Syngo.CT CaScoring

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Siemens Medical Solutions USA, Inc. % Tabitha Estes Regulatory Affairs Specialist 810 Innovation Drive KNOXVILLE TN 37932 Re: K201034 Trade/Device Name: Syngo.CT CaScoring Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: JAK Dated: April 17, 2020 Received: April 20, 2020 Dear Tabitha Estes: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmp/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. 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 May 14, 2020 {1}------------------------------------------------ https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, For Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K201034 Device Name syngo.CT CaScoring ### Indications for Use (Describe) syngo.CT CaScoring is an image analysis software package for evaluating CT data sets. The software is designed to support the physician in evaluating and documenting calcified coronary lesions, using standard or low-dose spiral or sequential CT scanning data sets. After loading noncontrasted cardiac CT images, syngo. CT CaScoring can be used to mark calcified coronary lesions and to allocate each lesion to one of several coronary arteries, that is, the right coronary artery (RCA), the left main coronary artery (LM), the left anterior descending artery (LAD), and the left circumflex artery (CX). syngo. CT CaScoring calculates the Agatston equivalent score, the mass score and the volume score of each coronary artery as well as the corresponding total scores all coronary arteries. syngo.CT CaScoring allows the user to create a paper report including the calcium scoring data, any user-documented images, cited literature and additional relevant information. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|---------------------------------------------| | 区 Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) | ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. 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 OMB number." {3}------------------------------------------------ # Section 5 510(k) Summary #### I. Identification of the Submitter ### Importer/Distributor Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Malvern, PA 19355 Establishment Registration Number 2240869 ### Manufacturing Site Siemens Healthcare GmbH Siemensstr 1 D-91301 Forchheim, Germany # Establishment Registration Number 3004977335 # Submitter Contact Person: Tabitha Estes Regulatory Affairs Specialist Siemens Medical Solutions, Inc. USA 810 Innovation Drive Knoxville, TN 37932 Phone: (865) 804-4553 Email: tabitha.estes(@siemens-healthineers.com # Alternate Contact: Alaine Medio #### II. Device Name and Classification | Product Name: | syngo.CT CaScoring | |-----------------------|----------------------------------| | Propriety Trade Name: | syngo.CT CaScoring | | Classification Name: | Computed Tomography X-ray System | | Classification Panel: | Radiology | | CFR Section: | 21 CFR §892.1750 | | Device Class: | Class II | | Product Code: | 90 JAK | # III. Predicate Device | Trade Name: | syngo.CT CaScoring | |-----------------------|----------------------------------| | 510(k) Number: | K192763 | | Clearance Date: | 12/17/2019 | | Classification Name: | Computed Tomography X-ray System | | Classification Panel: | Radiology | | CFR Section: | 21 CFR §892.1750 | {4}------------------------------------------------ | Device Class: | Class II | |---------------|----------| | Product Code: | 90 JAK | #### Device Description IV. The post-processing application syngo.CT CaScoring SOMARIS/8 VB50 is designed to support the physician in evaluating and documenting calcified coronary lesions. After loading non-contrasted cardiac CT images, syngo.CT CaScoring can be used to interactively mark calcified coronary lessions and to allocate each lesion to one of several coronary arteries, that is, the right coronary artery (RCA), the left main coronary artery (LM), the left anterior descending artery (LAD), and the left circumflex artery (CX). syngo.CT CaScoring calculates the Agatston-equivalent score, the mass score and the volume score of each coronary artery as well as the corresponding total scores across all coronary arteries. syngo.CT CaScoring allows the user to create a paper report including the calcium scoring data, any user-documented images, cited literature and additional relevant information. For the current software version SOMARIS/8 VB50 one major and one minor change have been implemented: - . Since the last 510(k) clearance of the predicate device (syngo.CT Calcium Scoring SOMARIS/8 VB40, K192763, clearance date 12/17/2019) the algorithm to precompute the calcium score has been enhanced and extended. In the subject device, the CaScoring algorithm was extended to label coronary calcifications as belonging to either the left main, left anterior descending, left circumflex or right coronary artery. - . This version contains UI (user-interface) modifications. #### V. Indications