Pt. 876 21 CFR Ch. I (4–1–16 Edition)

(b) Classification. Class II (special 876.9 Limitations of exemptions from sec- controls). The special controls for this tion 510(k) of the Federal Food, Drug, device are: and Cosmetic Act (the act). (1) The patient contacting compo- Subpart B—Diagnostic Devices nents must be demonstrated to be bio- compatible. 876.1075 Gastroenterology-urology biopsy (2) Non-clinical performance testing instrument. must demonstrate that the device per- 876.1300 Ingestible telemetric gastro- forms as intended under anticipated intestinal capsule imaging system. 876.1330 Colon capsule system. conditions of use. The following per- 876.1400 pH electrode. formance characteristics must be dem- 876.1500 Endoscope and accessories. onstrated: 876.1620 Urodynamics measurement system. (i) Mechanical integrity testing (e.g., 876.1725 Gastrointestinal motility moni- tensile strength testing, fatigue test- toring system. ing) and 876.1735 Electrogastrography system. (ii) Shelf life testing. 876.1800 Urine flow or volume measuring (3) The technical specifications must system. include pressure measurement accu- Subpart C—Monitoring Devices racy to characterize device perform- ance. 876.2040 Enuresis alarm. (4) Clinical performance testing must 876.2050 Prostate lesion documentation sys- document any adverse events observed tem. during clinical use, and demonstrate Subpart D—Prosthetic Devices that the device performs as intended under anticipated conditions of use. 876.3350 Penile inflatable implant. (5) Labeling must include the fol- 876.3630 Penile rigidity implant. lowing: 876.3750 Testicular prosthesis. (i) Appropriate warnings and pre- Subpart E—Surgical Devices cautions, (ii) A detailed summary of the clin- 876.4020 Fiberoptic light ureteral catheter. ical testing pertinent to use of the de- 876.4270 rod. vice including a detailed summary of 876.4300 Endoscopic electrosurgical unit and the device-related complications or ad- accessories. verse events, 876.4370 Gastroenterology-urology evacuator. (iii) Detailed instructions on how to 876.4400 Hemorrhoidal ligator. fit the device to the patient, and 876.4480 Electrohydraulic lithotriptor. (iv) Instructions for reprocessing of 876.4500 Mechanical lithotriptor. any reusable components. 876.4530 Gastroenterology-urology (6) Patient labeling must be provided fiberoptic retractor. and must include: 876.4560 Ribdam. (i) Relevant warnings, precautions, 876.4590 Interlocking urethral sound. 876.4620 Ureteral stent. and adverse effects/complications, 876.4650 Water jet renal stone dislodger sys- (ii) Information on how to correctly tem. wear the device, 876.4680 Ureteral stone dislodger. (iii) The potential risks and benefits 876.4730 Manual gastroenterology-urology associated with the use of the device, surgical instrument and accessories. (iv) Alternative treatments, and 876.4770 Urethrotome. (v) Reprocessing instructions. 876.4890 Urological table and accessories. [80 FR 46194, Aug. 4, 2015] Subpart F—Therapeutic Devices 876.5010 Biliary catheter and accessories. PART 876—GASTROENTEROLOGY- 876.5015 Pancreatic drainage stent and de- UROLOGY DEVICES livery system. 876.5020 External penile rigidity devices. Subpart A—General Provisions 876.5025 Vibrator for climax control of pre- mature ejaculation. Sec. 876.5030 Continent catheter. 876.1 Scope. 876.5090 Suprapubic urological catheter and 876.3 Effective dates of requirement for pre- accessories. market approval. 876.5130 Urological catheter and accessories.

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876.5140 Urethral insert with pump for blad- vices intended for human use that are der drainage. in commercial distribution. 876.5160 Urological clamp for males. (b) The identification of a device in a 876.5210 Enema kit. 876.5220 Colonic irrigation system. regulation in this part is not a precise 876.5250 Urine collector and accessories. description of every device that is, or 876.5270 Implanted electrical urinary con- will be, subject to the regulation. A tinence device. manufacturer who submits a pre- 876.5280 Implanted mechanical/hydraulic market notification submission for a urinary continence device. device under part 807 may not show 876.5310 Nonimplanted, peripheral electrical merely that the device is accurately continence device. described by the section title and iden- 876.5320 Nonimplanted electrical continence tification provisions of a regulation in device. 876.5365 Esophageal dilator. this part, but shall state why the de- 876.5450 Rectal dilator. vice is substantially equivalent to 876.5470 Ureteral dilator. other devices, as required by § 807.87. 876.5520 Urethral dilator. (c) To avoid duplicative listings, a 876.5530 Implantable transprostatic tissue gastroenterology-urology device that retractor system. has two or more types of uses (e.g., 876.5540 Blood access device and accessories. used both as a diagnostic device and as 876.5600 Sorbent regenerated dialysate de- a therapeutic device) is listed only in livery system for hemodialysis. one subpart. 876.5630 system and ac- cessories. (d) References in this part to regu- 876.5665 Water purification system for latory sections of the Code of Federal hemodialysis. Regulations are to chapter I of title 21, 876.5820 Hemodialysis system and acces- unless otherwise noted. sories. (e) Guidance documents referenced in 876.5830 Hemodialyzer with disposable in- this part are available on the Internet sert (Kiil type). at http://www.fda.gov/MedicalDevices/ 876.5860 High permeability hemodialysis system. DeviceRegulationandGuidance/ 876.5870 Sorbent hemoperfusion system. GuidanceDocuments/default.htm.. 876.5880 Isolated kidney perfusion and [52 FR 17737, May 11, 1987; 52 FR 22577, June transport system and accessories. 12, 1987, as amended at 69 FR 77623, Dec. 28, 876.5885 Tissue culture media for human ex 2004; 78 FR 18233, Mar. 26, 2013] vivo tissue and cell culture processing applications. § 876.3 Effective dates of requirement 876.5895 Ostomy irrigator. for premarket approval. 876.5900 Ostomy pouch and accessories. 876.5920 Protective garment for inconti- A device included in this part that is nence. classified into class III (premarket ap- 876.5930 Rectal control system. proval) shall not be commercially dis- 876.5955 Peritoneo-venous shunt. tributed after the date shown in the 876.5970 support. regulation classifying the device unless 876.5980 Gastrointestinal tube and acces- sories. the manufacturer has an approval 876.5990 Extracorporeal shock wave under section 515 of the act (unless an lithotripter. exemption has been granted under sec- tion 520(g)(2) of the act). An approval AUTHORITY: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371. under section 515 of the act consists of FDA’s issuance of an order approving SOURCE: 48 FR 53023, Nov. 23, 1983, unless an application for premarket approval otherwise noted. (PMA) for the device or declaring com- pleted a product development protocol Subpart A—General Provisions (PDP) for the device. (a) Before FDA requires that a device EDITORIAL NOTE: Nomenclature changes to commercially distributed before the part 876 appear at 73 FR 35341, June 23, 2008. enactment date of the amendments, or a device that has been found substan- § 876.1 Scope. tially equivalent to such a device, has (a) This part sets forth the classifica- an approval under section 515 of the act tion of gastroenterology-urology de- FDA must promulgate a regulation

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under section 515(b) of the act requir- ably foreseeable characteristics of ing such approval, except as provided commercially distributed devices with- in paragraph (b) of this section. Such a in that generic type or, in the case of regulation under section 515(b) of the in vitro diagnostic devices, only to the 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- (b) The modified device operates cial distribution on or after May 28, using a different fundamental sci- 1976, including a device formerly mar- entific technology than a legally mar- keted that has been substantially al- keted device in that generic type of de- tered, is classified by statute (section vice; e.g., a surgical instrument cuts 513(f) of the act) into class III without tissue with a laser beam rather than any grace period and FDA must have with a sharpened metal blade, or an in issued an order approving a PMA or de- vitro diagnostic device detects or iden- claring completed a PDP for the device tifies infectious agents by using before the device is commercially dis- deoxyribonucleic acid (DNA) probe or tributed unless it is reclassified. If nucleic acid hybridization technology FDA knows that a device being com- rather than culture or immunoassay mercially distributed may be a ‘‘new’’ technology; or device as defined in this section be- (c) The device is an in vitro device cause of any new intended use or other that is intended: reasons, FDA may codify the statutory (1) For use in the diagnosis, moni- classification of the device into class toring, or screening of neoplastic dis- III for such new use. Accordingly, the eases with the exception of regulation for such a class III device immunohistochemical devices; states that as of the enactment date of (2) For use in screening or diagnosis the amendments, May 28, 1976, the de- of familial or acquired genetic dis- vice must have an approval under sec- orders, including inborn errors of me- tion 515 of the act before commercial tabolism; distribution. (3) For measuring an analyte that [52 FR 17737, May 11, 1987] serves as a surrogate marker for screening, diagnosis, or monitoring § 876.9 Limitations of exemptions from life-threatening diseases such as ac- section 510(k) of the Federal Food, quired immune deficiency syndrome Drug, and Cosmetic Act (the act). (AIDS), chronic or active hepatitis, tu- The exemption from the requirement berculosis, or myocardial infarction or of premarket notification (section to monitor therapy; 510(k) of the act) for a generic type of (4) For assessing the risk of cardio- class I or II device is only to the extent vascular diseases; that the device has existing or reason- (5) For use in diabetes management;

