(75 days)
The intended use of the device is to assist users in achieving a full erection, i.e., to create an erection in men with erectile dysfunction by means of an applied vacuum to the penis, which draws blood to the penile corpora cavernosa, causing the penis to become erect and rigid. The constriction bands are then placed around the base of the erect penis to restrict the flow of venous blood leaving the penis.
Not Found
I am sorry, but the provided text does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets them. The text is a 510(k) clearance letter for the V.T.S., Inc. V.T.-3 device, which describes its indication for use (assisting men with erectile dysfunction to achieve an erection using a vacuum device).
However, it does not include:
- A table of acceptance criteria and reported device performance.
- Sample sizes, data provenance, or details about the test set.
- Information on experts, ground truth establishment, or adjudication methods.
- Details of any Multi-Reader Multi-Case (MRMC) comparative effectiveness study, including effect sizes.
- Results of a standalone algorithm performance study.
- The type of ground truth used.
- Sample size for the training set or how its ground truth was established.
This document merely grants clearance based on substantial equivalence to a predicate device, as opposed to providing detailed performance study results that would typically be found in a clinical study report or a more comprehensive summary of safety and effectiveness data.
{0}------------------------------------------------
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Image /page/0/Picture/3 description: The image shows a black and white logo. The logo appears to be a stylized representation of three birds in flight, stacked vertically. The word "DEPARTMENT" is written vertically along the left side of the logo, with the letters rotated 90 degrees counterclockwise.
OCT 2 1999
Mr. Dennis Bell General Manager/Secretary V.T.S., Inc. 701 S. Main Newkirk. OK 74647
Re: K992442 V.T.S. Inc. V.T. -3 Dated: July 19, 1999 Received: July 22, 1999 Unclassified Procode: 78 LKY
Dear Mr. Bell:
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 legally marketed predicate devices marketed in interstate commerce pror 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 (QS) for Medical Devices: General requlation (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 regult 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/dsma/dsmamain.html".
Sincerely yours,
CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{1}------------------------------------------------
Page
| 510(k) Number (if Known): | K992442 |
|---|---|
| Device Name: | V.T.S., Inc. V.T.-3 |
| Indications for Use: |
The intended use of the device is to assist users in achieving a full erection, i.e., to create an erection in men with erectile dysfunction by means of an applied vacuum to the penis, which draws blood to the penile corpora cavernosa, causing the penis to become erect and rigid. The constriction bands are then placed around the base of the erect penis to restrict the flow of venous blood leaving the penis.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use X
1
David A. Glynn
Division Sign Off
(Division Sign-Off) Division of Reproductive, Abdominal, ENT and Radiological Devi 510(k) Number .
(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.