CMR42 CARDIAC MRI IMAGING SYSTEM, 2.1.23
Device Facts
| Record ID | K082628 |
|---|---|
| Device Name | CMR42 CARDIAC MRI IMAGING SYSTEM, 2.1.23 |
| Applicant | Circle Cardiovascular Imaging, Inc. |
| Product Code | LLZ · Radiology |
| Decision Date | Nov 20, 2008 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.2050 |
| Device Class | Class 2 |
| Attributes | Software as a Medical Device |
Indications for Use
cmr42 is intended to be used for viewing, post-processing and quantitative evaluation of cardiovascular magnetic resonance (MR) images in a Digital Imaging and Communications in Medicine (DICOM) Standard format. It enables: Importing Cardiac MR Images in DICOM format Supporting clinical diagnostics by qualitative analysis of the cardiac MR images using display functionality such as panning, windowing, zooming, navigation through series/slices and phases. Supporting clinical diagnostics by quantitative measurement of the heart and adjacent vessels in cardiac MR images, specifically distance, area, volume and mass Supporting clinical diagnostics by using area and volume measurements for measuring LV function and derived parameters cardiac output and cardiac index in long axis and short axis cardiac MR images. Flow quantifications based on velocity encodes images It shall be used by qualified medical professionals, experienced in examining and evaluating cardiovascular MR images, for the purpose of obtaining diagnostic information as part of a comprehensive diagnostic decision-making process. cmr42 is a software application that can be used as a stand-alone product or in a networked environment. The target population for the cmr42 is not restricted, however the image acquisition by a cardiac magnetic resonance scanner may limit the use of the device for certain sectors of the general public. cmr42 shall not be used to view or analyze images of any part of the body except the cardiac magnetic resonance images acquired from a cardiovascular magnetic resonance scanner.
Device Story
cmr42 is a software application for qualitative and quantitative analysis of cardiovascular MR images in DICOM format. Input consists of cardiac MR images acquired from a scanner. The software provides tools for image display (panning, windowing, zooming, navigation) and quantitative measurements (distance, area, volume, mass, LV function, cardiac output, cardiac index, and flow quantification from velocity-encoded images). Used in hospital or private practice environments by qualified medical professionals. Output is visualized on a workstation, assisting clinicians in diagnostic decision-making. Benefits include objective, reproducible analysis of cardiac function and anatomy.
Clinical Evidence
Bench testing only. No clinical data provided. Safety and effectiveness were demonstrated through non-clinical testing according to a Master Software Test Plan.
Technological Characteristics
Software-only device; runs on MacOS and Microsoft Windows. Supports DICOM networking. Provides task-specific modules for qualitative/quantitative analysis of cardiac MR images. No hardware components.
Indications for Use
Indicated for use by qualified medical professionals to view, post-process, and quantitatively evaluate cardiovascular MR images. Target population is unrestricted, though limited by patient suitability for cardiac MR scanning. Contraindicated for non-cardiac MR 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
- MRI-MAGNETIC RESONANCE ANALYTICAL SOFTWARE SYSTEM (MASS) (K994283)
- MRI-Flow Analytical Software (FLOW) (K994282)
Submission Summary (Full Text)
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# 510(k) Summary (REVISED) - K082628 cmr42 Cardiac MR Software Application
| Submitter's Name | Circle Cardiovascular Imaging Inc. |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address | Suite 130, 3553 31 Street NW, Calgary, AB, Canada T2L 2K7 |
| Establishment<br>Registration Number | Not available |
| Date of Summary | November 05, 2008 |
| Telephone Number | 1 403 775 1857 |
| Fax Number | 1 403 270 2384 |
| Email | shirantha@circlecvi.com |
| Contact Person | Shirantha Samarappuli |
| Name of the Device | cmr42 |
| 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 | cmr42 is intended to be used for viewing, post-processing and<br>quantitative evaluation of cardiovascular magnetic resonance<br>(MR) images in a Digital Imaging and Communications in<br>Medicine (DICOM) Standard format.<br>It enables:<br>Importing Cardiac MR Images in DICOM format Supporting clinical diagnostics by qualitative analysis of the cardiac MR images using display functionality such as panning, windowing, zooming, navigation through series/slices and phases. Supporting clinical diagnostics by quantitative measurement of the heart and adjacent vessels in cardiac MR images, specifically distance, area, volume and mass Supporting clinical diagnostics by using area and volume measurements for measuring LV function and |
| Document No. | N/A |
| Rev | 00 |
| File name: | cmr42 Traditional 510k Submission - 510k Summary |
| Sheet | Page 1 of 7 |
| 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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cmr42 Traditional 510(k) K082628
derived parameters cardiac output and cardiac index in long axis and short axis cardiac MR images.
• Flow quantifications based on velocity encodes images
It shall be used by qualified medical professionals, experienced in examining and evaluating cardiovascular MR images, for the purpose of obtaining diagnostic information as part of a comprehensive diagnostic decision-making process. cmr<sup>42</sup> is a software application that can be used as a stand-alone product or in a networked environment.
