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 Description

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.

AI/ML Overview

The provided text is a 510(k) summary for the Imagyn Medical Technologies, Inc.'s Impower™ Vacuum Erection Device. This submission primarily focuses on establishing "substantial equivalence" to a predicate device rather than presenting a performance study with defined acceptance criteria and detailed study results as would be found in a clinical trial or a more extensive performance evaluation for a novel device.

Therefore, many of the requested elements for describing acceptance criteria and study details are not present in this type of regulatory document. I will fill in the information based on what is available and explicitly state when information is not provided.

Here's the breakdown:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Not explicitly defined in the provided document. The primary 'acceptance criteria' for a 510(k) in this context is demonstrating substantial equivalence to a legally marketed predicate device.	The device 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, it is "substantially equivalent."

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not applicable/Not provided. This submission relies on a comparison to a predicate device and its known performance, rather than new testing on a specific "test set" of patients.
Data Provenance: Not applicable/Not provided.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Number of Experts: Not applicable/Not provided.
Qualifications of Experts: Not applicable/Not provided.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable/Not provided.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

MRMC Study: No, not applicable for this 510(k) submission.
Effect Size: Not applicable.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Standalone Performance: Not applicable. This is a mechanical medical device, not an AI algorithm.

7. The Type of Ground Truth Used

Type of Ground Truth: Not applicable in the sense of a test set with established ground truth for performance metrics. The "ground truth" for this 510(k) submission is the performance and safety profile of the predicate device (Impower (Catalyst) System, 510(k) No. K920409), to which the new device is being compared for substantial equivalence.

8. The Sample Size for the Training Set

Sample Size: Not applicable/Not provided. This is a mechanical device, not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Ground Truth Establishment: Not applicable.

Summary of the Study per the provided text:

The provided document describes a 510(k) notification of intent to market the Impower™ Vacuum Erection Device. The "study" presented here is a substantial equivalence comparison to a legally marketed predicate device, the Impower (Catalyst) System (K920409).

The core of the submission is the claim that the new Impower device is substantially equivalent because:

It uses the same vacuum method and technological characteristics to create and maintain an erection as the predicate device.
It uses the same components and materials as the predicate device.

The FDA reviewed this claim and determined that the device is substantially equivalent for its stated indications for use (treatment or management of erectile dysfunction/impotence). This means that, based on the comparison provided, the FDA found no new questions of safety or effectiveness were raised by the new device compared to the predicate. No new clinical trials or performance studies with specific acceptance criteria and patient cohorts are described in the provided summary as being part of this 510(k) submission process.

Summary

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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: (714) 668-5858 Fax: (714) 668-5856

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:

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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Image /page/1/Picture/0 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

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 (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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

Regulation Number and Section

§ 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.