(66 days)
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Not Found
No
The summary describes a mechanical biopsy device and needle with a surface treatment for MRI compatibility. There is no mention of software, algorithms, or any features indicative of AI/ML.
No.
The device is used for biopsy (diagnosis) and surgical procedures, not for treating a disease or condition.
Yes
The device is used for biopsy, which involves collecting tissue samples to aid in diagnosis.
No
The device description explicitly states it consists of a BiopsyGun and a CoaxNeedle, which are physical hardware components used for biopsy procedures.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a person's health. They are used for diagnosis, monitoring, or screening.
- The Dasm MRI/Conventional Biopsy Set is a device used within the body to collect tissue samples. The description clearly states it's used for "automatic biopsy of soft tissues" and "open and percutaneous surgical procedures of the brain."
While the device is used to obtain a sample that might later be used in an IVD test (e.g., a pathologist examining the tissue under a microscope), the device itself is a surgical instrument for tissue collection, not an IVD.
N/A
Intended Use / Indications for Use
The Daum MRI/Conventional Biopsy Set consists of two parts, the Daum BiopsyGun and the Daum CoaxNeedle. The BiopsyGun is used for automatic biopsy of soft tissues, and the CoaxNeedle is intended for use in open and percutaneous surgical procedures of the brain. The patented surface treatment of the needle optimizes its use in the MRI setting, producing a low-artifact visualization of the needle,
Product codes
KNW
Device Description
The Daum MRI/Conventional Biopsy Set consists of two parts, the Daum BiopsyGun and the Daum CoaxNeedle.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
MRI
Anatomical Site
soft tissues, brain
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the circle is an abstract symbol that resembles a stylized caduceus or a bird in flight, composed of three curved lines.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 25 1999
Daum Corporation c/o Mr. E. J. Smith Smith Associates P.O. Box 4341 Crofton, Maryland 21114
Re: K991366
Trade Name: Daum MRI/Conventional Biopsy Set Regulatory Class: II Product Code: KNW Dated: April 20, 1999 Received: April 20, 1999
Dear Mr. Smith:
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 (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 (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 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 the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. E. J. Smith
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 vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. 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,
Celia M. Witten, Ph.D., M.D.
Director
Division of General and
Restorative Devices
Office of Device Evaluation
Center for Devices and
Radiological Health
Enclosure
2
510(k) Number (if known):
Device Name: Daum MRI/Conventional Biopsy Set
Classification Panel:
Indication for Use:
The Dasm MRI/Conventional Biopsy Set consists of two parts, the Daum BiopsyGun and the Daum CoaxNeedle. The BiopsyGun is used for automatic biopsy of soft tissues, and the CoaxNeedle is intended for use in open and percutaneous surgical procedures of the brain. The patented surface treatment of the needle optimizes its use in the MRI setting, producing a low-artifact visualization of the needle,
( PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of device Evaluation (ODE)
| Prescription Use | X | or | Over-the-Counter Use | |
|---|---|---|---|---|
| ------------------ | --- | ---- | ---------------------- | -- |
(Division Sign-Off)
Division of General Restorative Devices
| 510(k) Number | K991366 |
|---|---|
| --------------- | --------- |