(182 days)
The VTU-1 is intended to aid in the production and maintenance of a penile erection in individuals suffering from impotence.
Not Found
This document is a 510(k) clearance letter from the FDA for a Vacuum Erection System. It does not contain information about acceptance criteria or a study proving that the device meets those criteria. Such information would typically be found in the manufacturer's 510(k) submission, which is not provided here.
Therefore, I cannot provide the requested information. The document explicitly states that the FDA "reviewed your Section 510(k) notification of intent to market the device...and we have determined the device is substantially equivalent...to devices marketed in interstate commerce prior to May 28, 1976." This indicates a substantial equivalence pathway, not a performance study against specific acceptance criteria.
§ 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.