POS-T-VAC (REJOYN VACUUM ERECTION DEVICE)

K981011 · Pos-T-Vac, Inc. · LKY · Aug 28, 1998 · Gastroenterology, Urology

Device Facts

• Record ID: K981011
• Device Name: POS-T-VAC (REJOYN VACUUM ERECTION DEVICE)
• 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

The intended use of the Rejoyn Vacuum Erection Device is to assist users in achieving a full erection, i.e., to create an erection in men with erectile dysfunction by means of an applied vacuum to the penis, which draws blood to the penile corpora cavernosa, causing the penis to become erect and rigid. The constriction bands are then placed around the base of the erect penis to restrict the flow of venous blood leaving the penis.

Device Story

The Rejoyn Vacuum Erection Device is an over-the-counter (OTC) mechanical aid for erectile dysfunction. It consists of a vacuum cylinder, a pump mechanism, and constriction bands. The user places the cylinder over the penis and operates the pump to create a vacuum; this negative pressure draws blood into the penile corpora cavernosa, inducing rigidity. Once the desired erection is achieved, the user applies a constriction band to the base of the penis to impede venous outflow and maintain the erection. The device is intended for patient self-use in a home setting. It provides a non-pharmacological, non-surgical method for managing erectile dysfunction.

Clinical Evidence

No clinical data provided; substantial equivalence is based on device design and intended use.

Technological Characteristics

Mechanical vacuum-based system; includes a cylinder, manual or powered pump, and elastic constriction bands. No electronic software or complex algorithms involved.

Indications for Use

Indicated for men with erectile dysfunction to assist in achieving and maintaining a penile erection.

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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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: K981011 Rejoyn Vacuum Erection Device (OTC) 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 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 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/cdrb/dsmaldsmam.html".

Sincerely 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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510(k) Number (if known):_

Pos-T-Vac Rejoyn Vacuum Erection Device Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications for Use:

The intended use of the Rejoyn Vacuum Erection Device is to assist users in achieving a full erection, i.e., to create an erection in men with erectile dysfunction by means of an applied vacuum to the penis, which draws blood to the penile corpora cavernosa, causing the penis to become erect and rigid. The constriction bands are then 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 *\$\checkmark\$*

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological De 510(k) Number

(Optional Format 1-2-96)