(158 days)
Intended to achieve a penile erection for males suffering from erectile dysfunction.
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.
The provided text is a 510(k) submission for the Rapport V.T.D. (Vacuum Therapy Device), seeking substantial equivalence to the Osbon Erec-Aid. The document primarily focuses on the description and intended use of the device, and its operational similarity to the predicate device. Crucially, it does not include a dedicated study section with specific acceptance criteria or an analysis of performance against those criteria.
Instead, the submission states: "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." This indicates that the "study" demonstrating performance was likely a comparison of vacuum characteristics between the Rapport VTD and the Osbon Erec-Aid, rather than a clinical trial with predefined acceptance criteria.
Given the limited information, I will infer the acceptance criteria and study details based on the statements provided and typical 510(k) submission practices for non-clinical performance.
Here's an analysis based on the available text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Primary: Vacuum performance of Rapport VTD is substantially equivalent to the Osbon Erec-Aid. | "The vacuum performance of the Rapport VTD is similar to the Osbon Erec-Aid (as detailed in Section 6)." |
| Secondary (Inferred): Device is safe and effective when used as directed. | "The device is safe and effective when used as directed." |
Note: The specific quantitative metrics for "vacuum performance" and the tolerance for "similar" are not provided in this summary. Section 6, mentioned in the document, would contain these details.
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a clinical test set or human subject data. The "study" appears to be a bench test comparison of the physical characteristics (vacuum performance) of the Rapport VTD against the Osbon Erec-Aid.
- Test Set Sample Size: Not applicable in the context of human subjects. For a bench test, it would refer to the number of Rapport VTD units and Osbon Erec-Aid units tested. This number is not specified in the provided text.
- Data Provenance: Not applicable in the context of human data. The data would be generated from laboratory measurements of the devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not applicable. The ground truth for a bench test comparison of vacuum performance would be the measured vacuum characteristics of the predicate device, the Osbon Erec-Aid, established through engineering specifications and calibration. No human experts are used to "establish ground truth" in this type of comparison beyond potentially calibrating equipment and interpreting technical specifications.
4. Adjudication Method for the Test Set
Not applicable. There is no mention of a human test set requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. A MRMC study is relevant for diagnostic imaging or subjective assessment tasks involving multiple human readers. This submission describes a physical device for erectile dysfunction and its performance relative to a predicate device, not a diagnostic or interpretive task.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance)
Not applicable. This device is a physical medical device, not an algorithm or AI system.
7. Type of Ground Truth Used
The ground truth used for the performance comparison was the vacuum performance characteristics of the predicate device, the Osbon Erec-Aid, likely derived from its established specifications or direct measurement.
8. Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device that requires a training set. The "training" for the device's design would be based on engineering principles and the design of the predicate device.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As this is not an AI/machine learning device, there is no training set or associated ground truth in that context.
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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 (301) 594-4613. Additionally, for question and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
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)
§ 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.