392 Part 878—General and Plastic Surgery Devices

Pt. 878 21 CFR Ch. I (4–1–11 Edition)

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 878.4370 Surgical drape and drape accessories. SURGERY DEVICES 878.4380 Drape adhesive. 878.4400 Electrosurgical cutting and coagu- Subpart A—General Provisions lation device and accessories. 878.4410 Low energy ultrasound wound Sec. cleaner. 878.1 Scope. 878.4440 Eye pad. 878.3 Effective dates of requirement for pre- 878.4450 Nonabsorbable gauze for internal market approval. use. 878.9 Limitations of exemptions from sec- 878.4460 Surgeon’s glove. tion 510(k) of the Federal Food, Drug, 878.4470 Surgeon’s gloving cream. and Cosmetic Act (the act). 878.4480 Absorbable powder for lubricating a surgeon’s glove. Subpart B—Diagnostic Devices 878.4490 Absorbable hemostatic agent and 878.1800 Speculum and accessories. dressing. 878.4493 Absorbable poly(glycolide/L-lactide) Subpart C [Reserved] surgical suture. 878.4494 Absorbable poly(hydroxybutyrate) Subpart D—Prosthetic Devices surgical suture produced by recombinant DNA technology. 878.3250 External facial fracture fixation ap- 878.4495 Stainless steel suture. pliance. 878.4520 Polytetrafluoroethylene injectable. 878.3300 Surgical mesh. 878.4580 Surgical lamp. 878.3500 Polytetrafluoroethylene with car- 878.4630 Ultraviolet lamp for dermatologic bon fibers composite implant material. disorders. 878.3530 Silicone inflatable breast pros- 878.4635 Ultraviolet lamp for tanning. thesis. 878.4660 Skin marker. 878.3540 Silicone gel-filled breast prosthesis. 878.4680 Nonpowered, single patient, port- 878.3550 Chin prosthesis. able suction apparatus. 878.3590 Ear prosthesis. 878.4683 Non-Powered suction apparatus de- 878.3610 Esophageal prosthesis. vice intended for negative pressure 878.3680 Nose prosthesis. wound therapy. 878.3720 Tracheal prosthesls. 878.4700 Surgical microscope and acces- 878.3750 External prosthesis adhesive. sories. 878.3800 External aesthetic restoration pros- 878.4730 Surgical skin degreaser or adhesive thesis. tape solvent. 878.3900 Inflatable extremity splint. 878.4750 Implantable staple. 878.3910 Noninflatable extremity splint. 878.4760 Removable skin staple.

392

VerDate Mar<15>2010 12:50 Apr 27, 2011 Jkt 223072 PO 00000 Frm 00402 Fmt 8010 Sfmt 8010 Y:\SGML\223072.XXX 223072 WReier-Aviles on DSKGBLS3C1PROD with CFR Food and Drug Administration, HHS § 878.3

878.4780 Powered suction pump. this part, but shall state why the de- 878.4800 Manual surgical instrument for vice is substantially equivalent to general use. other devices, as required by § 807.87 of 878.4810 Laser surgical instrument for use in this chapter. general and plastic surgery and in dermatology. (c) To avoid duplicative listings, a 878.4820 Surgical instrument motors and ac- general and plastic surgery device that cessories/attachments. has two or more types of uses (e.g., 878.4830 Absorbable surgical gut suture. used both as a diagnostic device and as 878.4840 Absorbable polydioxanone surgical a therapeutic device) is listed in one suture. subpart only. 878.4930 Suture retention device. (d) References in this part to regu- 878.4950 Manual operating table and acces- latory sections of the Code of Federal sories and manual operating chair and accessories. Regulations are to chapter I of title 21 878.4960 Operating tables and accessories unless otherwise noted. and operating chairs and accessories. (e) Guidance documents referenced in 878.5000 Nonabsorbable poly(ethylene this part are available on the Internet terephthalate) surgical suture. at http://www.fda.gov/cdrh/guid- 878.5010 Nonabsorbable polypropylene sur- ance.html. gical suture. 878.5020 Nonabsorbable polyamide surgical [53 FR 23872, June 24, 1988, as amended at 67 suture. FR 77676, Dec. 19, 2002] 878.5030 Natural nonabsorbable silk surgical suture. § 878.3 Effective dates of requirement 878.5035 Nonabsorbable expanded polytetra- for premarket approval. fluoroethylene surgical suture. A device included in this part that is 878.5040 Suction lipoplasty system. classified into class III (premarket ap- Subpart F—Therapeutic Devices proval) shall not be commercially distributed after the date shown in the 878.5070 Air-handling apparatus for a sur- regulation classifying the device unless gical operating room. the manufacturer has an approval 878.5350 Needle-type epilator. under section 515 of the act (unless an 878.5360 Tweezer-type epilator. exemption has been granted under sec- 878.5650 Topical oxygen chamber for extremities. tion 520(g)(2) of the act). An approval 878.5900 Nonpneumatic tourniquet. under section 515 of the act consists of 878.5910 Pneumatic tourniquet. FDA’s issuance of an order approving an application for premarket approval AUTHORITY: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371. (PMA) for the device or declaring completed a product development protocol SOURCE: 53 FR 23872, June 24, 1988, unless (PDP) for the device. otherwise noted. (a) Before FDA requires that a device EDITORIAL NOTE: Nomenclature changes to commercially distributed before the part 878 appear at 73 FR 35341, June 23, 2008. enactment date of the amendments, or a device that has been found substan- Subpart A—General Provisions tially equivalent to such a device, has an approval under section 515 of the § 878.1 Scope. act, FDA must promulgate a regula- (a) This part sets forth the classification under section 515(b) of the act re- tion of general and plastic surgery de- quiring such approval, except as pro- vices intended for human use that are vided in paragraphs (b) and (c) of this in commercial distribution. section. Such a regulation under sec- (b) The identification of a device in a tion 515(b) of the act shall not be effec- regulation in this part is not a precise tive during the grace period ending on description of every device that is, or the 90th day after its promulgation or will be, subject to the regulation. A on the last day of the 30th full calendar manufacturer who submits a pre- month after the regulation that classi- market notification submission for a fies the device into class III is effec- device under part 807 cannot show tive, whichever is later. See section merely that the device is accurately 501(f)(2)(B) of the act. Accordingly, un- described by the section title and iden- less an effective date of the require- tification provision of a regulation in ment for premarket approval is shown

393

VerDate Mar<15>2010 12:50 Apr 27, 2011 Jkt 223072 PO 00000 Frm 00403 Fmt 8010 Sfmt 8010 Y:\SGML\223072.XXX 223072 WReier-Aviles on DSKGBLS3C1PROD with CFR § 878.9 21 CFR Ch. I (4–1–11 Edition)

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 within 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 (c) A device identified in a regulation rather than culture or immunoassay in this part that is classified into class technology; or III and that is subject to the transi- (c) The device is an in vitro device tional provisions of section 520(l) of the that is intended: act is automatically classified by statute into class III and must have an ap- (1) For use in the diagnosis, moni- proval under section 515 of the act be- toring, or screening of neoplastic dis- fore being commercially distributed. eases with the exception of Accordingly, the regulation for such a immunohistochemical devices; class III transitional device states that (2) For use in screening or diagnosis as of the enactment date of the amend- of familial or acquired genetic dis- ments, May 28, 1976, the device must orders, including inborn errors of me- have an approval under section 515 of tabolism; the act before commercial distribution. (3) For measuring an analyte that serves as a surrogate marker for § 878.9 Limitations of exemptions from screening, diagnosis, or monitoring section 510(k) of the Federal Food, life-threatening diseases such as ac- Drug, and Cosmetic Act (the act). quired immune deficiency syndrome The exemption from the requirement (AIDS), chronic or active hepatitis, tu- of premarket notification (section berculosis, or myocardial infarction or 510(k) of the act) for a generic type of to monitor therapy; class I or II device is only to the extent (4) For assessing the risk of cardio- that the device has existing or reason- vascular diseases; ably foreseeable characteristics of (5) For use in diabetes management;

