TruPlan Computed Tomography (CT) Imaging Software

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Circle Cardiovascular Imaging, Inc. % Sydney Toutant Regulatory Affairs Lead Suite 1100 - 800 5th Ave. SW Calgary, Alberta T2P 3T6 CANADA January 18, 2023 ### Re: K222593 Trade/Device Name: TruPlan Computed Tomography (CT) Imaging Software Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: QIH, LLZ Dated: December 9, 2022 Received: December 9, 2022 Dear Sydney Toutant: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. 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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. Jessica Lamb Jessica Lamb, Ph.D. Assistant Director Imaging Software DHT8B: Division of Radiological 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) K222593 Device Name TruPlan Computed Tomography (CT) Imaging Software Indications for Use (Describe) TruPlan enables visualization and measurement of structures of the heart and vessels for: - · Pre-procedural planning and sizing for the left atrial appendage closure (LAAC) procedure - · Post-procedural evaluation for the LAAC procedure To facilitate the above, TruPlan provides general functionality such as: - · Segmentation of cardiovascular structures - · Visualization and image reconstruction techniques: 2D review, Volume Rendering, MPR - · Simulation of TEE views, ICE views, and fluoroscopic rendering - · Measurement and annotation tools - · Reporting tools TruPlan's intended patient population is comprised of adult patients. | Type of Use (Select one or both, as applicable) | |-------------------------------------------------| |-------------------------------------------------| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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The following 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of the Safe Medical Device Act 1990 and 21 CFR 807.92(c). #### l. SUBMITTER | Submitter's Name: | Circle Cardiovascular Imaging, Inc. | |-------------------|-----------------------------------------------------------| | Address: | Suite 1100 – 800 5th Ave SW, Calgary, AB, Canada, T2P 3T6 | | Date Prepared: | January 16 2023 | | Telephone Number: | +1 587 747 4692 | | Contact Person : | Sydney Toutant | | Email: | sydney.toutant@circlecvi.com | #### II. DEVICE | Name of the Device: | TruPlan Computed Tomography (CT) Imaging Software | |--------------------------|---------------------------------------------------| | Short Brand Name: | TruPlan | | Common or Usual Name: | Automated Radiological Image Processing System | | Classification Name: | Medical image management and processing system | | Proposed Classification: | Device Class: II | | | Primary Product Code: QIH | | | Secondary Product Code: LLZ | | | Regulation Number: 21 CFR 892.2050 | #### PREDICATE DEVICES lll. The primary predicate is the previously cleared version of TruPlan, manufactured by Circle CVI and cleared under K202212. 3mensio Workstation, manufactured by Pie Medical Imaging and cleared under K153736, is used as a secondary predicate. The predicate devices have not been subject to a design-related recall. {4}------------------------------------------------ #### IV. DEVICE DESCRIPTION The TruPlan Computed Tomography (CT) Imaging Software application ("TruPlan") is a software as a medical device that helps qualified users with image-based pre-procedural planning and post-procedural follow-up of the Left Atrial Appendage Closure (LAAC) procedure using CT data. TruPlan is designed to support the anatomical assessment of the Left Atrial Appendage (LAA) prior to and following the LAAC procedure. This includes the assessment of the LAA size, shape, and relationships with adjacent cardiac and extracardiac structures. This assessment helps the physician determine the size of a closure device needed for the LAAC procedure and evaluate LAAC device placement in a follow-up CT study. The TruPlan application is a visualization software and has basic measurement tools. The device is intended to be used as an aid to the existing standard of care and does not replace existing software applications physicians use for planning or follow-up for a LAAC procedure. Pre-existing CT images are uploaded in TruPlan manually by the end-user. The images can be viewed by the user in the original CT image as well as simulated views. The software displays the views in a modular format as follows: - Left Atrial Appendage (LAA) . - Fluoroscopy (Fluoro, simulation) ● - Trans Esophageal Echo (TEE, simulation) ● - Intra Cardiac Echography (ICE, simulation) ● - . Thrombus - Follow-up - Multiplanar Reconstruction (MPR) - Reporting ● These views offer the user visualization and quantification capabilities for pre-procedural planning and post-procedural follow-up of the LAAC procedure; none are intended for diagnosis. The quantification tools are based on user-identified regions of interest and are user-modifiable. The device allows users to perform the measurements (all done on MPR viewers) listed in Table 1, below. TruPlan implements machine learning techniques to aid device use as follows: - 1. Left Heart Segmentation. TruPlan generates a 3D rendering of the left side of the heart (including left ventricle, left atrium, and LAA) using machine learning methodology. The 3D rendering is for visualization purposes