GE DISCOVERY IGS ANGIOGRAPHIC,FLUOROSCOPIC X-RAY SYSTEM

{0}------------------------------------------------ K113403 FEB 1 4 2012 GE Healthcare 510{k} Premarket Notification Submission Discovery IGS 730 ## 510(k) Summary In accordance with 21 CFR 807.92 the following summary of information is provided: | Date Summary was | November 10th, 2011 | |--------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Prepared:<br>Submitter: | GE Healthcare<br>GE Medical Systems, SCS<br>283 RUE DE LA MINIERE<br>78530 BUC - FRANCE<br>T: +33-(0)1-30-70-47-41 | | Primary Contact Person: | Michel Genuer<br>GE Healthcare (GE Medical Systems, SCS)<br>Regulatory Affairs Leader,<br>283 RUE DE LA MINIERE<br>78530 BUC - FRANCE<br>T: +33-(0)1-30-70-47-41<br>Email: michel.genuer@ge.com | | Secondary Contact Person: | Carol Alloian<br>Regulatory Affairs Leader,<br>GE Healthcare<br>9900 W innovation drive<br>Wauwatosa, WI, USA, 53226-4856<br>T: (847) 244-8327<br>F: (847) 589-8524<br>Email: carol.alloian@ge.com | | Device/Trade Name: | GE Discovery IGS angiographic, fluoroscopic X- ray systems | | Common/Usual Name: | angiographic, fluoroscopic X- ray system | | Regulation Description:<br>Regulation number:<br>Product Code:<br>Class:<br>Predicate Device(s): | Angiographic X- ray system<br>892.1600.<br>90 IZI, OWB, JAA<br>II<br>K111209: INTEGRATED INNOVA - SSI SYSTEM OPTION GE Medical Systems<br>K090745: Siemens Artis Zee | | Device Description: | The proposed device, Discovery IGS 730 is an X-ray angiographic system with a 30cm detector size. The proposed device introduces a | | | new fixed C arm positioner that will be the basis of the Discovery IGS<br>X-ray angiographic systems platform. The proposed device will be<br>offered with 2 product configurations, Interventional and OR<br>configuration. The indications for use are expanded to include<br>image-guided surgical procedures and open surgery procedures for<br>the OR configuration of the product.<br>The X-ray tube, the collimator, the X-ray power unit, the flat panel,<br>the X-ray control and image processing chain are the same as the<br>GE Innova systems. | | Intended Use:<br>Indications for Use: | The angiographic X-ray systems are indicated for use in generating<br>fluoroscopic and rotational images of human anatomy for<br>cardiovascular, vascular and non-vascular, diagnostic and<br>interventional procedures.<br>Additionally, with the OR table, the angiographic X-ray systems are<br>indicated for use in generating fluoroscopic and rotational images of<br>human anatomy for image-guided surgical procedures. The OR<br>table is suitable for interventional and surgical procedures. | | Technology: | The proposed Discovery IGS 730 system employs the same<br>fundamental scientific technology as its predicate devices. | | Determination of Substantial<br>Equivalence: | Summary of Non-Clinical Tests:<br>Non-clinical verification and validation tests were performed to<br>verify and validate the system functionally for the intended use.<br>The following quality assurance measures were applied to the<br>development of the system:<br>Risk Analysis Requirements Reviews Design Reviews Testing on unit level (Module verification) Integration testing (System verification) Performance testing (Verification) Safety testing (Verification) Simulated use testing (Validation) | | | The Discovery IGS 730 system is designed in compliance with<br>voluntary standards as detailed in Section 9 of this premarket<br>submission. Verification and Validation (V&V) was performed and<br>passed. | | | Summary of Clinical Tests:<br>The subject of this premarket submission, Discovery IGS 730, did not<br>require clinical studies to support substantial equivalence in the<br>intended clinical environment. | | Conclusion: | GE Healthcare considers the Discovery IGS 730 to be as safe and<br>effective as its predicates devices, and its performances to be<br>substantially equivalent to the predicate devices. | Confidential and Privileged. This document contains confidential and privileged trade secrets and other information of General Electric Co. and os such may not be disclosed to others not employed by General Electric Co. All rights reserved Image /page/0/Picture/7 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined and enclosed within a circular border. The border has a decorative, wave-like pattern around the letters. ---- {1}------------------------------------------------ Image /page/1/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined within a circular border. The design is simple and iconic, representing the company's brand identity. ## GE Healthcare 510(k) Premarket Notification Submission Discovery IGS 730 Confidential and Privileged. This document continential ond privileged trode secrets and other information of General Electric Co. and os such may not be disclosed to others Co. All rights reserved {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined in a stylized, cursive font. The intertwined letters are enclosed within a circular border, which has decorative swirls or flourishes at the top and bottom. 1 ## GE Healthcare 510(k) Premarket Notification Submission T Discovery IGS 730 Confidential and Privileged. This document confidential and privileged trade secrets and other information of General Electric Co. and as such may not be disclosed to others not employed by General Electric Co. All rights reserved {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized emblem. The emblem is a blue graphic of what appears to be an abstract caduceus, a symbol often associated with healthcare organizations. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 Mr. Michael Genuer Regulatory Affairs Leader GE Healthcare GE Medical System SCS 283 Rue de la Miniere 78530 BUC FRANCE JUL 3 0 2012 Re: K113403 Trade/Device Name: Discover IGS 730 Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OWB, JAA and IZI Dated: November 10, 2011 Received: November 17, 2011 Dear Mr. Genuer: This letter corrects our substantially equivalent letter of February 14, 2012. 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 (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 (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 Parts 801 and 809); medical device reporting (reporting of {4}------------------------------------------------ medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/cdrh/industry/support/index.html. Sincerely Yours, Janine M. Morris Janine M. Morri Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows a black and white logo. The logo is circular and contains the letters 'GE' in a stylized, intertwined design. The letters are surrounded by a circular border, giving the logo a classic and recognizable appearance. GE Healthcare 510(k) Premarket Notification Submission Discovery IGS 730 510(k) Number (if known): To Be Assigned Device Name: Discovery IGS 730 Indications for Use: The angiographic X-ray systems are indicated for use in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and non-vascular, diagnostic and interventional procedures. Additionally, with the OR table, the angiographic X-ray systems are indicated for use in generating fluoroscopic and rotational images of human anatomy for image-guided surgical procedures. The OR table is suitable for interventional and surgical procedures. Prescription Use_x (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use_ (Part 21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Mary, Stootel ✓ (Division Sign-Off) Division of Neurological Devices Office of In Vitro Diagnostic Device Evaluation and Safety 510K KU3403