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lubricating or dusting powder used in the glove is excluded.

(b) Classification. Class I. $878.4470 Surgeon's gloving cream.

(a) Identification. Surgeon's gloving cream is an ointment intended to be used to lubricate the user's hand before putting on a surgeon's glove.

(b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter. (53 FR 23872, June 24, 1988, as amended at 59 FR 63010, Dec. 7, 1994) $878.4480 Absorbable powder for lu

bricating a surgeon's glove. (a) Identification. Absorbable powder for lubricating a surgeon's glove is a powder made from corn starch that meets the specifications for absorbable powder in the United States Pharmacopeia (U.S.P.) and that is intended to be used to lubricate the surgeon's hand before putting on a surgeon's glove. The device is absorbable through biological degradation.

(b) Classification. Class III.

(c) Date PMA or notice of completion of a PDP is required. As of May 28, 1976, an approval under section 515 of the act is required before this device may be commercially distributed. See 8878.3. 8878.4490 Absorbable hemostatic

agent and dressing. (a) Identification. An absorbable hemostatic agent or dressing is a device intended to produce hemostasis by accelerating the clotting process of blood. It is absorbable.

(b) Classification. Class III.

(c) Date PMA or notice of completion of a PDP is required. As of May 28, 1976, an approval under section 515 of the act is required before this device may be commercially distributed. See 8878.3. 8878.4493 Absorbable poly(glycolide/L

lactide) surgical suture. (a) Identification. An absorbable poly(glycolide/L-lactide) surgical suture (PGL suture) is an absorbable sterile, flexible strand as prepared and synthesized from homopolymers of glycolide and copolymers made from 90 percent glycolide and 10 percent Llactide, and is indicated for use in soft

$878.4495 Stainless steel suture.

(a) Identification. A stainless steel suture is a needled or unneedled nonabsorbable surgical suture composed of 316L stainless steel, in USP sizes 12–0 through 10, or a substantially equivalent stainless steel suture, intended for use in abdominal wound closure, intestinal anastomosis, hernia repair, and sternal closure.

(b) Classification. Class II (special controls). [65 FR 19836, Apr. 13, 2000] $ 878.4520 Polytetrafluoroethylene

injectable. (a) Identification. Polytetrafluoroethylene injectable is an injectable paste prosthetic device composed of polytetrafluoroethylene intended to be used to augment or reconstruct a vocal cord.

(b) Classification. Class III.

(c) Date PMA or notice of completion of a PDP is required. As of May 28, 1976, an approval under section 515 of the act is required before this device may be commercially distributed. See $878.3. 8878.4580 Surgical lamp.

(a) Identification. A surgical lamp (including a fixture) is a device intended to be used to provide visible illumination of the surgical field or the patient.

(b) Classification. Class II. 8878.4630 Ultraviolet lamp for der

matologic disorders. (a) Identification. An ultraviolet lamp for dermatologic disorders is a device (including a fixture) intended to provide ultraviolet radiation of the body to photoactivate a drug in the treatment of a dermatologic disorder if the

labeling of the drug intended for use with the device bears adequate directions for the device's use with that drug.

(b) Classification. Class II.

(b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter. [55 FR 48440, Nov. 20, 1990, as amended at 59 FR 63010, Dec. 7, 1994]

8878.4635 Ultraviolet lamp for tan

ning. (a) Identification. An ultraviolet lamp for tanning is a device that is a lamp (including a fixture) intended to provide ultraviolet radiation to tan the skin. See $ 1040.20 of this chapter.

(b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter. (55 FR 48440, Nov. 20, 1990, as amended at 59 FR 63010, Dec. 7, 1994]

and

8 878.4730 Surgical skin degreaser or

adhesive tape solvent. (a) Identification. A surgical skin degreaser or an adhesive tape solvent is a device that consists of a liquid such as 1,1,2-trichloro-1,2,2-trifluoroethane; 1,1,1-trichloroethane;

1,1,1-trichloroethane with mineral spirits intended to be used to dissolve surface skin oil or adhesive tape.

(b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter. [53 FR 23872, June 24, 1988, as amended at 59 FR 63010, Dec. 7, 1994]

$ 878.4660 Skin marker.

(a) Identification. A skin marker is a pen-like device intended to be used to write on the patient's skin, e.g., to outline surgical incision sites or mark anatomical sites for accurate blood pressure measurement.

(b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter. (53 FR 23872, June 24, 1988, as amended at 59 FR 63010, Dec. 7, 1994]

$ 878.4750 Implantable staple.

