cvi42 Software Application

K242781 · Circle Cardiovascular Imaging, Inc. · QIH · Oct 15, 2024 · Radiology

Device Facts

• Record ID: K242781
• Device Name: cvi42 Software Application
• Applicant: Circle Cardiovascular Imaging, Inc.
• Product Code: QIH · Radiology
• Decision Date: Oct 15, 2024
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: AI/ML, Software as a Medical Device

Intended Use

cvi42 is intended to be used by qualified medical professionals for viewing, post-processing and quantitative evaluation of cardiovascular magnetic resonance (MR) images and cardiovascular computed tomography (CT) images in a Digital Imaging and Communications in Medicine Standard format, for the purpose of obtaining diagnostic information as part of a comprehensive diagnostic decision-making process

Device Story

cvi42 is a software-as-a-medical-device (SaMD) for cardiovascular image analysis. It accepts DICOM-formatted MR and CT images from external scanners. The software provides visualization, post-processing, and quantification tools, including semi-automated machine learning (ML) algorithms for contouring regions of interest (e.g., heart chambers, coronary vessels). Physicians use the graphical interface to perform qualitative assessments and quantitative measurements (e.g., strain, calcium scoring, cardiac function). The output supports clinical diagnostics and decision-making. Used in clinical settings by qualified medical professionals. Benefits include standardized, efficient analysis of cardiovascular structures and function, aiding in the evaluation and follow-up of cardiac lesions and disease.

Clinical Evidence

No clinical studies were performed. Bench testing included verification and validation per ISO 13485, BS EN 62304, and ISO 14971. ML algorithms were validated using 235 anonymized patient images (MR/CT) from multiple vendors. CMR function analysis showed 97-100% classification accuracy and 5-10% volumetric MAE. Calcium scoring accuracy was 86-99%. Coronary analysis centerline performance was 82-94%. CT function segmentation (LV/RV) achieved Dice coefficients >82-86%, HD <9.5-18mm, and EF bias of 1.3% (LV) and -5.5% (RV).

Technological Characteristics

SaMD; runs on macOS/Windows. DICOM compliant. Features: 2D/3D visualization, MPR, MIP, VRT, CPR, bone/table removal. ML-based segmentation for cardiac chambers, coronary centerlines, and calcium scoring. Rule-based algorithms for strain, flow, and volumetric measurements. Standalone or networked deployment. No physical components.

Indications for Use

Indicated for viewing, post-processing, and qualitative/quantitative evaluation of cardiovascular MR and CT images in DICOM format. Enables import, display (panning, windowing, zooming, 3D/multiplanar reconstruction), and quantitative measurement (distance, area, volume, mass, signal intensity) of heart/vessels. Supports cardiac function analysis (EDV, ESV, SV, EF, CO, CI), flow quantification, strain analysis (2D LV myocardial function), and coronary CT analysis (calcium scoring, vessel/valve visualization). Intended for adult population for semi-automated ML workflows; manual workflows have no age restriction. Contraindicated for non-cardiac images.

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

• cmr2 (K082628)
• ct42 (K111373)
• cvi42 vascular add-on (K141480)
• cvi42 Auto (K213998)
• Strain Module (K232661)
• CT Function (K241038)

Submission Summary (Full Text)

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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 seal of the Department of Health & Human Services. To the right of the seal is the FDA logo in blue, with the words "U.S. FOOD & DRUG" on one line and "ADMINISTRATION" on the line below. The logo is simple and professional, and it is easily recognizable.

Circle Cardiovascular Imaging Inc. Omar Naimi Regulatory Affairs Analyst Suite 1800, 707 8 Avenue SW Calgary, AB T2P 1H5 Canada

## Re: K242781

October 15, 2024

Trade/Device Name: cvi42 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: September 13, 2024 Received: September 16, 2024

Dear Omar Naimi:

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.

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"

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(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 (QS) 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 (OS) 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.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system.

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.

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-regulatory

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assistance/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

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 Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

Submission Number (if known)

### K242781

Device Name

### cvi42 Software Application

### Indications for Use (Describe)

cvi42 is intended to be used for viewing, post-processing, qualitative and quantitative evaluation of cardiovascular magnetic resonance (MR) images and computed tomography (CT) images in a Digital Imaging and Communications in Medicine (DICOM) Standard format.

lt enables:

· Importing cardiac MR & CT Images in DICOM format.