only; no measurement or annotations can be done using this view. - 2. Landing Zone Detection. TruPlan uses machine learning techniques to initialize landing zone detection. No measurements are computed until the user reviews and corrects this initialization. The data used to train TruPlan's machine learning algorithms were sourced from multiple clinical sites from urban centers and from different countries. The Left Heart Segmentation algorithm was trained on a total of 113 cases from the U.S., Canada, Germany, and other locations acquired using Siemens, GE, Toshiba, and Philips scanners where the left heart structures were manually Circle Cardiovascular Imaging Inc. {5}------------------------------------------------ annotated by multiple expert readers. The Landing Zone Detection algorithm was trained on a total of 273 cases from various sites across the U.S. acquired using Siemens, GE, Toshiba, and Philips scanners where the landing zone was manually contoured by expert readers. When selecting data for training, the importance of model generalization was considered and data was selected such that a good distribution of patient demographics, scanner, and image parameters were represented. The separation into training versus validation datasets is made on the study level to ensure no overlap between the two sets. As such, different scans from the same study were not split between the training and validation datasets. None of the cases used for model validation were used for training the machine learning models. Table 1. TruPlan's measurement functionality and the specific module/workflow and measurement application for which it is used. | Measurement [units] | Description | Module / Workflow | Application | |-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Distance [mm] | Length between two points,<br>for both curved lines<br>(splines) and straight lines,<br>including the diameter<br>(including min, max,<br>average) resulting from<br>closed splines and depth of<br>the LAA | All modules | Diameter & depth of LAA<br>landing zone (LAA module);<br>distance between points of<br>interest; diameter of a peri-<br>device leak (Follow-up<br>module) | | Perimeter [mm] | The perimeter of a contour<br>(closed spline) | All modules | Perimeter of LAA landing zone<br>(LAA module); perimeter of<br>other contours of interest | | Area [mm²] | The area within a contour | All modules | Area of LAA landing zone<br>(LAA module); area of other<br>contours<br>of interest | | Angle [degrees] | The angle of an object /<br>structure of interest | All modules | Angle between two lines of<br>interest | | Signal intensity<br>[HU] | Hounsfield value (in<br>Hounsfield Units, HU) of the<br>underlying pixels | All modules | Signal intensity of pixels in the<br>regular vs. delayed scan<br>(Thrombus module); average<br>signal intensity within distal<br>LAA (Follow-up module);<br>intensity of other pixels of<br>interest | | Coordinates<br>[mm, mm, mm] | Location in the x-, y-, and z-<br>planes of a point | All modules | Coordinates of points of<br>interest on a 3D rendering,<br>for export purposes | {6}------------------------------------------------ These measurements are all manually placed by the user as annotations (overlays) and report the information calculated using the underlying pixels. TruPlan also provides reporting functionality to capture screenshots and measurements and to store them as a PDF document. TruPlan is installed either as a standalone software onto the user's desktop or laptop computer, or as a server within the hospital infrastructure with a thick-client software on multiple users' desktop or laptop computers. #### V. INDICATIONS FOR USE TruPlan enables visualization and measurement of structures of the heart and vessels for: - Pre-procedural planning and sizing for the left atrial appendage closure (LAAC) . procedure - Post-procedural evaluation for the LAAC procedure To facilitate the above, TruPlan provides general functionality such as: - Segmentation of cardiovascular structures ● - . Visualization and image reconstruction techniques: 2D review, Volume Rendering, MPR - Simulation of TEE views, ICE views, and fluoroscopic rendering ● - Measurement and annotation tools - Reporting tools ● TruPlan's intended patient population is comprised of adult patients. Image /page/6/Picture/14 description: The image shows a yellow warning sign. The sign is in the shape of a triangle with a thick black border. Inside the triangle is a large black exclamation point. IMPORTANT: TruPlan is intended to be used as a pre-procedural planning aid, and LAAC procedures should be performed per the chosen LAAC device's approved IFU. Image /page/6/Picture/16 description: The image shows a yellow triangle with a black exclamation point inside. The triangle is a warning sign, indicating a potential hazard or danger. The exclamation point emphasizes the importance of the warning. The sign is commonly used to alert people to be cautious and pay attention to their surroundings. IMPORTANT: TruPlan is intended to be used as a post-procedural assessment aid, and all clinical decisions should be made per the chosen LAAC device's approved IFU. {7}------------------------------------------------ #### VI. COMPARISON WITH PREDICATE DEVICES The detailed analysis of the subject device and the primary and secondary