SPEED-CUT AUTOMATIC BIOPSY SYSTEM

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of a human figure. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JUL 8 1698 Mr. Paul L. Hawthrone ·U.S. Representative Gallini U.S. 3991 Glenside Drive, Suite F Richmond, Virginia 23229 Re: K981301 Trade Name: Speed-Cut® Automatic Biopsy System Regulatory Class: II Product Code: KNW Dated: April 2, 1998 Received: April 9, 1998 ## Dear Mr. Hawthrone: 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. 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. {1}------------------------------------------------ ## Page 2 - Mr. Paul L. Hawthrone 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, Sincerely yours, [signature] Celia M. Witten, Ph.B., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ 7/07/98 18:41 FAX 804068 5873 CARPENTER CO. 002 Page 1 of 1 | 510(k) Number (if known) | K981301 | |--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Name: | Speed-Cut® Automatic Biopsy System | | Indications for Use: | The Speed-Cut is an automatic disposable biopsy instrument designed to take core samples from a variety of soft tissues including the liver, prostate and kidney. | (PLEASE DO NOT WRITE BELOW THIS LINE—CONTINUE ON ANOTHER PAGE IF NEEDED.) Concurrence of CDRH, Office of Device Evaluation (ODE)SCOTT Division Division of General Restorative Devices 510(k) Number K981701 Prescription Use (Per 21 CFR 801.109) OR Over-the-Counter Use _ (Optional Format 1-2-96)