392 Part 878—General and Plastic Surgery

§ 876.5990 21 CFR Ch. I (4–1–08 Edition)

sterile infant gavage set, gastro- ‘‘Guidance for the Content of Pre- intestinal string and tubes to locate in- market Notifications (510(k)’s) for ternal bleeding, double lumen tube for Extracorporeal Shock Wave intestinal decompression or intubation, Lithotripters Indicated for the Frag- feeding tube, gastroenterostomy tube, mentation of Kidney and Ureteral Levine tube, nasogastric tube, single Calculi.’’) lumen tube with mercury weight bal- loon for intestinal intubation or de- [65 FR 48612, Aug. 9, 2000] compression, and gastro-urological ir- rigation tray (for gastrological use). PART 878—GENERAL AND PLASTIC (b) Classification. (1) Class II (special SURGERY DEVICES controls). The barium enema retention catheter and tip with or without a bag Subpart A—General Provisions that is a gastrointestinal tube and ac- Sec. cessory is exempt from the premarket 878.1 Scope. notification procedures in subpart E of 878.3 Effective dates of requirement for pre- this part subject to the limitations in market approval. § 876.9. 878.9 Limitations of exemptions from sec- (2) Class I (general controls) for the tion 510(k) of the Federal Food, Drug, dissolvable nasogastric feed tube guide and Cosmetic Act (the act). for the nasogastric tube. The class I device is exempt from the premarket no- Subpart B—Diagnostic Devices tification procedures in subpart E of 878.1800 Speculum and accessories. part 807 of this chapter subject to § 876.9. Subpart C [Reserved] [49 FR 573, Jan. 5, 1984, as amended at 65 FR Subpart D—Prosthetic Devices 2317, Jan. 14, 2000; 65 FR 76932, Dec. 8, 2000] 878.3250 External facial fracture fixation ap- § 876.5990 Extracorporeal shock wave pliance. lithotripter. 878.3300 Surgical mesh. (a) Identification. An extracorporeal 878.3500 Polytetrafluoroethylene with car- shock wave lithotripter is a device that bon fibers composite implant material. focuses ultrasonic shock waves into the 878.3530 Silicone inflatable breast prosthesis. body to noninvasively fragment uri- 878.3540 Silicone gel-filled breast prosthesis. nary calculi within the kidney or ure- 878.3550 Chin prosthesis. ter. The primary components of the de- 878.3590 Ear prosthesis. vice are a shock wave generator, high 878.3610 Esophageal prosthesis. voltage generator, control console, im- 878.3680 Nose prosthesis. aging/localization system, and patient 878.3720 Tracheal prosthesls. table. Prior to treatment, the urinary 878.3750 External prosthesis adhesive. stone is targeted using either an inte- 878.3800 External aesthetic restoration prosthesis. gral or stand-alone localization/imag- 878.3900 Inflatable extremity splint. ing system. Shock waves are typically 878.3910 Noninflatable extremity splint. 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 878.4014 Nonresorbable gauze/sponge for ex- onto the stone with either a specially ternal use. designed reflector, dish, or acoustic 878.4018 Hydrophilic wound dressing. lens. The shock waves are created 878.4020 Occlusive wound dressing. under water within the shock wave 878.4022 Hydrogel wound dressing and burn generator, and are transferred to the dressing. patient’s body using an appropriate 878.4025 Silicone sheeting. acoustic interface. After the stone has 878.4040 Surgical apparel. been fragmented by the focused shock 878.4100 Organ bag. 878.4160 Surgical camera and accessories. waves, the fragments pass out of the 878.4200 Introduction/drainage catheter and body with the patient’s urine. accessories. (b) Classification. Class II (special 878.4300 Implantable clip. controls) (FDA guidance document: 878.4320 Removable skin clip.

