Biograph Vision

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Siemens Medical Solutions USA, Inc. % Alaine Medio PET Regulatory Projects Manager 810 Innovation Drive KNOXVILLE TN 37932 Re: K180811 Trade/Device Name: Biograph Vision PET/CT Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: II Product Code: KPS, JAK Dated: March 28, 2018 Received: March 29, 2018 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. 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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. May 23, 2018 {1}------------------------------------------------ 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. For comprehensive regulatory information about mediation-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, Michael D. O'Hara For 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}------------------------------------------------ DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration ## Indications for Use 510(k) Number (if known) K180811 Device Name Biograph Vision PET/CT Indications for Use (Describe) The Siemens Biograph Vision PET/CT systems are combined X-Rav 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 determinine various metabolic (molecular) and physiologic functions within the human body and utilizes the CT for fast attenuation correction mans 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 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 of the inages 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. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | <span> ☑ Prescription Use (Part 21 CFR 801 Subpart D) </span> <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> | 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. 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 "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 QMB number." {3}------------------------------------------------ Identification of the Submitter # 510(k) Summary as required by 21 CFR Part 807.87(h) | 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)218-2703 | | Fax Number: | (865)218-3019 | | Date of Submission: | March 28,2018 | | 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 mCT Family of PET/CT Systems | |--------------------------|---------------------------------------| | Manufacturer: | Siemens Medical Solutions USA, Inc. | | Product Code: | 90 KPS and 90 JAK | | Device Class: | Class II | | 510(k) Number: | K173578 | | Reference Devices: | | | Device Name: | Discovery MI | |----------------|---------------------------------| | 510(k) Number: | K161574 | | Device Name: | Ingenuity Digital PET/CT System | | 510(k) Number: | K123599 | #### 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 mCT (K173578). The key difference between the Biograph mCT (predicate device) and the Biograph Vision PET/CT is the replacement of PhotoMultiplier Tubes (PMT) with Silicon PhotoMultipliers (SiPM). SiPMs are a photon sensitive technology built by combining a solid state photodiode array and a silicon substrate. The SiPMs allow close coupling to the scintillators (crystals) and a higher active area of detectors to scintillators. This combination results in superior performance compared to the photomultiplier tubes design used in previous generation PET block detectors. {5}------------------------------------------------ #### Intended Use: The Biograph Vision PET/CT systems are radiological imaging system 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 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 Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information. {6}------------------------------------------------ #### Performance Testing / Safety and Effectiveness: PET Testing in accordance with NEMA NU2:2012 was conducted on the Biograph Vision 600. | Performance Criteria | Results | Acceptance | |----------------------------------------------------------------|---------|--------------------------| | Resolution - Full Size | | | | Transverse Resolution FWHM @ 1 cm | Pass | ≤ 4.0 mm | | Transverse Resolution FWHM @ 10 cm | Pass | ≤ 4.8 mm | | Transverse Resolution FWHM @ 20 cm | Pass | ≤ 5.2 mm | | Axial Resolution FWHM @ 1 cm | Pass | ≤ 4.3 mm | | Axial Resolution FWHM @ 10 cm | Pass | ≤ 5.4 mm | | Axial Resolution FWHM @ 20 cm | Pass | ≤ 5.4 mm | | Count Rate / Scatter / Sensitivity | | | | Sensitivity @435 keV LLD | Pass | ≥ 15.0 cps/kBq | | Count Rate peak NECR | Pass | ≥250 kcps @ ≤ 32 kBq/cc | | Count Rate peak trues | Pass | ≥1100 kcps @ ≤ 56 kBq/cc | | Scatter Fraction at peak NECR | Pass | ≤43% | | Mean bias (%) at peak NEC | Pass | ≤ 6% | | Image Quality (4 to 1) - (% Contrast / Background Variability) | | | | 10mm sphere | Pass | ≥ 55% / ≤ 10% | | 13mm sphere | Pass | ≥ 60% / ≤ 9% | | 17mm sphere | Pass | ≥ 65% / ≤8% | | 22mm sphere | Pass | ≥ 70% / ≤7% | | 28mm sphere | Pass | ≥ 75% / ≤ 6% | | 37mm sphere | 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. 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 {7}------------------------------------------------ - 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. 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 mCT predicate device.