syngo.CT Applications

{0}------------------------------------------------ January 4, 2024 Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. Siemens Medical Solutions USA, Inc. Clayton Ginn Regulatory Affairs Professional 810 Innovation Drive KNOXVILLE, TN 37932 Re: K232136 Trade/Device Name: syngo.CT Applications Regulation Number: 21 CFR 892.1750 Regulation Name: Computed Tomography X-Ray System Regulatory Class: Class II Product Code: JAK Dated: December 13, 2023 Received: December 13, 2023 Dear Clayton Ginn: 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 (the 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 available 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. Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). {1}------------------------------------------------ Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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. 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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 mediation-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, Image /page/1/Picture/6 description: The image shows the name "Gabriela M. Rodal -S" in a simple, sans-serif font. The text is arranged vertically, with "Gabriela M." on the first line and "Rodal -S" on the second line. The text is black against a white background. Digitally signed by Gabriela M. Rodal -S for Lu Jiang, Ph.D. Assistant Director DHT8B: Division of Radiologic Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K232136 Device Name syngo.CT Applications Indications for Use (Describe) syngo.CT Applications is a set of software applications for advanced visualization, measurement, and evaluation for specific body regions. This software package is designed to support the radiologists and physicians from emergency medicine, specialty care, urgent care, and general practice e.g. in the: - · Evaluation of perfusion of organs and tumors and myocardial tissue perfusion - · Evaluation of bone structures and detection of bone lesions - · Evaluation of CT images of the heart - · Evaluation of the coronary lesions - · Evaluation of the mandible and maxilla - · Evaluation of dynamic vessels and extended phase handling · Evaluation of the liver and its intrahepatic vessel structures to identify the vascular territories of sub-vessel systems in the liver - Evaluation of neurovascular structures - · Evaluation of the lung parenchyma - · Evaluation of non-enhanced Head CT images - · Evaluation of vascular lesions | Type of Use (Select one or both, as applicable) | |-------------------------------------------------| |-------------------------------------------------| | <div> <span> <span style="font-size:16px">☒</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | |--------------------------------------------------------------------------------------------------------------------| | <div> <span> <span style="font-size:16px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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Identification of the Submitter | Submitter / Primary Contact Person | Clayton Ginn | |------------------------------------|-----------------------------------------------| | | Regulatory Affairs | | | clayton.ginn@siemens-healthineers.com | | | +1 (865) 898-2692 | | Secondary Contact Person | Monsuru (Kenny) Bello | | | Regulatory Affairs | | | monsuru.bello@siemens-healthineers.com | | | +1 (240) 601-3848 | | Submitter Address | Siemens Medical Solutions, Inc. USA | | | Molecular Imaging | | | 810 Innovation Drive | | | Knoxville, TN 37932 | | | Establishment Registration Number: 1034973 | | Manufacturing Site | Siemens Healthcare GmbH | | | Siemensstr 1 -or- Rittigfeld | | | Forchheim, Bavaria, DE 91301 | | | Establishment Registration Number: 3004977335 | | Importer/Distributor | Siemens Medical Solutions USA, Inc. | | | 40 Liberty Boulevard | | | Malvern, PA 19355 | | | Establishment Registration Number: 2240869 | # 2. Device Name and Classification | Product Name: | syngo.CT Applications | |-----------------------|-------------------------------------| | Propriety Trade Name: | syngo.CT Applications | | Regulation Name: | Computed tomography x-ray system | | Classification Name: | System, X-ray, Tomography, Computed | | Classification Panel: | Radiology | | CFR Section: | 21 CFR §892.1750 | | Device Class: | Class II | | Product Code: | JAK | # 3. Predicate Devices #### Primary Predicate