(72 days)
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.
cmr42 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. 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.
The provided 510(k) summary for the cmr42 Cardiac MR Software Application (K082628) describes its intended use and a general statement about testing but does not provide a detailed table of acceptance criteria or the specific results of a study proving the device meets these criteria.
Instead, the summary states:
"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."
This indicates that internal testing was conducted to specifications but the specific acceptance criteria and detailed performance metrics are not publicly available in this document. The submission focuses on demonstrating substantial equivalence to predicate devices (MRI-MAGNETIC RESONANCE ANALYTICAL SOFTWARE SYSTEM (MASS) K994283 and MRI-Flow Analytical Software K994282) rather than publishing detailed performance studies against explicitly stated acceptance criteria.
Therefore, for most of the requested information, the answer is "Not provided in the given document."
Here's a breakdown of what can be extracted or inferred based on the supplied text:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Inferred from device description and comparison) | Reported Device Performance (General Statement) |
|---|---|
| Qualitative Analysis: - Viewing, panning, windowing, zooming - Navigation through series/slices and phases | Demonstrated safety and effectiveness for qualitative analysis. |
| Quantitative Measurements: - Distance, area, volume, mass of heart and adjacent vessels - LV function, cardiac output, cardiac index from long and short axis images | Demonstrated safety and effectiveness for quantitative measurements; performs "as well as or better than" predicate devices. |
| Flow Quantifications: - Based on velocity encoded images | Demonstrated safety and effectiveness for flow quantifications; performs "as well as or better than" predicate devices. |
| Image Compatibility: - Import DICOM-format Cardiac MR Images - Images from all MRI scanner vendors supported | Functionality confirmed. |
| User Interface and Functionality: - Graphical user interface - Comprehensive tool sets - Dynamic display of ventricular contractions - DICOM compliant networking - Reports with visualization and quantitative parameters | Functionality confirmed and described as having "task specific modules with corresponding tool sets." |
| General Performance: - Safety and Effectiveness | Non-clinical testing demonstrates safety and effectiveness. Performs "as well as or better than" the legally marketed predicate devices. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not provided in the given document. The document only mentions "non-clinical testing" and testing "according to the specifications that are documented in a Master Software Test Plan." Specifics about the test set, its size, or its provenance are not included.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not provided in the given document. The document does not describe the methodologies for establishing ground truth or the involvement of experts in the testing phase. The device itself is intended for use by "qualified medical professionals, experienced in examining and evaluating cardiovascular MR images."
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not provided in the given document. No information on adjudication methods for establishing ground truth or evaluating test results is given.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC comparative effectiveness study is not mentioned as part of this 510(k) submission. The submission focuses on the standalone performance of the software in comparison to predicate devices, not on human reader performance with or without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, a standalone evaluation was implicitly done. The "cmr42" is described as a "software application" for viewing, post-processing, and quantitative evaluation. The testing described is "non-clinical testing" to demonstrate its safety and effectiveness and that it performs as well as or better than predicate devices. This implies evaluating the software's performance on its own capabilities.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not explicitly stated in the given document. Since the device performs quantitative measurements (distance, area, volume, mass), the ground truth for testing would likely involve highly accurate reference measurements, possibly derived from manual expert measurements, phantoms, or other validated methods. However, the specific type of ground truth is not detailed.
8. The sample size for the training set:
- Not applicable / Not provided. The cmr42 is described as an "Image Processing System" and "software application" for analysis. At the time of this 2008 submission, the focus for such devices was primarily on deterministic algorithms and user-driven analysis tools rather than AI/machine learning models that require distinct training sets. Therefore, a "training set" in the modern AI sense is unlikely to have been a component of its development or evaluation, and no such information is provided.
9. How the ground truth for the training set was established:
- Not applicable. As a training set is not mentioned, the method for establishing its ground truth is also not provided.
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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 |
| EstablishmentRegistration Number | Not available |
| Date of Summary | November 05, 2008 |
| Telephone Number | 1 403 775 1857 |
| Fax Number | 1 403 270 2384 |
| 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 CommunicationsSystemDevice Class: IIProduct Code: LLZRegulation Number: 21 CFR 892.2050 |
| Indications for Use | cmr42 is intended to be used for viewing, post-processing andquantitative evaluation of cardiovascular magnetic resonance(MR) images in a Digital Imaging and Communications inMedicine (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 |
| 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. Thisdocument may not, in whole or in part, be duplicated, disclosed, or used for design or manufacturing purposeswithout the prior written permission of CIRCLE Cardiovascular Imaging, Inc. |
{1}------------------------------------------------
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. 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.
