§ 874.5550 21 CFR Ch. I (4–1–08 Edition)

Drug Administration on or before July subpart E of part 807 of this chapter 13, 1999 for any tongs antichoke device subject to § 874.9. that was in commercial distribution [51 FR 40389, Nov. 6, 1986, as amended at 65 before May 28, 1976, or that has, on or FR 2316, Jan. 14, 2000] before July 13, 1999, been found to be substantially equivalent to a tongs antichoke device that was in commer- PART 876—GASTROENTEROLOGY- cial distribution before May 28, 1976. UROLOGY DEVICES Any other tongs antichoke device shall have an approved PMA or declared Subpart A—General Provisions completed PDP in effect before being Sec. placed in commercial distribution. 876.1 Scope. 876.3 Effective dates of requirement for pre- [51 FR 40389, Nov. 6, 1986, as amended at 64 market approval. FR 18329, Apr. 14, 1999] 876.9 Limitations of exemptions from sec- tion 510(k) of the Federal Food, Drug, § 874.5550 Powered nasal irrigator. and Cosmetic Act (the act). (a) Identification. A powered nasal irrigator is an AC-powered device in- Subpart B—Diagnostic Devices tended to wash the nasal cavity by 876.1075 Gastroenterology-urology biopsy means of a pressure-controlled pul- instrument. sating stream of water. The device con- 876.1300 Ingestible telemetric gastro- sists of a control unit and pump con- intestinal capsule imaging system. nected to a spray tube and nozzle. 876.1400 pH electrode. (b) Classification. Class I (general con- 876.1500 Endoscope and accessories. trols). The device is exempt from the 876.1620 Urodynamics measurement system. premarket notification procedures in 876.1725 Gastrointestinal motility moni- toring system. subpart E of part 807 of this chapter 876.1735 Electrogastrography system. subject to § 874.9. 876.1800 Urine flow or volume measuring [55 FR 48440, Nov. 20, 1990, as amended at 65 system. FR 2316, Jan. 14, 2000] Subpart C—Monitoring Devices § 874.5800 External nasal splint. 876.2040 Enuresis alarm. (a) Identification. An external nasal splint is a rigid or partially rigid de- Subpart D—Prosthetic Devices vice intended for use externally for im- 876.3350 Penile inflatable implant. mobilization of parts of the nose. 876.3630 Penile rigidity implant. (b) Classification. Class I (general con- 876.3750 Testicular prosthesis. trols). The device is exempt from the premarket notification procedures in Subpart E—Surgical Devices subpart E of part 807 of this chapter 876.4020 Fiberoptic light ureteral catheter. subject to the limitations in § 874.9. 876.4270 rod. [51 FR 40389, Nov. 9, 1986, as amended at 52 876.4300 Endoscopic electrosurgical unit and FR 32111, Aug. 25, 1987; 59 FR 63009, Dec. 7, accessories. 1994; 66 FR 38801, July 25, 2001] 876.4370 Gastroenterology-urology evacuator. § 874.5840 Antistammering device. 876.4400 Hemorrhoidal ligator. 876.4480 Electrohydraulic lithotriptor. (a) Identification. An antistammering 876.4500 Mechanical lithotriptor. device is a device that electronically 876.4530 Gastroenterology-urology generates a noise when activated or fiberoptic retractor. when it senses the user’s speech and 876.4560 Ribdam. that is intended to prevent the user 876.4590 Interlocking urethral sound. from hearing the sounds of his or her 876.4620 Ureteral stent. own voice. The device is used to mini- 876.4650 Water jet renal stone dislodger sys- mize a user’s involuntary hesitative or tem. 876.4680 Ureteral stone dislodger. repetitive speech. 876.4730 Manual gastroenterology-urology (b) Classification. Class I (general con- surgical instrument and accessories. trols). The device is exempt from the 876.4770 Urethrotome. premarket notification procedures in 876.4890 Urological table and accessories.

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Subpart F—Therapeutic Devices (b) The identification of a device in a regulation in this part is not a precise 876.5010 Biliary catheter and accessories. description of every device that is, or 876.5020 External penile rigidity devices. 876.5030 Continent catheter. will be, subject to the regulation. A 876.5090 Suprapubic urological catheter and manufacturer who submits a pre- accessories. market notification submission for a 876.5130 Urological catheter and accessories. device under part 807 may not show 876.5160 Urological clamp for males. merely that the device is accurately 876.5210 Enema kit. described by the section title and iden- 876.5220 Colonic irrigation system. tification provisions of a regulation in 876.5250 Urine collector and accessories. 876.5270 Implanted electrical urinary con- this part, but shall state why the de- tinence device. vice is substantially equivalent to 876.5280 Implanted mechanical/hydraulic other devices, as required by § 807.87. urinary continence device. (c) To avoid duplicative listings, a 876.5310 Nonimplanted, peripheral electrical gastroenterology-urology device that continence device. has two or more types of uses (e.g., 876.5320 Nonimplanted electrical continence used both as a diagnostic device and as device. 876.5365 Esophageal dilator. a therapeutic device) is listed only in 876.5450 Rectal dilator. one subpart. 876.5470 Ureteral dilator. (d) References in this part to regu- 876.5520 Urethral dilator. latory sections of the Code of Federal 876.5540 Blood access device and accessories. Regulations are to chapter I of title 21, 876.5600 Sorbent regenerated dialysate de- unless otherwise noted. livery system for hemodialysis. (e) Guidance documents referenced in 876.5630 system and ac- cessories. this part are available on the Internet 876.5665 Water purification system for at http://www.fda.gov/cdrh/guid- hemodialysis. ance.html. 876.5820 Hemodialysis system and acces- [52 FR 17737, May 11, 1987; 52 FR 22577, June sories. 12, 1987, as amended at 69 FR 77623, Dec. 28, 876.5830 Hemodialyzer with disposable in- 2004] sert (Kiil type). 876.5860 High permeability hemodialysis system. § 876.3 Effective dates of requirement 876.5870 Sorbent hemoperfusion system. for premarket approval. 876.5880 Isolated kidney perfusion and A device included in this part that is transport system and accessories. classified into class III (premarket ap- 876.5885 Tissue culture media for human ex proval) shall not be commercially dis- vivo tissue and cell culture processing tributed after the date shown in the applications. 876.5895 Ostomy irrigator. regulation classifying the device unless 876.5900 Ostomy pouch and accessories. the manufacturer has an approval 876.5920 Protective garment for inconti- under section 515 of the act (unless an nence. exemption has been granted under sec- 876.5955 Peritoneo-venous shunt. tion 520(g)(2) of the act). An approval 876.5970 support. under section 515 of the act consists of 876.5980 Gastrointestinal tube and acces- FDA’s issuance of an order approving sories. 876.5990 Extracorporeal shock wave an application for premarket approval lithotripter. (PMA) for the device or declaring com- pleted a product development protocol AUTHORITY: 21 U.S.C. 351, 360, 360c, 360e, (PDP) for the device. 360j, 360l, 371. (a) Before FDA requires that a device SOURCE: 48 FR 53023, Nov. 23, 1983, unless commercially distributed before the otherwise noted. enactment date of the amendments, or a device that has been found substan- Subpart A—General Provisions tially equivalent to such a device, has an approval under section 515 of the act § 876.1 Scope. FDA must promulgate a regulation (a) This part sets forth the classifica- under section 515(b) of the act requir- tion of gastroenterology-urology de- ing such approval, except as provided vices intended for human use that are in paragraph (b) of this section. Such a in commercial distribution. regulation under section 515(b) of the

