OEC BRIVO 865 ADVANCE, OEC BRIVO 785 ESSENTIAL, AND OEC BRIVO 715 PRIME

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the date "MAY 17 2013" in bold, black font. The month is written in all capital letters, followed by the day and year. The numbers are clearly legible, and the overall image is simple and straightforward. K123603 Page 1 of 6 GE Healthcare OEC® Brivo® 510(k) Premarket Notification Submission ### 510(k) Summary In accordance with 21 CFR 807.92 the following summary of information is provided: Date: April 30, 2013 the system. | Submitter: | GE Healthcare Surgery<br>384 Wright Brothers Drive<br>Salt Lake City, UT 84116 | |---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Primary Contact Person: | Gerald Buss<br>Director Regulatory Affairs<br>GE Healthcare Surgery<br>Phone: (801) 517-6591 Fax: (414) 908-9249 | | Secondary Contact Person: | Jeff Wagner<br>Regulatory Affairs Manager<br>GE Healthcare Surgery<br>Phone: (801) 517-6415 Fax: (801) 517-6566 | | Device (Trade Name): | OEC® Brivo® 865 Plus, OEC® Brivo® 785 Essential, and OEC®<br>Brivo® 715 Prime | | Common/Usual Name: | Mobile Fluoroscopic Imaging System | | Classification Names: | 21 CFR 892.1650 Image-intensified fluoroscopic x-ray system | | Product Code: | 90OXO, 90JAA | | Predicate Device(s): | K111551 OEC® 9800 / OEC® 9800 Plus | | Device Description: | The OEC® Brivo® is a system used to assist trained<br>physicians. The system is used to provide X-Ray images<br>while the physician performs a medical procedure. Images<br>from the system help the physician to visualize the patients'<br>anatomy. This visualization helps to localize surgical<br>regions of interest and pathology. The images provide real-<br>time visualization and records of pre-surgical anatomy, in<br>vivo-surgical activity and post-surgical outcomes.<br>The system is composed of two primary physical elements.<br>The first is referred to as the "C-Arm" because of its "C"<br>shaped image gantry; the second referred to as the | The system is used in different surgical procedures. "Workstation" because this is the primary user interface to Image /page/0/Picture/8 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined in a stylized, cursive font. The letters are enclosed within a circular shape that has a textured or patterned border. The logo is black and white. {1}------------------------------------------------ Image /page/1/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circular border. The design has a vintage or classic appearance, with a slightly rough or textured look. ## GE Healthcare OEC® Brivo® 510(k) Premarket Notification Submission Orthopedic Physicians may use the system to help perform hip replacements and reconstructions of badly fractured bones. Orthopedic Physicians may use the system to help perform hip replacements and reconstructions of badly fractured bones. The procedures that these surgeons perform are broadly referred to as "Clinical Applications". The system is controlled and run in a clinical environment. The system employs X-Rays as its imaging technology. An X-Ray Generator located in the base of the C-Arm creates high voltage. High voltage is carried to the X-Ray tube across a set of cables. The X-Ray tube emits X-Rays that are directed toward the patient under the control of the operator. The Physician defines the desired view for the specific clinical procedure and directs the operator. The X-Rays pass through the patient and are captured by the image intensifier (II). Image intensifier images are captured by a camera and displayed on the image monitor located on the Workstation. The system operator and/or Physician view the images as they are displayed and they may choose to store the images for later review. In order to perform these procedures different views of the human anatomy are required, so the system is designed with the ability to rotate and translate the C-Arm's image gantry to obtain different viewing angles. In addition since there is variation in thickness and density of the anatomy the operator has the ability to adjust the X-Ray Generator technique, image size and orientation to account for the anatomical differences. The OEC® Brivo® Mobile C-Arm X-Ray Products are designed to provide digital spot-film imaging and fluoroscopic image guidance for all adult and pediatric populations for orientations between patient anatomy and surgical instruments. The product is used for general surgical applications and musculoskeletal procedures to visualize, for example, implant localization/s or needle positions for aspirations, injections or biopsy. The OEC® Brivo® is not indicated for interventional use. The OEC® Brivo® (all models) is not indicated for Technology: interventional use (specifically vascular and cardiac applications) as is the OEC® 9800 (both models). As a noninterventional use device, the OEC® Brivo® does not require Intended Use: {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 letters are enclosed within a circular border that has a textured or patterned design. The logo is black and