REJOYN CONSTRICTION RING KIT, POS-T-VAC B-100 RING KIT, POS-T-VAC B-25 RING KIT AND POS-T-VAC B-10 RING KIT

K981180 · Pos-T-Vac, Inc. · LKY · Aug 28, 1998 · Gastroenterology, Urology

Device Facts

• Record ID: K981180
• Device Name: REJOYN CONSTRICTION RING KIT, POS-T-VAC B-100 RING KIT, POS-T-VAC B-25 RING KIT AND POS-T-VAC B-10 RING KIT
• Applicant: Pos-T-Vac, Inc.
• Product Code: LKY · Gastroenterology, Urology
• Decision Date: Aug 28, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5020
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

All four sets of constriction rings, the Rejoyn Constriction Ring Kit, B-100, B-25, and B-10, are used to maintain penile rigidity in men with erectile dysfunction by restricting penile venous outflow after the patient has obtained an erection (either with the aid of a vacuum pump, or naturally). The constriction band is placed around the base of the erect penis to restrict the flow of venous blood leaving the penis.

Device Story

Constriction ring kits (Rejoyn, B-100, B-25, B-10) designed for men with erectile dysfunction; used to maintain penile rigidity. Device consists of elastic constriction bands placed manually around the base of an erect penis. Mechanism of action: mechanical restriction of venous blood outflow from the penis to sustain erection. Intended for over-the-counter (OTC) use by patients. No electronic components, software, or automated processing involved. Benefit: assists in maintaining erection for sexual activity.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Mechanical constriction rings; elastic material construction; non-powered; manual application; no software or electronic components.

Indications for Use

Indicated for men with erectile dysfunction to maintain penile rigidity by restricting venous outflow after achieving an erection naturally or via vacuum pump.

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.

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 28 1998

Pos-T-Vac. Inc. c/o Mr. Mark A. Heller Hale & Dorr LLP 1455 Pennsylvania Avenue, N.W. Washington, DC 20004

Re: K981180 OTC Constriction Ring Kits (Rejoyn, B-100, B-25, B-10) Dated: June 30, 1998 Received: July 1, 1998 Unclassified/Procode: 78 LKY

Dear Mr. Heller:

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

Sincerery, yours,

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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Page __ 1 __ of ___ 1

| 510(k) Number (if known): | K981180 |
|---------------------------|-------------------------------------------------------------------------------|
| Device Name: | Rejoyn Constriction Ring Kit, B-100 Ring Kit, B-25 Ring Kit and B-10 Ring Kit |

Indications for Use:

All four sets of constriction rings, the Rejoyn Constriction Ring Kit, B-100, B-25, and B-10, are used to maintain penile rigidity in men with erectile dysfunction by restricting penile venous outflow after the patient has obtained an erection (either with the aid of a vacuum pump, or naturally). The constriction band is placed around the base of the erect penis to restrict the flow of venous blood leaving the penis.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | |
|----------------------|--------------------------------------------------------------------|
| (Per 21 CFR 801.109) | |
| | OR |
| Over-the-Counter Use | ✓ |
| | (Optional Format 1-2-96) |
| | (Division Sign-Off) |
| | Division of Reproductive, Abdominal, ENT, and Radiological Devices |
| 510(k) Number | K981180 |