(219 days)
Not Found
Yes
The document explicitly states that the device "uses machine learning techniques" and describes the training and validation of these "machine learning algorithms."
No.
The device is for viewing, post-processing, and qualitative evaluation of images to assist physicians in qualitative assessment and quantitative measurements, and provides diagnostic information to support decision-making, rather than directly treating or preventing disease.
Yes
Explanation: The "Intended Use" section explicitly states that the device is for "obtaining diagnostic information as part of a comprehensive decision-making process." The "Device Description" also mentions that it provides "clinical diagnosis decision support tools."
Yes
The device description explicitly states that cvi42 Auto is a "software as a medical device (SaMD)" and that it "does not interface directly with any data collection equipment; instead, the software uploads data files previously generated by such equipment." This confirms it is a software-only device.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- cvi42 Auto's Function: cvi42 Auto processes and analyzes medical images (MR and CT scans) of the cardiovascular system. It does not perform tests on biological samples. Its purpose is to assist physicians in interpreting existing images and making measurements.
Therefore, while cvi42 Auto is a medical device used for diagnostic purposes, it falls under the category of medical imaging software rather than an In Vitro Diagnostic.
No
The input text does not contain any explicit statement that the FDA has reviewed and approved or cleared a Predetermined Change Control Plan (PCCP) for this specific device. The section "Control Plan Authorized (PCCP) and relevant text" explicitly states "Not Found".
Intended Use / Indications for Use
cvi42 Auto is intended to be used for viewing, post-processing, qualitative evaluation of cardiovascular magnetic resonance (MR) and computed tomography (CT) images in a Digital Imaging and Communications in Medicine (DICOM) Standard format.
It enables a set of tools to assist physicians in qualitative assessment of cardiac images and quantitative measurements of the heart and adjacent vessels: perform calcium scoring: and to confirm the presence of physician-identified lesion in blood vessels.
The target population for cvi42 Auto's manual workflows is not restricted; however, cvi42 Auto's semi-automated machine learning algorithms are intended for an adult population.
cvi42 Auto shall be used only for cardiac images acquired from an MR or CT scanner. It shall be used by qualified medical professionals, experienced in examining and evaluating cardiovascular MR or CT images, for the purpose of obtaining diagnostic information as part of a comprehensive decision-making process.
Product codes
QIH, LLZ
Device Description
cvi42 Auto is a software as a medical device (SaMD) that is intended for evaluating CT and MR images of the cardiovascular system. Combining digital image processing, visualization, guantification, and reporting tools, cvi42 Auto device is designed to support the physician in confirming the presence or absence of physician-identified lesion in blood vessels and evaluation, documentation and follow up of any such lesions.
cvi42 Auto uses machine learning techniques to aid in semi-automatic contouring of regions of interest of cardiac magnetic resonance (MR) or computed tomography (CT) images as follows:
-
- Cardiac Function: semi-automatic contouring of the four heart chambers (including left ventricle, left atrium, right ventricle, right atrium) in MR images.
-
- Calcium Assessment: using pixel intensity technique, identify calcified plaque in major coronary arteries in non-contrast enhanced CT images.
-
- Coronary Analysis: semi-automatic placement of centerline in coronary vessels to visualize the coronary arteries and assess stenosis in non-contrast enhanced CT images.
The data used to train these machine learning algorithms were sourced from multiple clinical sites from urban centers and from different countries. When selecting data for training, the importance of model generalization was considered and data was selected such that a good distribution of patient demographics, scanner, and image parameters were represented. The separation into training versus validation datasets is made on the study level to ensure no overlap between the two sets. As such, different scans from the same study were not split between the training and validation datasets. None of the cases used for model validation were used for training the machine learning models.
cvi42 Auto software has a graphical user interface which allows users to analyze cardiac images qualitatively and quantitatively for volume/mass, function and signal intensity changes including a reporting function.
