Synapse 3D Cardiac Tools is medical imaging software used with Synapse 3D Base Tools that is intended to provide trained medical professionals with tools to aid them in reading, interpreting, reporting, and treatment planning. Synapse 3D Cardiac Tools accepts DICOM compliant medical images acquired from a variety of imaging devices including, CT, MR, NM, and XA.

This product is not intended for use with or for the primary diagnostic interpretation of Mammography images. Addition to the tools in Synapse 3D Base Tools, Synapse 3D Cardiac Tools for specific clinical applications which provide targeted workflows, custom UI, targeted measurements and reporting functions including:

A Functional cardiac analysis for CT left ventriculography images: which is intended to evaluate the functional characteristics of heart
A Functional cardiac analysis for non-contrast MR heart images: which is intended to evaluate the functional characteristics of heart
A Coronary artery analysis for CT coronary arteriography images: which is intended for the qualitative and quantitative analysis of coronary arteries
A Coronary artery analysis for MR heart images: which is intended for the qualitative and quantitative analysis of coronary arteries
A Calcium scoring for non-contrast CT heart images: which is intended for non-invasive identification and quantification of calcified atherosclerotic plaques in the coronary arteries using tomographic medical image data and clinically accepted calcium scoring algorithms
A Cardiac Fusion: which is intended to analyze cardiac anatomy and pathology with a fused image of functional data (e.g. NM image, Bulls eye) and anatomical data
A Aortic Valve Analysis for contrast CT heart images: which is intended for visualization of the heart, aorta regions, and contour of the aorta, measurement of the vicinity of the aortic valve, measurement of the calcification area in the aorta.

Device Description

Synapse 3D Cardiac Tools is the updated version of previously-cleared Synapse 3D Cardiac Tools software (cleared by CDRH via K120636 on 07/05/2012).

Synapse 3D Cardiac Tools is used in addition to the Synapse 3D Base Tools (K120361) to analyze the images acquired from CT and MR. Synapse 3D Cardiac Tools is intended to provide trained medical professionals with tools to aid them in reading, interpreting, and treatment planning of DICOM compliant medical images.

Synapse 3D Cardiac Tools is an application that supports the cardiac function, cardiac fusion, and coronary artery analysis of both the computed tomography (CT) and magnetic resonance (MR) images. Synapse 3D Cardiac Tools also supports the calcium scoring for non-contrast CT images.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Preamble: The provided 510(k) summary focuses on demonstrating substantial equivalence to predicate devices, primarily K120636 and K120367. The testing described is general to software verification and validation, rather than a specific clinical performance study with detailed acceptance criteria for diagnostic metrics. The document emphasizes that the device is an "updated version" and an "application that supports" trained medical professionals, suggesting it's a tool for analysis rather than an autonomous diagnostic algorithm.

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) document does not contain a specific table of quantitative acceptance criteria for diagnostic performance metrics (e.g., sensitivity, specificity, accuracy) for a standalone AI algorithm. It describes general verification and validation activities for software and accuracy for measurements.

The document states: "Pass/Fail criteria were based on the requirements and intended use of the product. Test results showed that all tests successfully passed."

Based on the information, here's a conceptual table. Since quantitative diagnostic performance metrics are not given, the "Reported Device Performance" is inferred from the overall statement of successful testing.

Acceptance Criteria Category	Specific Criteria (Inferred/General)	Reported Device Performance
System Functionality	Meets Software Requirements Specification, intended use.	All tests passed successfully.
Segmentation Accuracy	Accurate segmentation of cardiac structures (details not specified).	Achieved expected accuracy performance.
Measurement Accuracy	Accurate measurements (e.g., ejection fraction, volumes, calcification scores, aortic valve dimensions).	Achieved expected accuracy performance.
Interfacing	Seamless integration with DICOM-compliant systems.	All tests passed successfully.
Usability	User-friendly interface and workflow (details not specified).	All tests passed successfully.
Serviceability	Maintainable and serviceable (details not specified).	All tests passed successfully.
Labeling	Complies with labeling requirements.	All tests passed successfully.
Risk Mitigation	All identified hazards appropriately mitigated.	All tests passed successfully.
Overall Performance	Safe and effective, substantially equivalent to predicate devices.	Demonstrated substantial equivalence; found safe and effective.

