Year 2000 Date Problem and Medical Devices

[Code of Federal Regulations]
[Title 21, Volume 8, Parts 800 to 1299]
[Revised as of April 1, 1998]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR878]

[Page 347-359]

TITLE 21--FOOD AND DRUGS

CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES--(Continued)

PART 878--GENERAL AND PLASTIC SURGERY DEVICES

Subpart A--General Provisions

Sec.
878.1 Scope.
878.3 Effective dates of requirement for premarket approval.

[[Page 348]]

878.9 Limitations of exemptions from section 510(k) of the Federal
Food, Drug, and Cosmetic Act (the act).

Subpart B--Diagnostic Devices

878.1800 Speculum and accessories.

Subpart C [Reserved]

Subpart D--Prosthetic Devices

878.3250 External facial fracture fixation appliance.
878.3300 Surgical mesh.
878.3500 Polytetrafluoroethylene with carbon fibers composite implant
material.
878.3530 Silicone inflatable breast prosthesis.
878.3540 Silicone gel-filled breast prosthesis.
878.3550 Chin prosthesis.
878.3590 Ear prosthesis.
878.3610 Esophageal prosthesis.
878.3680 Nose prosthesis.
878.3720 Tracheal prosthesls.
878.3750 External prosthesis adhesive.
878.3800 External aesthetic restoration prosthesis.
878.3900 Inflatable extremity splint.
878.3910 Noninflatable extremity splint.
878.3925 Plastic surgery kit and accessories.

Subpart E--Surgical Devices

878.4040 Surgical apparel.
878.4100 Organ bag.
878.4160 Surgical camera and accessories.
878.4200 Introduction/drainage catheter and accessories.
878.4300 Implantable clip.
878.4320 Removable skin clip.
878.4350 Cryosurgical unit and accessories.
878.4370 Surgical drape and drape accessories.
878.4380 Drape adhesive.
878.4400 Electrosurgical cutting and coagulation device and
accessories.
878.4440 Eye pad.
878.4450 Nonabsorbable gauze for internal use.
878.4460 Surgeon's glove.
878.4470 Surgeon's gloving cream.
878.4480 Absorbable powder for lubricating a surgeon's glove.
878.4490 Absorbable hemostatic agent and dressing.
878.4493 Absorbable poly(glycolide/L-lactide) surgical suture.
878.4520 Polytetrafluoroethylene injectable.
878.4580 Surgical lamp.
878.4630 Ultraviolet lamp for dermatologic disorders.
878.4635 Ultraviolet lamp for tanning.
878.4660 Skin marker.
878.4680 Nonpowered, single patient, portable suction apparatus.
878.4700 Surgical microscope and accessories.
878.4730 Surgical skin degreaser or adhesive tape solvent.
878.4750 Implantable staple.
878.4760 Removable skin staple.
878.4780 Powered suction pump.
878.4800 Manual surgical instrument for general use.
878.4810 Laser surgical instrument for use in general and plastic
surgery and in dermatology.
878.4820 Surgical instrument motors and accessories/attachments.
878.4830 Absorbable surgical gut suture.
878.4930 Suture retention device.
878.4950 Manual operating table and accessories and manual operating
chair and accessories.
878.4960 Operating tables and accessories and operating chairs and
accessories.
878.5000 Nonabsorbable poly(ethylene terephthalate) surgical suture.
878.5010 Nonabsorbable polypropylene surgical suture.
878.5020 Nonabsorbable polyamide surgical suture.
878.5030 Natural nonabsorbable silk surgical suture.
878.5040 Suction lipoplasty system.

Subpart F--Therapeutic Devices

878.5070 Air-handling apparatus for a surgical operating room.
878.5350 Needle-type epilator.
878.5360 Tweezer-type epilator.
878.5650 Topical oxygen chamber for extremities.
878.5900 Nonpneumatic tourniquet.
878.5910 Pneumatic tourniquet.

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.

Source: 53 FR 23872, June 24, 1988, unless otherwise noted.

