-type epilator. of the device that may contact the pa- (a) Identification. A needle-type epila- tient are biocompatible. tor is a device intended to destroy the (2) Electrical safety and electro- dermal papilla of a hair by applying magnetic compatibility testing must electric current at the tip of a fine nee- demonstrate that the device performs dle that has been inserted close to the as intended. hair shaft, under the skin, and into the (3) Software verification, validation, dermal papilla. The electric current and hazard analysis must be performed. may be high-frequency AC current, (4) Performance data must dem- high-frequency AC combined with DC onstrate the sterility of the patient contacting components of the device. current, or DC current only. (5) Performance data must support (b) Classification. Class I (general con- the shelf life of the sterile components trols). The device is exempt from the of the device by demonstrating contin- premarket notification procedures in

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subpart E of part 807 of this chapter, the availability of this guidance docu- subject to the limitations in § 878.9. ment. [53 FR 23872, June 24, 1988, as amended at 61 [76 FR 22807, Apr. 25, 2011] FR 1123, Jan. 16, 1996; 66 FR 38803, July 25, 2001] § 878.5900 Nonpneumatic tourniquet. (a) Identification. A nonpneumatic § 878.5360 Tweezer-type epilator. tourniquet is a device consisting of a (a) Identification. The tweezer-type strap or tubing intended to be wrapped epilator is an electrical device intended around a patient’s limb and tightened to remove hair. The energy provided at to reduce circulation. the tip of the tweezer used to remove (b) Classification. Class I (general con- hair may be radio frequency, galvanic trols). The device is exempt from the (direct current), or a combination of premarket notification procedures in radio frequency and galvanic energy. subpart E of part 807 of this chapter, (b) Classification. Class I (general con- subject to the limitations in § 878.9. trols). The device is exempt from pre- [53 FR 23872, June 24, 1988, as amended at 54 market notification procedures in sub- FR 13828, Apr. 5, 1989; 59 FR 63010, Dec. 7, part E of part 807 of this chapter sub- 1994; 66 FR 38803, July 25, 2001] ject to § 878.9. § 878.5910 Pneumatic tourniquet. [63 FR 57060, Oct. 26, 1998] (a) Identification. A pneumatic tour- niquet is an air-powered device con- § 878.5400 Low level laser system for sisting of a pressure-regulating unit, aesthetic use connecting tubing, and an inflatable (a) Identification. A Low Level Laser cuff. The cuff is intended to be wrapped System for Aesthetic Use is a device around a patient’s limb and inflated to using low level laser energy for the dis- reduce or totally occlude circulation ruption of adipocyte cells within the during surgery. fat layer for the release of fat and (b) Classification. Class I (general con- lipids from these cells for noninvasive trols). The device is exempt from the aesthetic use. premarket notification procedures in (b) Classification. Class II (special subpart E of part 807 of this chapter, controls). The special control for this subject to the limitations in § 878.9. device is the FDA guidance document [53 FR 23872, June 24, 1988, as amended at 61 entitled ‘‘Guidance for Industry and FR 1123, Jan. 16, 1996; 66 FR 38803, July 25, Food and Drug Administration Staff; 2001] Class II Special Controls Guidance Document: Low Level Laser System for PART 880—GENERAL HOSPITAL Aesthetic Use.’’ See § 878.1(e) for the AND PERSONAL USE DEVICES availability of this guidance document. [76 FR 20842, Apr. 14, 2011] Subpart A—General Provisions Sec. § 878.5650 Topical oxygen chamber for 880.1 Scope. extremities. 880.3 Effective dates of requirement for pre- (a) Identification. A topical oxygen market approval. chamber for extremities is a device 880.9 Limitations of exemptions from sec- that is intended to surround a patient’s tion 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). limb and apply humidified oxygen topi- cally at a pressure slightly greater Subpart B [Reserved] than atmospheric pressure to aid heal- ing of chronic skin ulcers such as bed- Subpart C—General Hospital and Personal sores. Use Monitoring Devices (b) Classification. Class II (special 880.2200 Liquid crystal forehead tempera- controls). The special control for this ture strip. 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.

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