Biograph Vision

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Siemens Medical Solutions USA, Inc. % Alaine Medio PET Regulatory Projects Manager 810 Innovation Drive KNOXVILLE TN 37932 May 6, 2019 Re: K190900 Trade/Device Name: Biograph Vision PET/CT Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: Class II Product Code: KPS, JAK Dated: April 5, 2019 Received: April 8, 2019 Dear Alaine Medio: 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. 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 {1}------------------------------------------------ https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 medical devices and radiation-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, For Thalia T. Mills, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 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) K190900 Device Name Biograph Vision PET/CT #### Indications for Use (Describe) The Siemens Biograph Vision PET/CT systems are combined X-Ray Computed Tomography (CT) and Position Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information. The CT component produces cross-sectional images of the body by computer reconstruction of X-Ray wansmission data from either the same axial plane taken at different angles or spiral planes taken at different angles. The PET subsystem images and measures the distribution of PET radiopharmaceuticals in humans for the purpose of determining various metabolic (molecular) and physiologic functions within the human body and utilizes the CT for fast attenuation correction maps for PET studies and precise anatomical reference for the fused PET and CT images. The system maintains independent functionality of the CT and PET devices, allowing for single modality CT and / or PET diagnostic imaging. These systems are intended to be utilized by approxiately trained health care professionals to aid in detecting. diagnosing, staging and restaging of lesions, tumors, disease and organ function for the evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The images produced by the system can also be used by the physician to aid in radiotherapy treatment planning and interventional radiology procedures. This CT system can be used for low dose lung cancer screening in high risk populations * * As defined by professional medical societies. Please refer to clinical literature, including the results of the National Lune Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information. | Type of Use (Select one or both, as applicable) | <table style="border:none"><tr><td><span> <b> <span style="font-size: 16px">☒</span> </b> Prescription Use (Part 21 CFR 801 Subpart D) </span></td><td><span> <b> <span style="font-size: 16px">☐</span> </b> Over-The-Counter Use (21 CFR 801 Subpart C) </span></td></tr></table> | <span> <b> <span style="font-size: 16px">☒</span> </b> Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span> <b> <span style="font-size: 16px">☐</span> </b> Over-The-Counter Use (21 CFR 801 Subpart C) </span> | |-------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------| | <span> <b> <span style="font-size: 16px">☒</span> </b> Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span> <b> <span style="font-size: 16px">☐</span> </b> Over-The-Counter Use (21 CFR 801 Subpart C) </span> | | | CONTINUE ON A SEPARATE PAGE IF NEEDED. 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Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [PRAStaff@fda.hhs.gov](mailto:PRAStaff@fda.hhs.gov) *"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."* {3}------------------------------------------------ # 510(k) Summary as required by 21 CFR Part 807.87(h) | Identification of the Submitter | | |---------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------| | Submitter: | Alaine Medio<br>Regulatory Affairs<br>Siemens Medical Solutions USA, Inc.<br>Molecular Imaging<br>810 Innovation Drive<br>Knoxville, TN 37932 | | Alternative Contact: | Tabitha Estes<br>Regulatory Affairs | | Manufacturer: | Siemens Medical Solutions USA, Inc.<br>Molecular Imaging<br>2501 North Barrington Road<br>Hoffman Estates, IL 60192 | | Telephone Number: | (865)206-0337 | | Fax Number: | (865)218-3019 | | Date of Submission: | April 5, 2019 | | Identification of the product | | | Device Proprietary Name: | Biograph Vision PET/CT | | Common Name: | Positron Emission Tomography (PET) System<br>Computed Tomography (CT) System | | Classification Name: | Emission Computed Tomography System per 21 CFR<br>892.1200<br>Computed Tomography X-Ray System per 21 CFR 892.1750 | | Product Code: | 90 KPS and 90 JAK | | Classification Panel: | Radiology | | Device Class: | Class II | {4}------------------------------------------------ #### Marketed Devices to which Equivalence is claimed #### Predicate: | Device Proprietary Name: | Biograph Vision PET/CT | |--------------------------|------------------------------------| | Manufacturer: | Siemens Medical Solutions USA, Inc | | Product Code: | 90 KPS and 90 JAK | | Device Class: | Class II | | 510(k) Number: | K180811 | | Reference Devices: | | | Device Name: | Biograph mCT | | 510(k) Number: | K173578 | #### Device Description: The Biograph Vision systems are combined multi-slice X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners. These systems are designed for whole body oncology, neurology and cardiology examinations. The Biograph Vision systems