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act shall not be effective during the extent that misdiagnosis as a result of grace period ending on the 90th day using the device would not be associ- after its promulgation or on the last ated with high morbidity or mortality. day of the 30th full calendar month Accordingly, manufacturers of any after the regulation that classifies the commercially distributed class I or II device into class III is effective, which- device for which FDA has granted an ever is later. See section 501(f)2)(B) of exemption from the requirement of the act. Accordingly, unless an effec- premarket notification must still sub- tive date of the requirement for pre- mit a premarket notification to FDA market approval is shown in the regu- before introducing or delivering for in- lation for a device classified into class troduction into interstate commerce III in this part, the device may be for commercial distribution the device commerically distributed without when: FDA’s issuance of an order approving a (a) The device is intended for a use PMA or declaring completed a PDP for different from the intended use of a le- the device. If FDA promulgates a regu- gally marketed device in that generic lation under section 515(b) of the act type of device; e.g., the device is in- requiring premarket approval for a de- tended for a different medical purpose, vice, section 501(f)(1)(A) of the act ap- or the device is intended for lay use plies to the device. where the former intended use was by (b) Any new, not substantially equiv- health care professionals only; alent, device introduced into commer- cial distribution on or after May 28, (b) The modified device operates 1976, including a device formerly mar- using a different fundamental sci- keted that has been substantially al- entific technology than a legally mar- tered, is classified by statute (section keted device in that generic type of de- 513(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 iden- before 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, moni- III for such new use. Accordingly, the toring, or screening of neoplastic dis- regulation 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 dis- tion 515 of the act before commercial orders, including inborn errors of me- distribution. tabolism; (3) For measuring an analyte that [52 FR 17737, May 11, 1987] serves as a 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 ac- Drug, and Cosmetic Act (the act). quired immune deficiency syndrome The exemption from the requirement (AIDS), chronic or active hepatitis, tu- of 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 cardio- that 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;

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(7) For detection of antibodies to transmitter, and battery), an antenna microorganisms other than array, a receiving/recording unit, a immunoglobulin G (IgG) or IgG assays data storage device, computer software when the results are not qualitative, or to process the images, and accessories. are used to determine immunity, or the (b) Classification. Class II (special assay is intended for use in matrices controls). The special control is FDA’s other than serum or plasma; guidance, ‘‘Class II Special Controls (8) For noninvasive testing as defined Guidance Document: Ingestible Tele- in § 812.3(k) of this chapter; and metric Gastrointestinal Capsule Imag- (9) For near patient testing (point of ing Systems; Final Guidance for Indus- care). try and FDA.’’ [65 FR 2316, Jan. 14, 2000] [67 FR 3433, Jan. 24, 2002]

Subpart B—Diagnostic Devices § 876.1400 Stomach pH electrode. (a) Identification. A stomach pH elec- § 876.1075 Gastroenterology-urology trode is a device used to measure biopsy instrument. intragastric and intraesophageal pH (a) Identification. A gastroenterology- (hydrogen ion concentration). The pH urology biopsy instrument is a device electrode is at the end of a flexible lead used to remove, by cutting or aspira- which may be inserted into the esoph- tion, a specimen of tissue for micro- agus or stomach through the patient’s scopic examination. This generic type mouth. The device may include an in- of device includes the biopsy punch, tegral gastrointestinal tube. gastrointestinal mechanical biopsy in- (b) Classification. Class I. The device strument, suction biopsy instrument, is exempt from the premarket notifica- gastro-urology biopsy needle and nee- tion procedures in subpart E of part 807 dle set, and nonelectric biopsy forceps. of this chapter. This section does not apply to biopsy [48 FR 53023, Nov. 23, 1983, as amended at 61 instruments that have specialized uses FR 1122, Jan. 16, 1996] in other medical specialty areas and that are covered by classification regu- § 876.1500 Endoscope and accessories. lations in other parts of the device (a) Identification. An endoscope and classification regulations. accessories is a device used to provide (b) Classification. (1) Class II (per- access, illumination, and allow obser- formance standards). vation or manipulation of body cav- (2) Class I for the biopsy forceps ities, hollow organs, and canals. The cover and the non-electric biopsy for- device consists of various rigid or flexi- ceps. The devices subject to this para- ble instruments that are inserted into graph (b)(2) are exempt from the pre- body spaces and may include an optical market notification procedures in sub- system for conveying an image to the part E of part 807 of this chapter sub- user’s eye and their accessories may ject to the limitations in § 876.9. assist in gaining access or increase the [48 FR 53023, Nov. 23, 1983, as amended at 61 versatility and augment the capabili- FR 1122, Jan. 16, 1996; 66 FR 38801, July 25, ties of the devices. Examples of devices 2001] that are within this generic type of de- vice include cleaning accessories for § 876.1300 Ingestible telemetric gastro- endoscopes, photographic accessories intestinal capsule imaging system. for endoscopes, nonpowered anoscopes, (a) Identification. An ingestible tele- binolcular attachments for endoscopes, metric gastrointestinal capsule imag- pocket battery boxes, flexible or rigid ing system is used for visualization of choledochoscopes, colonoscopes, diag- the small bowel mucosa as an adjunc- nostic cystoscopes, cystourethroscopes, tive tool in the detection of abnormali- enteroscopes, ties of the small bowel. The device cap- esophagogastroduodenoscopes, rigid tures images of the small bowel with a esophagoscopes, fiberoptic illuminators wireless camera contained in a capsule. for endoscopes, incandescent endoscope This device includes an ingestible cap- lamps, biliary pancreatoscopes, sule (containing a light source, camera, proctoscopes, resectoscopes,

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nephroscopes, sigmoidoscopes, excludes any device that uses air to fill ureteroscopes, urethroscopes, the bladder. endomagnetic retrievers, cytology (b) Classification. Class II (special brushes for endoscopes, and lubricating controls). The device is exempt from jelly for transurethral surgical instru- the premarket notification procedures ments. This section does not apply to in subpart E of part 807 of this chapter endoscopes that have specialized uses subject to § 876.9. in other medical specialty areas and [48 FR 53023, Nov. 23, 1983, as amended at 63 that are covered by classification regu- FR 59228, Nov. 3, 1998] lations in other parts of the device classification regulations. § 876.1725 Gastrointestinal motility (b) Classification. (1) Class II (per- monitoring system. formance standards). (a) Identification. A gastrointestinal (2) Class I for the photographic acces- motility monitoring system is a device sories for endoscope, miscellaneous used to measure peristalic activity or bulb adapter for endoscope, binocular pressure in the stomach or attachment for endoscope, eyepiece at- by means of a probe with transducers tachment for prescription lens, teach- that is introduced through the mouth ing attachment, inflation bulb, meas- into the . The de- uring device for panendoscope, photo- vice may include signal conditioning, graphic equipment for physiologic amplifying, and recording equipment. function monitor, special lens instru- This generic type of device includes the ment for endoscope, smoke removal esophageal motility monitor and tube, tube, rechargeable battery box, pocket the gastrointestinal motility (elec- battery box, bite block for endoscope, trical) system, and certain accessories, and cleaning brush for endoscope. The such as a pressure transducer, ampli- devices subject to this paragraph (b)(2) fier, and external recorder. are exempt from the premarket notifi- (b) Classification. Class II (perform- cation procedures in subpart E of part ance standards). 807of this chapter, subject to the limi- § 876.1735 Electrogastrography system. tations in § 876.9. (a) Identification. An [48 FR 53023, Nov. 23, 1983, as amended at 61 electrogastrography system (EGG) is a FR 1122, Jan. 16, 1996; 66 FR 38801, July 25, device used to measure gastric 2001] myoelectrical activity as an aid in the diagnosis of gastric motility disorders. § 876.1620 Urodynamics measurement The device system includes the exter- system. nal recorder, amplifier, skin electrodes, (a) Identification. A urodynamics strip chart, cables, analytical software, measurement system is a device used and other accessories. to measure volume and pressure in the (b) Classification. Class II (Special urinary bladder when it is filled Controls). The special controls are as through a catheter with carbon dioxide follows: or water. The device controls the sup- (1) The sale, distribution and use of ply of carbon dioxide or water and may this device are restricted to prescrip- also record the electrical activity of tion use in accordance with § 801.109 of the muscles associated with urination. this chapter. The device system may include trans- (2) The labeling must include specific ducers, electronic signal conditioning instructions: and display equipment, a catheter (i) To describe proper patient set-up withdrawal device to enable a urethral prior to the start of the test, including pressure profile to be obtained, and the proper placement of electrodes; special catheters for urethral (ii) To describe how background data profilometry and electrodes for should be gathered and used to elimi- electromyography. This generic type of nate artifact in the data signal; device includes the cystometric gas (iii) To describe the test protocol (in- (carbon dioxide) device, the cluding the measurement of baseline cystometric hydrualic device, and the data) that may be followed to obtain electrical recording cystometer, but the EGG signal; and

