(595 days)
Not Found
Not Found
No
The summary provides no information suggesting the use of AI or ML. The device description is a simple "Intracavity Needle Guide Kit," which is a mechanical device.
No
A needle guide kit is a surgical accessory used to aid in procedures like biopsies or fluid aspirations, but it does not directly treat a disease or condition itself.
No
Explanation: The available information contains "Not Found" for "Intended Use / Indications for Use" and the device description "Intracavity Needle Guide Kit" does not inherently suggest a diagnostic function. There is no information to support it being a diagnostic device.
No
The device description "Intracavity Needle Guide Kit" strongly suggests a physical hardware component (a needle guide), not a software-only device.
Based on the provided information, it is highly unlikely that this device is an IVD (In Vitro Diagnostic).
Here's why:
- No mention of in vitro testing: The description "Intracavity Needle Guide Kit" suggests a device used within the body (intracavity) to guide a needle. IVDs are used to examine specimens outside the body (in vitro), such as blood, urine, or tissue samples.
- Lack of typical IVD information: The missing sections like "Intended Use / Indications for Use," "Description of the training set, sample size, data source, and annotation protocol," and "Summary of Performance Studies" are all crucial for describing and evaluating an IVD. Their absence further supports the conclusion that this is not an IVD.
Therefore, based on the limited information provided, this device appears to be a surgical or procedural accessory, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Not Found
Product codes
90 ITX
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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 seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is a stylized image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Anders Weilandt President Arlanda Medicinska Instrument Co. Turebergsvagen 5 191 47 Sollentuna Sweden
Re: K955668 Intracavity Needle Guide Kit Dated: July 15, 1997 Received: July 18, 1997 Regulatory Class: II 21 CFR 892.1570/Procode: 90 ITX
Jul 30 1997
Dear Mr. Weilandt:
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 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, 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 (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 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 yitro 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 (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,
K. William Yu
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