Subpart A--General Provisions

Sec. 878.1 Scope.

(a) This part sets forth the classification of general and plastic
surgery devices intended for human use that are in commercial
distribution.
(b) The identification of a device in a regulation in this part is
not a precise description of every device that is, or will be, subject
to the regulation. A manufacturer who submits a premarket notification
submission for a device under part 807 cannot show merely that the
device is accurately described by the section title and identification
provision of a regulation in this part, but shall state why the device
is substantially equivalent to

[[Page 349]]

other devices, as required by Sec. 807.87 of this chapter.
(c) To avoid duplicative listings, a general and plastic surgery
device that has two or more types of uses (e.g., used both as a
diagnostic device and as a therapeutic device) is listed in one subpart
only.
(d) References in this part to regulatory sections of the Code of
Federal Regulations are to chapter I of title 21 unless otherwise noted.

Sec. 878.3 Effective dates of requirement for premarket approval.

A device included in this part that is classified into class III
(premarket approval) shall not be commercially distributed after the
date shown in the regulation classifying the device unless the
manufacturer has an approval under section 515 of the act (unless an
exemption has been granted under section 520(g)(2) of the act). An
approval under section 515 of the act consists of FDA's issuance of an
order approving an application for premarket approval (PMA) for the
device or declaring completed a product development protocol (PDP) for
the device.
(a) Before FDA requires that a device commercially distributed
before the enactment date of the amendments, or a device that has been
found substantially equivalent to such a device, has an approval under
section 515 of the act, FDA must promulgate a regulation under section
515(b) of the act requiring such approval, except as provided in
paragraphs (b) and (c) of this section. Such a regulation under section
515(b) of the act shall not be effective during the grace period ending
on the 90th day after its promulgation or on the last day of the 30th
full calendar month after the regulation that classifies the device into
class III is effective, whichever is later. See section 501(f)(2)(B) of
the act. Accordingly, unless an effective date of the requirement for
premarket approval is shown in the regulation for a device classified
into class III in this part, the device may be commercially distributed
without FDA's issuance of an order approving a PMA or declaring
completed a PDP for the device. If FDA promulgates a regulation under
section 515(b) of the act requiring premarket approval for a device,
section 501(f)(1)(A) of the act applies to the device.
(b) Any new, not substantially equivalent, device introduced into
commercial distribution on or after May 28, 1976, including a device
formerly marketed that has been substantially altered, is classified by
statute (section 513(f) of the act) into class III without any grace
period and FDA must have issued an order approving a PMA or declaring
completed a PDP for the device before the device is commercially
distributed unless it is reclassified. If FDA knows that a device being
commercially distributed may be a ``new'' device as defined in this
section because of any new intended use or other reasons, FDA may codify
the statutory classification of the device into class III for such new
use. Accordingly, the regulation for such a class III device states that
as of the enactment date of the amendments, May 28, 1976, the device
must have an approval under section 515 of the act before commercial
distribution.
(c) A device identified in a regulation in this part that is
classified into class III and that is subject to the transitional
provisions of section 520(l) of the act is automatically classified by
statute into class III and must have an approval under section 515 of
the act before being commercially distributed. Accordingly, the
regulation for such a class III transitional device states that as of
the enactment date of the amendments, May 28, 1976, the device must have
an approval under section 515 of the act before commercial distribution.

Sec. 878.9 Limitations of exemptions from section 510(k) of the Federal
Food, Drug, and Cosmetic Act (the act).

