TruPlan

{0}------------------------------------------------ February 19, 2021 Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue. Circle Cardiovascular Imaging Inc. % Shirantha Samarappuli, Ph.D. VP - Regulatory Affairs and QMS Suite 1100-800 5th Ave SW Calgary, Alberta T2P 3T6 CANADA Re: K202212 Trade/Device Name: TruPlan Computed Tomography (CT) Imaging Software Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: January 15, 2021 Received: January19, 2021 Dear Dr. Samarappuli: 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). 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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) K202212 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. 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 | Type of Use (Select one or both, as applicable) | <div> <input type="checkbox"/> </div> | <div> <input type="checkbox"/> </div> | |-------------------------------------------------|---------------------------------------|---------------------------------------| |-------------------------------------------------|---------------------------------------|---------------------------------------| |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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SUBMITTER | Submitter's Name: | Circle Cardiovascular Imaging, Inc. | |-------------------|-----------------------------------------------------------| | Address: | Suite 1100 – 800 5th Ave SW, Calgary, AB, Canada, T2P 3T6 | | Date Prepared: | January 13, 2021 | | Telephone Number: | +1 403 338 1870 | | Fax Number: | +1 403 338 1895 | | Contact Person: | Dr. Shirantha Samarappuli | | Email: | shirantha.samarappuli@circlecvi.com | #### II. DEVICE | Name of the Device: | TruPlan Computed Tomography (CT) Imaging Software | |--------------------------|-----------------------------------------------------------------------------| | Short Brand Name: | TruPlan | | Common or Usual Name: | Image Processing System | | Classification Name: | Picture Archiving and Communications System | | Proposed Classification: | Device Class: II<br>Product Code: LLZ<br>Regulation Number: 21 CFR 892.2050 | #### PREDICATE DEVICE lll. 3mensio Workstation, manufactured by Pie Medical Imaging under K153736 This predicate has not been subject to a design-related recall. #### IV. DEVICE DESCRIPTION The TruPlan Computed Tomography (CT) Imaging Software application (referred to herein as "TruPlan") is a software as a medical device (SAMD) that helps qualified users with imagebased pre-operative planning of Left Atrial Appendage Closure (LAAC) procedure using CT {4}------------------------------------------------ data. The TruPlan device is designed to support the anatomical assessment of the Left Atrial Appendage (LAA) prior to 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. 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. It is not replacing the existing software applications physicians use for planning the Left Atrial Appendage Closure procedure. Pre-existing CT images are uploaded in TruPlan application 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: - . LAA - Fluoro (fluoroscopy, simulation) . - . Trans Esophageal Echo (TEE, simulation) - Intra Cardiac Echography (ICE, simulation) . - . Thrombus - Multiplanar Reconstruction (MPR) ● Each of these views offer the user visualization and quantification capabilities for pre-procedural planning of the Left Atrial Appendage Closure 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. | Measurement<br>[units] | Description | Module<br>workflow | Application | |------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------|----------------------------------------------------------------------------------------------------| | Distance<br>[mm] | Length between two points,<br>for both curved lines (splines)<br>and straight lines, including<br>the diameter (including min,<br>max, average) resulting from<br>closed splines and depth of the<br>LAA | All modules | Diameter & depth of<br>LAA landing zone<br>(LAA module);<br>distance between<br>points of interest | | Perimeter<br>[mm] | The perimeter of a contour<br>(closed spline) | All modules | Perimeter of LAA<br>landing zone (LAA<br>module); perimeter of<br>other contours of<br>interest | | Area [mm²] | The area within a contour | All modules | Area of LAA landing<br>zone (LAA module);<br>area of other contours<br>of interest | | Angle<br>[degrees] | The angle of an<br>object/structure of interest | All modules | Angle between two<br>lines of interest | | Table 1. TruPlan's measurement functionality and the specific module/workflow and | | | |-----------------------------------------------------------------------------------|--|--| | measurement application for which it is used. | | | {5}------------------------------------------------ | Signal<br>intensity [HU] | Hounsfield value (in<br>Hounsfield Units, HU) of the<br>underlying pixels | Thrombus | Signal intensity of<br>pixels in the regular vs.<br>delayed scan; intensity<br>of other pixels of<br>interest | |--------------------------------|---------------------------------------------------------------------------|-------------|---------------------------------------------------------------------------------------------------------------| | Coordinates<br>[mm, mm,<br>mm] | Location in the x-, y-, and z-<br>planes of a point | All modules | Coordinates of points<br>of interest on a 3D<br>rendering, for export<br>purposes | These measurements are all manually placed by the user as annotations (overlays) and report the information calculated using the underlying pixels. Additionally, the device generates a 3D rendering of the heart (including left ventricle, left atrium, and LAA) using machine learning methodology. The 3D rendering is for visualization purposes only. No measurements or annotation can be done using this view. TruPlan also provides reporting functionality to capture screenshots and measurements and to store them as a PDF document. TruPlan is installed as a standalone software onto the user's Windows PC (desktop) or laptop (Windows is the only supported operating system). TruPlan does not operate on a server or