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878.4350 Cryosurgical unit and accessories. Subpart F—Therapeutic Devices 878.4370 Surgical drape and drape accessories. 878.5070 Air-handling apparatus for a sur- 878.4380 Drape adhesive. gical operating room. 878.4400 Electrosurgical cutting and coagu- 878.5350 Needle-type epilator. lation device and accessories. 878.5360 Tweezer-type epilator. 878.4410 Low energy ultrasound wound 878.5650 Topical oxygen chamber for ex- cleaner. tremities. 878.4440 Eye pad. 878.5900 Nonpneumatic tourniquet. 878.4450 Nonabsorbable gauze for internal 878.5910 Pneumatic tourniquet. use. AUTHORITY: 21 U.S.C. 351, 360, 360c, 360e, 878.4460 Surgeon’s glove. 360j, 360l, 371. 878.4470 Surgeon’s gloving cream. 878.4480 Absorbable powder for lubricating a SOURCE: 53 FR 23872, June 24, 1988, unless surgeon’s glove. otherwise noted. 878.4490 Absorbable hemostatic agent and dressing. Subpart A—General Provisions 878.4493 Absorbable poly(glycolide/L-lactide) surgical suture. § 878.1 Scope. 878.4494 Absorbable poly(hydroxybutyrate) surgical suture produced by recombinant (a) This part sets forth the classifica- DNA technology. tion of general and plastic surgery de- 878.4495 Stainless steel suture. vices intended for human use that are 878.4520 Polytetrafluoroethylene injectable. in commercial distribution. 878.4580 Surgical lamp. (b) The identification of a device in a 878.4630 Ultraviolet lamp for dermatologic regulation in this part is not a precise disorders. description of every device that is, or 878.4635 Ultraviolet lamp for tanning. will be, subject to the regulation. A 878.4660 Skin marker. manufacturer who submits a pre- 878.4680 Nonpowered, single patient, port- market notification submission for a able suction apparatus. device under part 807 cannot show 878.4700 Surgical microscope and accessories. merely that the device is accurately 878.4730 Surgical skin degreaser or adhesive described by the section title and iden- tape solvent. tification provision of a regulation in 878.4750 Implantable staple. this part, but shall state why the de- 878.4760 Removable skin staple. vice is substantially equivalent to 878.4780 Powered suction pump. other devices, as required by § 807.87 of 878.4800 Manual surgical instrument for this chapter. general use. (c) To avoid duplicative listings, a 878.4810 Laser surgical instrument for use in general and plastic surgery device that general and plastic surgery and in der- has two or more types of uses (e.g., matology. 878.4820 Surgical instrument motors and ac- used both as a diagnostic device and as cessories/attachments. a therapeutic device) is listed in one 878.4830 Absorbable surgical gut suture. subpart only. 878.4840 Absorbable polydioxanone surgical (d) References in this part to regu- suture. latory sections of the Code of Federal 878.4930 Suture retention device. Regulations are to chapter I of title 21 878.4950 Manual operating table and acces- unless otherwise noted. sories and manual operating chair and (e) Guidance documents referenced in accessories. this part are available on the Internet 878.4960 Operating tables and accessories and operating chairs and accessories. at http://www.fda.gov/cdrh/guid- 878.5000 Nonabsorbable poly(ethylene ance.html. terephthalate) surgical suture. [53 FR 23872, June 24, 1988, as amended at 67 878.5010 Nonabsorbable polypropylene sur- FR 77676, Dec. 19, 2002] gical suture. 878.5020 Nonabsorbable polyamide surgical § 878.3 Effective dates of requirement suture. for premarket approval. 878.5030 Natural nonabsorbable silk surgical suture. A device included in this part that is 878.5035 Nonabsorbable expanded polytetra- classified into class III (premarket ap- fluoroethylene surgical suture. proval) shall not be commercially dis- 878.5040 Suction lipoplasty system. tributed after the date shown in the