The Food and Drug Administration's (FDA's) decision to grant an
exemption from the requirement of premarket notification (section 510(k)
of the act) for a generic type of class I device is based upon the
existing and reasonably foreseeable characteristics of commercially
distributed devices within that generic type. Because FDA cannot
anticipate every change in intended use or characteristic that could
significantly affect a device's safety or effectiveness, manufacturers
of any commercially distributed class I device for

[[Page 350]]

which FDA has granted an exemption from the requirement of premarket
notification must still submit a premarket notification to FDA before
introducing or delivering for introduction into interstate commerce for
commercial distribution the device when:
(a) The device is intended for a use different from its intended use
before May 28, 1976, or the device is intended for a use different from
the intended use of a preamendments device to which it has been
determined to be substantially equivalent; e.g., the device is intended
for a different medical purpose, or the device is intended for lay use
where the former intended use was by health care professionals only; or
(b) The modified device operates using a different fundamental
scientific technology than that in use in the device before May 28,
1976; e.g., a surgical instrument cuts tissue with a laser beam rather
than with a sharpened metal blade, or an in vitro diagnostic device
detects or identifies infectious agents by using a deoxyribonucleic acid
(DNA) probe or nucleic acid hybridization technology rather than culture
or immunoassay technology.
[54 FR 13827, Apr. 5, 1989; 54 FR 16438-T, Apr. 24, 1989]

Subpart B--Diagnostic Devices

Sec. 878.1800 Speculum and accessories.

(a) Identification. A speculum is a device intended to be inserted
into a body cavity to aid observation. It is either nonilluminated or
illuminated and may have various accessories.
(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 13827, Apr. 5, 1989; 59
FR 63010, Dec. 7, 1994]

Subpart C [Reserved]

Subpart D--Prosthetic Devices

Sec. 878.3250 External facial fracture fixation appliance.

(a) Identification. An external facial fracture fixation appliance
is a metal apparatus intended to be used during surgical reconstruction
and repair to immobilize maxillofacial bone fragments in their proper
facial relationship.
(b) Classification. Class I. If the device is made of the same
materials that were used in the device before May 28, 1976, it 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 13827, Apr. 5, 1989]

Sec. 878.3300 Surgical mesh.

(a) Identification. Surgical mesh is a metallic or polymeric screen
intended to be implanted to reinforce soft tissue or bone where weakness
exists. Examples of surgical mesh are metallic and polymeric mesh for
hernia repair, and acetabular and cement restrictor mesh used during
orthopedic surgery.
(b) Classification. Class II.

Sec. 878.3500 Polytetrafluoroethylene with carbon fibers composite
implant material.

(a) Identification. A polytetrafluoroethylene with carbon fibers
composite implant material is a porous device material intended to be
implanted during surgery of the chin, jaw, nose, or bones or tissue near
the eye or ear. The device material serves as a space-occupying
substance and is shaped and formed by the surgeon to conform to the
patient's need.
(b) Classification. Class II.

Sec. 878.3530 Silicone inflatable breast prosthesis.

(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. No
effective date has been established of the requirement for premarket
approval. See Sec. 878.3.

[[Page 351]]

Sec. 878.3540 Silicone gel-filled breast prosthesis.

(a) Identification--(1) Single-lumen silicone gel-filled breast
prosthesis. A single-lumen 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 sterile isotonic saline before or after
implantation. The device is intended to be implanted to augment or
reconstruct the female breast.
(3) Polyurethane covered silicone gel-filled breast prosthesis. A
polyurethane covered silicone gel-filled breast prosthesis is an inner
silicone rubber shell made of polysiloxane(s), such as
polydimethylsiloxane and polydiphenylsiloxane, with an outer 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]

Sec. 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.

Sec. 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.

Sec. 878.3610 Esophageal prosthesis.

(a) Identification. An esophageal prosthesis is a plastic tube or
tube-like device that may have mesh reinforcement that is intended to be
implanted in, or affixed externally to, the chest and throat to restore
the esophagus or provide pharyngoesophageal continuity.
(b) Classification. Class III.
(c) Date PMA or notice of completion of a PDP is required. No
effective date has been established of the requirement for premarket
approval. See Sec. 878.3.

Sec. 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.

Sec. 878.3720 Tracheal prosthesis.

(a) Identification. A tracheal prosthesis is a tubular device
intended to be implanted to reconstruct the trachea.
(b) Classification. Class III.
(c) Date PMA or notice of completion of a PDP is required. No
effective date has been established of the requirement for premarket
approval. See Sec. 878.3.