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(6) For identifying or inferring the wireless camera contained in a capsule. identity of a microorganism directly This device includes an ingestible cap- from clinical material; sule (containing a light source, camera, (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] § 876.1330 Colon Subpart B—Diagnostic Devices system. § 876.1075 Gastroenterology-urology (a) Identification. A prescription, sin- biopsy instrument. gle-use ingestible capsule designed to acquire video images during natural (a) Identification. A gastroenterology- propulsion through the digestive sys- urology biopsy instrument is a device tem. It is specifically designed to vis- used to remove, by cutting or aspira- ualize the colon for the detection of tion, a specimen of tissue for micro- polyps. It is intended for use only in scopic examination. This generic type patients who had an incomplete optical of device includes the biopsy punch, with adequate prepara- gastrointestinal mechanical biopsy in- tion, and a complete evaluation of the strument, suction biopsy instrument, colon was not technically possible. gastro-urology biopsy needle and nee- (b) Classification. Class II (special dle set, and nonelectric biopsy forceps. controls). The special controls for this This section does not apply to biopsy device are: instruments that have specialized uses (1) The capsule must be demonstrated in other medical specialty areas and to be biocompatible. that are covered by classification regu- (2) Non-clinical testing data must lations in other parts of the device demonstrate the mechanical and func- classification regulations. tional integrity of the device under (b) Classification. (1) Class II (per- physically stressed conditions. The fol- formance standards). lowing performance characteristics (2) Class I for the biopsy forceps must be tested and detailed protocols cover and the non-electric biopsy for- must be provided for each test: ceps. The devices subject to this para- (i) Bite test to ensure that the cap- graph (b)(2) are exempt from the pre- sule can withstand extreme cases of market notification procedures in sub- biting. part E of part 807 of this chapter sub- (ii) pH resistance test to evaluate in- ject to the limitations in § 876.9. tegrity of the capsule when exposed to [48 FR 53023, Nov. 23, 1983, as amended at 61 a range of pH values. FR 1122, Jan. 16, 1996; 66 FR 38801, July 25, (iii) Battery life test to demonstrate 2001] that the capsule’s operating time is not constrained by the battery capacity. § 876.1300 Ingestible telemetric gastro- (iv) Shelf-life testing to demonstrate intestinal capsule imaging system. that the device performs as intended at (a) Identification. An ingestible tele- the proposed shelf-life date. metric gastrointestinal capsule imag- (v) Optical testing to evaluate funda- ing system is used for visualization of mental image quality characteristics the small bowel mucosa as an adjunc- such as resolution, field of view, depth tive tool in the detection of abnormali- of field, distortion, signal-to-noise ties of the small bowel. The device cap- ratio, uniformity, and image artifacts. tures images of the small bowel with a A test must be performed to evaluate

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the potential of scratches, caused by ment of positive percent agreement travelling through the gastrointestinal and negative percent agreement com- tract, on the transparent window of the pared to a clinically acceptable alter- capsule and their impact on the optical native structural imaging method. and color performance. (4) Clinician labeling must include: (vi) An optical safety analysis must (i) Specific instructions and the clin- be performed based on maximum ical and technical expertise needed for (worst-case) light exposure to internal the safe use of the device. gastrointestinal mucosa, and covering (ii) A detailed summary of the clin- ultraviolet, visible, and near-infrared ical testing pertinent to use of the de- ranges, as appropriate. A mitigation analysis must be provided. vice, including the percentage of pa- (vii) A color performance test must tients in which a polyp was correctly be provided to compare the color dif- identified by capsule endoscopy, but ferences between the input scene and also the percent of patients in which output image. the capsule either missed or falsely (viii) The video viewer must clearly identified a polyp with respect to the present the temporal or spatial rela- clinically acceptable alternative struc- tionship between any two frames as a tural imaging method. real-time lapse or a travel distance. (iii) The colon cleansing procedure. The video viewer must alert the user (iv) A detailed summary of the device when the specific video interval is cap- technical parameters. tured at a frame rate lower than the (v) A detailed summary of the device- nominal one due to communication er- and procedure-related complications rors. pertinent to use of the device. (ix) A performance test evaluating (vi) An expiration date/shelf life. the latency caused by any adaptive al- (5) Patient labeling must include: gorithm such as adjustable frame rate (i) An explanation of the device and must be provided. (x) If the capsule includes a localiza- the mechanism of operation. tion module, a localization perform- (ii) Patient preparation procedure. ance test must be performed to verify (iii) A brief summary of the clinical the accuracy and precision of locating study. The summary should not only the capsule position within the colon. include the percentage of patients in (xi) A data transmission test must be which a polyp was correctly identified performed to verify the robustness of by capsule endoscopy, but also the per- the data transmission between the cap- cent of patients in which the capsule sule and the recorder. Controlled signal either missed or falsely identified a attenuation should be included for sim- polyp with respect to the clinically ac- ulating a non-ideal environment. ceptable alternative structural imag- (xii) Software validation, ing method. verification, and hazards analysis must (iv) A summary of the device- and be provided. procedure-related complications perti- (xiii) Electrical equipment safety, in- nent to use of the device. cluding thermal and mechanical safety and electromagnetic compatibility [79 FR 28403, May 16, 2014] (EMC) testing must be performed. If the environments of intended use in- § 876.1400 Stomach pH electrode. clude locations outside of hospitals and (a) Identification. A stomach pH elec- clinics, appropriate higher immunity trode is a device used to measure test levels must be used. Labeling must intragastric and intraesophageal pH include appropriate EMC information. (hydrogen ion concentration). The pH (xiv) Information demonstrating im- electrode is at the end of a flexible lead munity from wireless hazards. which may be inserted into the esoph- (3) The clinical performance charac- agus or stomach through the patient’s teristics of the device for the detection mouth. The device may include an in- of colon polyps must be established. tegral gastrointestinal tube. Demonstration of the performance characteristics must include assess-

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(b) Classification. Class I. The device battery box, bite block for endoscope, is exempt from the premarket notifica- and cleaning brush for endoscope. The tion procedures in subpart E of part 807 devices subject to this paragraph (b)(2) of this chapter. are exempt from the premarket notifi- cation procedures in subpart E of part [48 FR 53023, Nov. 23, 1983, as amended at 61 FR 1122, Jan. 16, 1996] 807of this chapter, subject to the limi- tations in § 876.9. § 876.1500 Endoscope and accessories. [48 FR 53023, Nov. 23, 1983, as amended at 61 (a) Identification. An endoscope and FR 1122, Jan. 16, 1996; 66 FR 38801, July 25, accessories is a device used to provide 2001] access, illumination, and allow obser- vation or manipulation of body cav- § 876.1620 Urodynamics measurement system. ities, hollow organs, and canals. The device consists of various rigid or flexi- (a) Identification. A urodynamics ble instruments that are inserted into measurement system is a device used body spaces and may include an optical to measure volume and pressure in the system for conveying an image to the urinary bladder when it is filled user’s eye and their accessories may through a catheter with carbon dioxide assist in gaining access or increase the or water. The device controls the sup- versatility and augment the capabili- ply of carbon dioxide or water and may ties of the devices. Examples of devices also record the electrical activity of that are within this generic type of de- the muscles associated with urination. vice include cleaning accessories for The device system may include trans- endoscopes, photographic accessories ducers, electronic signal conditioning for endoscopes, nonpowered anoscopes, and display equipment, a catheter binolcular attachments for endoscopes, withdrawal device to enable a urethral pocket battery boxes, flexible or rigid pressure profile to be obtained, and choledochoscopes, colonoscopes, diag- special catheters for urethral nostic cystoscopes, cystourethroscopes, profilometry and electrodes for enteroscopes, electromyography. This generic type of esophagogastroduodenoscopes, rigid device includes the cystometric gas esophagoscopes, fiberoptic illuminators (carbon dioxide) device, the for endoscopes, incandescent endoscope cystometric hydrualic device, and the lamps, biliary pancreatoscopes, electrical recording cystometer, but proctoscopes, resectoscopes, excludes any device that uses air to fill nephroscopes, sigmoidoscopes, the bladder. ureteroscopes, urethroscopes, (b) Classification. Class II (special endomagnetic retrievers, cytology controls). The device is exempt from brushes for endoscopes, and lubricating the premarket notification procedures jelly for transurethral surgical instru- in subpart E of part 807 of this chapter ments. This section does not apply to subject to § 876.9. endoscopes that have specialized uses [48 FR 53023, Nov. 23, 1983, as amended at 63 in other medical specialty areas and FR 59228, Nov. 3, 1998] that are covered by classification regu- lations in other parts of the device § 876.1725 Gastrointestinal motility classification regulations. monitoring system. (b) Classification. (1) Class II (per- (a) Identification. A gastrointestinal formance standards). motility monitoring system is a device (2) Class I for the photographic acces- used to measure peristalic activity or sories for endoscope, miscellaneous pressure in the stomach or bulb adapter for endoscope, binocular by means of a probe with transducers attachment for endoscope, eyepiece at- that is introduced through the mouth tachment for prescription lens, teach- into the . The de- ing attachment, inflation bulb, meas- vice may include signal conditioning, uring device for panendoscope, photo- amplifying, and recording equipment. graphic equipment for physiologic This generic type of device includes the function monitor, special lens instru- esophageal motility monitor and tube, ment for endoscope, smoke removal the gastrointestinal motility (elec- tube, rechargeable battery box, pocket trical) system, and certain accessories,

