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.

ErecAid® System-OTC and StayErec® System Tension Rings-OTC
These devices are intended for the treatment or management of erectile dysfunction/impotence.

Device Description

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.

AI/ML Overview

The provided text describes a 510(k) submission for the ErecAid™ Vacuum Erection and StayErec® Tension Ring Devices. This is largely a pre-market notification with a focus on demonstrating substantial equivalence to previously approved devices, rather than a clinical study evaluating novel performance criteria.

Therefore, many of the requested elements for describing an acceptance criteria study (such as sample sizes, ground truth establishment, expert adjudication, MRMC studies, or standalone algorithm performance) are not applicable or explicitly mentioned in this document. The document relies on equivalence to known predicate devices rather than new performance data against a specific set of acceptance criteria.

Here's a breakdown of the available information based on your request, with an emphasis on what is present and what is not:

1. A table of acceptance criteria and the reported device performance

This document does not present a table of acceptance criteria and specific performance metrics for the ErecAid and StayErec devices. The primary "acceptance criterion" being met is substantial equivalence to predicate devices. The document implies that the device performs equivalently to the predicate devices because it uses the "same vacuum method and technological characteristics" and "uses the same components and materials."

Acceptance Criteria (Implied)	Reported Device Performance
Substantial Equivalence to Predicate Devices	The ErecAid and StayErec devices are "substantially equivalent" to predicate devices (ErecAid System Classic, ErecAid System Esteem Battery, StayErec Tension Rings) based on identical intended use, same vacuum method and technological characteristics, and same components and materials.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. This document does not describe a clinical study with a test set. The determination of substantial equivalence is based on a comparison of technical characteristics and intended use with existing predicate devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. No ground truth establishment by experts for a test set is mentioned.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No adjudication method is mentioned as there's no clinical test set.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a mechanical medical device, not an AI or imaging diagnostic tool, so an MRMC study is not relevant or mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a mechanical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. The "ground truth" for this submission is the established performance and safety of the predicate devices. The new device is deemed acceptable because it is sufficiently similar to these already approved devices.

8. The sample size for the training set

Not applicable. No training set is involved as this is not an AI/machine learning device.

9. How the ground truth for the training set was established

Not applicable.

Summary

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K974173
41

FEB 2 5 1998

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 100Newport Beach, CA 92660
Phone:	(714) 720-8855
Fax:	(714) 720-8809

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:

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.

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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 (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/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

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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

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.