(70 days)
The VISER™ penile tumescence monitor is a noninvasive monitoring device used to measure intracavernosal pressure (ICP) and blood flow in the penis. This monitoring assists the physician in the diagnosis of erectile dysfunction. VISERTM is a prescriptive device to be used under the direction of a physician or other authorized health care professional.
Not Found
This document is a 510(k) clearance letter for the VISER™ Penile Tumescence Monitor. It indicates that the device has been found substantially equivalent to a legally marketed predicate device.
The provided text does not include details about acceptance criteria, device performance from a study, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, types of ground truth, or training set information. These details are typically found in the 510(k) submission itself, which is not fully included here.
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 legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976..."
This means the FDA did not require a new clinical study to establish safety and effectiveness, but rather determined that the new device is as safe and effective as a device already on the market. Therefore, the detailed study information requested is not present in this clearance letter.
Without the actual 510(k) submission, it's impossible to answer the specific questions about acceptance criteria and study details.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL -7 1999
Mr. Dale Coleman, MS, RAC, CQE Requiatory Affairs Manager Laborie Medical Technologies Corp. 310 Hurricane Lane #2 Williston, VT 05495-2070
Re: K991479 VISER™ Penile Tumescence Monitor Dated: April 22, 1999 Received: April 28, 1999 Unclassified Procode: 78 LIL
Dear Mr. Coleman:
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 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 (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 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
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K991479 510(k) NUMBER (IF KNOWN) :
DEVICE NAME : VISER™M
INDICATIONS FOR USE :
The VISER™ penile tumescence monitor is a noninvasive monitoring device used to measure intracavernosal pressure (ICP) and blood flow in the penis. This monitoring assists the physician in the diagnosis of erectile dysfunction. VISERTM is a prescriptive device to be used under the direction of a physician or other authorized health care professional.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescriptive Use
(Per 21 CFR 801.109)
OR
Over-The-Counter-use
(Optional Format 1-2-96)
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number
N/A