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such as a pressure transducer, ampli- signal conditioning and display equip- fier, and external recorder. ment. This generic type of device in- (b) Classification. Class II (perform- cludes the electrical urinometer, me- ance standards). chanical urinometer, nonelectric uri- nometer, disposable nonelectric urine § 876.1735 Electrogastrography system. flow rate measuring device, and (a) Identification. An uroflowmeter. electrogastrography system (EGG) is a (b) Classification. (1) Class II (special device used to measure gastric controls). The device is exempt from myoelectrical activity as an aid in the the premarket notification procedures diagnosis of gastric motility disorders. in subpart E of part 807 of this chapter The device system includes the exter- nal recorder, amplifier, skin electrodes, subject to § 876.9. strip chart, cables, analytical software, [48 FR 53023, Nov. 23, 1983, as amended at 61 and other accessories. FR 1122, Jan. 16, 1996; 63 FR 59228, Nov. 3, (b) Classification. Class II (Special 1998] Controls). The special controls are as follows: Subpart C—Monitoring Devices (1) The sale, distribution and use of this device are restricted to prescrip- § 876.2040 Enuresis alarm. tion use in accordance with § 801.109 of this chapter. (a) Identification. An enuresis alarm (2) The labeling must include specific is a device intended for use in treat- instructions: ment of bedwetting. Through an elec- (i) To describe proper patient set-up trical trigger mechanism, the device prior to the start of the test, including sounds an alarm when a small quantity the proper placement of electrodes; of urine is detected on a sensing pad. (ii) To describe how background data This generic type of device includes should be gathered and used to elimi- conditioned response enuresis alarms. nate artifact in the data signal; (b) Classification. Class II (special (iii) To describe the test protocol (in- controls). The device is exempt from cluding the measurement of baseline the premarket notification procedures data) that may be followed to obtain in subpart E of part 807 of this chapter the EGG signal; and subject to § 876.9. (iv) To explain how data results may be interpreted. [48 FR 53023, Nov. 23, 1983, as amended at 63 (3) The device design should ensure FR 59228, Nov. 3, 1998] that the EGG signal is distinguishable from background noise that may inter- § 876.2050 Prostate lesion documenta- fere with the true gastric myoelectric tion system. signal. (a) Identification. A prostate lesion (4) Data should be collected to dem- documentation system is a prescription onstrate that the device has adequate device intended for use in producing an precision and the EGG signal is repro- image of the prostate as an aid in docu- ducible and is interpretable. menting prostate abnormalities pre- [64 FR 51444, Sept. 23, 1999] viously identified during a digital rec- tal examination. The device uses pres- § 876.1800 Urine flow or volume meas- sure sensors and image reconstruction uring system. software to produce a prostate image (a) Identification. A urine flow or vol- that highlights regional differences in ume measuring system is a device that intraprostatic tissue elasticity or stiff- measures directly or indirectly the vol- ness. The device is limited to use as a ume or flow of urine from a patient, ei- documentation tool and is not intended ther during the course of normal urina- for diagnostic purposes or for influ- tion or while the patient is catheter- encing any clinical decisions. ized. The device may include a drip (b) Classification. Class II (special chamber to reduce the risk of retro- controls). The special controls for this grade bacterial contamination of the bladder and a transducer and electrical device are:

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(1) Non-clinical and clinical perform- PDP in effect before being placed in ance testing must demonstrate the ac- commercial distribution. curacy and reproducibility of the con- [48 FR 53023, Nov. 23, 1983, as amended at 52 structed image. FR 17738, May 11, 1987; 65 FR 19658, Apr. 12, (2) Appropriate analysis/testing must 2000] validate electromagnetic compat- ibility, electrical safety, thermal safe- § 876.3630 Penile rigidity implant. ty, and mechanical safety. (a) Identification. A penile rigidity (3) Appropriate software verification, implant is a device that consists of a validation, and hazard analysis must pair of semi-rigid rods implanted in the be performed. corpora cavernosa of the penis to pro- (4) All elements of the device that vide rigidity. It is intended to be used may contact the patient must be dem- in men diagnosed as having erectile dysfunction. onstrated to be biocompatible. (b) Classification. Class II. The special (5) Methods and instructions for re- control for this device is the FDA guid- processing of any reusable components ance entitled ‘‘Guidance for the Con- must be properly validated. tent of Premarket Notifications for (6) The labeling must include specific Penile Rigidity Implants.’’ information needed to ensure proper use of the device. [65 FR 4882, Feb. 2, 2000] [80 FR 72900, Nov. 23, 2015] § 876.3750 Testicular prosthesis. (a) Identification. A testicular pros- Subpart D—Prosthetic Devices thesis is an implanted device that con- sists of a solid or gel-filled silicone rub- § 876.3350 Penile inflatable implant. ber prosthesis that is implanted sur- gically to resemble a testicle. (a) Identification. A penile inflatable (b) Classification. Class III (premarket implant is a device that consists of two approval). inflatable cylinders implanted in the (c) Date premarket approval application penis, connected to a reservoir filled (PMA) or notice of product development with radiopaque fluid implanted in the protocol (PDP) is required. A PMA or no- abdomen, and a subcutaneous manual tice of completion of a PDP is required pump implanted in the scrotum. When to be filed with the Food and Drug Ad- the cylinders are inflated, they provide ministration on or before July 5, 1995, rigidity to the penis. This device is for any testicular prosthesis that was used in the treatment of erectile impo- in commercial distribution before May tence. 28, 1976, or that has on or before July 5, (b) Classification. Class III (premarket 1995, been found to be substantially approval). equivalent to a testicular prosthesis (c) Date premarket approval application that was in commercial distribution (PMA) or notice of completion of a prod- before May 28, 1976. Any other testic- uct development protocol (PDP) is re- ular prosthesis shall have an approved quired. A PMA or a notice of comple- PMA or a declared completed PDP in tion of a PDP is required to be filed effect before being placed in commer- cial distribution. with the Food and Drug Administra- tion on or before July 11, 2000, for any [48 FR 53023, Nov. 23, 1983, as amended at 52 penile inflatable implant that was in FR 17738, May 11, 1987; 60 FR 17216, Apr. 5, commercial distribution before May 28, 1995] 1976, or that has, on or before July 11, 2000, been found to be substantially Subpart E—Surgical Devices equivalent to a penile inflatable im- § 876.4020 Fiberoptic light ureteral plant that was in commercial distribu- catheter. tion before May 28, 1976. Any other (a) Identification. A fiberoptic light penile inflatable implant shall have an ureteral catheter is a device that con- approved PMA or a declared completed sists of a fiberoptic bundle that emits light throughout its length and is

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shaped so that it can be inserted into (2) Class I for the gastroenterology- the ureter to enable the path of the urology evacuator when manually pow- ureter to be seen during lower abdom- ered. The device subject to this para- inal or pelvic surgery. 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 FR 25049, June 12, 1989; 63 FR 59228, Nov. 3, (a) Identification. A colostomy rod is 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).

§ 876.4300 Endoscopic electrosurgical § 876.4480 Electrohydraulic unit and accessories. lithotriptor. (a) Identification. An endoscopic (a) Identification. An electrohydraulic electrosurgical unit and accessories is lithotriptor is an AC-powered device a device used to perform used to fragment urinary bladder electrosurgical procedures through an stones. It consists of a high voltage endoscope. This generic type of device source connected by a cable to a bipo- includes the electrosurgical generator, lar electrode that is introduced into patient plate, electric biopsy forceps, the urinary bladder through a cysto- electrode, flexible snare, scope. The electrode is held against the electrosurgical alarm system, stone in a water-filled bladder and re- electrosurgical power supply unit, elec- peated electrical discharges between trical clamp, self-opening rigid snare, the two poles of the electrode cause flexible suction coagulator electrode, electrohydraulic shock waves which patient return wristlet, contact jelly, disintegrate the stone. adaptor to the cord for transurethral (b) Classification. Class II. The special surgical instruments, the electric cord control for this device is FDA’s ‘‘Guid- for transurethral surgical instruments, ance for the Content of Premarket No- and the transurethral desiccator. tifications for Intracorporeal (b) Classification. Class II (perform- Lithotripters.’’ ance standards). [48 FR 53023, Nov. 23, 1983, as amended at 52 FR 17738, May 11, 1987; 65 FR 17145, Mar. 31, § 876.4370 Gastroenterology-urology 2000] evacuator. (a) Identification. A gastroenterology- § 876.4500 Mechanical lithotriptor. urology evacuator is a device used to (a) Identification. A mechanical remove debris and fluids during gastro- lithotriptor is a device with steel jaws enterological and urological procedures that is inserted into the urinary blad- by drainage, aspiration, or irrigation. der through the urethra to grasp and This generic type of device includes the crush bladder stones. fluid evacuator system, manually pow- (b) Classification. Class II (perform- ered bladder evacuator, and the AC- ance standards). powered vacuum pump. (b) Classification. (1) Class II (special § 876.4530 Gastroenterology-urology controls) for the gastroenterology-urol- fiberoptic retractor. ogy evacuator when other than manu- (a) Identification. A gastroenterology- ally powered. The device is exempt urology fiberoptic retractor is a device from the premarket notification proce- that consists of a mechanical retractor dures in subpart E of part 807 of this with a fiberoptic light system that is chapter subject to § 876.9. used to illuminate deep surgical sites.

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(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) Identification. A water jet renal subpart E of part 807 of this chapter stone dislodger system is a device used subject to the limitations in § 876.9. 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 in the surgical removal of kidney § 876.4560 Ribdam. 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- [48 FR 53023, Nov. 23, 1983, as amended at 63 trols). The device is exempt from the FR 59228, Nov. 3, 1998] premarket notification procedures in subpart E of part 807 of this chapter § 876.4680 Ureteral stone dislodger. subject to the limitations in § 876.9. (a) Identification. A ureteral stone [48 FR 53023, Nov. 23, 1983, as amended at 54 dislodger is a device that consists of a FR 25049, June 12, 1989; 66 FR 38801, July 25, bougie or a catheter with an expand- 2001] able wire basket near the tip, a special flexible tip, or other special construc- § 876.4590 Interlocking urethral sound. tion. It is inserted through a cysto- (a) Identification. An interlocking scope and used to entrap and remove urethral sound is a device that consists stones from the ureter. This generic of two metal sounds (elongated instru- type of device includes the metal bas- ments for exploring or sounding body ket and the flexible ureteral stone cavities) with interlocking ends, such dislodger. as with male and female threads or a (b) Classification. Class II (special rounded point and mating socket, used controls). The device is exempt from in the repair of a ruptured urethra. The the premarket notification procedures device may include a protective cap to in subpart E of part 807 of this chapter fit over the metal threads. subject to § 876.9. (b) Classification. Class I (general con- [48 FR 53023, Nov. 23, 1983, as amended at 63 trols). The device is exempt from the FR 59228, Nov. 3, 1998] premarket notification procedures in subpart E of part 807 of this chapter § 876.4730 Manual gastroenterology- subject to the limitations in § 876.9. urology surgical instrument and ac- cessories. [48 FR 53023, Nov. 23, 1983, as amended at 61 (a) Identification. A manual gastro- FR 1122, Jan. 16, 1996; 66 FR 38801, July 25, enterology-urology surgical instru- 2001] ment and accessories is a device de- § 876.4620 Ureteral stent. signed to be used for gastro- enterological and urological surgical (a) Identification. A ureteral stent is a procedures. The device may be nonpow- tube-like implanted device that is in- ered, hand-held, or hand-manipulated. serted into the ureter to provide Manual gastroenterology-urology sur- ureteral rigidity and allow the passage gical instruments include the biopsy of urine. The device may have finger- forceps cover, biopsy tray without bi- like protrusions or hooked ends to keep opsy instruments, line clamp, nonpow- the tube in place. It is used in the ered rectal probe, nonelectrical clamp, treatment of ureteral injuries and colostomy spur-crushers, locking de- ureteral obstruction. vice for intestinal clamp, needle hold- (b) Classification. Class II (perform- er, gastro-urology hook, gastro-urology ance standards). probe and director, nonself-retaining

