(98 days)
Not Found
No
The description details a feature tracking algorithm based on a deformable model and control points, which is a traditional image processing technique, not explicitly AI/ML. There is no mention of AI, ML, or related terms like neural networks or deep learning.
No
The device provides diagnostic information for suspected heart disease but does not actively treat or alleviate a medical condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the measurements provided by the software are "used by qualified medical professionals... for the purpose of obtaining diagnostic information for patients with suspected heart disease as part of a comprehensive diagnostic decision-making process." This indicates the device's role in aiding diagnosis.
Yes
The device description explicitly states it is a "software device" and its functionality is independent of the acquisition equipment. It integrates into existing image viewing software and does not interface directly with data collection equipment.
Based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the measurements provided by the software are used by qualified medical professionals "for the purpose of obtaining diagnostic information for patients with suspected heart disease as part of a comprehensive diagnostic decision-making process." This aligns with the definition of an IVD, which is used to examine specimens derived from the human body to provide information for diagnostic purposes.
- Device Description: While the device processes images, the output (measurements of myocardial function) is used to aid in the diagnosis of heart disease. This is a key characteristic of an IVD.
- Input: The input is CMR images, which are derived from the human body.
- Output: The output is quantitative measurements (displacement, velocity, strain rate, time to peak, torsion, strains, strain rates, displacements, velocities, and torsion) that are used for diagnostic purposes.
While the device processes images and doesn't directly analyze a biological specimen in the traditional sense (like blood or urine), the information derived from the images (which are of the human body) is used for diagnostic purposes. Regulatory bodies often consider software that analyzes medical images for diagnostic purposes to fall under the IVD category, especially when the output is quantitative data used in clinical decision-making.
The fact that it's compared to a predicate device (K120135; 2D Cardiac Performance Analysis MR 1.0 (2D CPA MR)) which is also likely an IVD further supports this conclusion.
N/A
Intended Use / Indications for Use
The Myocardial Strain Software Application is intended for qualitative and quantitative evaluation of cardiovascular magnetic resonance (CMR) images. It provides measurements of 2D LV myocardial function (displacement, velocity, strain rate, time to peak, and torsion); these measurements are used by qualified medical professionals, experienced in examining and evaluating CMR images, for the purpose of obtaining diagnostic information for patients with suspected heart disease as part of a comprehensive diagnostic decision-making process.
Product codes
LLZ
Device Description
Circle's Myocardial Strain Software Application (Strain Module) is a software device that enables the analysis of CMR images acquired using SSFP cine imaging. It is designed to support physicians in the visualization, evaluation, and analysis of myocardial tissue deformation through CMR feature tracking. The device is intended to be used as an aid to the existing standard of care and does not replace existing software applications that physicians use. The Strain Module can be integrated into an image viewing software intended for visualization of cardiac images, such as Circle's FDA-cleared cvi42 software. The Strain Module does not interface directly with any data collection equipment, and its functionality is independent of the type of vendor acquisition equipment. The analysis results are available on-screen or can be saved for future review.
Mentions image processing
Yes
Mentions AI, DNN, or ML
No
Input Imaging Modality
cardiovascular MR images in a DICOM Standard format; SSFP cine imaging; cine MR images
Anatomical Site
LV myocardial (Left Ventricle myocardial)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified medical professionals, experienced in examining and evaluating CMR images
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)
Performance testing was conducted to verify compliance with specified design requirements in accordance with ISO 13485:2016, IEC 62304:2015, ISO 14971:2019, and DICOM standards.
Verification and validation testing were conducted to ensure specifications and performance of the device and were performed per the FDA Guidance "Technical Performance Assessment of Quantitative Imaging in Radiological Device Premarket Submission". No clinical studies were necessary to support substantial equivalence.
Strain Module 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.
