Food and Drug Administration, HHS § 878.4820
release of subcutaneous tissue for im- needle, osteotome, pliers, rasp, re- provement in the appearance of tainer, retractor, saw, scalpel blade, cellulite. The device consists of a cut- scalpel handle, one-piece scalpel, snare, ting tool powered by a motor and a spatula, stapler, disposable or reusable means for instrument guidance to con- stripper, stylet, suturing apparatus for trol the areas of subcutaneous tissue the stomach and intestine, measuring cutting underneath the cellulite de- tape, and calipers. A surgical instru- pressions or dimples. ment that has specialized uses in a spe- (b) Classification. Class II (special cific medical specialty is classified in controls). The special controls for this separate regulations in parts 868 device are: through 892. (1) Non-clinical testing must be per- (b) Classification. Class I (general con- formed to demonstrate that the device trols). The device is exempt from the meets all design specifications and per- premarket notification procedures in formance requirements, and to dem- subpart E of part 807 of this chapter, onstrate durability and mechanical in- subject to the limitations in § 878.9. tegrity of the device. (2) In vivo evaluation of the device [53 FR 23872, June 24, 1988, as amended at 54 must demonstrate device performance, FR 13828, Apr. 5, 1989; 59 FR 63010, Dec. 7, including the safety of the release 1994; 66 FR 38803, July 25, 2001] methodology and blood loss at the § 878.4810 Laser surgical instrument treatment sites. for use in general and plastic sur- (3) All elements of the device that gery and in dermatology. may contact the patient must be dem- onstrated to be biocompatible. (a) Identification. (1) A carbon dioxide (4) Electrical safety and electro- laser for use in general surgery and in magnetic compatibility of the device dermatology is a laser device intended must be demonstrated. to cut, destroy, or remove tissue by (5) The labeling must include a sum- light energy emitted by carbon dioxide. mary of in vivo evaluation data and all (2) An argon laser for use in derma- the device specific warnings, pre- tology is a laser device intended to de- cautions, and/or contraindications. stroy or coagulate tissue by light en- (6) Sterility and shelf-life testing for ergy emitted by argon. the device must demonstrate the ste- (b) Classification. (1) Class II. rility of patient contacting compo- (2) Class I for special laser gas mix- nents and the shelf life of these compo- tures used as a lasing medium for this nents. class of lasers. The devices subject to this paragraph (b)(2) are exempt from [79 FR 31861, June 3, 2014] the premarket notification procedures § 878.4800 Manual surgical instrument in subpart E of part 807 of this chapter, for general use. subject to the limitations in § 878.9. (a) Identification. A manual surgical [53 FR 23872, June 24, 1988, as amended at 61 instrument for general use is a non- FR 1123, Jan. 16, 1996; 66 FR 38803, July 25, powered, hand-held, or hand-manipu- 2001] lated device, either reusable or dispos- able, intended to be used in various § 878.4820 Surgical instrument motors general surgical procedures. The device and accessories/attachments. includes the applicator, clip applier, bi- (a) Identification. Surgical instrument opsy brush, manual dermabrasion motors and accessories are AC-pow- brush, scrub brush, cannula, ligature ered, battery-powered, or air-powered carrier, chisel, clamp, contractor, cu- devices intended for use during surgical rette, cutter, dissector, elevator, skin procedures to provide power to operate graft expander, file, forceps, gouge, in- various accessories or attachments to strument guide, needle guide, hammer, cut hard tissue or bone and soft tissue. hemostat, amputation hook, ligature Accessories or attachments may in- passing and knot-tying instrument, clude a bur, chisel (osteotome), knife, blood lancet, mallet, disposable dermabrasion brush, dermatome, drill or reusable aspiration and injection bit, hammerhead, pin driver, and saw needle, disposable or reusable suturing blade.
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