ERECAID SYSTEM/STAY EREC SYSTEM

K974173 · Imagyn Medical Technologies, Inc. · LKY · Feb 25, 1998 · Gastroenterology, Urology

Device Facts

• Record ID: K974173
• Device Name: ERECAID SYSTEM/STAY EREC SYSTEM
• Applicant: Imagyn Medical Technologies, Inc.
• Product Code: LKY · Gastroenterology, Urology
• Decision Date: Feb 25, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5020
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ErecAid device is used to assist in creating and maintaining an erection suitable for sexual intercourse. These devices are intended for the treatment or management of erectile dysfunction/impotence.

Device Story

ErecAid system is a vacuum erection device used for the treatment or management of erectile dysfunction. The system consists of a vacuum pump, a clear plastic cylinder, tension rings, an insert ring, and personal lubricant. The user places the penis into the cylinder and operates the vacuum pump to create negative pressure, which draws blood into the penis to induce an erection. Once the erection is achieved, a tension ring is placed at the base of the penis to maintain rigidity by restricting venous outflow. The device is intended for over-the-counter (OTC) use by patients. It provides a non-invasive mechanical method to assist in achieving and maintaining an erection suitable for sexual intercourse.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and design similarities to predicate devices.

Technological Characteristics

Mechanical vacuum erection system. Components include a vacuum pump, clear plastic cylinder, tension rings, and insert ring. Operates via manual or battery-powered vacuum generation to induce penile engorgement. Materials are identical to previously cleared predicate devices.

Indications for Use

Indicated for the treatment or management of erectile dysfunction/impotence in patients requiring assistance to create and maintain an erection suitable for sexual intercourse.

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

• ErecAid System Classic (K841257)
• ErecAid System Esteem Battery (K912736/A)
• StayErec Tension Rings (K901318)

Submission Summary (Full Text)

{0}------------------------------------------------

K974173
41

FEB 2 5 1998

11.

## 510(k) Summary

# Imagyn Medical Technologies, Inc. ErecAid™Vacuum Erection and StayErec® Tension Ring Devices

- I. General Information on Submitter:

| Name: | Imagyn Medical Technologies, Inc. |
|----------|-----------------------------------------------------|
| Address: | 5 Civic Plaza, Suite 100<br>Newport Beach, CA 92660 |
| Phone: | [phone] |
| Fax: | [phone] |

| Name of Contact Person: | Ronald H. Bergeson |
|-------------------------|--------------------|
| Date Summary Prepared: | November 4, 1997 |

- II. General Information on Device

| Name: | ErecAid® System Vacuum Erection System - OTC |
|-------|----------------------------------------------|
| | StayErec® Tension Rings - OTC |

Classification Name: External Penile Rigidity Device

- III. Predicate Devices: ErecAid System Classic (510(k) No. K841257) ErecAid System Esteem Battery (510(k) No. K912736/A) StayErec Tension Rings (510(k) No. K901318)
- IV. . Description of the Device:

The Imagyn Medical Technologies, Inc. ErecAid System Classic vacuum erection system ("ErecAid") consists of a vacuum pump, tension rings, insert ring, clear plastic cylinder, and a tube of personal lubricant. The StayErec Tension Ring consists of a ring of the same material, and used in the same manner as the predicate device.

- V. Intended Use: The ErecAid device is used to assist in creating and maintaining an erection suitable for sexual intercourse. These devices are intended for the treatment or management of erectile dysfunction/impotence.
#### VI. Substantial Equivalence

The ErecAid uses the same vacuum method and technological characteristics to create and maintain an erection as the predicate devices. It also uses the same components and materials as the predicate devices. Therefore, the ErecAid and StayErec devices are substantially equivalent to its predicate devices.

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, but with three wavy lines instead of snakes.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 5 1998

Mr. Ronald H. Bergeson Corporate Director of Regulatory Affairs Imagyn Medical Technologies, Inc. 27651 La Paz Road Laguna Niguel, CA 92677

Re: K974173

ErecAid® Systems Classic, Esteem Manual, and Esteem Battery Models-OTC and StayErec® Tension Rings-OTC Dated: January 23, 1998 Received: January 26, 1998 Unclassified/Procode: 78 LKY

Dear Mr. Bergeson:

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 Devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, subject to the general controls provisions of 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 II (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 requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (2) CFR Part 820) and that through periodic OS 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 of affect any obligation you might have under sections 531 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 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed prodication 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 (2) CFR Part 801 and additionally 809.10 for in yitte 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/dsmamain.html"

Sincerely yours,

W. Liao Yu

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

{2}------------------------------------------------

1

### K974173 510 (k) Number (if known):

### ErecAid® System Vacuum Erection Device-OTC, and Device Name: StayErec® System Tension Rings-OTC

Indications for Use:

-

ErecAid® System-OTC and StayErec® System Tension Rings-OTC

These devices are intended for the treatment or management of erectile dysfunction/impotence.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Robert R Ratliff/

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number_197413

Prescription Use (Per 21 CFR 801.1091 OR

**Over-The-Counter Use**

(Optional Format 1-2-96)

000000