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(iv) To explain how data results may in subpart E of part 807 of this chapter be interpreted. subject to § 876.9. (3) The device design should ensure [48 FR 53023, Nov. 23, 1983, as amended at 63 that the EGG signal is distinguishable FR 59228, Nov. 3, 1998] from background noise that may inter- fere with the true gastric myoelectric Subpart D—Prosthetic Devices signal. (4) Data should be collected to dem- § 876.3350 Penile inflatable implant. onstrate that the device has adequate (a) Identification. A penile inflatable precision and the EGG signal is repro- implant is a device that consists of two ducible and is interpretable. inflatable cylinders implanted in the [64 FR 51444, Sept. 23, 1999] penis, connected to a reservoir filled with radiopaque fluid implanted in the § 876.1800 Urine flow or volume meas- abdomen, and a subcutaneous manual uring system. pump implanted in the scrotum. When (a) Identification. A urine flow or vol- the cylinders are inflated, they provide ume measuring system is a device that rigidity to the penis. This device is used in the treatment of erectile impo- measures directly or indirectly the vol- tence. ume or flow of urine from a patient, ei- (b) Classification. Class III (premarket ther during the course of normal urina- approval). tion or while the patient is catheter- (c) Date premarket approval application ized. The device may include a drip (PMA) or notice of completion of a prod- chamber to reduce the risk of retro- uct development protocol (PDP) is re- grade bacterial contamination of the quired. A PMA or a notice of comple- bladder and a transducer and electrical tion of a PDP is required to be filed signal conditioning and display equip- with the Food and Drug Administra- ment. This generic type of device in- tion on or before July 11, 2000, for any cludes the electrical urinometer, me- penile inflatable implant that was in chanical urinometer, nonelectric uri- commercial distribution before May 28, nometer, disposable nonelectric urine 1976, or that has, on or before July 11, flow rate measuring device, and 2000, been found to be substantially uroflowmeter. equivalent to a penile inflatable im- (b) Classification. (1) Class II (special plant that was in commercial distribu- controls). The device is exempt from tion before May 28, 1976. Any other the premarket notification procedures penile inflatable implant shall have an in subpart E of part 807 of this chapter approved PMA or a declared completed subject to § 876.9. PDP in effect before being placed in commercial distribution. [48 FR 53023, Nov. 23, 1983, as amended at 61 FR 1122, Jan. 16, 1996; 63 FR 59228, Nov. 3, [48 FR 53023, Nov. 23, 1983, as amended at 52 1998] FR 17738, May 11, 1987; 65 FR 19658, Apr. 12, 2000]

Subpart C—Monitoring Devices § 876.3630 Penile rigidity implant. § 876.2040 Enuresis alarm. (a) Identification. A penile rigidity implant is a device that consists of a (a) Identification. An enuresis alarm pair of semi-rigid rods implanted in the is a device intended for use in treat- corpora cavernosa of the penis to pro- ment of bedwetting. Through an elec- vide rigidity. It is intended to be used trical trigger mechanism, the device in men diagnosed as having erectile sounds an alarm when a small quantity dysfunction. of urine is detected on a sensing pad. (b) Classification. Class II. The special This generic type of device includes control for this device is the FDA guid- conditioned response enuresis alarms. ance entitled ‘‘Guidance for the Con- (b) Classification. Class II (special tent of Premarket Notifications for controls). The device is exempt from Penile Rigidity Implants.’’ the premarket notification procedures [65 FR 4882, Feb. 2, 2000]

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§ 876.3750 Testicular prosthesis. § 876.4300 Endoscopic electrosurgical unit and accessories. (a) Identification. A testicular pros- thesis is an implanted device that con- (a) Identification. An endoscopic sists of a solid or gel-filled silicone rub- electrosurgical unit and accessories is ber prosthesis that is implanted sur- a device used to perform gically to resemble a testicle. electrosurgical procedures through an (b) Classification. Class III (premarket endoscope. This generic type of device includes the electrosurgical generator, approval). patient plate, electric biopsy forceps, (c) Date premarket approval application electrode, flexible snare, (PMA) or notice of product development electrosurgical alarm system, protocol (PDP) is required. A PMA or no- electrosurgical power supply unit, elec- tice of completion of a PDP is required trical clamp, self-opening rigid snare, to be filed with the Food and Drug Ad- flexible suction coagulator electrode, ministration on or before July 5, 1995, patient return wristlet, contact jelly, for any testicular prosthesis that was adaptor to the cord for transurethral in commercial distribution before May surgical instruments, the electric cord 28, 1976, or that has on or before July 5, for transurethral surgical instruments, 1995, been found to be substantially and the transurethral desiccator. equivalent to a testicular prosthesis (b) Classification. Class II (perform- that was in commercial distribution ance standards). before May 28, 1976. Any other testic- ular prosthesis shall have an approved § 876.4370 Gastroenterology-urology PMA or a declared completed PDP in evacuator. effect before being placed in commer- (a) Identification. A gastroenterology- cial distribution. urology evacuator is a device used to remove debris and fluids during gastro- [48 FR 53023, Nov. 23, 1983, as amended at 52 enterological and urological procedures FR 17738, May 11, 1987; 60 FR 17216, Apr. 5, by drainage, aspiration, or irrigation. 1995] This generic type of device includes the fluid evacuator system, manually pow- Subpart E—Surgical Devices ered bladder evacuator, and the AC- powered vacuum pump. § 876.4020 Fiberoptic light ureteral (b) Classification. (1) Class II (special catheter. controls) for the gastroenterology-urol- (a) Identification. A fiberoptic light ogy evacuator when other than manu- ureteral catheter is a device that con- ally powered. The device is exempt sists of a fiberoptic bundle that emits from the premarket notification proce- light throughout its length and is dures in subpart E of part 807 of this shaped so that it can be inserted into chapter subject to § 876.9. the ureter to enable the path of the (2) Class I for the gastroenterology- ureter to be seen during lower abdom- urology evacuator when manually pow- inal or pelvic surgery. ered. The device subject to this para- graph (b)(2) is exempt from the pre- (b) Classification. Class II (perform- market notification procedures in sub- ance standards). part E of part 807 of this chapter. § 876.4270 Colostomy rod. [48 FR 53023, Nov. 23, 1983, as amended at 54 (a) Identification. A colostomy rod is FR 25049, June 12, 1989; 63 FR 59228, Nov. 3, 1998] a device used during the loop colos- tomy procedure. A loop of colon is sur- § 876.4400 Hemorrhoidal ligator. gically brought out through the ab- (a) Identification. A hemorrhoidal dominal wall and the stiff colostomy ligator is a device used to cut off the rod is placed through the loop tempo- blood flow to hemorrhoidal tissue by rarily to keep the colon from slipping means of a ligature or band placed back through the surgical opening. around the hemorrhoid. (b) Classification. Class II (perform- (b) Classification. Class II (perform- ance standards). ance standards).

