CENTRION 500 C-ARM SYSTEM

{0}------------------------------------------------ ## 510(k) Summary KOSO866 # Centrion 500 C-Arm System Classification Name: Image-Intensified Fluoroscopy Device 21 CFR 892.1650 Companiy. OsteoSys Phone: (+082) 2-2041-5600 Fax: (+082) 2-2041-5602 Contact: :Henry Jang, Prepared: December 15, 2004 ## LEGALLY MARKETED PREDICATE DEVICE A. The Centrion 500 C-Arm System is substantially equivalent to the General Electric OEC FLEXIVIEW 8800 Digital Mobile Imaging System (K003837). ### DEVICE DESCRIPTION B. The Centrion 500 C-Arm System. Is a digital C-Arm-type fluoroscopic system. It includes nearly every feature that exists on currently marketed System: "It interacts noany, while enclosing those features in a products, nact system, and adding a Real-Time Pulsed Fluoroscopy more offical by John Pulsed Fluoroscopy mode can significantly reduce the dose to the patient, without compromising image quality. Dose reductions of up to 85% are possible. ## INTENDED USE C. The Centrion 500 C-Arm System is designed to provide fluoroscopic and I he Sonthon 800 of the patient during diagnostic and surgical procedures. Clinical applications include, but are not limited to, general surgery, Olintour upplications in thopedic,neurologic, vascular, and emergency gastro inteotinal, archogio, exhoply be used for other imaging applications at the physician's discretion. ## SUBSTANTIAL EQUIVALENCE SUMMARY D. The Centrion 500 C-Arm System is a medical device, and it has the The Ochthon 000 our as the legally marketed predicate device. The Same indications for acc as the same technological characteristics Centrion 300 0-Amil Oyets. This premarket notification has described most {1}------------------------------------------------ characteristics of the Centrion 500 C-Arm System in sufficient detail to onaracteribated on lequivalence.1 For a few characteristics, such as electrical safety, testing to the requirements of consensus standards was carried out to assure equivalence ## TECHNOLOGICAL CHARACTERISTICS E. The technological characteristics of the proposed and predicate devices are Both use a digital image receptor and standard image the same. നം - oulation software tools to display real-time digital fluoroscopic images. #### ii TESTING The device was tested to the requirements of the following several standards that pertain to x-ray devices: IEC-60601-1-3 - General Requirements for Radiation Protection in Diagnostic X-Ray Equipment. IEC-60601-2-7 - Particular Requirements for the Safety of High-Voltage Generators of Diagnostic X-Ray Generators IEC-60601-2-28 - Particular Requirements for the Safety of X-Ray Source Assemblies and X-Ray Tube Assemblies for Medical Diagnosis. IEC-60601-2-32 -- Particular Requirements for the Safety of Associated Equipment of X-Ray Equipment. 21 CFR 1020 #### CONCLUSIONS G. This pre-market notification has demonstrated Substantial Equivalence as defined and understood in Sections 513(f)(1) and 513(i)(1) of the Federal Food Drug and Cosmetic Act and various guidance documents issued by the Center for Devices and Radiological Health. The meaning of the terms "substantial equivalence" and "substantially equivalent" 1 as used in this 510(k) is limited to the way they are defined in, and used by FDA in as used in this 510(K) is linked to the way 170) (1) of the Federal Food, Drug, and Cosmetic Act. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three lines extending from its head, representing health, hope, and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. Public Health Service APR 2 7 2005 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 OsteoSys. % T. Whit Athey, Ph.D. Senior Consultant The Health Policy Resources Group, LLC 2305 Gold Mine Road, Suite 200 BROOKVILLE MD 20833-2233 Re: K050866 Trade/Device Name: Centrion 500 C-Arm System Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: JAA Dated: April 5, 2005 Received: April 5, 2005 Dear Dr. Athey: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce pror 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) that do not require approval of a premarket approval application (PMA). 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA 's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {3}------------------------------------------------ This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter: | 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 | |-----------------|----------------------------------|--------------| | 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 | | 21 CFR 892.xxxx | (Radiology) | 240-276-0120 | | Other | | 240-276-0100 | Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, Nancy C. Brogdon Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ ## Indications for Use KoS0866 510(k) Number (if known): Centrion 500 C-Arm System Device Name:__________________________________________________________________________________________________________________________________________________________________ Indications For Use: The Centrion 500 C-Arm System is designed to provide fluoroscopic and spot-film imaging of the patient i he Centrion 500 C-Arm System is designed to provide , but are not limited to, general during diagnostic and surgical procedures. Oilfical upplications inc. and emergency room procedures. surgery, gastro-intestinal, urologic, orthopedic,neurologic, vascularios surgery, gastro-intestinal, urologic, orthopodic,hoaler, the physician's discretion. Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use __ (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Page 1 of 1 Nancy Brandon (Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number _ 000051