394

VerDate Mar<15>2010 12:50 Apr 27, 2011 Jkt 223072 PO 00000 Frm 00404 Fmt 8010 Sfmt 8010 Y:\SGML\223072.XXX 223072 WReier-Aviles on DSKGBLS3C1PROD with CFR Food and Drug Administration, HHS § 878.3530

(6) For identifying or inferring the § 878.3300 Surgical mesh. identity of a microorganism directly (a) Identification. Surgical mesh is a from clinical material; metallic or polymeric screen intended (7) For detection of antibodies to to be implanted to reinforce soft tissue microorganisms other than or bone where weakness exists. Exam- immunoglobulin G (IgG) or IgG assays ples of surgical mesh are metallic and when the results are not qualitative, or polymeric mesh for hernia repair, and are used to determine immunity, or the acetabular and cement restrictor mesh assay is intended for use in matrices used during orthopedic surgery. other than serum or plasma; (b) Classification. Class II. (8) For noninvasive testing as defined in § 812.3(k) of this chapter; and § 878.3500 Polytetrafluoroethylene (9) For near patient testing (point of with carbon fibers composite implant material. care). (a) Identification. A polytetrafluoro- [65 FR 2317, Jan. 14, 2000] ethylene with carbon fibers composite implant material is a porous device Subpart B—Diagnostic Devices material intended to be implanted during surgery of the chin, jaw, nose, or § 878.1800 Speculum and accessories. bones or tissue near the eye or ear. The (a) Identification. A speculum is a de- device material serves as a space-occu- vice intended to be inserted into a body pying substance and is shaped and formed by the surgeon to conform to cavity to aid observation. It is either the patient’s need. nonilluminated or illuminated and (b) Classification. Class II. may have various accessories. (b) Classification. Class I (general con- § 878.3530 Silicone inflatable breast trols). The device is exempt from the prosthesis. premarket notification procedures in (a) Identification. A silicone inflatable subpart E of part 807 of this chapter, breast prosthesis is a silicone rubber subject to the limitations in § 878.9. shell made of polysiloxane(s), such as [53 FR 23872, June 24, 1988, as amended at 54 polydimethylsiloxane and FR 13827, Apr. 5, 1989; 59 FR 63010, Dec. 7, polydiphenylsiloxane, that is inflated 1994; 66 FR 38802, July 25, 2001] to the desired size with sterile isotonic saline before or after implantation. Subpart C [Reserved] The device is intended to be implanted to augment or reconstruct the female breast. Subpart D—Prosthetic Devices (b) Classification. Class III. (c) Date PMA or notice of completion of § 878.3250 External facial fracture fixa- a PDP is required. A PMA or a notice of tion appliance. completion of a PDP is required to be (a) Identification. An external facial filed with the Food and Drug Adminis- fracture fixation appliance is a metal tration on or before November 17, 1999, apparatus intended to be used during for any silicone inflatable breast pros- surgical reconstruction and repair to thesis that was in commercial distribu- immobilize maxillofacial bone frag- tion before May 28, 1976, or that has, on ments in their proper facial relation- or before November 17, 1999, been found ship. to be substantially equivalent to a sili- (b) Classification. Class I (general con- cone inflatable breast prosthesis that trols). The device is exempt from the was in commercial distribution before premarket notification procedures in May 28, 1976. Any other silicone inflat- subpart E of part 807 of this chapter able breast prosthesis shall have an ap- subject to § 878.9. proved PMA or a declared completed PDP in effect before being placed in [53 FR 23872, June 24, 1988, as amended at 54 commercial distribution. FR 13827, Apr. 5, 1989; 65 FR 2317, Jan. 14, 2000] [53 FR 23872, June 24, 1988, as amended at 64 FR 45161, Aug. 19, 1999]

395

VerDate Mar<15>2010 12:50 Apr 27, 2011 Jkt 223072 PO 00000 Frm 00405 Fmt 8010 Sfmt 8010 Y:\SGML\223072.XXX 223072 WReier-Aviles on DSKGBLS3C1PROD with CFR § 878.3540 21 CFR Ch. I (4–1–11 Edition)

§ 878.3540 Silicone gel-filled breast commercial distribution before May 28, prosthesis. 1976. Any other silicone gel-filled (a) Identification—(1) Single-lumen sili- breast prosthesis shall have an ap- cone gel-filled breast prosthesis. A single- proved PMA in effect before being lumen silicone gel-filled breast pros- placed in commercial distribution. thesis is a silicone rubber shell made of [53 FR 23872, June 24, 1988, as amended at 56 polysiloxane(s), such as FR 14627, Apr. 10, 1991] polydimethylsiloxane and polydiphenylsiloxane. The shell either § 878.3550 Chin prosthesis. contains a fixed amount cross-linked (a) Identification. A chin prosthesis is polymerized silicone gel, filler, and sta- a silicone rubber solid device intended bilizers or is filled to the desired size to be implanted to augment or recon- with injectable silicone gel at time of struct the chin. implantation. The device is intended to (b) Classification. Class II. be implanted to augment or reconstruct the female breast. § 878.3590 Ear prosthesis. (2) Double-lumen silicone gel-filled (a) Identification. An ear prosthesis is breast prosthesis. A double lumen sili- a silicone rubber solid device intended cone gel-filled breast prosthesis is a sil- to be implanted to reconstruct the ex- icone rubber inner shell and a silicone ternal ear. rubber outer shell, both shells made of (b) Classification. Class II. polysiloxane(s), such as polydimethylsiloxane and § 878.3610 Esophageal prosthesis. polydiphenylsiloxane. The inner shell (a) Identification. An esophageal pros- contains fixed amounts of cross-linked thesis is a rigid, flexible, or expandable polymerized silicone gel, fillers, and tubular device made of a plastic, stabilizers. The outer shell is inflated metal, or polymeric material that is to the desired size with sterile isotonic intended to be implanted to restore the saline before or after implantation. structure and/or function of the esoph- The device is intended to be implanted agus. The metal esophageal prosthesis to augment or reconstruct the female may be uncovered or covered with a breast. polymeric material. This device may (3) Polyurethane covered silicone gel- also include a device delivery system. filled breast prosthesis. A polyurethane (b) Classification. Class II. The special covered silicone gel-filled breast pros- control for this device is FDA’s ‘‘Guid- thesis is an inner silicone rubber shell ance for the Content of Premarket No- made of polysiloxane(s), such as tification Submissions for Esophageal polydimethylsiloxane and and Tracheal Prostheses.’’ polydiphenylsiloxane, with an outer silicone adhesive layer and an outer [65 FR 17145, Mar. 31, 2000] covering of polyurethane; contained within the inner shell is a fixed amount § 878.3680 Nose prosthesis. of cross-linked polymerized silicone (a) Identification. A nose prosthesis is gel, fillers, and stabilizers and an inert a silicone rubber solid device intended support structure compartmentalizing to be implanted to augment or recon- the silicone gel. The device is intended struct the nasal dorsum. to be implanted to augment or recon- (b) Classification. Class II. struct the female breast. (b) Classification. Class III. § 878.3720 Tracheal prosthesis. (c) Date premarket approval application (a) Identification. The tracheal pros- (PMA) is required. A PMA is required to thesis is a rigid, flexible, or expandable be filed with the Food and Drug Ad- tubular device made of a silicone, ministration on or before July 9, 1991 metal, or polymeric material that is for any silicone gel-filled breast pros- intended to be implanted to restore the thesis that was in commercial distribu- structure and/or function of the tration before May 28, 1976, or that has on chea or trachealbronchial tree. It may or before July 9, 1991 been found to be be unbranched or contain one or two substantially equivalent to a silicone branches. The metal tracheal pros- gel-filled breast prosthesis that was in thesis may be uncovered or covered

