Discovery XR656 HD

{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: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue. GE HUALUN MEDICAL SYSTEMS CO. Ltd. % Kenny Ma Regulatory Affairs Manager No.1 YongChang North Road, Economic Technological Development Zone Beijing, 100176 Beijing CHINA ## Re: K172869 Trade/Device Name: Discovery XR656 HD Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: KPR, MOB Dated: September 14, 2017 Received: September 20, 2017 ## Dear Kenny Ma: 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); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.qov October 20, 2017 {1}------------------------------------------------ If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevicesforYou/Industry/default.htm. 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 Industry and Consumer Education (DICE) 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. Robert Oaks 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) K172869 Device Name Discovery XR656 HD Indications for Use (Describe) The Discovery XR656 HD is intended to generate digital radiographic images of the skull, spinal column, chest, abdomen, extremities, and other body parts in patients of all ages. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position and the system is intended for use in all routine radiography exams. Optional image pasting function enables the operator to stitch sequentially acquired radiographs into a single image. The device is not intended for mammographic applications. | Type of Use (Select one or both, as applicable) | | |------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------| | <span style="text-decoration: overline;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="text-decoration: overline;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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The logo is simple and recognizable. # 510(k) Summary In accordance with 21 CFR 807.92 the following summary of information is provided: | Date: | October 19, 2017 | |------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Submitter: | GE Healthcare, (GE HUALUN MEDICAL SYSTEMS CO. Ltd)<br>No.1 Yong Chang North Road, Beijing Economic<br>Technological Development Zone BEIJING 100176 CHINA | | Primary Contact<br>Person: | Kenny Ma<br>Regulatory Affairs Manager<br>GE Healthcare, (GE HUALUN MEDICAL SYSTEMS CO. Ltd)<br>Office: +86 18101130591<br>Email: Kenny.Ma@ge.com | | Secondary Contact<br>Person: | Chris Paulik<br>Regulatory Affairs Manager<br>GE Healthcare, (GE Medical Systems, LLC)<br>+1 262-548-2010<br>Email: Christopher.A.Paulik@ge.com | | Device Trade Name: | Discovery XR656 HD | | Common/Usual Name: | Digital Radiographic X-Ray System | | Classification Names:<br>Product Code: | Regulation Name: Stationary X-Ray System<br>Regulation: 21 CFR 892.1680<br>Classification: Class II<br>Product Codes: KPR, MQB | | Predicate Device: | Optima XR646 (K143270)<br>Regulation Name: Stationary X-Ray System<br>Regulation: 21 CFR 892.1680<br>Classification: Class II<br>Product Codes: KPR, MQB | | Reference Devices: | 1) PerkinElmer XRpad2 3025 HWC-M Flat Panel Detector (K161942)<br>Regulation Name: Stationary X-Ray System<br>Regulation: 21 CFR 892.1680<br>Classification: Class II<br>Product Codes: MQB<br>2) PerkinElmer XRpad2 4336 HWC-M Flat Panel Detector (K161966)<br>Regulation Name: Stationary X-Ray System<br>Regulation: 21 CFR 892.1680<br>Classification: Class II<br>Product Codes: MQB<br>3) Discovery XR656 With VolumeRad (Digital Tomosynthesis) (K132261)<br>Regulation Name: Stationary X-Ray System<br>Regulation: 21 CFR 892.1680<br>Classification: Class II<br>Product Codes: KPR, MQB, IZF | | Device Description: | The Discovery XR656 HD Radiography X-ray System is designed as a<br>modular system with components that include an Overhead Tube<br>Suspension with tube/collimator, wallstand, Table, X-ray generator,<br>and wireless digital detectors. The System generates diagnostic<br>radiographic images which can be sent through a DICOM network<br>for applications including printing, viewing, and storage.<br>The components may be combined in different configurations to<br>meet specific customer needs. In addition, upgrade configurations<br>are available for predicate devices.<br>The optional image pasting function enables the operator to stitch<br>sequentially acquired radiographs into a single image. | | Intended Use: | General Purpose Digital Radiographic Imaging System | | Indications for Use: | The Discovery XR656 HD is intended to generate digital radiographic<br>images of the skull, spinal column, chest, abdomen, extremities, and<br>other body parts in patients of all ages. Applications can be<br>performed with the patient sitting, standing, or lying in the prone or<br>supine position and the system is intended for use in all routine<br>radiography exams. Optional image pasting function enables the<br>operator to stitch sequentially acquired radiographs into a single<br>image.<br>The device is not intended for mammographic applications. | | Technology: | The Discovery XR656 HD employs the same fundamental scientific<br>technology as its predicate device. The intended use and patient<br>populations are the same between Discovery XR656 HD and<br>predicate device. The indication for use is the same except that | | Discovery XR656 HD does not include the Dual Energy advanced<br>application that is provided with the predicate device. The Discovery<br>XR656 HD did not change system software architecture, operator<br>I/F, Tube, or generator. It does incorporate the same 6-axis<br>Overhead Tube Suspension (OTS) and Overhead Bridge that enables<br>the automatic positioning feature and image pasting technique<br>from the referenced Discovery XR656 (K132261), but does not<br>include the VolumeRad indication from this referenced device. The<br>difference being introduced with the Discovery XR656 HD is that<br>exposures can be captured with cleared detectors of multiple sizes.