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(a) Identification. A silicone inflatable breast prosthesis is a silicone rubber shell made of polysiloxane(s), such as polydimethylsiloxane and polydiphenylsiloxane, that is inflated to the desired size with sterile isotonic saline before or after implantation. The device is intended to be implanted to augment or reconstruct the female breast.

(b) Classification. Class III.

(c) Date PMA or notice of completion of a PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before November 17, 1999, for any silicone inflatable breast prosthesis that was in commercial distribution before May 28, 1976, or that has, on or before November 17, 1999, been found to be substantially equivalent to a silicone inflatable breast prosthesis that was in commercial distribution before May 28, 1976. Any other silicone inflatable breast prosthesis shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.

[53 FR 23872, June 24, 1988, as amended at 64 FR 45161, Aug. 19, 1999]

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(a) Identification-(1) Single-lumen silicone gel-filled breast prosthesis. A singlelumen silicone gel-filled breast prosthesis is a silicone rubber shell made of polysiloxane(s), such as polydimethylsiloxane and polydiphenylsiloxane. The shell either contains a fixed amount cross-linked polymerized silicone gel, filler, and stabilizers or is filled to the desired size with injectable silicone gel at time of implantation. The device is intended to be implanted to augment or reconstruct the female breast.

(2) Double-lumen silicone gel-filled breast prosthesis. A double lumen silicone gel-filled breast prosthesis is a silicone rubber inner shell and a silicone rubber outer shell, both shells made of polysiloxane(s), such as polydimethylsiloxane and polydiphenylsiloxane. The inner shell contains fixed amounts of cross-linked polymerized silicone gel, fillers, and stabilizers. The outer shell is inflated to the desired size with ster

ile isotonic saline before or after implantation. The device is intended to be implanted to augment or reconstruct the female breast.

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(3) Polyurethane covered silicone gelfilled breast prosthesis. A polyurethane covered silicone gel-filled breast prosthesis is an inner silicone rubber shell made such of polysiloxane(s), polydimethylsiloxane polydiphenylsiloxane, with silicone adhesive layer and an outer covering of polyurethane; contained within the inner shell is a fixed amount of cross-linked polymerized silicone gel, fillers, and stabilizers and an inert support structure compartmentalizing the silicone gel. The device is intended to be implanted to augment or reconstruct the female breast.

(b) Classification. Class III.

(c) Date premarket approval application (PMA) is required. A PMA is required to be filed with the Food and Drug Administration on or before July 9, 1991 for any silicone gel-filled breast prosthesis that was in commercial distribution before May 28, 1976, or that has on or before July 9, 1991 been found to be substantially equivalent to a silicone gel-filled breast prosthesis that was in commercial distribution before May 28, 1976. Any other silicone gel-filled breast prosthesis shall have an approved PMA in effect before being placed in commercial distribution.

[53 FR 23872, June 24, 1988, as amended at 56 FR 14627, Apr. 10, 1991]

§ 878.3550 Chin prosthesis.

(a) Identification. A chin prosthesis is a silicone rubber solid device intended to be implanted to augment or reconstruct the chin.

(b) Classification. Class II.

§ 878.3590 Ear prosthesis.

(a) Identification. An ear prosthesis is a silicone rubber solid device intended to be implanted to reconstruct the external ear.

(b) Classification. Class II.

$878.3610 Esophageal prosthesis.

(a) Identification. An esophageal prosthesis is a rigid, flexible, or expandable tubular device made of a plastic, metal, or polymeric material that is intended to be implanted to restore the

structure and/or function of the esophagus. The metal esophageal prosthesis may be uncovered or covered with a polymeric material. This device may also include a device delivery system.

(b) Classification. Class II. The special control for this device is FDA's "Guidance for the Content of Premarket Notification Submissions for Esophageal and Tracheal Prostheses."

[65 FR 17145, Mar. 31, 2000]

§ 878.3680 Nose prosthesis.

(a) Identification. A nose prosthesis is a silicone rubber solid device intended to be implanted to augment or reconstruct the nasal dorsum.

(b) Classification. Class II.

§ 878.3720 Tracheal prosthesis.

(a) Identification. The tracheal prosthesis is a rigid, flexible, or expandable tubular device made of a silicone,

metal, or polymeric material that is intended to be implanted to restore the structure and/or function of the trachea or trachealbronchial tree. It may be unbranched or contain one or two branches. The metal tracheal prosthesis may be uncovered or covered with a polymeric material. This device may also include a device delivery system.