396

VerDate Mar<15>2010 12:50 Apr 27, 2011 Jkt 223072 PO 00000 Frm 00406 Fmt 8010 Sfmt 8010 Y:\SGML\223072.XXX 223072 WReier-Aviles on DSKGBLS3C1PROD with CFR Food and Drug Administration, HHS § 878.3925

with a polymeric material. This device § 878.3900 Inflatable extremity splint. may also include a device delivery sys- (a) Identification. An inflatable ex- tem. tremity splint is a device intended to (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 [65 FR 17146, Mar. 31, 2000] subpart E of part 807 of this chapter, subject to the limitations in § 878.9. § 878.3750 External prosthesis adhesive. [53 FR 23872, June 24, 1988, as amended at 59 FR 63010, Dec. 7, 1994; 66 FR 38802, July 25, (a) Identification. An external pros- 2001] thesis adhesive is a silicone-type adhesive intended to be used to fasten to § 878.3910 Noninflatable extremity the body an external aesthetic restora- splint. 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 sterile, 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 an ear, breast, or nose. Usually the de- chapter, with respect to complaint vice is made of silicone rubber and it files. may be fastened to the body with an [53 FR 23872, June 24, 1988, as amended at 54 external prosthesis adhesive. The de- FR 13827, Apr. 5, 1989; 65 FR 2317, Jan. 14, vice is not intended to be implanted. 2000] (b) Classification. Class I (general controls). The device is exempt from the § 878.3925 Plastic surgery kit and ac- premarket notification procedures in cessories. subpart E of part 807 of this chapter, (a) Identification. A plastic surgery subject to the limitations in § 878.9. If kit and accessories is a device intended the device is intended for use without to be used to reconstruct maxillofacial an external prosthesis adhesive to fas- deficiencies. The kit contains surgical ten it to the body, the device is exempt instruments and materials used to from the current good manufacturing make maxillofacial impressions before practice requirements of the quality molding an external prosthesis. system regulation in part 820 of this (b) Classification. Class I (general con- chapter, with the exception of § 820.180, trols). The device is exempt from the with respect to general requirements premarket notification procedures in concerning records, and § 820.198, with subpart E of part 807 of this chapter respect to complaint files. subject to § 878.9. [53 FR 23872, June 24, 1988, as amended at 59 [53 FR 23872, June 24, 1988, as amended at 54 FR 63010, Dec. 7, 1994; 66 FR 38802, July 25, FR 13827, Apr. 5, 1989; 65 FR 2317, Jan. 14, 2001] 2000]

397

VerDate Mar<15>2010 12:50 Apr 27, 2011 Jkt 223072 PO 00000 Frm 00407 Fmt 8010 Sfmt 8010 Y:\SGML\223072.XXX 223072 WReier-Aviles on DSKGBLS3C1PROD with CFR § 878.4010 21 CFR Ch. I (4–1–11 Edition)

Subpart E—Surgical Devices (b) Classification. Class II (special controls). The special control for this § 878.4010 Tissue adhesive. device is FDA’s ‘‘Guidance for Industry (a) Tissue adhesive for the topical ap- and FDA Staff; Class II Special Con- proximation of skin—(1) Identification. A trols Guidance Document: Tissue Adhe- tissue adhesive for the topical approxi- sive with Adjunct Wound Closure De- mation of skin is a device intended for vice Intended for the Topical Approxi- topical closure of surgical incisions, in- mation of Skin.’’ See § 878.1(e) for the cluding laparoscopic incisions, and availability of this guidance document. simple traumatic lacerations that have [75 FR 68794, Nov. 10, 2010] easily approximated skin edges. Tissue adhesives for the topical approxima- § 878.4014 Nonresorbable gauze/sponge tion of skin may be used in conjunction for external use. with, but not in place of, deep dermal stitches. (a) Identification. A nonresorbable (2) Classification. Class II (special con- gauze/sponge for external use is a ster- trols). The special control for this de- ile or nonsterile device intended for vice is FDA’s ‘‘Class II Special Controls medical purposes, such as to be placed Guidance Document: ‘‘Tissue Adhesive directly on a patient’s wound to absorb for the Topical Approximation of exudate. It consists of a strip, piece, or Skin.’’ See § 878.1(e) of this chapter for pad made from open woven or the availability of this guidance docu- nonwoven mesh cotton cellulose or a ment. simple chemical derivative of cellulose. (b) Tissue adhesive for non-topical This classification does not include a use—(1) Identification. A tissue adhesive nonresorbable gauze/sponge for exter- for non-topical use, including adhesives nal use that contains added drugs such intended for use in the embolization of as antimicrobial agents, added bio- brain arteriovenous malformation or logics such as growth factors, or is for use in ophthalmic surgery, is a de- composed of materials derived from vice used for adhesion of internal tis- animal sources. sues and vessels. (b) Classification. Class I (general con- (2) Classification. Class III (premarket trols). The device is exempt from the approval). As of May 28, 1976, an ap- premarket notification procedures in proval under section 515 of the act is part 807, subpart E of this chapter sub- required before this device may be ject to the limitations in § 878.9. commercially distributed. See § 878.3 of this chapter. [64 FR 53929, Oct. 5, 1999] [73 FR 31033, May 30, 2008] § 878.4015 Wound dressing with poly § 878.4011 Tissue adhesive with ad- (diallyl dimethyl ammonium chlo- junct wound closure device for top- ride) (pDADMAC) additive. ical approximation of skin. (a) Identification. A wound dressing (a) Identification. A tissue adhesive with pDADMAC additive is intended with adjunct wound closure device in- for use as a primary dressing for exud- tended for the topical approximation of ing wounds, 1st and 2d degree burns, skin is a device indicated for topical and surgical wounds, to secure and pre- application only to hold closed easily vent movement of a primary dressing, approximated skin edges of wounds and as a wound packing. from surgical incisions, including (b) Classification. Class II (special punctures from minimally invasive controls). The special control is: the surgery, and simple, thoroughly FDA guidance document entitled cleansed, trauma-induced lacerations. ‘‘Class II Special Controls Guidance It may be used in conjunction with, but Document: Wound Dressing With Poly not in place of, deep dermal stitches. (Diallyl Dimethyl Ammonium Chlo- Additionally, the adjunct wound clo- ride) (pDADMAC) Additive.’’ See sure device component maintains tem- § 878.1(e) for availability of this guid- porary skin edge alignment along the ance document. length of wound during application of the liquid adhesive. [74 FR 53167, Oct. 16, 2009]

398

VerDate Mar<15>2010 12:50 Apr 27, 2011 Jkt 223072 PO 00000 Frm 00408 Fmt 8010 Sfmt 8010 Y:\SGML\223072.XXX 223072 WReier-Aviles on DSKGBLS3C1PROD with CFR Food and Drug Administration, HHS § 878.4040

