RATATIONAL ANGIOGRAPHY OPTION FOR PHILIPS MULTIDIAGNOST 4

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows a logo for Philips. The logo is in black and white and features the word "PHILIPS" at the top. Below the word is a circular emblem with two stars and two wavy lines inside of it. The logo is enclosed in a shield-like shape. ## Philips Medical Systems P.O. Box 10000, 5680 DA Best. The Nett Department of Health and Human Services Center for Devices and Radiological Health Office of Device Evaluation Pre-Market Notification section. JUL - 3 1997 TOM XRD XDB 087-970165/RR/π 1997.03.17 ## SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION for ## PHILIPS MULTI DIAGNOST 4 - ROTATIONAL ANGIOGRAPHY OPTION This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990. The undersigned certifies that the 510(k) Pre-Market notification for the above referenced product contains adequate information and data to enable CDRH to determine substantial equivalence. This information and data is summarized as follows: - 1. The MD 4 Rotational Angiography option is subject to Federal Performance Standards, defined in 21CFR - part 1000; - 2. The MD 4 Rotational Angiography option will be manufactured in accordance with voluntary safety standards, such as UL 187 ; - 3. The information for Users contains comprehensive information to insure safe and effective use; - 4. Past experience with substantially equivalent predicate devices has shown our device to be safe and effective when used as directed in the Information for Users. Refer to the Philips Integris V3000 Rotational Angio function, cleared under K923813 Ing. R.W.Rijntjes Approbation manager Quality Assurance dept. XCP / XCP Quality Assurance dept. XSB / XCB Philips Medical Systems Nederland BV Best, The Netherlands. 522 104 2803 Stuis 6. Best The Nethe 3 40 27 91 11 +31 40 27 622 05 ercial Register Eindho {1}------------------------------------------------ Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird. Food and Druq Administration 9200 Corporate Boulevard Rockville MD 20850 Peter Altman Director of Regulatory Affairs Philips Medical Systems 710 Bridgeport Avenue Shelton , CT 06484-0917 Re: K971489 Rotational Angiography Option for Philips MultiDIAGNOST 4 Dated: April 21, 1997 Received: April 23, 1997 Regulatory class: II 21 CFR 892.1600/Procode: 90 IZI JUL - 3 1997 Dear Mr. Altman: 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 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. 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) 594-4613. Additionally, for question and advertising of your device. Dease 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 vours, h.T. Hiau Yu. Lillian Yin. Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ Unknown K97148 510(k) Number (if known): ____ Rotational Angiography Option for Philips MultiDIAGNOST 4 Device Name : Indications For Use : The Rotational Angiography Option for Philips MultiDIAGNOST 4 is indicated for use in Angiographic diagnostic imaging examinations. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Elvin A. Beysson (Division Sign-Off) Division of Reproductive, Abdominal, ENT and Radiological Devices 510(k) Number OR Prescription Use ( Per 21 CFR 801.109 Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (Optional Format 1-2-96)