• Supporting clinical diagnostics by qualitative analysis of cardiac MR & CT images using display functionality such as panning, windowing, zooming, navigation through series/slices and phases, 3D reconstruction of images including multiplanar reconstructions of the images.

• Supporting clinical diagnostics by quantitative measurement of the heart and adjacent vessels in cardiac MR & CT images, specifically signal intensity, distance, area, volume, and mass.

• Supporting clinical diagnostics by using area and volume for measuring cardiac function and derived parameters cardiac output and cardiac index in long axis and short axis cardiac MR & CT images.

• Flow quantifications based on velocity encoded cardiac MR images (including two and four dimensional flow analysis).

• Strain analysis of cardiac MR images by providing measurements of 2D LV myocardial function (displacement, velocity, strain, strain rate, time to peak, and torsion).

· Supporting clinical diagnostics of cardiac CT images including quantitative measurements of calcified plaques in the coronary arteries (calcium scoring), specifically Agatston and volume and mass calcium scores, visualization and quantitative measurement of heart structures including coronaries, femoral, aortic, and mitral valves.

· Evaluating CT and MR images of blood vessels. Combining digital image processing and visualization tools such as multiplanar reconstruction (MPR), thin/thick maximum intensity projection (MIP), inverted MIP thin/thick, volume rendering technique (VRT), curved planar reformation (CPR), 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 confirming the presence of physician identified lesion in blood vessels and evaluation, documentation and follow up of any such lesions.

cvi42 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. cvi42 is a software application that can be used as a stand-alone product or in a networked environment.

The target population for cvi42 and its manual workflows is not restricted; however, cvi42's semiautomated machine learning algorithms, included in the MR Function and CORE CT modules, are intended for an adult population. Further, image acquisition by a cardiac MR or CT scanner may limit the use of the software for certain sectors of the general public.

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cvi42 shall not be used to view or analyze images of any part of the body except the cardiac images acquired from a cardiovascular magnetic resonance or computed tomography scanner.

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/5/Picture/2 description: The image shows the logo for Circle Cardiovascular Imaging. The logo features a stylized green and yellow circle above the word "circle" in gray lowercase letters. Below "circle" are the words "CARDIOVASCULAR IMAGING" in smaller, gray, uppercase letters.

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 1800 – 707 8th Ave SW, Calgary, AB, Canada, T2P 1H5 |
| Date Prepared: | October 11 2024 |
| Telephone Number: | [phone] |
| Contact Person : | Omar Naimi |
| Email: | [e-mail] |

#### ll. DEVICE

| 510(k): | K242781 |
|--------------------------|--------------------------------------------------|
| Name of the Device: | cvi42 Software Application |
| Short Brand Name: | cvi42 |
| Common or Usual Name: | Automated Radiological Image Processing Software |
| Classification Name: | Medical image management and processing system |
| Proposed Classification: | Device Class: II |
| | Product Codes: QIH, LLZ |
| | Regulation Number: 21 CFR 892.2050 |

#### ���. PREDICATE DEVICE

The primary predicate is cmr2 under K082628, and the additional predicates are ct42 under K111373, cvi42 vascular add-on under K141480, cvi42 Auto under K213998, Strain Module under 232661, and CT Function under 241038. Each of the predicate devices are manufactured by Circle Cardiovascular Imaging Inc.

The predicate devices have not been subject to a design-related recall.

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#### IV. DEVICE DESCRIPTION

cvi42 Software Application ("cvi42") 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, quantification, and reporting tools, cvi42 is designed to support physicians in the evaluation and analysis of cardiovascular imaqing studies.

cvi42 uses machine learning techniques to aid in semi-automatic contouring of regions of interest in cardiac MR or 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 has a graphical user interface which allows users to analyze cardiac MR & CT images qualitatively and quantitatively.

cvi42 accepts uploaded data files previously acquired by MR or CT scanners or other data collection equipment but does not interface directly with such equipment. Its functionality is independent of the type of vender acquisition equipment. The analysis results are available onscreen and can be saved with the software for future review.