The tracking performance and the clinically relevant Global Longitudinal and Global Circumferential strains were validated using a combination of simple and realistic phantoms, real MRI data, and analytical solutions. The tracking performance was evaluated with simple analytical phantoms generated with variable input parameters; the deformation field generated by the strain module was evaluated on realistic phantoms with artificially imposed known deformation field and perturbations; and the performance of the constrained tissue tracking algorithm was also compared to manual tracking in ES phase by three expert readers. The computation of the deformation metrics from the tracked deformations were evaluated analytically.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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).
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.
Circle Cardiovascular Imaging % Sydney Toutant Regulatory Affairs Manager Suite 110 - 800 5th Ave SW Calgary, AB T2P 3T6 Canada
Re: K232661
December 7, 2023
Trade/Device Name: Myocardial Strain Software Application Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: LLZ Dated: November 10, 2023 Received: November 13, 2023
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 (the 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 available 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.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
2
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 DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
Submission Number (if known)
Device Name
Myocardial Strain Software Application
Indications for Use (Describe)
The Myocardial Strain Software Application is intended for qualitative and quantitative evaluation of cardiovascular magnetic resonance (CMR) images. It provides measurements of 2D LV myocardial function (displacement, velocity, strain rate, time to peak, and torsion); these measurements are used by qualified medical professionals, experienced in examining and evaluating CMR images, for the purpose of obtaining diagnostic information for patients with suspected heart disease as part of a comprehensive diagnostic decision-making process.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/4/Picture/2 description: The image contains the logo for Circle Cardiovascular Imaging. The logo features a stylized green circle that is not fully closed, with a lighter green gradient towards the inside of the circle. Below the circle is the word "circle" in a gray, sans-serif font, and below that is the phrase "CARDIOVASCULAR IMAGING" in a smaller, sans-serif font, also in gray.
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: | August 31 2023 |
| Telephone Number: | +1 587 747 4692 |
| Contact Person : | Sydney Toutant |
| Email: | sydney.toutant@circlecvi.com |
II. DEVICE
| Name of the Device: | Myocardial Strain Software Application |
|---|---|
| Short Brand Name: | Strain Module |
| Common or Usual Name: | Radiological Image Processing System |
| Classification Name: | Medical image management and processing system |
| Proposed Classification: | Device Class: II |
| Product Code: LLZ | |
| Regulation Number: 21 CFR 892.2050 |
lll. PREDICATE DEVICE
The predicate device is 2D Cardiac Performance Analysis MR 1.0 (2D CPA MR) manufactured by TomTec Imaging Systems GmbH and cleared under K120135.
The predicate device has not been subject to a design-related recall.
5
IV. DEVICE DESCRIPTION
Circle's Myocardial Strain Software Application (Strain Module) is a software device that enables the analysis of CMR images acquired using SSFP cine imaging. It is designed to support physicians in the visualization, evaluation, and analysis of myocardial tissue deformation through CMR feature tracking. The device is intended to be used as an aid to the existing standard of care and does not replace existing software applications that physicians use. The Strain Module can be integrated into an image viewing software intended for visualization of cardiac images, such as Circle's FDA-cleared cvi42 software. The Strain Module does not interface directly with any data collection equipment, and its functionality is independent of the type of vendor acquisition equipment. The analysis results are available on-screen or can be saved for future review.
The Strain Module implements an algorithm for deformations modeling of topologies that relies on a two-dimensional (2D) version of the nearly incompressible deformable model. The deformation of the model is assumed to be completely determined by a set of control points placed on the middle curve of the myocardial wall; these points are first defined by the end-user in a reference phase, and then detected in all other phases based on the feature tracked boundaries and incompressibility constraint of the model. Once this feature tracking is complete, the Strain Module computes and reports various global and regional deformation quantities such as strains (including Global Longitudinal Strain (GLS) and Global Circumferential Strain (GCS)), strain rates, displacements, velocities, and torsion. These measurements of myocardial deformation can be made, as appropriate, in the radial, circumferential, or longitudinal directions. Note that the feature tracking and deformation quantity computation is purely mathematical; the Strain Module does not involve any artificial intelligence (AI) or machine learning (ML).