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retractor, rings, nonelec- Subpart F—Therapeutic Devices trical snare, rectal specula, bladder neck spreader, self-retaining retractor, § 876.5010 Biliary catheter and acces- and scoop. sories. (b) Classification. Class I (general con- (a) Identification. A biliary catheter trols). The device is exempt from the and accessories is a tubular flexible de- premarket notification procedures in vice used for temporary or prolonged subpart E of part 807 of this chapter drainage of the biliary tract, for subject to the limitations in § 876.9. splinting of the during heal- ing, or for preventing stricture of the [48 FR 53023, Nov. 23, 1983, as amended at 54 bile duct. This generic type of device FR 25049, June 12, 1989; 66 FR 38801, July 25, may include a bile collecting bag that 2001] is attached to the biliary catheter by a § 876.4770 Urethrotome. connector and fastened to the patient with a strap. (a) Identification. A urethrotome is a (b) Classification. Class II (perform- device that is inserted into the urethra ance standards). and used to cut urethral strictures and enlarge the urethra. It is a metal in- § 876.5015 Pancreatic drainage stent strument equipped with a dorsal-fin and delivery system. cutting blade which can be elevated (a) Identification. A pancreatic drain- from its sheath. Some urethrotomes in- age stent is a prescription device that corporate an optical channel for visual consists of a self-expanding, covered, control. metallic stent, intended for placement (b) Classification. Class II (perform- to facilitate transmural endoscopic ance standards). drainage of pancreatic pseudocysts. This stent is intended to be removed § 876.4890 Urological table and acces- upon confirmation of pseudocyst reso- sories. lution. This device may also include a (a) Identification. A urological table delivery system. and accessories is a device that con- (b) Classification. Class II (special sists of a table, stirrups, and belts used controls). The special controls for this to support a patient in a suitable posi- device are: tion for endoscopic procedures of the (1) The device and elements of the de- lower urinary tract. The table can be livery device that may contact the pa- adjusted into position manually or tient must be demonstrated to be bio- electrically. compatible. (2) Performance data must dem- (b) Classification. (1) Class II (special onstrate the sterility of patient-con- controls) for the electrically powered tacting components of the device. urological table and accessories. The (3) Performance data must support device is exempt from the premarket the shelf life of the device by dem- notification procedures in subpart E of onstrating continued sterility, package part 807 of this chapter subject to integrity, and device functionality § 876.9. over the requested shelf life. (2) Class I for the manually powered (4) Non-clinical testing data must table and accessories, and for stirrups demonstrate that the stent and deliv- for electrically powered table. The de- ery system perform as intended under vice subject to this paragraph (b)(2) is anticipated conditions of use. The fol- exempt from the premarket notifica- lowing performance characteristics tion procedures in subpart E of part 807 must be tested: of this chapter subject to the limita- (i) Deployment testing of the stent tions in § 876.9. and delivery system must be conducted under simulated use conditions. [48 FR 53023, Nov. 23, 1983, as amended at 61 FR 1122, Jan. 16, 1996; 63 FR 59228, Nov. 3, (ii) Removal force testing must be 1998; 66 FR 38801, July 25, 2001] conducted. The removal force testing must demonstrate that the stent can be safely removed, and that the stent

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will remain in place when subjected to (vii) A detailed summary of the forces encountered during use. device- and procedure-related com- (iii) Expansion force testing must be plications pertinent to use of the de- conducted. The expansion force must vice. demonstrate that the forces exerted by (viii) An expiration date/shelf life. the stent will not damage the tissue surrounding the stent. [79 FR 30724, May 29, 2014] (iv) Compression force testing must § 876.5020 External penile rigidity de- be conducted. The compression force vices. must demonstrate that the stent will withstand the forces encountered dur- (a) Identification. External penile ri- ing use. gidity devices are devices intended to (v) Dimensional verification testing create or maintain sufficient penile ri- must be conducted. gidity for sexual intercourse. External (vi) Tensile testing of joints and ma- penile rigidity devices include vacuum terials must be conducted. The min- pumps, constriction rings, and penile imum acceptance criteria must be ade- splints which are mechanical, powered, quate for its intended use. or pneumatic devices. (vii) Fatigue testing must be con- (b) Classification. Class II (special ducted. Material strength must dem- controls). The devices are exempt from onstrate that the stent will withstand the premarket notification procedures forces encountered during use. in subpart E of part 807 of this chapter (viii) Corrosion testing must be con- subject to the limitations in § 876.9. The ducted. Corrosion resistance must dem- special control for these devices is the onstrate that the stent will withstand FDA guidance document entitled conditions encountered during use. ‘‘Class II Special Controls Guidance (5) Non-clinical testing must evalu- Document: External Penile Rigidity ate the compatibility of the stent in a Devices.’’ See § 876.1(e) for the avail- magnetic resonance (MR) environment. ability of this guidance document. (6) Well-documented clinical experi- [69 FR 77623, Dec. 28, 2004] ence must demonstrate safe and effec- tive use, and capture any adverse § 876.5025 Vibrator for climax control events observed during clinical use. of premature ejaculation. (7) Labeling must include the fol- (a) Identification. A vibrator for cli- lowing: max control of premature ejaculation (i) Appropriate instructions, warn- is used for males who suffer from pre- ings, cautions, limitations, and infor- mature ejaculation. It is designed to mation related to the safe use of the increase the time between arousal and device, including deployment of the de- ejaculation using the stimulating vi- vice, maintenance of the drainage bratory effects of the device on the lumen, and removal of the device. penis. (ii) A warning that the safety and pa- (b) Classification. Class II (special tency of the stent has not been estab- controls). The special controls for this lished beyond the duration of the docu- device are: mented clinical experience. (1) The labeling must include specific (iii) Specific instructions and the instructions regarding the proper qualifications and clinical training placement and use of the device. needed for the safe use of the device, (2) The portions of the device that including deployment of the device, contact the patient must be dem- maintenance of the drainage lumen, onstrated to be biocompatible. and removal of the device. (3) Appropriate analysis/testing must (iv) Information on the patient popu- demonstrate electromagnetic compat- lation for which the device has been ibility safety, electrical safety, and demonstrated to be effective. thermal safety of the device. (v) A detailed summary of the clin- (4) Mechanical safety testing must ical experience pertinent to use of the demonstrate that the device will with- device. stand forces encountered during use. (vi) A detailed summary of the device technical parameters. [80 FR 30355, May 28, 2015]

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§ 876.5030 Continent ileostomy cath- eters, urethral catheters, coude´ cath- eter. eters, balloon retention type catheters, (a) Identification. A continent ileos- straight catheters, upper urinary tract tomy catheter is a flexible tubular de- catheters, double lumen female vice used as a form during surgery for urethrographic catheters, disposable continent ileostomy and it provides ureteral catheters, male drainage after surgery. Additionally, urethrographic catheters, and the device may be inserted periodically urological catheter accessories includ- by the patient for routine care to ing ureteral catheter stylets, ureteral empty the ileal pouch. This generic catheter adapters, ureteral catheter type of device includes the rectal cath- holders, ureteral catheter stylets, eter for continent ileostomy. ureteral catheterization trays, and the (b) Classification. Class I (general con- gastro-urological irrigation tray (for trols). The device is exempt from the urological use). premarket notification procedures in (b) Classification. (1) Class II (per- subpart E of part 807 of this chapter formance standards). subject to the limitations in § 876.9. (2) Class I for the ureteral stylet (guidewire), stylet for gastrourological [48 FR 53023, Nov. 23, 1983, as amended at 54 catheter, ureteral catheter adapter, FR 25050, June 12, 1989; 66 FR 38801, July 25, ureteral catheter connector, and 2001] ureteral catheter holder. The devices § 876.5090 Suprapubic urological cath- subject to this paragraph (b)(2) are ex- eter and accessories. empt from the premarket notification 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 through the abdominal wall into the [48 FR 53023, Nov. 23, 1983, as amended at 61 urinary bladder with the aid of a trocar FR 1122, Jan. 16, 1996; 66 FR 38801, July 25, and cannula. The device is used to pass 2001] fluids to and from the urinary tract. This generic type of device includes the § 876.5140 Urethral insert with pump suprapubic catheter and tube, Malecot for bladder drainage. catheter, catheter punch instrument, (a) Identification. A urethral insert suprapubic drainage tube, and the with pump for bladder drainage is a suprapubic cannula and trocar. catheter-like device with internal (b) Classification. (1) Class II (per- pump mechanism that is placed in the formance standards). urethra. Under patient control the in- (2) Class I for the catheter punch in- ternal pump draws urine out of the strument, nondisposable cannula and bladder when voiding is desired, and trocar, and gastro-urological trocar. blocks urine flow when continence is The devices subject to this paragraph desired. The device is intended for use (b)(2) are exempt from the premarket by women who cannot empty their notification procedures in subpart E of bladder due to impaired detrusor con- part 807 of this chapter subject to the tractility. limitations in § 876.9. (b) Classification. Class II (special controls). The special controls for this [48 FR 53023, Nov. 23, 1983, as amended at 61 FR 1122, Jan. 16, 1996; 66 FR 38801, July 25, device are: 2001] (1) The elements of the device that may contact the urinary tract must be § 876.5130 Urological catheter and ac- demonstrated to be biocompatible. cessories. (2) Performance data must dem- (a) Identification. A urological cath- onstrate the sterility of the device eter and accessories is a flexible tubu- components that contact the urinary lar device that is inserted through the tract. urethra and used to pass fluids to or (3) Performance data must support from the urinary tract. This generic shelf life by demonstrating continued type of device includes radiopaque sterility of the device (or the sterile urological catheters, ureteral cath- components), package integrity, and