§ 878.4018 Hydrophilic wound dress- philic polymers or other material in ing. combination with water (at least 50 (a) Identification. A hydrophilic percent) and capable of absorbing wound dressing is a sterile or non-ster- exudate. This classification does not ile device intended to cover a wound include a hydrogel wound dressing that and to absorb exudate. It consists of contains added drugs such as anti- nonresorbable materials with hydro- microbial agents, added biologics such philic properties that are capable of ab- as growth factors, or is composed of sorbing exudate (e.g., cotton, cotton materials derived from animal sources. derivatives, alginates, dextran, and (b) Classification. Class I (general con- rayon). This classification does not in- trols). The device is exempt from the clude a hydrophilic wound dressing premarket notification procedures in that contains added drugs such as anti- part 807, subpart E of this chapter sub- microbial agents, added biologics such ject to the limitations in § 878.9. as growth factors, or is composed of materials derived from animal sources. [64 FR 53929, Oct. 5, 1999] (b) Classification. Class I (general controls). The device is exempt from the § 878.4025 Silicone sheeting. premarket notification procedures in (a) Identification. Silicone sheeting is part 807, subpart E of this chapter sub- intended for use in the management of ject to the limitations in § 878.9. closed hyperproliferative (hypertrophic [64 FR 53929, Oct. 5, 1999] and keloid) scars. (b) Classification. Class I (general con- § 878.4020 Occlusive wound dressing. trols). The device is exempt from the (a) Identification. An occlusive wound premarket notification procedures in dressing is a nonresorbable, sterile or subpart E of part 807 of this chapter non-sterile device intended to cover a subject to the limitations in § 878.9. wound, to provide or support a moist [69 FR 48148, Aug. 9, 2004] wound environment, and to allow the exchange of gases such as oxygen and § 878.4040 Surgical apparel. water vapor through the device. It consists of a piece of synthetic polymeric (a) Identification. Surgical apparel are material, such as polyurethane, with or devices that are intended to be worn by without an adhesive backing. This clas- operating room personnel during sur- sification does not include an occlusive gical procedures to protect both the wound dressing that contains added surgical patient and the operating drugs such as antimicrobial agents, room personnel from transfer of micro- added biologics such as growth factors, organisms, body fluids, and particulate or is composed of materials derived material. Examples include surgical from animal sources. caps, hoods, masks, gowns, operating (b) Classification. Class I (general con- room shoes and shoe covers, and isola- trols). The device is exempt from the tion masks and gowns. Surgical suits premarket notification procedures in and dresses, commonly known as scrub part 807, subpart E of this chapter sub- suits, are excluded. ject to the limitations in § 878.9. (b) Classification. (1) Class II (special [64 FR 53929, Oct. 5, 1999] controls) for surgical gowns and surgical masks. § 878.4022 Hydrogel wound dressing (2) Class I (general controls) for sur- and burn dressing. gical apparel other than surgical gowns (a) Identification. A hydrogel wound and surgical masks. The class I device dressing is a sterile or non-sterile de- is exempt from the premarket notifica- vice intended to cover a wound, to ab- tion procedures in subpart E of part 807 sorb wound exudate, to control bleed- of this chapter subject to § 878.9. ing or fluid loss, and to protect against abrasion, friction, desiccation, and con- [53 FR 23872, June 24, 1988, as amended at 65 tamination. It consists of a FR 2317, Jan. 14, 2000] nonresorbable matrix made of hydro-

399

VerDate Mar<15>2010 12:50 Apr 27, 2011 Jkt 223072 PO 00000 Frm 00409 Fmt 8010 Sfmt 8010 Y:\SGML\223072.XXX 223072 WReier-Aviles on DSKGBLS3C1PROD with CFR § 878.4100 21 CFR Ch. I (4–1–11 Edition)

§ 878.4100 Organ bag. § 878.4300 Implantable clip. (a) Identification. An organ bag is a (a) Identification. An implantable clip device that is a flexible plastic bag in- is a clip-like device intended to con- tended to be used as a temporary recep- nect internal tissues to aid healing. It tacle for an organ during surgical pro- is not absorbable. cedures to prevent moisture loss. (b) Classification. Class II. (b) Classification. Class I (general con- § 878.4320 Removable skin clip. trols). The device is exempt from the premarket notification procedures in (a) Identification. A removable skin 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- ical massager intended for the disrup- [53 FR 23872, June 24, 1988, as amended at 54 tion of adipocyte cells intended for FR 13827, Apr. 5, 1989; 66 FR 38802, July 25, non-invasive aesthetic use. 2001] (b) Classification. Class II (special controls). The special controls for this § 878.4200 Introduction/drainage cath- device is FDA’s ‘‘Guidance for Industry eter and accessories. and FDA Staff; Class II Special Con- (a) Identification. An introduction/ trols Guidance Document: Contact drainage catheter is a device that is a Cooling System for Aesthetic Use.’’ See flexible single or multilumen tube in- § 878.1(e) for the availability of this tended to be used to introduce nondrug guidance document. fluids into body cavities other than [76 FR 6553, Feb. 7, 2011] blood vessels, drain fluids from body cavities, or evaluate certain physio- § 878.4350 Cryosurgical unit and acces- logic conditions. Examples include irri- sories. gation and drainage catheters, pedi- (a) Identification—(1) Cryosurgical unit atric catheters, peritoneal catheters with a liquid nitrogen cooled cryoprobe (including dialysis), and other general and accessories. A cryosurgical unit surgical catheters. An introduction/ with a liquid nitrogen cooled cryoprobe drainage catheter accessory is intended and accessories is a device intended to to aid in the manipulation of or inser- destroy tissue during surgical proce- tion of the device into the body. Exam- dures by applying extreme cold. ples of accessories include adaptors, (2) Cryosurgical unit with a nitrous connectors, and catheter needles. oxide cooled cryoprobe and accessories. A (b) Classification. Class I (general con- cryosurgical unit with a nitrous oxide trols). The device is exempt from the cooled cryoprobe and accessories is a device intended to destroy tissue dur- premarket notification procedures in ing surgical procedures, including subpart E of part 807 of this chapter urological applications, by applying ex- subject to § 878.9. treme cold. [53 FR 23872, June 24, 1988, as amended at 65 (3) Cryosurgical unit with a carbon di- FR 2318, Jan. 14, 2000] oxide cooled cryoprobe or a carbon dioxide

400

VerDate Mar<15>2010 12:50 Apr 27, 2011 Jkt 223072 PO 00000 Frm 00410 Fmt 8010 Sfmt 8010 Y:\SGML\223072.XXX 223072 WReier-Aviles on DSKGBLS3C1PROD with CFR Food and Drug Administration, HHS § 878.4450