The device allows users to perform the measurements listed in Table 1.
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| Table 1. Measurements in the Strain Module | ||
|---|---|---|
| -------------------------------------------- | -- | -- |
| Measurement [units] | Description | Workflow | Application |
|---|---|---|---|
| Strain [%] | In general, myocardial strain is a measure of the deformation in | ||
| shape and dimension of the heart muscle during the cardiac | |||
| cycle. Mathematically Circle uses the Lagrangian strain tensor | |||
| and measures the deformation with respect to the reference (end | |||
| diastole) phase. The radial, circumferential and longitudinal | |||
| strains are defined as the strain tensor evaluated in the radial, | |||
| circumferential and longitudinal directions on the appropriate SAX | |||
| or LAX slices (in 2D), respectively. | • SAX-Circumferential | ||
| • SAX-Radial | |||
| • LAX-Longitudinal | |||
| • LAX-Radial | • This measurement for the global | ||
| myocardium, or specific regions of | |||
| myocardium, can be represented over | |||
| time by Strain Curves. | |||
| • Strain is also presented as an Image | |||
| Overlay. | |||
| Peak Strain [%] | The maximum of the strain in absolute value, over the whole | ||
| cardiac cycle. | • SAX-Circumferential | ||
| • SAX-Radial | |||
| • LAX-Longitudinal | |||
| • LAX-Radial | • This measurement, on a regional basis, | ||
| can be visualized and reported in Polar | |||
| Maps. | |||
| Note: Global peak circumferential strain | |||
| and global peak longitudinal strain can | |||
| be added by the user to the clinical | |||
| report. | |||
| Time to Peak Strain [ms] | Trigger time elapsed from the first phase till the phase where the | ||
| peak strain has been reached. | • SAX-Circumferential | ||
| • SAX-Radial | |||
| • LAX-Longitudinal | |||
| • LAX-Radial | • Polar Maps, as above. | ||
| Strain Rate [1/s] | Derivative of the strain with respect to time. | • SAX-Circumferential | |
| • SAX-Radial | |||
| • LAX-Longitudinal | |||
| • LAX-Radial | • Strain Curves, as above. | ||
| Peak Systolic Strain Rate | |||
| [1/s] | The maximum of the strain rate in absolute value over all phases | ||
| starting from the end systole till the next diastole. | • SAX-Circumferential | ||
| • SAX-Radial | |||
| • LAX-Longitudinal | |||
| • LAX-Radial | • Polar Maps, as above. | ||
| Peak Diastolic Strain Rate | |||
| [1/s] | The maximum of the strain rate in absolute value over all phases | ||
| starting from the end diastole till the next systole. | • SAX-Circumferential | ||
| • SAX-Radial | |||
| • LAX-Longitudinal | |||
| • LAX-Radial | • Polar Maps, as above. | ||
| Displacement | |||
| [mm or degree] | The displacement vector represents the position of a point with | ||
| respect to the position of that point in the reference (end diastole) | |||
| phase. The radial (both SAX and LAX) and longitudinal (LAX) | • SAX-Circumferential | ||
| • SAX-Radial | |||
| • LAX-Longitudinal | • Strain Curves, as above. | ||
| Displacement is also presented as an | |||
| Image Overlay. | |||
| displacements are expressed in mm and the circumferential | |||
| (SAX) displacement is presented in degree. | • LAX-Radial | ||
| Peak Displacement [mm or | |||
| degree] | The maximum of the displacement in absolute value, over the | ||
| whole cardiac cycle (expressed in mm for radial and longitudinal, | |||
| and in degree for circumferential displacements). | • SAX-Circumferential | ||
| • SAX-Radial | |||
| • LAX-Longitudinal | |||