The device can be integrated into a hospital, private practice environment, or medical research institution and provides clinical diagnosis decision support tools for the cardiovascular MR and CT technique.
Additionally, the software is designed to generate 3D view of the heart in CT images for qualitative assessment of the coronary artery. No quantitative assessment can be made from the 3D image.
The software does not interface directly with any data collection equipment; instead, the software uploads data files previously generated by such equipment. Its functionality is independent of the type of vendor acquisition equipment. The analysis results are available on-screen and can be saved within the software for future review.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Yes
Input Imaging Modality
MR and CT
Anatomical Site
cardiovascular system, heart and adjacent vessels, blood vessels, four heart chambers (including left ventricle, left atrium, right ventricle, right atrium), major coronary arteries, coronary vessels
Indicated Patient Age Range
The target population for cvi42 Auto's manual workflows is not restricted; however, cvi42 Auto's semi-automated machine learning algorithms are intended for an adult population.
Intended User / Care Setting
qualified medical professionals, experienced in examining and evaluating cardiovascular MR or CT images, for the purpose of obtaining diagnostic information as part of a comprehensive decision-making process. The device can be integrated into a hospital, private practice environment, or medical research institution.
Description of the training set, sample size, data source, and annotation protocol
The data used to train these machine learning algorithms were sourced from multiple clinical sites from urban centers and from different countries. When selecting data for training, the importance of model generalization was considered and data was selected such that a good distribution of patient demographics, scanner, and image parameters were represented. The separation into training versus validation datasets is made on the study level to ensure no overlap between the two sets. As such, different scans from the same study were not split between the training and validation datasets. None of the cases used for model validation were used for training the machine learning models.
Description of the test set, sample size, data source, and annotation protocol
Across all MR and CT machine manufacturers, n = 235 anonymized patient images were used for the validation of cvi42 Auto. This translates into 70 samples for Coronary Analysis, 102 samples for Calcium analysis, 63 samples for SAX Function contouring, 63 for each of 2-CV, 3-CV, and 4CV LAX function contouring, and 252 samples for Function Classification. Image information for all samples was anonymized and limited to ePHI-free DICOM headers. At least 50% of the data came from a U.S. population.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Validation of Machine Learning Derived Outputs.
The machine learning algorithms of cvi42 Auto (MR-CMR Function, CT-Coronary, and CT-Calcium) have been trained and tested on images acquired from major vendors of MR and CT imaging devices. All data used for validation were not used during the development of the training algorithms.
Across all MR and CT machine manufacturers, n = 235 anonymized patient images were used for the validation of cvi42 Auto. This translates into 70 samples for Coronary Analysis, 102 samples for Calcium analysis, 63 samples for SAX Function contouring, 63 for each of 2-CV, 3-CV, and 4CV LAX function contouring, and 252 samples for Function Classification. Image information for all samples was anonymized and limited to ePHI-free DICOM headers. At least 50% of the data came from a U.S. population.
All performance testing results met Circle's pre-defined acceptance criteria.
- For CMR function analysis, the performance acceptance criteria were pre-defined to . evaluate the performance of the ML model based on classification accuracy defined by true positives (TP), true negatives (TN), false positives (FP), and false negatives (FN). Mean volume prediction error (Mean Absolute Error, or MAE) was also calculated. Series classification performance results were between 97 % - 100%. Volumetric MAE for SAX were between 7% - 10%, and volumetric MAE for LAX were between 5% - 9%.
- . For Calcium analysis, the performance acceptance criteria were pre-defined to evaluate the performance of the ML model based on classification accuracy defined by TP. TN, FP, and FN. Classification performance results were between 86% - 99%.
- . For Coronary analysis, the performance acceptance criteria were pre-defined to evaluate the centerline quality and performance (based on TP and FN), and success rate for relevant masks. Centerline performance results were between 82% - 94%. Mask performance results were between 98% - 100%.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
CMR function analysis:
Classification accuracy defined by true positives (TP), true negatives (TN), false positives (FP), and false negatives (FN).