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

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

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

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

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part 820 of this chapter, with the excep- § 878.4018 Hydrophilic wound dress- tion of § 820.180 of this chapter, with re- ing. spect to general requirements con- (a) Identification. A hydrophilic cerning records, and § 820.198 of this wound dressing is a sterile or non-ster- chapter, with respect to complaint ile device intended to cover a wound files. and to absorb exudate. It consists of nonresorbable materials with hydro- [53 FR 23872, June 24, 1988, as amended at 54 philic properties that are capable of ab- FR 13827, Apr. 5, 1989; 65 FR 2317, Jan. 14, 2000] sorbing exudate (e.g., cotton, cotton derivatives, alginates, dextran, and § 878.3925 Plastic surgery kit and ac- rayon). This classification does not in- cessories. clude a hydrophilic wound dressing that contains added drugs such as anti- (a) Identification. A plastic surgery microbial agents, added biologics such kit and accessories is a device intended as growth factors, or is composed of to be used to reconstruct maxillofacial materials derived from animal sources. deficiencies. The kit contains surgical (b) Classification. Class I (general con- instruments and materials used to trols). The device is exempt from the make maxillofacial impressions before premarket notification procedures in molding an external prosthesis. part 807, subpart E of this chapter sub- (b) Classification. Class I (general con- ject to the limitations in § 878.9. trols). The device is exempt from the [64 FR 53929, Oct. 5, 1999] premarket notification procedures in subpart E of part 807 of this chapter § 878.4020 Occlusive wound dressing. subject to § 878.9. (a) Identification. An occlusive wound [53 FR 23872, June 24, 1988, as amended at 54 dressing is a nonresorbable, sterile or FR 13827, Apr. 5, 1989; 65 FR 2317, Jan. 14, non-sterile device intended to cover a 2000] wound, to provide or support a moist wound environment, and to allow the Subpart E—Surgical Devices exchange of gases such as oxygen and water vapor through the device. It con- § 878.4014 Nonresorbable gauze/sponge sists of a piece of synthetic polymeric for external use. material, such as polyurethane, with or without an adhesive backing. This clas- (a) Identification. A nonresorbable sification does not include an occlusive gauze/sponge for external use is a ster- wound dressing that contains added ile or nonsterile device intended for drugs such as antimicrobial agents, medical purposes, such as to be placed added biologics such as growth factors, directly on a patient’s wound to absorb or is composed of materials derived exudate. It consists of a strip, piece, or from animal sources. pad made from open woven or (b) Classification. Class I (general con- nonwoven mesh cotton cellulose or a trols). The device is exempt from the simple chemical derivative of cellulose. premarket notification procedures in This classification does not include a part 807, subpart E of this chapter sub- nonresorbable gauze/sponge for exter- ject to the limitations in § 878.9. nal use that contains added drugs such [64 FR 53929, Oct. 5, 1999] as antimicrobial agents, added biologics such as growth factors, or is § 878.4022 Hydrogel wound dressing composed of materials derived from and burn dressing. animal sources. (a) Identification. A hydrogel wound (b) Classification. Class I (general con- dressing is a sterile or non-sterile de- trols). The device is exempt from the vice intended to cover a wound, to ab- premarket notification procedures in sorb wound exudate, to control bleed- part 807, subpart E of this chapter sub- ing or fluid loss, and to protect against ject to the limitations in § 878.9. abrasion, friction, desiccation, and contamination. It consists of a [64 FR 53929, Oct. 5, 1999] nonresorbable matrix made of hydrophilic polymers or other material in

