Revolution Maxima, Revolution Ace

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services - USA. To the right of the symbol, there is the FDA logo in blue, with the words "U.S. FOOD & DRUG" on one line and "ADMINISTRATION" on the line below. The logo is simple and professional, conveying the organization's role in regulating food and drugs. October 24, 2019 GE Hangwei Medical Systems Co.,Ltd. % Haibo He Regulatory Affairs Leader West Area of Building No.3, No.1 Yongchang North Road Economic and Technological Development Area. Beijing 100176 CHINA Re: K192686 Trade/Device Name: Revolution Maxima Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: JAK Dated: September 25, 2019 Received: September 26, 2019 Dear Haibo He: 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. 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For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration #### Indications for Use 510(k) Number (if known) K192686 Device Name Revolution Maxima Indications for Use (Describe) The system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes, including Axial, Cine, Helical (Volumetric), Cardiac, and Gated acquisitions. These images may be obtained either with or without contrast. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories. This device may include data and image processing to produce images in a variety of trans-axial and reformatted planes. Further the images can be post processed to produce additional imaging planes or analysis results. The system is indicated for head, whole body, cardiac and vascular X-ray Computed Tomography applications in patients of all ages. The device output is a valuable medical tool for the diagnosis of disease, trauma, or abnormality and for planning, guiding, and monitoring therapy. | Type of Use (Select one or both, as applicable) | <span> <span style="padding-right: 20px;"> <span style="padding-right: 5px;">☑</span>Prescription Use (Part 21 CFR 801 Subpart D) </span> <span> <span style="padding-right: 5px;">□</span>Over-The-Counter Use (21 CFR 801 Subpart C) </span> </span> | |-------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| |-------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| CONTINUE ON A SEPARATE PAGE IF NEEDED. 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The logo is simple, clean, and recognizable. ### GE Healthcare 510(k) Premarket Notification Submission for Revolution Maxima # 510(k) Summary This 510(k) summary of Safety and Effectiveness information is submitted in accordance with the requirement of 21 CFR Part 807.87(h). In accordance with 21 CFR 807.92 the following summary of information is provided: | Date: | September 25, 2019 | |----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Submitter: | GE Hangwei Medical Systems Co.,Ltd.<br>West Area of Building No.3, No.1 Yongchang North<br>Road, Beijing Economic and Technological Development<br>Area, BEIJING 100176 CHINA | | Primary Contact Person: | Haibo He<br>Regulatory Affairs Leader<br>GE Healthcare<br>Phone Number: (86)-10-57083413<br>e-mail: Haibo.he1@ge.com | | Secondary Contact Persons: | John Jaeckle<br>Chief Regulatory Affairs Strategist<br>GE Healthcare<br>Phone Number: 262-424-9547<br>e-mail: John.Jaeckle.com<br><br>Helen Peng<br>Sr Regulatory Affairs Director<br>GE Healthcare<br>Phone Number: 262-4248222<br>e-mail: hong.peng@ge.com | | Product Identification | Revolution Maxima | | Device Trade Name: | Revolution Maxima | | Common/Usual Name: | Revolution Ace | | Regulation Number<br>/ Classification: | Computed Tomography X-ray System, 21 CFR 892.1750<br>/ Class II | {4}------------------------------------------------ Image /page/4/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 three white teardrop shapes around the outside of the circle. The logo is simple and recognizable. 510(k) Premarket Notification Submission for Revolution Maxima | Product Code: | 90-JAK | |---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Manufacturer | GE Hangwei Medical Systems Co.,Ltd.<br>West Area of Building No.3, No.1 Yongchang North<br>Road, Beijing Economic and Technological Development<br>Area, BEIJING 100176 CHINA | | Predicate Device Information: | | | Device Name | Optima CT660 | | 510 (K) number | K131576 cleared on August, 2013 | | Regualation Number/<br>Classification | Computed Tomography X-ray System, 21 CFR 892.1750 /<br>Class II | | Product Code | 90-JAK | #### Marketed Devices: The Revolution Maxima is a CT device built upon the existing technologies of the predicate device, GE Healthcare' s currently marketed Computed Tomography X-ray System Optima CT660 (K131576). It is of comparable type and substantially equivalent to Optima CT660. In addition, the system has the same intended use and indication for use as that of the predicate device. The system is labeled as the Revolution Maxima, with an alternate name Revolution Ace. ### Device Description: The Revolution Maxima CT system is composed of a gantry, patient table, operator console, host computer, and power distribution unit (PDU), and interconnecting cables. The system also includes image acquisition and reconstruction hardware/software, general system software, accompanying documents, and associated accessories, interconnections. The Revolution Maxima system is an evolutionary configuration of the predicate Optima CT660 CT system (K131576). All of the hardware functionality is identical to the predicate, however, some