Mean volume prediction error (Mean Absolute Error, or MAE).
Series classification performance results were between 97 % - 100%.
Volumetric MAE for SAX were between 7% - 10%.
Volumetric MAE for LAX were between 5% - 9%.
Calcium analysis:
Classification accuracy defined by TP. TN, FP, and FN.
Classification performance results were between 86% - 99%.
Coronary analysis:
Centerline quality and performance (based on TP and FN).
Success rate for relevant masks.
Centerline performance results were between 82% - 94%.
Mask performance results were between 98% - 100%.
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).
0
Image /page/0/Picture/0 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 & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. Food & Drug Administration".
Circle Cardiovascular Imaging, Inc. % Sydney Toutant Regulatory Affairs Lead Suite 1100 - 800 5th Ave. SW Calgary, Alberta T2P 3T6 CANADA
7/28/2022
Re: K213998
Trade/Device Name: cvi42 Auto Imaging Software Application Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: QIH, LLZ Dated: June 27, 2022 Received: June 28, 2022
Dear Sydney Toutant:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. 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 medical devices and radiation-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. Ph.D. Assistant Director Imaging Software Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K213998
Device Name cvi42 Auto Imaging Software Application
Indications for Use (Describe)
cvi42 Auto is intended to be used for viewing, post-processing, qualitative evaluation of cardiovasular magnetic resonance (MR) and computed tomography (CT) images in a Digital Imaging and Communications in Medicine (DICOM) Standard format.
It enables a set of tools to assist physicians in qualitative assessment of cardiac images and quantitative measurements of the heart and adjacent vessels: perform calcium scoring: and to confirm the presence of physician-identified lesion in blood vessels.
The target population for cvi42 Auto's manual workflows is not restricted; however, cvi42 Auto's semi-automated machine learning algorithms are intended for an adult population.
cvi42 Auto shall be used only for cardiac images acquired from an MR or CT scanner. It shall be used by qualified medical professionals, experienced in examining and evaluating cardiovascular MR or CT images, for the purpose of obtaining diagnostic information as part of a comprehensive 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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3
Image /page/3/Picture/1 description: The image shows the logo for Circle Cardiovascular Imaging. The logo features a stylized green circle that is not fully closed, with the color transitioning to yellow in the open section. Below the circle, the word "circle" is written in a gray, sans-serif font, and beneath that, the words "CARDIOVASCULAR IMAGING" are written in a smaller, sans-serif font, stacked on top of each other.
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: | July 25 2022 |
| Telephone Number: | +1 587 747 4692 |
| Contact Person: | Sydney Toutant |
| Email: | sydney.toutant@circlecvi.com |
II. DEVICE
| Name of the Device: | cvi42 Auto Imaging Software Application |
|---|---|
| Short Brand Name: | cvi42 Auto |
| Common or Usual Name: | Automated Radiological Image Processing System |
| Classification Name: | Medical image management and processing system |
| Proposed Classification: | Device Class: II |
| Primary Product Code: QIH | |
| Secondary Product Code: LLZ | |
| Regulation Number: | 21 CFR 892.2050 |
lll. PREDICATE DEVICES
The primary predicate is cm42 manufactured by Circle Cardiovascular Imaging Inc. under K082628. cvi42, manufactured by Circle Cardiovascular Imaging Inc. under K141480, is used as a secondary predicate device and ct4, manufactured by Circle Cardiovascular Imaging Inc. under K111373, is used as a tertiary predicate device. The predicate devices have not been subject to a design-related recall.
