(104 days)
The VED VALU and VED VALU ULTRA vacuum erection devices consist of two main parts: the vacuum pump and constriction ring.
Vacuum Pump - used to create an erection in men with erectlie dysfunction by means of an applied vacuum to the penis, which draws blood into the penlle corpora cavernosa causing the penis to become erect and rigid.
Constriction Ring - used to maintain penile rigidity in me with erectile dysfunction by restricting penile venous outflow after the patient has obtained an erection with the ald of a vacuum pump.
VED VALU and VED VALU ULTRA are designed to help you create an erection sufficient to penetrate the vagina and have sexual intercourse. They are intented for use by men who have full or parlal impotence. NOTE: Neither the VED VALU nor the VED VALU ULTRA is a contraceptive.
The VED VALU and VED VALU ULTRA vacuum erection devices consist of two main parts: the vacuum pump and constriction ring.
The provided text is a 510(k) premarket notification letter from the FDA regarding two vacuum erection devices, VED® VALU™ (Manual Pump) and VED® VALU™ (Electric Pump). This document primarily establishes that the devices are substantially equivalent to previously marketed devices and permits them to be marketed.
It does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria. The letter and the accompanying "Indications For Use" form do not detail performance metrics, sample sizes for testing, expert qualifications, ground truth establishment, or any comparative effectiveness studies.
Therefore, I cannot populate the table or answer the specific questions related to acceptance criteria and performance studies based on the provided text. The document is a regulatory approval letter, not a performance study report.
§ 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.