(149 days)
All four sets of constriction rings, the Rejoyn Constriction Ring Kit, B-100, B-25, and B-10, are used to maintain penile rigidity in men with erectile dysfunction by restricting penile venous outflow after the patient has obtained an erection (either with the aid of a vacuum pump, or naturally). The constriction band is placed around the base of the erect penis to restrict the flow of venous blood leaving the penis.
Not Found
The provided documents are a 510(k) clearance letter and an "Indications for Use" statement for the Rejoyn, B-100, B-25, and B-10 Constriction Ring Kits. These documents confirm that the devices have received market clearance based on substantial equivalence to predicate devices, but they do not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.
Therefore, I cannot provide the requested information. The documents are purely regulatory approval notices and do not detail any performance evaluation studies.
§ 876.5020 External penile rigidity devices.
(a)
Identification. External penile rigidity devices are devices intended to create or maintain sufficient penile rigidity for sexual intercourse. External penile rigidity devices include vacuum pumps, constriction rings, and penile splints which are mechanical, powered, or pneumatic devices.(b)
Classification. Class II (special controls). The devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9. The special control for these devices is the FDA guidance document entitled “Class II Special Controls Guidance Document: External Penile Rigidity Devices.” See § 876.1(e) for the availability of this guidance document.