Discovery MI Gen2

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GE Medical Systems, LLC. % Ms. Laura Turner Regulatory Affairs Leader 3000 North Grandview Blvd WAUKESHA WI 53188 Re: K211846 Trade/Device Name: Discovery MI Gen2 Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: Class II Product Code: KPS, JAK Dated: June 14, 2021 Received: June 15, 2021 Dear Ms. Turner: 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. 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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, 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) K211846 Device Name Discovery MI Gen2 #### Indications for Use (Describe) The GE Discovery MI Gen2 is a PET/CT system for producing attenuation corrected PET images. It is intended to be used by qualified health care professionals for imaging the distribution and localization of any positron-emitting radiopharmaceutical in a patient, for the assessment of metabolic (molecular) and physiologic function in patients, with a wide range of sizes and extent of disease, of all ages. Discovery MI Gen2 is intended to image the whole body, head, heart, bone, the gastrointestinal and lymphatic systems, and other organs. The images produced by the system may be used by physicians to aid in radiotherapy treatment planning, therapy guidance and monitoring, and in interventional radiology procedures. The images may also be used for precise functional and anatomical mapping (localization, registration, and fusion). When used with radiopharmaceuticals approved by the regulatory in the country of use, the raw and image data is an aid in; detection, localization, evaluation, diagnosis, staging, monitoring, and/or follow up, of abnormalities, lesions, tumors, inflammation, infection, organ function, disorders, and/or disease, such as, but not limited to, those in oncology, cardiology, and neurology. Examples of which are: Cardiology: - Cardiovascular disease - · Myocardial perfusion - · Myocardial viability - Cardiac inflammation - · Coronary artery disease Neurology: - · Epilepsy · Dementia, such as Alzheimer's disease, Lewy body dementia, Parkinson's disease with dementia, and frontotemporal dementia - · Movement disorders, such as Parkinson's and Huntington's disease - Tumors - · Inflammation - · Cerebrovascular disease such as acute stroke, chronic and acute ischemia - · Traumatic Brain Injury (TBI) Oncology/Cancer: - Non-Small Cell Lung Cancer - Small Cell Lung Cancer - Breast Cancer - · Prostate Cancer - · Hodgkin's disease - Non-Hodgkin's lymphoma - · Colorectal Cancer - Melanoma Discovery MI Gen2 is also intended for stand-alone, diagnostic CT imaging in accordance with the stand-alone CT {3}------------------------------------------------ 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. 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The logo is colored in a light blue hue, and the background is white. # K211846 # 510(k) SUMMARY OF SAFETY AND EFFECTIVNESS This 510(k) summary of Safety and Effectiveness information is submitted in accordance with the requirement of 21 CFR Part 807.87(h): | Date: | June 14, 2021 | |---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Submitter: | GE Medical Systems, LLC<br>3000 North Grandview Blvd<br>Waukesha, WI 53188 | | Primary Contact: | Laura Turner<br>Regulatory Affairs Leader<br>GE Healthcare<br>Phone 262-200-1044<br>Email: laura.turner@ge.com | | Secondary Contacts: | John Jaeckle<br>Chief Regulatory Affairs Strategist<br>GE Healthcare<br>Tel: 262-424-9547<br>Email: john.jaeckle@med.ge.com<br>Helen Peng<br>Regulatory Affairs Director<br>GE Healthcare | # PRODUCT IDENTIFICTION | Device Name: | Discovery MI Gen 2<br>Also marketed as Discovery MI, Discovery MI Gen2, Discovery Max<br>and Discovery Max+ | |------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------| | Regulation number/<br>Product Code | Emission Computed Tomography System per 21CFR 892.1200<br>Computed Tomography X-ray System per 21 CFR892.1750 / 90 KPS<br>and 90 JAK | Email: hong.peng@med.ge.com {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 three white teardrop shapes around the outside of the circle. The logo is simple and recognizable. Device Classification Class II #### Predicate Device Information: | Device Name | Discovery MI | |------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------| | Manufacturer | GE Medical System, LLC. | | | 3000 North Grandview Blvd | | | Waukesha, WI 53188 | | 510(k) number | K161574 cleared on August 11, 2016 | | Regulation number<br>/product Code | Emission Computed Tomography System per 21CFR 892.1200<br>Computed Tomography X-ray System per 21 CFR892.1750 / 90 KPS<br>and 90 JAK | #### Device Description: GE's Discovery MI (DMI) Gen2, same as the unmodified predicate device, is a hybrid digital PET/CT diagnostic imaging system combining a GE Positron Emission Tomography (PET) System and a GE Computed Tomography (CT) System. The DMI Gen2 is intended for CT attenuation corrected, anatomically localized PET imaging of the distribution