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$878.3530 Silicone inflatable breast ile isotonic saline before or after improsthesis.

plantation. The device is intended to be (a) Identification. A silicone inflatable

implanted to augment or reconstruct breast prosthesis is a silicone rubber

the female breast. shell made of polysiloxane(s), such as

(3) Polyurethane covered silicone gelpolydimethylsiloxane

and

filled breast prosthesis. A polyurethane polydiphenylsiloxane, that is inflated

covered silicone gel-filled breast prosto the desired size with sterile isotonic

thesis is an inner silicone rubber shell saline before or after implantation.

made of polysiloxane(s), such

and The device is intended to be implanted polydimethylsiloxane

an outer to augment or reconstruct the female polydiphenylsiloxane, with breast.

silicone adhesive layer and an outer (b) Classification. Class III.

covering of polyurethane; contained (c) Date PMA or notice of completion of

within the inner shell is a fixed amount a PDP is required. A PMA or a notice of of cross-linked polymerized silicone completion of a PDP is required to be

gel, fillers, and stabilizers and an inert filed with the Food and Drug Adminis

support structure compartmentalizing tration on or before November 17, 1999,

the silicone gel. The device is intended for any silicone inflatable breast pros

to be implanted to augment or reconthesis that was in commercial distribu

struct the female breast. tion before May 28, 1976, or that has, on

(b) Classification. Class III. or before November 17, 1999, been found

(c) Date premarket approval application to be substantially equivalent to a sili

(PMA) is required. A PMA is required to cone inflatable breast prosthesis that

be filed with the Food and Drug Adwas in commercial distribution before

ministration on or before July 9, 1991 May 28, 1976. Any other silicone inflat

for any silicone gel-filled breast prosable breast prosthesis shall have an ap

thesis that was in commercial distribuproved PMA or a declared completed

tion before May 28, 1976, or that has on PDP in effect before eing placed in

or before July 9, 1991 been found to be commercial distribution.

substantially equivalent to a silicone

gel-filled breast prosthesis that was in (53 FR 23872, June 24, 1988, as amended at 64

commercial distribution before May 28, FR 45161, Aug. 19, 1999)

1976. Any other silicone gel-filled $ 878.3540 Silicone gel-filled breast

breast prosthesis shall have an approsthesis.

proved PMA in effect before being

placed in commercial distribution. (a) Identification—(1) Single-lumen silicone gel-filled breast prosthesis. A single

(53 FR 23872, June 24, 1988, as amended at 56 lumen silicone gel-filled breast pros

FR 14627, Apr. 10, 1991) thesis is a silicone rubber shell made of

8 878.3550 Chin prosthesis. polysiloxane(s), such as polydimethylsiloxane and polydiphenylsiloxane. The (a) Identification. A chin prosthesis is shell either contains a fixed amount

a silicone rubber solid device intended cross-linked polymerized silicone gel,

to be implanted to augment or reconfiller, and stabilizers or is filled to the

struct the chin. desired size with injectable silicone gel

(b) Classification. Class II. at time of implantation. The device is

$878.3590 Ear prosthesis. intended to be implanted to augment or reconstruct the female breast.

(a) Identification. An ear prosthesis is (2) Double-lumen silicone gel-filled a silicone rubber solid device intended breast prosthesis. A double lumen sili- to be implanted to reconstruct the excone gel-filled breast prosthesis is a sil- ternal ear. icone rubber inner shell and a silicone (b) Classification. Class II. rubber outer shell, both shells made of polysiloxane(s), such as polydimethyl

8878.3610 Esophageal prosthesis. siloxane and polydiphenylsiloxane. The (a) Identification. An esophageal prosinner shell contains fixed amounts of thesis is a rigid, flexible, or expandable cross-linked polymerized silicone gel, tubular device made of a plastic, fillers, and stabilizers. The outer shell metal, or polymeric material that is is inflated to the desired size with ster- 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.

8878.3800 External aesthetic restora

tion 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)

8 878.3720 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)

8878.3900 Inflatable extremity splint.

(a) Identification. An inflatable extremity splint is a device intended to be inflated to immobilize a limb or an extremity.

(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]

8878.3750 External prosthesis adhe

sive. (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)

$ 878.3910 Noninflatable extremity

splint. (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]

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 8 878.9.

$ 878.3925 Plastic surgery kit and ac

cessories. (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]

(64 FR 53929, Oct. 5, 1999)

8 878.4020 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 8878.9.

Woven

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 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 8878.9. (64 FR 53929, Oct. 5, 1999)

or

[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 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

a

8 878.4018 Hydrophilic wound dress

ing. (a) Identification. A hydrophilic wound dressing is a sterile or non-sterile device intended to cover a wound and to absorb exudate. It consists of nonresorbable materials with hydro

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 8 878.9. [64 FR 53929, Oct. 5, 1999)

8 878.4040 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)

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 cath

eter 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)

8878.4100 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]

$ 878.4300 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]

8 878.4160 Surgical camera and acces

sories. (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

8 878.4350 Cryosurgical unit and acces

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

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

(2) Cryosurgical unit with a nitrous oride 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, hemangiomas (benign tumors sisting 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.

or

8 878.4440 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)

con

$ 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

of a transurethral prostatectomy.

(b) Classification. Class II.

$ 878.4450 Nonabsorbable gauze for in

ternal use. (a) Identification. 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]

$ 878.4380 Drape adhesive.

(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

8 878.4460 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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