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| Measurement [units] | Description | Application |
|--------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------|
| Distance [mm] | Length between two points, for both<br>curved lines (splines) and straight lines,<br>including the diameter (including min,<br>max, average) resulting from closed<br>splines and depth | Diameter & depth of cardiovascular<br>structures of interest |
| Perimeter [mm] | The perimeter of a contour (closed spline) | Perimeter of cardiovascular structures of<br>interest |
| Area [cm²] | The area within contour(s) | Area of cardiovascular structures of interest |
| Signal intensity [HU]<br>(modality CT) / Intensity<br>[unitless] (modality MR) | Modality CT: Hounsfield value (in<br>Hounsfield Units, HU) of the underlying<br>pixels<br>Modality MR: Intensity / shade of grey<br>(high, intermediate, low) of underlying<br>pixels | Intensity of pixels in cardiovascular<br>structures of interest |
| Volume [mm³ or mL] | The volume within contour(s) | Volume of cardiovascular structures of<br>interest |
| Coordinates [mm, mm, mm] | Location in the x-, y-, and z-planes of a<br>point | Coordinates of points of interest on a 3D<br>rendering, for export purposes |
| Mass [g] | The mass within contour(s) | Mass of cardiovascular structures of interest |
| Displacement [mm or<br>degree] | The displacement vector represents the<br>position of a point with respect to the<br>position of that point in the reference (end<br>diastole) phase. | Strain within cardiovascular structures of<br>interest (e.g., myocardium) |
| Agatston Score [HU] | Industry-standard measure for coronary<br>calcium based on volume and intensity of<br>calcified plaque | For assessing overall calcified plaque<br>burden in coronary arteries. |
| Angle [degrees] | The angle of an object/structure of<br>interest | Angle between two lines of interest |
| Stenosis [%] | The narrowing of a vessel in area or<br>diameter compared to a normal reference<br>location | For measuring an abnormal narrowing in an<br>artery |
| Velocity [mL/min or cm/s] | The velocity of moving objects within<br>contour(s) | Velocity within cardiovascular structures of<br>interest (e.g., blood flow) |
| Strain [%] | Strain is a measure of the deformation in<br>shape and dimension of the heart muscle<br>during the cardiac cycle. | Strain within cardiovascular structures of<br>interest (e.g., myocardium) |
| | | |
| Strain Rate [1/s] | Derivative of strain with respect to time | Strain within cardiovascular structures of<br>interest, as above |
| Time to Peak [ms] | Trigger time elapsed from the first phase<br>till the phase where the peak strain has<br>been reached. | Strain within cardiovascular structures of<br>interest, as above |
| Torsion [degree/cm] | The difference in rotation between the<br>apical and basal slices divided by the<br>apical and basal slices. Note<br>circumferential displacement represents<br>an angle. | Strain within cardiovascular structures of<br>interest, as above |
| End Diastolic Volume [mL] | LV/RV cavity volume at the phase<br>defined as the ED | Calculated clinical data for LV/RV |
| End Systolic Volume [mL] | LV/RV cavity volume at the phase<br>defined as the ES | Calculated clinical data for LV/RV |
| Stroke Volume [mL] | Stroke volume is the volume of blood<br>pumped out of the LV/RV during each<br>cardiac contraction and is represented by<br>the difference of EDV and ESV. | Calculated clinical data for LV/RV |
| Ejection Fraction [%] | Ejection fraction is measured as a<br>percentage of the total amount of blood in<br>LV/RV that is pumped out with each<br>cardiac cycle. It is calculated by dividing<br>the SV by EDV. | Calculated clinical data for LV/RV |
| Cardiac Output [L/min] | Cardiac output is the amount of blood<br>pumped by the heart in a minute and is<br>calculated by multiplying the SV with<br>heart rate per minute. | Calculated clinical data for LV/RV |
| Cardiac Index [L/min/m²] | Cardiac index is a hemodynamic<br>parameter that relates the CO from LV in<br>one minute to BSA and is obtained by<br>dividing the CO by BSA. | Calculated clinical data for LV |
| End Diastolic Mass [g] | LV myocardial mass at the phase defined<br>as the ED and is calculated by multiplying<br>the myocardial volume in ED phase with<br>myocardial density (1.05 g/ml). | Calculated clinical data for LV |
| End Systolic Mass [g] | LV myocardial mass at the phase defined<br>as the ES and is calculated by multiplying<br>the myocardial volume in ES phase with<br>myocardial density (1.05 g/ml). | Calculated clinical data for LV |
| Body Surface Area [m²] | The total surface area of the body | Surface area of the patient body used in<br>medical indicators or assessments |

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#### V. INTENDED USE / INDICATIONS FOR USE

### Intended Use

cvi42 is intended to be used by qualified medical professionals for viewing, post-processing and quantitative evaluation of cardiovascular magnetic resonance (MR) images and cardiovascular computed tomography (CT) images in a Digital Imaging and Communications in Medicine Standard format, for the purpose of obtaining diagnostic information as part of a comprehensive diaqnostic decision-making process