The target population for the cmr<sup>42</sup> is not restricted, however the image acquisition by a cardiac magnetic resonance scanner may limit the use of the device for certain sectors of the general public.
cmr<sup>42</sup> shall not be used to view or analyze images of any part of the body except the cardiac magnetic resonance images acquired from a cardiovascular magnetic resonance scanner.
| Identification of the Legally Marketed Device (Predicate Device) | MRI-MAGNETIC RESONANCE ANALYTICAL SOFTWARE SYSTEM (MASS) |
|------------------------------------------------------------------|----------------------------------------------------------|
| Classification Name: | System, Nuclear Magnetic Resonance Imaging |
| Device Class: | II |
| Product Code: | LNH |
| Regulation Number: | 21 CFR 892.1000 |
| 510k #: | K994283 |
| | MRI-Flow Analytical Software (FLOW) |
|----------------------|--------------------------------------------|
| Classification Name: | System, Nuclear Magnetic Resonance Imaging |
| Device Class: | II |
| Product Code: | LNH |
| Regulation Number: | 21 CFR 892.1000 |
| 510K #: | K994282 |
#### Device Description
cmr42 is a dedicated software application for cvaluating cardiovascular images in a DICOM Standard format. The software
| Document No. | Rev | File name: | Sheet |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----|-----------------------------------|-------------|
| N/A | 00 | cmr42 Traditional 510k Submission | Page 2 of 7 |
| 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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CIRCLE Cardiovascular Imaging Inc.
can be used as a stand-alone product that can be integrated into a hospital or private practice environment. cmr42 has a graphical user interface which allows users to qualitatively and quantitatively analyze cardiac images for volume/mass, and flow quantification. It provides a comprehensive set of tools for the analysis of Cardiovascular Magnetic Resonance (CMR) images.
| Document No. | Rev | File name: | Sheet |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----|-----------------------------------|-------------|
| N/A | 00 | cmr42 Traditional 510k Submission | Page 3 of 7 |
| 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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# 510(k) SUMMARY, continued
## Indications for Use Comparison
| DEVICE | INDICATIONS FOR USE |
|-----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| cmr42 CARDIAC MR<br>SOFTWARE<br>K082628 | cmr42 is intended to be used for viewing, post-processing and<br>quantitative evaluation of cardiovascular magnetic resonance<br>(MR) images in a Digital Imaging and Communications in<br>Medicine (DICOM) Standard format.<br>It enables; |
| | • Importing Cardiac MR Images in DICOM format |
| | • Supporting clinical diagnostics by qualitative analysis<br>of the cardiac MR images using display functionality<br>such as panning, windowing, zooming, navigation<br>through series/slices and phases. |
| | • Supporting clinical diagnostics by quantitative<br>measurement of the heart and adjacent vessels in<br>cardiac MR images, specifically distance, area,<br>volume and mass |
| | • Supporting clinical diagnostics by using area and<br>volume measurements for measuring LV function and<br>derived parameters cardiac output and cardiac index in<br>long axis and short axis cardiac MR images. |
| | • Flow quantifications based on velocity encodes<br>images |
| | It shall be used by qualified medical professionals,<br>experienced in examining and evaluating cardiovascular MR<br>images, for the purpose of obtaining diagnostic information as<br>part of a comprehensive diagnostic decision-making process.<br>cmr42 is a software application that can be used as a stand-<br>alone product or in a networked environment. |
| | The target population for the cmr42 is not restricted, however<br>the image acquisition by a cardiac magnetic resonance<br>scanner may limit the use of the device for certain sectors of<br>the general public. |
| | cmr42 shall not be used to view or analyze images of any part<br>of the body except the cardiac magnetic resonance images<br>acquired from a cardiovascular magnetic resonance scanner. |
| Document No. | Rev | File name: | Sheet |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----|-----------------------------------|-------------|
| N/A | 00 | cmr42 Traditional 510k Submission | Page 4 of 7 |
| 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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:
| DEVICE | INDICATIONS FOR USE |
|------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| MRI-MAGNETIC<br>RESONANCE<br>ANALYTICAL<br>SOFTWARE<br>SYSTEM<br>(MASS)<br>K994283 | MASS, including its option, has been developed for the<br>objective and reproducible analysis of multi-slice, multi-phase<br>left and right ventricular function from cardiac MR data sets.<br>The software enables the display of images for use by trained<br>medical personnel.<br>Intended purposes are:<br>1. Supporting clinical diagnoses about the status of the<br>global and regional function and anatomy of the cardiac<br>chambers;<br>2. Supporting the subsequent clinical decision making<br>processes;<br>3. Supporting the use in clinical research trials, directed at<br>studying changes in function and anatomy of the heart<br>chambers as a result of interventions; |
| MRI-FLOW<br>ANALYTICAL<br>SOFTWARE<br>K994282 | Flow has been developed for the objective and reproducible<br>analysis of velocity-encoded cine MR imaging studies of<br>arterial vessels and heart valves. Intended purposes are:<br>1. Supporting clinical diagnoses about the status of the<br>function of the cardiac chambers;<br>2. Supporting clinical diagnoses about the status of the flow<br>velocity and volume flow through cardiac and peripheral<br>vessels, both under basal and increased flow conditions;<br>3. Supporting subsequent clinical decision making purposes;<br>4. Supporting the use in clinical research trials, directed at<br>studying changes in function of the heart chambers and in<br>the flow through cardiac and peripheral vessels as a result<br>of interventions. |