provide registration and fusion of high-resolution metabolic and anatomic information from the two major components of each system (PET and CT). Additional components of the system include a patient handling system and acquisition and processing workstations with associated software. Biograph Vision software is a command based program used for patient management, data management, scan control, image reconstruction and image archival and evaluation. All images conform to DICOM imaging format requirements. The Biograph Vision PET/CT, which is the subject of this application, is substantially equivalent to the commercially available Biograph Vision PET/CT (K180811). The key differences between the current Biograph Vision (predicate device) and the Biograph Vision PET/CT that is the subject of this application is the addition of two new models (Biograph Vision 450 and Biograph Vision 450 Edge) with a smaller axial PET Field of View, as well as additional software modifications to daily / weekly Quality Control that is applicable to all models of the Biograph Vision. {5}------------------------------------------------ ## Intended Use: The Biograph Vision PET/CT systems are radiological imaging systems that are a combination of a positron emission tomography (PET) camera system for nuclear medicine images, and a computed tomography (CT) camera system for x-ray images. The nuclear medicine images and the x-ray images may be registered and displayed in a fused format (overlaid in the same orientation) for the anatomical localization of the nuclear medicine data (i.e., distribution of radiopharmaceuticals). The PET and CT portions of the system may be used independently or in combination. The PET and CT images may be transferred to other systems for radiation therapy planning or additional processing. ## Indications for Use The Siemens Biograph Vision PET/CT systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information. The CT component produces cross-sectional images of the body by computer reconstruction of X-Ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles. The PET subsystem images and measures the distribution of PET radiopharmaceuticals in humans for the purpose of determining various metabolic (molecular) and physiologic functions within the human body and utilizes the CT for fast attenuation correction maps for PET studies and precise anatomical reference for the fused PET and CT images. The system maintains independent functionality of the CT and PET devices, allowing for single modality CT and / or PET diagnostic imaging. These systems are intended to be utilized by appropriately trained health care professionals to aid in detecting, localizing, diagnosing, staging of lesions, tumors, disease and organ function for the evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The images produced by the system can also be used by the physician to aid in radiotherapy treatment planning and interventional radiology procedures. This CT system can be used for low dose lung cancer screening in high risk populations.* *As defined by professional medical societies. Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information. {6}------------------------------------------------ ## Summary of the Technological Characteristics of the Biograph Vision compared to the predicate device: The Biograph Vision PET/CT, which is the subject of this application, is substantially equivalent to the commercially available Biograph Vision PET/CT (K180811). The key differences between the current Biograph Vision (predicate device) and the Biograph Vision PET/CT that is the subject of this application is the addition of two new models (Biograph Vision 450 and Biograph Vision 450 Edge) with a smaller axial PET Field of View: | Feature | Biograph Vision 450<br>/ 450 Edge | Biograph Vision<br>600 / 600 Edge<br>(K180811) | Comparison to Predicate<br>Device - K180811 | |---------------------------------|------------------------------------------------------------------|------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | General Specifications | | | | | Height | 203.6 cm (80.2 in) | 203.6 cm (80.2 in) | No Change | | Width | 234.4 cm (92.3in) | 234.4 cm (92.3in) | No Change | | Depth | 136 cm (53.6 in) | 136 cm (53.6 in) | No Change | | Weight | 3734 kg (8231 lbs) | 3759kg (8287 lbs) | Reduction of detectors for new<br>models. | | Patient Port Diameter | 78 cm (30.7 in) | 78 cm (30.7 in) | No Change | | Power Requirements | 380-480V~, 50/60Hz,<br>10 kVA Continuous,<br>150kVA Intermittent | 380-480V~, 50/60Hz,<br>10 kVA Continuous,<br>150kVA Intermittent | No Change | | PET System | | | | | Detectors | SiPM with Lutetium<br>Oxyorthosilicate (LSO)<br>crystals | SiPM with Lutetium<br>Oxyorthosilicate<br>(LSO) crystals | No Change | | PET Axial FOV | 200 mm | 263 mm | Reduction of detectors for new<br>models with smaller PET Axial<br>Field of View. | | Performance<br>Specifications | Tested in Accordance<br>with NEMA NU2 2018 | Tested in Accordance<br>with NEMA NU2 2018 | See below for PET Performance<br>specifications. Changes in<br>Count Rate peak NECR, Count<br>Rate peak Trues and Sensitivity<br>due to difference in Axial Field<br>of View for new models. | | CT System | | | | | CT subcomponent<br>incorporated | SOMATOM Definition<br>AS / AS+ and<br>SOMATOM Definition<br>Edge | SOMATOM Definition<br>AS / AS+ and<br>SOMATOM