(137 days)
The ACTIS® (Venous Flow Controller) device is an erection enhancement device that is designed to slow venous outflow from the penis and thus aid in the normal erection process.
It is a linear elastic tube with an O ring and ball locking unit that allows ease of adjustment to increase or decrease tension. Placement is around the base of the penis.
I am sorry, but the provided text does not contain the information required to describe the acceptance criteria and study details as per your request. The document is a 510(k) summary for a medical device (ACTIS® Venous Flow Controller) and primarily focuses on its description, intended use, and substantial equivalence to a predicate device. It does not include performance data, study design details, or acceptance criteria in the format you've specified.
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510(k) SUMMARY, SAFETY AND EFFECTIVENESS 12.
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and 21CFR 807.92:
The ACTIS® (Venous Flow Controller) device is an erection enhancement device that is designed to slow venous outflow from the penis and thus aid in the normal erection process. It is a linear elastic tube with an O ring and ball locking unit that allows ease of adjustment to increase or decrease tension. Placement is around the base of the penis.
Directions and diagrams for proper use, care, and recommended duration of application of the ACTIS® device are part of the materials provided to the patient. The ease of adjustability provides a high degree of safety when used according to the directions.
VIVUS ACTIS® device is substantially equivalent to the marketed ENCORE Revive® series of tension rings.
Neii Hernandez
Neil Gesundheit, M.D. Vice President Clinical and Regulatory Affairs VIVUS, Inc.
Originally submitted July 25, 1996 Revised October 7, 1996
§ 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.