(158 days)
Osbon Erec-Aid
Not Found
No
The summary describes a mechanical vacuum therapy device and does not mention any AI or ML components or functionalities.
Yes
The device is intended to treat erectile dysfunction by creating and maintaining an erection, which is a therapeutic purpose.
No
The device description states its intended use is to "create and maintain an erection" for "impotence management," and it works on a "vacuum principle, creating a negative pressure around the penis thus creating an erection." This indicates it is a therapeutic device designed to treat a condition, not to diagnose one.
No
The device description explicitly states it is a "Vacuum Therapy Device" and works on a "vacuum principle," indicating a physical hardware component is involved in creating negative pressure. The reference to "device construction is detailed in the section on PRODUCT DESCRIPTION" further supports the presence of hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to achieve a penile erection for males suffering from erectile dysfunction. This is a therapeutic purpose, directly treating a physical condition.
- Device Description: The description explains how the device works mechanically (vacuum principle) to create an erection. It does not involve analyzing biological samples (like blood, urine, or tissue) to diagnose or monitor a condition.
- Lack of IVD Characteristics: There is no mention of analyzing samples, performing tests on biological materials, or providing diagnostic information.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
Intended to achieve a penile erection for males suffering from erectile dysfunction.
Product codes
78 LKY
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
penile
Indicated Patient Age Range
males
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Osbon Erec-Aid
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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.
1
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
2
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)