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(b) Classification. Class II (performance standards).

$ 876.5895 Ostomy irrigator.

(a) Identification. An ostomy irrigator is a device that consists of a container for fluid, tubing with a cone-shaped tip or a soft and flexible catheter with a retention shield and that is used to wash out the colon through a colostomy, a surgically created opening of the colon on the surface of the body.

(b) Classification. Class II (performance standards).

of this chapter. The device is also exempt from the current good manufacturing practice regulations in part 820 of this chapter, with the exception of $ 820.180, regarding general requirements concerning records, and $820.198, regarding complaint files. [48 FR 53023, Nov. 23, 1983, as amended at 54 FR 25050, June 12, 1989)

$ 876.5900 Ostomy pouch and acces

sories. (a) Identification. An ostomy pouch and accessories is a device that consists of a bag that is attached to the patient's skin by an adhesive material and that is intended for use as a receptacle for collection of fecal material or urine following an ileostomy, colostomy, or ureterostomy (a surgically created opening of the small intestine, large intestine, or the ureter on the surface of the body). This generic type of device and its accessories includes the ostomy pouch, ostomy adhesive, the disposable colostomy appliance, ostomy collector, colostomy pouch, urinary ileostomy bag, urine collecting ureterostomy bag, ostomy drainage bag with adhesive, stomal bag, ostomy protector, and the ostomy size selector, but excludes ostomy pouches which incorporate arsenic-containing compounds.

(b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter. [48 FR 53023, Nov. 23, 1983, as amended at 54 FR 25050, June 12, 1989)

$ 876.5955 Peritoneo-venous shunt.

(a) Identification. A peritoneo-venous shunt is an implanted device that consists of a catheter and a pressure activated one-way valve. The catheter is implanted with one end in the peritoneal cavity and the other in a large vein. This device enables ascitic fluid in the peritoneal cavity to flow into the venous system for the treatment of intractable ascites.

(b) Classification. Class II. The special controls for this device are FDA's:

(1) "Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices-Part I: Evaluation and Testing,''

(2) "510(k) Sterility Review Guidance of 2/12/90 (K90-1)," and

(3) Backflow specification and testing to prevent reflux of blood into the shunt.

(48 FR 53023, Nov. 23, 1983, as amended at 52 FR 17738, May 11, 1987; 65 FR 17145, Mar. 31, 2000]

8 876.5920 Protective garment for in

continence. (a) Identification. A protective garment for incontinence is a device that consists of absorbent padding and a fluid barrier and that is intended to protect an incontinent patient's garment from the patient's excreta. This generic type of device does not include diapers for infants.

(b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807

$ 876.5970 Hernia support.

(a) Identification. A hernia support is a device, usually made of elastic, canvas, leather, or metal, that is intended to be placed over a hernial opening (a weakness in the abdominal wall) to prevent protrusion of the abdominal contents. This generic type of device includes the umbilical truss.

(b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter. The device is exempt from the current good manufacturing practice regulations in part 820 of this chapter, with the exception of $820.180, regarding general requirements concerning records, and § 820.198, regarding complaint files. [48 FR 53023, Nov. 23, 1983, as amended at 59 FR 63010, Dec. 7, 1994)

$876.5980 Gastrointestinal tube and cally repelled membranes, or piezoaccessories.

electric crystal arrays, and focused (a) Identification. A gastrointestinal

onto the stone with either a specially tube and accessories is a device that

designed reflector, dish, or acoustic consists of flexible or semi-rigid tubing

lens. The shock waves are created used for instilling fluids into, with

under water within the shock wave drawing fluids from, splinting, or sup

generator, and are transferred to the pressing bleeding of the alimentary

patient's body using an appropriate tract. This device may incorporate an

acoustic interface. After the stone has integral inflatable balloon for reten- been fragmented by the focused shock tion or hemostasis. This generic type

waves, the fragments pass out of the of device includes the hemostatic bag, body with the patient's urine. irrigation and aspiration catheter (gas- (b) Classification. Class II (special tric, colonic, etc.), rectal catheter, controls) (FDA guidance document: sterile infant gavage set, gastro

"Guidance for the Content of Preintestinal string and tubes to locate in- market Notifications (510(k)'s) for ternal bleeding, double lumen tube for Extracorporeal Shock Wave intestinal decompression or intubation, Lithotripters Indicated for the Fragfeeding tube, gastroenterostomy tube, mentation of Kidney and Ureteral Levine tube, nasogastric tube, single

Calculi.") lumen tube with mercury weight bal

[65 FR 48612, Aug. 9, 2000] loon for intestinal intubation or decompression, and gastro-urological ir

PART 878-GENERAL AND PLASTIC rigation tray (for gastrological use). (b) Classification. (1) Class II (special

SURGERY DEVICES controls). The barium enema retention catheter and tip with or without a bag

Subpart A-General Provisions that is a gastrointestinal tube and ac

Sec. cessory is exempt from the premarket

878.1 Scope. notification procedures in subpart E of

878.3 Effective dates of requirement for prethis part subject to the limitations in

market approval. $876.9.