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§ 876.4480 Electrohydraulic subpart E of part 807 of this chapter lithotriptor. subject to the limitations in § 876.9. (a) Identification. An electrohydraulic [48 FR 53023, Nov. 23, 1983, as amended at 54 lithotriptor is an AC-powered device FR 25049, June 12, 1989; 66 FR 38801, July 25, used to fragment urinary bladder 2001] stones. It consists of a high voltage source connected by a cable to a bipo- § 876.4590 Interlocking urethral sound. lar electrode that is introduced into (a) Identification. An interlocking the urinary bladder through a cysto- urethral sound is a device that consists scope. The electrode is held against the of two metal sounds (elongated instru- stone in a water-filled bladder and re- ments for exploring or sounding body peated electrical discharges between cavities) with interlocking ends, such the two poles of the electrode cause as with male and female threads or a electrohydraulic shock waves which rounded point and mating socket, used disintegrate the stone. in the repair of a ruptured urethra. The (b) Classification. Class II. The special device may include a protective cap to control for this device is FDA’s ‘‘Guid- ance for the Content of Premarket No- fit over the metal threads. tifications for Intracorporeal (b) Classification. Class I (general con- Lithotripters.’’ trols). The device is exempt from the premarket notification procedures in [48 FR 53023, Nov. 23, 1983, as amended at 52 subpart E of part 807 of this chapter FR 17738, May 11, 1987; 65 FR 17145, Mar. 31, subject to the limitations in § 876.9. 2000] [48 FR 53023, Nov. 23, 1983, as amended at 61 § 876.4500 Mechanical lithotriptor. FR 1122, Jan. 16, 1996; 66 FR 38801, July 25, (a) Identification. A mechanical 2001] lithotriptor is a device with steel jaws that is inserted into the urinary blad- § 876.4620 Ureteral stent. der through the urethra to grasp and (a) Identification. A ureteral stent is a crush bladder stones. tube-like implanted device that is in- (b) Classification. Class II (perform- serted into the ureter to provide ance standards). ureteral rigidity and allow the passage of urine. The device may have finger- § 876.4530 Gastroenterology-urology like protrusions or hooked ends to keep fiberoptic retractor. the tube in place. It is used in the (a) Identification. A gastroenterology- treatment of ureteral injuries and urology fiberoptic retractor is a device ureteral obstruction. that consists of a mechanical retractor (b) Classification. Class II (perform- with a fiberoptic light system that is ance standards). used to illuminate deep surgical sites. (b) Classification. Class I (general con- § 876.4650 Water jet renal stone trols). The device is exempt from the dislodger system. premarket notification procedures in (a) A water jet renal subpart E of part 807 of this chapter Identification. subject to the limitations in § 876.9. stone dislodger system is a device used to dislodge stones from renal calyces [48 FR 53023, Nov. 23, 1983, as amended at 54 (recesses of the pelvis of the kidney) by FR 25049, June 12, 1989; 66 FR 38801, July 25, means of a pressurized stream of water 2001] through a conduit. The device is used § 876.4560 Ribdam. in the surgical removal of kidney stones. (a) Identification. A ribdam is a device (b) Classification. Class II (special that consists of a broad strip of latex controls). The device is exempt from with supporting ribs used to drain sur- the premarket notification procedures gical wounds where copious urine in subpart E of part 807 of this chapter drainage is expected. subject to § 876.9. (b) Classification. Class I (general con- trols). The device is exempt from the [48 FR 53023, Nov. 23, 1983, as amended at 63 premarket notification procedures in FR 59228, Nov. 3, 1998]

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§ 876.4680 Ureteral stone dislodger. cutting blade which can be elevated from its sheath. Some urethrotomes in- (a) Identification. A ureteral stone dislodger is a device that consists of a corporate an optical channel for visual bougie or a catheter with an expand- control. able wire basket near the tip, a special (b) Classification. Class II (perform- flexible tip, or other special construc- ance standards). tion. It is inserted through a cysto- § 876.4890 Urological table and acces- scope and used to entrap and remove sories. stones from the ureter. This generic type of device includes the metal bas- (a) Identification. A urological table ket and the flexible ureteral stone and accessories is a device that con- dislodger. sists of a table, stirrups, and belts used (b) Classification. Class II (special to support a patient in a suitable posi- controls). The device is exempt from tion for endoscopic procedures of the the premarket notification procedures lower urinary tract. The table can be in subpart E of part 807 of this chapter adjusted into position manually or subject to § 876.9. electrically. (b) Classification. (1) Class II (special [48 FR 53023, Nov. 23, 1983, as amended at 63 controls) for the electrically powered FR 59228, Nov. 3, 1998] urological table and accessories. The § 876.4730 Manual gastroenterology- device is exempt from the premarket urology surgical instrument and ac- notification procedures in subpart E of cessories. part 807 of this chapter subject to § 876.9. (a) Identification. A manual gastro- enterology-urology surgical instru- (2) Class I for the manually powered ment and accessories is a device de- table and accessories, and for stirrups signed to be used for gastro- for electrically powered table. The de- enterological and urological surgical vice subject to this paragraph (b)(2) is procedures. The device may be nonpow- exempt from the premarket notifica- ered, hand-held, or hand-manipulated. tion procedures in subpart E of part 807 Manual gastroenterology-urology sur- of this chapter subject to the limita- gical instruments include the biopsy tions in § 876.9. forceps cover, biopsy tray without bi- [48 FR 53023, Nov. 23, 1983, as amended at 61 opsy instruments, line clamp, nonpow- FR 1122, Jan. 16, 1996; 63 FR 59228, Nov. 3, ered rectal probe, nonelectrical clamp, 1998; 66 FR 38801, July 25, 2001] colostomy spur-crushers, locking de- vice for intestinal clamp, needle hold- Subpart F—Therapeutic Devices er, gastro-urology hook, gastro-urology probe and director, nonself-retaining § 876.5010 Biliary catheter and acces- retractor, rings, nonelec- sories. trical snare, rectal specula, bladder (a) Identification. A biliary catheter neck spreader, self-retaining retractor, and accessories is a tubular flexible de- and scoop. vice used for temporary or prolonged (b) Classification. Class I (general con- drainage of the biliary tract, for trols). The device is exempt from the splinting of the during heal- premarket notification procedures in ing, or for preventing stricture of the subpart E of part 807 of this chapter bile duct. This generic type of device subject to the limitations in § 876.9. may include a bile collecting bag that [48 FR 53023, Nov. 23, 1983, as amended at 54 is attached to the biliary catheter by a FR 25049, June 12, 1989; 66 FR 38801, July 25, connector and fastened to the patient 2001] with a strap. (b) Classification. Class II (perform- § 876.4770 Urethrotome. ance standards). (a) Identification. A urethrotome is a device that is inserted into the urethra § 876.5020 External penile rigidity de- and used to cut urethral strictures and vices. enlarge the urethra. It is a metal in- (a) Identification. External penile ri- strument equipped with a dorsal-fin gidity devices are devices intended to

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create or maintain sufficient penile ri- The devices subject to this paragraph gidity for sexual intercourse. External (b)(2) are exempt from the premarket penile rigidity devices include vacuum notification procedures in subpart E of pumps, constriction rings, and penile part 807 of this chapter subject to the splints which are mechanical, powered, limitations in § 876.9. or pneumatic devices. [48 FR 53023, Nov. 23, 1983, as amended at 61 (b) Classification. Class II (special FR 1122, Jan. 16, 1996; 66 FR 38801, July 25, controls). The devices are exempt from 2001] the premarket notification procedures in subpart E of part 807 of this chapter § 876.5130 Urological catheter and ac- subject to the limitations in § 876.9. The cessories. special control for these devices is the (a) Identification. A urological cath- FDA guidance document entitled eter and accessories is a flexible tubu- ‘‘Class II Special Controls Guidance lar device that is inserted through the Document: External Penile Rigidity urethra and used to pass fluids to or Devices.’’ See § 876.1(e) for the avail- from the urinary tract. This generic ability of this guidance document. type of device includes radiopaque [69 FR 77623, Dec. 28, 2004] urological catheters, ureteral cath- eters, urethral catheters, coude´ cath- § 876.5030 Continent ileostomy cath- eters, balloon retention type catheters, eter. straight catheters, upper urinary tract (a) Identification. A continent ileos- catheters, double lumen female tomy catheter is a flexible tubular de- urethrographic catheters, disposable vice used as a form during surgery for ureteral catheters, male continent ileostomy and it provides urethrographic catheters, and drainage after surgery. Additionally, urological catheter accessories includ- the device may be inserted periodically ing ureteral catheter stylets, ureteral by the patient for routine care to catheter adapters, ureteral catheter empty the ileal pouch. This generic holders, ureteral catheter stylets, type of device includes the rectal cath- ureteral catheterization trays, and the eter for continent ileostomy. gastro-urological irrigation tray (for (b) Classification. Class I (general con- urological use). trols). The device is exempt from the (b) Classification. (1) Class II (per- premarket notification procedures in formance standards). subpart E of part 807 of this chapter (2) Class I for the ureteral stylet subject to the limitations in § 876.9. (guidewire), stylet for gastrourological catheter, ureteral catheter adapter, [48 FR 53023, Nov. 23, 1983, as amended at 54 ureteral catheter connector, and FR 25050, June 12, 1989; 66 FR 38801, July 25, ureteral catheter holder. The devices 2001] subject to this paragraph (b)(2) are ex- § 876.5090 Suprapubic urological cath- empt from the premarket notification eter and accessories. procedures in subpart E of part 807 of (a) Identification. A suprapubic this chapter subject to the limitations urological catheter and accessories is a in § 876.9. flexible tubular device that is inserted [48 FR 53023, Nov. 23, 1983, as amended at 61 through the abdominal wall into the FR 1122, Jan. 16, 1996; 66 FR 38801, July 25, urinary bladder with the aid of a trocar 2001] and cannula. The device is used to pass fluids to and from the urinary tract. § 876.5160 Urological clamp for males. This generic type of device includes the (a) Identification. A urological clamp suprapubic catheter and tube, Malecot for males is a device used to close the catheter, catheter punch instrument, urethra of a male to control urinary in- suprapubic drainage tube, and the continence or to hold anesthetic or ra- suprapubic cannula and trocar. diography contrast media in the ure- (b) Classification. (1) Class II (per- thra temporarily. It is an external formance standards). clamp. (2) Class I for the catheter punch in- (b) Classification. Class I (general con- strument, nondisposable cannula and trols). Except when intended for inter- trocar, and gastro-urological trocar. nal use or use on females, the device is