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combination with water (at least 50 tacle for an organ during surgical pro- percent) and capable of absorbing cedures to prevent moisture loss. exudate. This classification does not (b) Classification. Class I (general con- include a hydrogel wound dressing that trols). The device is exempt from the contains added drugs such as anti- premarket notification procedures in microbial agents, added biologics such subpart E of part 807 of this chapter as growth factors, or is composed of subject to § 878.9. materials derived from animal sources. [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 part 807, subpart E of this chapter sub- § 878.4160 Surgical camera and acces- ject to the limitations in § 878.9. sories. [64 FR 53929, Oct. 5, 1999] (a) Identification. A surgical camera and accessories is a device intended to § 878.4025 Silicone sheeting. be used to record operative procedures. (a) Identification. Silicone sheeting is (b) Classification. Class I (general con- intended for use in the management of trols). The device is exempt from the closed hyperproliferative (hypertrophic premarket notification procedures in and keloid) scars. subpart E of part 807 of this chapter, subject to the limitations in § 878.9. (b) Classification. Class I (general controls). The device is exempt from the [53 FR 23872, June 24, 1988, as amended at 54 premarket notification procedures in FR 13827, Apr. 5, 1989; 66 FR 38802, July 25, subpart E of part 807 of this chapter 2001] subject to the limitations in § 878.9. § 878.4200 Introduction/drainage cath- [69 FR 48148, Aug. 9, 2004] eter and accessories. (a) Identification. An introduction/ § 878.4040 Surgical apparel. drainage catheter is a device that is a (a) Identification. Surgical apparel are flexible single or multilumen tube in- devices that are intended to be worn by tended to be used to introduce nondrug operating room personnel during sur- fluids into body cavities other than gical procedures to protect both the blood vessels, drain fluids from body surgical patient and the operating cavities, or evaluate certain physio- 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. (a) Identification. An implantable clip § 878.4100 Organ bag. 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- is not absorbable. tended to be used as a temporary recep- (b) Classification. Class II.

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§ 878.4320 Removable skin clip. other contamination. The device in- (a) Identification. A removable skin cludes a plastic wound protector that clip is a clip-like device intended to may adhere to the skin around a sur- connect skin tissues temporarily to aid gical incision or be placed in a wound healing. It is not absorbable. 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 § 878.9. transurethral prostatectomy. (b) Classification. Class II. [53 FR 23872, June 24, 1988, as amended at 65 FR 2318, Jan. 14, 2000] § 878.4380 Drape adhesive. § 878.4350 Cryosurgical unit and acces- (a) Identification. A drape adhesive is sories. a device intended to be placed on the (a) Identification—(1) Cryosurgical unit skin to attach a surgical drape. with a liquid nitrogen cooled cryoprobe (b) Classification. Class I (general con- and accessories. A cryosurgical unit trols). The device is exempt from the with a liquid nitrogen cooled cryoprobe premarket notification procedures in and accessories is a device intended to subpart E of part 807 of this chapter, destroy tissue during surgical proce- subject to the limitations in § 878.9. dures by applying extreme cold. (2) Cryosurgical unit with a nitrous [53 FR 23872, June 24, 1988, as amended at 59 oxide cooled cryoprobe and accessories. A FR 63010, Dec. 7, 1994; 66 FR 38802, July 25, cryosurgical unit with a nitrous oxide 2001] cooled cryoprobe and accessories is a § 878.4400 Electrosurgical cutting and device intended to destroy tissue dur- coagulation device and accessories. ing surgical procedures, including urological applications, by applying ex- (a) Identification. An electrosurgical treme cold. cutting and coagulation device and ac- (3) Cryosurgical unit with a carbon di- cessories is a device intended to re- oxide cooled cryoprobe or a carbon dioxide move tissue and control bleeding by dry ice applicator and accessories. A use of high-frequency electrical cur- cryosurgical unit with a carbon dioxide rent. cooled cryoprobe or a carbon dioxide (b) Classification. Class II. dry ice applicator and accessories is a device intended to destroy tissue dur- § 878.4410 Low energy ultrasound ing surgical procedures by applying ex- wound cleaner. treme cold. The device is intended to (a) Identification. A low energy treat disease conditions such as tu- ultrasound wound cleaner is a device mors, skin cancers, acne scars, or that uses ultrasound energy to vapor- hemangiomas (benign tumors con- ize a solution and generate a mist that sisting of newly formed blood vessels) is used for the cleaning and mainte- and various benign or malignant gyne- cological conditions affecting vulvar, nance debridement of wounds. Low lev- vaginal, or cervical tissue. The device els of ultrasound energy may be carried is not intended for urological applica- to the wound by the saline mist. tions. (b) Classification. Class II (special (b) Classification. Class II. controls). The special control is FDA’s guidance document entitled ‘‘Class II § 878.4370 Surgical drape and drape Special Controls Guidance Document: accessories. Low Energy Ultrasound Wound Clean- (a) Identification. A surgical drape er.’’ See § 878.1(e) for the availability of and drape accessories is a device made this guidance document. of natural or synthetic materials in- [70 FR 67355, Nov. 7, 2005] tended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and

