DAUM BIOPSYGUN

K974576 · Daum Corp. · KNW · Mar 6, 1998 · Gastroenterology, Urology

Device Facts

• Record ID: K974576
• Device Name: DAUM BIOPSYGUN
• Applicant: Daum Corp.
• Product Code: KNW · Gastroenterology, Urology
• Decision Date: Mar 6, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1075
• Device Class: Class 2

Intended Use

The Daum BiopsyGun is deigned to automatically perform a biopsy of soft tissues. The Daum BiopsyGun is also a low-artifact-instrument designed to be used in the MRI for the above purpose. Federal (U.S.A) law restricts this device to sale by or on the order of a physician.

Device Story

Daum BiopsyGun is an automated instrument for soft tissue biopsy; specifically engineered for use within MRI environments to minimize imaging artifacts. Device is operated by physicians in clinical settings. It functions as a mechanical tool to facilitate tissue sampling. By reducing artifacts, it allows for precise needle placement under MRI guidance, potentially improving diagnostic accuracy and patient outcomes during biopsy procedures.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Automated soft tissue biopsy instrument; designed for MRI compatibility (low-artifact). Mechanical operation.

Indications for Use

Indicated for automatic soft tissue biopsy. Intended for use in MRI environments. Restricted to prescription use by physicians.

Regulatory Classification

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.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR - 6 1998

Daum Corporation ·C/O Mr. E. J. Smith Smith Associates P.O. Box 4341 Crofton, Maryland 21114

Re: K974576 Trade Name: Daum BiopsyGun Requlatory Class: II Product Code: KNW December 8, 1997 Dated: December 8, 1997 Received:

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 The general controls provisions of the Act 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 (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 requlations.

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Page 2 - Mr. 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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

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K974576

Page 1 of 1

510(k) Number (if known):

Device Name: Daum BiopsyGun

Classification Panel: FCG

Indications for Use:

The Daum BiopsyGun is deigned to automatically perform a biopsy of soft tissues. The Daum BiopsyGun is also a low-artifact-instrument designed to be used in the MRI for the above purpose.

Federal (U.S.A) law restricts this device to sale by or on the order of a physician.

(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 JC974576
510(k) Number

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