IMPOWER EXTERNAL VACUUM SYSTEM

K980291 · Imagyn Medical Technologies, Inc. · LKY · Mar 11, 1998 · Gastroenterology, Urology

Device Facts

• Record ID: K980291
• Device Name: IMPOWER EXTERNAL VACUUM SYSTEM
• Applicant: Imagyn Medical Technologies, Inc.
• Product Code: LKY · Gastroenterology, Urology
• Decision Date: Mar 11, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5020
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

Impower System is an external vacuum erection device used for the management of erectile dysfunction. The system consists of a vacuum pump, a clear plastic cylinder, tension rings, seal rings, 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 desired rigidity is achieved, a tension ring is placed at the base of the penis to maintain the erection 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 sexual intercourse.

Clinical Evidence

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

Technological Characteristics

Mechanical vacuum erection device. Components include a vacuum pump, tension rings, seal rings, and a clear plastic cylinder. Operates via manual vacuum generation. No electronic, software, or energy-based components.

Indications for Use

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

• Impower (Catalyst) System (K920409)

Submission Summary (Full Text)

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K980291

Pinl

# 510(k) Summary Imagyn Medical Technologies, Inc. Impower™Vacuum Erection Device

### I. General Information on Submitter:

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

MAR 1 1 1998

| Name of Contact Person: | Ronald H. Bergeson |
|-------------------------|--------------------|
| Date Summary Prepared: | January 23, 1998 |

- II. General Information on Device
Name:

Impower System Vacuum Erection System - OTC

III. Classification Name: External Penile Rigidity Device

IV. . Predicate Devices: Impower (Catalyst) System (510(k) No. K920409)

- I. Description of the Device:
The Imagyn Medical Technologies, Inc.'s Impower System vacuum erection device ("Impower") consists of a vacuum pump, tension rings, seal rings, clear plastic cylinder, and a tube of personal lubricant.

## V. Intended Use:

f

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

#### VI. Substantial Equivalence

The Impower uses the same vacuum method and technological characteristics to create and maintain an erection as the predicate device. It also uses the same components and materials as the predicate device. Therefore, the Impower device is substantially equivalent to its predicate device.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K980291

Imagyn Medical Technologies Impower™ Vacuum Erection Device - OTC Dated: January 23, 1998 Received: January 26, 1998 MAR 19988 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 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 (OS) 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/odrh/dsmaldsmamain.html".

Sincerely yours.

Lillian Yin, Ph.D.

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

Enclosure

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# ODE INDICATIONS FOR USE FORM

510 (k) Number (if known):

Impower Vacuum Erection Device-OTC Device Name:

Indications for Use:

This device is 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)

Dale D. Antling

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 1980291 510(k) Number_

Prescription Use (Per 21 CFR 801.1091 OR

Over-The-Counter Use

(Optional Format 1-2-96)

Impower™ Vacuum Erection Device Imagyn Medical Technologies, Inc.

01/23/98

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