Device: | Trade Name: | syngo.CT Applications | |-----------------------|-------------------------------------| | 510(k) Number: | K220450 | | Clearance Date: | 03/07/2022 | | Regulation Name: | Computed tomography x-ray system | | Classification Name: | System, X-ray, Tomography, Computed | | Classification Panel: | Radiology | {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the word "Healthineers" is a graphic of orange dots arranged in a circular pattern. CFR Section: 21 CFR §892.1750 Device Class: Class II Product Code: JAK #### Reference Devices | Trade Name: | syngo.CT CaScoring | |-----------------------|-------------------------------------| | 510(k) Number: | K221219 | | Clearance Date: | 05/17/2022 | | Regulation Name: | Computed tomography x-ray system | | Classification Name: | System, X-ray, Tomography, Computed | | Classification Panel: | Radiology | | CFR Section: | 21 CFR §892.1750 | | Device Class: | Class II | | Product Code: | JAK | | Trade Name: | syngo.CT Extended Functionality | | 510(k) Number: | K203699 | | Clearance Date: | 04/30/2021 | | Regulation Name: | Computed tomography x-ray system | | Classification Name: | System, X-ray, Tomography, Computed | | Classification Panel: | Radiology | | CFR Section: | 21 CFR §892.1750 | | Device Class: | Class II | JAK #### 4. Device Description Product Code: The syngo.CT Applications are syngo based post-processing software applications to be used for viewing and evaluating CT images provided by a CT diagnostic device and enabling structured evaluation of CT images. The syngo.CT Applications is a combination of fourteen (14) medical devices which are handled as features / functionalities within syngo.CT Applications. The table below shows the functionalities of syngo.CT Applications: | Single<br>Application | Functionality and description | |----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | syngo.CT Body<br>Perfusion | • Evaluation of perfusion of organs and tumors.<br>• Calculation blood flow, blood volume and permeability from sets of images<br>reconstructed from dynamic CT data acquired after the injection of contrast media<br>• Separate calculation of arterial and portal venous component of hepatic perfusion<br>• Evaluation of regions of interest and visual inspection of time density curves<br>• Deconvolution methods | | Single<br>Application | Functionality and description | | syngo.CT Bone<br>Reading | • visualizations of spine and rib structures<br>• multiplanar reconstruction (MPR) thin/thick, maximum intensity projection (MIP)<br>thin/thick, inverted MIP thin/thick, volume rendering technique (VRT)<br>• geometric measurement tools (distance line, polyline, marker, arrow, angle)<br>• HU measurement tools (Pixel lens, ROI circle, ROI polygonal, ROI freehand, VOI<br>sphere)<br>• curved MPR visualization (unfolded ribs and spine views), crosssection MPRs<br>• tools for creation and editing of anatomical centerline paths<br>• tools for creation and editing of anatomical labels | | syngo.CT<br>Cardiac<br>Function | • Evaluation of CT images of the heart.<br>• Digital image processing and visualization tools (2D, 3D and 4D display of dynamic data),<br>• Evaluation tools (structural and functional analysis of heart chambers and valves, and analysis of myocardial tissue)<br>• Reporting tools | | syngo.CT<br>CaScoring | • Loading of a series of appropriate CT- or MR-Images from the patient database<br>• Browsing, selecting, and displaying images for searching calcium regions/lesions<br>• Interactive definition of ROIs and assignment of the four major coronary arteries (LM, LAD, CX and RCA) to the lesions<br>• Calculation and display of the 2D-Agatston score/factor or other metric on the defined ROIs<br>• Interactive definition of ROIs (for example noise) to disqualify the region from participation in the score<br>• Displaying the score in form of result tables/reports on paper and/or film<br>• Pan and Zoom functionality/windowing<br>• Reformatting<br>• Comparison of score to cited literature | | syngo.CT<br>Coronary<br>Analysis | • Evaluating of cardiac CT angiography (CTA) volume data sets<br>• Combination of digital image processing and visualization tools (multiplanar reconstruction (MPR) thin/thick, maximum intensity projection (MIP) thin/thick, inverted MIP thin/thick, volume rendering technique (VRT), curved planar reformation (CPR))<br>• Evaluation tools (coronary vessel centerline