4
IV. DEVICE DESCRIPTION
cvi42 Auto is a software as a medical device (SaMD) that is intended for evaluating CT and MR images of the cardiovascular system. Combining digital image processing, visualization, guantification, and reporting tools, cvi42 Auto device is designed to support the physician in confirming the presence or absence of physician-identified lesion in blood vessels and evaluation, documentation and follow up of any such lesions.
cvi42 Auto uses machine learning techniques to aid in semi-automatic contouring of regions of interest of cardiac magnetic resonance (MR) or computed tomography (CT) images as follows:
-
- Cardiac Function: semi-automatic contouring of the four heart chambers (including left ventricle, left atrium, right ventricle, right atrium) in MR images.
-
- Calcium Assessment: using pixel intensity technique, identify calcified plaque in major coronary arteries in non-contrast enhanced CT images.
-
- Coronary Analysis: semi-automatic placement of centerline in coronary vessels to visualize the coronary arteries and assess stenosis in non-contrast enhanced CT images.
The data used to train these machine learning algorithms were sourced from multiple clinical sites from urban centers and from different countries. When selecting data for training, the importance of model generalization was considered and data was selected such that a good distribution of patient demographics, scanner, and image parameters were represented. The separation into training versus validation datasets is made on the study level to ensure no overlap between the two sets. As such, different scans from the same study were not split between the training and validation datasets. None of the cases used for model validation were used for training the machine learning models.
cvi42 Auto software has a graphical user interface which allows users to analyze cardiac images qualitatively and quantitatively for volume/mass, function and signal intensity changes including a reporting function.
The device can be integrated into a hospital, private practice environment, or medical research institution and provides clinical diagnosis decision support tools for the cardiovascular MR and CT technique.
Additionally, the software is designed to generate 3D view of the heart in CT images for qualitative assessment of the coronary artery. No quantitative assessment can be made from the 3D image.
The software does not interface directly with any data collection equipment; instead, the software uploads data files previously generated by such equipment. Its functionality is independent of the type of vendor acquisition equipment. The analysis results are available on-screen and can be saved within the software for future review.
5
> INDICATIONS FOR USE
cvi42 Auto is intended to be used for viewing, post-processing, qualitative and quantitative evaluation of cardiovascular magnetic resonance (MR) and computed tomography (CT) images in a Digital Imaging and Communications in Medicine (DICOM) Standard format.
It enables a set of tools to assist physicians in qualitative assessment of cardiac images and quantitative measurements of the heart and adjacent vessels; perform calcium scoring; and to confirm the presence or absence of physician-identified lesion in blood vessels.
The target population for cvi42 Auto's manual workflows is not restricted; however, cvi42 Auto's semi-automated machine learning algorithms are intended for an adult population.
cvi42 Auto shall be used only for cardiac images acquired from an MR or CT scanner. It shall be used by qualified medical professionals, experienced in examining and evaluating cardiovascular MR or CT images, for the purpose of obtaining diagnostic information as part of a comprehensive diagnostic decision-making process.
VI. COMPARISON WITH PREDICATE DEVICES
The detailed analysis of the subject device and the primary and secondary predicate devices (shown in Table 1 and Table 2) demonstrates that the subject device is substantially equivalent in indications for use, intended use, technological characteristics, functionality, and operating principles with the primary predicate (K082628) and substantially equivalent in intended use and technological characteristics with the secondary predicate (K141480) and tertiary predicate (K111373). Of the three characteristics (technical, biological, and clinical) required for the demonstration of equivalence, biological characteristics are not applicable since the subject device and the predicate devices are all software as a medical device applications with no tangible component interfacing with the body.
6
| Subject Device | Primary Predicate | Secondary Predicate | Tertiary Predicate | |
|---|---|---|---|---|
| cvi42 Auto (K213998) | cmr42 (K082628) | cvi42 (K141480) | ct42 (K111373) | |
| Manufactured by Circle | Manufactured by Circle | Manufactured by Circle | Manufactured by Circle | |
| Intended Use | Viewing, post-processing, | |||
| qualitative and quantitative | ||||
| evaluation of blood vessels and | ||||
| cardiovascular MR and CT images | ||||
| in DICOM format. | Viewing, post-processing, | |||
| qualitative and quantitative | ||||
| evaluation of cardiovascular MR | ||||
| images in DICOM format. | Viewing, post-processing, | |||
| qualitative and quantitative | ||||
| evaluation of blood vessels and | ||||
| cardiovascular MR and CT images | ||||
| in DICOM format. | Viewing, post-processing, | |||
| qualitative and quantitative | ||||
| evaluation of cardiovascular CT | ||||
| images in DICOM format. | ||||
| Indications for | ||||
| Use | cvi42 Auto is intended to be used | |||
| for viewing, post-processing, | ||||
| qualitative and quantitative | ||||
| evaluation of cardiovascular | ||||
| magnetic resonance (MR) and | ||||
| computed tomography (CT) images | ||||
| in a Digital Imaging and | ||||
| Communications in Medicine | ||||
| (DICOM) Standard format. |
It enables a set of tools to assist
physicians in qualitative
assessment of cardiac images and
quantitative measurements of the
heart and adjacent vessels;
perform calcium scoring; and to
confirm the presence or absence of
physician-identified lesion in blood
vessels.
The target population for cvi42
Auto's manual workflows is not
restricted; however, cvi42 Auto's
semi-automated machine learning
algorithms are intended for an adult
population.
cvi42 Auto shall be used only for
cardiac images acquired from an
MR or CT scanner. It shall be used
by qualified medical professionals,
experienced in examining and | cmr42 is intended to be used for
viewing, post-processing and
quantitative evaluation of
cardiovascular magnetic resonance
(MR) images in a Digital Imaging
and Communications in Medicine
(DICOM) Standard format.
It enables:
• Importing Cardiac MR Images in
DICOM format
• Supporting clinical diagnostics by
qualitative analysis of the cardiac
MR images using display
functionality such as panning,
windowing, zooming, navigation
through series/slices and phases.
• Supporting clinical diagnostics by
quantitative measurement of the
heart and adjacent vessels in
cardiac MR images, specifically
distance, area, volume and mass
• Supporting clinical diagnostics by
using area and volume
measurements for measuring LV
function and derived parameters
cardiac output and cardiac index in
long axis and short axis cardiac MR
images.
• Flow quantifications based on
velocity encodes images | cvi42 vascular analysis add-on is
an image analysis software
package add-on for evaluating CT
and MR images of blood vessels.
Combining digital image processing
and visualization tools such as
multiplaner reconstruction (MPR),
thin/think maximum intensity
projection (MIP) thin and think,
inverted MIP thin and think, volume
rendering technique (VRT), curved
planner reformation, processing
tools such as bone removal (based
on both single energy and dual
energy) table removal and
evaluation tools (vessel centerline
calculation, lumen calculation,
stenosis calculation) and reporting
tools (lesion location, lesion
characteristics) and key images),
the software package is designed
to support the physician in
conforming the presence or
absence of physician identified
lesion in blood vessels and
evaluation, documentation and
follow up of any such lesions.
It shall be used by qualified medical
professionals, experienced in
examining and evaluating
cardiovascular CT or MR images | ct42 is intended to be used for
viewing, post-processing and
quantitative evaluation of
cardiovascular computed
tomography (CT) images in a
Digital Imaging and
Communications in Medicine
(DICOM) Standard format.
It enables:
• Importing Cardiac CT Images in
DICOM format
• Supporting clinical diagnostics by
qualitative analysis of the cardiac
CT images using display
functionality such as panning,
windowing, zooming, navigation
through series/slices and phases,
3D reconstruction of images
including multi-lanner
reconstructions of the images.
• Supporting clinical diagnostics by
quantitative measurement of the
heart and adjacent vessels in
cardiac CT images, specifically
distance, area, volume and mass
• Supporting clinical diagnostics by
using area and volume
measurements for measuring LV
function and derived parameters
cardiac output and cardiac index in
long axis and short axis cardiac CT
images |
| Subject Device | Primary Predicate | Secondary Predicate | Tertiary Predicate | |
| cvi42 Auto (K213998) | cmr42 (K082628) | cvi42 (K141480) | ct42 (K111373) | |
| Manufactured by Circle | Manufactured by Circle | Manufactured by Circle | Manufactured by Circle | |
| evaluating cardiovascular MR or
CT images, for the purpose of
obtaining diagnostic information as
part of a comprehensive diagnostic
decision-making process. | It shall be used by qualified medical
professionals, experienced in
examining and evaluating
cardiovascular MR images, for the
purpose of obtaining diagnostic
information as part of a
comprehensive diagnostic decision-
making process. cmr42 is a software
application that can be used as a
stand-alone product or in a
networked environment. | for the purpose of obtaining
diagnostic information as part of a
comprehensive diagnostic decision-
making process. cvi42 is a software
application that can be used as a
stand-alone product or in a
networked environment.
The target population for the cvi42
is not restricted. | • Supporting clinical diagnostics by
quantitative measurements of
calcified plaques in the coronary
arteries (calcium scoring),
specifically Agatston and volume
and mass calcium scores
It shall be used by qualified
medical professionals, experienced
in examining and evaluating
cardiovascular CT images, for the
purpose of obtaining diagnostic | |
| | The target population for the cmr42
is not restricted, however the image
acquisition by a cardiac magnetic
resonance scanner may limit the
use of the device for certain sectors
of the general public. | | information as part of a
comprehensive diagnostic
decision-making process. ct42 is a
software application that can be
used as a stand-alone product or
in a networked environment. | |
| | cmr42 shall not be used to view or
analyze images of any part of the
body except the cardiac magnetic
resonance images acquired from a
cardiovascular magnetic resonance
scanner. | | The target population for the ct42 is
not restricted, however the image
acquisition by a cardiac CT
scanner may limit the use of the
device for certain sectors of the
general public. | |
| | | | ct42 shall not be used to view or
analyze images of any part of the
body except the cardiac CT
images acquired from a
cardiovascular CT scanner. | |
| Feature | Subject Device
cvi42 Auto (K213998)
Manufactured by Circle | Primary Predicate
cmr42 (K082628)
Manufactured by Circle | Secondary Predicate
cvi42 (K141480)
Manufactured by Circle | Tertiary Predicate
ct42 (K111373)
Manufactured by Circle |
| Device Class | II | II | II | II |
| Device Classification | QIH, LLZ | LLZ | LLZ | LLZ |
| Regulation Name | Medical image management
and processing system | Picture Archiving and
Communications System | Picture Archiving and
Communications System | Picture Archiving and
Communications System |
| Regulation Number | 21 CFR 892.2050 | 21 CFR 892.2050 | 21 CFR 892.2050 | 21 CFR 892.2050 |
| Imaging Modalities | MR and CT | MR | MR and CT | CT |
| DICOM Compliant | Yes | Yes | N/A | N/A |
| Import and display
MR/CT images | Yes | Yes (MR only) | Yes | Yes (CT only) |
| Post process CMR/CCT
images | Yes | Yes (MR only) | Yes | Yes (CT only) |
| Images can be
displayed by study and
series | Yes | Yes | N/A | N/A |
| Store images | Yes | Yes | N/A | N/A |
| 2D Imaging | Yes | Yes | N/A | N/A |
| 3D Imaging | Yes | No | Yes | Yes |
| Multiplanar Reformat
(MPR) | Yes | No | Yes | Yes |
| Navigation Tools | Panning,
Windowing,
Zooming
Series/slices and phases | Panning,
Windowing,
Zooming
Series/slices and phases | N/A | N/A |
| Measurements | Distance
Perimeter
Area
Signal Intensity
Volume | Distance
Perimeter
Area
Signal Intensity
Volume | N/A | N/A |
| Quantitative assessment
of cardiac function | Manual segmentation, and
semi-automatic segmentation
using Machine Learning
technique of four heart
chambers in long and short-
axis views | Manual segmentation of four
heart chambers in long and
short-axis views | Manual segmentation,
and semi-automatic
segmentation of four
heart chambers in long
and short-axis views | Manual segmentation,
and semi-automatic
segmentation of four
heart chambers in short-
axis views |
| Feature | Subject Device | Primary Predicate | Secondary Predicate | Tertiary Predicate |
| | cvi42 Auto (K213998) | cmr42 (K082628) | cvi42 (K141480) | ct42 (K111373) |
| | Manufactured by Circle | Manufactured by Circle | Manufactured by Circle | Manufactured by Circle |
| Centerline placement in
coronary vessels | Manual and semi-automatic
using Machine Learning
technique | Manual | Manual and semi-
automatic | Manual and semi-
automatic |
| Calcium Scoring | Yes, using ML methodology | No | No | Yes, using non-ML
methodology |
| Workstation operating | macOS,
Microsoft Windows | macOS,
Microsoft Windows | macOS,
Microsoft Windows | macOS,
Microsoft Windows |
| system | | | | |
Table 1. Comparison to the predicate devices.
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Table 2. Feature comparison table of cvi42 Auto with the predicate devices. Cells marked as N/A are features already supported by the primary predicate.
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VII. PERFORMANCE DATA AND TESTING
Performance testing was conducted to verify compliance with specified design requirements in accordance with ISO 13485:2016, IEC 62304:2015, ISO 14971:2019 and NEMA 3.1-3.20 (2016) DICOM standards.
Verification and validation testing were conducted to ensure specifications and performance of the device and were performed per the FDA Guidance documents "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" and "Content of Premarket Submission for Management of Cybersecurity in Medical Devices".
cvi42 Auto 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 software development process as described in the company's product development process.
Validation of Machine Learning Derived Outputs
The machine learning algorithms of cvi42 Auto (MR-CMR Function, CT-Coronary, and CT-Calcium) have been trained and tested on images acquired from major vendors of MR and CT imaging devices. All data used for validation were not used during the development of the training algorithms.
Across all MR and CT machine manufacturers, n = 235 anonymized patient images were used for the validation of cvi42 Auto. This translates into 70 samples for Coronary Analysis, 102 samples for Calcium analysis, 63 samples for SAX Function contouring, 63 for each of 2-CV, 3-CV, and 4CV LAX function contouring, and 252 samples for Function Classification. Image information for all samples was anonymized and limited to ePHI-free DICOM headers. At least 50% of the data came from a U.S. population.
All performance testing results met Circle's pre-defined acceptance criteria.
- For CMR function analysis, the performance acceptance criteria were pre-defined to . evaluate the performance of the ML model based on classification accuracy defined by true positives (TP), true negatives (TN), false positives (FP), and false negatives (FN). Mean volume prediction error (Mean Absolute Error, or MAE) was also calculated. Series classification performance results were between 97 % - 100%. Volumetric MAE for SAX were between 7% - 10%, and volumetric MAE for LAX were between 5% - 9%.
- . For Calcium analysis, the performance acceptance criteria were pre-defined to evaluate the performance of the ML model based on classification accuracy defined by TP. TN, FP, and FN. Classification performance results were between 86% - 99%.
- . For Coronary analysis, the performance acceptance criteria were pre-defined to evaluate the centerline quality and performance (based on TP and FN), and success rate for relevant masks. Centerline performance results were between 82% - 94%. Mask performance results were between 98% - 100%.
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VIII. CONCLUSIONS
The information submitted in this premarket notification, including the performance testing and predicate device comparisons, supports the safety and effectiveness of cvi42 Auto as compared to the predicate devices when used for the defined intended use.