2. Sample Size for the Test Set and Data Provenance

The document states: "In addition, we conducted the bench performance testing using actual clinical images to help demonstrate that the proposed device achieved the expected accuracy performance."

Sample Size for Test Set: Not specified. The exact number of "actual clinical images" used for bench performance testing is not mentioned.
Data Provenance: The images were "actual clinical images." The country of origin and whether they were retrospective or prospective are not specified.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

The document does not specify the number of experts used or their qualifications for establishing ground truth for the "actual clinical images."

4. Adjudication Method for the Test Set

The document does not specify any adjudication method (e.g., 2+1, 3+1) for establishing ground truth for the "actual clinical images."

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. The document does not mention a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. The focus is on the software's inherent functionality and measurement accuracy as a tool rather than its impact on human reader performance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The document describes "bench performance testing using actual clinical images to help demonstrate that the proposed device achieved the expected accuracy performance." This implies a standalone assessment of the device's accuracy in segmentation and measurement.

Yes, a standalone assessment of the device's performance was conducted, specifically for "segmentation accuracy test" and "measurement accuracy test." However, the specific metrics (e.g., Dice scores, absolute difference in measurements) and their success thresholds are not detailed.

7. The Type of Ground Truth Used

The document does not explicitly state the specific type of ground truth used (e.g., pathology, clinical outcomes). Given the context of "segmentation accuracy test" and "measurement accuracy test" using "actual clinical images" for cardiac analysis, the ground truth would most likely have been expert consensus or reference measurements manually performed by qualified experts on these clinical images.

8. The Sample Size for the Training Set

The document does not mention or specify a training set size. This is typical for 510(k) submissions for image processing tools that might use rule-based algorithms or pre-trained models. If machine learning was involved in specific features, the training data and methods are not detailed in this summary.

9. How the Ground Truth for the Training Set Was Established

Since a training set is not explicitly mentioned, the method for establishing its ground truth is also not described.

Summary

{0}------------------------------------------------

K 130383

5. 510(k) Summary

Date Prepared:

March 12, 2013

Submitter's Information:

FUJIFILM Medical Systems U.S.A., Inc. 419 West Avenue Stamford, Connecticut 06902

Telephone: (301) 251-1092 Fax: (203) 602-3785 Contact: Jyh-Shyan Lin

Device Trade Name:

Synapse 3D Cardiac Tools

Device Common Name:

Medical Image Processing and Analysis Software

Regulation Number:

21 CFR 892.2050

Device Classification:

Class II

Device Classification Name :

Picture Archiving and Communications System (PACS)

Panel:

Radiology

Product Code:

LLZ

Date Received:

TBD

Decision Date:

TBD

Decision:

TBD

APR 0 9 2013

{1}------------------------------------------------

Predicate Device:

Synapse 3D Cardiac Tools (K120636), FUJIFILM Medical Systems U.S.A., Inc. .
3mensio Structural Heart / Vascular (K120367), Pie Medical Imaging BV .

Description of the Device

Synapse 3D Cardiac Tools is the updated version of previously-cleared Synapse 3D Cardiac Tools software (cleared by CDRH via K120636 on 07/05/2012).