white. ## GE Healthcare OEC® Brivo® #### 510(k) Premarket Notification Submission the same capacity for long term or high capacity imaging that is necessary for the expanded use of the OEC® 9800. The OEC® Brivo® does not support applications associated with vascular use, but does support the OEC® 9800 applications in general surgery, orthopedics, and for general surgical applications and musculoskeletal procedures to visualize for example implant localization/s or needle positions for aspirations, injections or biopsy OEC® Brivo® does not include a 12" image intensifier option as does the OEC® 9800. The 9" version is sufficient for noninterventional use and has the same technology as the 9" option on the OEC® 9800. The OEC® Brivo® x-ray tube is a fixed anode with lower power and cooling capacity than the rotating anode tube used in the OEC® 9800. The OEC® Brivo® tube operates on the same general technology and does not require the same capacity as the predicate for effective performance of its intended use. Because the OEC® Brivo® x-ray tube requires less kV to perform its intended use, the OEC® Brivo® generator is a reduced capacity version of the OEC® 9800 generator. Higher ratings are associated with interventional procedures not indicated for OEC® Brivo® OEC® Brivo® is not offered with the same software options as OEC® 9800. Typical software options for interventional procedures for example, include digital cine, DSA, and Roadmapping. OEC® Brivo® is not available in a motorized version and does not feature motion sensing and control capability associated with motorized use. Motorized versions are typically associated with interventional procedures and not required for successful performance of OEC® Brivo"s intended use. All the features of the OEC® Brivo® are substantially equivalent to the similar feature on the OEC® 9800. For these features, the OEC® Brivo® devices employ the same fundamental scientific technology as the predicate device. {3}------------------------------------------------ ## GE Healthcare OEC® Brivo® 510(k) Premarket Notification Submission Summary of Non-Clinical Tests Determination of The OEC® Brivo® complies with the voluntary and Substantial Equivalence: mandatory standards listed in Table 1 below. The following tests were performed: . Software validation (Moderate level of concern) is - the confirmation that the software design inputs and system functionality are consistent with the user needs and intended uses. Software validation occurred both during and at the completion of the product development cycle and ensured that all requirements were fulfilled. - System verification methodology was hierarchal. . When components such as software and hardware were completed, component level tests were executed. Upon completion of component testing, subsystem and then system verification were also performed. The Design Verification of the OEC® Brivo confirms that design output meets design input requirements. - Dose verification, image quality assessment and . functional testing are included in system verification. A subset of this testing will be used to re-verify the device during manufacturing, installation and periodically through the product's life. - . Functional Product Simulated Use Testing ensures the system conforms to user needs and intended uses through simulated clinical workflow using step-bystep procedures that would be performed for representative clinical applications. Testing was performed by an orthopedic surgeon and trained clinical technicians confirming that OEC® Brivo® meets the user requirements and intended uses for the product. - Safety testing was performed in laboratory settings by . qualified technicians to confirm that the product met the requirements of the standards listed in Table I below. - Product Simulated Testing Performance Use . demonstrates that the fluoroscopic anatomical images provide clinically useful information through Image /page/3/Picture/9 description: The image is a blank white square. There are no objects or figures in the image. The image does not contain any text. The image is completely white. Image /page/3/Picture/11 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined within a circular frame. The letters are stylized and connected, giving the logo a distinctive and recognizable appearance. The logo is black and white. {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circular border. The letters are stylized and have a vintage appearance. The logo is black and white. # GE Healthcare OEC® Brivo® ### 510(k) Premarket Notification Submission visualization of anatomical details. Testing is performed by trained clinical representatives using anthropomorphic phantoms and confirmed that OEC Brivo® produces clinically useful images. - . External Image Quality Evaluation was performed on human cadavers by orthopedic surgeons to provide a representative sample of images that a user may encounter during intended use. Evaluation of the images by orthopedic surgeons and clinical representatives demonstrated OEC® Brivo® produces