MEGAVAC SYSTEM

K974196 · Barry J. Kaplan, Inc. · LKY · May 12, 1998 · Gastroenterology, Urology

Device Facts

• Record ID: K974196
• Device Name: MEGAVAC SYSTEM
• Applicant: Barry J. Kaplan, Inc.
• Product Code: LKY · Gastroenterology, Urology
• Decision Date: May 12, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5020
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Mega Vac System creates and maintains penile erection in impotent men.

Device Story

MegaVac System is an external penile rigidity device consisting of a vacuum pump and constriction rings. Used by patients for self-administration to treat impotence. Device creates a vacuum around the penis to induce engorgement; constriction rings are then applied to the base of the penis to maintain rigidity by restricting venous outflow. Device is intended for over-the-counter use to assist in achieving and maintaining an erection.

Clinical Evidence

No clinical data provided; substantial equivalence determination based on regulatory classification and intended use.

Technological Characteristics

External penile rigidity device comprising a vacuum pump and constriction rings. Mechanical operation via vacuum induction. No software or electronic components described.

Indications for Use

Indicated for impotent men to create and maintain penile erection.

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.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 2 1998

Dr. Barry J. Kaplan MegaVac Systems, Inc. 1286 University Avenue Suite 221 San Diego, CA 92103

Re: K974196

MegaVac System (Over-the-Counter Use) Dated: March 26, 1998 Received: March 30, 1998 Unclassified/Procode: 78 LKY

Dear Dr. Kaplan:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its Internet address "http://www.fda.gov/cdrh/dsmarnain.html".

Sincerely yours

Lillian Yin, Ph.D.

Director, Division of Reproductive, Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Statement of Indications for Use

K974196 510 (k)

Device Name: External Penile Rigidity Device including Vacuum Pump and Constriction Rings

Indications of Use: The Mega Vac System creates and maintains penile erection in impotent men.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Dolar R. Rathling/
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number_K974196

rescription Use (Pers 21 CFR 801.109) (Optional Format 1-2-96) Or

Image /page/1/Picture/10 description: The image shows the text "Over-The Counter Use" inside of an oval shape. The text is written in a typewriter-style font. The oval shape appears to be hand-drawn.

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