(197 days)
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
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 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.
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.
The provided text does not contain the detailed information required to describe the acceptance criteria and the comprehensive study that proves the device meets those criteria.
While the document (a 510(k) summary) mentions "Verification and validation activities were conducted to verify compliance with specified design requirements" and "Performance testing was conducted to verify compliance with specified design requirements," it does not provide any specific quantitative acceptance criteria or the actual performance data. It also states "No clinical studies were necessary to support substantial equivalence," which means there was no multi-reader multi-case (MRMC) study or standalone performance study in a clinical setting with human readers.
Therefore, I cannot fulfill most of the requested points from the input. However, based on the information provided, I can infer and state what is missing or not applicable.
Here's a breakdown of the requested information and what can/cannot be extracted from the provided text:
1. A table of acceptance criteria and the reported device performance
Cannot be provided. The document states that "performance testing was conducted to verify compliance with specified design requirements," and "Validated phantoms were used for assessing the quantitative measurement output of the device." However, it does not specify what those "specified design requirements" (i.e., acceptance criteria) were, nor does it report the actual quantitative performance results (e.g., accuracy, precision) of the device against those criteria.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
Cannot be provided. The document refers to "Validated phantoms" for quantitative measurement assessment. This implies synthetic or controlled data rather than patient data. No details are given regarding the number of phantoms used or their characteristics. There is no mention of "test set" in the context of patient data, data provenance, or whether it was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
Cannot be provided. Since no clinical test set with patient data is described, there's no mention of experts establishing ground truth for such a set. The testing was done on "validated phantoms" for "quantitative measurement output," suggesting a comparison against known ground truth values inherent to the phantom design rather than expert consensus on medical images.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Cannot be provided. Given the lack of a clinical test set and expert review, no adjudication method is mentioned or applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No, a MRMC study was NOT done. The document explicitly states: "No clinical studies were necessary to support substantial equivalence." This means there was no MRMC study to show human reader improvement with AI assistance. The submission relies on "performance testing and predicate device comparisons" for substantial equivalence.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Likely yes, for certain aspects, but specific performance data is not provided. The document mentions "Validated phantoms were used for assessing the quantitative measurement output of the device." This implies an algorithmic, standalone assessment of the device's measurement capabilities against the known values of the phantoms. However, the exact methodology, metrics, and results of this standalone performance are not detailed.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the quantitative measurement assessment was based on "Validated phantoms." This means the ground truth for measurements (e.g., distances, areas) would be the known, precisely manufactured dimensions of the phantoms, not expert consensus, pathology, or outcomes data.
8. The sample size for the training set
Cannot be provided. The document mentions that the device "generates a 3D rendering of the heart (including left ventricle, left atrium, and LAA) using machine learning methodology." This indicates that a training set was used for this specific function. However, the size of this training set is not mentioned anywhere in the provided text.
9. How the ground truth for the training set was established
Cannot be provided. While it's implied that there was a training set for the "machine learning methodology" used for 3D rendering, the document does not explain how the ground truth for this training set was established.
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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). 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. 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
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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see 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 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.
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
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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) | ||
|---|---|---|
| ------------------------------------------------- | --------------------------------------- | --------------------------------------- |
|X | Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/2 description: The image shows the logo for Circle Cardiovascular Imaging. The logo features a stylized green and yellow circle above the word "circle" in gray lowercase letters. Below the word "circle" are the words "CARDIOVASCULAR IMAGING" in gray capital letters.
l. 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: IIProduct Code: LLZRegulation 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
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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[units] | Description | Moduleworkflow | Application |
|---|---|---|---|
| Distance[mm] | Length between two points,for both curved lines (splines)and straight lines, includingthe diameter (including min,max, average) resulting fromclosed splines and depth of theLAA | All modules | Diameter & depth ofLAA landing zone(LAA module);distance betweenpoints of interest |
| Perimeter[mm] | The perimeter of a contour(closed spline) | All modules | Perimeter of LAAlanding zone (LAAmodule); perimeter ofother contours ofinterest |
| Area [mm²] | The area within a contour | All modules | Area of LAA landingzone (LAA module);area of other contoursof interest |
| Angle[degrees] | The angle of anobject/structure of interest | All modules | Angle between twolines of interest |
| Table 1. TruPlan's measurement functionality and the specific module/workflow and | ||
|---|---|---|
| measurement application for which it is used. |
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| Signalintensity [HU] | Hounsfield value (inHounsfield Units, HU) of theunderlying pixels | Thrombus | Signal intensity ofpixels in the regular vs.delayed scan; intensityof other pixels ofinterest |
|---|---|---|---|
| Coordinates[mm, mm,mm] | Location in the x-, y-, and z-planes of a point | All modules | Coordinates of pointsof interest on a 3Drendering, for exportpurposes |
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.
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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 andCommunications system | Picture Archiving andCommunications system |
| Regulation number | 21 CFR 892.2050 | 21 CFR 892.2050 |
| Indications for Use /Intended Use | TruPlan enables visualization andmeasurement of structures of theheart and vessels for:- Pre-procedural planning andsizing for the left atrialappendage closure (LAAC)procedureTo facilitate the above, TruPlanprovides general functionalitysuch as: | 3mensio enables visualization andmeasurement of structures of theheart and vessels for:- Pre-operational planning andsizing for cardiovascularinterventions and surgery- Postoperative evaluation- Support of clinical diagnosis byquantifying dimensions incoronary arteries- Support of clinical diagnosis byquantifying calcifications |
Table 2. Feature comparison table of TruPlan with the predicate device, 3mensio.
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| Segmentation of•cardiovascular structuresVisualization and image•reconstruction techniques: 2Dreview, Volume Rendering,MPRSimulation of TEE views, ICE•views, and fluoroscopicrenderingMeasurement and annotation•toolsReporting tools•TruPlan's intended patientpopulation is comprised of adultpatients. | (calcium scoring) in thecoronary arteriesTo facilitate the above, 3mensioprovides general functionality suchas:•Segmentation of cardiovascularstructuresVisualization and image•reconstruction techniques: 2Dreview, Volume Rendering,MPR, Curved MPR, StretchedCMPR, slabbing, MIP, AIP,MinIPMeasurement and annotation•toolsReporting tools•Automatic and manualcenterline detection | |||
|---|---|---|---|---|
| Technological Characteristics | ||||
| Input data type | CT data in DICOM format (vendorindependent) | CT data in DICOM format (vendorindependent) | ||
| Study list imagefunctionality | • Study/series previewing• Exporting• Deleting• Anonymizing• Search | • Study/series previewing• Exporting• Deleting• Anonymizing• Search | ||
| Image assessment -simulated views | • Fluoroscopy (grayscale3D rendering), to visualizerelationship among LAACprocedure relevantanatomical structures• TEE, to provide similarviews to intraproceduralTEE• ICE, to provide similarviews to intraproceduralICE | • Grayscale 3D rendering, tovisualize relationshipamong LAAC procedurerelevant anatomicalstructures• TEE, to provide similarviews to intraproceduralTEE |
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| Image assessment –other visualizationfunctionality | 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 –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.
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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).
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).