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exempt from the premarket notifica- (2) Class III (premarket approval) tion procedures in subpart E of part 807 when the device is intended for other of this chapter subject to § 876.9. uses, including colon cleansing rou- tinely for general well being. [48 FR 53023, Nov. 23, 1963, as amended at 65 FR 2317, Jan. 14, 2000] (c) Date PMA or notice of completion of a PDP is required. A PMA or a notice of § 876.5210 Enema kit. completion of a PDP is required to be (a) Identification. An enema kit is a filed with the Food and Drug Adminis- device intended to instill water or tration on or before December 26, 1996 other fluids into the colon through a for any colonic irrigation system de- nozzle inserted into the to pro- scribed in paragraph (b)(2) of this sec- mote evacuation of the contents of the tion that was in commercial distribu- lower colon. The device consists of a tion before May 28, 1976, or that has, on container for fluid connected to the or before December 26, 1996 been found nozzle either directly or via tubing. to be substantially equivalent to a co- This device does not include the co- lonic irrigation system described in lonic irrigation system (§ 876.5220). paragraph (b)(2) of this section that (b) Classification. Class I (general con- was in commercial distribution before trols). The device is exempt from the May 28, 1976. Any other colonic irriga- premarket notification procedures in tion system shall have an approved subpart E of part 807 of this chapter PMA in effect before being placed in subject to § 876.9. The device is exempt commercial distribution. from the current good manufacturing [48 FR 53023, Nov. 23, 1983, as amended at 52 practice regulations in part 820 of this FR 17738, May 11, 1987; 61 FR 50707, Sept. 27, chapter, with the exception of § 820.180 1996] of this chapter, with respect to general requirements concerning records, and § 876.5250 Urine collector and acces- § 820.198 of this chapter, with respect to sories. complaint files. (a) Identification. A urine collector [48 FR 53023, Nov. 23, 1963, as amended at 65 and accessories is a device intended to FR 2317, Jan. 14, 2000] collect urine. The device and acces- sories consist of tubing, a suitable re- § 876.5220 Colonic irrigation system. ceptacle, connectors, mechanical sup- (a) Identification. A colonic irrigation ports, and may include a means to pre- system is a device intended to instill vent the backflow of urine or ascent of water into the colon through a nozzle infection. The two kinds of urine col- inserted into the rectum to cleanse lectors are: (evacuate) the contents of the lower (1) A urine collector and accessories colon. The system is designed to allow intended to be connected to an indwell- evacuation of the contents of the colon ing catheter, which includes the uri- during the administration of the co- nary drainage collection kit and the lonic irrigation. The device consists of closed urine drainage system and a container for fluid connected to the drainage bag; and nozzle via tubing and includes a system (2) A urine collector and accessories which enables the pressure, tempera- not intended to be connected to an in- ture, or flow of water through the noz- dwelling catheter, which includes the zle to be controlled. The device may in- corrugated rubber sheath, pediatric clude a console-type toilet and nec- urine collector, leg bag for external essary fittings to allow the device to be use, urosheath type incontinence de- connected to water and sewer pipes. vice, and the paste-on device for incon- The device may use electrical power to tinence. heat the water. The device does not in- (b) Classification. (1) Class II (special clude the enema kit (§ 876.5210). controls) for a urine collector and ac- (b) Classification. (1) Class II (per- cessories intended to be connected to formance standards) when the device is an indwelling catheter. The device is intended for colon cleansing when exempt from the premarket notifica- medically indicated, such as before ra- tion procedures in subpart E of part 807 diological or endoscopic examinations. of this chapter subject to § 876.9.

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(2) Class I (general controls). For a clude the urethra. The totally im- urine collector and accessories not in- planted device may consist of a static tended to be connected to an indwell- pressure pad, or a system with a con- ing catheter, subject to the limitations tainer of radiopaque fluid in the abdo- in § 876.9. If the device is not labeled or men and a manual pump and valve otherwise represented as sterile, it is under the skin surface that is con- exempt from the current good manu- nected by tubing to an adjustable pres- facturing practice regulations in part sure pad or to a cuff around the ure- 820 of this chapter, with the exception thra. The fluid is pumped as needed of § 820.180, with respect to general re- from the container to inflate the pad or quirements concerning records, and cuff to pass on the urethra. § 820.198, with respect to complaint (b) Classification. Class III (premarket files. approval). [48 FR 53023, Nov. 23, 1983, as amended at 63 (c) Date PMA or notice of completion of FR 59228, Nov. 3, 1998; 65 FR 2317, Jan. 14, a PDP is required. A PMA or a notice of 2000; 66 FR 38802, July 25, 2001] completion of a PDP is required to be filed with the Food and Drug Adminis- § 876.5270 Implanted electrical urinary tration on or before December 26, 2000, continence device. for any implanted mechanical/hydrau- (a) Identification. An implanted elec- lic urinary continence device that was trical urinary device is a device in- in commercial distribution before May tended for treatment of urinary incon- 28, 1976, or that has, on or before De- tinence that consists of a receiver im- cember 26, 2000, been found to be sub- planted in the abdomen with electrodes stantially equivalent to an implanted for pulsed-stimulation that are im- mechanical/hydraulic urinary con- planted either in the bladder wall or in tinence device that was in commercial the pelvic floor, and a battery-powered distribution before May 28, 1976. Any transmitter outside the body. other implanted mechanical/hydraulic (b) Classification. Class III (premarket urinary continence device shall have approval). an approved PMA or a declared com- (c) Date PMA or notice of completion of pleted PDP in effect before being a PDP is required. A PMA or a notice of placed in commercial distribution. completion of a PDP is required to be [48 FR 53023, Nov. 23, 1983, as amended at 52 filed with the Food and Drug Adminis- FR 17738, May 11, 1987; 65 FR 57731, Sept. 26, tration on or before December 26, 1996 2000] for any implanted electrical urinary continence device that was in commer- § 876.5310 Nonimplanted, peripheral cial distribution before May 28, 1976, or electrical continence device. that has, on or before December 26, 1996 (a) Identification. A nonimplanted, pe- been found to be substantially equiva- ripheral electrical continence device is lent to an implanted electrical urinary a device that consists of an electrode continence device that was in commer- that is connected by an electrical cable cial distribution before May 28, 1976. to a battery-powered pulse source. The Any other implanted electrical urinary electrode is placed onto or inserted continence device shall have an ap- into the body at a peripheral location proved PMA or a declared completed and used to stimulate the nerves asso- PDP in effect before being placed in ciated with pelvic floor function to commercial distribution. maintain urinary continence. When [48 FR 53023, Nov. 23, 1983, as amended at 52 necessary, the electrode may be re- FR 17738, May 11, 1987; 61 FR 50707, Sept. 27, moved by the user. 1996] (b) Classification. Class II, subject to the following special controls: § 876.5280 Implanted mechanical/hy- (1) That sale, distribution, and use of draulic urinary continence device. this device are restricted to prescrip- (a) Identification. An implanted me- tion use in accordance with § 801.109 of chanical/hydraulic urinary continence this chapter. device is a device used to treat urinary (2) That the labeling must bear all in- incontinence by the application of con- formation required for the safe and ef- tinuous or intermittent pressure to oc- fective use of the device as outlined in

