(64 days)
An ultrasound accessory device used for positioning and guiding an ultrasound transducer probe during volume measurements of the prostate. Used in conjunction with a needle guide grid or radiation seed needle placement for the deposit of seeds.
Transducer Positioner
This appears to be a 510(k) clearance letter from the FDA for a device called "Ultrasound Transducer Positioner" (K973622). This type of document is a notification that the FDA has determined the device is "substantially equivalent" to a legally marketed predicate device, rather than a detailed study report proving its performance based on specific acceptance criteria.
Therefore, the provided text does not contain the information requested regarding acceptance criteria, reported device performance, study details (sample sizes, data provenance, expert qualifications, adjudication methods), MRMC studies, standalone performance, or ground truth establishment.
A 510(k) clearance typically relies on demonstrating substantial equivalence to a predicate device that has already established its safety and effectiveness. It does not usually involve new clinical trials with detailed performance metrics and acceptance criteria in the way a PMA (Pre-Market Approval) or other clinical study reports might.
To answer your request, I would need a different type of document, such as a summary of safety and effectiveness data, a clinical study report, or a detailed performance validation report for the device.
Without that information, I cannot fill out the requested table or answer the specific questions about acceptance criteria and the study that proves the device meets them.
{0}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle. The eagle is depicted in black and white, and the text is also in black. The seal is simple and iconic, representing the department's role in promoting the health and well-being of the nation.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Rick Pruter President Protek Medical Product, Inc. 221 E. Market Suite #291 Iowa City, Iowa 52245
Re:
K973622 Ultrasound Transducer Positioner Dated: September 22, 1997 Received: September 23, 1997 Regulatory class: II 21 CFR 892.1570/Procode: 90 ITX
NOV 26 1997
Dear Mr. Pruter:
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 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, 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 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 (2) 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/dsmamain.html".
Sincerely yours.
h. Lillian Yin, Ph.D. Yin
Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{1}------------------------------------------------
510 (k) Number (if known): _
Device Name: Transducer Positioner
Indications For Use:
An ultrasound accessory device used for positioning and guiding an ultrasound transducer probe during volume Used in conjunction with a measurements of the prostate. needle guide grid or radiation seed needle placement for the deposit of seeds.
(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
(Optional Format 1-2-96)
Elvin C. Leyson
(Division Sign-Off)
Division of Reproductive, Abdominal, El and Radiological Devic 510(k) Number
§ 892.1570 Diagnostic ultrasonic transducer.
(a)
Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.(b)
Classification. Class II.