dry ice applicator and accessories. A (b) Classification. Class II. cryosurgical unit with a carbon dioxide cooled cryoprobe or a carbon dioxide § 878.4410 Low energy ultrasound dry ice applicator and accessories is a wound cleaner. device intended to destroy tissue dur- (a) Identification. A low energy ing surgical procedures by applying ex- ultrasound wound cleaner is a device treme cold. The device is intended to that uses ultrasound energy to vapor- treat disease conditions such as tu- ize a solution and generate a mist that mors, skin cancers, acne scars, or is used for the cleaning and mainte- hemangiomas (benign tumors con- nance debridement of wounds. Low lev- sisting of newly formed blood vessels) and various benign or malignant gyne- els of ultrasound energy may be carried cological conditions affecting vulvar, to the wound by the saline mist. vaginal, or cervical tissue. The device (b) Classification. Class II (special is not intended for urological applica- controls). The special control is FDA’s tions. guidance document entitled ‘‘Class II (b) Classification. Class II. Special Controls Guidance Document: Low Energy Ultrasound Wound Clean- § 878.4370 Surgical drape and drape er.’’ See § 878.1(e) for the availability of accessories. this guidance document. (a) Identification. A surgical drape and drape accessories is a device made [70 FR 67355, Nov. 7, 2005] of natural or synthetic materials in- § 878.4440 Eye pad. tended to be used as a protective patient covering, such as to isolate a site (a) Identification. An eye pad is a de- of surgical incision from microbial and vice that consists of a pad made of var- other contamination. The device in- ious materials, such as gauze and cot- cludes a plastic wound protector that ton, intended for use as a bandage over may adhere to the skin around a sur- the eye for protection or absorption of gical incision or be placed in a wound secretions. to cover its exposed edges, and a latex (b) Classification. Class I (general con- drape with a self-retaining finger cot trols). The device is exempt from the that is intended to allow repeated in- premarket notification procedures in sertion of the surgeon’s finger into the subpart E of part 807 of this chapter, rectum during performance of a subject to the limitations in § 878.9. transurethral prostatectomy. (b) Classification. Class II. [53 FR 23872, June 24, 1988, as amended at 59 FR 63010, Dec. 7, 1994; 66 FR 38803, July 25, § 878.4380 Drape adhesive. 2001] (a) Identification. A drape adhesive is a device intended to be placed on the § 878.4450 Nonabsorbable gauze for in- skin to attach a surgical drape. ternal use. (b) Classification. Class I (general con- (a) Identification. Nonabsorbable trols). The device is exempt from the gauze for internal use is a device made premarket notification procedures in of an open mesh fabric intended to be subpart E of part 807 of this chapter, used inside the body or a surgical inci- subject to the limitations in § 878.9. sion or applied to internal organs or [53 FR 23872, June 24, 1988, as amended at 59 structures, to control bleeding, absorb FR 63010, Dec. 7, 1994; 66 FR 38802, July 25, fluid, or protect organs or structures 2001] from abrasion, drying, or contamination. The device is woven from mate- § 878.4400 Electrosurgical cutting and rial made of not less than 50 percent by coagulation device and accessories. mass cotton, cellulose, or a simple (a) Identification. An electrosurgical chemical derivative of cellulose, and cutting and coagulation device and ac- contains x-ray detectable elements. cessories is a device intended to re- (b) Classification. Class I (general con- move tissue and control bleeding by trols). The device is exempt from the use of high-frequency electrical cur- premarket notification procedures in rent.

401

VerDate Mar<15>2010 12:50 Apr 27, 2011 Jkt 223072 PO 00000 Frm 00411 Fmt 8010 Sfmt 8010 Y:\SGML\223072.XXX 223072 WReier-Aviles on DSKGBLS3C1PROD with CFR § 878.4460 21 CFR Ch. I (4–1–11 Edition)

subpart E of part 807 of this chapter, celerating the clotting process of subject to the limitations in § 878.9. blood. It is absorbable. (b) Classification. Class III. [53 FR 23872, June 24, 1988, as amended at 61 (c) Date PMA or notice of completion of FR 1123, Jan. 16, 1996; 66 FR 38803, July 25, 2001] a PDP is required. As of May 28, 1976, an approval under section 515 of the act is § 878.4460 Surgeon’s glove. required before this device may be commercially distributed. See § 878.3. (a) Identification. A surgeon’s glove is a device made of natural or synthetic § 878.4493 Absorbable poly(glycolide/L- rubber intended to be worn by oper- lactide) surgical suture. ating room personnel to protect a sur- (a) Identification. An absorbable gical wound from contamination. The poly(glycolide/L-lactide) surgical su- lubricating or dusting powder used in ture (PGL suture) is an absorbable the glove is excluded. sterile, flexible strand as prepared and (b) Classification. Class I (general con- synthesized from homopolymers of trols). glycolide and copolymers made from 90 [53 FR 23872, June 24, 1988, as amended at 66 percent glycolide and 10 percent L- FR 46952, Sept. 10, 2001] lactide, and is indicated for use in soft tissue approximation. A PGL suture § 878.4470 Surgeon’s gloving cream. meets United States Pharmacopeia (a) Identification. Surgeon’s gloving (U.S.P.) requirements as described in cream is an ointment intended to be the U.S.P. ‘‘Monograph for Absorbable used to lubricate the user’s hand before Surgical Sutures;’’ it may be putting on a surgeon’s glove. monofilament or multifilament (braid- (b) Classification. Class I (general con- ed) in form; it may be uncoated or trols). The device is exempt from the coated; and it may be undyed or dyed premarket notification procedures in with an FDA-approved color additive. subpart E of part 807 of this chapter, Also, the suture may be provided with subject to the limitations in § 878.9. or without a standard needle attached. (b) Classification. Class II (special [53 FR 23872, June 24, 1988, as amended at 59 controls). The special control for this FR 63010, Dec. 7, 1994; 66 FR 38803, July 25, device is FDA’s ‘‘Class II Special Con- 2001] trols Guidance Document: Surgical Su- tures; Guidance for Industry and § 878.4480 Absorbable powder for lu- FDA.’’ See § 878.1(e) for the availability bricating a surgeon’s glove. of this guidance document. (a) Identification. Absorbable powder for lubricating a surgeon’s glove is a [56 FR 47151, Sept. 18, 1991, as amended at 68 powder made from corn starch that FR 32984, June 3, 2003] meets the specifications for absorbable § 878.4494 Absorbable powder in the United States Pharma- poly(hydroxybutyrate) surgical su- copeia (U.S.P.) and that is intended to ture produced by recombinant DNA be used to lubricate the surgeon’s hand technology. before putting on a surgeon’s glove. (a) Identification. An absorbable The device is absorbable through bio- poly(hydroxybutyrate) surgical suture logical degradation. is an absorbable surgical suture made (b) Classification. Class III. of material isolated from prokaryotic (c) Date PMA or notice of completion of cells produced by recombinant a PDP is required. As of May 28, 1976, an deoxyribonucleic acid (DNA) tech- approval under section 515 of the act is nology. The device is intended for use required before this device may be in general soft tissue approximation commercially distributed. See § 878.3. and ligation. (b) Classification. Class II (special § 878.4490 Absorbable hemostatic controls). The special control for this agent and dressing. device is the FDA guidance document (a) Identification. An absorbable he- entitled ‘‘Class II Special Controls mostatic agent or dressing is a device Guidance Document: Absorbable intended to produce hemostasis by ac- Poly(hydroxybutyrate) Surgical Suture

402

VerDate Mar<15>2010 12:50 Apr 27, 2011 Jkt 223072 PO 00000 Frm 00412 Fmt 8010 Sfmt 8010 Y:\SGML\223072.XXX 223072 WReier-Aviles on DSKGBLS3C1PROD with CFR Food and Drug Administration, HHS § 878.4680

