MaxFOV 2

{0}------------------------------------------------ Image /page/0/Picture/10 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 eagle, and the text on the right is in blue. The words "U.S. FOOD & DRUG" are in a larger font size than the word "ADMINISTRATION". GE Medical Systems, LLC. % Ms. Amy Yang Regulatory Affairs Manager 3000 N Grandview Blvd WAUKESHA WI 53188 March 2, 2021 Re: K203617 Trade/Device Name: MaxFOV 2 Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: JAK Dated: December 9, 2020 Received: December 11, 2020 Dear Ms. Yang: 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/cfpmp/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. 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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 {1}------------------------------------------------ https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 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, For 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}------------------------------------------------ # Indications for Use 510(k) Number (if known) #### K203617 Device Name MaxFOV 2 Indications for Use (Describe) The deep learning based Max Field-of-View (MaxFOV 2) is a CT image reconstruction method intended to produce images of the head and whole-body using Axial, and Cine acquisitions. MaxFOV 2 is designed to extend the nominal display field of view (DFoV) for cases where patient size and positioning requirements result in a portion of the patient's body to be outside of the nominal DFoV. These extended FoV images are intended for use in radiation therapy planning and are clinically useful for the simulation and planning of radiation therapy for the treatment of cancer for patients. They can also be used for visualization of patient anatomy for cases not involving therapy planning. MaxFOV 2 is intended for patients of all ages, especially bariatric patients. | Type of Use (Select one or both, as applicable) | |-------------------------------------------------| |-------------------------------------------------| X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) #### 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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There are three white flourishes or droplets evenly spaced around the perimeter of the circle, adding a dynamic element to the design. ## 510(k) Summary In accordance with 21 CFR 807.92 the following summary of information is provided: | Date: | December 10, 2020 | |-------------------------------------|--------------------------------------------------------------------------------------------------------| | Submitter: | GE Medical Systems, LLC<br>3000 North Grandview Blvd<br>Waukesha, WI 53188 | | Primary Contact: | Amy Yang<br>Regulatory Affairs Manager<br>Phone: 414-514-3904<br>Email: Amy.yang@ge.com | | Secondary Contacts: | John Jaeckle<br>Chief Regulatory Affairs Engineer<br>Phone: 262-424-9547<br>Email: john.jaeckle@ge.com | | Device Trade Name: | MaxFOV 2 | | Device Classification | Class II | | Regulation Number/<br>Product Code: | 21 CFR 892.1750 Computed tomography x-ray system / JAK | | Predicate Device Information | | | Device Name: | LightSpeed Ultra with Wide View Option | | Manufacturer: | GE Medical Systems, LLC | | 510(k) Number: | K023332, Cleared on October 23, 2002 | | Regulation Number/<br>Product Code: | 21 CFR 892.1750 Computed tomography x-ray system / JAK | | Reference Devices Information | | | Device Name: | SOMATOM DEFINITION AS OPEN | Manufacturer: Siemens Medical Systems, Inc. 510(k) Number: K130901 cleared on January 02, 2014 Regulation Number/ 21 CFR 892.1750 Computed tomography x-ray system / JAK Product Code: {4}------------------------------------------------ # GE Healthcare 510(k) Premarket Notification Submission Image /page/4/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 blue circle. There are four white, teardrop-shaped elements surrounding the circle, positioned at the cardinal directions. The logo is simple and iconic, representing the long-standing brand identity of General Electric. ### Device Description The MaxFOV 2 is an enhanced Extended Field of View (EFOV) reconstruction option for GE's CT scanners. The MaxFOV 2 utilizes a new deep learning algorithm to extend the display field of view (DFOV) beyond the CT system's scan field of View (SFOV) of 50cm to up to 80cm depending on the bore size of the CT system. CT scanners use the EFOV reconstruction algorithms to visualize tissue truncated due to large patient habitus and/or off-center patient positioning. Same as the Wide View option on the predicate, the MaxFOV 2 is designed to enable a clinically useful visualization of the skin line and CT Number of human body parts located outside of the SFOV. EFOV images are especially useful for radiation therapy planning and they can also be used for visualization of patient anatomy outside of the SFOV for routine CT imaging. This DL enabled new MaxFOV2 EFOV reconstruction process offers improved performance over the existing WideView option on the predicate device. The DL MaxFOV2 algorithm was designed and tested for GE's multiple CT scanner platforms of various bore sizes from 70cm to 80cm. These CT systems with the integrated MaxFOV 2 option remain compliant with the same standards as base CT systems. This option is commercially marketed as MaxFOV2. ### Intended Use The MaxFOV 2 reconstruction software is intended for head and whole body CT scans. ### Indications for Use The deep learning based Max Field-of-View (MaxFOV 2) is a CT image reconstruction method intended to produce images of the head and whole-body using Axial, Helical, and Cine acquisitions. MaxFOV 2 is designed to extend the nominal display field of view (DFoV) for cases where patient size and positioning requirements result in a portion of the patient's body to be outside of the nominal DFoV. These extended FoV images are intended for use in radiation therapy planning and are clinically useful for the simulation and planning of radiation