(243 days)
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Not Found
No
The summary does not mention AI, ML, or any related terms, and the device description is not available to infer such capabilities.
No
The device is used for fine needle aspiration, which is a diagnostic procedure, not a therapeutic one.
No
The device is indicated for ultrasound-guided fine needle aspiration, which is a procedure for obtaining tissue samples, not for diagnosing a condition based on analysis of images or other data.
No
The intended use describes a device for ultrasound-guided fine needle aspiration, which inherently involves physical components (needle, aspiration mechanism) and is not solely software.
Based on the provided information, the Thyrosampler® Kurtaran Frass is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens from the human body. The intended use of the Thyrosampler® is for ultrasound-guided fine needle aspiration of thyroid nodules. This is a procedure to collect a sample, not to examine it.
- The description focuses on the collection process. The intended use describes the target (thyroid nodules), the size and depth limitations, and the guidance method (ultrasound). It does not mention any analysis or testing of the collected sample.
Therefore, the Thyrosampler® Kurtaran Frass is a device used for a medical procedure (sample collection), not for in vitro diagnostic testing of a sample.
N/A
Intended Use / Indications for Use
The Thyrosampler® Kurtaran Frass is indicated for ultrasound guided fine needle aspiration of soft thyroid nodules that are about 1 cm or greater in diameter, located up to depth of 4 cm from the skin.
Product codes
FCG
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
thyroid
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 876.1075 Gastroenterology-urology biopsy instrument.
(a)
Identification. A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification. (1) Class II (performance standards).(2) Class I for the biopsy forceps cover and the non-electric biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circle around the eagle. The eagle is depicted in black, and the text is also in black against a white background. The seal is simple and iconic, representing the department's role in public health and human services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
ACD Medical Innovation Corp. % Regulatory Insight, Inc. Mr. Kevin Walls 13 Red Fox Lane Littleton, Colorado 80127
MAY 3 0 2007
Re: K062979
Trade/Device Name: Thyrosampler® Kurtaran Frass Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-urology biopsy instrument Regulatory Class: II Product Code: FCG Dated: May 15, 2007 Received: May 16, 2007
Dear Mr. Walls:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (Special Controls) or class III (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Mr. Kevin Walls
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerelv
Roffm strasler
Mark N. Mcllravey
Ma Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known):
Device Name: Thyrosampler® Kurtaran Frass
Indications for Use: The Thyrosampler® Kurtaran Frass is indicated for ultrasound guided fine needle aspiration of soft thyroid nodules that are about 1 cm or greater in diameter, located up to depth of 4 cm from the skin.
Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
Page 1 of 1
510(k) Number 1662979