<br>These cleared detectors utilize WiFi (802.11) instead of Ultra<br>Wideband (UWB) technology to transfer the image to the system. To<br>accommodate the cleared wireless detectors, the Discovery XR656<br>HD changed the following from the predicate device: | | | | Wireless communication hardware for detector<br>communication was changed from UWB to WiFi (802.11) Elevating Table and Wallstand Detector Housing geometry<br>and its associated detector charging hardware and<br>firmware to accommodate the 17 inch x 14 inch cleared<br>wireless detectors System software to accomplish the following: WiFi (802.11) association and pairing with the<br>cleared wireless detectors Synchronizing the image acquisition and image<br>retrieval from the cleared wireless detectors Image processing algorithms to accommodate<br>multiple image matrix sizes User interface updates for image acquisition to incorporate<br>the cleared wireless detectors into the user workflow | | Determination of<br>Substantial<br>Equivalence: | Summary of Non-Clinical Tests: | | | The Discovery XR656 HD and its applications comply with voluntary<br>standards: | | | ES60601-1 Medical electrical equipment - Part 1: General<br>requirements for basic safety and essential performance ; IEC 60601-1-2 Medical Electrical Equipment - Part 1-2: General<br>Requirements for Basic Safety and Essential Performance –<br>Collateral Standard: Electromagnetic Compatibility -<br>Requirements and Tests ; IEC 60601-1-3 Medical Elec. Equipment - P. 1: General Req. for<br>Safety 3. Collateral Standard: General Req. for Radiation<br>Protection in Diagnostic XRay Equipment ; IEC 60601-1-6 Medical electrical equipment - Part 1-6: General<br>requirements for safety - Collateral Standard: Usability ; | | • | IEC 60601-2-54 Medical electrical equipment - Part 2- 54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy; | | • | IEC 62366 Medical devices - Application of usability engineering to medical Devices; | | • | PS 3.1 - 3.20 Digital Imaging and Communications in Medicine (DICOM) set. (Radiology). | | The following quality assurance measures were applied to the development of the system: | | | 1. | Risk Analysis | | 2. | Requirements Reviews | | 3. | Design Reviews | | 4. | Testing on unit level (Module verification) | | 5. | Integration testing (System verification) | | 6. | Performance testing (Verification) | | 7. | Safety testing (Verification) | | 8. | Simulated use testing (Validation) | | New risks were identified for incorporating wireless image transfer between the cleared wireless detector and the base system. These risks were reviewed and mitigated with design controls and labeling. The mitigations were verified and validated as a part of the design verification and validation testing that has been executed with acceptable results. The testing/documentation we provided for the device Discovery XR656 HD were according to the following FDA guidance documents: | | | • | Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices; | | • | Content of Premarket Submissions for Management of Cybersecurity in Medical Devices | | <b>Summary of Clinical Tests:</b> | | | The subject of this premarket submission, Discovery XR656 HD, did not require clinical studies to support substantial equivalence for the incorporation WiFi (802.11) enabled detectors due to these detectors having their own 510(k) clearance. The detectors used to verify and validate the Discovery XR656 HD were the PerkinElmer, Inc. XRpad2 3025 HWC-M Flat Panel Detector cleared under K161942 and the PerkinElmer, Inc. XRpad2 4336 HWC-M Flat Panel Detector cleared under K161966. | | | Design verification and validation testing was performed to confirm that the safety and effectiveness of the device has not been affected. The test plans and results have been executed with | | | Conclusion: | The Discovery XR656 HD device incorporates cleared radiographic<br>detectors to capture radiographic images and utilizes a tether or<br>wireless technology to transfer the images to the base system. This<br>update to this system does not result in any new potential safety<br>risks, it has the same technological characteristics, and perform as<br>well as the devices currently on the market. | | | After analyzing design verification and validation testing on the<br>bench it is the conclusion of GE Healthcare that the Discovery XR656<br>HD to be as safe, as effective, and performance is substantially<br>equivalent to the predicate devices. | {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for General Electric (GE). The logo consists of the letters "GE" in a stylized script, enclosed within a blue circle. There are also three water droplets surrounding the circle. {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows the logo for General Electric (GE). The logo consists of the letters 'GE' in a stylized, cursive font, enclosed within a circular frame. There are three water droplets surrounding the circle. The logo is in a blue color and is set against a white background. {6}------------------------------------------------ Image /page/6/Picture/1 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 also some white swirls around the letters. The logo is simple and recognizable. {7}------------------------------------------------ Image /page/7/Picture/1 description: The image shows the logo for General Electric (GE). The logo is a blue circle with the letters "GE" in a stylized script in the center. The letters are also blue. There are white swirls around the perimeter of the circle, giving the impression of movement or energy.