therapy for the treatment of cancer for patients. They can also be used for visualization of patient anatomy for cases not involving therapy planning. MaxFOV 2 is intended for patients of all ages, especially bariatric patients. #### Technological Characteristics The MaxFOV 2 employs the same fundamental technology as that of the WideView on the predicate device. It is used in the same clinical environment and by the same intended users. Use of the MaxFOV2 does not require change in the CT scanner hardware and does not alter the CT system's control mechanism, or energy type or operating principles. The table below summarizes the substantive feature/technological differences between the predicate device and the proposed device: {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for GE (General Electric). The logo is a blue circle with the letters "GE" in a stylized, cursive font in the center. There are three water droplet shapes surrounding the circle, one on the top, and one on each side. The logo is simple and recognizable, and it is associated with a well-known and established company. # GE Healthcare 510(k) Premarket Notification Submission | Specification | Predicate Device | Proposed Device | |-----------------------------------------|---------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Wide View (K023332) | MaxFOV 2 | | Patient Population | Patients of all ages | Same | | Intended users | Dosimetrist<br>Medical Physicists<br>Radiation Oncologists | Same | | Clinical Use | Routine Clinical Use | Same | | Targeted clinical condition,<br>anatomy | Part of scanned object is located out of<br>the scan field of view. | Same | | Compatible Scan modes | Compatible with Axial, Helical, and Cine<br>scan modes. | Same | | Technology/Principles | Analytical model - classic algorithm where<br>the measured sinogram is expanded to<br>cover a FOV larger than SFOV. | MaxFOV 2 uses a CNN which is trained on<br>multiple CT scanners. MaxFOV 2's<br>reconstruction process (algorithm) contains<br>a Deep Learning based component. | | Extended Field of View Spec | Allows visualization of up to 65cm | Allows visualization of up to 80cm, same as<br>reference device | The MaxFOV 2 option has same intended use, indications for use and substantially equivalent technological characteristics as its predicate and reference device. The changes and the different technological characteristics do not raise new or different questions of safety and effectiveness. The software was developed, verified, and validated under GE Healthcare's QMS including software development lifecycle. ## Determination of Substantial Equivalence Summary of Non-Clinical Testing MaxFOV 2 has successfully completed the design control activities per our quality system that conforms to the Quality System Regulations of 21CFR 820 and ISO 13485, including the Software Development Life Cycle process per IEC62304. The following quality assurance measures have been applied to the development of the system: - Risk Analysis - Required Reviews - Design Reviews - . Software Development Lifecycle - . Testing on unit level (Module verification) - . Integration testing (System verification) - . Performance testing (Verification) - Safety testing (Verification) - . Simulated use testing (Validation) {6}------------------------------------------------ # GE Healthcare 510(k) Premarket Notification Submission 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 decorative swirls around the letters and the outer edge of the circle. The logo is simple and recognizable, and it is associated with a well-known and established company. A suite of engineering bench testing using phantoms was performed to evaluate image quality performance of MaxFOV 2. These tests include: - . MaxFOV 2 Patient contour (Skin line) accuracy and CT Number accuracy - . MaxFOV 2 IQ Performance Evaluation using a very large phantom - MaxFOV 2 Performance Evaluation Using an anthropomorphic phantom This set of testing was repeated and performed on different GE CT system platforms, all test results demonstrated MaxFOV 2's consistent and acceptable performance. The complete testing and results did not raise different questions of safety and effectiveness than associated with predicate device. We consider the proposed device is substantially equivalent to the predicate and reference devices, and hence is safe and effective for its intended use. ### Summary of Clinical Testing A clinical reader study with 49 CT exams was conducted. The exams were acquired from different GE CT system platforms and were scored by 5 external, clinical readers. The exams represent typical and challenging RTP-relative scenarios where the MaxFOV2 will likely be used. The readers used a 5 point Likert scale to score the images for each of the following aspects: depiction of the patient's skin surface; depicted tissue densities in the extended FOV region; and overall image quality. The results of the study support substantial equivalence and performance claims. #### Substantial Equivalence MaxFOV 2 was developed under GE Healthcare's quality system. MaxFOV2's design, verification, validation and risk management processes did not identify any new hazards, unexpected results, or adverse effects stemming from the changes to the predicate. Software verification & validation, along with bench testing and the clinical reader study demonstrate that MaxFOV 2 is substantially equivalent and hence as safe and as effective as the legally marketed predicate device, hence is safe and effective for its intended use. The substantial equivalence is also based on the submitted software documentation that is consistent with the appropriate Level of Concern as recommended by pre-market software guidance. #### Conclusion Based on development under GE Healthcare's quality system, the successful verification and validation, engineering bench and clinical testing, GE Healthcare believes that MaxFOV 2 is substantially equivalent to the predicate device and hence is safe and effective for its intended use.