PHILIPS INTEGRIS V5000 AND BV5000

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the Philips logo. The logo consists of the word "PHILIPS" in uppercase letters above a circular emblem. The emblem features two stars, one at the top and one at the bottom, with three wavy lines in between, resembling water or sound waves. The logo is simple and iconic, representing the brand's identity. Image /page/0/Picture/1 description: The image shows the word "PHILIPS" in large, bold, black letters at the top. Below the word "PHILIPS" is a handwritten number that appears to be "K77:34-8.2". The handwritten number is in a smaller font size and is less clear than the word "PHILIPS". ## Philips Medical Systems # 510(k) Summary of Safety and Effectiveness NCV | Company name: | Philips Medical Systems North America Company | |----------------------|-----------------------------------------------------------------| | Address: | 710 Bridgeport Avenue<br>Shelton, CT 06484 | | Contact person: | P. Altman | | Telephone number: | 203-926-7031 | | Prepared: | September 10, 1997 | | Device name: | Philips INTEGRIS V5000 FAMILY | | Classification name: | Angiographic X-ray system, 21 CFR 892.1600<br>Class II (90 IZI) | | Common/Usual name: | Angiographic x-ray system | | Predicate Device(s): | Philips Integris V3000 ( Re.: K910370) | #### Intended use: The Philips INTEGRIS V5000 and BV5000 system family is intended for use in dedicated vascular and neurovascular applications, including diagnostic and interventional procedures. This includes, e.g., peripheral, cerebral, thoracic and abdominal angiography as well as PTA's stent placements, embolisations, and thrombolysis. The systems are also intended for use in mixed cardiac/vascular/neuro applications and also non vascular interventions. ### System description: The family of Philips INTEGRIS V5000 and BV5000 systems are angiographic X ray systems for vascular, neurovascular and cardiovascular procedures, as well as nonvascular procedures. The monoplane Philips INTEGRIS V5000 system features a ceiling suspended CESAR C-arm stand that can be configured with a 12" or 15" Image Intensifier. In the biplane system, Philips INTEGRIS BV5000, a floor mounted CESAR C-arm stand is combined with a ceiling suspended double C-Arc (LARC). The Floormounted CESAR C-arm stand can be configured with a 12" or 15" Image Intensifier, the LARC always features a 12" Image Intensifier. Philips Medical Systems North America Company 710 Bridgeport Avenue P.O. Box 860 Shelton, Connecticut 06484-0917 Tel: (203) 926-7674 Fax: (203) 929-6099 {1}------------------------------------------------ Image /page/1/Picture/2 description: The image shows the symbol for the Department of Health & Human Services. The symbol is a stylized eagle with three lines representing its wings and body. The words "DEPARTMENT OF HEALTH & HUMAN" are written vertically along the left side of the symbol. The word "SERVICES" is written vertically along the right side of the symbol. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 ## NOV 10 1997 Peter Altman Director of Regulatory Affairs Philips Medical Systems North America Company 710 Bridgeport Avenue P.O. Box 860 Shelton, Connecticut 06484-0917 Re: K973482 Philips Integris V5000 and BV5000 Dated: September 12, 1997 Received: September 15, 1997 Regulatory class: II 21 CFR 892.1600/Procode: 90 IZI 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, 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 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 vitto diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for question 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 vours h. Lillian Yin, Ph.D. 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}------------------------------------------------ 510(k) Number (if known): __ Unknown Philips Integris V5000 and BV5000 Systems Device Name : Indications For Use : The Philips INTEGRIS V5000 and BV5000 system family is intended for use in dedicated vascular and neurovascular applications, including diagnostic and interventional procedures. This includes, e.g., peripheral, cerebral, thoracic and abdominal angiography as well as PTA's stent placements, embolisations, and thrombolysis. The systems are also intended for use in mixed cardiac/vascular/neuro applications and also non vascular interventions. ### (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) lam (Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number Prescription Use (Per 21 CFR 801.109 OR Over-The-Counter Use (Optional Format 1-2-96)