DAUM BONE BIOPSY SET

{0}------------------------------------------------ JUN 2 9 1998 K981320 ## 510(K) SUMMARY ## DAUM BONE BIOPSY SET | Submitter Name: | DAUM Corporation | |-----------------|------------------| |-----------------|------------------| - 1450 South Rolling Road Address: Submitter Baltimore, Maryland 21227 - Person: Pete Osborn Contact - 410-455-5786 Phone Number: - Facsimile Number: 410-455-5787 - Prepared: 3 April 1998 Date - Trade Name: DAUM Bone Biopsy Set Device - Name: Bone Biopsy Needle Device Common - Name: Classification Set, Biopsy Needle - DAUM Biopsy Needle Predicate Devices: The DAUM Bone Biopsy Set consists of a working tube, Device Description: stylet, power drill drive, manual drill and an ejector drift. The drill is supplied as a disposable unit. All of the other components of the set are supplied as reusable products. - The DAUM Bone Biopsy Set is intended for the biopsy of Intended Use: bone tissue. Technological Both the DAUM Biopsy Needle and the Bone Biopsy Set Device are substantially equivalent in design, material, intended Characteristics and Comparison Predicate use and function. to Devices(s): The DAUM Bone Biopsy Set has been tested for MR Safety Performance Data: in a 0.2T static magnetic field and was found to be acceptable for patient use in this environment. - Conclusion: The DAUM Bone Biopsy Set which is intended for the biopsy of bone tissue is also a low-artifact-instrument designed to be used in the MRI for the above purpose. {1}------------------------------------------------ 。 Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JUN 2 9 1998 · DAUM Corporation c/ o Mr. Gary J. Sfeir, RAC Greatbatch Scientific 9645 Wehrle Drive Clarence, New York 14031 Re: K981320 Trade Name: DAUM Bone Biopsy Set Regulatory Class: II Product Code: KNW Dated: April 7, 1998 Received: April 10, 1998 Dear Mr. Sfeir: 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 (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. {2}------------------------------------------------ Page 2 - Mr. Gary J. Sfeir 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 {3}------------------------------------------------ 510(k)Number(if known): Device Name: DAUM Bone Biopsy Set Classification Panel: Indications for Use: K981320 The DAUM Bone Biopsy Set is intended for the biopsy of bone tissue. The DAUM Bone Biopsy Set 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. tcollez (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use_ or Over-the-Counter Use__________________________________________________________________________________________________________________________________________________________