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§ 801.109(c) of this chapter, including a § 876.5470 Ureteral dilator. detailed summary of the clinical infor- (a) Identification. A ureteral dilator is mation upon which the instructions a device that consists of a specially are based. shaped catheter or bougie and is used [65 FR 18237, Apr. 7, 2000] to dilate the ureter at the place where a stone has become lodged or to dilate § 876.5320 Nonimplanted electrical a ureteral stricture. continence device. (b) Classification. Class II (perform- (a) Identification. A nonimplanted ance standards). electrical continence device is a device that consists of a pair of electrodes on § 876.5520 Urethral dilator. a plug or a pessary that are connected (a) Identification. A urethral dilator is by an electrical cable to a battery-pow- a device that consists of a slender hol- ered pulse source. The plug or pessary low or solid instrument made of metal, is inserted into the rectum or into the plastic, or other suitable material in a vagina and used to stimulate the mus- cylindrical form and in a range of sizes cles of the pelvic floor to maintain uri- and flexibilities. The device may in- nary or fecal continence. When nec- clude a mechanism to expand the por- essary, the plug or pessary may be re- tion of the device in the urethra and moved by the user. This device ex- indicate the degree of expansion on a cludes an AC-powered nonimplanted dial. It is used to dilate the urethra. electrical continence device and the This generic type of device includes the powered vaginal muscle stimulator for mechanical urethral dilator, urological therapeutic use (§ 884.5940). bougies, metal or plastic urethral (b) Classification. Class II (perform- sound, urethrometer, filiform, and fili- ance standards). form follower. (b) Classification. (1) Class II (per- § 876.5365 Esophageal dilator. formance standards). (2) Class I for the urethrometer, (a) Identification. An esophageal dila- urological bougie, filiform and filiform tor is a device that consists of a cylin- follower, and metal or plastic urethral drical instrument that may be hollow sound. The devices subject to this para- and weighted with mercury or a metal graph (b)(2) are exempt from the pre- olive-shaped weight that slides on a market notification procedures in sub- guide, such as a string or wire and is part E of part 807 of this chapter sub- used to dilate a stricture of the esoph- ject to the limitations in § 876.9. agus. This generic type of device in- cludes esophageal or gastrointestinal [48 FR 53023, Nov. 23, 1983, as amended at 61 bougies and the esophageal dilator FR 1122, Jan. 16, 1996; 66 FR 38802, July 25, (metal olive). 2001] (b) Classification. Class II (perform- § 876.5540 Blood access device and ac- ance standards). cessories. § 876.5450 Rectal dilator. (a) Identification. A blood access de- vice and accessories is a device in- (a) Identification. A rectal dilator is a tended to provide access to a patient’s device designed to dilate the anal blood for hemodialysis or other chronic sphincter and canal when the size of uses. When used in hemodialysis, it is the anal opening may interfere with its part of an artificial kidney system for function or the passage of an exam- the treatment of patients with renal ining instrument. failure or toxemic conditions and pro- (b) Classification. Class I (general con- vides access to a patient’s blood for trols). The device is exempt from the hemodialysis. The device includes im- premarket notification procedures in planted blood access devices, non- subpart E of part 807 of this chapter implanted blood access devices, and ac- subject to the limitations in § 876.9. cessories for both the implanted and [48 FR 53023, Nov. 23, 1983, as amended at 61 nonimplanted blood access devices. FR 1122, Jan. 16, 1996; 66 FR 38802, July 25, (1) The implanted blood access device 2001] consists of various flexible or rigid

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tubes, which are surgically implanted § 876.5600 Sorbent regenerated in appropriate blood vessels, may come dialysate delivery system for hemo- through the skin, and are intended to dialysis. remain in the body for 30 days or more. (a) Identification. A sorbent regen- This generic type of device includes erated dialysate delivery system for various shunts and connectors specifi- hemodialysis is a device that is part of cally designed to provide access an artificial kidney system for the to blood, such as the arteriovenous (A-V) treatment of patients with renal fail- shunt cannula and vessel tip. ure or toxemic conditions, and that (2) The nonimplanted blood access consists of a sorbent cartridge and the device consists of various flexible or means to circulate dialysate through rigid tubes, such as catheters, cannulae this cartridge and the dialysate com- or hollow needles, which are inserted partment of the dialyzer. The device is into appropriate blood vessels or a vas- used with the extracorporeal blood sys- cular graft prosthesis (§§ 870.3450 and tem and the dialyzer of the hemo- 870.3460), and are intended to remain in dialysis system and accessories the body for less than 30 days. This ge- (§ 876.5820). The device includes the neric type of device includes fistula means to maintain the temperature, needles, the single needle dialysis set conductivity, electrolyte balance, flow (coaxial flow needle), and the single rate and pressure of the dialysate, and needle dialysis set (alternating flow alarms to indicate abnormal dialysate needle). conditions. The sorbent cartridge may (3) Accessories common to either include absorbent, ion exchange and type include the shunt adaptor, catalytic materials. cannula clamp, shunt connector, shunt (b) Classification. Class II (perform- stabilizer, vessel dilator, disconnect ance standards). forceps, shunt guard, crimp plier, tube plier, crimp ring, joint ring, fistula § 876.5630 Peritoneal dialysis system adaptor, and declotting tray (including and accessories. contents). (a) Identification. (1) A peritoneal di- (b) Classification. (1) Class III (pre- alysis system and accessories is a de- market approval) for the implanted vice that is used as an artificial kidney blood access device. system for the treatment of patients (2) Class II (performance standards) with renal failure or toxemic condi- for the nonimplanted blood access de- tions, and that consists of a peritoneal vice. access device, an administration set for (3) Class II (performance standards) peritoneal dialysis, a source of for accessories for both the implanted dialysate, and, in some cases, a water and the nonimplanted blood access de- purification mechanism. After the vices not listed in paragraph (b)(4) of dialysate is instilled into the patient’s this section. peritoneal cavity, it is allowed to dwell (4) Class I for the cannula clamp, dis- there so that undesirable substances connect forceps, crimp plier, tube plier, from the patient’s blood pass through crimp ring, and joint ring, accessories the lining membrane of the peritoneal for both the implanted and non- cavity into this dialysate. These sub- implanted blood access device. The de- stances are then removed when the vices subject to this paragraph (b)(4) dialysate is drained from the patient. are exempt from the premarket notifi- The peritoneal dialysis system may cation procedures in subpart E of part regulate and monitor the dialysate 807 of this chapter subject to the limi- temperature, volume, and delivery rate tations in § 876.9. together with the time course of each (c) Date PMA or notice of completion of cycle of filling, dwell time, and drain- a PDP is required. No effective date has ing of the peritoneal cavity or manual been established of the requirement for controls may be used. This generic de- premarket approval for the device de- vice includes the semiautomatic and scribed in paragraph (b)(1). See § 876.3. the automatic peritoneal delivery sys- [48 FR 53023, Nov. 23, 1983, as amended at 52 tem. FR 17738, May 11, 1987; 61 FR 1122, Jan. 16, (2) The peritoneal access device is a 1996; 66 FR 38802, July 25, 2001] flexible tube that is implanted through

