OEC One

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the text "FDA U.S. FOOD & DRUG ADMINISTRATION" on the right. The symbol on the left is a stylized image of a caduceus, which is a traditional symbol of medicine. The text on the right is in a blue sans-serif font. The word "FDA" is in a larger font than the rest of the text. November 9, 2017 GE Hualun Medical Systems Co., Ltd. Lifeng Wang Regulatory Affairs Manager No 1 Yong Chang North Road Beijing Economic Technological Development Zone Beijing, 100176, China Re: K172700 Trade/Device Name: OEC One™ Regulation Number: 21 CFR 892.1650 Regulation Name: Image-Intensified Fluoroscopic X-Ray System Regulatory Class: Class II Product Code: OWB. OXO. JAA Dated: September 7, 2017 Received: September 7, 2017 Dear Lifeng Wang: 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 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); {1}------------------------------------------------ and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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. 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Sincerely, Robert Oolo Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K172700 Device Name OEC One™ #### Indications for Use (Describe) The OEC One mobile C-arm system is designed to provide fluoroscopic and digital spot/film images of adult and pediatric patient populations during diagnostic, interventional, and surgical procedures. Examples of a clinical application may include: orthopedic, gastrointestinal, endoscopic, critical care, and emergency procedures. | Type of Use (Select one or both, as applicable) | | |----------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------| | <div> <span> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> | ### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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The circle is surrounded by swirling, wave-like shapes, also in blue, which give the logo a dynamic and fluid appearance. ## GE Healthcare 510(k) Premarket Notification Submission- OEC One™ ## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS In accordance with the requirements of 21 CFR 807.92 the following summary of information is provided: | Date: | Sep 7, 2017 | |----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Submitter: | GE HUALUN MEDICAL SYSTEMS CO. Ltd.<br>No.1 Yong Chang North Road, Beijing Economic<br>Technological Development Zone<br>Beijing 100176, China | | Manufacturer/<br>Manufacturing Location | GE HUALUN MEDICAL SYSTEMS CO. Ltd.<br>No.1 Yong Chang North Road, Beijing Economic<br>Technological Development Zone<br>Beijing 100176, China | | Primary Contact Person: | Lifeng Wang<br>Regulatory Affairs Manager<br>GE Healthcare<br>+86 10 57083145<br>Lifeng.Wang@ge.com | | Secondary Contact Person: | Helen Peng<br>Regulatory Affairs Director<br>GE Healthcare<br>+1 262 424-8222<br>Hong.Peng@ge.com | | Device Trade Name: | OEC One™ | | Classification Names: | Image-intensified fluoroscopic x-ray system | | Device Class | Class II | | Classification regulation: | 21CFR 892.1650 | | Primary Product Code: | OXO | | Secondary Product Code: | JAA, OWB | | Predicate Device(s): | K123603 OEC Brivo, 892.1650, OXO | | Device Description: | The OEC One™ is a mobile C-arm x-ray system to provide<br>fluoroscopic images of the patient during diagnostic,<br>interventional, and surgical procedures such as orthopedic,<br>gastrointestinal, endoscopic, urologic, neurologic, critical care,<br>and emergency procedures. These images help the physician<br>visualize the patient's anatomy and localize clinical regions of<br>interest. The system consists of a mobile stand with an<br>articulating arm attached to it to support an image display monitor<br>(widescreen monitor) and a TechView tablet, and a "C" shaped<br>Page 1 of 3 | | Intended Use: | The OEC One™ mobile C-arm system is intended to provide fluoroscopic and digital spot/film images of the patient anatomy, interventional tools/devices, and/or contrast agents during diagnostic, interventional, and surgical procedures. | | Indications for Use | The OEC One™ mobile C-arm system is designed to provide fluoroscopic and digital spot/film images of adult and pediatric patient populations during diagnostic, interventional, and surgical procedures. Examples of a clinical application may include: orthopedic, gastrointestinal, endoscopic, urologic, neurologic, critical care, and emergency procedures. | | Technology: | The modified OEC One™ employs the same fundamental scientific technology as that of the unmodified predicate device(K123603). The primary change for the subject device was to integrate the separate mainframe and workstation of the predicate device into a compact configuration to save the space of the operation room with smaller foot print and to offer better workflow, ergonomics and usability.<br><br>Additionally, a separate articulating arm attached to the mobile stand was added to support the single widescreen image display monitor and a TechView tablet and to offer more degrees of freedom for easier positioning and maneuverability.<br><br>The software was updated primarily to support changing to a single image display monitor, adding a new TechView tablet, consolidation of user interface, and modifying existing features for Adaptive Dynamic Range Optimization(ARDO) and motion artifact reduction. Additionally, the software was also modified to add an Alternating Current (AC) recovery feature and to comply to NEMA XR-27(User Quality Mode) requirement. | | Determination of<br>Substantial Equivalence: | Summary of Non-Clinical Testing:<br>Verification and validation including hazard mitigation has been<br>executed with results demonstrating the OEC One™ system met<br>design input and user needs. | | | The system has been tested by an NRTL and certified compliant<br>with the IEC 60601-1 Ed. 3 series, including IEC60601-2-54 and<br>IEC 60601-2-43. All applicable 21CFR Subchapter J<br>performance standards are met. | | | The OEC One™ system was developed under the GE<br>Healthcare's Quality Management System, including design<br>controls, risk management and software development life cycle<br>processes. The following quality assurance measures were<br>applied to the development of the system:<br>Risk AnalysisRequired ReviewsDesign ReviewsUnit Testing (Sub System verification)Integration testing (System verification)Performance testing (Verification)Safety testing (Verification)Simulated use testing (Validation) | | | Additional engineering bench testing on image performance using<br>anthropomorphic phantoms was also performed. All the image<br>quality/performance testing identified for fluoroscopy found in<br>FDA's "Information for Industry: X-ray Imaging Devices-<br>Laboratory Image Quality and Dose Assessment, Tests and<br>Standards" was performed with acceptable results. | | | The substantial equivalence was also based on software<br>documentation for a "Moderate" level of concern device. | | | Clinical Testing:<br>Because OEC One's modification based on the predicate device<br>does not change the system's intended use and represent<br>equivalent technological characteristics, clinical studies are not<br>required to support substantial equivalence. | | Conclusion: | The differences discussed in this section do not introduce any<br>adverse effects nor raise new questions of safety and<br>effectiveness. Based on the successful verification and validation<br>testing, additional engineering bench testing, conformance to<br>standards, and development under GE Healthcare's Quality<br>Management System, we believe that the OEC One is of<br>comparable type and substantially equivalent to the predicate<br>device OEC Brivo Series (K123603). | {4}------------------------------------------------ # GE Healthcare Image /page/4/Picture/1 description: The image shows the logo for General Electric (GE). The logo is a blue circle with the letters "GE" in white, stylized script in the center. The circle is surrounded by a swirling, decorative pattern, also in white, that gives the impression of movement or energy. ## 510(k) Premarket Notification Submission- OEC One™ {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for General Electric (GE). The logo is a blue circle with the letters "GE" in a stylized font in the center. There are decorative swirls around the letters. The logo is simple and recognizable. # GE Healthcare 510(k) Premarket Notification Submission- OEC One™