Produced by Recombinant DNA Tech- tions for the device’s use with that nology.’’ For the availability of this drug. guidance document see § 878.1(e). (b) Classification. Class II. [72 FR 43146, Aug. 3, 2007] § 878.4635 Ultraviolet lamp for tan- § 878.4495 Stainless steel suture. ning. (a) Identification. A stainless steel su- (a) Identification. An ultraviolet lamp ture is a needled or unneedled non- for tanning is a device that is a lamp absorbable surgical suture composed of (including a fixture) intended to pro- 316L stainless steel, in USP sizes 12–0 vide ultraviolet radiation to tan the through 10, or a substantially equiva- skin. See § 1040.20 of this chapter. lent stainless steel suture, intended for (b) Classification. Class I (general con- use in abdominal wound closure, intes- trols). The device is exempt from the tinal anastomosis, hernia repair, and premarket notification procedures in sternal closure. subpart E of part 807 of this chapter, (b) Classification. Class II (special subject to the limitations in § 878.9. controls). The special control for this device is FDA’s ‘‘Class II Special Con- [55 FR 48440, Nov. 20, 1990, as amended at 59 trols Guidance Document: Surgical Su- FR 63010, Dec. 7, 1994; 66 FR 38803, July 25, tures; Guidance for Industry and 2001] FDA.’’ See § 878.1(e) for the availability § 878.4660 Skin marker. of this guidance document. (a) Identification. A skin marker is a [65 FR 19836, Apr. 13, 2000, as amended at 68 pen-like device intended to be used to FR 32984, June 3, 2003] write on the patient’s skin, e.g., to out- § 878.4520 Polytetrafluoroethylene line surgical incision sites or mark an- injectable. atomical sites for accurate blood pres- (a) Identification. Polytetrafluoro- sure measurement. ethylene injectable is an injectable (b) Classification. Class I (general con- paste prosthetic device composed of trols). The device is exempt from the polytetrafluoroethylene intended to be premarket notification procedures in used to augment or reconstruct a vocal subpart E of part 807 of this chapter, cord. subject to the limitations in § 878.9. (b) Classification. Class III. [53 FR 23872, June 24, 1988, as amended at 59 (c) Date PMA or notice of completion of FR 63010, Dec. 7, 1994; 66 FR 38803, July 25, a PDP is required. As of May 28, 1976, an 2001] approval under section 515 of the act is required before this device may be § 878.4680 Nonpowered, single patient, commercially distributed. See § 878.3. portable suction apparatus. § 878.4580 Surgical lamp. (a) Identification. A nonpowered, single patient, portable suction apparatus (a) A surgical lamp (in- Identification. is a device that consists of a manually cluding a fixture) is a device intended operated plastic, disposable evacuation to be used to provide visible illumina- system intended to provide a vacuum tion of the surgical field or the patient. for suction drainage of surgical (b) Classification. Class II. wounds. § 878.4630 Ultraviolet lamp for der- (b) Classification. Class I (general con- matologic disorders. trols). The device is exempt from the (a) Identification. An ultraviolet lamp premarket notification procedures in for dermatologic disorders is a device subpart E of part 807 of this chapter (including a fixture) intended to pro- subject to § 878.9. vide ultraviolet radiation of the body [53 FR 23872, June 24, 1988, as amended at 65 to photoactivate a drug in the treat- FR 2318, Jan. 14, 2000] ment of a dermatologic disorder if the labeling of the drug intended for use with the device bears adequate direc-

403

VerDate Mar<15>2010 12:50 Apr 27, 2011 Jkt 223072 PO 00000 Frm 00413 Fmt 8010 Sfmt 8010 Y:\SGML\223072.XXX 223072 WReier-Aviles on DSKGBLS3C1PROD with CFR § 878.4683 21 CFR Ch. I (4–1–11 Edition)

§ 878.4683 Non-Powered suction appa- § 878.4750 Implantable staple. ratus device intended for negative (a) Identification. An implantable sta- pressure wound therapy. ple is a staple-like device intended to (a) Identification. A non-powered suc- connect internal tissues to aid healing. tion apparatus device intended for neg- It is not absorbable. ative pressure wound therapy is a de- (b) Classification. Class II. vice that is indicated for wound management via application of negative § 878.4760 Removable skin staple. pressure to the wound for removal of (a) Identification. A removable skin fluids, including wound exudate, irriga- staple is a staple-like device intended tion fluids, and infectious materials. It to connect external tissues temporarily is further indicated for management of to aid healing. It is not absorbable. wounds, burns, flaps, and grafts. (b) Classification. Class I (general con- (b) Classification. Class II (special trols). The device is exempt from the controls). The special control for this premarket notification procedures in device is FDA’s ‘‘Class II Special Con- subpart E of part 807 of this chapter trols Guidance Document: Non-powered subject to § 878.9. Suction Apparatus Device Intended for Negative Pressure Wound Therapy [53 FR 23872, June 24, 1988, as amended at 65 FR 2318, Jan. 14, 2000] (NPWT).’’ See § 878.1(e) for the availability of this guidance document. § 878.4780 Powered suction pump. [75 FR 70114, Nov. 17, 2010] (a) Identification. A powered suction pump is a portable, AC-powered or § 878.4700 Surgical microscope and ac- compressed air-powered device in- cessories. tended to be used to remove infectious (a) Identification. A surgical micro- materials from wounds or fluids from a scope and accessories is an AC-powered patient’s airway or respiratory support device intended for use during surgery system. The device may be used during to provide a magnified view of the sur- surgery in the operating room or at the gical field. patient’s bedside. The device may in- (b) Classification. Class I (general con- clude a microbial filter. trols). The device is exempt from the (b) Classification. Class II. premarket notification procedures in subpart E of part 807 of this chapter, § 878.4800 Manual surgical instrument for general use. subject to the limitations in § 878.9. (a) Identification. A manual surgical [55 FR 48440, Nov. 20, 1990, as amended at 59 instrument for general use is a non- FR 63010, Dec. 7, 1994; 66 FR 38803, July 25, powered, hand-held, or hand-manipu- 2001] lated device, either reusable or dispos- § 878.4730 Surgical skin degreaser or able, intended to be used in various adhesive tape solvent. general surgical procedures. The device includes the applicator, clip applier, bi- (a) Identification. A surgical skin opsy brush, manual dermabrasion degreaser or an adhesive tape solvent is brush, scrub brush, cannula, ligature a device that consists of a liquid such carrier, chisel, clamp, contractor, cu- as 1,1,2-trichloro-1,2,2-trifluoroethane; rette, cutter, dissector, elevator, skin 1,1,1-trichloroethane; and 1,1,1-tri- graft expander, file, forceps, gouge, in- chloroethane with mineral spirits instrument guide, needle guide, hammer, tended to be used to dissolve surface hemostat, amputation hook, ligature skin oil or adhesive tape. passing and knot-tying instrument, (b) Classification. Class I (general con- knife, blood lancet, mallet, disposable trols). The device is exempt from the or reusable aspiration and injection premarket notification procedures in needle, disposable or reusable suturing subpart E of part 807 of this chapter, needle, osteotome, pliers, rasp, re- subject to the limitations in § 878.9. tainer, retractor, saw, scalpel blade, [53 FR 23872, June 24, 1988, as amended at 59 scalpel handle, one-piece scalpel, snare, FR 63010, Dec. 7, 1994; 66 FR 38803, July 25, spatula, stapler, disposable or reusable 2001] stripper, stylet, suturing apparatus for

