CT42 CARDIAC COMPUTED TOMOGRAPHY (CT) SOFTWARE

K111373 · Circle Cardiovascular Imaging, Inc. · LLZ · Aug 23, 2011 · Radiology

Device Facts

• Record ID: K111373
• Device Name: CT42 CARDIAC COMPUTED TOMOGRAPHY (CT) SOFTWARE
• Applicant: Circle Cardiovascular Imaging, Inc.
• Product Code: LLZ · Radiology
• Decision Date: Aug 23, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

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-planner 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. 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 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. 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.

Device Story

Software application for qualitative and quantitative analysis of DICOM-formatted cardiovascular CT images; used in hospital or private practice environments by qualified medical professionals. Inputs: ECG-gated cardiac CT images. Processing: display tools (panning, zooming, 3D/multi-planar reconstruction); quantitative measurement tools for distance, area, volume, mass, LV function (cardiac output/index), and coronary artery calcium scoring (Agatston, volume, mass). Outputs: visual analysis and quantitative metrics to assist clinicians in diagnostic decision-making. Benefits: provides standardized measurements for cardiac evaluation and plaque assessment.

Clinical Evidence

Bench testing only. Software verified and validated according to a Master Software Test Plan to demonstrate safety and effectiveness for defined indications.

Technological Characteristics

Software-based image processing system; DICOM compliant; standalone or networked deployment. Features include 3D reconstruction, multi-planar reconstruction, and quantitative measurement tools for cardiac CT. No hardware components.

Indications for Use

Indicated for viewing, post-processing, and quantitative evaluation of cardiovascular CT images. Target population is unrestricted, though limited by cardiac CT scanner acquisition capabilities. Contraindicated for non-cardiac CT 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

• Ziosoft - Cardiac Function Analysis & Calcium Scoring (K083446)

Submission Summary (Full Text)

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K111373

AUG 2 3 2011

# 510(K) SUMMARY

Image /page/0/Picture/3 description: The image shows a logo with the word "circle" in lowercase letters, with a broken circle above it. Below the word "circle" is the text "CARDIOVASCULAR IMAGING" in all caps. The font appears to be sans-serif and slightly distressed, giving it a textured look.

| Submitter's Name | Circle Cardiovascular Imaging Inc. |
|--------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address | Suite 12, 3535 Research Road NW, Calgary, AB, Canada T2L 2K8 |
| Establishment<br>Registration Number | 3007301305 |
| Date of Summary | May 12, 2011 |
| Telephone Number<br>Fax Number | 1 403 338 1870<br>1 403 338 1895 |
| Email | [e-mail] |
| Contact Person | Shirantha Samarappuli |
| Name of the Device | ct42 Cardiac Computed Tomography (CT) Software |
| Common or Usual Name | Image Processing System |
| Classification Name | Classification Name: Picture Archiving and Communications<br>System<br>Device Class: II<br>Product Code: LLZ<br>Regulation Number: 21 CFR 892.2050 |
| Indications for Use | ct42 is intended to be used for viewing, post-processing and<br>quantitative evaluation of cardiovascular computed<br>tomography (CT) images in a Digital Imaging and<br>Communications in Medicine (DICOM) Standard format.<br>It enables;<br>● Importing Cardiac CT Images in DICOM format<br>● Supporting clinical diagnostics by qualitative analysis<br>of the cardiac CT images using display functionality<br>such as panning, windowing, zooming, navigation<br>through series/slices and phases, 3D reconstruction of |

- images including multi-planner reconstructions of the

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| CIRCLE Cardiovascular Imaging Inc. | ct ⁴²<br>Traditional 510(k) |
|------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | <ul><li>images.</li><li>Supporting clinical diagnostics by quantitative measurement of the heart and adjacent vessels in cardiac CT images, specifically distance, area, volume and mass</li><li>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.</li><li>Supporting clinical diagnostics by quantitative measurements of calcified plaques in the coronary arteries (calcium scoring), specifically Agatston and volume and mass calcium scores</li></ul> |
| | It shall be used by qualified medical professionals, experienced in examining and evaluating cardiovascular CT images, for the purpose of obtaining diagnostic information as part of a comprehensive diagnostic decision-making process. ct ⁴² is a software application that can be used as a stand-alone product or in a networked environment. |
| | The target population for the ct ⁴² 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. |
| | ct ⁴² 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. |
| Device Description | ct ⁴² is a dedicated software application for evaluating cardiovascular images in a DICOM Standard format. The software can be used as a stand-alone product that can be integrated into a hospital or private practice environment. ct ⁴² has a graphical user interface which allows users to qualitatively and quantitatively analyze cardiac CT images for volume/mass, and calcium scoring. It provides a comprehensive set of tools for the analysis of Cardiovascular Computed Tomography (CT) images. |

