(a) Identification. A temporarily-placed urethral opening system for symptoms of benign prostatic hyperplasia (BPH) is a prescription use device that is inserted transurethrally and deployed at the prostate. The implant is designed to increase prostatic urethral patency by increasing prostatic opening. It is intended for the treatment of symptoms due to urinary outflow obstruction secondary to BPH in men.

(b) Classification. Class II (special controls). The special controls for this device are:

(1) Clinical performance testing with the device under anticipated conditions of use must evaluate improvement in urinary outflow symptoms and document the adverse event profile.

(2) The patient-contacting components of the device must be demonstrated to be biocompatible.

(3) Performance data must demonstrate the sterility of the patient-contacting components of the device.

(4) Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the labeled shelf life.

(5) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:

(i) Deployment and removal; and

(ii) Mechanical strength.

(6) Labeling must include:

(i) Instructions for use, including the recommended training for safe use of the device;

(ii) A summary of the clinical performance testing conducted with the device, including device- and procedure-related adverse events; and

(iii) A shelf life.