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tification provisions of a regulation in this part, but shall state why the device is substantially equivalent to other devices, as required by $ 807.87.

(c) To avoid duplicative listings, a gastroenterology-urology device that has two or more types of uses (e.g., used both as a diagnostic device and as a therapeutic device) is listed only in one subpart.

(d) References in this part to regulatory sections of the Code of Federal Regulations are to chapter I of title 21, unless otherwise noted.

(52 FR 17737, May 11, 1987; 52 FR 22577, June 12, 1987)

876.5160 Urological clamp for males. 876.5210 Enema kit. 876.5220 Colonic irrigation system. 876.5250 Urine collector and accessories. 876.5270 Implanted electrical urinary con

tinence device. 876.5280 Implanted mechanical/hydraulic

urinary continence device. 876.5310 Nonimplanted, peripheral electrical

continence device. 876.5320 Nonimplanted electrical continence

device. 876.5365 Esophageal dilator. 876.5450 Rectal dilator. 876.5470 Ureteral dilator. 876.5520 Urethral dilator. 876.5540 Blood access device and accessories. 876.5600 Sorbent regenerated dialysate de

livery system for hemodialysis. 876.5630 Peritoneal dialysis system and ac

cessories. 876.5665 Water purification system for

hemodialysis. 876.5820 Hemodialysis system and acces

sories. 876.5830 Hemodialyzer with disposable in

sert (Kiil type). 876.5860 High permeability hemodialysis

system. 876.5870 Sorbent hemoperfusion system. 876.5880 Isolated kidney perfusion and

transport system and accessories. 876.5895 Ostomy irrigator. 876.5900 Ostomy pouch and accessories. 876.5920 Protective garment for inconti

nence. 876.5955 Peritoneo-venous shunt. 876.5970 Hernia support. 876.5980 Gastrointestinal tube and

sories. 876.5990 Extracorporeal shock

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

SOURCE: 48 FR 53023, Nov. 23, 1983, unless otherwise noted.

acces

wave

$ 876.3 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 paragraph (b) 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 commerically distributed without FDA's issuance of an order approving a

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PMA or declaring completed a PDP for (a) The device is intended for a use the device. If FDA promulgates a regu- different from the intended use of a lelation under section 515(b) of the act gally marketed device in that generic requiring premarket approval for a de- type of device; e.g., the device is invice, section 501(f)(1)(A) of the act ap- tended for a different medical purpose, plies to the device.

or the device is intended for lay use (b) Any new, not substantially equiv- where the former intended use was by alent, device introduced into commer- health care professionals only; cial distribution on or after May 28, (b) The modified device operates 1976, including a device formerly mar- using a different fundamental sciketed that has been substantially al- entific technology than a legally martered, is classified by statute (section keted device in that generic type of de513(f) of the act) into class III without vice; e.g., a surgical instrument cuts any grace period and FDA must have tissue with a laser beam rather than issued an order approving a PMA or de- with a sharpened metal blade, or an in claring completed a PDP for the device vitro diagnostic device detects or idenbefore the device is commercially dis- tifies infectious agents by using tributed unless it is reclassified. If deoxyribonucleic acid (DNA) probe or FDA knows that a device being com- nucleic acid hybridization technology mercially distributed may be a "new" rather than culture or immunoassay device as defined in this section be- technology; or cause of any new intended use or other (c) The device is an in vitro device reasons, FDA may codify the statutory that is intended: classification of the device into class

(1) For use in the diagnosis, moniIII for such new use. Accordingly, the toring, or screening of neoplastic disregulation for such a class III device

eases with the exception of states that as of the enactment date of

immunohistochemical devices; the amendments, May 28, 1976, the de- (2) For use in screening or diagnosis vice must have an approval under sec

of familial or acquired genetic distion 515 of the act before commercial

orders, including inborn errors of medistribution.

tabolism; (52 FR 17737, May 11, 1987)

(3) For measuring an analyte that

surrogate marker for $ 876.9 Limitations of exemptions from screening, diagnosis, or monitoring

section 510(k) of the Federal Food, life-threatening diseases such as acDrug, and Cosmetic Act (the act).

quired immune deficiency syndrome The exemption from the requirement (AIDS), chronic or active hepatitis, tuof premarket notification (section berculosis, or myocardial infarction or 510(k) of the act) for a generic type of

to monitor therapy; class I or II device is only to the extent (4) For assessing the risk of cardiothat the device has existing or reason

vascular diseases; ably foreseeable characteristics of (5) For use in diabetes management; commercially distributed devices with- (6) For identifying or inferring the in that generic type or, in the case of identity of a microorganism directly in vitro diagnostic devices, only to the from clinical material; extent that misdiagnosis as a result of

(7) For detection of antibodies to using the device would not be associ

microorganisms other

than ated with high morbidity or mortality. immunoglobulin G (IgG) or IgG assays Accordingly, manufacturers

of any

when the results are not qualitative, or commercially distri ite clas I or II

are used to determine immunity, or the device for which FDA has granted an

assay is intended for use in matrices exemption from the requirement of other than serum or plasma; premarket notification must still sub

