RESTORE VACUUM ERECTION DEVICE, CONFIDE VACUUM ERECTION DEVICE, PEP (PENILE ERECTION PROGRAM), RELY VACUUM ERECTION DEV)

K981506 · Repro-Med Systems, Inc. · LKY · Jun 25, 1998 · Gastroenterology, Urology

Device Facts

• Record ID: K981506
• Device Name: RESTORE VACUUM ERECTION DEVICE, CONFIDE VACUUM ERECTION DEVICE, PEP (PENILE ERECTION PROGRAM), RELY VACUUM ERECTION DEV)
• Applicant: Repro-Med Systems, Inc.
• Product Code: LKY · Gastroenterology, Urology
• Decision Date: Jun 25, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5020
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Vacuum Pump - used to create an erection in men with erectile dysfunction by means of an applied vacuum to the penis, which draws blood into the penile corpora cavernosa causing the penis to become erect and rigid. Constriction Ring - used to maintain penile rigidity in men with erectile dysfunction by restricting penile venous outflow after the patient has obtained an erection with the aid of a vacuum pump.

Device Story

RESTORE Vacuum Erection Device is an external penile rigidity system for men with erectile dysfunction. System components include a vacuum pump, ABS plastic vacuum cylinder, PVC tubing, cylinder end cap, cushion seal, constriction rings, and water-based lubricant. Operation involves placing the cylinder over the penis and using the vacuum pump to create negative pressure, drawing blood into the corpora cavernosa to induce an erection. Once erect, a constriction ring is applied to the base of the penis to restrict venous outflow and maintain rigidity. The device is intended for patient self-use. It provides a non-invasive mechanical method to achieve and maintain an erection, potentially improving sexual function for patients with erectile dysfunction.

Clinical Evidence

No clinical data provided; substantial equivalence is based on identical technological characteristics and materials to legally marketed predicate devices.

Technological Characteristics

System consists of a vacuum pump, ABS plastic cylinder, PVC tubing, and constriction rings. Materials are identical to predicate devices. Device is a mechanical, non-powered or manual vacuum-based system. No software or electronic components.

Indications for Use

Indicated for men with erectile dysfunction to create and maintain penile rigidity.

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

• Erecaid System Classic (K841257)
• Erecaid System / Stay Erec System (K974173)
• Pro-Long Rings (K904485)

Submission Summary (Full Text)

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JUN 2 5 1998

## Premarket Notification [510(k)] Summary

| Submitter's Name: | Repro-Med Systems, Inc. |
|-------------------|----------------------------------------|
| Address: | 24 Carpenter Road<br>Chester, NY 10918 |
| Telephone: | 800-624-9600 |
| Fax: | 914-469-5518 |

Contact Person: Andrew Sealfon

Date 510(k) Summary Prepared: June 24, 1998

510(k) Number:

K981506

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| Trade or Proprietary Name(s): | RESTORE Vacuum Erection Device |
|-------------------------------|-------------------------------------------------------------------------------------------------------------|
| Common Name: | External Penile Rigidity Device |
| Classification Name: | Vacuum Pump And Constriction Rings |
| Predicate Device(s): | Erecaid System Classic (K841257)<br>Erecaid System / Stay Erec System (K974173)<br>Pro-Long Rings (K904485) |

## Device Description:

The RESTORE Vacuum Erection Device consists of a vacuum pump, ABS plastic vacuum cylinder, connecting PVC tubing, cylinder end cap, cushion seal, constriction rings, a tube of personal water-based lubricant and a convenient travel case.

Intended Use:

## Intended Use and Indications

The RESTORE Vacuum Erection Device consists of two main parts: the vacuum pump and constriction rings.

Vacuum Pump - used to create an erection in men with erectile dysfunction by means of an applied vacuum to the penis, which draws blood into the penile corpora cavemosa causing the penis to become erect and rigid.

Constriction Ring - used to maintain penile rigidity in me with erectile dysfunction by restricting penile venous outflow after the patient has obtained an erection with the aid of a vacuum pump.

Summary of Technological Characteristics to Predicate Device:

The RESTORE Vacuum Erection Device vacuum pump is substantially equivalent to the first two (2) predicate devices listed above. Repro-Med Systems, Inc. owns the proprietary technology for the Osbon products (predicate devices) and has been the sole manufacturer for the Erecaid System Classic vacuum pump since 1989.

The RESTORE Vacuum Erection Device Constriction Rings are identical to the Pro-Long rings (predicate device). Repro-Med has entered into a contractual agreement to market the Pro-Long rings as a component of the RESTORE device.

All component materials are identical to the named predicate devices and, therefore, the RESTORE Vacuum Erection Device is substantially equivalent.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 25 1998

Mr. Andrew I. Sealfon President Repro-Med Systems, Inc. 24 Carpenter Road Chester, New York 10918

Dear Mr. Andrew I. Sealfon:

Re: K981506

RESTORE™ Vacuum Erection Device - OTC Dated: April 24, 1998 Received: April 27, 1998 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 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 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 does not affect any obligation you might have under sections 531 through 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" (2) 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/dsmaldsmamain.html".

Sincerely yours

Lillian Yin, Ph.D.

Director, Division of Reproductive, Abdominal, Ear, Nose and Thre and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

K981506

Device Name:

RESTORE Vacuum Erection Device

Indications For Use:

The RESTORE Vacuum Erection Device consists of two main parts: the vacuum pump and constriction ring. Intended use statements for these are as follows.

Vacuum Pump (intended use) - used to create an erection in men with erectile dysfunction by means of an applied vacuum to the penis, which draws blood into the penile corpora cavernosa causing the penis to become erect and rigid.

Constriction Ring (intended use) - used to maintain penile rigidity in men with erectile dysfunction by restricting penile venous outflow after the patient has obtained an erection with the aid of a vacuum pump.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Robert P. Satting/

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 11981506 510(k) Number_

OR

Prescription Use ***_***

(Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)