| Document No. | N/A |
|--------------|-----------------------------------------------|
| Rev | 00 |
| File name: | cmr <sup>42</sup> Traditional 510k Submission |
| Sheet | Page 5 of 7 |
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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# 510(k) SUMMARY, continued
Device Comparison Table
| | Submission<br>cmr42<br>Cardiac MR<br>Software<br>K082628 | Predicate<br>MRI-MAGNETIC<br>RESONANCE<br>ANALYTICAL<br>SOFTWARE<br>SYSTEM (MASS)<br>K994283 | Predicate<br>MRI-Flow Analytical<br>Software<br>K994282 |
|----------------------------------------------------------------------------------------------------------|----------------------------------------------------------|----------------------------------------------------------------------------------------------|---------------------------------------------------------|
| Images from all MRI scanner<br>vendors supported | X | X | X |
| Workstation operating system | MacOS,<br>Microsoft<br>Windows | Microsoft Windows,<br>Unix, Linux | Microsoft Windows,<br>Unix, Linux |
| Import and display magnetic<br>resonance images | X | X | X |
| DICOM compliant networking | X | X | X |
| Images can be displayed by<br>study and series | X | | |
| Store images | X | X | X |
| Quantitative assessment of<br>cardiac function | X | X | X |
| Task specific modules with<br>corresponding tool sets | X | | |
| Analysis of velocity-encoded<br>images | X | | X |
| Dynamic display of ventricular<br>contractions | X | X | |
| Reports containing<br>visualization of images and<br>quantitative parameters | X | X | X |
| Analyzes long and short-axis<br>views of the heart for<br>quantitative assessment of<br>cardiac function | X | X | |
| Document No. | Rev | File name: | Sheet | |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----|-----------------------------------|-------------|--|
| N/A | 00 | cmr42 Traditional 510k Submission | Page 6 of 7 | |
| 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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CIRCLE Cardiovascular Imaging Inc.
#### 510(k) SUMMARY, continued
Description and Testing: cmr42 have been tested according to the specifications that are Conclusion of Testing 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 cm42 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 | cmr42 Traditional 510k Submission | Page 7 of 7 |
| 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/7/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features the department's name encircling a symbol. The symbol is a stylized representation of three overlapping human figures, suggesting collaboration and support. The seal is in black and white.
## DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Shirantha Samarappuli Director-Regulatory Affairs & Quality Assurance Circle Cardiovascular Imaging, Inc. Suite 130, 31 Street NW Calgary, Alberta, T2L 2K7 CANADA
NOV 2 0 2008
Re: K082628
Trade/Device Name: cmr42 Cardiac Magnetic Resonance Imaging Software Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: November 11, 2008 Received: November 12, 2008
Dear Mr. 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, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
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#### Page 2
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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|----------------|----------------------------------|--------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part.807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
loque An Whang
Joyce M. Whang, Ph.D. Acting Director. Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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## INDICATIONS FOR USE
## 510(k) Number (if known): K082628
# Device: cmr42 Cardiac Magnetic Resonance Imaging Software
#### Indications for Use:
cmr is intended to be used for vicwing, post-processing and quantitative evaluation of cardiovascular magnetic resonance (MR) images in a Digital Imaging and Communications in Medicine (DICOM) Standard format. It enables;
- . Importing Cardiac MR Images in DICOM format
- Supporting clinical diagnostics by qualitative analysis of the cardiac MR images . using display functionality such as panning, windowing, zooming, navigation through series/slices and phases.
- Supporting clinical diagnostics by quantitative measurement of the heart and . adjacent vessels in cardiac MR images, specifically distance, area, volume and mass
- Supporting clinical diagnostics by using area and volume measurements for . measuring LV function and derived parameters cardiac output and cardiac of long axis and short axis cardiac MR images.
- . Flow quantifications based on velocity encodes images
It shall be used by qualified medical professionals, experienced in examining and evaluating cardiovascular MR images, for the purpose of obtaining diagnostic information as part of a comprehensive diagnostic decision-making process. cmr3 is a software application that can be used as a stand-alone product or in a networked environment.
The target population for the cmr44 is not restricted, however the image acquisition by a cardiac magnetic resonance scanner may limit the use of the device for certain sectors of the general public.
cmr2 shall not be used to view or analyze images of any part of the body except the cardiac magnetic resonance images acquired from a cardiovascular magnetic resonance scanner.
| Prescription Use<br>(Part 21 CFR 801 Subpart D) | X |
|-------------------------------------------------|--------|
| | AND/OR |
| Over-The-Counter Use<br>(21 CFR 801 Subpart C) | |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF
NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|--------------------------------------------------------------|--|
| Division of Reproductive, Abdominal and Radiological Devices | |
