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The inFlow Intraurethral Valve-Pump and Activator is a replaceable urinary prosthesis that is intended for use in female patients 18 years of age or older who have incomplete bladder emptying due to impaired detrusor contractility of neurologic origin, and who are capable of operating it in accordance with instructions or who have trained caregivers. The device must be replaced every 29 days (or less).

The inFlow Intraurethral Valve-Pump and Activator is a system that is designed for the management of impaired detrusor contractility in adult females, and consists of the following three components: - inFlow device: This is the primary component of the system (Figure 1). The inFlow device is a temporary (≤ 29 days) urethral insert, consisting of a silicone (b)(4) TS/CCI which (b)(4) TS/CCl and an internal valve and pump mechanism. This insert is available in multiple shaft lengths selected based on the length of the female urethra. The distal end of the device has six flexible fins to retain the tip of the device at the bladder neck and minimize expulsion. The proximal end of the device has a flange that rests against the urethral meatus to prevent migration into the bladder. The inFlow device is labeled to be replaced every 29 days (or less). It is mounted on and inserted with the aid of a disposable "Introducer" , and is removed by manually pulling the proximal flange. - Activator: The Activator is a battery-powered (b)(4) TS/CCI handheld remote control, which, when held close to the patient's pubic region and turned ON, magnetically actuates (rotates) the internal inFlow pump mechanism to transfer urine out of the bladder. After voiding, the Activator closes an internal magnetic valve to block urine flow. When not in use, a protective shield covers the Activator's magnet to minimize interference. This component only contacts the patient's hand. - Sizing Device: To determine the proper inFlow device size to use in a given patient, the physician uses a separately-packaged Sizing Device. The Sizing Device is a single-use device that is inserted into the urethra to measure the distance between the bladder neck and urethral meatus. This component is constructed from a (b)(4) TS/CCl This component contacts the patient's intact urethra mucosa for a maximum of several minutes.