(23 days)
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No
The summary describes a simple mechanical needle guide/grid accessory for ultrasound, with no mention of image processing, AI, ML, or any data-driven performance studies typically associated with AI/ML devices.
No.
A needle guidance device for prostate biopsies assists in diagnostic procedures and radiation seed placement, which is a treatment modality, but the device itself is an accessory that guides other tools, not directly providing therapy or diagnosis.
No
Explanation: The device is a needle guidance device used during prostate biopsies or radiation seed placement. It assists in guiding needles and is an accessory to an ultrasound system, but it does not diagnose medical conditions itself. It's a tool for interventional procedures, not for diagnosis.
No
The device description explicitly states "Needle Guide/Grid," which is a physical hardware component used in conjunction with an ultrasound transducer. The summary does not mention any software-only functionality.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states the device is a "needle guidance device for prostate biopsies or radiation seed placement/needles used as an accessory with an ultrasound transducer and system." This describes a physical tool used to guide a needle during a medical procedure performed on the body, not a test performed on a sample taken from the body.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, chemical reactions, or diagnostic testing performed on bodily fluids or tissues.
Therefore, this device falls under the category of a medical device used for procedural guidance, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
A needle guidance device for prostate biopsies or radiation seed placement/needles used as an accessory with an ultrasound transducer and system.
Product codes
90 ITX
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Ultrasound
Anatomical Site
Prostate
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
0
Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the logo is a stylized image of a human figure.
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
1
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)