878.9 Limitations of exemptions from sec(2) Class I (general controls) for the tion 510(k) of the Federal Food, Drug, dissolvable nasogastric feed tube guide and Cosmetic Act (the act). for the nasogastric tube. The class I device is exempt from the premarket no

Subpart B-Diagnostic Devices tification procedures in subpart E of

878.1800 Speculum and accessories. part 807 of this chapter subject to $ 876.9.

Subpart C [Reserved) (49 FR 573, Jan. 5, 1984, as amended at 65 FR 2317, Jan. 14, 2000; 65 FR 76932, Dec. 8, 2000)

Subpart D-Prosthetic Devices 8 876.5990 Extracorporeal shock wave

878.3250 External facial fracture fixation aplithotripter.

pliance.

878.3300 Surgical mesh. (a) Identification. An extracorporeal

878.3500 Polytetrafluoroethylene with carshock wave lithotripter is a device that bon fibers composite implant material. focuses ultrasonic shock waves into the 878.3530 Silicone inflatable breast prosbody to noninvasively fragment uri- thesis. nary calculi within the kidney or ure- 878.3540 Silicone gel-filled breast prosthesis. ter. The primary components of the de

878.3550 Chin prosthesis. vice are a shock wave generator, high

878.3590 Ear prosthesis. voltage generator, control console, im

878.3610 Esophageal prosthesis.

878.3680 Nose prosthesis. aging/localization system, and patient

878.3720 Tracheal prosthesls. table. Prior to treatment, the urinary

878.3750 External prosthesis adhesive. stone is targeted using either an inte

878.3800 External aesthetic restoration prosgral or stand-alone localization/imag

thesis. ing system. Shock waves are typically 878.3900 Inflatable extremity splint. generated using electrostatic spark dis- 878.3910 Noninflatable extremity splint. charge (spark gap), electromagneti- 878.3925 Plastic surgery kit and accessories.

Subpart E-Surgical Devices

878.5020 Nonabsorbable polyamide surgical

suture. 878.5030 Natural nonabsorbable silk surgical

suture. 878.5035 Nonabsorbable expanded polytetra

fluoroethylene surgical suture. 878.5040 Suction lipoplasty system.

Subpart F-Therapeutic Devices 878.5070 Air-handling apparatus for a sur

gical operating room. 878.5350 Needle-type epilator. 878.5360 Tweezer-type epilator. 878.5650 Topical oxygen chamber for ex

tremities. 878.5900 Nonpneumatic tourniquet. 878.5910 Pneumatic tourniquet.

AUTHORITY: 21 U.S.C. 351, 360, 360c, 360e, 3600, 3601, 371.

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

Subpart A-General Provisions

878.4014 Nonresorbable gauze/sponge for ex

ternal use. 878.4018 Hydrophilic wound dressing. 878.4020 Occlusive wound dressing. 878.4022 Hydrogel wound dressing and burn

dressing. 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 acces

sories. 878.4380 Drape adhesive. 878.4400 Electrosurgical cutting and coagu

lation 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. 878.4495 Stainless steel 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, port

able suction apparatus. 878.4700 Surgical microscope and acces

sories. 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 der

matology. 878.4820 Surgical instrument motors and ac

cessories/attachments. 878.4830 Absorbable surgical gut suture. 878.4930 Suture retention device. 878.4950 Manual operating table and acces

sories 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 sur

gical suture.

a

8 878.1 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 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 other devices, as required by $ 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.

8 878.3 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

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(1) 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.

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

$ 878.9 Limitations of exemptions from

section 510(k) of the Federal Food,

Drug, and Cosmetic Act (the act). The exemption from the requirement of premarket notification (section 510(k) of the act) for a generic type of class I or II device is only to the extent that the device has existing or reasonably foreseeable characteristics of commercially distributed devices within that generic type or, in the case of in vitro diagnostic devices, only to the extent that misdiagnosis as a result of using the device would not be associated with high morbidity or mortality. Accordingly, manufacturers of any commercially distributed class I or II device for 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 the intended use of a legally marketed device in that generic type of device; 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;

(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

eases

(b) The modified device operates using a different fundamental scientific technology than a legally marketed device in that generic type of device; 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 deoxyribonucleic acid (DNA) probe or nucleic acid hybridization technology rather than culture or immunoassay technology; or

(c) The device is an in vitro device that is intended:

(1) For use in the diagnosis, monitoring, or screening of neoplastic dis

with the exception of immunohistochemical devices;

(2) For use in screening or diagnosis of familial or acquired genetic disorders, including inborn errors of metabolism;

(3) For measuring an analyte that serves

surrogate marker for screening, diagnosis, monitoring life-threatening diseases such as acquired immune deficiency syndrome (AIDS), chronic or active hepatitis, tuberculosis, or myocardial infarction or to monitor therapy;

(4) For assessing the risk of cardiovascular diseases;

(5) For use in diabetes management; (6) For identifying or inferring the identity of a microorganism directly from clinical material;

(7) For detection of antibodies to microorganisms other

than immunoglobulin G (IgG) or IgG assays when the results are not qualitative, or are used to determine immunity, or the assay is intended for use in matrices other than serum or plasma;

(8) For noninvasive testing as defined in $ 812.3(k) of this chapter; and

(9) For near patient testing (point of care). [65 FR 2317, Jan. 14, 2000)

$ 878.3250 External facial fracture fixa

tion 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 (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]

as

a

or

$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.

Subpart B-Diagnostic Devices $ 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.

8878.3500 Polytetrafluoroethylene

with carbon fibers composite im

plant 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.

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