REJOYN PENILE SUPPORT SYSTEM

K971576 · American Medtech · LKY · Oct 16, 1997 · Gastroenterology, Urology

Device Facts

• Record ID: K971576
• Device Name: REJOYN PENILE SUPPORT SYSTEM
• Applicant: American Medtech
• Product Code: LKY · Gastroenterology, Urology
• Decision Date: Oct 16, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5020
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Rejoyn Penile Support System is intended for use by men who have an inability to engage in sexual intercourse due to a flaccid or partially erect penis resulting from impotence.

Device Story

Rejoyn Penile Support System; external penile rigidity device. Consists of semi-rigid split support sleeve molded from medical grade rubber; includes attachment strap fastened behind scrotum. Optional lubricated latex cover for comfort. Available in reusable or single-use disposable versions. Used by patients to facilitate sexual intercourse. Mechanical support provides rigidity to flaccid or partially erect penis.

Clinical Evidence

No clinical data.

Technological Characteristics

Semi-rigid support sleeve; medical grade rubber; attachment strap; optional latex cover; 2 1/4" length. Mechanical support principle. No energy source. Non-sterile.

Indications for Use

Indicated for men experiencing inability to engage in sexual intercourse due to flaccid or partially erect penis resulting from impotence.

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

• Various pre-amendment 'penile splints'

Submission Summary (Full Text)

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

K971576

1 of 2

## Revised Appendix C

## 510(k) Summary American MedTech Rejoyn Penile Support System

OCT 16 1997

## General Information on Submitter: I.

| Name: | American MedTech, Division of Gain, Inc. |
|-------------------------|----------------------------------------------|
| Address: | 2124 University Avenue<br>St. Paul, MN 55114 |
| Telephone: | [phone] |
| Fax: | [phone] |
| Name of Contact Person: | Mr. John C. Field |
| Date Summary Prepared: | September 30, 1997 |

## General Information on Device II.

Rejoyn Penile Support System Name: External Penile Rigidity Device Classification Name:

Predicate Device: Various pre-amendment "penile splints." III.

Description of the Device: IV.

The Rejoyn penile support system consists of a semi-rigid split support sleeve molded from medical grade rubber with an attachment strap. The sleeve is placed over the penis with the split side down and the strap is fastened behind the scrotum. The sleeve is approximately 2 1/4" long. The system may also include a lubricated latex cover which may be worn over the sleeve to enhance comfort.

Another version of the Rejoyn system includes a single-use, disposable support sleeve in lieu of the reusable support sleeve. The single-use sleeve is made of the same materials as the reusable sleeve but is removed after use by breaking off one end of the attachment strap at a specified location.

The Rejoyn system will be available in five different package variations: (1) one support sleeve, three covers and one tube of lubricating jelly; (2) one support sleeve and one tube of lubricating jelly; (3) one support sleeve and three covers; (4) three single-use support sleeves, three covers and one tube of lubricating jelly; and (5) three single-use support sleeves and three covers. Replacement covers and lubricating jelly also will be available separately.

V. Intended Use:

The Rejoyn Penile Support System is intended for use by men who have an inability to engage in sexual intercourse due to a flaccid or partially erect penis resulting from impotence.

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

Technological Characteristics of Device Compared to Predicate Device: VI. The technological characteristics of the Rejoyn system are very similar to those of the predicate devices: flexible, but firm, medical grade rubber sleeve; reusability; and easy cleanability.

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

Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The seal is black and white.

OCT 16 1997

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

American MedTech A Division of Gain, Inc. c/o Mr. Donald R. Stone McKenna & Cuneo, L.L.P. 1900 K Street, N.W. Washington, D.C. 20006-1108

Dear Mr. Stone:

Re: K971576 Rejoyn Penile Support System Dated: August 14, 1997 Received: August 15, 1997 Regulatory Class: Unclassified Product Code: 78 LKY

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 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 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 equivation assumes compliance with the Current Good Manufacturing Practice requirement, 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 531 through 542 of the Act for devices under 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 yitto diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for question 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.

William 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

{3}------------------------------------------------

K971576 510(k) Number (if known):

Device Name: Rejoyn Penile Support System

Indications For Use:

.. .

.

The Rejoyn Penile Support System is intended for use by men who have an inability to engage in sexual intercourse due to a flaccid or partially erect penis resulting from impotence.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Diber R. Ratliff

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices ) ୧ ન 510(k) Number _ 11 1

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

10-1'