cloud. #### V. INDICATIONS FOR USE/ INTENDED USE TruPlan enables visualization and measurement of structures of the heart and vessels for preprocedural planning and sizing for the left atrial appendage closure (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. {6}------------------------------------------------ #### VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH PREDICATE DEVICE TruPlan is considered to be substantially equivalent to 3mensio Workstation (hereaffer "3mensio"), a commercially available device manufactured by Pie Medical Imaging. Both devices enable visualization and quantification of the heart and cardiovascular structures and are intended for pre-procedural planning and sizing of the implantable device. Of the three characteristics (technical, biological, and clinical) required for the demonstration of equivalence, biological characteristics are not applicable since both TruPlan and 3mensio are standalone software applications with no tangible component interfacing with the body. Table 2 compares the individual features/characteristics for the two devices. | Feature / Characteristic | New Device | Predicate Device | |---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | General information | | | | Device name | TruPlan | 3mensio | | Manufacturer | Circle Cardiovascular Imaging | Pie Medical Imaging | | 510(k) number | K202212 | K153736 | | Device Class | II | II | | Device classification | LLZ | LLZ | | Regulation Name | Picture Archiving and<br>Communications system | Picture Archiving and<br>Communications system | | Regulation number | 21 CFR 892.2050 | 21 CFR 892.2050 | | Indications for Use /<br>Intended Use | TruPlan enables visualization and<br>measurement of structures of the<br>heart and vessels for:<br>- Pre-procedural planning and<br>sizing for the left atrial<br>appendage closure (LAAC)<br>procedure<br>To facilitate the above, TruPlan<br>provides general functionality<br>such as: | 3mensio enables visualization and<br>measurement of structures of the<br>heart and vessels for:<br>- Pre-operational planning and<br>sizing for cardiovascular<br>interventions and surgery<br>- Postoperative evaluation<br>- Support of clinical diagnosis by<br>quantifying dimensions in<br>coronary arteries<br>- Support of clinical diagnosis by<br>quantifying calcifications | Table 2. Feature comparison table of TruPlan with the predicate device, 3mensio. {7}------------------------------------------------ | | Segmentation of<br>•<br>cardiovascular structures<br>Visualization and image<br>•<br>reconstruction techniques: 2D<br>review, Volume Rendering,<br>MPR<br>Simulation of TEE views, ICE<br>•<br>views, and fluoroscopic<br>rendering<br>Measurement and annotation<br>•<br>tools<br>Reporting tools<br>•<br>TruPlan's intended patient<br>population is comprised of adult<br>patients. | (calcium scoring) in the<br>coronary arteries<br>To facilitate the above, 3mensio<br>provides general functionality such<br>as:<br>•<br>Segmentation of cardiovascular<br>structures<br>Visualization and image<br>•<br>reconstruction techniques: 2D<br>review, Volume Rendering,<br>MPR, Curved MPR, Stretched<br>CMPR, slabbing, MIP, AIP,<br>MinIP<br>Measurement and annotation<br>•<br>tools<br>Reporting tools<br>•<br>Automatic and manual<br>centerline detection | | | |---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--| | Technological Characteristics | | | | | | Input data type | CT data in DICOM format (vendor<br>independent) | CT data in DICOM format (vendor<br>independent) | | | | Study list image<br>functionality | • Study/series previewing<br>• Exporting<br>• Deleting<br>• Anonymizing<br>• Search | • Study/series previewing<br>• Exporting<br>• Deleting<br>• Anonymizing<br>• Search | | | | Image assessment -<br>simulated views | • Fluoroscopy (grayscale<br>3D rendering), to visualize<br>relationship among LAAC<br>procedure relevant<br>anatomical structures<br>• TEE, to provide similar<br>views to intraprocedural<br>TEE<br>• ICE, to provide similar<br>views to intraprocedural<br>ICE | • Grayscale 3D rendering, to<br>visualize relationship<br>among LAAC procedure<br>relevant anatomical<br>structures<br>• TEE, to provide similar<br>views to intraprocedural<br>TEE | | | {8}------------------------------------------------ | Image assessment –<br>other visualization<br>functionality | 2D 3D (with manual & semi-automatic segmentation) 4D (cine) MPR Annotations | 2D 3D (with manual & semi-automatic segmentation) 4D (cine) MPR Annotations Curved MPR Stretch CMPR Slabbing MIP AIP MinIP Centreline extraction Calcium scoring | |------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Image assessment –<br>measurement functionality | Distance (length, diameter, perimeter) Area Angle Signal intensity Coordinates | Distance (length, diameter, perimeter) Area Angle Signal intensity Coordinates Volume | | Report functionality | Patient/study information Screenshots Measurements Free text Device sizing table (for reference only) for LAA procedure | Patient/study information Screenshots Measurements Free text Device-specific reports for procedures covered in intended use | | Operating system | Microsoft Windows | Microsoft Windows | | DICOM compliant | YES | YES | #### PERFORMANCE DATA VII. Verification and validation activities were conducted to verify compliance with specified design requirements in accordance with applicable harmonized and consensus standards and following applicable FDA Guidance documents. Validated phantoms were used for assessing the quantitative measurement output of the device. Performance testing was conducted to verify compliance with specified design requirements in accordance with ISO 13485:2016, IEC 62304:2015, IEC 62366:2015 and ISO 14971:2007. {9}------------------------------------------------ DICOM conformance testing was performed to verify compliance with NEMA 3.1-3.20 (2011) 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. #### VIII. CONCLUSIONS The information submitted in this premarket notification, including the performance testing and predicate device comparisons, support the safety and effectiveness of the TruPlan software as compared to the predicate device, 3mensio (K153736).