of positron-emitting radiopharmaceuticals. lt is intended to image the whole body, head, heart, brain, lung, breast, bone, the gastrointestinal and lymphatic systems, and other organs. The system is also intended for stand-alone, diagnostic CT imaging. GE has modified the cleared Discovery MI (K161574) within our design controls to include a 6ring configuration that provides 30 cm Axial Field of View (AFOV) coverage. DMI Gen2 employs the same detector design architecture and manufacturing process as in the predicate to offer scalable ring configurations (3-ring, 4-ring, 5-ring and 6-ring) to have scalable AFOV coverage (15cm, 20cm, 25cm and 30cm) and corresponding imaging performances. The introduction of the 30 cm configuration comes with several clinical benefits. The higher AFOV coverage, compared to other Discovery MI configurations, allows a patient to be scanned using fewer field of views, which could allow for scanning in shorter time. Additionally, sensitivity of the 30 cm system is higher compared to other configurations, like the Discovery MI 25 cm, which assists in dose reduction and better detectability of small lesions. These claims are not clinical instructions/recommendations to a physician on how their patient(s) should be scanned. Rather, they are system imaging performance-related claims. {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, cursive font, enclosed within a blue circle. There are three white, teardrop-shaped elements evenly spaced around the perimeter of the circle, giving the impression of motion or energy. This modified system has the same intended use and indications for use as its predicate device. The modified system employs the same basic fundamental operating principles as the existing marketed product Discovery MI, and is of comparable type and substantially equivalent to its predicate device. #### Intended Use The Discovery MI Gen2 PET/CT system is intended for CT attenuation corrected, anatomically localized PET imaging of the distribution of positron-emitting radiopharmaceuticals. It is intended to image the whole body, head, heart, brain, lung, breast, bone, the gastrointestinal and lymphatic systems, and other organs. The system is also intended for stand-alone, diagnostic CT imaging. #### Indications for Use The GE Discovery MI Gen2 is a PET/CT system for producing attenuation corrected PET images. lt is intended to be used by qualified health care professionals for imaging the distribution and localization of any positron-emitting radiopharmaceutical in a patient, for the assessment of metabolic (molecular) and physiologic function in patients, with a wide range of sizes and extent of disease, of all ages. Discovery MI Gen2 is intended to image the whole body, head, heart, brain, lung, breast, bone, the gastrointestinal and lymphatic systems, and other organs. The images produced by the system may be used by physicians to aid in radiotherapy treatment planning, therapy guidance and monitoring, and in interventional radiology procedures. The images may also be used for precise functional and anatomical mapping (localization, registration, and fusion). When used with radiopharmaceuticals approved by the regulatory authority in the country of use, the raw and image data is an aid in; detection, evaluation, diagnosis, staging, restaging, monitoring, and/or follow up, of abnormalities, lesions, tumors, inflammation, infection, organ function, disorders, and/or disease, such as, but not limited to, those in oncology, cardiology, and neurology. Examples of which are: #### Cardiology: - Cardiovascular disease - Myocardial perfusion - Myocardial viability - Cardiac inflammation - Coronary artery disease #### Neurology: {7}------------------------------------------------ Image /page/7/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 blue circle. The circle has decorative swirls or flourishes around the perimeter, giving it a classic and recognizable appearance. - Epilepsy - . Dementia, such as Alzheimer's disease, Lewy body dementia, Parkinson's disease with dementia, and frontotemporal dementia - Movement disorders, such as Parkinson's and Huntington's disease - Tumors - . Inflammation - Cerebrovascular disease such as acute stroke, chronic and acute ischemia - Traumatic Brain Injury (TBI) #### Oncology/Cancer: - Non-Small Cell Lung Cancer - Small Cell Lung Cancer - Breast Cancer - Prostate Cancer - Hodgkin's disease - Non-Hodgkin's lymphoma - Colorectal Cancer - . Melanoma Discovery MI Gen2 is also intended for stand-alone, diagnostic CT imaging in accordance with the stand-alone CT system's cleared indications for use # Technology Discovery MI Gen2 employs the same basic operating principles and fundamental technologies as the predicate device. The table below summarizes the substantive feature/technological differences between the predicate device and the proposed device: {8}------------------------------------------------ Image /page/8/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 circle. There are decorative flourishes