Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes standard image viewing, post-processing, and quantitative analysis tools without mentioning AI or ML algorithms.

Therapeutic

No
The device is described as a software application for viewing, post-processing, and quantitative evaluation of cardiovascular MR images to support clinical diagnostics, not for providing therapy.

Diagnostic

Yes
The device is described as "Supporting clinical diagnostics by qualitative analysis... and quantitative measurement..." and states its purpose is "obtaining diagnostic information as part of a comprehensive diagnostic decision-making process."

SaMD (Software as a Medical Device)

Yes

The device description explicitly states that cmr42 is a "dedicated software application" and can be used as a "stand-alone product". The intended use and device description focus solely on the software's functionality for viewing, post-processing, and quantitative evaluation of existing medical images. There is no mention of any accompanying hardware component that is part of the device itself.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
Device Function: The description clearly states that cmr42 is a software application used for viewing, post-processing, and quantitative evaluation of cardiovascular magnetic resonance (MR) images. These images are acquired directly from a patient using an MR scanner, not from a sample taken from the body.
Intended Use: The intended use focuses on supporting clinical diagnostics by analyzing the MR images themselves, performing measurements on the images, and deriving parameters from those measurements. This is image analysis, not analysis of a biological sample.

Therefore, because cmr42 operates on medical images acquired directly from the patient rather than on samples taken from the patient's body, it does not fit the definition of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

Product codes

LLZ

Device Description

cmr42 is a dedicated software application for cvaluating 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.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

cardiovascular magnetic resonance (MR) images

Anatomical Site

Heart, adjacent vessels, cardiac chambers

Indicated Patient Age Range

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.

Intended User / Care Setting

qualified medical professionals, experienced in examining and evaluating cardiovascular MR images / hospital or private practice environment

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

cmr42 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.

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K994283, K994282

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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).

Summary

0

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
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
System
Device Class: II
Product Code: LLZ
Regulation Number: 21 CFR 892.2050
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
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
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.

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. 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.

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. 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.

3

510(k) SUMMARY, continued

Indications for Use Comparison

DEVICE	INDICATIONS FOR USE
cmr42 CARDIAC MR
SOFTWARE
K082628	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.

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
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.

4

:

DEVICE	INDICATIONS FOR USE
MRI-MAGNETIC
RESONANCE
ANALYTICAL
SOFTWARE
SYSTEM
(MASS)
K994283	MASS, including its option, has been developed for the
objective and reproducible analysis of multi-slice, multi-phase
left and right ventricular function from cardiac MR data sets.
The software enables the display of images for use by trained
medical personnel.
Intended purposes are:

Supporting clinical diagnoses about the status of the
global and regional function and anatomy of the cardiac
chambers;
Supporting the subsequent clinical decision making
processes;
Supporting the use in clinical research trials, directed at
studying changes in function and anatomy of the heart
chambers as a result of interventions; |
| MRI-FLOW
ANALYTICAL
SOFTWARE
K994282 | Flow has been developed for the objective and reproducible
analysis of velocity-encoded cine MR imaging studies of
arterial vessels and heart valves. Intended purposes are:
Supporting clinical diagnoses about the status of the
function of the cardiac chambers;
Supporting clinical diagnoses about the status of the flow
velocity and volume flow through cardiac and peripheral
vessels, both under basal and increased flow conditions;
Supporting subsequent clinical decision making purposes;
Supporting the use in clinical research trials, directed at
studying changes in function of the heart chambers and in
the flow through cardiac and peripheral vessels as a result
of 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

| | Submission
cmr42
Cardiac MR
Software
K082628 | Predicate
MRI-MAGNETIC
RESONANCE
ANALYTICAL
SOFTWARE
SYSTEM (MASS)
K994283 | Predicate
MRI-Flow Analytical
Software
K994282 |
|----------------------------------------------------------------------------------------------------------|----------------------------------------------------------|----------------------------------------------------------------------------------------------|---------------------------------------------------------|
| Images from all MRI scanner
vendors supported | X | X | X |
| Workstation operating system | MacOS,
Microsoft
Windows | Microsoft Windows,
Unix, Linux | Microsoft Windows,
Unix, Linux |
| Import and display magnetic
resonance images | X | X | X |
| DICOM compliant networking | X | X | X |
| Images can be displayed by
study and series | X | | |
| Store images | X | X | X |
| Quantitative assessment of
cardiac function | X | X | X |
| Task specific modules with
corresponding tool sets | X | | |
| Analysis of velocity-encoded
images | X | | X |
| Dynamic display of ventricular
contractions | X | X | |
| Reports containing
visualization of images and
quantitative parameters | X | X | X |
| Analyzes long and short-axis
views of the heart for
quantitative assessment of
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
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.

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. 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.

7

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

9

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