ACTIS (VENOUS FLOW CONTROLLER)

K962915 · Vivus, Inc. · LKY · Dec 10, 1996 · Gastroenterology, Urology

Device Facts

• Record ID: K962915
• Device Name: ACTIS (VENOUS FLOW CONTROLLER)
• Applicant: Vivus, Inc.
• Product Code: LKY · Gastroenterology, Urology
• Decision Date: Dec 10, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5020
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

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.

Device Story

ACTIS Venous Flow Controller; linear elastic tube with O-ring and ball locking mechanism; placed around base of penis; manually adjusted to increase/decrease tension; slows venous outflow to aid erection process; patient-operated; intended for home use.

Clinical Evidence

No clinical data provided; device relies on mechanical design for intended function.

Technological Characteristics

Linear elastic tube; O-ring and ball locking mechanism for tension adjustment; mechanical device; no energy source; non-sterile.

Indications for Use

Indicated for patients requiring erection enhancement by slowing venous outflow from the penis.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• ENCORE Revive® series of tension rings

Submission Summary (Full Text)

{0}

DEC 10 1996
K962915
K962915

# 12. 510(k) SUMMARY, SAFETY AND EFFECTIVENESS

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.

Neil Gesundheit, M.D.
Vice President
Clinical and Regulatory Affairs
VIVUS, Inc.

Originally submitted July 25, 1996
Revised October 7, 1996

072