### Indications for Use

cvi42 is intended to be used for viewing, post-processing, qualitative evaluation of cardiovascular magnetic resonance (MR) images and computed tomography (CT) images in a Digital Imaging and Communications in Medicine (DICOM) Standard format.

lt enables:

- . Importing cardiac MR & CT Images in DICOM format.
- . Supporting clinical diagnostics by qualitative analysis of cardiac MR & CT images using display functionality such as panning, windowing, zooming, navigation through series/slices and phases, 3D reconstruction of images including multiplanar reconstructions of the images.
- . Supporting clinical diagnostics by quantitative measurement of the heart and adjacent vessels in cardiac MR & CT images, specifically signal intensity, distance, area, volume, and mass.
- . Supporting clinical diagnostics by using area and volume for measuring cardiac function and derived parameters cardiac output and cardiac index in long axis and short axis cardiac MR & CT images.
- . Flow quantifications based on velocity encoded cardiac MR images (including two and four dimensional flow analysis).
- . Strain analysis of cardiac MR images by providing measurements of 2D LV myocardial function (displacement, velocity, strain, strain rate, time to peak, and torsion).
- . Supporting clinical diagnostics of cardiac CT images including quantitative measurements of calcified plaques in the coronary arteries (calcium scoring), specifically Agatston and volume and mass calcium scores, visualization and quantitative measurement of heart structures including coronaries, femoral, aortic, and mitral valves.
- . Evaluating CT and MR images of blood vessels. Combining digital image processing and visualization tools such as multiplanar reconstruction (MPR), thin/thick maximum intensity projection (MIP), inverted MIP thin/thick, volume rendering technique (VRT), curved planar reformation (CPR), 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

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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 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. cvi42 is a software application that can be used as a stand-alone product or in a networked environment.

The target population for cvi42 and its manual workflows is not restricted; however, cvi42's semiautomated machine learning algorithms, included in the MR Function and CORE CT modules, are intended for an adult population. Further, image acquisition by a cardiac MR or CT scanner may limit the use of the software for certain sectors of the general public.

cvi42 shall not be used to view or analyze images of any part of the body except the cardiac images acquired from a cardiovascular magnetic resonance or computed tomography scanner.

#### 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 predicates (K092628, K111373, K141480, K213998, K232661, and K241038). 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 application with no tangible component interfacing with the body.

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| Table 2. Subject Device Intended Use / Indications for Use | |
|------------------------------------------------------------|--|
|------------------------------------------------------------|--|