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the abdominal wall into the peritoneal dialysate delivery system, and acces- cavity and that may have attached sories. Blood from a patient flows cuffs to provide anchoring and a skin through the tubing of the seal. The device is either a single use extracorporeal blood system and acces- peritioneal catheter, intended to re- sories to the blood compartment of the main in the peritoneal cavity for less dialyzer, then returns through further than 30 days, or a long term peritoneal tubing of the extracorporeal blood sys- catheter. Accessories include stylets tem to the patient. The dialyzer has and trocars to aid in the insertion of two compartments that are separated the catheter and an obturator to main- by a semipermeable membrane. While tain the patency of the surgical fistula the blood is in the blood compartment, in the abdominal wall between treat- undesirable substances in the blood ments. pass through the semipermeable mem- (3) The disposable administration set brane into the dialysate in the for peritoneal dialysis consists of tub- dialysate compartment. The dialysate ing, an optional reservoir bag, and ap- delivery system controls and monitors propriate connectors. It may include a the dialysate circulating through the peritoneal dialysate filter to trap and dialysate compartment of the dialyzer. remove contaminating particles. (1) The extracorporeal blood system (4) The source of dialysate may be and accessories consists of tubing, sterile prepackaged dialysate (for semi- pumps, pressure monitors, air foam or automatic peritoneal dialysate deliv- bubble detectors, and alarms to keep ery systems or ‘‘cycler systems’’) or blood moving safely from the blood ac- dialysate prepared from dialysate con- cess device and accessories for hemo- centrate and sterile purified water (for dialysis (§ 876.5540) to the blood com- automatic peritoneal dialysate deliv- partment of the dialyzer and back to ery systems or ‘‘reverse osmosis’’ sys- the patient. tems). Prepackaged dialysate intended (2) The conventional dialyzer allows for use with either of the peritoneal a transfer of water and solutes between dialysate delivery systems is regulated the blood and the dialysate through by FDA as a drug. the semipermeable membrane. The (b) Classification. Class II (perform- semipermeable membrane of the con- ance standards). ventional dialyzer has a sufficiently low permeability to water that an § 876.5665 Water purification system ultrafiltration controller is not re- for hemodialysis. quired to prevent excessive loss of (a) Identification. A water purification water from the patient’s blood. This system for hemodialysis is a device conventional dialyzer does not include that is intended for use with a hemo- hemodialyzers with the disposable in- dialysis system and that is intended to serts (Kiil type) (§ 876.5830) or dialyzers remove organic and inorganic sub- of high permeability (§ 876.5860). stances and microbial contaminants (3) The dialysate delivery system from water used to dilute dialysate consists of mechanisms that monitor concentrate to form dialysate. This ge- and control the temperature, conduc- neric type of device may include a tivity, flow rate, and pressure of the water softener, sediment filter, carbon dialysate and circulates dialysate filter, and water distillation system. through the dialysate compartment of (b) Classification. Class II (perform- the dialyzer. The dialysate delivery ance standards). system includes the dialysate con- centrate for hemodialysis (liquid or § 876.5820 Hemodialysis system and ac- powder) and alarms to indicate abnor- cessories. mal dialysate conditions. This (a) Identification. A hemodialysis sys- dialysate delivery system does not in- tem and accessories is a device that is clude the sorbent regenerated dialysate used as an artificial kidney system for delivery system for hemodialysis the treatment of patients with renal (§ 876.5600), the dialysate delivery sys- failure or toxemic conditions and that tem of the peritoneal dialysis system consists of an extracorporeal blood sys- and accessories (§ 876.5630), or the con- tem, a conventional dialyzer, a trolled dialysate delivery system of the

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high permeability hemodialysis system therapies as hemodialysis, § 876.5860). hemofiltration, hemoconcentration, (4) Remote accessories to the hemo- and hemodiafiltration. Using a dialysis system include the unpowered hemodialyzer with a semipermeable dialysis chair without a scale, the pow- membrane that is more permeable to ered dialysis chair without a scale, the water than the semipermeable mem- dialyzer holder set, dialysis tie gun and brane of the conventional hemodialysis ties, and hemodialysis start/stop tray. system (§ 876.5820), the high perme- (b) Classification. (1) Class II (per- ability hemodialysis system removes formance standards) for hemodialysis toxins or excess fluid from the pa- systems and all accessories directly as- tient’s blood using the principles of sociated with the extracorporeal blood convection (via a high ultrafiltration system and the dialysate delivery sys- rate) and/or diffusion (via a concentra- tem. tion gradient in dialysate). During (2) Class I for other accessories of the treatment, blood is circulated from the hemodialysis system remote from the patient through the hemodialyzer’s extracorporeal blood system and the blood compartment, while the dialysate delivery system, such as the dialysate solution flows countercurrent unpowered dialysis chair, hemodialysis through the dialysate compartment. In start/stop tray, dialyzer holder set, and this process, toxins and/or fluid are dialysis tie gun and ties. The devices transferred across the membrane from subject to this paragraph (b)(2) are ex- the blood to the dialysate compart- empt from the premarket notification ment. The hemodialysis delivery ma- procedures in subpart E of part 807 of chine controls and monitors the pa- this chapter subject to the limitations rameters related to this processing, in- in § 876.9. cluding the rate at which blood and [48 FR 53023, Nov. 23, 1983, as amended at 54 dialysate are pumped through the sys- FR 25050, June 12, 1989; 66 FR 38802, July 25, tem, and the rate at which fluid is re- 2001] moved from the patient. The high per- meability hemodialysis system con- § 876.5830 Hemodialyzer with dispos- sists of the following devices: able insert (Kiil type). (1) The hemodialyzer consists of a (a) Identification. A hemodialyzer semipermeable membrane with an in with disposable inserts (Kiil type) is a vitro ultrafiltration coefficient (Kuf) device that is used as a part of an arti- greater than 8 milliliters per hour per ficial kidney system for the treatment conventional millimeter of mercury, as of patients with renal failure or tox- measured with bovine or expired emic conditions and that includes dis- human blood, and is used with either posable inserts consisting of layers of an automated ultrafiltration controller semipermeable membranes which are or anther method of ultrafiltration sandwiched between support plates. control to prevent fluid imbalance. The device is used with the (2) The hemodialysis delivery ma- extracorporeal blood system and the chine is similar to the extracorporeal dialysate delivery system of the hemo- blood system and dialysate delivery dialysis system and accessories system of the hemodialysis system and (§ 876.5820). accessories (§ 876.5820), with the addi- (b) Classification. Class II (perform- tion of an ultrafiltration controller and ance standards). mechanisms that monitor and/or con- [48 FR 53023, Nov. 23, 1983, as amended at 53 trol such parameters as fluid balance, FR 11253, Apr. 6, 1988] dialysate composition, and patient treatment parameters (e.g., blood pres- § 876.5860 High permeability hemo- sure, hematocrit, urea, etc.). dialysis system. (3) The high permeability hemo- (a) Identification. A high permeability dialysis system accessories include, hemodialysis system is a device in- but are not limited to, tubing lines and tended for use as an artificial kidney various treatment related monitors system for the treatment of patients (e.g., dialysate pH, blood pressure, with renal failure, fluid overload, or hematocrit, and blood recirculation toxemic conditions by performing such monitors).

