GENESIS

{0}------------------------------------------------ # | | | | 22768 # JAN 1 8 2013 ・・ ### 510(k) SUMMARY ### Dornier MedTech America, Inc.'s GENESIS | Submitter Name and<br>Address: | Dornier MedTech America, Inc.<br>1155 Roberts Blvd.<br>Kennesaw, GA 30144 | |----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person: | John Hoffer<br>Vice President, Quality/Regulatory/Clinical | | Phone Number: | 770-514-6163 | | Fax Number: | 770-514-6291 | | Date Prepared: | December 18, 2012 | | Device Trade Name(s): | GENESIS | | Device Common Name /<br>Classification Name: | Image-intensified fluoroscopic x-ray system (Product Code: JAA) | | Predicate Device(s): | Dornier Urotract (K955019)<br>Siemens Uroskop Omnia (K101491) | | General Device<br>Description: | The Dornier GENESIS is an Image Intensified Fluoroscopic X-ray<br>System (i.e., a solid state x-ray imager (flat panel/digital imager)).<br>The GENESIS consists of the following components: an x-ray<br>generator and tube housing, flat panel detector, monitors and<br>procedure table. An X-ray cabinet contains system elements such<br>as the X-ray generator, power electronics and electronics for the<br>imaging chain. | | Intended Use /<br>Indications for Use: | The Dornier Genesis is an image intensified, fluoroscopic x-ray<br>system that is intended for use in a wide field of applications,<br>including all general examinations in urology and gynecology, as<br>well as endoscopic and contrast examinations, imaging with<br>radiography and/or fluoroscopy on patients in either the horizontal or<br>vertical position. | | Technological<br>Characteristics: | From a clinical perspective and comparing design specifications, the<br>Dornier GENESIS and the predicate devices are substantially<br>equivalent. Based on the technological characteristics and overall<br>performance of the devices, Dornier believes that no significant<br>differences exist between the proposed product and the predicate<br>devices. | | Performance Data | The GENISIS was tested per the following recognized testing<br>standards:<br>IEC 60601-1: Medical electrical equipment. Part 1: General<br>requirements for safety (2005). IEC 60601-1-2: Medical electrical equipment. Part 1-2:<br>General requirements for safety; Electromagnetic<br>compatibility-requirements and tests (2007). IEC 60601-1-3: Medical electrical equipment. Part 1:<br>General requirements for safety; general requirements for<br>radiation protection in diagnostic X-ray equipment (2008). IEC 60601-1-6: Medical electrical equipment. Part 1-6:<br>General requirements for basic safety and essential<br>performance -Collateral standard: Usability (2008). IEC 60601-2-7: Medical electrical equipment. Part 2-7:<br>Particular requirements for the safety of high voltage<br>generators of diagnostic X-ray generators (1998). IEC 60601-2-28: Medical electrical equipment. Part 2:<br>Particular requirements for the safety of X-ray source<br>assemblies and X-ray tube assemblies for medical diagnosis<br>(2010). IEC 60601-2-54: Medical electrical equipment. Part 2-54:<br>Particular requirements for the basic safety and essential<br>performance of X-ray equipment for radiography and<br>radioscopy (2009). | | | In addition, per FDA's Guidance Document entitled Guidance for the<br>Submission of 510(k)s for Solid State X-ray Imaging Devices<br>(August 6, 1999), the company completed all required nonclinical<br>and clinical testing for the subject device. In all instances, the<br>GENESIS functioned as intended and the results observed were as<br>expected. With regard to the completed concurrence study, the<br>results confirm that the GENESIS has at least equivalent<br>performance to the predicate Urotract. | | Substantial Equivalence | Based on the technological characteristics and overall performance<br>of the devices, Dornier believes that the GENESIS and the predicate<br>devices selected are substantially equivalent and that the<br>differences between the devices are minor and do not raise new<br> | | | In sum, the GENESIS is as safe and effective as the identified<br>predicate devices. The GENESIS has the same intended<br>uses/indications for use and similar technological characteristics,<br>and principles of operation as its predicate device. The minor<br>technological differences between the GENESIS and its predicate<br>devices raise no new issues of safety or effectiveness.<br>Performance data demonstrate that the GENESIS is as safe and<br>effective as the identified predicate devices. Thus, the GENESIS is<br>substantially equivalent. | {1}------------------------------------------------ : {2}------------------------------------------------ #### DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The eagle is oriented towards the upper right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular fashion around the left side of the eagle. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 January 18, 2013 Dornier MedTech America, Inc. % John J. Smith, M.D., J.D. Partner Hogan Lovells US LLP 555 Thirteenth Street, NW WASHINGTON DC 20004 Re: K122768 Trade/Device Name: GENESIS Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: JAA Dated: January 2, 2013 Received: January 2, 2013 Dear Dr. Smith: 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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. {3}------------------------------------------------ If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. 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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Sincerely yours, # Sean M. Boyd -S for Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ ## Indications for Use 510(k) Number (if known): K122768 Device Name: Dornier GENESIS Indications For Use: The Dornier GENESIS is intended for use in a wide field of applications, including all general examinations in urology and gynecology, as well as endoscopic and contrast examinations, imaging with radiography and/or fluoroscopy on patients in either the horizontal or vertical position. Prescription Use (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) # Sean M. Boyd -S Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) (Division Sigm Off) Division of Radiologii **Limits of In Vitro Diagnostics and Radiological Use** 51060 K122768 Page Page 1 of 1