(b) Classification. Class II. The special control for this device is FDA's "Guidance for the Content of Premarket Notification Submissions for Esophageal and Tracheal Prostheses."

[65 FR 17146, Mar. 31, 2000]

§ 878.3750 External prosthesis adhesive.

(a) Identification. An external prosthesis adhesive is a silicone-type adhesive intended to be used to fasten to the body an external aesthetic restoration prosthesis, such as an artificial

nose.

(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]

§ 878.3800 External aesthetic restoration prosthesis.

(a) Identification. An external aesthetic restoration prosthesis is a device intended to be used to construct an external artificial body structure, such as an ear, breast, or nose. Usually the device is made of silicone rubber and it may be fastened to the body with an external prosthesis adhesive. The device is not intended to be implanted.

(b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter. If the device is intended for use without an external prosthesis adhesive to fasten it to the body, the device is exempt from the current good manufacturing practice regulations in part 820 of this chapter. with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.

[53 FR 23872, June 24, 1988, as amended at 59 FR 63010, Dec. 7, 1994]

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(a) Identification. A noninflatable extremity splint is a device intended to immobilize a limb or an extremity. It is not inflatable.

(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. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice regulations in part 820 of this chapter, with the exception of § 820.180 of this chapter, with respect to general requirements concerning records, and § 820.198 of this

chapter, with respect to complaint files.

[53 FR 23872, June 24, 1988, as amended at 54 FR 13827, Apr. 5, 1989; 65 FR 2317, Jan. 14, 2000]

§878.3925 Plastic surgery kit and accessories.

(a) Identification. A plastic surgery kit and accessories is a device intended to be used to reconstruct maxillofacial deficiencies. The kit contains surgical instruments and materials used to make maxillofacial impressions before molding an external prosthesis.

(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 54 FR 13827, Apr. 5, 1989; 65 FR 2317, Jan. 14, 2000]

Subpart E-Surgical Devices

§878.4014 Nonresorbable gauze/sponge for external use.

(a) Identification. A nonresorbable gauze/sponge for external use is a sterile or nonsterile device intended for medical purposes, such as to be placed directly on a patient's wound to absorb exudate. It consists of a strip, piece, or pad made from open Woven or nonwoven mesh cotton cellulose or a simple chemical derivative of cellulose. This classification does not include a nonresorbable gauze/sponge for external use that contains added drugs such as antimicrobial agents, added biologics such as growth factors, or is composed of materials derived from animal sources.

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

[64 FR 53929, Oct. 5, 1999]

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philic properties that are capable of absorbing exudate (e.g., cotton, cotton derivatives, alginates, dextran, and rayon). This classification does not include a hydrophilic wound dressing that contains added drugs such as antimicrobial agents, added biologics such as growth factors, or is composed of materials derived from animal sources.

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

[64 FR 53929, Oct. 5, 1999]

§ 878.4020 Occlusive wound dressing.

(a) Identification. An occlusive wound dressing is a nonresorbable, sterile or non-sterile device intended to cover a wound, to provide or support a moist wound environment, and to allow the exchange of gases such as oxygen and water vapor through the device. It consists of a piece of synthetic polymeric material, such as polyurethane, with or without an adhesive backing. This classification does not include an occlusive wound dressing that contains added drugs such as antimicrobial agents, added biologics such as growth factors, or is composed of materials derived from animal sources.

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

[64 FR 53929, Oct. 5, 1999]

§ 878.4022 Hydrogel wound dressing and burn dressing.

(a) Identification. A hydrogel wound dressing is a sterile or non-sterile device intended to cover a wound, to absorb wound exudate, to control bleeding or fluid loss, and to protect against abrasion, friction, desiccation, and contamination. It consists of a nonresorbable matrix made of hydrophilic polymers or other material in combination with water (at least 50 percent) and capable of absorbing exudate. This classification does not include a hydrogel wound dressing that contains added drugs such as antimicrobial agents, added biologics such

as growth factors, or is composed of materials derived from animal sources.

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

[64 FR 53929, Oct. 5, 1999]

§ 878.4040 Surgical apparel.

(a) Identification. Surgical apparel are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Examples include surgical caps, hoods, masks, gowns, operating room shoes and shoe covers, and isolation masks and gowns. Surgical suits and dresses, commonly known as scrub suits, are excluded.