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(b) Classification. Class II. The special and to maintain the organ in a near- controls for this device are FDA’s: normal physiologic state until it is (1) ‘‘Use of International Standard transplanted into a recipient patient. ISO 10993 ‘Biological Evaluation of This generic type of device may in- Medical Device—Part I: Evaluation and clude tubing, catheters, connectors, an Testing,’ ’’ ice storage or freezing container with (2) ‘‘Guidance for the Content of or without bag or preservatives, 510(k)s for Conventional and High Per- pulsatile or nonpulsatile hypothermic meability Hemodialyzers,’’ isolated organ perfusion apparatus (3) ‘‘Guidance for Industry and CDRH with or without oxygenator, and dis- Reviewers on the Content of Pre- posable perfusion set. market Notifications for Hemodialysis (b) Classification. Class II (perform- Delivery Systems,’’ ance standards). (4) ‘‘Guidance for the Content of Pre- market Notifications for Water Purifi- § 876.5885 Tissue culture media for cation Components and Systems for human ex vivo tissue and cell cul- Hemodialysis,’’ and ture processing applications. (5) ‘‘Guidance for Hemodialyzer (a) Identification. Tissue culture Reuse Labeling.’’ media for human ex vivo tissue and cell culture processing applications consist [65 FR 17145, Mar. 31, 2000] of cell and tissue culture media and § 876.5870 Sorbent hemoperfusion sys- components that are composed of tem. chemically defined components (e.g., amino acids, vitamins, inorganic salts) (a) Identification. A sorbent that are essential for the ex vivo devel- hemoperfusion system is a device that opment, survival, and maintenance of consists of an extracorporeal blood sys- tissues and cells of human origin. The tem similar to that identified in the solutions are indicated for use in hemodialysis system and accessories human ex vivo tissue and cell culture (§ 876.5820) and a container filled with processing applications. adsorbent material that removes a (b) Classification. Class II (special wide range of substances, both toxic controls): FDA guidance document, and normal, from blood flowing through it. The adsorbent materials ‘‘Class II Special Controls Guidance are usually activated-carbon or resins Document: Tissue Culture Media for which may be coated or immobilized to Human Ex Vivo Processing Applica- prevent fine particles entering the pa- tions; Final Guidance for Industry and tient’s blood. The generic type of de- FDA Reviewers.’’ vice may include lines and filters spe- [66 FR 27025, May 16, 2001] cifically designed to connect the device to the extracorporeal blood system. § 876.5895 Ostomy irrigator. The device is used in the treatment of (a) Identification. An ostomy irrigator poisoning, drug overdose, hepatic is a device that consists of a container coma, or metabolic disturbances. for fluid, tubing with a cone-shaped tip (b) Classification. Class III (premarket or a soft and flexible catheter with a approval). retention shield and that is used to (c) Date PMA or notice of completion of wash out the colon through a colos- a PDP is required. No effective date has tomy, a surgically created opening of been established of the requirement for the colon on the surface of the body. premarket approval. See § 876.3. (b) Classification. Class II (perform- [48 FR 53023, Nov. 23, 1983, as amended at 52 ance standards). FR 17738, May 11, 1987] § 876.5900 Ostomy pouch and acces- § 876.5880 Isolated kidney perfusion sories. and transport system and acces- (a) Identification. An ostomy pouch sories. and accessories is a device that con- (a) Identification. An isolated kidney sists of a bag that is attached to the perfusion and transport system and patient’s skin by an adhesive material accesssories is a device that is used to and that is intended for use as a recep- support a donated or a cadaver kidney tacle for collection of fecal material or

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urine following an ileostomy, colos- in the peritoneal cavity to flow into tomy, or ureterostomy (a surgically the venous system for the treatment of created opening of the , intractable ascites. , or the ureter on the (b) Classification. Class II. The special surface of the body). This generic type controls for this device are FDA’s: of device and its accessories includes (1) ‘‘Use of International Standard the ostomy pouch, ostomy adhesive, ISO 10993 ‘Biological Evaluation of the disposable colostomy appliance, Medical Devices—Part I: Evaluation ostomy collector, colostomy pouch, and Testing,’ ’’ urinary ileostomy bag, urine collecting (2) ‘‘510(k) Sterility Review Guidance ureterostomy bag, ostomy drainage of 2/12/90 (K90–1),’’ and bag with adhesive, stomal bag, ostomy protector, and the ostomy size selector, (3) Backflow specification and testing but excludes ostomy pouches which in- to prevent reflux of blood into the corporate arsenic-containing com- shunt. pounds. [48 FR 53023, Nov. 23, 1983, as amended at 52 (b) Classification. Class I (general con- FR 17738, May 11, 1987; 65 FR 17145, Mar. 31, trols). The device is exempt from the 2000] premarket notification procedures in subpart E of part 807 of this chapter § 876.5970 Hernia support. subject to the limitations in § 876.9. (a) Identification. A hernia support is [48 FR 53023, Nov. 23, 1983, as amended at 54 a device, usually made of elastic, can- FR 25050, June 12, 1989; 66 FR 38802, July 25, vas, leather, or metal, that is intended 2001] to be placed over a hernial opening (a weakness in the abdominal wall) to § 876.5920 Protective garment for in- prevent protrusion of the abdominal continence. contents. This generic type of device (a) Identification. A protective gar- includes the umbilical truss. ment for incontinence is a device that (b) Classification. Class I (general con- consists of absorbent padding and a trols). The device is exempt from the fluid barrier and that is intended to premarket notification procedures in protect an incontinent patient’s gar- subpart E of part 807 of this chapter ment from the patient’s excreta. This subject to the limitations in § 876.9. The generic type of device does not include device is also exempt from the current diapers for infants. good manufacturing practice regula- (b) Classification. Class I (general con- tions in part 820 of this chapter, with trols). The device is exempt from the premarket notification procedures in the exception of § 820.180, regarding subpart E of part 807 of this chapter general requirements concerning subject to the limitations in § 876.9. The records, and § 820.198, regarding com- device is also exempt from the current plaint files. good manufacturing practice regula- [48 FR 53023, Nov. 23, 1983, as amended at 59 tions in part 820 of this chapter, with FR 63010, Dec. 7, 1994; 66 FR 38802, July 25, the exception of § 820.180, regarding 2001] general requirements concerning records, and § 820.198, regarding com- § 876.5980 Gastrointestinal tube and plaint files. accessories. [48 FR 53023, Nov. 23, 1983, as amended at 54 (a) Identification. A gastrointestinal FR 25050, June 12, 1989; 66 FR 38802, July 25, tube and accessories is a device that 2001] consists of flexible or semi-rigid tubing used for instilling fluids into, with- § 876.5955 Peritoneo-venous shunt. drawing fluids from, splinting, or sup- (a) Identification. A peritoneo-venous pressing bleeding of the alimentary shunt is an implanted device that con- tract. This device may incorporate an sists of a catheter and a pressure acti- integral inflatable balloon for reten- vated one-way valve. The catheter is tion or hemostasis. This generic type implanted with one end in the peri- of device includes the hemostatic bag, toneal cavity and the other in a large irrigation and aspiration catheter (gas- vein. This device enables ascitic fluid tric, colonic, etc.), rectal catheter,

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sterile infant gavage set, gastro- ‘‘Guidance for the Content of Pre- intestinal 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 Frag- feeding tube, gastroenterostomy tube, mentation of Kidney and Ureteral Levine tube, nasogastric tube, single Calculi.’’) lumen tube with mercury weight bal- loon for intestinal intubation or de- [65 FR 48612, Aug. 9, 2000] compression, and gastro-urological ir- rigation tray (for gastrological use). PART 878—GENERAL AND PLASTIC (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 pre- this 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 de- vice 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 Subpart D—Prosthetic Devices 2317, Jan. 14, 2000; 65 FR 76932, Dec. 8, 2000] 878.3250 External facial fracture fixation ap- § 876.5990 Extracorporeal shock wave pliance. lithotripter. 878.3300 Surgical mesh. (a) Identification. An extracorporeal 878.3500 Polytetrafluoroethylene with car- shock wave lithotripter is a device that bon fibers composite implant material. focuses ultrasonic shock waves into the 878.3530 Silicone inflatable breast pros- thesis. body to noninvasively fragment uri- 878.3540 Silicone gel-filled breast prosthesis. nary calculi within the kidney or ure- 878.3550 Chin prosthesis. ter. The primary components of the de- 878.3590 Ear prosthesis. vice are a shock wave generator, high 878.3610 Esophageal prosthesis. voltage generator, control console, im- 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 pros- thesis. gral or stand-alone localization/imag- 878.3900 Inflatable extremity splint. ing system. Shock waves are typically 878.3910 Noninflatable extremity splint. generated using electrostatic spark dis- 878.3925 Plastic surgery kit and accessories. charge (spark gap), electromagneti- cally repelled membranes, or piezo- Subpart E—Surgical Devices electric crystal arrays, and focused 878.4014 Nonresorbable gauze/sponge for ex- onto the stone with either a specially ternal use. designed reflector, dish, or acoustic 878.4018 Hydrophilic wound dressing. lens. The shock waves are created 878.4020 Occlusive wound dressing. under water within the shock wave 878.4022 Hydrogel wound dressing and burn generator, and are transferred to the dressing. patient’s body using an appropriate 878.4025 Silicone sheeting. acoustic interface. After the stone has 878.4040 Surgical apparel. been fragmented by the focused shock 878.4100 Organ bag. 878.4160 Surgical camera and accessories. waves, the fragments pass out of the 878.4200 Introduction/drainage catheter and body with the patient’s urine. accessories. (b) Classification. Class II (special 878.4300 Implantable clip. controls) (FDA guidance document: 878.4320 Removable skin clip.

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