predicate devices (shown in Table 2 and Table 3) demonstrates that the subject device is substantially equivalent in indications for use / intended use, technological characteristics, functionality, and operating principles with the primary predicate (K202212) and with the secondary predicate (K153736). Of the three characteristics (technical, biological, and clinical) required for the demonstration of equivalence, biological characteristics are not applicable since the subject device and both predicate devices are software as a medical device application with no tangible component interfacing with the body. | Subject Device | Primary Predicate | Secondary Predicate | |---------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------| | TruPlan v3.0 (K222593) | TruPlan v1.0 (K202212) | 3mensio (K153736) | | Manufactured by Circle | Manufactured by Circle | Manufactured by Pie Medical Imaging | | TruPlan enables visualization and<br>measurement of structures of the heart<br>and vessels for: | TruPlan enables visualization and<br>measurement of structures of the heart<br>and vessels for pre-procedural planning<br>and sizing for the left atrial appendage<br>closure (LAAC) procedure. | 3mensio Workstation enables visualization<br>and measurement of structures of the<br>heart and vessels for: | | • Pre-procedural planning and sizing for<br>the left atrial appendage closure<br>(LAAC) procedure | To facilitate the above, TruPlan provides<br>general functionality such as: | • Pre-operational planning and sizing<br>for cardiovascular interventions and<br>surgery | | • Post-procedural evaluation for the<br>LAAC procedure | • Segmentation of cardiovascular<br>structures | • Postoperative evaluation | | To facilitate the above, TruPlan provides<br>general functionality such as: | • Visualization and image<br>reconstruction techniques: 2D review,<br>Volume Rendering, MPR | • Support of clinical diagnosis by<br>quantifying dimensions in coronary<br>arteries | | • Segmentation of cardiovascular<br>structures | • Simulation of TEE views, ICE views,<br>and fluoroscopic rendering | • Support of clinical diagnosis by<br>quantifying calcifications (calcium<br>scoring) in the coronary arteries | | • Visualization and image<br>reconstruction techniques: 2D review,<br>Volume Rendering, MPR | • Measurement and annotation tools | To facilitate the above, 3mensio<br>Workstation provides general functionality<br>such as: | | • Simulation of TEE views, ICE views,<br>and fluoroscopic rendering | • Reporting tools | • Segmentation of cardiovascular<br>structures | | • Measurement and annotation tools | TruPlan's intended patient population is<br>comprised of adult patients. | • Automatic and manual centerline<br>detection | | • Reporting tools | | • Visualization and image<br>reconstruction techniques: 2D review,<br>Volume Rendering, MPR, Curved<br>MPR, Stretched CMPR, Slabbing,<br>MIP, AIP, MinIP | | TruPlan's intended patient population is<br>comprised of adult patients. | | • Measurement and annotation tools | | | | • Reporting tools | | | Table 2. Indications for Use comparison to predicate devices. | | | |------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | | | | | | | | | | Feature | Subject Device | Primary Predicate | Secondary Predicate | | | TruPlan v3.0 (K222593) | TruPlan v1.0 (K202212) | 3mensio (K153736) | | | Manufactured by Circle | Manufactured by Circle | Manufactured by Pie Medical | | Device Class | II | II | II | | Device Classification | QIH<br>LLZ | LLZ | LLZ | | Regulation Name | Medical image management and<br>processing system | Picture Archiving and<br>Communications System | Picture Archiving and<br>Communications System | | Regulation Number | 21 CFR 892.2050 | 21 CFR 892.2050 | 21 CFR 892.2050 | | Input data type | CT data in DICOM format (vendor<br>independent) | CT data in DICOM format (vendor<br>independent) | CT data in DICOM (vendor<br>independent) | | Landing Zone<br>Detection | Semi-automatic initialization of the<br>landing zone using Machine<br>Learning techniques; manual<br>confirmation of the landing zone | Manual initialization and<br>confirmation of the landing zone | Manual initialization and<br>confirmation of the landing zone | | Left Heart<br>Segmentation | Semi-automatic segmentation for<br>3D visualization of the left heart<br>using Machine Learning<br>techniques; manual editing of 3D<br>views possible | Semi-automatic segmentation for<br>3D visualization of the left heart<br>using Machine Learning<br>techniques; manual editing of 3D<br>views possible | Semi-automatic segmentation for<br>3D visualization of the left heart;<br>manual editing of 3D views possible | | Study list image<br>functionality | Study/series previewing Exporting Deleting Anonymizing Search | Study/series previewing Exporting Deleting Anonymizing Search | Study/series previewing Exporting Deleting Anonymizing Search | | Image assessment –<br>simulated views | Fluoroscopy (grayscale 3D<br>rendering), to visualize<br>relationship among LAAC<br>procedure relevant<br>anatomical structures TEE, to provide similar views<br>to intraprocedural TEE ICE, to provide similar views<br>to intraprocedural ICE | Fluoroscopy (grayscale 3D<br>rendering), to visualize<br>relationship among LAAC<br>procedure relevant<br>anatomical structures TEE, to provide similar views<br>to intraprocedural