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device functionality over the requested (v) The potential risks and benefits shelf life. associated with the use of the device. (4) Non-clinical testing data must (vi) Post-insertion care instructions. demonstrate that the device performs (vii) Alternative treatments. as intended under anticipated condi- [80 FR 18309, Apr. 6, 2015] tions of use. The following performance characteristics must be tested: § 876.5160 Urological clamp for males. (i) Urine flow rate testing. (a) Identification. A urological clamp (ii) Valve integrity testing. for males is a device used to close the (iii) Bladder neck retention force urethra of a male to control urinary in- testing. continence or to hold anesthetic or ra- (iv) Pump/valve endurance testing. diography contrast media in the ure- (v) Encrustation testing. thra temporarily. It is an external (vi) Remote control reliability, me- clamp. chanical integrity, and battery life (b) Classification. Class I (general con- testing. trols). Except when intended for inter- (5) Clinical testing must demonstrate nal use or use on females, the device is safe and effective use, document the exempt from the premarket notifica- device acceptance rate and the adverse tion procedures in subpart E of part 807 event profile associated with clinical of this chapter subject to § 876.9. use, and demonstrate that the device [48 FR 53023, Nov. 23, 1963, as amended at 65 performs as intended under anticipated FR 2317, Jan. 14, 2000] conditions of use. (6) Labeling must include: § 876.5210 Enema kit. (i) Specific instructions, contra- (a) Identification. An enema kit is a indications, warnings, cautions, limita- device intended to instill water or tions, and the clinical training needed other fluids into the colon through a for the safe use of the device. nozzle inserted into the to pro- (ii) Statement of the maximum in- mote evacuation of the contents of the sert indwelling period. lower colon. The device consists of a (iii) Information on the patient edu- container for fluid connected to the cation and support program prior to nozzle either directly or via tubing. and during initial device use. This device does not include the co- (iv) Information on the patient popu- lonic irrigation system (§ 876.5220). lation for which the device has been (b) Classification. Class I (general con- demonstrated to be safe and effective. trols). The device is exempt from the (v) Information on how the device op- premarket notification procedures in erates and the recommended treatment subpart E of part 807 of this chapter regimen. subject to § 876.9. The device is exempt (vi) A detailed summary of the from the current good manufacturing device- and procedure-related com- practice requirements of the quality plications or adverse events pertinent system regulation in part 820 of this to use of the device. chapter, with the exception of § 820.180 (vii) An expiration date/shelf life. of this chapter, with respect to general (7) Patient labeling must be provided requirements concerning records, and and must include: § 820.198 of this chapter, with respect to (i) Relevant contraindications, warn- complaint files. ings, precautions, and adverse events/ [48 FR 53023, Nov. 23, 1963, as amended at 65 complications. FR 2317, Jan. 14, 2000] (ii) Information on how the device operates and the recommended treat- § 876.5220 Colonic irrigation system. ment regimen. (a) Identification. A colonic irrigation (iii) Information on the patient edu- system is a device intended to instill cation and support program prior to water into the colon through a nozzle and during initial device use. inserted into the rectum to cleanse (iv) Information on the patient popu- (evacuate) the contents of the lower lation for which there is clinical evi- colon. The system is designed to allow dence of safety and effectiveness. evacuation of the contents of the colon

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during the administration of the co- closed urine drainage system and lonic irrigation. The device consists of drainage bag; and a container for fluid connected to the (2) A urine collector and accessories nozzle via tubing and includes a system not intended to be connected to an in- which enables the pressure, tempera- dwelling catheter, which includes the ture, or flow of water through the noz- corrugated rubber sheath, pediatric zle to be controlled. The device may in- urine collector, leg bag for external clude a console-type toilet and nec- use, urosheath type incontinence de- essary fittings to allow the device to be vice, and the paste-on device for incon- connected to water and sewer pipes. tinence. The device may use electrical power to (b) Classification—(1) Class II (special heat the water. The device does not in- controls) for a urine collector and acces- clude the enema kit (§ 876.5210). sories intended to be connected to an in- (b) Classification. (1) Class II (per- dwelling catheter. The device is exempt formance standards) when the device is from the premarket notification proce- intended for colon cleansing when dures in subpart E of part 807 of this medically indicated, such as before ra- chapter subject to § 876.9. diological or endoscopic examinations. (2) Class I (general controls). For a (2) Class III (premarket approval) urine collector and accessories not in- when the device is intended for other tended to be connected to an indwell- uses, including colon cleansing rou- ing catheter, the device is exempt from tinely for general well being. the premarket notification procedures (c) Date PMA or notice of completion of in subpart E of part 807 of this chapter a PDP is required. A PMA or a notice of subject to the limitations in § 876.9. If completion of a PDP is required to be the device is not labeled or otherwise filed with the Food and Drug Adminis- represented as sterile, it is exempt tration on or before December 26, 1996 from the current good manufacturing for any colonic irrigation system de- practice requirements of the quality scribed in paragraph (b)(2) of this sec- system regulation in part 820 of this tion that was in commercial distribu- chapter, with the exception of § 820.180, tion before May 28, 1976, or that has, on with respect to general requirements or before December 26, 1996 been found concerning records, and § 820.198, with to be substantially equivalent to a co- respect to complaint files. lonic irrigation system described in [48 FR 53023, Nov. 23, 1983, as amended at 63 paragraph (b)(2) of this section that FR 59228, Nov. 3, 1998; 65 FR 2317, Jan. 14, was in commercial distribution before 2000; 66 FR 38802, July 25, 2001; 73 FR 34860, May 28, 1976. Any other colonic irriga- June 19, 2008] tion system shall have an approved PMA in effect before being placed in § 876.5270 Implanted electrical urinary commercial distribution. continence device. [48 FR 53023, Nov. 23, 1983, as amended at 52 (a) Identification. An implanted elec- FR 17738, May 11, 1987; 61 FR 50707, Sept. 27, trical urinary device is a device in- 1996] tended for treatment of urinary incon- tinence that consists of a receiver im- § 876.5250 Urine collector and acces- planted in the abdomen with electrodes sories. for pulsed-stimulation that are im- (a) Identification. A urine collector planted either in the bladder wall or in and accessories is a device intended to the pelvic floor, and a battery-powered collect urine. The device and acces- transmitter outside the body. sories consist of tubing, a suitable re- (b) Classification. Class III (premarket ceptacle, connectors, mechanical sup- approval). ports, and may include a means to pre- (c) Date PMA or notice of completion of vent the backflow of urine or ascent of a PDP is required. A PMA or a notice of infection. The two kinds of urine col- completion of a PDP is required to be lectors are: filed with the Food and Drug Adminis- (1) A urine collector and accessories tration on or before December 26, 1996 intended to be connected to an indwell- for any implanted electrical urinary ing catheter, which includes the uri- continence device that was in commer- nary drainage collection kit and the cial distribution before May 28, 1976, or

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that has, on or before December 26, 1996 § 876.5310 Nonimplanted, peripheral been found to be substantially equiva- electrical continence device. lent to an implanted electrical urinary (a) Identification. A nonimplanted, pe- continence device that was in commer- ripheral electrical continence device is cial distribution before May 28, 1976. a device that consists of an electrode Any other implanted electrical urinary that is connected by an electrical cable continence device shall have an ap- to a battery-powered pulse source. The proved PMA or a declared completed electrode is placed onto or inserted PDP in effect before being placed in into the body at a peripheral location commercial distribution. and used to stimulate the nerves asso- ciated with pelvic floor function to [48 FR 53023, Nov. 23, 1983, as amended at 52 FR 17738, May 11, 1987; 61 FR 50707, Sept. 27, maintain urinary continence. When 1996] necessary, the electrode may be re- moved by the user. § 876.5280 Implanted mechanical/hy- (b) Classification. Class II, subject to draulic urinary continence device. the following special controls: (a) Identification. An implanted me- (1) That sale, distribution, and use of chanical/hydraulic urinary continence this device are restricted to prescrip- device is a device used to treat urinary tion use in accordance with § 801.109 of incontinence by the application of con- this chapter. tinuous or intermittent pressure to oc- (2) That the labeling must bear all in- clude the urethra. The totally im- formation required for the safe and ef- planted device may consist of a static fective use of the device as outlined in pressure pad, or a system with a con- § 801.109(c) of this chapter, including a detailed summary of the clinical infor- tainer of radiopaque fluid in the abdo- mation upon which the instructions men and a manual pump and valve are based. under the skin surface that is con- nected by tubing to an adjustable pres- [65 FR 18237, Apr. 7, 2000] sure pad or to a cuff around the ure- thra. The fluid is pumped as needed § 876.5320 Nonimplanted electrical from the container to inflate the pad or continence device. cuff to pass on the urethra. (a) Identification. A nonimplanted (b) Classification. Class III (premarket electrical continence device is a device approval). that consists of a pair of electrodes on (c) Date PMA or notice of completion of a plug or a pessary that are connected a PDP is required. A PMA or a notice of by an electrical cable to a battery-pow- completion of a PDP is required to be ered pulse source. The plug or pessary filed with the Food and Drug Adminis- is inserted into the rectum or into the vagina and used to stimulate the mus- tration on or before December 26, 2000, cles of the pelvic floor to maintain uri- for any implanted mechanical/hydrau- nary or fecal continence. When nec- lic urinary continence device that was essary, the plug or pessary may be re- in commercial distribution before May moved by the user. This device ex- 28, 1976, or that has, on or before De- cludes an AC-powered nonimplanted cember 26, 2000, been found to be sub- electrical continence device and the stantially equivalent to an implanted powered vaginal muscle stimulator for mechanical/hydraulic urinary con- therapeutic use (§ 884.5940). tinence device that was in commercial (b) Classification. Class II (perform- distribution before May 28, 1976. Any ance standards). other implanted mechanical/hydraulic urinary continence device shall have § 876.5365 Esophageal dilator. an approved PMA or a declared com- (a) Identification. An esophageal dila- pleted PDP in effect before being tor is a device that consists of a cylin- placed in commercial distribution. drical instrument that may be hollow [48 FR 53023, Nov. 23, 1983, as amended at 52 and weighted with mercury or a metal FR 17738, May 11, 1987; 65 FR 57731, Sept. 26, olive-shaped weight that slides on a 2000] guide, such as a string or wire and is

