THE PERFORMANCE PLUS CONFIDENCE RINGS, THE PERFORMANCE PLUS ERECTION INDUCER DEVICE

K974082 · Performance Plus, Inc. · LKY · Feb 27, 1998 · Gastroenterology, Urology

Device Facts

• Record ID: K974082
• Device Name: THE PERFORMANCE PLUS CONFIDENCE RINGS, THE PERFORMANCE PLUS ERECTION INDUCER DEVICE
• Applicant: Performance Plus, Inc.
• Product Code: LKY · Gastroenterology, Urology
• Decision Date: Feb 27, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5020
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

Performance Plus Confidence Rings are devices that are placed around the base of the penis to help sustain an erection. An erection is achieved when the spongy corpora of the penis fills with arterial blood during sexual stimulation. In certain men, the penis may not become fully erect because the penile venous system drains too rapidly or leaks blood from the corpora. The rings operate by limiting venous return from the major superficial veins of the penis. The E.I.D. system is an external erection device that induces penile rigidity though vacuum assisted vascular engorgement of the penis. Once erection is achieved, a Confidence ring is placed at the base of the penis to sustain the erection.

Device Story

System comprises soft, pliable Confidence Rings and Erection Inducer Device (E.I.D.) vacuum pump system. E.I.D. uses vacuum chamber to induce penile rigidity via vascular engorgement; Confidence Ring placed at base of penis post-engorgement to limit venous return and sustain erection. Intended for over-the-counter use by patients. Device provides mechanical assistance for erectile dysfunction; no electronic or software components.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

System consists of vacuum tumescence pump, vacuum chamber with inserts, soft/pliable constriction rings, lubricating gel, and carrying case. Mechanical operation; no energy source or software.

Indications for Use

Indicated for men experiencing erectile dysfunction who require assistance achieving or sustaining penile rigidity. Contraindications not specified.

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

• Confidence Rings (K891125)
• Erection Inducer Device (E.I.D.) (K896060)

Submission Summary (Full Text)

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FEB 2 7 1998

2 pages Performance Plus Inc. 510(k) Notification: OTC Labeling Confidence Rings/Erection Inducer Device Attachment 1

Attachment #1

## Performance Plus, Inc. Summary of Safety and Efficacy

K974082

## Applicant Information:

1

Performance Plus, Inc. 801 South Church St., Suite 7 Mount Laurel, NJ 08054

## 510(k) Summary Prepared by:

Carolann Kotula Official Correspondent for Performance Plus, Inc. c/o mdi Consultants, Inc. 55 Northern Boulevard Great Neck, NY 11021

| Phone: | [phone] |
|--------|----------------|
| Fax: | [phone] |

Date 510(k) Summary Prepared:

October 22, 19997

## Name/Classification of the Device:

| Classification Name: | External penile rigidity device (product code 78LKY) |
|-----------------------|----------------------------------------------------------------------------------------------------------|
| Common Name: | Penile constriction ring<br>Penile vacuum pump |
| Proprietary Name: | The Performance Plus Confidence Rings<br>The Performance Plus Erection Inducer<br>Device (E.I.D.) |
| Classification/Panel: | External penile rigidity devices have not been classified. The Urology panel would classify this device. |

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PG. Zor 2

Comparative Information: These devices are identical to the predicates, K891125(Confidence Rings) and K896060 (E.I.D) in materials,dimensions, performance, and intended use. The labeling is changed to provide the information needed for safe over the counter use of these devices.

Description of the Subject Devices: The Performance Plus Confidence rings are soft, pliable rings with a tab for removal. The E.I.D. system consists of a vacuum tumescence pump, a vacuum chamber with inserts, Confidence rings, lubricating gel, instructions for use, and a carrying case.

Intended Use: Performance Plus Confidence Rings are devices that are placed around the base of the penis to help sustain an erection. An erection is achieved when the spongy corpora of the penis fills with arterial blood during sexual stimulation. In certain men, the penis may not become fully erect because the penile venous system drains too rapidly or leaks blood from the corpora. The rings operate by limiting venous return from the major superficial veins of the penis.

The E.I.D. system is an external erection device that induces penile rigidity though vacuum assisted vascular engorgement of the penis. Once erection is achieved, a Confidence ring is placed at the base of the penis to sustain the erection.

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Image /page/2/Picture/2 description: The image shows the logo for the Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol is a stylized representation of an eagle or bird, with three curved lines forming the body and wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 7 1998

Performance Plus, Inc. c/o Ms. Carolann Kotula Vice President RA/QA MDI Consultants, Inc. 55 Northern Blvd. Great Neck, NY 11021

Re: K974082

Performance Plus Confidence Rings - OTC Performance Plus Erection Inducer Device (E.I.D.) - OTC Dated: January 31, 1998 Received: February 3, 1998 Unclassified/Procode: 78 LKY

Dear Ms. Kotula:

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 ensement date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Felecal Food, Drug, and Comment Act (Act). You may, therefore, market the device, 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 (Special Controls) or 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 Feleval Resulations, 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 (2) 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 deccribed in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predication 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/cdr/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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Attachment 3

Performance Plus Inc. 510(k) Notification: OTC Labeling Confidence Rings/Erection Inducer Device

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Performance Plus, Inc. Confidence Rings and Erection Inducer Device.

Indications for Use:

Performance Plus Confidence Rings are devices that are placed around the base of the penis to help sustain an erection. An erection is achieved when the spongy corpora of the penis fills with arterial blood during sexual stimulation. In certain men, the penis may not become fully erect because the penile venous system drains too rapidly or leaks blood from the corpora. The rings operate by limiting venous return from the major superficial veins of the penis.

The E.I.D. system is an external erection device that induces penile rigidity though vacuum assisted vascular engorgement of the penis. Once erection is achieved, a Confidence ring is placed at the base of the penis to sustain the erection.

(Please Do Not Write Below this Line/Continue on Another Page if Needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Rabert R Matthing /

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

510(k) Number K974082

Prescription Use (per 21 CFR 801.109)

OR

Over the Counter Use \