RAPPORT V.T.D.

K971443 · Owen Mumford USA, Inc. · LKY · Sep 26, 1997 · Gastroenterology, Urology

Device Facts

• Record ID: K971443
• Device Name: RAPPORT V.T.D.
• Applicant: Owen Mumford USA, Inc.
• Product Code: LKY · Gastroenterology, Urology
• Decision Date: Sep 26, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5020
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Intended to achieve a penile erection for males suffering from erectile dysfunction.

Device Story

Rapport V.T.D. is an external penile rigidity device for management of erectile dysfunction. Device utilizes vacuum principle to create negative pressure around penis, inducing erection. System intended for use by patients. Operation involves manual or mechanical vacuum generation to draw blood into penile tissue; device maintains erection via constriction. Clinical benefit is restoration of erectile function for sexual activity. Device is non-invasive, mechanical system.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on design and performance similarity to the predicate device.

Technological Characteristics

External vacuum-based penile rigidity device. Mechanical operation; no electronic or software components. Materials and construction details are referenced as standard for this device class.

Indications for Use

Indicated for males suffering from erectile dysfunction to achieve and maintain 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.

Predicate Devices

• Osbon Erec-Aid

Submission Summary (Full Text)

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K971443

P171

## RAPPORT V.T.D. 510k SUBMISSION

# SUMMARY

SEP 26 1997

Submitted by:

Robert E. Shaw Owen Mumford, Inc. 849 Pickens Industrial Drive Suite 14 Marietta, GA 30062-3165

Rapport VTD Device Name: Substantial Equivalence: Osbon Erec-Aid Classification Name: External Penile Rigidity Device

#### DESCRIPTION:

The Rapport Vacuum Therapy Device is an impotence management system providing men with erectile dysfunction to create and maintain an erection.

The device works on a vacuum principle, creating a negative pressure around the penis thus creating an erection.

The device construction is detailed in the section on PRODUCT DESCRIPTION.

### INTENDED USE:

Intended to achieve a penile erection for males suffering from erectile dysfunction (See Section on INTENDED USE), the same as the substantially equivalent OSBON Erec-Aid.

#### OPERATIONAL:

The principle of operation and design concepts are substantially equivalent to the OSBON Erec-Aid.

### PERFORMANCE:

The vacuum performance of the Rapport VTD is similar to the Osbon Erec-Aid (as detailed in Section 6). The device is safe and effective when used as directed.

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Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the circle is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 6 1997

Mr. Robert E. Shaw Vice President Owen Mumford, Inc. 849 Pickens Industrial Drive, Suite 14 Marietta, Georgia 30062-3165

Re: K971443

Rapport V.T.D. Dated: July 28, 1997 Received: July 30, 1997 Regulatory class: unclassified Product code: 78 LKY

Dear Mr. Shaw:

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 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 requirement, as set forth in the Quality System Regulation (QS) 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 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 question and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation of the regulation of the regulation of the regulation "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 vours.

WJ Liao 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

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510(k) Number (if known): __ K9714433

Device Name: Rapport V.T.D.

Indications For Use:

Intended to achieve a penile erection for males suffering from erectile dysfunction.

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# Concurrence of CDRH, Office of Device Evaluation (ODE)

Raino D. Nethany

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

510(k) Number K971443

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use

.

(Optional Format 1-2-96)