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used to dilate a stricture of the esoph- part E of part 807 of this chapter sub- agus. This generic type of device in- ject to the limitations in § 876.9. 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- ance standards). § 876.5530 Implantable transprostatic tissue retractor system. § 876.5450 Rectal dilator. (a) Identification. An implantable (a) Identification. A rectal dilator is a transprostatic tissue retractor system device designed to dilate the anal is a prescription use device that con- sphincter and canal when the size of sists of a delivery device and implant. the anal opening may interfere with its The delivery device is inserted function or the passage of an exam- transurethrally and deploys the im- ining instrument. plant through the prostate. It is de- (b) Classification. Class I (general con- signed to increase prostatic urethral trols). The device is exempt from the patency by providing prostate lobe tis- premarket notification procedures in sue retraction while preserving the po- subpart E of part 807 of this chapter tential for future prostate procedures subject to the limitations in § 876.9. and is intended for the treatment of symptoms due to urinary outflow ob- [48 FR 53023, Nov. 23, 1983, as amended at 61 struction secondary to benign prostatic FR 1122, Jan. 16, 1996; 66 FR 38802, July 25, 2001] hyperplasia in men. (b) Classification. Class II (special § 876.5470 Ureteral dilator. controls). The special controls for this device are: (a) Identification. A ureteral dilator is (1) The elements of the device that a device that consists of a specially may contact the patient must be dem- shaped catheter or bougie and is used onstrated to be biocompatible. to dilate the ureter at the place where (2) Performance data must dem- a stone has become lodged or to dilate onstrate the sterility of the patient- a ureteral stricture. contacting components of the device. (b) Classification. Class II (perform- (3) Performance data must support ance standards). shelf life by demonstrating continued sterility of the device (of the patient- § 876.5520 Urethral dilator. contacting components), package in- (a) Identification. A urethral dilator is tegrity, and device functionality over a device that consists of a slender hol- the requested shelf life. low or solid instrument made of metal, (4) Non-clinical testing data must plastic, or other suitable material in a demonstrate that the device performs cylindrical form and in a range of sizes as intended under anticipated condi- and flexibilities. The device may in- tions of use. The following performance clude a mechanism to expand the por- characteristics must be tested: tion of the device in the urethra and (i) Deployment testing must be con- indicate the degree of expansion on a ducted. dial. It is used to dilate the urethra. (ii) Mechanical strength must be con- This generic type of device includes the ducted. mechanical urethral dilator, urological (iii) Resistance-to-degradation test- bougies, metal or plastic urethral ing must be conducted. sound, urethrometer, filiform, and fili- (5) Non-clinical testing must evalu- form follower. ate the compatibility of the device in a (b) Classification. (1) Class II (per- magnetic resonance environment. formance standards). (6) In vivo testing must demonstrate (2) Class I for the urethrometer, safe and effective use, assess the im- urological bougie, filiform and filiform pact of the implants on the ability to follower, and metal or plastic urethral perform subsequent treatments, docu- sound. The devices subject to this para- ment the adverse event profile associ- graph (b)(2) are exempt from the pre- ated with clinical use, and demonstrate market notification procedures in sub- that the device performs as intended

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under anticipated conditions of use. A–V shunt cannulae (with vessel tips). The following performance characteris- The implanted blood access device may tics must be tested: also contain coatings or additives (i) Deployment testing must be con- which may provide additional ducted. functionality to the device. (ii) Implant migration must be con- (2) The nonimplanted blood access ducted. device consists of various flexible or (7) Labeling must bear all informa- rigid tubes, such as catheters, cannulae tion required for safe and effective use or hollow needles, which are inserted of the device, and must include: into appropriate blood vessels or a vas- (i) Specific instructions, warnings, cular graft prosthesis (§§ 870.3450 and cautions, limitations, and the clinical 870.3460), and are intended to remain in training needed for the safe use of the the body for less than 30 days. This ge- device. neric type of device includes fistula (ii) Information on the patient popu- needles, the single needle dialysis set lation for which the device has been (coaxial flow needle), and the single demonstrated to be effective. needle dialysis set (alternating flow (iii) A detailed summary of the de- needle). vice technical parameters. (iv) Information on how the device (3) Accessories common to either operates and the typical course of type include the shunt adaptor, treatment. cannula clamp, shunt connector, shunt (v) An expiration date/shelf life. stabilizer, vessel dilator, disconnect (vi) A detailed summary of the forceps, shunt guard, crimp plier, tube device- and procedure-related com- plier, crimp ring, joint ring, fistula plications or adverse events pertinent adaptor, and declotting tray (including to use of the device. contents). (b) Classification. (1) Class II (special [79 FR 43249, July 25, 2014] controls) for the implanted blood ac- § 876.5540 Blood access device and ac- cess device. The special controls for cessories. this device are: (i) Components of the device that (a) Identification. A blood access de- come into human contact must be dem- vice and accessories is a device in- onstrated to be biocompatible. Mate- tended to provide access to a patient’s rial names and specific designation blood for hemodialysis or other chronic numbers must be provided. uses. When used in hemodialysis, it is part of an artificial kidney system for (ii) Performance data must dem- the treatment of patients with renal onstrate that the device performs as failure or toxemic conditions and pro- intended under anticipated conditions vides access to a patient’s blood for of use. The following performance hemodialysis. The device includes im- characteristics must be tested: planted blood access devices, non- (A) Pressure versus flow rates for implanted blood access devices, and ac- both arterial and venous lumens, from cessories for both the implanted and the minimum flow rate to the max- nonimplanted blood access devices. imum flow rate in 100 milliliter per (1) The implanted blood access device minute increments, must be estab- is a prescription device and consists of lished. The fluid and its viscosity used various flexible or rigid tubes, such as during testing must be stated. catheters, or cannulae, which are sur- (B) Recirculation rates for both for- gically implanted in appropriate blood ward and reverse flow configurations vessels, may come through the skin, must be established, along with the and are intended to remain in the body protocol used to perform the assay, for 30 days or more. This generic type which must be provided. of device includes various catheters, (C) Priming volumes must be estab- shunts, and connectors specifically de- lished. signed to provide access to blood. Ex- (D) Tensile testing of joints and ma- amples include single and double terials must be conducted. The min- lumen catheters with cuff(s), fully sub- imum acceptance criteria must be ade- cutaneous port-catheter systems, and quate for its intended use.

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(E) Air leakage testing and liquid (2) Proper care and maintenance of leakage testing must be conducted. the device and device exit site; (F) Testing of the repeated clamping (3) Removal of the device; of the extensions of the catheter that (4) Anticoagulation; simulates use over the life of the de- (5) Management of obstruction and vice must be conducted, and retested thrombus formation; and for leakage. (6) Qualifications for clinical pro- (G) Mechanical hemolysis testing viders performing the insertion, main- must be conducted for new or altered tenance, and removal of the devices. device designs that affect the blood (vi) In addition to Special Controls in flow pattern. paragraphs (b)(1)(i) through (v) of this (H) Chemical tolerance of the device section, implanted blood access devices to repeated exposure to commonly used that include subcutaneous ports must disinfection agents must be estab- include the following: lished. (A) Labeling must include the rec- (iii) Performance data must dem- ommended type of needle for access as onstrate the sterility of the device. well as detailed instructions for care (iv) Performance data must support and maintenance of the port, subcuta- the shelf life of the device for contin- neous pocket, and skin overlying the ued sterility, package integrity, and port. functionality over the requested shelf (B) Performance testing must include life that must include tensile, repeated results on repeated use of the ports clamping, and leakage testing. that simulates use over the intended (v) Labeling of implanted blood ac- life of the device. cess devices for hemodialysis must in- (C) Clinical performance testing clude the following: must demonstrate safe and effective (A) Labeling must provide arterial use and capture any adverse events ob- and venous pressure versus flow rates, served during clinical use. either in tabular or graphical format. The fluid and its viscosity used during (vii) In addition to Special Controls testing must be stated. in paragraphs (b)(1)(i) through (v) of (B) Labeling must specify the for- this section, implanted blood access de- ward and reverse recirculation rates. vices with coatings or additives must (C) Labeling must provide the arte- include the following: rial and venous priming volumes. (A) A description and material char- (D) Labeling must specify an expira- acterization of the coating or additive tion date. material, the purpose of the coating or (E) Labeling must identify any dis- additive, duration of effectiveness, and infecting agents that cannot be used to how and where the coating is applied. clean any components of the device. (B) An identification in the labeling (F) Any contraindicated disinfecting of any coatings or additives and a sum- agents due to material incompatibility mary of the results of performance must be identified by printing a warn- testing for any coating or material ing on the catheter. Alternatively, con- with special characteristics, such as traindicated disinfecting agents must decreased thrombus formation or anti- be identified by a label affixed to the microbial properties. patient’s medical record and with writ- (C) A Warning Statement in the la- ten instructions provided directly to beling for potential allergic reactions the patient. including anaphylaxis if the coating or (G) Labeling must include a patient additive contains known allergens. implant card. (D) Performance data must dem- (H) The labeling must contain com- onstrate efficacy of the coating or ad- prehensive instructions for the fol- ditive and the duration of effective- lowing: ness. (1) Preparation and insertion of the (viii) The following must be included device, including recommended site of for A–V shunt cannulae (with vessel insertion, method of insertion, and a tips): reference on the proper location for tip (A) The device must comply with placement; Special Controls in paragraphs (b)(1)(i)