Definition<br>Edge | No Change | Additional changes include updates to the quality control software to implement: - . QualityGuard (a feature previously cleared with the Biograph mCT K173578) that provides for phantom-free daily calibration activities; and - . Bad Block Correction, where the system compensates for bad blocks in the reconstructed image without affecting image quality. {7}------------------------------------------------ Both features are provided for all models of Biograph Vision, and are designed to improve quality control workflow while minimizing system downtime. #### Performance Testing / Safety and Effectiveness: PET Testing in accordance with NEMA NU2:2018 was conducted on the various Biograph Vision models. | Performance Criteria | Biograph Vision 450 / 450 Edge | | Biograph Vision 600 / 650 Edge | | | |----------------------------------------------------------------|--------------------------------|-------------------------|--------------------------------|--------------------------|--| | Resolution - Full Size | Results | Acceptance | Results | Acceptance | | | Transverse Resolution<br>FWHM @ 1 cm | Pass | ≤ 4.0 mm | Pass | ≤ 4.0 mm | | | Transverse Resolution<br>FWHM @ 10 cm | Pass | ≤ 4.8 mm | Pass | ≤ 4.8 mm | | | Transverse Resolution<br>FWHM @ 20 cm | Pass | ≤ 5.2 mm | Pass | ≤ 5.2 mm | | | Axial Resolution<br>FWHM @ 1 cm | Pass | ≤ 4.3 mm | Pass | ≤ 4.3 mm | | | Axial Resolution<br>FWHM @ 10 cm | Pass | ≤ 5.4 mm | Pass | ≤ 5.4 mm | | | Axial Resolution<br>FWHM @ 20 cm | Pass | ≤ 5.4 mm | Pass | ≤ 5.4 mm | | | Count Rate / Scatter / Sensitivity / etc. | | | | | | | Sensitivity @435 keV<br>LLD | Pass | ≥ 8.0 cps/kBq | Pass | ≥ 15.0 cps/kBq | | | Count Rate peak NECR | Pass | ≥140 kcps @ ≤ 32 kBq/cc | Pass | ≥250 kcps @ ≤ 32 kBq/cc | | | Count Rate peak trues | Pass | ≥600 kcps @ ≤ 56 kBq/cc | Pass | ≥1100 kcps @ ≤ 56 kBq/cc | | | Scatter Fraction at<br>peak NECR | Pass | ≤43% | Pass | ≤43% | | | Mean bias (%) at peak<br>NEC | Pass | ≤ 6% | Pass | ≤ 6% | | | Co-Registration<br>Accuracy | Pass | ≤ 5 mm | Pass | ≤ 5 mm | | | Time of Flight<br>Resolution at peak NEC | Pass | ≤249 ps | Pass | ≤249 ps | | | Image Quality (4 to 1) - (% Contrast / Background Variability) | | | | | | | 10mm sphere | Pass | ≥ 55% / ≤ 10% | Pass | ≥ 55% / ≤ 10% | | | 13mm sphere | Pass | ≥ 60% / ≤ 9% | Pass | ≥ 60% / ≤ 9% | | | 17mm sphere | Pass | ≥ 65% / ≤ 8% | Pass | ≥ 65% / ≤ 8% | | | 22mm sphere | Pass | ≥ 70% / ≤ 7% | Pass | ≥ 70% / ≤ 7% | | | 28mm sphere | Pass | ≥ 75% / ≤ 6% | Pass | ≥ 75% / ≤ 6% | | | 37mm sphere | Pass | > 80% /<5% | Pass | > 80% /<5% | | Performance testing for the CT subsystem was included in the original premarket notification for the CT subsystems and there have been no changes affecting this testing. {8}------------------------------------------------ Risk Management is ensured via a risk analysis in compliance with ISO 14971 to identify and provide mitigation to potential hazards beginning early in the design cycle and continuing throughout the development of the product. Siemens Medical Solutions, USA Inc. adheres to recognized and established industry standards such as IEC 60601-1 series and 21 CFR 1020.30 and 21 CFR 1020.33 to minimize electrical, mechanical and radiation hazards. Siemens claims compliance with the following product standards for the Biograph Vision: - IEC 60601-1: 2005+ A1:2012 - IEC 60601-1-2: 2014 - IEC 60601-1-3: 2013 - IEC 60601-1-6:2010 +A1:2013 - IEC 60601-2-28:2010 ● - IEC 60601-2-44: 2009 + A1:2012 + A2:2016 - IEC 62366-1:2015 - IEC 61223-2-6:2006 - IEC 61223-3-5:2004 - NEMA XR 25: 2010 - NEMA XR 28: 2013 - NEMA XR 29: 2013 - NEMA PS3.1-3.20 Additionally, the Biograph Vision has been developed in accordance with the requirements of the following standards: - IEC 62304:2006 +A1:2015 - ISO 14971:2012 (ISO 14971:2007) The device labeling contains instructions for use and any necessary cautions and warnings to provide for safe and effective use of the device. Cybersecurity information in accordance with FDA Guidance documents issued October 2, 2014 has been provided. The Biograph Vision software has specific cybersecurity controls to prevent unauthorized access, modifications, misuse or denial of use. Additionally, controls are enabled to prevent the unauthorized use of information that is stored, accessed or transferred between the Biograph Vision and external devices. Verification and validation of Siemens systems is performed in accordance with documented procedures, design and code reviews, test plans and specifications. Traceability of the requirements specified in the requirement specifications and functional specifications is ensured during component integration, software validation and system testing. {9}------------------------------------------------ All Performance testing met the predetermined acceptance values. This, coupled with the successful verification and validation testing demonstrates that the Biograph Vision functions as intended and that performance is comparable to the predicate devices. #### Statement regarding Substantial Equivalence: There have been no changes implemented in the Biograph Vision that impact either the fundamental scientific technology or the indications for use. The Biograph Vision described in this Premarket Notification is substantially equivalent to the currently commercially available Biograph Vision predicate device.