calculation, stenosis calculation and plaque analysis) and reporting tools (lesion location, lesion characteristics and key images),<br>• Designed to support the physician in confirming the presence or absence of physician-identified coronary lesions and evaluation, documentation and follow-up of any such lesion These visualization/evaluation tools allow for characterization (geometry (length, lumen diameter, cross section area, stenos is grade) and appearance (HU values)) of coronary lesions and lesion size over time, helping the physician to assess the changes in their growth. It is also designed to help the physician classify conspicuous regions of tissue | | Single<br>Application | Functionality and description | | syngo.CT<br>Dental | • Basic reading tools (multiplanar reconstruction (MPR), maximum intensity projection<br>(MIP), volume rendering technique (VRT), minimal intensity projection (MinIP)<br>• Basic geometric measurement tools (distance line, polyline, marker, arrow, angle)<br>• Basic HU measurement tools (Pixel lens, ROI Circle, ROI polygonal, ROI freehand, VOI<br>sphere, VOI freehand)<br>• Dedicated dental visualization tools (Dental panoramic views (curved MPRs) and<br>dental paraxial views (cross-section MPRs) that are calculated based on a manually<br>defined centerline)<br>• Tool to manually outline the mandibular canal<br>• Tool that allows paraxial and panoramic result images to be saved as dental range<br>series.<br>• True Size (1:1) printing of panoramic and paraxial images to allow anatomy to be<br>printed in its actual size on the film sheet. | | syngo.CT<br>Dynamic<br>Angio | • Visualization of flow of contrast from the arteries to the veins with contrast enhanced<br>CT images<br>• Supports in the evaluation of regions of interest, the visual inspection of time<br>attenuation curves, and the creation of specific CT volumes, for example, arterial or<br>venous phase. | | syngo.CT Liver<br>Analysis | • Evaluation of the liver volume and examination of the vessels of the liver<br>• Computation and manual correction of liver volumes<br>• Computation and manual correction of tumor volumes and extent<br>• Computation and manual correction of liver vessel tree structure<br>• Computation of territories based on vessel branches<br>• Tumor position in relation to vessels (i.e., 3D visualization of liver, tumor, and vessels)<br>• Manual definition of separation plane proposals<br>• Computation of volume of liver parts<br>• Combination of information from different CT and MR phase volumes | | syngo.CT<br>Myocard<br>Perfusion | • Evaluation of the perfusion of the myocardium<br>• Calculation of blood flow, blood volume, and other hemodynamic parameters from<br>sets of images reconstructed from dynamic CT data acquired after the injection of<br>contrast media<br>• Evaluation of regions of interest and the visual inspection of time attenuation curves | | syngo.CT<br>Neuro DSA | • Removing of bone structures from CT Angiography (CTA) data sets of the cerebral<br>vasculature<br>• Bone removal is based on a bone mask created from an additional non enhanced CT<br>(NECT) scan that was three-dimensionally registered to the CTA data set | | Single<br>Application | Functionality and description | | syngo.CT<br>Neuro<br>Perfusion | • The syngo.CT Neuro Perfusion software package is designed to evaluate areas of<br>brain perfusion. The software processes images or volumes that were reconstructed<br>from continuously acquired CT data after the injection of contrast media.<br>• Generation of the following result volumes: Cerebral blood flow (CBF), Cerebral blood<br>volume (CBV), Local bolus timing (time to start (TTS), time to peak (TTP), time to drain<br>(TTD)), Mean transit time (MTT), Transit time to the center of the IRF (TMax), Flow<br>extraction product (permeability), Temporal MIP, Temporal Average, Baseline<br>Volume , Modified dynamic input data<br>• The software allows the calculation of mirrored regions of interest and the visual<br>inspection of time attenuation curves.<br>• One clinical application is to visualize the apparent blood perfusion and to calculate<br>Hypoperfused Area and Mismatch Ratio in the brain tissue affected by acute stroke.