| 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. Thisdocument may not, in whole or in part, be duplicated, disclosed, or used for design or manufacturing purposeswithout the prior written permission of CIRCLE Cardiovascular Imaging, Inc. |
{2}------------------------------------------------
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. Thisdocument may not, in whole or in part, be duplicated, disclosed, or used for design or manufacturing purposeswithout the prior written permission of CIRCLE Cardiovascular Imaging, Inc. |
{3}------------------------------------------------
510(k) SUMMARY, continued
Indications for Use Comparison
| DEVICE | INDICATIONS FOR USE |
|---|---|
| cmr42 CARDIAC MRSOFTWAREK082628 | cmr42 is intended to be used for viewing, post-processing andquantitative evaluation of cardiovascular magnetic resonance(MR) images in a Digital Imaging and Communications inMedicine (DICOM) Standard format.It enables; |
| • Importing Cardiac MR Images in DICOM format | |
| • Supporting clinical diagnostics by qualitative analysisof the cardiac MR images using display functionalitysuch as panning, windowing, zooming, navigationthrough series/slices and phases. | |
| • Supporting clinical diagnostics by quantitativemeasurement of the heart and adjacent vessels incardiac MR images, specifically distance, area,volume and mass | |
| • Supporting clinical diagnostics by using area andvolume measurements for measuring LV function andderived parameters cardiac output and cardiac index inlong axis and short axis cardiac MR images. | |
| • Flow quantifications based on velocity encodesimages | |
| It shall be used by qualified medical professionals,experienced in examining and evaluating cardiovascular MRimages, for the purpose of obtaining diagnostic information aspart 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, howeverthe image acquisition by a cardiac magnetic resonancescanner may limit the use of the device for certain sectors ofthe general public. | |
| cmr42 shall not be used to view or analyze images of any partof the body except the cardiac magnetic resonance imagesacquired 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. Thisdocument may not, in whole or in part, be duplicated, disclosed, or used for design or manufacturing purposeswithout the prior written permission of CIRCLE Cardiovascular Imaging, Inc. |
{4}------------------------------------------------
:
| DEVICE | INDICATIONS FOR USE |
|---|---|
| MRI-MAGNETICRESONANCEANALYTICALSOFTWARESYSTEM(MASS)K994283 | MASS, including its option, has been developed for theobjective and reproducible analysis of multi-slice, multi-phaseleft and right ventricular function from cardiac MR data sets.The software enables the display of images for use by trainedmedical personnel.Intended purposes are:1. Supporting clinical diagnoses about the status of theglobal and regional function and anatomy of the cardiacchambers;2. Supporting the subsequent clinical decision makingprocesses;3. Supporting the use in clinical research trials, directed atstudying changes in function and anatomy of the heartchambers as a result of interventions; |
| MRI-FLOWANALYTICALSOFTWAREK994282 | Flow has been developed for the objective and reproducibleanalysis of velocity-encoded cine MR imaging studies ofarterial vessels and heart valves. Intended purposes are:1. Supporting clinical diagnoses about the status of thefunction of the cardiac chambers;2. Supporting clinical diagnoses about the status of the flowvelocity and volume flow through cardiac and peripheralvessels, both under basal and increased flow conditions;3. Supporting subsequent clinical decision making purposes;4. Supporting the use in clinical research trials, directed atstudying changes in function of the heart chambers and inthe flow through cardiac and peripheral vessels as a resultof interventions. |
| Document No. | N/A |
|---|---|
| Rev | 00 |
| File name: | cmr 42 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.
{5}------------------------------------------------
510(k) SUMMARY, continued
Device Comparison Table
| Submissioncmr42Cardiac MRSoftwareK082628 | PredicateMRI-MAGNETICRESONANCEANALYTICALSOFTWARESYSTEM (MASS)K994283 | PredicateMRI-Flow AnalyticalSoftwareK994282 | |
|---|---|---|---|
| Images from all MRI scannervendors supported | X | X | X |
| Workstation operating system | MacOS,MicrosoftWindows | Microsoft Windows,Unix, Linux | Microsoft Windows,Unix, Linux |
| Import and display magneticresonance images | X | X | X |
| DICOM compliant networking | X | X | X |
| Images can be displayed bystudy and series | X | ||
| Store images | X | X | X |
| Quantitative assessment ofcardiac function | X | X | X |
| Task specific modules withcorresponding tool sets | X | ||
| Analysis of velocity-encodedimages | X | X | |
| Dynamic display of ventricularcontractions | X | X | |
| Reports containingvisualization of images andquantitative parameters | X | X | X |
| Analyzes long and short-axisviews of the heart forquantitative assessment ofcardiac 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. Thisdocument may not, in whole or in part, be duplicated, disclosed, or used for design or manufacturing purposeswithout the prior written permission of CIRCLE Cardiovascular Imaging, Inc. |
{6}------------------------------------------------
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. Thisdocument may not, in whole or in part, be duplicated, disclosed, or used for design or manufacturing purposeswithout 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.
{8}------------------------------------------------
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(Part 21 CFR 801 Subpart D) | X |
|---|---|
| AND/OR | |
| Over-The-Counter Use(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 |
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).