404

VerDate Mar<15>2010 12:50 Apr 27, 2011 Jkt 223072 PO 00000 Frm 00414 Fmt 8010 Sfmt 8010 Y:\SGML\223072.XXX 223072 WReier-Aviles on DSKGBLS3C1PROD with CFR Food and Drug Administration, HHS § 878.4930

the stomach and intestine, measuring subpart E of part 807 of this chapter tape, and calipers. A surgical instru- subject to § 878.9. ment that has specialized uses in a spe- [55 FR 48440, Nov. 20, 1990, as amended at 65 cific medical specialty is classified in FR 2318, 2000] separate regulations in parts 868 through 892. § 878.4830 Absorbable surgical gut su- (b) Classification. Class I (general con- ture. trols). The device is exempt from the (a) Identification. An absorbable sur- premarket notification procedures in gical gut suture, both plain and chro- subpart E of part 807 of this chapter, mic, is an absorbable, sterile, flexible subject to the limitations in § 878.9. thread prepared from either the serosal connective tissue layer of beef (bovine) [53 FR 23872, June 24, 1988, as amended at 54 or the submucosal fibrous tissue of FR 13828, Apr. 5, 1989; 59 FR 63010, Dec. 7, sheep (ovine) intestine, and is intended 1994; 66 FR 38803, July 25, 2001] for use in soft tissue approximation. (b) Classification. Class II (special § 878.4810 Laser surgical instrument controls). The special control for this for use in general and plastic surgery and in dermatology. device is FDA’s ‘‘Class II Special Con- trols Guidance Document: Surgical Su- (a) Identification. (1) A carbon dioxide tures; Guidance for Industry and laser for use in general surgery and in FDA.’’ See § 878.1(e) for the availability dermatology is a laser device intended of this guidance document. to cut, destroy, or remove tissue by [54 FR 50738, Dec. 11, 1989, as amended at 68 light energy emitted by carbon dioxide. FR 32984, June 3, 2003] (2) An argon laser for use in dermatology is a laser device intended to de- § 878.4840 Absorbable polydioxanone stroy or coagulate tissue by light en- surgical suture. ergy emitted by argon. (a) Identification. An absorbable (b) Classification. (1) Class II. polydioxanone surgical suture is an ab- (2) Class I for special laser gas mix- sorbable, flexible, sterile, tures used as a lasing medium for this monofilament thread prepared from class of lasers. The devices subject to polyester polymer poly (p-dioxanone) this paragraph (b)(2) are exempt from and is intended for use in soft tissue the premarket notification procedures approximation, including pediatric car- in subpart E of part 807 of this chapter, diovascular tissue where growth is ex- subject to the limitations in § 878.9. pected to occur, and ophthalmic surgery. It may be coated or uncoated, [53 FR 23872, June 24, 1988, as amended at 61 undyed or dyed, and with or without a FR 1123, Jan. 16, 1996; 66 FR 38803, July 25, standard needle attached. 2001] (b) Classification. Class II (special controls). The special control for the § 878.4820 Surgical instrument motors device is FDA’s ‘‘Class II Special Con- and accessories/attachments. trols Guidance Document: Surgical Su- (a) Identification. Surgical instrument tures; Guidance for Industry and motors and accessories are AC-pow- FDA.’’ See § 878.1(e) for the availability ered, battery-powered, or air-powered of this guidance document. devices intended for use during surgical [67 FR 77676, Dec. 19, 2002] procedures to provide power to operate various accessories or attachments to § 878.4930 Suture retention device. cut hard tissue or bone and soft tissue. (a) Identification. A suture retention Accessories or attachments may in- device is a device, such as a retention clude a bur, chisel (osteotome), bridge, a surgical button, or a suture dermabrasion brush, dermatome, drill bolster, intended to aid wound healing bit, hammerhead, pin driver, and saw by distributing suture tension over a blade. larger area in the patient. (b) Classification. Class I (general con- (b) Classification. Class I (general controls). The device is exempt from the trols). The device is exempt from the premarket notification procedures in premarket notification procedures in

405

VerDate Mar<15>2010 12:50 Apr 27, 2011 Jkt 223072 PO 00000 Frm 00415 Fmt 8010 Sfmt 8010 Y:\SGML\223072.XXX 223072 WReier-Aviles on DSKGBLS3C1PROD with CFR § 878.4950 21 CFR Ch. I (4–1–11 Edition)

subpart E of part 807 of this chapter, Nonabsorbable Surgical Sutures; it subject to the limitations in § 878.9. may be provided uncoated or coated; and it may be undyed or dyed with an [53 FR 23872, June 24, 1988, as amended at 59 FR 63010, Dec. 7, 1994; 66 FR 38803, July 25, appropriate FDA listed color additive. 2001] Also, the suture may be provided with or without a standard needle attached. § 878.4950 Manual operating table and (b) Classification. Class II (special accessories and manual operating controls). The special control for this chair and accessories. device is FDA’s ‘‘Class II Special Con- (a) Identification. A manual operating trols Guidance Document: Surgical Su- table and accessories and a manual op- tures; Guidance for Industry and erating chair and accessories are non- FDA.’’ See § 878.1(e) for the availability powered devices, usually with movable of this guidance document. components, intended to be used to [56 FR 24685, May 31, 1991, as amended at 68 support a patient during diagnostic ex- FR 32984, June 3, 2003] aminations or surgical procedures. (b) Classification. Class I (general con- § 878.5010 Nonabsorbable poly- trols). The device is exempt from the propylene surgical suture. premarket notification procedures in (a) Identification. Nonabsorbable poly- subpart E of part 807 of this chapter, propylene surgical suture is a subject to the limitations in § 878.9. monofilament, nonabsorbable, sterile, [53 FR 23872, June 24, 1988, as amended at 54 flexible thread prepared from long- FR 13828, Apr. 5, 1989; 59 FR 63010, Dec. 7, chain polyolefin polymer known as 1994; 66 FR 38803, July 25, 2001] polypropylene and is indicated for use in soft tissue approximation. The poly- § 878.4960 Operating tables and acces- propylene surgical suture meets United sories and operating chairs and ac- States Pharmacopeia (U.S.P.) require- cessories. ments as described in the U.S.P. Mono- (a) Identification. Operating tables graph for Nonabsorbable Surgical Su- and accessories and operating chairs tures; it may be undyed or dyed with and accessories are AC-powered or air- an FDA approved color additive; and powered devices, usually with movable the suture may be provided with or components, intended for use during di- without a standard needle attached. agnostic examinations or surgical pro- (b) Classification. Class II (special cedures to support and position a pa- controls). The special control for this tient. device is FDA’s ‘‘Class II Special Con- (b) Classification. Class I (general controls Guidance Document: Surgical Su- trols). The device is exempt from the tures; Guidance for Industry and premarket notification procedures in FDA.’’ See § 878.1(e) for the availability subpart E of part 807 of this chapter of this guidance document. subject to § 878.9. [56 FR 24685, May 31, 1991, as amended at 68 [55 FR 48440, Nov. 20, 1990, as amended at 65 FR 32984, June 3, 2003] FR 2318, Jan. 14, 2000] § 878.5020 Nonabsorbable polyamide § 878.5000 Nonabsorbable surgical suture. poly(ethylene terephthalate) sur- (a) Identification. Nonabsorbable poly- gical suture. amide surgical suture is a nonabsorb- (a) Identification. Nonabsorbable able, sterile, flexible thread prepared poly(ethylene terephthalate) surgical from long-chain aliphatic polymers suture is a multifilament, nonabsorb- Nylon 6 and Nylon 6,6 and is indicated able, sterile, flexible thread prepared for use in soft tissue approximation. from fibers of high molecular weight, The polyamide surgical suture meets long-chain, linear polyesters having re- United States Pharmacopeia (U.S.P.) current aromatic rings as an integral requirements as described in the U.S.P. component and is indicated for use in monograph for nonabsorbable surgical soft tissue approximation. The sutures; it may be monofilament or poly(ethylene terephthalate) surgical multifilament in form; it may be pro- suture meets U.S.P. requirements as vided uncoated or coated; and it may described in the U.S.P. Monograph for be undyed or dyed with an appropriate

406

VerDate Mar<15>2010 12:50 Apr 27, 2011 Jkt 223072 PO 00000 Frm 00416 Fmt 8010 Sfmt 8010 Y:\SGML\223072.XXX 223072 WReier-Aviles on DSKGBLS3C1PROD with CFR Food and Drug Administration, HHS § 878.5350