hardware changes have been made that did not change the system's performance specifications such as the new liquid metal bearing tube for improved tube life and reliability, the upgraded DAS and detector to improve the manufacturability and lower electronic nosie for better low signal performace and thermal management. ldentical to the predicate, Revolution Maxima generates cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes, {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for General Electric (GE). The logo consists of the letters "GE" written in a stylized, cursive font, enclosed within a blue circle. The circle has a white border with wave-like designs, giving it a dynamic and modern appearance. The blue color is consistent throughout the logo, providing a clean and recognizable brand identity. 510(k) Premarket Notification Submission for Revolution Maxima including Axial, Cine, Helical (Volumetric), Cardiac, and Gated acquisitions modes. Revolution Maxima's Intended Use and Indications for Use remain identical to those of the predicate device. The Revolution Maxima CT system is a head and whole body CT system incorporating the same basic fundamental operating principles and the same indications for use as the predicate device. It's materials and construction are identical to our existing marketed products. Revolution Maxima remains compliant with IEC 60601-1 Ed. 3.1 and associated collateral and particular standards, NEMA XR 25, XR 28, and 21 CFR Subchapter J performance standards. The accompanying documents also contain the information in support of IEC61223-3-5 Ed. 1.0 for acceptance testing. The performance and image quality specifications are identical/equivalent to the predicate. The gantry has a 70 cm bore with a maximum FOV of 50 cm. Available rotation speeds range from 0.35 to 2.0 seconds. Same as the predicate, the Revolution Maxima has three types of reconstruction methods available: FBP, ASiR, and ASiR-V (K133640). The performance of ASiR-V on Revolution Maxima is identical to that on the predicate Optima CT660. Revolution Maxima includes most of the available features on the current production predicate device Optima CT660. The new changes incorporated into Revolution Maxima are primarily addition of a few features found on other GE current production CT systems, e.g. updated newer ITE host computer, Digital Tilt as an alternative to the tilted gantry, improved metal artifacts reduction called Smart MAR and 1024x1024 Recon. Digital Tilt is a software reformatting of the reconstructed images so that they appear like those reconstructed from a tilted gantry. The smaller pixel sizes of 1024 Recon improves the spatial resolution which is useful in clinical applications that would benefit from increased spatial resolution, especially those applications where a large display field of view is desired to simultaneously image corresponding left/right anatomy for comparison (e.g. highresolution lungs, internal auditory canals). There are other unique changes for Revolution Maxima which includes new gantry covers with more aesthetic and modern industry design, new gantry display panel on two tablets with high resolution touchscreens, one on each side of the gantry for improved access and usability. These gantry display tablets replace the single display screen located at the top center of the gantry in the predicate device and host the web based user interface for a new and improved workflow called "Express mode" which seamlessly displays the related protocols associated with order information in the RIS Intended Use: {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' in a stylized script, enclosed within a circular frame. The frame has a wavy design, resembling water or energy currents. The logo is colored in a bright blue hue. 510(k) Premarket Notification Submission for Revolution Maxima The system is intended to be used for head, whole body Computed Tomography applications. #### Indications for Use: The system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes, including Axial, Cine, Helical (Volumetric), Cardiac, and Gated acquisitions. These images may be obtained either with or without contrast. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories. This device may include data and image processing to produce images in a variety of transaxial and reformatted planes. Further the images can be post processed to produce additional imaging planes or analysis results. The system is indicated for head, whole body, cardiac and vascular X-ray Computed Tomography applications in patients of all ages. The device output is a valuable medical tool for the diagnosis of disease, trauma, or abnormality and for planning, guiding, and monitoring therapy. ### Technology: Revolution Maxima includes most of the available features on the current production predicate device Optima CT660 and employs the same fundmental technologies as those of the predicate device. The changes incorporated into Revolution Maxima are primarily addition of a few features found on other GE current production CT systems, e.g. updated newer host computer, There are other unique changes for Revolution Maxima which are primarily for new industry design, IQ improvement, and workflow optimization. These include new gantry covers, new gantry display panel with two tablets located on both sides of the gantry with web based UI to auto display related protocols associated with order information in the RIS. The table below summarizes the substantive feature/technological differences between the predicate device and the proposed 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 in the center. There are decorative swirls around the outside of the circle. The logo is simple and recognizable, and it is associated with a well-known company. 