TEE ICE, to provide similar views<br>to intraprocedural ICE | Grayscale 3D rendering, to<br>visualize relationship among<br>LAAC procedure relevant<br>anatomical structures TEE, to provide similar views to<br>intraprocedural TEE | | Image assessment –<br>other visualization<br>functionality | 2D 3D (with manual & semi-<br>automatic segmentation) 4D (cine) MPR Annotations | 2D 3D (with manual & semi-<br>automatic segmentation) 4D (cine) MPR Annotations | 2D 3D (with manual & semi-<br>automatic segmentation) 4D (cine) MPR Annotations Curved MPR Stretch CMPR Slabbing MIP AIP MinIP Centreline extraction Calcium coring | | Image assessment –<br>measurement<br>functionality | Distance (length, diameter,<br>perimeter) Area Angle Signal intensity Coordinates | Distance (length, diameter,<br>perimeter) Area Angle Signal intensity Coordinates | Distance (length, diameter,<br>perimeter) Area Angle Signal intensity Coordinates Volume | | Report functionality | Patient/study information | Patient/study information | Patient/study information | | Feature | Subject Device | Primary Predicate | Secondary Predicate | | | <i>TruPlan v3.0</i> (K222593) | <i>TruPlan v1.0</i> (K202212) | <i>3mensio</i> (K153736) | | | Manufactured by Circle | Manufactured by Circle | Manufactured by Pie Medical | | | Screenshots | Screenshots | Screenshots | | | ● | ● | ● | | | Measurements | Measurements | Measurements | | | ● | ● | ● | | | Free text | Free text | Free text | | | ● | ● | ● | | | Device sizing table (for | Device sizing table (for | Device-specific reports for | | | reference only) for LAA | reference only) for LAA | procedures covered in intended | | | procedure | procedure | use | | Operating system | Microsoft Windows<br>Apple macOS | Microsoft Windows | Microsoft Windows | | DICOM compliant | Yes | Yes | Yes | {8}------------------------------------------------ Table 3. Feature comparison to primary and secondary predicate devices. Circle Cardiovascular Imaging Inc. Non-Confidential {9}------------------------------------------------ #### VII. PERFORMANCE DATA AND TESTING Performance testing was conducted to verify compliance with specified design requirements in accordance with ISO 13485:2016, IEC 62304:2015, ISO 14971:2019, and NEMA 3.1-3.20 (2016) DICOM standards. Verification and validation testing were conducted to ensure specifications and performance of the device and were performed per the FDA Guidance documents "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" and "Content of Premarket Submission for Management of Cybersecurity in Medical Devices". No clinical studies were necessary to support substantial equivalence. TruPlan has been tested according to the specifications that are documented in a Master Software Test Plan. Testing is an integral part of Circle Cardiovascular Imaging Inc.'s software development as described in the company's product development process. ### Validation of Machine Learning Derived Outputs The machine learning algorithms of TruPlan (left heart segmentation, landing zone detection) have been trained and tested on images acquired from major vendors of CT imaging devices. All data used for validation were not used during the development of the training algorithms. Across all CT machine manufacturers, n = 633 anonymized patient images were used for the validation of TruPlan. This translates into 533 samples (age and sex information unknown due to anonymization) for Left Heart Segmentation, and 100 samples (59 male and 41 female samples acquired from patients between 56 to 90+ years of age) for Landing Zone Detection. Image information for all samples was anonymized and limited to ePHI-free DICOM headers. The validation data was sourced from multiple sites across the U.S. and other urban regions. All performance testing results met Circle's pre-defined acceptance criteria. - . For the Left Heart Segmentation algorithm, the performance acceptance criteria were predefined to evaluate the performance of the ML model based on seqmentation accuracy defined by probability of bone removal and probability of LAA visualization. The validation data was collected from the U.S., Canada, South America, Europe, and Asia acquired {10}------------------------------------------------ using Siemens, GE, Toshiba, and Philips scanners. Bone was removed in 532/533 cases (99.81%); the LAA was correctly visualized by the rendering algorithm in 519/533 cases (97.37%). - For the Landing Zone Detection algorithm, the performance acceptance criteria were pre-. defined to evaluate the performance of the ML model based on detection accuracy defined by plane and contour center distance. The validation data was collected from various sites across the U.S., acquired using Siemens, GE, Toshiba, and Philips scanners. The landing zone was manually contoured by multiple expert readers for evaluation. Landing zone plane distance was within 10 mm in 97/100 cases (97%) with a mean distance of 3.87 mm; the landing zone contour center distance was within 12 mm in 99/100 cases (99%) with a mean distance of 2.92 mm. #### VIII. CONCLUSIONS The information submitted in this premarket notification, including the performance testing and predicate device comparisons, support the safety and effectiveness of TruPlan as compared to the predicate devices when used for the defined intended use.