(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.

[80 FR 18309, Apr. 6, 2015]