510(k) Premarket Notification Submission for Revolution Maxima | Subsystem | Predicate Device<br>Optima CT660 (K131576) | Proposed Device<br>Revolution Maxima | |--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Gantry Display<br>Panel | Gantry Display<br>- Video touchscreen on top<br>center of gantry<br>- Emergency patient exam<br>- Display gantry and table<br>position information.<br>- Display multiple system<br>status.<br>- Display patient and exam<br>information.<br>- Display Patient ECG<br>waveform.<br>- Default Patient Positioning<br>(DPP).<br>- Play movie. | Gantry Display<br>"Xtream Tablet" (the "tablet"<br>is not removable)<br>- HD Video touchscreen on<br>each side of gantry<br>- New-Patient/Emergency<br>Patient exam.<br>- Display gantry and table<br>position information.<br>- Display multiple system<br>status.<br>- Display patient and exam<br>information.<br>- Display Patient ECG<br>waveform.<br>- Default Patient Positioning<br>(DPP).<br>- Play movie. | | 1024x1024 Image<br>Recon | Not Available | Available | | Related Protocols | Not Available | Available | | Smart MAR | Not Available | Available | | Tilt | Physical tilt | Digital Tilt | The changes described above do not change the fundamental control mechanism, operating principle, energy type, and do not change the intended use from the predicate device Optima CT660. ### Risk Analysis: Potential electrical, mechanical, and radiation hazards are identified in risk management including hazard analysis and controlled by: - । System verification and validation to ensure performance to specifications, Federal Regulations, and user requirements. {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the logo for GE, which is a well-known multinational conglomerate. The logo consists of the letters 'GE' written in a stylized, cursive font. The letters are enclosed within a blue circle, and there are decorative water droplet-like shapes surrounding the circle. The overall design is simple, clean, and recognizable. 510(k) Premarket Notification Submission for Revolution Maxima - -Adherence and certification to industry and international standards. (UL/CSA and IEC60601-1 Ed.3.1 and associated collateral and particular standards for CT). - Compliance to applicable CDRH 21 CFR subchapter J requirements. - - Compliance to NEMA XR 25, XR 26, and XR 28. The device is designed and manufactured under the Quality System Regulations of 21 CFR 820 and ISO 13485. #### Determination of Substantial Equivalence: The Revolution Maxima has completed testing and in compliance with AAMI/ANSI ES 60601-1 and IEC60601-1 Ed. 3.1 and its associated collateral and particular standards, 21 CFR Subchapter J, and NEMA standards XR 25, XR 26, and XR 28. The device has successfully completed all testing per our quality system as well as addition engineering bench testing in support of this submission. It was designed and is manufactured under the Quality System Regulations of 21 CFR 820 and ISO 13485. The following quality assurance measures were applied to the development of the system: - Risk Analysis - Required Reviews - Design Reviews - Testing on unit level (Module verification) - · Integration testing (System verification) - Performance testing (Verification) - · Safety testing (Verification) - Simulated use testing (Validation) GE believes the Revolution Maxima system is of comparable type and substantially equivalent to our currently marketed system Optima CT660(K131576). The substantial equivalence was also based on software documentation for a "Moderate" level of concern device. ### Summary of Additional Testing #### Non-Clinical Testing: The verification and validation testing have been successfully completed as required by design control procedures under GE Healthcare's quality system. This includes risk management, software verification and validation testing as well as image quality and dose performance using standard IQ and QA phantoms, such as Metal artifact {9}------------------------------------------------ Image /page/9/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' in a stylized, cursive font, enclosed within a circular border. The letters and the border are in a light blue color. There are also three white water droplet shapes around the border of the circle. 510(k) Premarket Notification Submission for Revolution Maxima reduction(MAR) testing, image quality testing on 1024 Recon and the performance testing in accordance with IEC 61223-3-5 ed 2 (FDIS). Non-clinical bench test results demonstrated the subject device performs equivalently to the predicate device. #### Clinical Testing: The Revolution Maxima can be fully tested on the engineering bench thus no additional clinical testing was required. #### Substantial Equivalence Conclusion: Based on the conformance to standards, development under our quality system, and the engineering testing provided, GE Healthcare believes that the Revolution Maxima is as safe and effective, and performs in a substantially equivalent manner to the predicate device Optima CT660 (K131576).