<br>• Areas of decreased perfusion appear as areas of changed signal intensity: Lower<br>signal, intensity for CBF and CBV, Higher signal intensity for TTP, TTD, MTT, and TMax<br>• A second application is to visualize blood brain barrier disturbances by modeling<br>extra-vascular leakage of blood into the interstitial space. This additional capability<br>may improve the differential diagnosis of brain tumors and may be helpful in therapy<br>monitoring. | | syngo.CT<br>Pulmo 3D | • syngo.CT Pulmo 3D analyses the lung, either completely or in parts, identifying areas<br>with lower or higher Hounsfield values in comparison to a predefined threshold.<br>These areas are evaluated using statistical methods such as histograms and<br>percentiles.<br>• Examination of the lung parenchyma and the airways of the lung<br>• Evaluation Tools (computation of lung volumes, display of statistics related to the<br>lung, setting of markers, airway measurements) | | syngo.CT Skull<br>Unfolding | • This software provides advanced visualization of the skull and brain surface for easy<br>manual identification, marking and reporting of pathologies such as skull fractures<br>and hematomas. | | syngo.CT<br>Vascular<br>Analysis | • syngo.CT Vascular Analysis is an image analysis software package for evaluating<br>enhanced CT images.<br>• Visualization tools (multiplanar reconstruction (MPR) thin/thick, maximum intensity<br>projection (MIP) thin/thick, inverted MIP thin/thick, volume rendering technique<br>(VRT), curved planar reformation (CPR), processing tools (bone removal (based both<br>on single energy and Dual Energy), table removal)<br>• Evaluation tools (vessel centerline calculation, lumen calculation, stenosis calculation)<br>• Reporting tools (lesion location, lesion characteristics and key images),<br>• the software package is designed to support the physician in confirming the presence<br>or absence of physician-identified lesions in blood vessels and evaluation,<br>documentation and follow-up of any such lesion. These<br>visualization/processing/evaluation tools allow for characterization (geometry<br>(length, lumen diameter, cross section area, stenosis grade) and appearance (HU<br>values)) of vascular lesions and lesion size over time, helping the physician to assess<br>the changes in their growth. It is also designed to help the physician classify<br>conspicuous regions of tissue. | {5}------------------------------------------------ Image /page/5/Picture/0 description: The image contains the logo for Siemens Healthineers. The word "SIEMENS" is in teal, and the word "Healthineers" is in orange. To the right of the word "Healthineers" is a graphic of orange dots. {6}------------------------------------------------ Image /page/6/Picture/0 description: The image contains the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange. To the right of the words is a cluster of orange dots. {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the Siemens Healthineers logo. The word "SIEMENS" is in teal, and the word "Healthineers" is in orange. To the right of the word "Healthineers" is a graphic of orange dots. {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the Siemens Healthineers logo. The word "SIEMENS" is in teal, and the word "Healthineers" is in orange. To the right of the words is a graphic of orange dots in a circular pattern. The logo is simple and modern. This subject device which is versioned as SOMARIS/8 VB80 includes the f - syngo.CT CaScoring Added to the subject device as a fourteenth application and extended the . export function to include a DICOM Structured Report. - . syngo.CT Pulmo 3D – Added an interface to syngo.CT Lung CAD (latest clearance: K203258, K231157), and integrated the lung lobe segmentation algorithm from syngo.CT Extended Functionality (K203699). #### 5. Indications for Use syngo.CT Applications is a set of software applications for advanced visualization, measurement, and evaluation for specific body regions. This software package is designed to support the radiologists and physicians from emergency medicine, specialty care, urgent care, and general practice e.g. in the: - Evaluation of perfusion of organs and tumors and myocardial tissue perfusion - . Evaluation of bone structures and detection of bone lesions - Evaluation of CT images of the heart - Evaluation of the coronary lesions - Evaluation of the mandible and maxilla - Evaluation of dynamic vessels and extended phase handling - . Evaluation of the liver and its intrahepatic vessel structures to identify the vascular territories of sub-vessel systems in the liver - Evaluation of neurovascular structures - . Evaluation of the