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§ 878.4440 Eye pad. (b) Classification. Class I (general con- (a) Identification. An eye pad is a de- trols). The device is exempt from the vice that consists of a pad made of var- premarket notification procedures in ious materials, such as gauze and cot- subpart E of part 807 of this chapter, ton, intended for use as a bandage over subject to the limitations in § 878.9. the eye for protection or absorption of [53 FR 23872, June 24, 1988, as amended at 59 secretions. FR 63010, Dec. 7, 1994; 66 FR 38803, July 25, (b) Classification. Class I (general con- 2001] trols). The device is exempt from the premarket notification procedures in § 878.4480 Absorbable powder for lu- subpart E of part 807 of this chapter, bricating a surgeon’s glove. subject to the limitations in § 878.9. (a) Identification. Absorbable powder for lubricating a surgeon’s glove is a [53 FR 23872, June 24, 1988, as amended at 59 powder made from corn starch that FR 63010, Dec. 7, 1994; 66 FR 38803, July 25, 2001] meets the specifications for absorbable powder in the United States Pharma- § 878.4450 Nonabsorbable gauze for in- copeia (U.S.P.) and that is intended to ternal use. be used to lubricate the surgeon’s hand (a) Identification. Nonabsorbable before putting on a surgeon’s glove. gauze for internal use is a device made The device is absorbable through bio- of an open mesh fabric intended to be logical degradation. used inside the body or a surgical inci- (b) Classification. Class III. sion or applied to internal organs or (c) Date PMA or notice of completion of structures, to control bleeding, absorb a PDP is required. As of May 28, 1976, an fluid, or protect organs or structures approval under section 515 of the act is from abrasion, drying, or contamina- required before this device may be tion. The device is woven from mate- commercially distributed. See § 878.3. rial made of not less than 50 percent by § 878.4490 Absorbable hemostatic mass cotton, cellulose, or a simple agent and dressing. chemical derivative of cellulose, and contains x-ray detectable elements. (a) Identification. An absorbable he- (b) Classification. Class I (general con- mostatic agent or dressing is a device trols). The device is exempt from the intended to produce hemostasis by ac- premarket notification procedures in celerating the clotting process of subpart E of part 807 of this chapter, blood. It is absorbable. subject to the limitations in § 878.9. (b) Classification. Class III. (c) Date PMA or notice of completion of [53 FR 23872, June 24, 1988, as amended at 61 a PDP is required. As of May 28, 1976, an FR 1123, Jan. 16, 1996; 66 FR 38803, July 25, approval under section 515 of the act is 2001] required before this device may be § 878.4460 Surgeon’s glove. commercially distributed. See § 878.3. (a) Identification. A surgeon’s glove is § 878.4493 Absorbable poly(glycolide/L- a device made of natural or synthetic lactide) surgical suture. rubber intended to be worn by oper- (a) Identification. An absorbable ating room personnel to protect a sur- poly(glycolide/L-lactide) surgical su- gical wound from contamination. The ture (PGL suture) is an absorbable lubricating or dusting powder used in sterile, flexible strand as prepared and the glove is excluded. synthesized from homopolymers of (b) Classification. Class I (general con- glycolide and copolymers made from 90 trols). percent glycolide and 10 percent L- [53 FR 23872, June 24, 1988, as amended at 66 lactide, and is indicated for use in soft FR 46952, Sept. 10, 2001] tissue approximation. A PGL suture meets United States Pharmacopeia § 878.4470 Surgeon’s gloving cream. (U.S.P.) requirements as described in (a) Identification. Surgeon’s gloving the U.S.P. ‘‘Monograph for Absorbable cream is an ointment intended to be Surgical Sutures;’’ it may be used to lubricate the user’s hand before monofilament or multifilament (braid- putting on a surgeon’s glove. ed) in form; it may be uncoated or

