(197 days)
Not Found
Yes
The device description explicitly states that it generates a 3D rendering of the heart using "machine learning methodology".
No.
The device functions as a visualization and planning tool for medical procedures, and is not directly used to treat or cure a disease or condition.
No
Each of the views offer the user visualization and quantification capabilities for pre-procedural planning of the Left Atrial Appendage Closure procedure; none are intended for diagnosis.
Yes
The device description explicitly states "The TruPlan Computed Tomography (CT) Imaging Software application (referred to herein as "TruPlan") is a software as a medical device (SAMD)". It is installed as a standalone software on a user's PC and processes pre-existing CT images. There is no mention of accompanying hardware components that are part of the medical device itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- TruPlan's Function: TruPlan operates on pre-existing CT images of the heart and vessels. It does not analyze biological specimens taken from the patient. Its purpose is for pre-procedural planning and sizing based on anatomical visualization and measurements derived from these images.
- Intended Use: The intended use clearly states "visualization and measurement of structures of the heart and vessels for pre-procedural planning and sizing for the left atrial appendage closure (LAAC) procedure." This is an imaging-based planning tool, not a diagnostic test performed on a biological sample.
- Device Description: The description reinforces that it's a "software as a medical device (SAMD)" that uses "CT data" for "image-based pre-operative planning." It explicitly states that the views are "none are intended for diagnosis."
Therefore, TruPlan falls under the category of medical imaging software used for planning and visualization, not as an In Vitro Diagnostic device.
No
The letter does not explicitly state that the FDA has reviewed and approved or cleared the PCCP for this specific device. The critical section for PCCP authorization is "Control Plan Authorized (PCCP) and relevant text," which explicitly states "Not Found."
Intended Use / 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.
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
Product codes (comma separated list FDA assigned to the subject device)
LLZ
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 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 | Module workflow | Application |
|---|---|---|---|
| Distance [mm] | Length between two points, for both curved lines (splines) and straight lines, including the diameter (including min, max, average) resulting from closed splines and depth of the LAA | All modules | Diameter & depth of LAA landing zone (LAA module); distance between points of interest |
| Perimeter [mm] | The perimeter of a contour (closed spline) | All modules | Perimeter of LAA landing zone (LAA module); perimeter of other contours of interest |
| Area [mm²] | The area within a contour | All modules | Area of LAA landing zone (LAA module); area of other contours of interest |
| Angle [degrees] | The angle of an object/structure of interest | All modules | Angle between two lines of interest |
| Signal intensity [HU] | Hounsfield value (in Hounsfield Units, HU) of the underlying pixels | Thrombus | Signal intensity of pixels in the regular vs. delayed scan; intensity of other pixels of interest |
| Coordinates [mm, mm, mm] | Location in the x-, y-, and z-planes of a point | All modules | Coordinates of points of interest on a 3D rendering, for export purposes |
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 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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
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.
Input Imaging Modality
CT data in DICOM format (vendor independent)
Anatomical Site
Heart and vessels (specifically Left Atrial Appendage)
Indicated Patient Age Range
Adult patients
Intended User / Care Setting
Qualified users; standalone software on user's Windows PC (desktop) or laptop.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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). 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
1
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
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) | ||
|---|---|---|
| ------------------------------------------------- | --------------------------------------- | --------------------------------------- |
|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: II |
| Product Code: LLZ | |
| 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
[units] | Description | Module
workflow | Application |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------|----------------------------------------------------------------------------------------------------|
| Distance
[mm] | Length between two points,
for both curved lines (splines)
and straight lines, including
the diameter (including min,
max, average) resulting from
closed splines and depth of the
LAA | All modules | Diameter & depth of
LAA landing zone
(LAA module);
distance between
points of interest |
| Perimeter
[mm] | The perimeter of a contour
(closed spline) | All modules | Perimeter of LAA
landing zone (LAA
module); perimeter of
other contours of
interest |
| Area [mm²] | The area within a contour | All modules | Area of LAA landing
zone (LAA module);
area of other contours
of interest |
| Angle
[degrees] | The angle of an
object/structure of interest | All modules | Angle between two
lines of interest |
| Table 1. TruPlan's measurement functionality and the specific module/workflow and | ||
|---|---|---|
| measurement application for which it is used. |
5
| Signal
intensity [HU] | Hounsfield value (in
Hounsfield Units, HU) of the
underlying pixels | Thrombus | Signal intensity of
pixels in the regular vs.
delayed scan; intensity
of other pixels of
interest |
|--------------------------------|---------------------------------------------------------------------------|-------------|---------------------------------------------------------------------------------------------------------------|
| Coordinates
[mm, mm,
mm] | Location in the x-, y-, and z-
planes of a point | All modules | Coordinates of points
of interest on a 3D
rendering, for export
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 | |
| Communications system | Picture Archiving and | |
| Communications system | ||
| Regulation number | 21 CFR 892.2050 | 21 CFR 892.2050 |
| Indications for Use / | ||
| Intended 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
To facilitate the above, TruPlan
provides general functionality
such as: | 3mensio enables visualization and
measurement of structures of the
heart and vessels for: - Pre-operational planning and
sizing for cardiovascular
interventions and surgery - Postoperative evaluation
- Support of clinical diagnosis by
quantifying dimensions in
coronary arteries - Support of clinical diagnosis by
quantifying calcifications |
Table 2. Feature comparison table of TruPlan with the predicate device, 3mensio.
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| | 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. | (calcium scoring) in the
coronary arteries
To facilitate the above, 3mensio
provides general functionality such
as:
•
Segmentation of cardiovascular
structures
Visualization and image
•
reconstruction techniques: 2D
review, Volume Rendering,
MPR, Curved MPR, Stretched
CMPR, slabbing, MIP, AIP,
MinIP
Measurement and annotation
•
tools
Reporting tools
•
Automatic and manual
centerline detection | | |
|---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| Technological Characteristics | | | | |
| Input data type | CT data in DICOM format (vendor
independent) | CT data in DICOM format (vendor
independent) | | |
| Study list image
functionality | • Study/series previewing
• Exporting
• Deleting
• Anonymizing
• Search | • Study/series previewing
• Exporting
• Deleting
• Anonymizing
• Search | | |
| Image assessment -
simulated views | • Fluoroscopy (grayscale
3D rendering), to visualize
relationship among LAAC
procedure relevant
anatomical structures
• TEE, to provide similar
views to intraprocedural
TEE
• ICE, to provide similar
views to intraprocedural
ICE | • Grayscale 3D rendering, to
visualize relationship
among LAAC procedure
relevant anatomical
structures
• TEE, to provide similar
views to intraprocedural
TEE | | |
8
| Image assessment –
other visualization
| 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 – | ||
| 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).