lung parenchyma - Evaluation of non-enhanced Head CT images - Evaluation of vascular lesions #### 6. Indications for Use Comparison to the Predicate Device There is no change to the indications for use. Each bulleted function in the indications for use relates to one of the now bundled applications. The new application syngo.CT CaScoring falls under the phrase 'Evaluation of coronary lesions'. | Function | Related Application | |-------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------| | Evaluation of perfusion of organs and tumors and myocardial<br>tissue perfusion | syngo.CT Body Perfusion<br>syngo.CT Myocardial Perfusion | | Evaluation of bone structures and detection of bone lesions | syngo.CT Bone Reading<br>syngo.CT Skull Unfolding | | Evaluation of CT images of the heart | syngo.CT Cardiac Function | | Evaluation of the coronary lesions | syngo.CT Coronary Analysis<br>syngo.CT CaScoring | | Evaluation of the mandible and maxilla | syngo.CT Dental | | Evaluation of dynamic vessels and extended phase handling | syngo.CT Dynamic Angio | | Evaluation of the liver and its intrahepatic vessel structures to<br>identify the vascular territories of sub-vessel systems in the liver | syngo.CT Liver Analysis | {9}------------------------------------------------ Image /page/9/Picture/0 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is in teal, and the word "Healthineers" is in orange. To the right of the word "Healthineers" is a series of orange dots that are arranged in a circular pattern. | Evaluation of neurovascular structures | syngo.CT Neuro Perfusion | |-------------------------------------------|----------------------------| | Evaluation of the lung parenchyma | syngo.CT Pulmo 3D | | Evaluation of non-enhanced Head CT images | syngo.CT Neuro DSA | | Evaluation of vascular lesions | syngo.CT Vascular Analysis | # 7. Comparison of Technological Characteristics with the Predicate Device The subject device is a combination of the fourteen (14) medical devices. The main functionalities of the predicate device is unchanged for syngo.CT Applications SOMARIS/VB70 except the minor changes within syngo.CT Pulmo 3D. For this subject device, the legally marketed syngo.CT CaScoring application was bundled to the subject device and the export function was extended. | Subject Device<br>syngo.CT Applications<br>(SOMARIS/8 VB80) | Predicate Device<br>syngo.CT Applications<br>(SOMARIS/8 VB70) | Comparison Result | |---------------------------------------------------------------------|---------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Built-in applications in the subject device "syngo.CT Applications" | | | | syngo.CT Body Perfusion | syngo.CT Body Perfusion | Same | | syngo.CT Bone Reading | syngo.CT Bone Reading | Same | | syngo.CT Cardiac Function | syngo.CT Cardiac Function | Same | | syngo.CT Coronary Analysis | syngo.CT Coronary Analysis | Same | | syngo.CT Dynamic Angio | syngo.CT Dynamic Angio | Same | | syngo.CT Dental | syngo.CT Dental | Same | | syngo.CT Liver Analysis | syngo.CT Liver Analysis | Same | | syngo.CT Myocardial Perfusion | syngo.CT Myocardial Perfusion | Same | | syngo.CT Neuro DSA | syngo.CT Neuro DSA | Same | | syngo.CT Neuro Perfusion | syngo.CT Neuro Perfusion | Same | | syngo.CT Pulmo 3D | syngo.CT Pulmo 3D | Extended<br>Implementation of a software interface<br>which provided a connection to the<br>external medical device syngo.CT Lung<br>CAD with separate clearance.<br>Additionally, integration of the lung lobe<br>segmentation feature which remains<br>unchanged as compared to the reference<br>device syngo.CT Extended Functionality<br>(K203699). | | syngo.CT Skull Unfolding | syngo.CT Skull Unfolding | Same | | syngo.CT Vascular Analysis | syngo.CT Vascular Analysis | Same | {10}------------------------------------------------ Image /page/10/Picture/0 description: The image contains the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the words is a graphic of orange dots. | Subject Device<br>syngo.CT Applications<br>(SOMARIS/8 VB80) | Predicate Device<br>syngo.CT Applications<br>(SOMARIS/8 VB70) | Comparison Result | |-------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | syngo.CT CaScoring | Not available in the predicate device<br>but former separately cleared as<br>syngo.CT CaScoring (K221219,<br>clearance date 05/17/2022) | Extended<br>This medical device has been included to<br>the software package syngo.CT<br>Applications