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through (v) of this section with the ex- conditions. The sorbent cartridge may ception of paragraphs (b)(1)(ii)(B), include absorbent, ion exchange and (b)(1)(ii)(C), (b)(1)(v)(B), and (b)(1)(v)(C), catalytic materials. which do not apply. (b) Classification. Class II (perform- (B) Labeling must include Warning ance standards). Statements to address the potential for vascular access steal syndrome, arte- § 876.5630 Peritoneal dialysis system rial stenosis, arterial thrombosis, and and accessories. hemorrhage including exsanguination (a) Identification. (1) A peritoneal di- given that the device accesses the arte- alysis system and accessories is a de- rial circulation. vice that is used as an artificial kidney (C) Clinical performance testing system for the treatment of patients must demonstrate safe and effective with renal failure or toxemic condi- use and capture any adverse events ob- served during clinical use. tions, and that consists of a peritoneal (2) Class II (performance standards) access device, an administration set for for the nonimplanted blood access de- peritoneal dialysis, a source of vice. dialysate, and, in some cases, a water (3) Class II (performance standards) purification mechanism. After the for accessories for both the implanted dialysate is instilled into the patient’s and the nonimplanted blood access de- peritoneal cavity, it is allowed to dwell vices not listed in paragraph (b)(4) of there so that undesirable substances this section. from the patient’s blood pass through (4) Class I for the cannula clamp, dis- the lining membrane of the peritoneal connect forceps, crimp plier, tube plier, cavity into this dialysate. These sub- crimp ring, and joint ring, accessories stances are then removed when the for both the implanted and non- dialysate is drained from the patient. implanted blood access device. The de- The peritoneal dialysis system may vices subject to this paragraph (b)(4) regulate and monitor the dialysate are exempt from the premarket notifi- temperature, volume, and delivery rate cation procedures in subpart E of part together with the time course of each 807 of this chapter subject to the limi- cycle of filling, dwell time, and drain- tations in § 876.9. ing of the peritoneal cavity or manual [48 FR 53023, Nov. 23, 1983, as amended at 52 controls may be used. This generic de- FR 17738, May 11, 1987; 61 FR 1122, Jan. 16, vice includes the semiautomatic and 1996; 66 FR 38802, July 25, 2001; 79 FR 43245, the automatic peritoneal delivery sys- July 25, 2014] tem. (2) The peritoneal access device is a § 876.5600 Sorbent regenerated dialysate delivery system for hemo- flexible tube that is implanted through dialysis. the abdominal wall into the peritoneal cavity and that may have attached (a) Identification. A sorbent regen- cuffs to provide anchoring and a skin erated dialysate delivery system for hemodialysis is a device that is part of seal. The device is either a single use an artificial kidney system for the peritioneal catheter, intended to re- treatment of patients with renal fail- main in the peritoneal cavity for less ure or toxemic conditions, and that than 30 days, or a long term peritoneal consists of a sorbent cartridge and the catheter. Accessories include stylets means to circulate dialysate through and trocars to aid in the insertion of this cartridge and the dialysate com- the catheter and an obturator to main- partment of the dialyzer. The device is tain the patency of the surgical fistula used with the extracorporeal blood sys- in the abdominal wall between treat- tem and the dialyzer of the hemo- ments. dialysis system and accessories (3) The disposable administration set (§ 876.5820). The device includes the for peritoneal dialysis consists of tub- means to maintain the temperature, ing, an optional reservoir bag, and ap- conductivity, electrolyte balance, flow propriate connectors. It may include a rate and pressure of the dialysate, and peritoneal dialysate filter to trap and alarms to indicate abnormal dialysate remove contaminating particles.

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(4) The source of dialysate may be (1) The extracorporeal blood system sterile prepackaged dialysate (for semi- and accessories consists of tubing, automatic peritoneal dialysate deliv- pumps, pressure monitors, air foam or ery systems or ‘‘cycler systems’’) or bubble detectors, and alarms to keep dialysate prepared from dialysate con- blood moving safely from the blood ac- centrate and sterile purified water (for cess device and accessories for hemo- automatic peritoneal dialysate deliv- dialysis (§ 876.5540) to the blood com- ery systems or ‘‘reverse osmosis’’ sys- partment of the dialyzer and back to tems). Prepackaged dialysate intended the patient. for use with either of the peritoneal (2) The conventional dialyzer allows dialysate delivery systems is regulated a transfer of water and solutes between by FDA as a drug. the blood and the dialysate through (b) Classification. Class II (perform- the semipermeable membrane. The ance standards). semipermeable membrane of the con- ventional dialyzer has a sufficiently § 876.5665 Water purification system low permeability to water that an for hemodialysis. ultrafiltration controller is not re- (a) Identification. A water purification quired to prevent excessive loss of system for hemodialysis is a device water from the patient’s blood. This that is intended for use with a hemo- conventional dialyzer does not include dialysis system and that is intended to hemodialyzers with the disposable in- 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- cessories. powder) and alarms to indicate abnor- 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 dialysate delivery system, and acces- high permeability hemodialysis system sories. Blood from a patient flows § 876.5860). through the tubing of the (4) Remote accessories to the hemo- extracorporeal blood system and acces- dialysis system include the unpowered sories to the blood compartment of the dialysis chair without a scale, the pow- dialyzer, then returns through further ered dialysis chair without a scale, the tubing of the extracorporeal blood sys- dialyzer holder set, dialysis tie gun and tem to the patient. The dialyzer has ties, and hemodialysis start/stop tray. two compartments that are separated (b) Classification. (1) Class II (per- by a semipermeable membrane. While formance standards) for hemodialysis the blood is in the blood compartment, systems and all accessories directly as- undesirable substances in the blood sociated with the extracorporeal blood pass through the semipermeable mem- system and the dialysate delivery sys- brane into the dialysate in the tem. dialysate compartment. The dialysate (2) Class I for other accessories of the delivery system controls and monitors hemodialysis system remote from the the dialysate circulating through the extracorporeal blood system and the dialysate compartment of the dialyzer. dialysate delivery system, such as the

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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). (b) Classification. Class II (perform- accessories (§ 876.5820), with the addi- ance standards). tion of an ultrafiltration controller and 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- dialysis system. sure, hematocrit, urea, etc.). (3) The high permeability hemo- (a) A high permeability Identification. 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). therapies as hemodialysis, hemofiltration, hemoconcentration, (b) Classification. Class II. The special and hemodiafiltration. Using a controls for this device are FDA’s: hemodialyzer with a semipermeable (1) ‘‘Use of International Standard membrane that is more permeable to ISO 10993 ‘Biological Evaluation of water than the semipermeable mem- Medical Device—Part I: Evaluation and brane of the conventional hemodialysis Testing,’ ’’ system (§ 876.5820), the high perme- (2) ‘‘Guidance for the Content of ability hemodialysis system removes 510(k)s for Conventional and High Per- toxins or excess fluid from the pa- meability Hemodialyzers,’’ tient’s blood using the principles of (3) ‘‘Guidance for Industry and CDRH convection (via a high ultrafiltration Reviewers on the Content of Pre- rate) and/or diffusion (via a concentra- market Notifications for Hemodialysis tion gradient in dialysate). During Delivery Systems,’’ treatment, blood is circulated from the (4) ‘‘Guidance for the Content of Pre- patient through the hemodialyzer’s market Notifications for Water Purifi- blood compartment, while the cation Components and Systems for dialysate solution flows countercurrent Hemodialysis,’’ and