| | Subject Device | | Primary Predicate<br>cmr42 (K082628) | Predicate<br>ct42 (K111373) | Predicate<br>cvi42 (K141480) | Predicate<br>cvi42 Auto (K213998) | Predicate<br>Strain (K232661) | Predicate<br>CT Function (K241038) |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | cvi42 Software Application (K242781) | | Manufactured by Circle | Manufactured by Circle | Manufactured by Circle | Manufactured by Circle | Manufactured by Circle | Manufactured by Circle |
| | Manufactured by Circle | Intended Use | Viewing, post-processing,<br>qualitative and quantitative<br>evaluation of cardiovascular MR<br>images in DICOM format. | Viewing, post-processing, qualitative<br>and quantitative evaluation of<br>cardiovascular CT images in DICOM<br>format. | Viewing, post-processing, qualitative<br>and quantitative evaluation of blood<br>vessels and cardiovascular MR and<br>CT images in DICOM format. | Viewing, post-processing, qualitative<br>and quantitative evaluation of blood<br>vessels and cardiovascular MR and<br>CT images in DICOM format. | The Myocardial Strain Software<br>Application is intended for qualitative<br>and quantitative evaluation of<br>cardiovascular MR images in a<br>DICOM Standard format. As<br>perquisite, the user confirms<br>endocardial and epicardial contours in<br>a reference phase, and the software<br>tracks features over the cardiac cycle<br>and computed 2D myocardial<br>deformation and movement (e.g.,<br>strain, displacement, velocity). | The Cardiac CT Function Software<br>Application is intended for qualitative<br>and quantitative evaluation of<br>cardiovascular CT images in a DICOM<br>Standard format, to calculate and<br>display cardiac function metrics (e.g.,<br>end diastolic volume, end systolic<br>volume, stroke volume, ejection fraction<br>cardiac output, cardiac index, and LV<br>myocardial mass). |
| Intended Use | cvi42 is intended to be used by qualified medical professionals for viewing, post-processing and quantitative evaluation of cardiovascular magnetic resonance (MR) images and cardiovascular computed tomography (CT) images in a Digital Imaging<br>and Communications in Medicine Standard format, for the purpose of obtaining diagnostic information as part of a comprehensive diagnostic decision-making process | Indications for Use | 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 | ct42 is intended to be used for viewing,<br>post-processing and quantitative<br>evaluation of cardiovascular computed<br>tomography (CT) images in a Digital<br>Imaging and Communications in<br>Medicine (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 CT<br>images using display functionality<br>such as panning, windowing,<br>zooming, navigation through<br>series/slices and phases, 3D<br>reconstruction of images including<br>multi-lanner reconstructions of the<br>images.<br>• Supporting clinical diagnostics by<br>quantitative measurement of the heart<br>and adjacent vessels in cardiac CT<br>images, specifically distance, area,<br>volume and mass<br>• Supporting clinical diagnostics by<br>using area and volume measurements<br>for measuring LV function and derived<br>parameters cardiac output and cardiac<br>index in long axis and short axis<br>cardiac CT images. | cvi42 vascular analysis add-on is an<br>image analysis software package add-<br>on for evaluating CT and MR images<br>of blood vessels. Combining digital<br>image processing and visualization<br>tools such as multiplanar<br>reconstruction (MPR), thin/think<br>maximum intensity projection (MIP)<br>thin and think, inverted MIP thin and<br>think, volume rendering technique<br>(VRT), curved planner reformation,<br>processing tools such as bone<br>removal (based on both single energy<br>and dual 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), the<br>software package is designed to<br>support the physician in conforming<br>the presence or absence of physician<br>identified lesion in blood vessels and<br>evaluation, documentation and follow<br>up of any such lesions.<br>It shall be used by qualified medical<br>professionals, experienced in<br>examining and evaluating<br>cardiovascular CT or MR images, for<br>the purpose of obtaining diagnostic | cvi42 Auto is intended to be used for<br>viewing, post-processing, qualitative<br>and quantitative evaluation of<br>cardiovascular magnetic resonance<br>(MR) and computed tomography (CT)<br>images in a Digital Imaging and<br>Communications in Medicine (DICOM)<br>Standard format.<br>It enables a set of tools to assist<br>physicians in qualitative assessment<br>of cardiac images and quantitative<br>measurements of the heart and<br>adjacent vessels; perform calcium<br>scoring; and to confirm the presence<br>or absence of physician-identified<br>lesion in blood vessels.<br>The target population for cvi42 Auto's<br>manual workflows is not restricted;<br>however, cvi42 Auto's semi-<br>automated machine learning<br>algorithms are intended for an adult<br>population.<br>cvi42 Auto shall be used only for<br>cardiac images acquired from an MR<br>or CT scanner. It shall be used by<br>qualified medical professionals,<br>experienced in examining and<br>evaluating cardiovascular MR or CT | The Myocardial Strain Software<br>Application is intended for qualitative<br>and quantitative evaluation of<br>cardiovascular magnetic resonance<br>(CMR) images. It provides<br>measurements of 2D LV myocardial<br>function (displacement, velocity,<br>strain, strain rate, time to peak, and<br>torsion); these measurements are<br>used by qualified medical<br>professionals, experiences in<br>examining and evaluating CMR<br>images, for the purpose of obtaining<br>diagnostic information for patients with<br>suspected heart disease as part of a<br>comprehensive diagnostic decision-<br>making process. | The Cardiac CT Function Software<br>Application is indicated to be use with<br>multi-phase, multi-slice cardiovascular<br>CT angiography images to assist<br>qualified medical professionals in<br>assessing and evaluating cardiac<br>function. CT Function includes manual<br>and semi-automatic heart segmentation<br>of 2 chambers (LV and RV) and<br>calculation of cardiac function metrics<br>including end diastolic volume, end<br>systolic volume, stroke volume, ejection<br>fraction, cardiac output, cardiac index,<br>and LV myocardial mass. |
| Indications for Use | cvi42 is intended to be used for viewing, post-processing, qualitative and quantitative evaluation of cardiovascular magnetic resonance (MR) images and computed tomography (CT) images in a Digital Imaging and Communications in Medicine<br>(DICOM) Standard format. | | | | | | | |
| | It enables:<br>Importing cardiac MR & CT Images in DICOM format. Supp…