(97 days)
The Vitality System consists of a manual vacuum pump, a cylinder, cushion inserts, constriction ring loader, constriction rings, and lubricant. The Vitality System's intended use is to manage erectile dysfunction by allowing the creation of a full erection suitable for sexual activity. This is accomplished through the use of the manual vacuum pump to remove air from the cylinder, creating vacuum pressure within the cylinder. Blood is thereby drawn into the penis, causing it to become erect. The constriction ring is then placed around the base of the erect penis to restrict the outflow of blood. When activity is complete, the ring is removed from the base of the penis. This product is intended for over the counter use.
The Vitality System consists of a manual vacuum pump, a cylinder, cushion inserts, constriction ring loader, constriction rings, and lubricant.
This document is a 510(k) clearance letter for the Vitality System™, a manual vacuum pump device for erectile dysfunction. As such, it does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria.
The letter confirms that the device is substantially equivalent to legally marketed predicate devices and is subject to general controls. It permits the device to be marketed.
To answer the requested questions, one would need access to the 510(k) submission document itself, or other clinical trial data for the device if it exists.
§ 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.