| • LAX-Radial | • Polar Maps, as above. | ||
| Time to Peak Displacement [ms] | Trigger time elapsed from the first phase till the phase where the | ||
| peak displacement has been reached. | • SAX-Circumferential | ||
| • SAX-Radial | |||
| • LAX-Longitudinal | |||
| • LAX-Radial | • Polar Maps, as above. | ||
| Velocity [mm/s or degree/s] | Derivative of the displacement with respect to time (expressed in | ||
| mm/s or degree/s, as appropriate). The circumferential velocity | |||
| represents an angular velocity. | • SAX-Circumferential | ||
| • SAX-Radial | |||
| • LAX-Longitudinal | |||
| • LAX-Radial | • Strain Curves, as above. | ||
| Peak Systolic Velocity [mm/s or | |||
| degree/s] | The maximum of the velocity in absolute value over all phases | ||
| starting from the end diastole till the next systole (expressed in | |||
| mm/s or degree/s, as appropriate). | • SAX-Circumferential | ||
| • SAX-Radial | |||
| • LAX-Longitudinal | |||
| • LAX-Radial | • Polar Maps, as above. | ||
| Peak Diastolic Velocity [mm/s or | |||
| degree/s] | The maximum of the velocity in absolute value over all phases | ||
| starting from the end systole till the next end diastole (expressed | |||
| in mm/s or degree/s, as appropriate). | • SAX-Circumferential | ||
| • SAX-Radial | |||
| • LAX-Longitudinal | |||
| • LAX-Radial | • Polar Maps, as above. | ||
| Torsion [deg/cm] | The difference in rotation between the apical and basal slices | ||
| divided by the distance between apical and basal slices. Note that | |||
| circumferential displacement represents an angle. | • SAX-Circumferential | • Strain Curves, as above. | |
| Torsion Rate [deg/(cm*s)] | The difference in rotational velocity between apical and basal | ||
| slices divided by the distance between the apical and basal | |||
| slices. Note that circumferential velocity represents an angular | |||
| velocity. | • SAX-Circumferential | • Strain Curves, as above. |
Circle Cardiovascular Imaging Inc.
Non-Confidential
7
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V. INTENDED USE / INDICATIONS FOR USE
Intended Use
The Myocardial Strain Software Application is intended for qualitative and quantitative evaluation of cardiovascular MR images in a DICOM Standard format. As prerequisite, the user confirms endocardial and epicardial contours in a reference phase, and the software tracks features over the cardiac cycle and computes 2D myocardial deformation and movement (e.g., strain, displacement, velocity).
Indications for Use
The Myocardial Strain Software Application is intended for qualitative evaluation of cardiovascular magnetic resonance (CMR) images. It provides measurements of 2D LV myocardial function (displacement, velocity, strain rate, time to peak, and torsion); these measurements are used by qualified medical professionals, experienced in examining and evaluating CMR images, for the purpose of obtaining diagnostic information for patients with suspected heart disease as part of a comprehensive diagnostic decision-making process.
VI. COMPARISON WITH PREDICATE DEVICE
The detailed analysis of the subject device and the predicate device (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 predicate (K120135). Of the three characteristics (technical, biological, and clinical) required for the demonstration of equivalence, biological characteristics are not applicable since both the subject device and predicate device are software as a medical device applications with no tangible component interfacing with the body.
