RADIONICS XDC EXTERNAL VENTRICULAR CATHETER

{0}------------------------------------------------ 9923779 SEP 8 1999 - Attachment.VI: Summary of Safety and Effectiveness Information [510(k) Summary] | SUBMITTER: | Radionics Inc,<br>76 Cambridge Street<br>Burlington, MA 01803<br>Tel.: (781) 272-1233<br>Fax: (781) 272-2428<br>Contact: Kevin J. O'Connell<br>Regulatory Engineer | |--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | PROPRIETARY NAME: | Radionics XDC Ventricular Catheter | | COMMON OR USUAL<br>NAME: | External Drainage Ventricular Catheter | | CLASSIFICATION CODE: | Shunt, Central Nervous System and Components<br>21 CFR, Section: 882.5550 | | PREDICATE DEVICE: | Clinical Neuro System's MoniTorr ICP™ Ventricular Catheter,<br>K922941<br>Medtronic Becker EDM Ventricular Catheters, 510(k) unk | | DESCRIPTION: | The External Drainage Ventricular Catheter consists of a barium<br>impregnated silicone tubing with flow holes at the distal end and<br>a luer lock connector for attachment to an external drainage<br>system. It is provided sterile for single use only. | | INTENDED USE: | As the proximal component for CSF drainage or monitoring<br>from the lateral ventricles of the brain | {1}------------------------------------------------ Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of a human figure, represented by three curved lines, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 SEP 8 1999 Mr. Kevin J. O'Connell Regulatory Engineer Radionics, Inc. 22 Terry Avenue Burlington, Massachusetts 01803 K992379 Re: > Trade Name: Radionics XDC Ventricular Catheter Regulatory Class: II Product Code: JXG Dated: July 15, 1999 Received: July 16, 1999 Dear Mr. O'Connell: 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. {2}------------------------------------------------ ## Page 2 - Mr. Kevin J. O'Connell 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, fi 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}------------------------------------------------ 2.0 ODE Indications Statement: Page 1 of 1 510(k) Number (if known): __ K992379 Device Name: Radionics XDC Ventricular Catheter Indications for use: As the proximal component for CSF drainage or monitoring from the lateral ventricles of the brain. (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) bocello 19 PRESCRIPTION USE X OR Over-The-Counter Use (Per 21 CFR 801.109 (Optional Format 1-2-96)