(a) Identification. An implantable staple is a staple-like device intended to connect internal tissues to aid aling It is not absorbable.

(b) Classification. Class II.

$878.4680 Nonpowered, single patient,

portable suction apparatus. (a) Identification. A nonpowered, single patient, portable suction apparatus is a device that consists of a manually operated plastic, disposable evacuation system intended to provide a vacuum for suction drainage of surgical wounds.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification 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)

$ 878.4760 Removable skin staple.

(a) Identification. A removable skin staple is a staple-like device intended to connect external tissues temporarily to aid healing. It is not absorbable.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification 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)

8 878.4700 Surgical microscope and ac

cessories. (a) Identification. A surgical microscope and accessories is an AC-powered device intended for use during surgery to provide a magnified view of the surgical field.

8878.4780 Powered suction pump.

(a) Identification. A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter.

(b) Classification. Class II.

the premarket notification procedures in subpart E of part 807 of this chapter. (53 FR 23872, June 24, 1988, as amended at 61 FR 1123, Jan. 16, 1996)

$ 878.4800 Manual surgical instrument

for general use. (a) Identification. A manual surgical instrument for general use is a nonpowered, hand-held, or hand-manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, blood lancet, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, tainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892.

(b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter. (53 FR 23872, June 24, 1988, as amended at 54 FR 13828, Apr. 5, 1989; 59 FR 63010, Dec. 7, 1994]

8878.4820 Surgical instrument motors

and accessories/attachments. (a) Identification. Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to $878.9.

a

re

(55 FR 48440, Nov. 20, 1990, as amended at 65 FR 2318, 2000)

8878.4830 Absorbable surgical gut su

ture. (a) Identification. An absorbable surgical gut suture, both plain and chromic, is an absorbable, sterile, flexible thread prepared from either the serosal connective tissue layer of beef (bovine) or the submucosal fibrous tissue of sheep (ovine) intestine, and is intended for use in soft tissue approximation.

(b) Classification. Class II. (54 FR 50738, Dec. 11, 1989)

$ 878.4810 Laser surgical instrument

for use in general and plastic sur

gery and in dermatology. (a) Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.

(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.

(b) Classification. (1) Class II.

(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from

8878.4930 Suture retention device.

(a) Identification. A suture retention device is a device, such as a retention bridge, a surgical button, or a suture bolster, intended to aid wound healing by distributing suture tension over a larger area in the patient.

(b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter. (53 FR 23872, June 24, 1988, as amended at 59 FR 63010, Dec. 7, 1994)

(b) Classification. Class II. (56 FR 24685, May 31, 1991)

a

$ 878.4950 Manual operating table and

accessories and manual operating

chair and accessories. (a) Identification. A manual operating table and accessories and a manual operating chair and accessories are nonpowered devices, usually with movable components, intended to be used to support a patient during diagnostic examinations or surgical procedures.

(b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter. (53 FR 23872, June 24, 1988, as amended at 54 FR 13828, Apr. 5, 1989; 59 FR 63010, Dec. 7, 1994]

$ 878.5010 Nonabsorbable

polypropylene surgical suture. (a) Identification. Nonabsorbable polypropylene surgical suture is monofilament, nonabsorbable, sterile, flexible thread prepared from longchain polyolefin polymer known as polypropylene and is indicated for use in soft tissue approximation. The polypropylene surgical suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be undyed or dyed with an FDA approved color additive; and the suture may be provided with or without a standard needle attached.

(b) Classification. Class II. (56 FR 24685, May 31, 1991)

$ 878.4960 Operating tables and acces

sories and operating chairs and ac

cessories. (a) Identification. Operating tables and accessories and operating chairs and accessories are AC-powered or airpowered devices, usually with movable components, intended for use during diagnostic examinations or surgical procedures to support and position a patient.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to $878.9. (55 FR 48440, Nov. 20, 1990, as amended at 65 FR 2318, Jan. 14, 2000)

$ 878.5020 Nonabsorbable polyamide

surgical suture. (a) Identification. Nonabsorbable polyamide surgical suture is a nonabsorbable, sterile, flexible thread prepared from long-chain aliphatic polymers Nylon 6 and Nylon 6,6 and is indicated for use in soft tissue approximation. The polyamide surgical suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. monograph for nonabsorbable surgical sutures; it may be monofilament or multifilament in form; it may be provided uncoated or coated; and it may be undyed or dyed with an appropriate FDA listed color additive. Also, the suture may be provided with or without a standard needle attached.

