RAPPORT V.T.D.

K982275 · Owen Mumford USA, Inc. · LKY · Dec 4, 1998 · Gastroenterology, Urology

Device Facts

• Record ID: K982275
• Device Name: RAPPORT V.T.D.
• Applicant: Owen Mumford USA, Inc.
• Product Code: LKY · Gastroenterology, Urology
• Decision Date: Dec 4, 1998
• 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 men suffering from erectile dysfunction.

Device Story

Rapport V.T.D. is a vacuum therapy impotence management system; non-surgical, non-invasive method for creating and maintaining penile erections. Device components include a hand pump, penile tube, loading cones, constriction rings, and a transfer sleeve. Operation involves using the hand pump and tube to create a vacuum to induce an erection, followed by the application of constriction rings to maintain it. Used by patients for erectile dysfunction management. Output is a physical state (erection) achieved through mechanical vacuum application. Benefits include non-invasive management of impotence.

Clinical Evidence

No new clinical data generated for this submission. Original data from K971443 indicated the device provided a solution to impotence problems in over 80% of study participants.

Technological Characteristics

Vacuum therapy system consisting of a hand pump, penile tube, loading cones, constriction rings, and transfer sleeve. Mechanical operation via manual vacuum creation. No software or electronic components.

Indications for Use

Indicated for men suffering from erectile dysfunction to achieve 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

• Rapport V.T.D. (K971443)

Submission Summary (Full Text)

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K982275

. . . .

DEC 4 1998

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## 510(k) SUMMARY RAPPORT V.T.D. OVER THE COUNTER SALES

| APPLICANTS ADDRESS: | Owen Mumford Inc<br>849 Pickens Industrial Drive<br>Suite 14<br>Marietta<br>GA 30062<br>USA |
|----------------------|----------------------------------------------------------------------------------------------|
| CONTACT: | Mr Robert Shaw |
| POSITION: | Director |
| TEL: | 770 425 5138 |
| FAX: | 770 426 5365 |
| REGISTRATION No: | 1058602 |
| TRADE NAME | RAPPORT V.T.DD. |
| COMMON NAME: | VACUUM THEARAPY PUMP |
| CLASSIFICATION NAME: | EXTERNAL PENILE RIGIDITY DEVICE. |
| CLASS: | UNCLASSIFIED |
| CLASSIFICTION PANEL: | GASTROENTEROLOGY & UROLOGY |
| PANEL CODE: | 78 LKY |
| CFR NUMBER: | Not allocated |
| MANUFACTURER: | Owen Mumford Limited<br>Brook Hill<br>Woodstock<br>Oxfordshire<br>OX20 1TU<br>United Kingdom |
| REGISTRATION No: | 8021764 |
| DATE PREPARED: | 24th September 1998 |

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# 510(k) SUMMARY RAPPORT V.T.D. OVER THE COUNTER SALES

K982275

### SUBTSANTIAL EQUIVALENCE

This product is identical, with the exception of the labelling, to the Owen Mumford Rapport V.T.D. for which 510(k) K971443 was issued on 26th September 1997.

#### DEVICE DESCRIPTION

The Rapport VTD is a vacuum therapy impotence management system providing a simple, non-surgical, non-invasive method of creating and maintaining an erection in men with erectile dysfunction.

The product consists of a hand pump and penile tube, used to create a vacuum, and loading cones, constriction rings and transfer sleeve used to maintain the erection.

#### INTENDED USE

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

#### TECHNICAL COMPARRISON

The VTD for over the counter sales is technically identical to the device to which substantial equivalence is claimed.

## NON-CLINICAL TRIAL DATA & CONCLUSIONS

No additional trial data has been generated for the counter version of the product as data supplied in the original 510(k) K971443 is considered adequate. The data showed that the device provided an answer to the impotence problems in over 80% of the men used in study.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 4 1998

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

Re: K982275 Rapport V.T.D .- OTC Dated: October 16, 1998 Received: October 19, 1998 Regulatory Class: Unclassified Procode: 78 LKY

Dear Mr. Robert 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 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 (Special Controls) or 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 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" (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/dsmaldsmamain.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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K 982275/S1 510(k) Number :

Rapport VTD Device Name:

### Indications For Use

Intended to achieve a pentle erection for men suffering from erectlie dysfunction t

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use . OR (Per 21 CFR 801.109)

Over-The-Counter Use

Vaind 4. Segmon
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number