OEC One

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November 16, 2018 GE Hualun Medical Systems Co., Ltd. c/o Lifeng Wang Regulatory Affairs Manager No.1 YongChang North Road, Beijing Economic Technological Development Zone 100176 Beijing CHINA Re: K182626 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: OXO, JAA, OWB Dated: September 21, 2018 Received: September 24, 2018 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. {1}------------------------------------------------ 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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Hse 2. Nils for Robert A. 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) K182626 Device Name OEC One™ #### Indications for Use (Describe) The OEC One mobile C-arm system is designed to provide fluoroscopic and digital spot images of adult and pediatric patient populations during diagnostic, interventional, and surgical procedures. Examples of a clinical application may include: orthopedic, gastrointestinal, endosic, neurologic, vascular, critical care, and emergency procedures. | Type of Use (Select one or both, as applicable) | | |----------------------------------------------------------------------------------|---------------------------------------------------------------------------------| | <div> <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. 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The color of the logo is a light blue. 510(k) Premarket Notification Submission- OEC One with Vascular Option K182626 # 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 21, 2018 | |-----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 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<br>Person: | Philip Malca<br>Regulatory Affairs Director<br>GE Healthcare<br>+33 646373852<br>Philip.Malca@ge.com | | Device Trade Name: | OEC One™ | | Classification Names: | Image-intensified fluoroscopic x-ray system | | Device Class | Class II | | Regulation Number: | 21CFR 892.1650 | | Primary Product Code: | OXO | | Secondary Product Code: | JAA, OWB | | Predicate Device(s): | Device Trade Name: OEC One™<br>510(k) Clearance: K172700<br>Classification Name: Image-intensified fluoroscopic x-ray system<br>Regulation number: 21CFR 892.1650<br>Primary Product Code: OXO<br>Secondary Product Code: JAA, OWB | {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'g' and 'e' intertwined in a stylized script, enclosed within a circular frame. The logo is blue, and the frame has a swirling design around the letters. 510(k) Premarket Notification Submission- OEC One with Vascular Option | Device Description: | The OEC One™ is a mobile C-arm x-ray system to provide fluoroscopic images of<br>the patient during diagnostic, interventional, and surgical procedures such as<br>orthopedic, gastrointestinal, endoscopic, urologic, vascular, neurologic, critical<br>care, and emergency procedures. These images help the physician visualize the<br>patient's anatomy and localize clinical regions of interest. The system consists of a<br>mobile stand with an articulating arm attached to it to support an image display<br>monitor (widescreen monitor) and a TechView tablet, and a "C" shaped apparatus<br>that has an image intensifier on the top of the C-arm and the X-ray Source assembly<br>at the opposite end. | |---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | The OEC One™ is capable of performing linear motions (vertical, horizontal) and<br>rotational motions (orbital, lateral, wig-wag) that allow the user to position the X-<br>ray image chain at various angles and distances with respect to the patient anatomy<br>to be imaged. The C- arm is mechanically balanced allowing for ease of movement<br>and capable of being "locked" in place using a manually activated lock. | | | The subject device is labelled as OEC One. | | Intended Use: | The OEC One™ mobile C-arm system is intended to provide fluoroscopic and<br>digital spot images of the patient anatomy, interventional tools/devices, and/or<br>contrast agents during diagnostic, interventional, and surgical procedures. | | Indications for Use | The OEC One™ mobile C-arm system is designed to provide fluoroscopic and<br>digital spot images of adult and pediatric patient populations during diagnostic,<br>interventional, and surgical procedures. Examples of a clinical application may<br>include: orthopedic, gastrointestinal, endoscopic, urologic, neurologic, vascular,<br>critical care, and emergency procedures. | #### Technology: The modified OEC One™ employs the same fundamental scientific technology as that of the unmodified predicate device(K172700). The primary change was to implement the vascular features such as Subtraction and Roadmap to help perform vascular procedures with the easiest workflow and least intervention by the user. A suite of supporting features such as Peak Opacification, Cine Recording/Playback, Re-registration, Variable Landmarking, Mask Save/Recall, and Reference Image Hold were added to further enhance the vascular workflows. Other incremental changes are summarized below: Film mode was withdrawn considering the state of the art and therefore the optional cassette holder which was withdrawn as well from the accessories of OEC One with the vascular option. Generator specification was changed by updating software. An optional off-the-shelf wireless foot switch was introduced to provide placement flexibility and reduces cable clutter. A new anti-scatter grid was introduced to improve system performance. The anti-scatter grid was used on OEC Brivo 865 (K123603) {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for General Electric (GE). The logo is a circular emblem with the letters "GE" intertwined in a stylized, cursive font. The letters and the surrounding circle are a light blue color, set against a white background. 