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coated; and it may be undyed or dyed § 878.4520 Polytetrafluoroethylene with an FDA-approved color additive. injectable. Also, the suture may be provided with (a) Identification. Polytetrafluoro- or without a standard needle attached. ethylene injectable is an injectable (b) Classification. Class II (special paste prosthetic device composed of controls). The special control for this polytetrafluoroethylene intended to be device is FDA’s ‘‘Class II Special Con- used to augment or reconstruct a vocal trols Guidance Document: Surgical Su- cord. tures; Guidance for Industry and FDA.’’ See § 878.1(e) for the availability (b) Classification. Class III. of this guidance document. (c) Date PMA or notice of completion of a PDP is required. As of May 28, 1976, an [56 FR 47151, Sept. 18, 1991, as amended at 68 approval under section 515 of the act is FR 32984, June 3, 2003] required before this device may be commercially distributed. See § 878.3. § 878.4494 Absorbable poly(hydroxybutyrate) surgical suture produced by recombinant DNA § 878.4580 Surgical lamp. technology. (a) Identification. A surgical lamp (in- (a) Identification. An absorbable cluding a fixture) is a device intended poly(hydroxybutyrate) surgical suture to be used to provide visible illumina- is an absorbable surgical suture made tion of the surgical field or the patient. of material isolated from prokaryotic (b) Classification. Class II. cells produced by recombinant deoxyribonucleic acid (DNA) tech- § 878.4630 Ultraviolet lamp for der- nology. The device is intended for use matologic disorders. in general soft tissue approximation (a) Identification. An ultraviolet lamp and ligation. for dermatologic disorders is a device (b) Classification. Class II (special (including a fixture) intended to pro- controls). The special control for this vide ultraviolet radiation of the body device is the FDA guidance document to photoactivate a drug in the treat- entitled ‘‘Class II Special Controls ment of a dermatologic disorder if the Guidance Document: Absorbable labeling of the drug intended for use Poly(hydroxybutyrate) Surgical Suture with the device bears adequate direc- 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 of this guidance document. § 878.4660 Skin marker. (a) Identification. A skin marker is a [65 FR 19836, Apr. 13, 2000, as amended at 68 FR 32984, June 3, 2003] pen-like device intended to be used to

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write on the patient’s skin, e.g., to out- premarket notification procedures in line surgical incision sites or mark an- subpart E of part 807 of this chapter, atomical sites for accurate blood pres- subject to the limitations in § 878.9. sure measurement. [53 FR 23872, June 24, 1988, as amended at 59 (b) Classification. Class I (general con- FR 63010, Dec. 7, 1994; 66 FR 38803, July 25, trols). The device is exempt from the 2001] premarket notification procedures in subpart E of part 807 of this chapter, § 878.4750 Implantable staple. subject to the limitations in § 878.9. (a) Identification. An implantable sta- [53 FR 23872, June 24, 1988, as amended at 59 ple is a staple-like device intended to FR 63010, Dec. 7, 1994; 66 FR 38803, July 25, connect internal tissues to aid healing. 2001] It is not absorbable. (b) Classification. Class II. § 878.4680 Nonpowered, single patient, portable suction apparatus. § 878.4760 Removable skin staple. (a) Identification. A nonpowered, sin- (a) Identification. A removable skin gle patient, portable suction apparatus staple is a staple-like device intended is a device that consists of a manually to connect external tissues temporarily operated plastic, disposable evacuation to aid healing. It is not absorbable. system intended to provide a vacuum (b) Classification. Class I (general con- for suction drainage of surgical trols). The device is exempt from the wounds. 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 § 878.9. premarket notification procedures in subpart E of part 807 of this chapter [53 FR 23872, June 24, 1988, as amended at 65 subject to § 878.9. FR 2318, Jan. 14, 2000] [53 FR 23872, June 24, 1988, as amended at 65 § 878.4780 Powered suction pump. FR 2318, Jan. 14, 2000] (a) Identification. A powered suction pump is a portable, AC-powered or § 878.4700 Surgical microscope and accessories. compressed air-powered device intended 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 subject to the limitations in § 878.9. for general use. [55 FR 48440, Nov. 20, 1990, as amended at 59 (a) Identification. A manual surgical FR 63010, Dec. 7, 1994; 66 FR 38803, July 25, instrument for general use is a non- 2001] powered, hand-held, or hand-manipu- 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 (a) Identification. A surgical skin includes the applicator, clip applier, bi- degreaser or an adhesive tape solvent is opsy brush, manual dermabrasion a device that consists of a liquid such brush, scrub brush, cannula, ligature as 1,1,2-trichloro-1,2,2-trifluoroethane; carrier, chisel, clamp, contractor, cu- 1,1,1-trichloroethane; and 1,1,1-tri- rette, cutter, dissector, elevator, skin chloroethane with mineral spirits in- graft expander, file, forceps, gouge, intended to be used to dissolve surface strument guide, needle guide, hammer, skin oil or adhesive tape. hemostat, amputation hook, ligature (b) Classification. Class I (general con- passing and knot-tying instrument, trols). The device is exempt from the knife, blood lancet, mallet, disposable