FDA listed color additive. Also, the su- (b) Classification. Class II (special ture may be provided with or without a controls). The special control for this standard needle attached. device is FDA’s ‘‘Class II Special Con- (b) Classification. Class II (special trols Guidance Document: Surgical Su- controls). The special control for this tures; Guidance for Industry and device is FDA’s ‘‘Class II Special Con- FDA.’’ See § 878.1(e) for the availability trols Guidance Document: Surgical Su- of this guidance document. tures; Guidance for Industry and [65 FR 20735, Apr. 18, 2000, as amended at 68 FDA.’’ See § 878.1(e) for the availability FR 32985, June 3, 2003] of this guidance document. § 878.5040 Suction lipoplasty system. [56 FR 24685, May 31, 1991, as amended at 68 FR 32985, June 3, 2003] (a) Identification. A suction lipoplasty system is a device intended for aes- § 878.5030 Natural nonabsorbable silk thetic body contouring. The device surgical suture. consists of a powered suction pump (a) Identification. Natural nonabsorb- (containing a microbial filter on the able silk surgical suture is a non- exhaust and a microbial in-line filter absorbable, sterile, flexible multifila- in the connecting tubing between the ment thread composed of an organic collection bottle and the safety trap), protein called fibroin. This protein is collection bottle, cannula, and con- derived from the domesticated species necting tube. The microbial filters, Bombyx mori (B. mori) of the family tubing, collection bottle, and cannula Bombycidae. Natural nonabsorbable silk must be capable of being changed be- surgical suture is indicated for use in tween patients. The powered suction soft tissue approximation. Natural pump has a motor with a minimum of nonabsorbable silk surgical suture 1/3 horsepower, a variable vacuum meets the United States Pharmacopeia range from 0 to 29.9 inches of mercury, (U.S.P.) monograph requirements for vacuum control valves to regulate the Nonabsorbable Surgical Suture (class vacuum with accompanying vacuum I). Natural nonabsorbable silk surgical gauges, a single or double rotary vane suture may be braided or twisted; it (with or without oil), a single or double may be provided uncoated or coated; diaphragm, a single or double piston, and it may be undyed or dyed with an and a safety trap. FDA listed color additive. (b) Classification. Class II (special (b) Classification. Class II (special controls). Consensus standards and la- controls). The special control for this beling restrictions. device is FDA’s ‘‘Class II Special Con- [63 FR 7705, Feb. 17, 1998] trols Guidance Document: Surgical Su- tures; Guidance for Industry and Subpart F—Therapeutic Devices FDA.’’ See § 878.1(e) for the availability of this guidance document. § 878.5070 Air-handling apparatus for a surgical operating room. [58 FR 57558, Oct. 26, 1993, as amended at 68 FR 32985, June 3, 2003] (a) Identification. Air-handling apparatus for a surgical operating room is a § 878.5035 Nonabsorbable expanded device intended to produce a directed, polytetrafluoroethylene surgical su- nonturbulent flow of air that has been ture. filtered to remove particulate matter (a) Identification. Nonabsorbable ex- and microorganisms to provide an area panded polytetrafluoroethylene free of contaminants to reduce the pos- (ePTFE) surgical suture is a sibility of infection in the patient. monofilament, nonabsorbable, sterile, (b) Classification. Class II. flexible thread prepared from ePTFE and is intended for use in soft tissue § 878.5350 Needle-type epilator. approximation and ligation, including (a) Identification. A needle-type epila- cardiovascular surgery. It may be tor is a device intended to destroy the undyed or dyed with an approved color dermal papilla of a hair by applying additive and may be provided with or electric current at the tip of a fine nee- without an attached needle(s). dle that has been inserted close to the

407

VerDate Mar<15>2010 12:50 Apr 27, 2011 Jkt 223072 PO 00000 Frm 00417 Fmt 8010 Sfmt 8010 Y:\SGML\223072.XXX 223072 WReier-Aviles on DSKGBLS3C1PROD with CFR § 878.5360 21 CFR Ch. I (4–1–11 Edition)

hair shaft, under the skin, and into the subpart E of part 807 of this chapter, dermal papilla. The electric current subject to the limitations in § 878.9. may be high-frequency AC current, [53 FR 23872, June 24, 1988, as amended at 54 high-frequency AC combined with DC FR 13828, Apr. 5, 1989; 59 FR 63010, Dec. 7, current, or DC current only. 1994; 66 FR 38803, July 25, 2001] (b) Classification. Class I (general controls). The device is exempt from the § 878.5910 Pneumatic tourniquet. premarket notification procedures in (a) Identification. A pneumatic tour- subpart E of part 807 of this chapter, niquet is an air-powered device con- subject to the limitations in § 878.9. sisting of a pressure-regulating unit, connecting tubing, and an inflatable [53 FR 23872, June 24, 1988, as amended at 61 FR 1123, Jan. 16, 1996; 66 FR 38803, July 25, cuff. The cuff is intended to be wrapped 2001] around a patient’s limb and inflated to reduce or totally occlude circulation § 878.5360 Tweezer-type epilator. during surgery. (b) Classification. Class I (general con- (a) Identification. The tweezer-type trols). The device is exempt from the epilator is an electrical device intended premarket notification procedures in to remove hair. The energy provided at subpart E of part 807 of this chapter, the tip of the tweezer used to remove subject to the limitations in § 878.9. hair may be radio frequency, galvanic (direct current), or a combination of [53 FR 23872, June 24, 1988, as amended at 61 radio frequency and galvanic energy. FR 1123, Jan. 16, 1996; 66 FR 38803, July 25, 2001] (b) Classification. Class I (general controls). The device is exempt from premarket notification procedures in sub- PART 880—GENERAL HOSPITAL part E of part 807 of this chapter sub- AND PERSONAL USE DEVICES ject to § 878.9. Subpart A—General Provisions [63 FR 57060, Oct. 26, 1998] Sec. § 878.5650 Topical oxygen chamber for 880.1 Scope. extremities. 880.3 Effective dates of requirement for premarket approval. (a) Identification. A topical oxygen 880.9 Limitations of exemptions from sec- chamber for extremities is a device in- tion 510(k) of the Federal Food, Drug, tended to surround hermetically a pa- and Cosmetic Act (the act). tient’s limb and apply humidified oxygen topically at a pressure slightly Subpart B [Reserved] greater than atmospheric pressure to aid healing of chronic skin ulcers or Subpart C—General Hospital and Personal bed sores. Use Monitoring Devices (b) Classification. Class III. 880.2200 Liquid crystal forehead tempera- (c) Date PMA or notice of completion of ture strip. a PDP is required. No effective date has 880.2400 Bed-patient monitor. been established of the requirement for 880.2420 Electronic monitor for gravity flow premarket approval. See § 878.3. infusion systems. 880.2460 Electrically powered spinal fluid § 878.5900 Nonpneumatic tourniquet. pressure monitor. 880.2500 Spinal fluid manometer. (a) Identification. A nonpneumatic 880.2700 Stand-on patient scale. tourniquet is a device consisting of a 880.2720 Patient scale. strap or tubing intended to be wrapped 880.2740 Surgical sponge scale. around a patient’s limb and tightened 880.2800 Sterilization process indicator. to reduce circulation. 880.2900 Clinical color change thermometer. (b) Classification. Class I (general con- 880.2910 Clinical electronic thermometer. trols). The device is exempt from the 880.2920 Clinical mercury thermometer. 880.2930 Apgar timer. premarket notification procedures in Subparts D–E [Reserved] 408

VerDate Mar<15>2010 12:50 Apr 27, 2011 Jkt 223072 PO 00000 Frm 00418 Fmt 8010 Sfmt 8006 Y:\SGML\223072.XXX 223072 WReier-Aviles on DSKGBLS3C1PROD with CFR