(101 days)
The intended use of the device is to assist men who have difficulty in achieving an erection by using the vacuum device and maintaining a satisfactory erection by using the constriction rings.
For men who are able to achieve an erection but not maintain it, the application of a constriction ring at the base of the penis can sufficiently reduce venous leak to maintain the erection. In this instance, they may not be required to use the vacuum device.
Vacuum Device and Constriction Ring Set
The provided document is a 510(k) premarket notification letter from the FDA for a medical device (VET-Co OTC Vacuum Device and Constriction Ring Set). This type of document is a regulatory approval and does not include detailed studies, acceptance criteria, or performance data in the format requested.
The letter explicitly states: "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... A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement... and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions."
This means the device was approved based on its substantial equivalence to existing, legally marketed predicate devices, not on a new clinical study demonstrating specific performance against predefined acceptance criteria. The detailed study information requested would typically be found in a clinical trial report or a performance study summary, which are not part of this 510(k) clearance letter.
Therefore, I cannot extract the requested information (acceptance criteria, specific study details, sample sizes, expert qualifications, etc.) from this document. The document only provides the intended use of the device: "to assist men who have difficulty in achieving an erection by using the vacuum device and maintaining a satisfactory erection by using the constriction rings."
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 9 1998
Re: K974215
VET-Co OTC Vacuum Device and Constriction Ring Set Dated: January 23, 1998 Received: January 23, 1998 Unclassified/Procode: 78 LKY
Mr. Jeff Shapiro V. P. of Operations/Marketing VET-Co, Inc. 3700 Fifth Avenue South Birmingham, AL 35222
Dear Mr. Shapiro:
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 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 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 yitze 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, "Misbanding 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/dsmam.html".
Sincerely yours,
h. 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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Statement for Intended Use for Vacuum Device and Constriction Rings
The intended use of the device is to assist men who have difficulty in achieving an erection by using the vacuum device and maintaining a satisfactory erection by using the constriction rings.
For men who are able to achieve an erection but not maintain it, the application of a constriction ring at the base of the penis can sufficiently reduce venous leak to maintain the erection. In this instance, they may not be required to use the vacuum device.
Robert D. Ratliff/
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number_________________________________________________________________________________________________________________________________________________________________
Prescription Use (Per 21 CFR 801.109)
L Over-the-Counter Use .
Jeff Shapiro V.P. of Operations/Marketing
§ 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.