useful images in a clinical environment. #### Summary of Clinical Tests The OEC® Brivo® is based on modifications to a cleared predicate device; these modifications resulted in a reduced number of available features as is consistent with the more limited indications for the OEC® Brivo® Mobile C-Arm X-Ray products. Because the OEC® Brivo® is based on modifications to a cleared device and because the indications are limited to surgical placement, clinical studies on living human patients were unnecessary to support substantial equivalence. The performance testing described above demonstrates that the Conclusion: OEC® Brivo® product is safe, effective and performs, for its limited intended use, in an equivalent manner to the predicate device and in accordance with its labeling. For equivalent intended uses, the OEC® Brivo® is substantially equivalent in performance to the OEC® 9800. | Standards<br>No. | Standards<br>Organization | Standards Title | Version | Date | |----------------------|---------------------------|-------------------------------------------------------------------------------------------------------------|---------|------| | 21 CFR<br>1020.30-32 | FDA | Federal Performance Standard for<br>Diagnostic X-ray Systems | 2012 | 2012 | | 60601-1 | UL | Medical Electrical Equipment, Part 1:<br>General Requirements for Basic<br>Safety and Essential Performance | 2005 | 2005 | | | | | | | Table 1 Product Standards Compliance | |--|--|--|--|--|--------------------------------------| |--|--|--|--|--|--------------------------------------| {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "G" and "E" intertwined within a circular border. The letters are stylized and appear to be hand-drawn or calligraphic. The logo is black and white. K123603 page 6 of 6 GE Healthcare OEC® Brivo® 510(k) Premarket Notification Submission | Standards<br>No. | Standards<br>Organization | Standards Title | Version | Date | |------------------|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|------| | 60601-1 | IEC | Medical Electrical Equipment, Part 1:<br>General Requirements for Basic<br>Safety and Essential Performance | Ed. 3 | 2005 | | 60601-1-2 | IEC | Medical electrical equipment - Part 1-<br>2: General requirements for basic<br>safety and essential performance -<br>Collateral standard: Electromagnetic<br>compatibility - Requirements and<br>tests | Ed. 3 | 2007 | | 60601-1-3 | IEC | Radiation Protection in Diagnostic X-<br>ray Equipment | Ed. 2 | 2008 | | 60601-1-6 | IEC | Medical electrical equipment - Part 1-<br>6: General requirements for basic<br>safety and essential performance -<br>Collateral standard: Usability | Ed. 3 | 2010 | | 60601-2-28 | IEC | Medical electrical equipment - Part 2-<br>28: Particular requirements for the<br>basic safety and essential performance<br>of X-ray tube assemblies for medical<br>diagnosis | Ed. 2 | 2010 | | 60601-2-54 | IEC | Medical electrical equipment - Part 2-<br>54: Particular requirements for the<br>basic safety and essential performance<br>of X-ray equipment for radiography<br>and radioscopy | Ed. 1 | 2009 | . {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol featuring three curved lines that resemble a person embracing another person. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 #### May 17. 2013 GE Healthcare Surgery (GE OEC Medical Systems, Inc.) % Mr. Gerald Buss Director Regulatory Affairs 384 Wright Brothers Drive SALT LAKE CITY UT 84116 DEPARTMENT OF HEALTH & HUMAN SERVICES Re: K123603 Trade/Device Name: OEC® Brivo® 865 Plus, OEC® Brivo® 785 Essential, and OEC® Brivo® 715 Prime Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OXO, JAA Dated: April 12, 2013 Received: April 16, 2013 Dear Mr. Buss: 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 {7}------------------------------------------------ Page 2 - Mr. Buss 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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/Safctv/ReportalProblem/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/ResourcesforYou/Industry/default.htm. Sincerely yours, Smh.7) Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health for Enclosure {8}------------------------------------------------ # Indications for Use 510(k) Number (if known): K123603 Device Name: OEC® Brivo® 865 Plus, OEC® Brivo® 785 Essential, and OEC® Brivo® 715 Prime The OEC® Brivo® Mobile C-Arm X-Ray Products are designed Indications for Use: to provide digital spot-film imaging and fluoroscopic image quidance for all adult and pediatric populations for orientations between patient anatomy and surgical instruments. The product is used for general surgical applications and musculoskeletal procedures to visualize, for example, implant localization/s or needle positions for aspirations, injections or biopsy. The OEC® Brivo® is not indicated for interventional use. Prescription Use V (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 In Vitro Diagnostics and Radiological Health (OIR) \$\sin(2)\$ (Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health K123603 510(k) Page 1 of 1