(186 days)
The Mega Vac System creates and maintains penile erection in impotent men.
External Penile Rigidity Device including Vacuum Pump and Constriction Rings
I am sorry, but the provided text does not contain information about the acceptance criteria, device performance, or any studies conducted to prove the device meets specific criteria. The document is a 510(k) clearance letter from the FDA for a device called "MegaVac System" and an "Indications for Use" statement. It primarily confirms that the device is substantially equivalent to legally marketed predicate devices and can be marketed.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as this information is not present in the given text.
§ 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.