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

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by distributing suture tension over a component and is indicated for use in larger area in the patient. soft tissue approximation. The (b) Classification. Class I (general con- poly(ethylene terephthalate) surgical trols). The device is exempt from the suture meets U.S.P. requirements as premarket notification procedures in described in the U.S.P. Monograph for 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.

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monograph for nonabsorbable surgical cardiovascular surgery. It may be sutures; it may be monofilament or undyed or dyed with an approved color multifilament in form; it may be pro- additive and may be provided with or vided uncoated or coated; and it may without an attached needle(s). be undyed or dyed with an appropriate (b) Classification. Class II (special FDA listed color additive. Also, the su- controls). The special control for this ture may be provided with or without a device is FDA’s ‘‘Class II Special Con- standard needle attached. trols Guidance Document: Surgical Su- (b) Classification. Class II (special tures; Guidance for Industry and controls). The special control for this 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. [56 FR 24685, May 31, 1991, as amended at 68 § 878.5040 Suction lipoplasty system. 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 derived from the domesticated species collection bottle, cannula, and con- Bombyx mori (B. mori) of the family necting tube. The microbial filters, Bombycidae. Natural nonabsorbable silk tubing, collection bottle, and cannula surgical suture is indicated for use in must be capable of being changed be- soft tissue approximation. Natural tween patients. The powered suction nonabsorbable silk surgical suture pump has a motor with a minimum of meets the United States Pharmacopeia 1/3 horsepower, a variable vacuum (U.S.P.) monograph requirements for range from 0 to 29.9 inches of mercury, Nonabsorbable Surgical Suture (class vacuum control valves to regulate the I). Natural nonabsorbable silk surgical vacuum with accompanying vacuum suture may be braided or twisted; it gauges, a single or double rotary vane may be provided uncoated or coated; (with or without oil), a single or double and it may be undyed or dyed with an diaphragm, a single or double piston, FDA listed color additive. and a safety trap. (b) Classification. Class II (special (b) Classification. Class II (special controls). The special control for this controls). Consensus standards and la- device is FDA’s ‘‘Class II Special Con- beling restrictions. trols Guidance Document: Surgical Su- tures; Guidance for Industry and [63 FR 7705, Feb. 17, 1998] FDA.’’ See § 878.1(e) for the availability of this guidance document. Subpart F—Therapeutic Devices [58 FR 57558, Oct. 26, 1993, as amended at 68 FR 32985, June 3, 2003] § 878.5070 Air-handling apparatus for a surgical operating room. § 878.5035 Nonabsorbable expanded polytetrafluoroethylene surgical su- (a) Identification. Air-handling appa- ture. ratus for a surgical operating room is a device intended to produce a directed, (a) Identification. Nonabsorbable expanded polytetrafluoroethylene nonturbulent flow of air that has been (ePTFE) surgical suture is a filtered to remove particulate matter monofilament, nonabsorbable, sterile, and microorganisms to provide an area flexible thread prepared from ePTFE free of contaminants to reduce the pos- and is intended for use in soft tissue sibility of infection in the patient. approximation and ligation, including (b) Classification. Class II.

