(158 days)
Not Found
No
The description focuses on mechanical components and vacuum therapy, with no mention of AI, ML, or related concepts.
Yes
The device is described as an "impotence management system" intended to "create and maintain an erection in men with erectile dysfunction," which directly addresses a medical condition, making it a therapeutic device.
No
Explanation: The device description states its purpose is to create and maintain an erection, not to diagnose a condition. It provides a therapeutic solution for erectile dysfunction.
No
The device description explicitly lists physical components like a hand pump, penile tube, loading cones, constriction rings, and transfer sleeve, indicating it is a hardware-based medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Function: The Rapport VTD is a physical device that directly interacts with the body (penile) to achieve a physical outcome (erection). It does not analyze any biological specimens.
- Intended Use: The intended use is to achieve a penile erection for men suffering from erectile dysfunction, which is a physical treatment/management rather than a diagnostic process.
Therefore, based on the provided information, the Rapport VTD falls under the category of a therapeutic or management device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Intended to achieve a penile erection for men suffering from erectile dysfunction.
Product codes (comma separated list FDA assigned to the subject device)
78 LKY
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
penile
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The data showed that the device provided an answer to the impotence problems in over 80% of the men used in study.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
. . . .
DEC 4 1998
510(k) SUMMARY RAPPORT V.T.D. OVER THE COUNTER SALES
| APPLICANTS ADDRESS: | Owen Mumford Inc
849 Pickens Industrial Drive
Suite 14
Marietta
GA 30062
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
Brook Hill
Woodstock
Oxfordshire
OX20 1TU
United Kingdom |
| REGISTRATION No: | 8021764 |
| DATE PREPARED: | 24th September 1998 |
1
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.
2
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
3
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