(8) For noninvasive testing as defined mit a premarket notification to FDA

in $812.3(k) of this chapter; and before introducing or delivering for introduction into interstate commerce

(9) For near patient testing (point of

care). for commercial distribution the device when:

[65 FR 2316, Jan. 14, 2000)

serves

as

a

Subpart B-Diagnostic Devices user's eye and their accessories may

assist in gaining access or increase the $ 876.1075 Gastroenterology-urology versatility and augment the capabilibiopsy instrument.

ties of the devices. Examples of devices (a) Identification. A gastroenterology

that are within this generic type of deurology biopsy instrument is a device vice include cleaning accessories for used to remove, by cutting or aspira- endoscopes, photographic accessories tion, a specimen of tissue for micro

for endoscopes, nonpowered anoscopes, scopic examination. This generic type

binolcular attachments for endoscopes, of device includes the biopsy punch,

pocket battery boxes, flexible or rigid gastrointestinal mechanical biopsy in

choledochoscopes, colonoscopes, diagstrument, suction biopsy instrument,

nostic cystoscopes, cystourethroscopes, gastro-urology biopsy needle and nee

enteroscopes, esophagogastroduodenodle set, and nonelectric biopsy forceps.

scopes, rigid esophagoscopes, fiberoptic This section does not apply to biopsy

illuminators for endoscopes, incandesinstruments that have specialized uses

cent endoscope lamps, biliary in other medical specialty areas and

pancreatoscopes, proctoscopes, resectothat are covered by classification regu

scopes, nephroscopes, sigmoidoscopes, lations in other parts of the device

ureteroscopes, urethroscopes, endoclassification regulations.

magnetic retrievers, cytology brushes (b) Classification. (1) Class II (per

for endoscopes, and lubricating jelly formance standards).

for transurethral surgical instruments.

This section (2) Class I for the biopsy forceps

does not apply to cover and the non-electric biopsy for

endoscopes that have specialized uses ceps. The devices subject to this para

in other medical specialty areas and graph (b)(2) are exempt from the pre

that are covered by classification regumarket notification procedures in sub

lations in other parts of the device

classification regulations. part E of part 807 of this chapter.

(b) Classification. (1) Class II (per[48 FR 53023, Nov. 23, 1983, as amended at 61 formance standards). FR 1122, Jan. 16, 1996)

(2) Class I for the photographic acces

sories for endoscope, miscellaneous 8876.1400 Stomach pH electrode.

bulb adapter for endoscope, binocular (a) Identification. A stomach pH elec- attachment for endoscope, eyepiece attrode is a device used to measure tachment for prescription lens, teachintragastric and intraesophageal pH ing attachment, inflation bulb, meas(hydrogen ion concentration). The pH uring device for panendoscope, photoelectrode is at the end of a flexible lead graphic equipment for physiologic which may be inserted into the esoph- function monitor, special lens instruagus or stomach through the patient's ment for endoscope, smoke removal mouth. The device may include an in- tube, rechargeable battery box, pocket tegral gastrointestinal tube.

battery box, bite block for endoscope, (b) Classification. Class I. The device

and cleaning brush for endoscope. The is exempt from the premarket notifica

devices subject to this paragraph (b)(2) tion procedures in subpart E of part 807 are exempt from the premarket notifiof this chapter.

cation procedures in subpart E of part (48 FR 53023, Nov. 23, 1983, as amended at 61

807 of this chapter. FR 1122, Jan. 16, 1996)

(48 FR 53023, Nov. 23, 1983, as amended at 61

FR 1122, Jan. 16, 1996) $ 876.1500 Endoscope and accessories. (a) Identification. An endoscope and

$876.1620 Urodynamics measurement accessories is a device used to provide

system. access, illumination, and allow obser- (a) Identification. A urodynamics vation or manipulation of body cav- measurement system is a device used ities, hollow organs, and canals. The to measure volume and pressure in the device consists of various rigid or flexi- urinary bladder when it is filled ble instruments that are inserted into through a catheter with carbon dioxide body spaces and may include an optical or water. The device controls the supsystem for conveying an image to the ply of carbon dioxide or water and may

also record the electrical activity of the muscles associated with urination. The device system may include transducers, electronic signal conditioning and display equipment, a catheter withdrawal device to enable a urethral pressure profile to be obtained, and special catheters for urethral profilometry and electrodes for electromyography. This generic type of device includes the cystometric gas (carbon dioxide) device, the cystometric hydrualic device, and the electrical recording cystometer, but excludes any device that uses air to fill the bladder.

(b) Classification. Class II (special contr The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to $876.9. (48 FR 53023, Nov. 23, 1983, as amended at 63 FR 59228, Nov. 3, 1998)

(1) The sale, distribution and use of this device are restricted to prescription use in accordance with $ 801.109 of this chapter.