for Use syngo.CT CaScoring is an image analysis software package for evaluating CT data sets. The software is designed to support the physician in evaluating and documenting calcified coronary lesions, using standard or low-dose spiral or sequential CT scanning data sets. After loading noncontrasted cardiac CT images, syngo.CT CaScoring can be used to mark calcified coronary lesions and to allocate each lesion to one of several coronary arteries, that is, the right coronary artery (RCA), the left main coronary artery (LM), the left anterior descending artery (LAD), and the left circumflex artery (CX). syngo.CT CaScoring calculates the Agatston equivalent score, the mass score and the volume score of each coronary artery as well as the corresponding total scores across all coronary arteries. syngo.CT CaScoring allows the user to create a paper report including the calcium scoring data. any userdocumented images, cited literature and additional relevant information. {5}------------------------------------------------ #### Comparison of Technological Characteristics with the Predicate Device VI. The differences and similarities between the above referenced predicate device are listed at a highlevel in the following table: | Feature | Subject Device | Predicate Devices | |---------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | syngo.CT CaScoring<br>(SOMARIS/8 VB50) | syngo.CT CaScoring<br>(SOMARIS/8 VB40) | | Modality | CT | CT | | Loading of a series of<br>appropriate CT from the patient<br>database | Yes | Yes | | Body Part | Heart / Chest | Heart / Chest | | Acquisition Part | ECG-gated / ECG-triggered | ECG-gated / ECG-triggered | | Automated Calcium Scoring<br>Evaluation | Assignment of a probability of a<br>candidate being a coronary<br>calcification based on location<br>within the heart, density, shape and<br>similar properties: if the probability<br>of a candidate is higher than a<br>predefined threshold, the candidate<br>is labelled as a calcification.<br>Each calcification is labeled<br>according to one of four coronary<br>arteries it most probably belongs to.<br>In addition, results of the evaluation<br>can be sent via Rapid Results<br>Technology to any generic DICOM<br>viewer.<br>Comparison to the predicate<br>device:<br>The first part of the automatic<br>Calcium Scoring algorithm works in<br>the same manner as cleared with the<br>predicate device. From functional<br>perspective there are no differences.<br>The second part (labeling of<br>calcifications according to coronary<br>artery) is new in the subject device. | Assignment of a probability of a candidate<br>being a coronary calcification based on<br>location within the heart, density, shape and<br>similar properties: if the probability of a<br>candidate is higher than a predefined<br>threshold, the candidate is labelled as a<br>calcification.<br>In addition, results of the evaluation can be<br>sent via Rapid Results Technology any<br>generic DICOM viewer. | | Browsing, selecting, and<br>displaying images for searching<br>calcium regions/lesions | Yes | Yes | | Interactive definition of ROIs and<br>assignment of the four major<br>coronary arteries (LM, LAD,CRC<br>and RCA) to the lesions | Yes | Yes | | Automatic definition of ROIs and<br>assignment of a generic calcium<br>label to the lesions | Yes | Yes | | Calculation and display of the<br>2D-Agatston score/factor or<br>other metric on the defined ROIs | Agatston, volume and mass scores | Agatston, volume and mass scores | | Interactive definition of ROIs (for<br>example noise) to disqualify the<br>region from participation in the<br>score | Yes | Yes | | Feature | Subject Device | Predicate Devices | | Displaying the score in form of<br>result tables/reports on paper<br>and/or film | syngo.CT CaScoring<br>(SOMARIS/8 VB50) | syngo.CT CaScoring<br>(SOMARIS/8 VB40) | | Pan and Zoom<br>functionality/windowing | Yes | Yes | | Reformatting | Yes | Yes | | Comparison of Score to Cited<br>Literature (including calculation<br>of coronary age) | Yes | Yes | | User Interface | syngo.via GUI<br>As part of a platform-wide change in this<br>software version, the user interface of<br>syngo.CT CaScoring was adapted to<br>follow the new user interface style<br>introduced in SOMARIS/8 VB50. | syngo.via GUI | | Archiving/Storing | CD-R, film, DVD, USB, Network | CD-R, film, DVD, USB, Network | | Hardware | As specified by syngo.via | As specified by syngo.via | | Communication | DICOM compatible | DICOM compatible | {6}------------------------------------------------ The subject device syngo. CT CaScoring does not have changes in fundamental scientific technology compared to the predicate device. The post-processing software functionality remains unchanged from the subject device and the predicate device. The operating principle and the scientific technology are the same; therefore, Siemens believes that syngo.CT CaScoring application is substantially equivalent to the predicate device. The major change in this