(98 days)
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No
The document describes a needle guide kit, which is a mechanical accessory for an ultrasound transducer. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML.
No
The device is described as an accessory for guiding a needle or catheter during diagnostic ultrasound procedures, specifically for biopsy or precise needle placement. It facilitates a diagnostic procedure rather than directly treating a condition.
No
Explanation: The device is a needle guide kit used during diagnostic ultrasound procedures to perform biopsies or precise needle placement. While it assists in a diagnostic procedure, the device itself does not perform diagnostic functions, but rather aids in invasive procedures.
No
The device is described as a "Needle Guide Kit" and "accessories for the Model ATL C3 Scanhead," which are physical components used for guiding a needle. This description clearly indicates a hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is used for guiding a needle or catheter during a diagnostic ultrasound procedure to perform a biopsy or precise needle placement. This is an accessory used in a medical procedure performed on a patient, not a test performed on a sample in vitro (outside the body).
- Device Description: The description reinforces that it's a "Needle Guide Kit for use with ATL Ultrasound Transducers," further indicating its role as an accessory for an imaging procedure.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
IVDs are devices used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. This needle guide kit does not fit that definition.
N/A
Intended Use / Indications for Use
The General Purpose ATL Needle Guide Kit consists of accessories for the Model ATL C3 Scanhead which are used for guiding a needle or catheter during a diagnostic ultrasound procedure in order to perform a biopsy or precise needle placement. The subject device is to be used only for those indications which have been FDA-cleared for the Model ATL C3 Scanhead (consult transducer manual).
Product codes
90 ITX
Device Description
The General Purpose ATL Needle Guide Kit consists of accessories for the Model ATL C3 Scanhead which are used for guiding a needle or catheter during a diagnostic ultrasound procedure in order to perform a biopsy or precise needle placement.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Ultrasound
Anatomical Site
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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
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Key Metrics
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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
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/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the seal is a stylized image of an eagle with three lines representing its wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 2 1998
Rick L. Pruter -PROTEK Medical Products, Inc. 221 E. Market Street, Suite 291 Iowa City, IA 52245-2166
Re: K973958 Trade Name: General Purpose ATL Needle Guide Kit Requlatory Class: II Product Code: 90 ITX Dated: December 11, 1997 Received: December 16, 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 You may, therefore, market the device, subject to the general controls (Act) . . provisions of the Act. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If vou purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510 (k) before including these components in your kit. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and 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 Requlation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (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.
1
Page 2 - Rick L. Pruter
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. I E you desire specific advice for your device on the 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/dsmamain.html" .
Sincerely yours,
David A. Szymon
for Lillian Yin, PhD.
Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
1.1
2
510(k) Number (if known):
Device Name: General Purpose Needle Guide Kit for use with ATL Ultrasound Transducers
Indications For Use:
The General Purpose ATL Needle Guide Kit consists of accessories for the Model ATL C3 Scanhead which are used for guiding a needle or catheter during a diagnostic ultrasound procedure in order to perform a biopsy or precise needle placement. The subject device is to be used only for those indications which have been FDA-cleared for the Model ATL C3 Scanhead (consult transducer manual).
(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
Edward A. Seegm
(Division Sign-Off) Division of Reproductive, Abdominal, ENT and Radiological De 510(k) Number
(Optional Format 1-2-96)