Sec. 878.3750 External prosthesis adhesive.

(a) Identification. An external prosthesis adhesive is a silicone-
type adhesive intended to be used to fasten to

[[Page 352]]

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]

Sec. 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 Sec. 820.180, with respect to general requirements
concerning records, and Sec. 820.198, with respect to complaint files.
[53 FR 23872, June 24, 1988, as amended at 59 FR 63010, Dec. 7, 1994]

Sec. 878.3900 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]

Sec. 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. If the device is made of the same
materials that were used in the device before May 28, 1976, it is exempt
from the premarket notification procedures in subpart E of part 807 of
this chapter. 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
Sec. 820.180, with respect to the general requirements concerning
records, and Sec. 820.198, with respect to complaint files.
[53 FR 23872, June 24, 1988, as amended at 54 FR 13827, Apr. 5, 1989]

Sec. 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. If the device is made of the same
materials that were used in the device before May 28, 1976, it 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 13827, Apr. 5, 1989]

Subpart E--Surgical Devices

Sec. 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. Class II for surgical gowns and surgical masks.
Class I for surgical apparel other than surgical gowns and surgical
masks.

[[Page 353]]

Sec. 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. The intestinal organ bag 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]

Sec. 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
notification 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]

Sec. 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.

Sec. 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.

Sec. 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.

Sec. 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 dioxide 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.

Sec. 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.

[[Page 354]]

Sec. 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
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]

Sec. 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.

Sec. 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]

Sec. 878.4450 Nonabsorbable gauze for internal 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]

Sec. 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 lubricating or dusting
powder used in the glove is excluded.
(b) Classification. Class I.

Sec. 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]

Sec. 878.4480 Absorbable powder for lubricating 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 Sec. 878.3.

Sec. 878.4490 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 Sec. 878.3.

[[Page 355]]

Sec. 878.4493 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 L-lactide, and is
indicated for use in soft tissue approximation. A PGL suture meets
United States Pharmacopeia (U.S.P.) requirements as described in the
U.S.P. ``Monograph for Absorbable Surgical Sutures;'' it may be
monofilament or multifilament (braided) in form; it may be uncoated or
coated; and it may be undyed or dyed with an FDA-approved color
additive. Also, the suture may be provided with or without a standard
needle attached.
(b) Classification. Class II.
[56 FR 47151, Sept. 18, 1991]

Sec. 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 Sec. 878.3.

Sec. 878.4580 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.

Sec. 878.4630 Ultraviolet lamp for dermatologic 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.

Sec. 878.4635 Ultraviolet lamp for tanning.

(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 Sec. 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]

Sec. 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]

Sec. 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.

Sec. 878.4700 Surgical microscope and accessories.

(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.
(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]

[[Page 356]]

Sec. 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; and 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]

Sec. 878.4750 Implantable staple.

(a) Identification. An implantable staple is a staple-like device
intended to connect internal tissues to aid healing. It is not
absorbable.
(b) Classification. Class II.

Sec. 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.

Sec. 878.4780 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.

Sec. 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, retainer, 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]

Sec. 878.4810 Laser surgical instrument for use in general and plastic
surgery 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 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]

Sec. 878.4820 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 a bur, chisel (osteotome),
dermabrasion brush, dermatome, drill

[[Page 357]]

bit, hammerhead, pin driver, and saw blade.
(b) Classification. Class I.
[55 FR 48440, Nov. 20, 1990]

Sec. 878.4830 Absorbable surgical gut suture.

(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]

Sec. 878.4930 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]

Sec. 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]

Sec. 878.4960 Operating tables and accessories and operating chairs and
accessories.