software version is that the Automated Calcium Scoring Evaluation algorithm has been extended to label calcifications according to coronary artery. # VII. Performance Data The following performance data were provided in support of the substantial equivalence determination. # Non-Clinical Testing This submission contains performance tests (Non-clincal test reports) to demonstrate continued conformance with special controls for medical devices containing software. Non-clinical tests (integration and functional) were conducted for syngo.CT CaScoring during product development. These tests have been performed to test the ability of the included features of the subject device. The results of these tests demonstrate that the subject device performs as intended. The result of all conducted testing was found acceptable to support the claim of substantial equivalence. # Performance Evaluation of the Algorithm Since the automatic scoring algorithm was retrained on re-annotated data as part of the vessel assignment extension, a complete performance evaluation (bench test and reader study) of the algorithm has been conducted additionally. The algorithm was successfully executed on all testing datasets. No data has been excluded from the analysis. The summary of the bench test is that an adequate and acceptable performance of the automatic scoring algorithm was found for the total Agatston-equivalent score and the classification into the corresponding Agatston score categories, which are the aspects of calcium scoring that have a well-established impact on management recommendations. All pre-specified acceptability criteria were passed. {7}------------------------------------------------ The conclusion of the ready study is that all prespecified acceptability thresholds were met by the results of this study. The reader study population is from a single, modern scanner. The overall statistics on the performance of the automatic scoring algorithm demonstrate a good comparability with the bench test population, which is considerably more diverse. There is less but still significant deviation of the automatic LM scores from the consensus annotations compared to the bench test. The overall pattern is very comparable between both populations. Thus, Siemens concludes that the results of the reader study are representative for the general performance of the algorithm. No statistically relevant difference between the performance of the three individual readers compared to their consensus, and the algorithm compared to the consensus was found. We conclude that the precise assignment of calcifications in the bifurcation region between left main, left anterior descending and left circumflex artery is a task that is similarly difficult for both human readers as well as the automatic scoring algorithm. Combined with the limited clinical relevance of the vessel-specific calcium scores, we therefore deem the performance of the automatic scoring algorithm in assigning calcifications to individual vessels adequate and acceptable. ### 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. | Recognition<br>Number | Product<br>Area | Title of Standard | Date of<br>Recognition | Standards<br>Development<br>Organization | |-----------------------|--------------------------|------------------------------------------------------------------------------------------------------------|------------------------|------------------------------------------| | 12-300 | Radiology | Digital Imaging and Communications in<br>Medicine (DICOM) Set; PS 3.1 – 3.20 | 06/27/2016 | NEMA | | 13-79 | Software | Medical Device Software -Software Life Cycle<br>Processes; 62304:2006 (1st Edition) | 01/14/2019 | AAMI, ANSI,<br>IEC | | 5-40 | Software/<br>Informatics | Medical devices – Application of risk<br>management to medical devices; 14971 Second<br>Edition 2007-03-01 | 06/27/2016 | ISO | | 5-114 | General I<br>(QS/RM) | Medical devices - Part 1: Application of<br>usability engineering to medical devices<br>IEC 62366-1:2015 | 12/23/2016 | IEC | Siemens hereby certifies that syngo.CT CaScoring will meet the following voluntary standards covering electrical and mechanical safety listed below, prior to introduction into interstate commerce: # VIII. Conclusion syngo.CT CaScoring has the same intended use and same indication for use as the predicate device. The technological characteristics such as evaluation and documentation of calcified coronary lesions are the same as the predicate device. The result of all testing conducted was found acceptable to support the claim of substantial equivalence. The comparison of technological characteristics, nonclinical performance data, 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 CaScoring, Siemens used the same testing with the same workflows as used to clear the predicate device. Siemens considers syngo.CT CaScoring to be as safe, as effective and with performance substantially equivalent to the commercially available predicate device.