(354 days)
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.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Bench Tests:
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Pull-out force testing (bladder neck retention strength) | (b)(4) TS/CCI | Pass |
| Flow rate test (urine flow rate) | (b)(4) TS/CCI | Pass |
| High pressure test (internal pump leakage when inactivated) | (b)(4) TS/CCI | Pass |
| Pump and valve endurance test (reliability of flow rate and continence over expected duration) | (b)(4) TS/CCI | Pass |
| Activator endurance test (Activator operation reliability over 5 years simulated use) | Speed: (b)(4) TS/CCI; Current: (b)(4) TS/CCI | Pass |
| Activator drop test (function after 50 cm drop) | No visible damage (exterior & interior); Function after drop with no discernible change in noise level. | Pass |
| Activator battery endurance test (duration of use with single set of batteries) | (b)(4) TS/CCI | Pass |
| Catheter DC magnetic field levels (DC magnetic field from insert does not exceed CRC Handbook standards for human exposure/affect electronic equipment) | (b)(4) TS/CCI | Pass |
| Activator DC magnetic field testing (DC magnetic field of Activator does not exceed CRC Handbook standards for human exposure/affect electronic equipment) | (b)(4) TS/CCI | Pass* *(b)(4) TS/CCI slightly exceeds criterion, but within safe levels for short use. |
| Activator AC magnetic field testing (AC magnetic fields generated by Activator do not generate dangerous induced currents) | (b)(4) TS/CCI | Pass |
| In vitro encrustation study (time to encrustation vs. Foley catheter) | (b)(4) TS/CCI | Pass* (inFlow device had less encrustation than Foley catheter.) |
Clinical Study (Effectiveness):
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Primary Effectiveness: PVR comparable to CIC (i.e., |
§ 876.5140 Urethral insert with pump for bladder drainage.
(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:
(i) Urine flow rate testing.
(ii) Valve integrity testing.
(iii) Bladder neck retention force testing.
(iv) Pump/valve endurance testing.
(v) Encrustation testing.
(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.
(6) Labeling must include:
(i) Specific instructions, contraindications, warnings, cautions, limitations, and the clinical training needed for the safe use of the device.
(ii) Statement of the maximum insert indwelling period.
(iii) Information on the patient education and support program prior to and during initial device use.
(iv) Information on the patient population for which the device has been demonstrated to be safe and effective.
(v) Information on how the device operates and the recommended treatment regimen.
(vi) A detailed summary of the device- and procedure-related complications or adverse events pertinent to use of the device.
(vii) An expiration date/shelf life.
(7) Patient labeling must be provided and must include:
(i) Relevant contraindications, warnings, precautions, and adverse events/complications.
(ii) Information on how the device operates and the recommended treatment regimen.
(iii) Information on the patient education and support program prior to and during initial device use.
(iv) Information on the patient population for which there is clinical evidence of safety and effectiveness.
(v) The potential risks and benefits associated with the use of the device.
(vi) Post-insertion care instructions.
(vii) Alternative treatments.