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(5) ‘‘Guidance for Hemodialyzer (A) A detailed summary of the de- Reuse Labeling.’’ vice-related and procedure-related complications pertinent to the use of [65 FR 17145, Mar. 31, 2000] the device; § 876.5870 Sorbent hemoperfusion sys- (B) A summary of the performance tem. data provided for the device, including (a) Identification. A sorbent a list of the drugs and/or poisons the hemoperfusion system is a prescription device has been demonstrated to re- device that consists of an move, and the extent for removal/de- extracorporeal blood system similar to pletion; and (vii) For those devices that incor- that identified in the hemodialysis sys- porate electrical components, appro- tem and accessories (§ 876.5820) and a priate analysis and testing must be container filled with adsorbent mate- conducted to verify electrical safety rial that removes a wide range of sub- and electromagnetic compatibility of stances, both toxic and normal, from the device. blood flowing through it. The adsorb- (2) Class III (premarket approval) ent materials are usually activated- when the device is intended for the carbon or resins which may be coated treatment of hepatic coma and meta- or immobilized to prevent fine par- bolic disturbances. ticles entering the patient’s blood. The (c) Date premarket approval application generic type of device may include (PMA) or notice of completion of product lines and filters specifically designed A to connect the device to the development protocol (PDP) is required. extracorporeal blood system. The de- PMA or notice of completion of a PDP vice is used in the treatment of poi- is required to be filed with FDA by soning, drug overdose, hepatic coma, or April 17, 2014, for any sorbent metabolic disturbances. hemoperfusion system indicated for (b) Classification. (1) Class II (special treatment of hepatic coma or meta- controls) when the device is intended bolic disturbances that was in commer- for the treatment of poisoning and cial distribution before May 28, 1976, or drug overdose. The special controls for that has, by April 17, 2014, been found this device are: to be substantially equivalent to any (i) The device must be demonstrated sorbent hemoperfusion device indicated to be biocompatible; for treatment of hepatic coma or meta- (ii) Performance data must dem- bolic disturbances that was in commer- onstrate the mechanical integrity of cial distribution before May 28, 1976. the device (e.g., tensile, flexural, and Any other sorbent hemoperfusion sys- structural strength), including testing tem device indicated for treatment of for the possibility of leaks, ruptures, hepatic coma or metabolic disturb- release of particles, and/or disconnec- ances shall have an approved PMA or tions under anticipated conditions of declared completed PDP in effect be- use; fore being placed in commercial dis- (iii) Performance data must dem- tribution. onstrate device sterility and shelf life; [79 FR 3094, Jan. 17, 2014] (iv) Bench performance testing must demonstrate device functionality in § 876.5880 Isolated kidney perfusion terms of substances, toxins, and drugs and transport system and acces- removed by the device, and the extent sories. that these are removed when the device (a) Identification. An isolated kidney is used according to its labeling, and to perfusion and transport system and ac- validate the device’s safeguards; cessories is a device that is used to sup- (v) A summary of clinical experience port a donated or a cadaver kidney and with the device that discusses and ana- to maintain the organ in a near-normal lyzes device safety and performance, physiologic state until it is trans- including a list of adverse events ob- planted into a recipient patient. This served during the testing, must be pro- generic type of device may include tub- vided; ing, catheters, connectors, an ice stor- (vi) Labeling must include the fol- age or freezing container with or with- lowing: out bag or preservatives, pulsatile or

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nonpulsatile hypothermic isolated the disposable colostomy appliance, organ perfusion apparatus with or ostomy collector, colostomy pouch, without oxygenator, and disposable urinary ileostomy bag, urine collecting perfusion set. ureterostomy bag, ostomy drainage (b) Classification. Class II (perform- bag with adhesive, stomal bag, ostomy ance standards). protector, and the ostomy size selector, but excludes ostomy pouches which in- § 876.5885 Tissue culture media for corporate arsenic-containing com- human ex vivo tissue and cell cul- pounds. ture processing applications. (b) Classification. Class I (general con- (a) Identification. Tissue culture trols). The device is exempt from the media for human ex vivo tissue and cell premarket notification procedures in culture processing applications consist subpart E of part 807 of this chapter of cell and tissue culture media and subject to the limitations in § 876.9. components that are composed of chemically defined components (e.g., [48 FR 53023, Nov. 23, 1983, as amended at 54 FR 25050, June 12, 1989; 66 FR 38802, July 25, amino acids, vitamins, inorganic salts) 2001] that are essential for the ex vivo devel- opment, survival, and maintenance of § 876.5920 Protective garment for in- tissues and cells of human origin. The continence. solutions are indicated for use in (a) Identification. A protective gar- human ex vivo tissue and cell culture ment for incontinence is a device that processing applications. consists of absorbent padding and a (b) Classification. Class II (special fluid barrier and that is intended to controls): FDA guidance document, protect an incontinent patient’s gar- ‘‘Class II Special Controls Guidance ment from the patient’s excreta. This Document: Tissue Culture Media for generic type of device does not include Human Ex Vivo Processing Applica- diapers for infants. tions; Final Guidance for Industry and (b) Classification. Class I (general con- FDA Reviewers.’’ trols). The device is exempt from the [66 FR 27025, May 16, 2001] premarket notification procedures in subpart E of part 807 of this chapter § 876.5895 Ostomy irrigator. subject to the limitations in § 876.9. The (a) Identification. An ostomy irrigator device is also exempt from the current is a device that consists of a container good manufacturing practice require- for fluid, tubing with a cone-shaped tip ments of the quality system regulation or a soft and flexible catheter with a in part 820 of this chapter, with the ex- retention shield and that is used to ception of § 820.180, regarding general wash out the colon through a colos- requirements concerning records, and tomy, a surgically created opening of § 820.198, regarding complaint files. the colon on the surface of the body. [48 FR 53023, Nov. 23, 1983, as amended at 54 (b) Classification. Class II (perform- FR 25050, June 12, 1989; 66 FR 38802, July 25, ance standards). 2001]

§ 876.5900 Ostomy pouch and acces- § 876.5930 Rectal control system. sories. (a) Identification. A rectal control (a) Identification. An ostomy pouch system is a prescription device in- and accessories is a device that con- tended to treat fecal incontinence by sists of a bag that is attached to the controlling the size of the rectal patient’s skin by an adhesive material lumen. The device is inserted in the va- and that is intended for use as a recep- gina and includes a portion that ex- tacle for collection of fecal material or pands to reduce the rectal lumen to urine following an ileostomy, colos- prevent stool leakage and retracts to tomy, or ureterostomy (a surgically allow normal passage of stool. The de- created opening of the , vice includes an external regulator to , or the ureter on the control the state of expansion. surface of the body). This generic type (b) Classification. Class II (special of device and its accessories includes controls). The special controls for this the ostomy pouch, ostomy adhesive, device are:

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(1) Clinical testing must document § 876.5955 Peritoneo-venous shunt. the device acceptance data and the ad- (a) Identification. A peritoneo-venous verse event profile associated with clinical use, and demonstrate that the shunt is an implanted device that con- device performs as intended under an- sists of a catheter and a pressure acti- ticipated conditions of use. vated one-way valve. The catheter is (2) The elements of the device that implanted with one end in the peri- contact vaginal tissue must be dem- toneal cavity and the other in a large onstrated to be biocompatible. vein. This device enables ascitic fluid in the peritoneal cavity to flow into (3) The cleaning and disinfection in- the venous system for the treatment of structions for the device must be vali- dated. intractable ascites. (4) Non-clinical (bench) testing must (b) Classification. Class II. The special demonstrate that the device performs controls for this device are FDA’s: as intended under anticipated condi- (1) ‘‘Use of International Standard tions of use. ISO 10993 ‘Biological Evaluation of (5) Non-clinical (bench) testing must Medical Devices—Part I: Evaluation demonstrate that the device does not: and Testing,’ ’’ (i) Enhance the growth of Staphy- (2) ‘‘510(k) Sterility Review Guidance lococcus aureus. of 2/12/90 (K90–1),’’ and (ii) Increase production of Toxic (3) Backflow specification and testing Shock Syndrome Toxin-1 by S. aureus. to prevent reflux of blood into the (iii) Alter the growth of normal vag- shunt. inal flora. [48 FR 53023, Nov. 23, 1983, as amended at 52 (6) Labeling must include: FR 17738, May 11, 1987; 65 FR 17145, Mar. 31, (i) Specific instructions, contra- 2000] indications, warnings, cautions, limita- tions, and the clinical training needed § 876.5970 Hernia support. for the safe use of the device. (a) Identification. A hernia support is (ii) The intended patient population a device, usually made of elastic, can- and the intended use environment. vas, leather, or metal, that is intended (iii) Information on how the device is to be placed over a hernial opening (a to be fitted, how the device operates, weakness in the abdominal wall) to and recommendations on device main- prevent protrusion of the abdominal tenance. contents. This generic type of device (iv) A detailed summary of the clin- includes the umbilical truss. ical testing pertinent to the use of the (b) Classification. Class I (general con- device, including a summary of the trols). The device is exempt from the device- and procedure-related com- premarket notification procedures in plications or adverse events related to subpart E of part 807 of this chapter use of the device, as well as relevant subject to the limitations in § 876.9. The safety and performance information. device is also exempt from the current (7) Patient labeling must be provided good manufacturing practice require- and must include: ments of the quality system regulation (i) Relevant contraindications, warn- in part 820 of this chapter, with the ex- ings, precautions, and adverse events/ ception of § 820.180, regarding general complications. requirements concerning records, and (ii) Information on how the device § 820.198, regarding complaint files. operates and the recommended device maintenance (i.e., care instructions), [48 FR 53023, Nov. 23, 1983, as amended at 59 including cleaning and disinfection. FR 63010, Dec. 7, 1994; 66 FR 38802, July 25, 2001] (iii) Information on the patient popu- lation for which there was a favorable § 876.5980 Gastrointestinal tube and benefit/risk assessment. accessories. (iv) The potential risks and benefits (a) Identification. A gastrointestinal associated with the use of the device. tube and accessories is a device that [80 FR 30933, June 1, 2015] consists of flexible or semi-rigid tubing

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used for instilling fluids into, with- under water within the shock wave drawing fluids from, splinting, or sup- generator, and are transferred to the pressing bleeding of the alimentary patient’s body using an appropriate tract. This device may incorporate an acoustic interface. After the stone has integral inflatable balloon for reten- been fragmented by the focused shock tion or hemostasis. This generic type waves, the fragments pass out of the of device includes the hemostatic bag, body with the patient’s urine. irrigation and aspiration catheter (gas- (b) Classification. Class II (special tric, colonic, etc.), rectal catheter, controls) (FDA guidance document: sterile infant gavage set, gastro- ‘‘Guidance for the Content of 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. 878.3530 Silicone inflatable breast pros- focuses ultrasonic shock waves into the 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. 878.3800 External aesthetic restoration pros- stone is targeted using either an inte- 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 878.4010 Tissue adhesive. onto the stone with either a specially 878.4011 Tissue adhesive with adjunct wound designed reflector, dish, or acoustic closure device for topical approximation lens. The shock waves are created of skin.

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