section_subject: "Urethral insert with pump for bladder drainage."
cfr_reference: "21 CFR 876.5140"
title_name: "Title 21"
title_subject: "Food and Drugs"
parts_covered: "Parts 800 to 1299"
revised_date: "Revised as of April 1, 2019"
publication_date: "As of April 1, 2019"
contains_description: "Containing a codification of documents of general applicability and future effect"
publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"
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(a)Identification. A urethral insert with pump for bladder drainage is a catheter-like device with internal pump mechanism that is placed in the urethra. Under patient control the internal pump draws urine out of the bladder when voiding is desired, and blocks urine flow when continence is desired. The device is intended for use by women who cannot empty their bladder due to impaired detrusor contractility.
(b)Classification. Class II (special controls). The special controls for this device are:
(1)The elements of the device that may contact the urinary tract must be demonstrated to be biocompatible.
(2)Performance data must demonstrate the sterility of the device components that contact the urinary tract.
(3)Performance data must support shelf life by demonstrating continued sterility of the device (or the sterile components), package integrity, and device functionality over the requested shelf life.
(4)Non-clinical testing data must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:
(vi)Remote control reliability, mechanical integrity, and battery life testing.
(5)Clinical testing must demonstrate safe and effective use, document the device acceptance rate and the adverse event profile associated with clinical use, and demonstrate that the device performs as intended under anticipated conditions of use.