(23 days)
A needle guidance device for prostate biopsies or radiation seed placement/needles used as an accessory with an ultrasound transducer and system.
Needle Guide/Grid
The provided text is a 510(k) clearance letter from the FDA for a device called "Needle Guide/Grid for Ultrasound Transducer." This document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or MRMC studies.
The letter primarily concerns the substantial equivalence determination of the device to legally marketed predicate devices, allowing it to be marketed. It lists the regulatory class and Procode, and outlines general controls provisions.
Therefore, I cannot fulfill your request for information on the acceptance criteria and the study that proves the device meets them, as this data is absent from the provided document.
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Food and Druq Administration 9200 Corporate Boulevard Rockville MD 20850
OCT - I 1997
Rick L. Pruter Protek Medical Products, Inc. 221 E Market Street Suite 291 Iowa City, IA 52245
Re: K973362
Needle Guide/Grid for Ultrasound Transducer Dated: September 4, 1997 Received: September 8, 1997 Regulatory class: II 21 CFR 892.1570/Procode: 90 ITX
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 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 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 (OS) 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 marked 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 yitto 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 (30th) 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,
W.Liau Yu
Lillian Yin, Ph.D.
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
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Page of
510 (k) Number (if known):
Device Name: Needle Guide/Grid
Indications For Use:
A needle guidance device for prostate biopsies or radiation seed placementineedles used as an accessory with an ultrasound transducer and system.
(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
David C. Bergman
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Device 510(k) Number .
(Optional Format 1-2-96)
§ 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.