(a) Identification. Operating tables and accessories and operating
chairs and accessories are AC-powered or air-powered devices, usually
with movable components, intended for use during diagnostic examinations
or surgical procedures to support and position a patient.
(b) Classification. Class I.
[55 FR 48440, Nov. 20, 1990]

Sec. 878.5000 Nonabsorbable poly(ethylene terephthalate) surgical
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.
(b) Classification. Class II.
[56 FR 24685, May 31, 1991]

Sec. 878.5010 Nonabsorbable polypropylene surgical suture.

(a) Identification. Nonabsorbable polypropylene surgical suture is a
monofilament, nonabsorbable, sterile, flexible thread prepared from
long-chain 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]

Sec. 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.

[[Page 358]]

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]

Sec. 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 meets
the United States Pharmacopeia (U.S.P.) monograph requirements for
Nonabsorbable Surgical Suture (class I). Natural nonabsorbable silk
surgical suture may be braided or twisted; it may be provided uncoated
or coated; and it may be undyed or dyed with an FDA listed color
additive.
(b) Classification. Class II (special controls).
[58 FR 57558, Oct. 26, 1993]

Sec. 878.5040 Suction lipoplasty system.

(a) Identification. A suction lipoplasty system is a device
intended for aesthetic body contouring. The device consists of a powered
suction pump (containing a microbial filter on the exhaust and a
microbial in-line filter in the connecting tubing between the collection
bottle and the safety trap), collection bottle, cannula, and connecting
tube. The microbial filters, tubing, collection bottle, and cannula must
be capable of being changed between patients. The powered suction pump
has a motor with a minimum of 1/3 horsepower, a variable vacuum range
from 0 to 29.9 inches of mercury, vacuum control valves to regulate the
vacuum with accompanying vacuum gauges, a single or double rotary vane
(with or without oil), a single or double diaphragm, a single or double
piston, and a safety trap.
(b) Classification. Class II (special controls). Consensus
standards and labeling restrictions.
[63 FR 7705, Feb. 17, 1998]

Subpart F--Therapeutic Devices

Sec. 878.5070 Air-handling apparatus for a surgical operating room.

(a) Identification. Air-handling apparatus for a surgical operating
room is a device intended to produce a directed, nonturbulent flow of
air that has been filtered to remove particulate matter and
microorganisms to provide an area free of contaminants to reduce the
possibility of infection in the patient.
(b) Classification. Class II.

Sec. 878.5350 Needle-type epilator.

(a) Identification. A needle-type epilator is a device intended to
destroy the dermal papilla of a hair by applying electric current at the
tip of a fine needle that has been inserted close to the hair shaft,
under the skin, and into the dermal papilla. The electric current may be
high-frequency AC current, high-frequency AC combined with DC current,
or DC current only.
(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]

Sec. 878.5360 Tweezer-type epilator.

(a) Identification. A tweezer-type epilator is an electrical device
intended for hair removal. The device provides a high-frequency electric
current at the tip of a tweezer used for removing hair.
(b) Classification. Class III.
(c) Date PMA or notice of completion of a PDP is required. No
effective date has been established of the requirement for premarket
approval. See Sec. 878.3.

[[Page 359]]

Sec. 878.5650 Topical oxygen chamber for extremities.

(a) Identification. A topical oxygen chamber for extremities is a
device intended to surround hermetically a patient's limb and apply
humidified oxygen topically at a pressure slightly greater than
atmospheric pressure to aid healing of chronic skin ulcers or bed sores.
(b) Classification. Class III.
(c) Date PMA or notice of completion of a PDP is required. No
effective date has been established of the requirement for premarket
approval. See Sec. 878.3.

Sec. 878.5900 Nonpneumatic tourniquet.

(a) Identification. A nonpneumatic tourniquet is a device consisting
of a strap or tubing intended to be wrapped around a patient's limb and
tightened to reduce circulation.
(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]

Sec. 878.5910 Pneumatic tourniquet.

(a) Identification. A pneumatic tourniquet is an air-powered device
consisting of a pressure-regulating unit, connecting tubing, and an
inflatable cuff. The cuff is intended to be wrapped around a patient's
limb and inflated to reduce or totally occlude circulation during
surgery.
(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]

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