(2) The labeling must include specific instructions:

(i) To describe proper patient set-up prior to the start of the test, including the proper placement of electrodes;

(ii) To describe how background data should be gathered and used to eliminate artifact in the data signal;

(iii) To describe the test protocol (including the measurement of baseline data) that may be followed to obtain the EGG signal; and

(iv) To explain how data results may be interpreted.

(3) The device design should ensure that the EGG signal is distinguishable from background noise that may interfere with the true gastric myoelectric signal.

(4) Data should be collected to demonstrate that the device has adequate precision and the EGG signal is reproducible and is interpretable. (64 FR 51444, Sept. 23, 1999]

8 876.1725 Gastrointestinal motility

monitoring system. (a) Identification. A gastrointestinal motility monitoring system is a device used to measure peristalic activity or pressure in the stomach or esophagus by means of a probe with transducers that is introduced through the mouth into the gastrointestinal tract. The device may include signal conditioning, amplifying, and recording equipment. This generic type of device includes the esophageal motility monitor and tube, the gastrointestinal motility (electrical) system, and certain accessories, such as a pressure transducer, amplifier, and external recorder.

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

$876.1800 Urine flow or volume meas

uring system. (a) Identification. A urine flow or volume measuring system is a device that measures directly or indirectly the volume or flow of urine from a patient, either during the course of normal urination or while the patient is catheterized. The device may include a drip chamber to reduce the risk of retrograde bacterial contamination of the bladder and a transducer and electrical signal conditioning and display equipment. This generic type of device includes the electrical urinometer, mechanical urinometer, nonelectric urinometer, disposable nonelectric urine flow rate measuring device, and uroflowmeter.

(b) Classification. (1) Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to $876.9. (48 FR 53023, Nov. 23, 1983, as amended at 61 FR 1122, Jan. 16, 1996; 63 FR 59228, Nov. 3, 1998]

8876.1735 Electrogastrography system. (a) Identification.

An electrogastrography system (EGG) is a device used to measure gastric myoelectrical activity as an aid in the diagnosis of gastric motility disorders. The device system includes the external recorder, amplifier, skin electrodes, strip chart, cables, analytical software, and other accessories.

(b) Classification. Class II (Special Controls). The special controls are as follows:

Subpart C-Monitoring Devices

$876.2040 Enuresis alarm.

(a) Identification. An enuresis alarm is a device intended for use in treatment of bedwetting. Through an electrical trigger mechanism, the device sounds an alarm when a small quantity of urine is detected on a sensing pad. This generic type of device includes conditioned response enuresis alarms.

(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to $876.9. [48 FR 53023, Nov. 23, 1983, as amended at 63 FR 59228, Nov. 3, 1998]

$ 876.3630 Penile rigidity implant.

(a) Identification. A penile rigidity implant is a device that consists of a pair of semi-rigid rods implanted in the corpora cavernosa of the penis to provide rigidity. It is intended to be used in men diagnosed as having erectile dysfunction.

(b) Classification. Class II. The special control for this device is the FDA guidance entitled “Guidance for the Content of Premarket Notifications for Penile Rigidity Implants." [65 FR 4882, Feb. 2, 2000)

Subpart D-Prosthetic Devices

8876.3350 Penile inflatable implant.

(a) Identification. A penile inflatable implant is a device that consists of two inflatable cylinders implanted in the penis, connected to a reservoir filled with radiopaque fluid implanted in the abdomen, and a subcutaneous manual pump implanted in the scrotum. When the cylinders are inflated, they provide rigidity to the penis. This device is used in the treatment of erectile impotence.

(b) Classification. Class III (premarket approval).

(c) Date premarket approval application (PMA) of notice of completion of a product development protocol (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 July 11, 2000, for any penile inflatable implant that was in commercial distribution before May 28, 1976, or that has, on or before July 11, 2000, been found to be substantially equivalent to a penile inflatable implant that was in commercial distribution before May 28, 1976. Any other penile inflatable implant shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution. (48 FR 53023, Nov. 23, 1983, as amended at 52 FR 17738, May 11, 1987; 65 FR 19658, Apr. 12, 2000]

8876.3750 Testicular prosthesis.

(a) Identification. A testicular prosthesis is an implanted device that consists of a solid or gel-filled silicone rubber prosthesis that is implanted surgically to resemble a testicle.

(b) Classification. Class III (premarket approval).

(c) Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. A PMA or notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before July 5, 1995, for any testicular prosthesis that was in commercial distribution before May 28, 1976, or that has on or before July 5, 1995, been found to be substantially equivalent to a testicular prosthesis that was in commercial distribution before May 28, 1976. Any other testicular prosthesis shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution. (48 FR 53023, Nov. 23, 1983, as amended at 52 FR 17738, May 11, 1987; 60 FR 17216, Apr. 5, 1995)

Subpart E-Surgical Devices $876.4020 Fiberoptic light ureteral

catheter. (a) Identification. A fiberoptic light ureteral catheter is a device that consists of a fiberoptic bundle that emits light throughout its length and is shaped so that it can be inserted into the ureter to enable the path of the ureter to be seen during lower abdominal or pelvic surgery.

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

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