and the country of the country of the county of

| Document No. | Rev | File name: | Sheet |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----|----------------------------------|---------------|
| N/A | 00 | ct42 Traditional 510k Submission | Page 23 of 78 |
| This document contains information, which is the property of CIRCLE Cardiovascular Imaging, Inc. This<br>document may not, in whole or in part, be duplicated, disclosed, or used for design or manufacturing purposes<br>without the prior written permission of CIRCLE Cardiovascular Imaging, Inc. | | | |

and the comments of the comments of the comments of

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CIRCLE Cardiovascular Imaging Inc.

· Craditional 510(k)

# 510(k) SUMMARY, continued

# Indications for Use Comparison

| DEVICE | INDICATIONS FOR USE |
|--------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ct42 | ct42 is intended to be used for viewing, post-processing and<br>quantitative evaluation of cardiovascular computed tomography (CT)<br>images in a Digital Imaging and Communications in Medicine<br>(DICOM) Standard format.<br>It enables;<br>Importing Cardiac CT Images in DICOM format |
| | Supporting clinical diagnostics by qualitative analysis of the<br>cardiac CT images using display functionality such as<br>panning, windowing, zooming, navigation through<br>series/slices and phases, 3D reconstruction of images<br>including multi-planner reconstructions of the images.Supporting clinical diagnostics by quantitative measurement<br>of the heart and adjacent vessels in cardiac CT images,<br>specifically distance, area, volume and massSupporting clinical diagnostics by using area and volume<br>measurements for measuring LV function and derived<br>parameters cardiac output and cardiac index in long axis and<br>short axis cardiac CT images.Supporting clinical diagnostics by quantitative measurements<br>of calcified plaques in the coronary arteries (calcium<br>scoring), specifically Agatston and volume and mass calcium<br>scores |
| | It shall be used by qualified medical professionals, experienced in<br>examining and evaluating cardiovascular CT images, for the purpose<br>of obtaining diagnostic information as part of a comprehensive<br>diagnostic decision-making process. ct42 is a software application that<br>can be used as a stand-alone product or in a networked environment. |
| | The target population for the ct42 is not restricted, however the image<br>acquisition by a cardiac CT scanner may limit the use of the device<br>for certain sectors of the general public. |
| | ct42 shall not be used to view or analyze images of any part of the<br>body except the cardiac CT images acquired from a cardiovascular<br>CT scanner. |

| Document No. | Rev | File name: | Sheet |
|--------------|-----|----------------------------------|---------------|
| N/A | 00 | ct42 Traditional 510k Submission | Page 24 of 78 |

This document contains information, which is the property of CIRCLE Cardiovascular Imaging, Inc. This document may not, in whole or in part, be duplicated, disclosed, or used for design or manufacturing purposes without the prior written permission of CIRCLE Cardiovascular Imaging, Inc.

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## CIRCLE Cardiovascular Imaging Inc.

and the same of the same of the same of the same of the same of the same

い ct42 Traditional 510(k)

| DEVICE | INDICATIONS FOR USE |
|------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| K083446 | The Cardiac Function Analysis software option for use with Ziostation is intended |
| Cardiac Function | for noninvasive post-processing of DICOM compliant cardiac CT images to semi- |
| Analysis | automatically calculate and display various functional parameters, such as left |
| Calcium Scoring | ventricular ejection fraction, end diastolic volume, end systolic volume, stroke<br>volume, cardiac output, cardiac index, wall<br>thickness, wall thickness ratio and regional wall motion display. These<br>measurements can be used to assist the clinician in a cardiac evaluation.<br>The Calcium Scoring software option for use with Ziostation is a non-invasive<br>post processing software tool that can be used with CT images to evaluate<br>calcified plaques in the coronary arteries, which may be a risk factor for coronary<br>artery disease. |

