cvi42 Auto Imaging Software Application

K213998 · Circle Cardiovascular Imaging, Inc. · QIH · Jul 28, 2022 · Radiology

Device Facts

• Record ID: K213998
• Device Name: cvi42 Auto Imaging Software Application
• Applicant: Circle Cardiovascular Imaging, Inc.
• Product Code: QIH · Radiology
• Decision Date: Jul 28, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: AI/ML, Software as a Medical Device

Intended 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.

Device Story

cvi42 Auto is a SaMD for cardiovascular MR and CT image analysis. It ingests DICOM-standard images from external scanners; it does not interface directly with acquisition hardware. The device provides tools for visualization, semi-automated contouring, and quantification. Machine learning algorithms assist in: 1) Cardiac function (four-chamber contouring in MR); 2) Calcium assessment (pixel intensity-based plaque identification in non-contrast CT); 3) Coronary analysis (centerline placement and stenosis assessment in CT). The software generates 3D heart views for qualitative assessment. Used in hospitals, private practices, or research institutions by qualified medical professionals. Output is displayed on-screen for physician review to support diagnostic decision-making regarding cardiac function, vessel lesions, and calcium scoring. Benefits include standardized, semi-automated analysis workflows for cardiovascular imaging.

Clinical Evidence

Bench testing only. Validation used 235 anonymized patient images across multiple vendors. Metrics: CMR function series classification accuracy 97-100%; volumetric MAE 5-10%. Calcium analysis classification accuracy 86-99%. Coronary analysis centerline performance 82-94%; mask performance 98-100%. Data included >50% U.S. population. All results met pre-defined acceptance criteria.

Technological Characteristics

SaMD; DICOM-compliant; runs on macOS and Microsoft Windows. Uses machine learning algorithms for semi-automated image segmentation and analysis. No physical components; no patient-contacting materials. Software development follows ISO 13485:2016, IEC 62304:2015, ISO 14971:2019, and NEMA 3.1-3.20 standards.

Indications for Use

Indicated for adult patients requiring qualitative and quantitative evaluation of cardiovascular MR and CT images. Used by qualified medical professionals for cardiac image assessment, heart/vessel measurements, calcium scoring, and lesion confirmation. No specific contraindications listed.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

• cmr42 (K082628)
• cvi42 (K141480)
• ct42 (K111373)

Submission Summary (Full Text)

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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

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about 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 ([e-mail]) or phone [phone] 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

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# 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) | |
|-------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|
| <span style="text-decoration: underline;"><b></b></span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="text-decoration: underline;"><b></b></span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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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: | [phone] |
| Contact Person: | Sydney Toutant |
| Email: | [e-mail] |

#### 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.

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#### 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:

- 1. Cardiac Function: semi-automatic contouring of the four heart chambers (including left ventricle, left atrium, right ventricle, right atrium) in MR images.
- 2. Calcium Assessment: using pixel intensity technique, identify calcified plaque in major coronary arteries in non-contrast enhanced CT images.
- 3. 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.

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#### > 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.

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| | 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,<br>qualitative and quantitative<br>evaluation of blood vessels and<br>cardiovascular MR and CT images<br>in DICOM format. | Viewing, post-processing,<br>qualitative and quantitative<br>evaluation of cardiovascular MR<br>images in DICOM format. | Viewing, post-processing,<br>qualitative and quantitative<br>evaluation of blood vessels and<br>cardiovascular MR and CT images<br>in DICOM format. | Viewing, post-processing,<br>qualitative and quantitative<br>evaluation of cardiovascular CT<br>images in DICOM format. |
| Indications for<br>Use | cvi42 Auto is intended to be used<br>for viewing, post-processing,<br>qualitative and quantitative<br>evaluation of cardiovascular<br>magnetic resonance (MR) and<br>computed tomography (CT) images<br>in a Digital Imaging and<br>Communications in Medicine<br>(DICOM) Standard format.<br><br>It enables a set of tools to assist<br>physicians in qualitative<br>assessment of cardiac images and<br>quantitative measurements of the<br>heart and adjacent vessels;<br>perform calcium scoring; and to<br>confirm the presence or absence of<br>physician-identified lesion in blood<br>vessels.<br><br>The target population for cvi42<br>Auto's manual workflows is not<br>restricted; however, cvi42 Auto's<br>semi-automated machine learning<br>algorithms are intended for an adult<br>population.<br><br>cvi42 Auto shall be used only for<br>cardiac images acquired from an<br>MR or CT scanner. It shall be used<br>by qualified medical professionals,<br>experienced in examining and | cmr42 is intended to be used for<br>viewing, post-processing and<br>quantitative evaluation of<br>cardiovascular magnetic resonance<br>(MR) images in a Digital Imaging<br>and Communications in Medicine<br>(DICOM) Standard format.<br>It enables:<br>• Importing Cardiac MR Images in<br>DICOM format<br>• Supporting clinical diagnostics by<br>qualitative analysis of the cardiac<br>MR images using display<br>functionality such as panning,<br>windowing, zooming, navigation<br>through series/slices and phases.<br>• Supporting clinical diagnostics by<br>quantitative measurement of the<br>heart and adjacent vessels in<br>cardiac MR images, specifically<br>distance, area, volume and mass<br>• Supporting clinical diagnostics by<br>using area and volume<br>measurements for measuring LV<br>function and derived parameters<br>cardiac output and cardiac index in<br>long axis and short axis cardiac MR<br>images.<br>• Flow quantifications based on<br>velocity encodes images | cvi42 vascular analysis add-on is<br>an image analysis software<br>package add-on for evaluating CT<br>and MR images of blood vessels.<br>Combining digital image processing<br>and visualization tools such as<br>multiplaner reconstruction (MPR),<br>thin/think maximum intensity<br>projection (MIP) thin and think,<br>inverted MIP thin and think, volume<br>rendering technique (VRT), curved<br>planner reformation, processing<br>tools such as bone removal (based<br>on both single energy and dual<br>energy) table removal and<br>evaluation tools (vessel centerline<br>calculation, lumen calculation,<br>stenosis calculation) and reporting<br>tools (lesion location, lesion<br>characteristics) and key images),<br>the software package is designed<br>to support the physician in<br>conforming the presence or<br>absence of physician identified<br>lesion in blood vessels and<br>evaluation, documentation and<br>follow up of any such lesions.<br><br>It shall be used by qualified medical<br>professionals, experienced in<br>examining and evaluating<br>cardiovascular CT or MR images | ct42 is intended to be used for<br>viewing, post-processing and<br>quantitative evaluation of<br>cardiovascular computed<br>tomography (CT) images in a<br>Digital Imaging and<br>Communications in Medicine<br>(DICOM) Standard format.<br>It enables:<br>• Importing Cardiac CT Images in<br>DICOM format<br>• Supporting clinical diagnostics by<br>qualitative analysis of the cardiac<br>CT images using display<br>functionality such as panning,<br>windowing, zooming, navigation<br>through series/slices and phases,<br>3D reconstruction of images<br>including multi-lanner<br>reconstructions of the images.<br>• Supporting clinical diagnostics by<br>quantitative measurement of the<br>heart and adjacent vessels in<br>cardiac CT images, specifically<br>distance, area, volume and mass<br>• Supporting clinical diagnostics by<br>using area and volume<br>measurements for measuring LV<br>function and derived parameters<br>cardiac output and cardiac index in<br>long axis and short axis cardiac CT<br>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<br>CT images, for the purpose of<br>obtaining diagnostic information as<br>part of a comprehensive diagnostic<br>decision-making process. | It shall be used by qualified medical<br>professionals, experienced in<br>examining and evaluating<br>cardiovascular MR images, for the<br>purpose of obtaining diagnostic<br>information as part of a<br>comprehensive diagnostic decision-<br>making process. cmr42 is a software<br>application that can be used as a<br>stand-alone product or in a<br>networked environment. | for the purpose of obtaining<br>diagnostic information as part of a<br>comprehensive diagnostic decision-<br>making process. cvi42 is a software<br>application that can be used as a<br>stand-alone product or in a<br>networked environment.<br>The target population for the cvi42<br>is not restricted. | • Supporting clinical diagnostics by<br>quantitative measurements of<br>calcified plaques in the coronary<br>arteries (calcium scoring),<br>specifically Agatston and volume<br>and mass calcium scores<br>It shall be used by qualified<br>medical professionals, experienced<br>in examining and evaluating<br>cardiovascular CT images, for the<br>purpose of obtaining diagnostic | |
| | The target population for the cmr42<br>is not restricted, however the image<br>acquisition by a cardiac magnetic<br>resonance scanner may limit the<br>use of the device for certain sectors<br>of the general public. | | information as part of a<br>comprehensive diagnostic<br>decision-making process. ct42 is a<br>software application that can be<br>used as a stand-alone product or<br>in a networked environment. | |
| | cmr42 shall not be used to view or<br>analyze images of any part of the<br>body except the cardiac magnetic<br>resonance images acquired from a<br>cardiovascular magnetic resonance<br>scanner. | | The target population for the ct42 is<br>not restricted, however the image<br>acquisition by a cardiac CT<br>scanner may limit the use of the<br>device for certain sectors of the<br>general public. | |
| | | | ct42 shall not be used to view or<br>analyze images of any part of the<br>body except the cardiac CT<br>images acquired from a<br>cardiovascular CT scanner. | |
| Feature | Subject Device<br>cvi42 Auto (K213998)<br>Manufactured by Circle | Primary Predicate<br>cmr42 (K082628)<br>Manufactured by Circle | Secondary Predicate<br>cvi42 (K141480)<br>Manufactured by Circle | Tertiary Predicate<br>ct42 (K111373)<br>Manufactured by Circle |
| Device Class | II | II | II | II |
| Device Classification | QIH, LLZ | LLZ…