(b) Classification. (1) Class II (special controls) for surgical gowns and surgical masks.

(2) Class I (general controls) for surgical apparel other than surgical gowns and surgical masks. The class I 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 2317, Jan. 14, 2000]

§ 878.4100 Organ bag.

(a) Identification. An organ bag is a device that is a flexible plastic bag intended to be used as a temporary receptacle for an organ during surgical procedures to prevent moisture loss.

(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 59 FR 63010, Dec. 7, 1994; 65 FR 2318, Jan. 14, 2000]

§ 878.4160 Surgical camera and accessories.

(a) Identification. A surgical camera and accessories is a device intended to be used to record operative procedures.

(b) Classification. Class I. The device is exempt from the premarket notifica

tion procedures in subpart E of part 807 of this chapter.

[53 FR 23872, June 24, 1988, as amended at 54 FR 13827, Apr. 5, 1989]

§ 878.4200 Introduction/drainage catheter and accessories.

(a) Identification. An introduction/ drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than blood vessels, drain fluids from body cavities, or evaluate certain physiologic conditions. Examples include irrigation and drainage catheters, pediatric catheters, peritoneal catheters (including dialysis), and other general surgical catheters. An introduction drainage catheter accessory is intended to aid in the manipulation of or insertion of the device into the body. Examples of accessories include adaptors, connectors, and catheter needles.

(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]

§ 878.4300 Implantable clip.

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

(b) Classification. Class II.

§ 878.4320 Removable skin clip.

(a) Identification. A removable skin clip is a clip-like device intended to connect skin 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]

§ 878.4350 Cryosurgical unit and accessories.

(a) Identification-(1) Cryosurgical unit with a liquid nitrogen cooled cryoprobe and accessories. A cryosurgical unit with a liquid nitrogen cooled cryoprobe

and accessories is a device intended to destroy tissue during surgical procedures by applying extreme cold.

(2) Cryosurgical unit with a nitrous oxide cooled cryoprobe and accessories. A cryosurgical unit with a nitrous oxide cooled cryoprobe and accessories is a device intended to destroy tissue during surgical procedures, including urological applications, by applying extreme cold.

(3) Cryosurgical unit with a carbon dioride cooled cryoprobe or a carbon dioxide dry ice applicator and accessories. A cryosurgical unit with a carbon dioxide cooled cryoprobe or a carbon dioxide dry ice applicator and accessories is a device intended to destroy tissue during surgical procedures by applying extreme cold. The device is intended to treat disease conditions such as tumors, skin cancers, acne scars, or hemangiomas (benign tumors consisting of newly formed blood vessels) and various benign or malignant gynecological conditions affecting vulvar, vaginal, or cervical tissue. The device is not intended for urological applications.

(b) Classification. Class II.

§ 878.4370 Surgical drape and drape

accessories.

(a) Identification. A surgical drape and drape accessories is a device made of natural or synthetic materials intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. The device includes a plastic wound protector that may adhere to the skin around a surgical incision or be placed in a wound to cover its exposed edges, and a latex drape with a self-retaining finger cot that is intended to allow repeated insertion of the surgeon's finger into the rectum during performance transurethral prostatectomy. (b) Classification. Class II.

§ 878.4380 Drape adhesive.

of a

(a) Identification. A drape adhesive is a device intended to be placed on the skin to attach a surgical drape.

(b) Classification. Class I. The device is exempt from the premarket notifica

tion 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]

§ 878.4400 Electrosurgical cutting and coagulation device and accessories.

(a) Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.

(b) Classification. Class II.

§878.4440 Eye pad.

(a) Identification. An eye pad is a device that consists of a pad made of various materials, such as gauze and cotton, intended for use as a bandage over the eye for protection or absorption of secretions.

(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]

§ 878.4450 Nonabsorbable gauze for internal use.

Identification.

(a) Nonabsorbable gauze for internal use is a device made of an open mesh fabric intended to be used inside the body or a surgical incision or applied to internal organs or structures, to control bleeding, absorb fluid, or protect organs or structures from abrasion, drying, or contamination. The device is woven from material made of not less than 50 percent by mass cotton, cellulose, or a simple chemical derivative of cellulose, and contains x-ray detectable elements.

(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 61 FR 1123, Jan. 16, 1996]

§ 878.4460 Surgeon's glove.

(a) Identification. A surgeon's glove is a device made of natural or synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. The

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