resembling water droplets or stylized leaves surrounding the circle. The logo is presented in a blue color scheme. # GE Healthcare 510(k) Premarket Notification Submission | Specification/<br>Attribute | Predicate Device | Proposed Device | |---------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Discovery MI K161574 | | | PET Gantry | Multiple detector ring size<br>configurations (15, 20, 25 cm axial<br>FOV) | Multiple detector ring size<br>configurations (15, 20, 25, 30 cm<br>axial FOV). | | Detector Unit | SiPM-based light sensor with ASIC | Same | | | LYSO scintillator crystal | LYSO or LGSO scintillator crystals | | CT System | Revolution EVO - Full suite of cleared<br>CT application software with<br>modifications (K131576) | Revolution EVO - Full suite of cleared<br>CT application software with<br>modifications including Deep<br>Learning Image Reconstruction<br>(DLIR) K193170 | | Whole Body<br>Dynamic Acquisition<br>(WBDA) | Whole body dynamic acquisition<br>capability enabled by manually<br>performing multiple passes that are<br>also referred as static scans of a<br>patient | Whole body dynamic acquisition<br>capability with automation to help<br>the user to perform the scan with<br>adequate user interface and<br>dedicated tools to improve the user<br>experience | | AutoIN | - | Allows the operator to move the<br>patient table from the operator<br>console within the operator room,<br>rather than from the gantry control<br>panel for landmarking | {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 blue circle. There are decorative swirls or flourishes around the outer edge of the circle, giving it a classic and recognizable appearance. # Determination of Substantial Equivalence Discovery MI Gen2 has completed testing and is in compliance with IEC 60601-1 Ed. 3, 21CFR Subchapter J, and NEMA XR-25, XR-26, XR-28 and XR-29. The proposed device has successfully completed all testing per our quality system as well as comparison testing to the predicate device. It was designed and is manufactured under the Quality System Regulations of 21CFR 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 Discovery MI Gen2 system is of comparable type and substantially equivalent to our currently marketed system Discovery MI (K161574). The substantial equivalence was also based on software documentation for a "Moderate" level of concern device. # Summary of Additional Testing A broad range of engineering tollowing GEHC's quality management system has been completed to demonstrate that the design outputs of the proposed device meet the design inputs, and the changes as compared to the predicate device do not raise new questions about safety and effectiveness. In addition to the standards certification testing and system verification and validation testing successfully completed, additional engineering (non-Clinical testing) was performed to provide the requisite data to substantiate performance claims and ultimately substantial equivalence to the legally marketed predicate device. # Non-Clinical Testing Image Performance evaluation testing used a variety of test methods and phantoms covering a broad base of relevant imaging performance and image quality test cases that demonstrate Discovery MI Gen2's ability to provide diagnostic and clinically relevant images across the full range of its expected use cases and patient populations. Mathematical and physics analysis {10}------------------------------------------------ Image /page/10/Picture/0 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 border. The logo is blue, and there are small, stylized water droplets or flourishes around the outer edge of the circle, adding a decorative element to the design. were performed to demonstrate that each performance claim was successfully verified and substantiated. All testing was performed using scientific methods that are standardized (e.g. NEMA, FDA Guidance), well established, and/or reviewed in previous GE's PETCT or Nuclear Medicine clearances. # Clinical Testing Discovery MI Gen2 is designed and built entirely from existing and cleared systems, subsystems, components, and technologies of its Predicate Device (Discovery MI). This type of change in Discovery MI Gen 2 is supported using scientific, established/standardized, engineering/physics-based performance testing, without inclusion of clinical images, to demonstrate that the device is as safe and as effective as the predicate devices. Given the above information and the type and scope of the changes, particularly the addition of the 30 cm, 6-ring, AFOV configuration, clinical testing is not required to demonstrate that the Discovery MI Gen 2 is as safe and as effective as the legally marketed predicate device. # Substantial Equivalence Conclusion: Based on the conformance to standards, development under our quality system, and the engineering testing provided, GE Healthcare believes that the Discovery MI Gen2 is as safe and effective, and performs in a substantially equivalent manner to the predicate device Discovery MI (K161574).