with no significant changes<br>respectively changes to the clinical<br>functionality of syngo.CT CaScoring. This<br>application has been formerly cleared<br>with K221219. Furthermore, the export<br>function has been extended. | #### 8. Performance Data The following performance data were provided in support of the substantial equivalence determination. #### Software Verification and Validation Software Documentation for a Moderate Level of Concern software per FDA's Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" issued on May 11, 2005 is also included as part of this submission. The performance data demonstrates continued conformance with special controls for medical devices containing software. The Risk Analysis was completed, and risk control implemented to mitigate identified hazards. The testing supports that all software specifications have met the acceptance criteria. Testing for verification and validation support the claim of substantial equivalence. #### Risk Analysis The risk analysis was completed, and risk control implemented to mitigate identified hazards. The testing results support that all the software specifications have met the acceptance criteria. Testing for verification and validation of the device was found acceptable to support the claims of substantial equivalence. Siemens hereby certifies that synqo.CT Applications meets the following FDA Recognized Consensus standards listed below: | Recognition<br>Number | Product<br>Area | Title of Standard | Date of<br>Recognition | Standards<br>Development<br>Organization | |-----------------------|--------------------------|-----------------------------------------------------------------------------------------------------|------------------------|------------------------------------------| | 12-349 | Radiology | Digital Imaging and Communications in Medicine<br>(DICOM) Set; PS 3.1 - 3.20 2022d | 12/19/2022 | NEMA | | 13-79 | Software | Medical Device Software – Software Life Cycle<br>Processes; 62304:2006 (1st Edition)/A1:2016 | 01/14/2019 | AAMI, ANSI,<br>IEC | | 5-125 | Software/<br>Informatics | Medical devices – Application of risk management to<br>medical devices; 14971 Third Edition 2019-12 | 12/23/2019 | ISO | {11}------------------------------------------------ Image /page/11/Picture/0 description: The image contains the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange. To the right of the word "Healthineers" is a graphic of orange dots. | 5-129 | General I<br>(QS/RM) | Medical devices - Part 1: Application of usability<br>engineering to medical devices<br>62366-1:2015+AMD1:2020 | 07/06/2020 | AAMI, ANSI,<br>IEC | |-------|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|--------------------| | 5-134 | General<br>(QS/RM) | Medical devices - Symbols to be used with medical<br>device labels, labelling, and information to be<br>supplied - Part 1: General requirements<br>ISO 15223-1 Fourth edition 2021-07 | 12/20/2021 | ISO | # 9. Conclusion The fundamental scientific technology and technological characteristics are the same as the predicate device and reference device. The built-in applications in the subject device remain unchanged as the built-in ones in the predicate device except the application syngo.CT Pulmo 3D which includes the changes as shown in the comparison table. The additional bundling of syngo.CT CaScoring to the subject device and the minor improvements and enhancements do not raise questions of safety and efficacy since the changes do not introduce any new clinical algorithms/features and they do not change the performance of subject device significantly. The result of all testing conducted was found acceptable to support the claim of substantial equivalence. The comparison of technological characteristics and software validation demonstrates that the subject device is as safe and effective when compared to the predicate device that is currently marketed for the same intended use. For the subject device, syngo.CT Applications, Siemens used the same testing with the same workflows as used to clear the predicate devices. Siemens considers synqo.CT Applications to be as safe, as effective and with performance substantially equivalent to the commercially available predicate device. Therefore, Siemens believes that the subject device, the syngo.CT Applications does not raise new questions of safety and effectiveness and is substantially equivalent to the predicate device.