§ 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 de- vice 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 pros- thesis. 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 pros- thesis. 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. 392 VerDate Aug<31>2005 09:33 May 12, 2008 Jkt 214072 PO 00000 Frm 00402 Fmt 8010 Sfmt 8010 Y:\SGML\214072.XXX 214072 dwashington3 on PRODPC61 with CFR Food and Drug Administration, HHS § 878.3 878.4350 Cryosurgical unit and accessories. Subpart F—Therapeutic Devices 878.4370 Surgical drape and drape acces- sories. 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 acces- sories. 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 393 VerDate Aug<31>2005 09:33 May 12, 2008 Jkt 214072 PO 00000 Frm 00403 Fmt 8010 Sfmt 8010 Y:\SGML\214072.XXX 214072 dwashington3 on PRODPC61 with CFR § 878.9 21 CFR Ch. I (4–1–08 Edition) 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).