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| Subject Device | Predicate Device | |
|---|---|---|
| Strain Module | 2D CPA MR (K120135) | |
| Manufactured by Circle | Manufactured by TomTec | |
| Intended | ||
| Use | The Myocardial Strain Software Application is intended | |
| for qualitative and quantitative evaluation of | ||
| cardiovascular MR images in a DICOM Standard | ||
| format. As prerequisite, the user confirms endocardial | ||
| and epicardial contours in a reference phase, and the | ||
| software tracks features over the cardiac cycle and | ||
| computes 2D myocardial deformation and movement | 2D CPA MR software is intended for quantification of | |
| the myocardial deformation (strain) and movement | ||
| (displacement / velocity) for digital magnetic | ||
| resonance images. Possible quantification results are | ||
| velocity, displacement, strain, strain rate, time-to-peak | ||
| and phase. | ||
| (e.g., strain, displacement, velocity). | Prerequisite is to draw a contour (endocard or | |
| endocard and epicard) in a digital magnetic resonance | ||
| image. Based on this manual drawn contour, the SW | ||
| calculates with a tracking algorithm the borders' | ||
| displacement. | ||
| Indications | ||
| for Use | The Myocardial Strain Software Application is intended | |
| for qualitative and quantitative evaluation of | ||
| cardiovascular magnetic resonance (CMR) images. It | ||
| provides measurements of 2D LV myocardial function | ||
| (displacement, velocity, strain, strain rate, time to | ||
| peak, and torsion); these measurements are used by | ||
| qualified medical professionals, experienced in | ||
| examining and evaluating CMR images, for the | ||
| purpose of obtaining diagnostic information for | ||
| patients with suspected heart disease as part of a | ||
| comprehensive diagnostic decision-making process. | 2D Cardiac Performance Analysis is intended for | |
| cardiac quantification based on magnetic resonance | ||
| images. It provides measurements of myocardial | ||
| function (displacement, velocity, strain, strain rate) that | ||
| is used for diagnostic purposes of patients with | ||
| suspected heart disease. |
Table 2. Intended use and indications comparison.
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| Feature | Subject Device | Predicate Device |
|---|---|---|
| Strain Module | ||
| Manufactured by Circle | 2D CPA MR (K120135) | |
| Manufactured by TomTec | ||
| Device Class | II | II |
| Product Code | LLZ | LLZ |
| Regulation Name | Medical image management and | |
| processing system | Picture Archiving and Communications | |
| System | ||
| Regulation Number | 21 CFR 892.2050 | 21 CFR 892.2050 |
| DICOM Compliant? | Yes | Yes |
| Input Data Type | cine MR images | |
| (vendor independent) | cine MR images | |
| (vendor independent) | ||
| Prerequisites | Endocardial and epicardial contours in | |
| reference phase(s). | Contours (endocardial, or endocardial and | |
| epicardial) in a digital magnetic resonance | ||
| image | ||
| Myocardial deformation | ||
| assessment technique | Feature tracking (FT) | Feature tracking (FT) |
| Comprehensive functional | ||
| assessment of myocardial function | Yes | Yes |
| 2D functional analysis of | ||
| myocardial deformation | Yes | Yes |
| Express parameters in their | ||
| spatial directions (e.g., | ||
| circumferential, longitudinal radial) | Yes | Yes |
| Overlay of tracked contour and | ||
| graphical displays for measured | ||
| parameters | Yes | Yes |
| Myocardial Function Global and | ||
| Regional Measurements | Displacement Velocity Strain Strain Rate Time to Peak Torsion | Displacement Velocity Strain Strain Rate Time to Peak |
| Operating System | Microsoft Windows | |
| Apple macOS | Microsoft Windows |
Table 3. Requlatory and technological features comparison
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 DICOM standards.
Verification and validation testing were conducted to ensure specifications and performance of the device and were performed per the FDA Guidance "Technical Performance Assessment of Quantitative Imaging in Radiological Device Premarket Submission". No clinical studies were necessary to support substantial equivalence.
Strain Module 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.
11
Validation of Outputs
The tracking performance and the clinically relevant Global Longitudinal and Global Circumferential strains were validated using a complination of simple and realistic phantoms, real MRI data, and analytical solutions. The tracking performance was evaluated with simple analytical phantoms generated with variable input parameters; the deformation field generated by the strain module was evaluated on realistic phantoms with artificially imposed known deformation field and perturbations; and the performance of the constrained tissue tracking algorithm was also compared to manual tracking in ES phase by three expert readers. The computation of the deformation metrics from the tracked deformations were evaluated analytically.
VIII. CONCLUSION
The information submitted in this premarket notification, including the performance testing and predicate device comparison, support the safety and effectiveness of Strain Module as compared to the predicate device when used for the defined intended use.