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## Device Comparison Table

·

| Feature | Ziosoft - Cardiac Function Analysis & Calcium Scoring | ct42 | Remarks |
|------------------------------------------------------|-------------------------------------------------------|----------------------------------------------|---------------------------------------------------|
| 510k # | K083446 | TBD | |
| Device Class | II | II | |
| Device Classification | LLZ | LLZ | |
| Regulation Name | Picture Archiving and communications systems | Picture Archiving and communications systems | |
| Regulation Number | 21 CFR 892.2050 | 21 CFR 892.2050 | |
| Post processes ECG gated - Cardiac CT images | YES | YES | |
| Image viewer functionality | YES | YES | |
| Left ventricular ejection fraction | YES | YES | |
| End diastolic volume | YES | YES | |
| End systolic volume | YES | YES | |
| Stroke volume | YES | YES | |
| Cardiac output | YES | YES | |
| Cardiac Index | YES | YES | |
| Wall thickness | YES | YES | |
| Wall thickness ratio | YES | YES | |
| Wall movement | YES | YES | |
| Volume Curve | YES | YES | |
| Calcium Scoring | YES | YES | |
| Evaluates calcified plaque in the coronary arteries, | YES | YES | |
| Agatston calcium score | YES | YES | |
| Volume calcium score | YES | YES | |
| Calcium mass/density calculations | YES | YES | Ziosoft calculate density and ct42 calculate mass |
| DICOM complaint | YES | YES | |

| Document No. | Rev | File name: | Sheet | | |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----|----------------------------------|---------------|--|--|
| N/A | 00 | ct42 Traditional 510k Submission | Page 25 of 78 | | |
| This document contains information, which is the property of CIRCLE Gardiovascular Imaging, Inc. This | | | | | |
| document may not, in whole or in part, be duplicated, disclosed, or used for design or manufacturing purposes<br>without the prior written permission of CIRCLE Cardiovascular Imaging, Inc. | | | | | |

.

.

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ct42 Traditional 510(k)

## 510(k) SUMMARY, continued

Description and Conclusion of Testing

#### Testing:

ct 4 have 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.

#### Conclusion:

The successful non-clinical testing demonstrates the safety and effectiveness of the ct22 when used for the defined indications for use and demonstrates that the device for which the 510(k) is submitted performs as well as or better than the legally marketed predicate device.

| Document No. | Rev | File name: | Sheet | | |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----|----------------------------------|---------------|--|--|
| N/A | 00 | ct42 Traditional 510k Submission | Page 26 of 78 | | |
| This document contains information, which is the property of CIRCLE Cardiovascular Imaging, Inc. This<br>document may not, in whole or in part, be duplicated, disclosed, or used for design or manufacturing purposes<br>without the prior written permission of CIRCLE Cardiovascular Imaging, Inc. | | | | | |

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Image /page/5/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle or bird symbol, with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

Shirantha Samarappuli, Ph.D. Vice President-Regulatory Affairs and Quality Assurance Circle Cardiovascular Imaging 12, 3535 Research Road NW Calgary, AB. T2L 2K8 CANADA

AUG 2 3 2011

Re: K111373

Trade/Device Name: ct12 Cardiac Computed Tomography (CT) Software Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ. Dated: August 10, 2011 Received: August 12, 2011

Dear Dr. Samarappuli:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.

Sincerely Yours.

Mary Patel

Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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CIRCLE Cardiovascular Imaging Inc.

Ct42 Traditional 510(k)

### INDICATIONS FOR USE

# 510(k) Number (if known): K ( 1 ( 37 3

# Device: ct22 Cardiac Computed Tomography (CT) Software

## Indications for Use:

ct 2 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 multiplanner 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.
- 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 information as part of a comprehensive diagnostic decision-making process. ct3 is a software application that can be used as a stand-alone product or in a networked environment.

The target population for the ct3 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.

ct ' 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.

Over-The-Counter Use Prescription Use AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mary Spatd
(Division Sign-On)

Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety