(158 days)
Intended to achieve a penile erection for men suffering from erectile dysfunction.
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.
The Rapport V.T.D. is a vacuum therapy impotence management system. The provided information leverages a previous 510(k) clearance (K971443) for the same device, stating that no new clinical trial data was generated for this submission. Therefore, the information below refers to the study cited in K971443.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Provide an answer to impotence problems. | "The data showed that the device provided an answer to the impotence problems in over 80% of the men used in study." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated, but the submission indicates "over 80% of the men used in study."
- Data Provenance: The original 510(k) (K971443) likely contained the details. This specific submission (K982275) states "No additional trial data has been generated... as data supplied in the original 510(k) K971443 is considered adequate." Therefore, the provenance details are not available in the provided text for K982275. Given the previous clearance, it implies the data was retrospective from a previous study. The country of origin for the data is not specified in the provided text.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- This information is not provided in the given text.
4. Adjudication Method for the Test Set
- This information is not provided in the given text.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The study in question evaluated the device's ability to help men achieve erections, not its performance with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- This device is a physical medical device (vacuum therapy pump), not an AI algorithm. Therefore, a standalone performance study in the context of AI algorithms is not applicable. The study evaluated the standalone performance of the physical device.
7. The Type of Ground Truth Used
- The ground truth was based on the ability of the device to "provide an answer to the impotence problems," which implies successful creation and maintenance of an erection in men with erectile dysfunction. This would likely be assessed by patient self-report or clinical observation of erectile rigidity, although specifics are not provided.
8. The Sample Size for the Training Set
- Not applicable in the context of an AI training set, as this is a physical medical device. The "sample size" refers to the patient cohort used in the study, not a training set for an algorithm.
9. How the Ground Truth for the Training Set Was Established
- Not applicable as this is a physical medical device and not an AI algorithm requiring a training set. The ground truth for the study was established by observing the device's effectiveness in addressing impotence.
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. . . .
DEC 4 1998
510(k) SUMMARY RAPPORT V.T.D. OVER THE COUNTER SALES
| APPLICANTS ADDRESS: | Owen Mumford Inc849 Pickens Industrial DriveSuite 14MariettaGA 30062USA |
|---|---|
| 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 LimitedBrook HillWoodstockOxfordshireOX20 1TUUnited Kingdom |
| REGISTRATION No: | 8021764 |
| DATE PREPARED: | 24th September 1998 |
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510(k) SUMMARY RAPPORT V.T.D. OVER THE COUNTER SALES
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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Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains an image of an eagle with its wings spread. The eagle is facing to the right and has three human faces incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the edge of the seal.
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 (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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
§ 876.5020 External penile rigidity devices.
(a)
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.(b)
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.