(b) Classification. Class II. (56 FR 24685, May 31, 1991]

$878.5000 Nonabsorbable

poly(ethylene terephthalate) sur

gical suture. (a) Identification. Nonabsorbable poly(ethylene terephthalate) surgical suture is a multifilament, nonabsorbable, sterile, flexible thread prepared from fibers of high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component and is indicated for use in soft tissue approximation. The poly(ethylene terephthalate) surgical suture meets U.S.P. requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be provided uncoated or coated; and it may be undyed or dyed with an appropriate FDA listed color additive. Also, the suture may be provided with or without a standard needle attached.

$ 878.5030 Natural nonabsorbable silk

surgical suture. (a) Identification. Natural nonabsorbable silk surgical suture is a nonabsorbable, sterile, flexible multifilament thread composed of an organic protein called fibroin. This protein is derived from the domesticated species Bombyx mori (B. mori) of the family Bombycidae. Natural nonabsorbable silk surgical suture is indicated for use in soft tissue approximation. Natural nonabsorbable silk surgical suture

a

meets the United States Pharmacopeia in the connecting tubing between the (U.S.P.) monograph requirements for collection bottle and the safety trap), Nonabsorbable Surgical Suture (class collection bottle, cannula, and conI). Natural nonabsorbable silk surgical necting tube. The microbial filters, suture may be braided or twisted; it tubing, collection bottle, and cannula may be provided uncoated or coated; must be capable of being changed beand it may be undyed or dyed with an tween patients. The powered suction FDA listed color additive.

pump has a motor with a minimum of (b) Classification. Class II (special 1/3 horsepower,

variable vacuum controls).

range from 0 to 29.9 inches of mercury,

vacuum control valves to regulate the (58 FR 57558, Oct. 26, 1993)

vacuum with accompanying vacuum $ 878.5035 Nonabsorbable expanded

gauges, a single or double rotary vane polytetrafluoroethylene surgical su- (with or without oil), a single or double ture.

diaphragm, a single or double piston, (a) Identification. Nonabsorbable ex

and a safety trap. panded polytetrafluoroethylene

(b) Classification. Class II (special (ePTFE) surgical suture is a

controls). Consensus standards and lamonofilament, nonabsorbable, sterile,

beling restrictions. flexible thread prepared from ePTFE (63 FR 7705, Feb. 17, 1998] and is intended for use in soft tissue approximation and ligation, including Subpart F-Therapeutic Devices cardiovascular surgery.

It may

be undyed or dyed with an approved color 8 878.5070 Air-handling apparatus for additive and may be provided with or a surgical operating room. without an attached needle(s).

(a) Identification. Air-handling appa(b) Classification. Class II (special ratus for a surgical operating room is a controls). FDA recognized consensus device intended to produce a directed. standards and device-specific labeling: nonturbulent flow of air that has been

(1) United States Pharmacopoeia filtered to remove particulate matter (USP) 21:

and microorganisms to provide an area (i) Monograph for Nonabsorbable Sur

free of contaminants to reduce the posgical Sutures;

sibility of infection in the patient. (ii) Sutures—Diameter <861>;

(b) Classification. Class II. (iii) Sutures Needle Attachment <871>; and

8 878.5350 Needle-type epilator. (iv) Tensile Strength <881>.

(a) Identification. A needle-type epila(2) Labeling:

tor is a device intended to destroy the (i) Contraindication: “This device is dermal papilla of a hair by applying contraindicated for use in ophthalmic electric current at the tip of a fine neeand neural tissues and for use in micro- dle that has been inserted close to the surgery."

hair shaft, under the skin, and into the (ii) “For Single Use Only."

dermal papilla. The electric current (iii) If the marketed suture has a dif- may be high-frequency AC current, ferent diameter than the diameter high-frequency AC combined with DC specified in USP 21–Suture Diameter current, or DC current only. <861>, then a tabular comparison of its (b) Classification. Class I. The device diameter and USP sizes should be in- is exempt from the premarket notificacluded in the labeling.

tion procedures in subpart E of part 807 [65 FR 20735, Apr. 18, 2000)

of this chapter.

(53 FR 23872, June 24, 1988, as amended at 61 8878.5040 Suction lipoplasty system.

FR 1123, Jan. 16, 1996) (a) Identification. A suction lipoplasty system is a device intended for aes

8 878.5360 Tweezer-type epilator. thetic body contouring. The device (a) Identification. The tweezer-type consists of a powered suction pump epilator is an electrical device intended (containing a microbial filter on the to remove hair. The energy provided at exhaust and a microbial in-line filter the tip of the tweezer used to remove

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