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§ 878.5350 Needle-type epilator. (b) Classification. Class I (general controls). The device is exempt from the (a) Identification. A needle-type epila- premarket notification procedures in tor is a device intended to destroy the subpart E of part 807 of this chapter, dermal papilla of a hair by applying subject to the limitations in § 878.9. electric current at the tip of a fine needle that has been inserted close to the [53 FR 23872, June 24, 1988, as amended at 54 hair shaft, under the skin, and into the FR 13828, Apr. 5, 1989; 59 FR 63010, Dec. 7, dermal papilla. The electric current 1994; 66 FR 38803, July 25, 2001] may be high-frequency AC current, high-frequency AC combined with DC § 878.5910 Pneumatic tourniquet. current, or DC current only. (a) Identification. A pneumatic tour- (b) Classification. Class I (general con- niquet is an air-powered device controls). The device is exempt from the sisting of a pressure-regulating unit, premarket notification procedures in connecting tubing, and an inflatable subpart E of part 807 of this chapter, cuff. The cuff is intended to be wrapped subject to the limitations in § 878.9. around a patient’s limb and inflated to reduce or totally occlude circulation [53 FR 23872, June 24, 1988, as amended at 61 during surgery. FR 1123, Jan. 16, 1996; 66 FR 38803, July 25, 2001] (b) Classification. Class I (general controls). The device is exempt from the § 878.5360 Tweezer-type epilator. premarket notification procedures in subpart E of part 807 of this chapter, (a) Identification. The tweezer-type subject to the limitations in § 878.9. epilator is an electrical device intended to remove hair. The energy provided at [53 FR 23872, June 24, 1988, as amended at 61 the tip of the tweezer used to remove FR 1123, Jan. 16, 1996; 66 FR 38803, July 25, hair may be radio frequency, galvanic 2001] (direct current), or a combination of radio frequency and galvanic energy. PART 880—GENERAL HOSPITAL (b) Classification. Class I (general con- AND PERSONAL USE DEVICES trols). The device is exempt from premarket notification procedures in sub- Subpart A—General Provisions part E of part 807 of this chapter subject to § 878.9. Sec. 880.1 Scope. [63 FR 57060, Oct. 26, 1998] 880.3 Effective dates of requirement for premarket approval. § 878.5650 Topical oxygen chamber for 880.9 Limitations of exemptions from sec- extremities. tion 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). (a) Identification. A topical oxygen chamber for extremities is a device in- Subpart B [Reserved] tended to surround hermetically a patient’s limb and apply humidified oxy- Subpart C—General Hospital and Personal gen topically at a pressure slightly Use Monitoring Devices greater than atmospheric pressure to aid healing of chronic skin ulcers or 880.2200 Liquid crystal forehead tempera- bed sores. ture strip. 880.2400 Bed-patient monitor. (b) Classification. Class III. 880.2420 Electronic monitor for gravity flow (c) Date PMA or notice of completion of infusion systems. a PDP is required. No effective date has 880.2460 Electrically powered spinal fluid been established of the requirement for pressure monitor. premarket approval. See § 878.3. 880.2500 Spinal fluid manometer. 880.2700 Stand-on patient scale. § 878.5900 Nonpneumatic tourniquet. 880.2720 Patient scale. 880.2740 Surgical sponge scale. (a) Identification. A nonpneumatic 880.2800 Sterilization process indicator. tourniquet is a device consisting of a 880.2900 Clinical color change thermometer. strap or tubing intended to be wrapped 880.2910 Clinical electronic thermometer. around a patient’s limb and tightened 880.2920 Clinical mercury thermometer. to reduce circulation. 880.2930 Apgar timer.

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