510(k) Premarket Notification Submission- OEC One with Vascular Option Other minor modifications have also been made in the software for Alternating Current (AC) recovery and tube heat management, as well as supporting GESAK (GE Service Access Key) to improve the access control. The table below summarizes the substantive feature/technological differences between the predicate device and the proposed device: | | Predicate Device (K172700) | Proposed Device | |------------------|--------------------------------------------------|--------------------------------------------------| | | OEC One | OEC One | | X-ray Generator | > 40 kHz High Frequency | > 40 kHz High Frequency | | | > Max Power 2.2 kW | > Max Power 2.5 kW | | | > Peak Tube Potential: 40-110 kVp | > Peak Tube Potential: 40-110 kVp | | | > Fluoroscopy: 0.1-4.0 mA | > Fluoroscopy: 0.1-4.0 mA | | | > High Level Fluoro: 0.2-12.0 mA | > High Level Fluoro: 0.2-25.0 mA | | | > Pulsed Fluoro: 1, 2, 4, 8 pulses/sec | > Pulsed Fluoro: 1, 2, 4, 8, 12 pulses/sec | | | > Digital Spot:0.2-10mA | > Digital Spot:0.2-10mA | | | (for 100-120V system) | (for 100-120V system) | | | > Film:1mAs-40mAs and constant<br>10mA | | | | (for 100-120V system) | | | Imaging Modes | > Continuous – Fluoroscopy | > Continuous – Fluoroscopy | | | o Normal Dose | o Normal Dose | | | o High Level Dose (aka High<br>Level Control) | o High Level Dose (aka High Level<br>Control) | | | o Low Dose | o Low Dose | | | > Pulsed Fluoroscopy | > Pulsed Fluoroscopy | | | o Normal Dose | o Normal Dose | | | o High Level Dose (aka High<br>Level Control) | o High Level Dose (aka High Level<br>Control) | | | o Low Dose | o Low Dose | | | > Digital Spot | > Digital Spot | | | > Film | > Roadmap | | | | o Normal Dose | | | | o Low Dose | | | | > Subtraction | | | Predicate Device (K172700) | Proposed Device | | | OEC One | OEC One | | | | o Normal Dose | | | | o Low Dose | | Imaging Features | > Auto X-Ray technique control | > Auto X-Ray technique control | | | > Noise and motion reduction (TNR) | > Noise and motion reduction (TNR) | | | > Auto/Manual Brightness and Contrast<br>Control | > Auto/Manual Brightness and Contrast<br>Control | | | > Negate | > Negate | | | > Swap and auto-swap | > Swap and auto-swap | | | > Save and auto-save | > Save and auto-save | | | > Last image hold | > Last image hold | | | > Edge enhancement | > Edge enhancement | | | > Zoom & Roam | > Zoom & Roam | | | > Image rotation | > Image rotation | | | > Image flip/ invert | > Image flip/ invert | | | > Manual/Auto Smart Metal | > Manual/Auto Smart Metal | | | > AutoTrak | > AutoTrak | | | > Patient Annotation | > Patient Annotation | | | > Markers | > Markers | | | > Measurement Functions | > Measurement Functions | | | | > Peak Opacification | | | | > Cine Recording/Playback | | | | o Cine Automatic Image<br>Playback | | | | o Cine Frame-by-Frame Review | | | | > Re-Registration | | | | > Variable Landmarking | | | | > Mask Save/Recall | | | | > Reference Image Hold | {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the General Electric (GE) logo. The logo is a blue circle with the letters "GE" in a stylized font in the center. There are two curved lines on either side of the circle, giving the impression of movement or energy. The logo is simple and recognizable, and it is associated with a well-known and established company. 510(k) Premarket Notification Submission- OEC One with Vascular Option The changes described above do not change the control mechanism, operating principle, or intended use in nature from the predicate device. {7}------------------------------------------------ Image /page/7/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 inside. There are decorative swirls around the letters. The logo is simple and recognizable, and it is associated with a well-known company. 510(k) Premarket Notification Submission- OEC One with Vascular Option ### Determination of Substantial Equivalence: ### Summary of Non-Clinical Testing: Verification and validation including risk mitigations have been executed with results demonstrating the OEC One™ system met the design inputs and user needs. The system has been tested by an NRTL and certified compliant with the IEC 60601-1 Ed. 3 series, including IEC60601-2-54:2009 and IEC 60601-2-43:2010. All applicable 21CFR Subchapter J performance standards were met. The OEC One™ system was developed under the GE Healthcare's Quality Management System, including design controls, risk management and software development life cycle processes. The following quality assurance measures were applied to the development of the system: - Risk Analysis - Required Reviews - · Design Reviews - · Unit 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 anthropomorphic phantoms was also performed. All the image quality/performance testing identified for fluoroscopy found in FDA's "Information for Industry: Xray Imaging Devices- Laboratory Image Quality and Dose Assessment. Tests and Standards' was performed with acceptable results. The substantial equivalence was also based on software documentation for a "Moderate" level of concern device. ### Clinical Testing: OEC One's modification, based on the predicate device, does not change the system's intended use in nature and keeps the same well-established technology as its predicate. This type of change is supported by scientific, established/standardized, engineering/physics-basic performance testing. The bench testing performed on this change has demonstrated that the user requirements were met. Therefore, for OEC One with vascular option configurations, clinical images are not required to demonstrate the substantial equivalence to the predicate device. #### Conclusion: The differences discussed in this section do not introduce any adverse effects nor raise new questions of safety and effectiveness. Based on the successful verification and validation testing, additional engineering bench testing, conformance to standards, and development under GE Healthcare's Quality Management System, we believe that the OEC One with vascular option is of comparable type and substantially equivalent to the predicate device OEC One (K172700).