TCA 5R / 5S

{0}------------------------------------------------ K010123 This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 and 21 CFR 807.92. | Submitter Name: | Dornier MedTech America, Inc. | |---------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Submitter Address: | 1155 Roberts Blvd.<br>Kennesaw, GA 30144 | | Contact Person: | Tim Thomas, Vice President<br>Regulatory/ Quality/ Clinical<br>MAR 09 2007 | | Phone Number: | 770-514-6163 | | Fax Number: | 770-514-6288 | | Establishment<br>Registration Number: | 1037955 | | Date Prepared: | January 12, 2007 | | Device Trade Name(s): | TCA 5R / 5S | | Device Common Name: | Fluoroscopic Imaging System or Mobile C-Arm | | Classification Name: | System, x-ray, fluoroscopic, image-intensified (JAA)<br>System, x-ray, mobile (IZL) | | Device Classification: | II (21 CFR Sec. 892.1650 and 892.1720)<br>(Image-intensified fluoroscopic x-ray system / Mobile<br>x-ray system) | | Predicate Device(s): | K992103 - Wuestec Medical Inc. (C-Quest) | | | K002198 - Fluoroscan Imaging Systems (Hologic)<br>(FlouroScan Profile) | | General Device<br>Description: | The TCA 5R / 5S are mobile C-arms specifically<br>designed for x-ray imaging | | Intended Use: | The TCA 5R / 5S C-arm systems are designed for x-<br>ray examinations, and in particular, for radioscopy,<br>radiography, and diagnosis dedicated to:<br>traumatology, pediatrics, simple interventional<br>radiology, pacemaker implantation, operating room<br>procedures, intensive care, and respiratory and<br>skeleton procedures. | | Technological<br>Characteristics: | The TCA 5R / 5S consists of two mobile units: a C-<br>Arm and a Monitor Trolley which holds one or two | {1}------------------------------------------------ monitors, an image processing system and possible accessories. The C-Arm stand supports the highvoltage generator, x-ray controls, and the "C" shaped arm which supports the x-ray tube and the image intensifier. The C-Arm is designed to move in various directions to allow for proper positioning with the patient based on the procedure. Additional technological characteristics are provided in Section 10 (Device Description) and Section 11 (Substantial Equivalence) The TCA 5R / 5S comply with the applicable performance standards listed in Section 8 Performance Data: (Declaration of Conformity) > Based on a comparison to the predicate device determined to be substantially equivalent through the 510(k) premarket notification process, Dornier MedTech America, Inc., concludes that the TCA 5R / 5S are as safe, as effective, and performs as well as other legally marketed C-arm devices. Conclusion: {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows a circular logo with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged around the perimeter. Inside the circle is a stylized graphic of three curved lines that resemble a human figure in motion. The lines are thick and black, and they create a sense of movement and energy. The logo is simple and modern, and it is likely used to represent the Department of Health & Human Services. ## DEPARTMENT OF HEALTH & HUMAN SERVICES Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850 Mr. Tim Thomas Vice President, Quality / Regulatory / Clinical Dornier MedTech America, Inc. 1155 Roberts Blvd. KENNESAW GA 30144 MAR 0 9 2007 Re: K070123 Trade/Device Name: TCA 5R / 5S Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile x-ray system Regulatory Class: II Product Code: JAA and IZL Dated: January 12, 2007 Received: January 17, 2007 Dear Mr. Thomas: 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 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) 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. Image /page/2/Picture/10 description: The image is a black and white circular logo. The logo has the text "1906-2006" at the top, "FDA" in the middle, and "Centennial" at the bottom. There are three stars below the word "Centennial". The logo is surrounded by a dotted border. Protecting and Promoting Public Health {3}------------------------------------------------ Page 2 - 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 (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 | |----------------|----------------------------------|--------------| | 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 | | 21 CFR 894.xxx | (Radiology) | 240-276-0120 | | Other | | 240-276-0100 | Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html. Sincerely yours, Nancy C. Hogdon 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 510(k) Number (if known): Device Name: Indications for Use: The TCA 5R / 5S C-arm systems are designed for x-ray examinations, and in particular, for radioscopy, radiography, and diagnosis dedicated to: traumatology, pediatrics, simple interventional radiology, pacemaker implantation, operating room procedures, intensive care, and respiratory and skeleton procedures. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number K070123