Unchanged Applications from the cleared version K103465

(1) Cardiac Function (CT)
Cardiac Function (CT) is an application for cardiac function evaluation which obtains the boundary between left ventricle and cardiac wall from CT left ventriculography images retrieved from multiple time phases and calculates ejection fraction, end-diastolic volume, end-systolic volume, stroke volume, etc.
(2) Cardiac Function (MR)
Cardiac Function (MR) is an application for cardiac function evaluation which obtains the boundary between left ventricle and cardiac wall from non-contrasted MR images retrieved from multiple time phases and calculates ejection fraction, end-diastolic volume, endsystolic volume, output volume per beat, etc.
(3) Coronary Artery Analysis (CT)
Coronary Artery Analysis (CT) is an application using CT coronary arteriography images to extract the path of the target blood vessels and to perform coronary artery evaluation.
(4) Calcium Scoring
The calcium scoring is an application which uses non-contrasted CT images to display the calcification area in the coronary artery with color separation and calculates the calcification quantitative values using the Agatston score method.
(5) Cardiac fusion
Cardiac fusion is an application to create an image having the mutual characteristics of source images of heart. Source images could be original image of CT, MR or NM and the functional image derived from the original image.

{2}------------------------------------------------

Unchanged Applications from the cleared version K120636

(1) Coronary Artery Analysis (MR)

Coronary Artery Analysis (MR) is an application using non-contrast MR heart images to extract the path of the target blood vessels and to perform coronary artery evaluation. The detail features available in this application are very similar to Coronary Artery Analysis (CT).

New Application in this submission

(1) Aortic Valve Analysis
Aortic Valve Analysis (CT) is an application using contrast-enhanced CT images for visualization of the heart, aorta regions, and contour of the aorta, measurement of the vicinity of the aortic valve, measurement of the calcification area in the aorta.

In addition to the common image processing functions (such as window width and window level, zooming, panning, flip, rotation, adding annotations on an image, measurement of lengths, areas, etc.), the following image processing tools are available to support the cardiac analysis of the CT and MR images. These tools belong to and are provided by Synapse 3D Base Tools (K120361) that is used with Synapse 3D Cardiac Tools (this submission).

. SUV evaluation: SUV average, standard deviation, etc. can be measured.
. Extraction and Deletion of 3D objects: Editing of mask areas using the smart cut feature.
. 3D clipping: The display area can be specified for 3D display.
Organ segmentation and removal: Organs and other areas of interest in the image data . can be segmented or removed.
Mask editing: The mask area can be edited by lines drawn in freehand, .
CPR: CPR images can be created along a specified center line. .
. Reformat Plane images in any direction can be created.
. Creation of video files: Video files with 2D or 3D display can be created.
Surface display: A polygon model of an image can be created. .

Indication for Use

This product is not intended for use with or for the primary diagnostic interpretation of Mammography images.

Addition to the tools in Synapse 3D Base Tools, Synapse 3D Cardiac Tools provides the tools for specific clinical applications which provide targeted workflows, custom Ul, targeted measurements and reporting functions including:

{3}------------------------------------------------

Functional cardiac analysis for CT left ventriculography images: which is intended to evaluate the functional characteristics of heart
Functional cardiac analysis for non-contrast MR heart images: which is intended to evaluate the functional characteristics of heart
Coronary artery analysis for CT coronary arteriography images: which is intended for the 水 qualitative and quantitative analysis of coronary arteries
Coronary artery analysis for MR heart images: which is intended for the qualitative and quantitative analysis of coronary arteries
A Calcium scoring for non-contrast CT heart images: which is intended for non-invasive identification and quantification of calcified atherosclerotic plaques in the coronary arteries using tomographic medical image data and clinically accepted calcium scoring algorithms
Cardiac Fusion: which is intended to analyze cardiac anatomy and pathology with a fused image of functional data (e.g. NM image, Bulls eye) and anatomical data.
Aortic Valve Analysis for contrast CT heart images: which is intended for visualization of the heart, aorta regions, and contour of the aorta, measurement of the aortic valve, measurement of the calcification area in the aorta.

Technological Characteristics

The proposed Synapse 3D Cardiac Tools and the predicate devices, Synapse 3D Cardiac Tools (K102636) and 3mensio Structural Heart / Vascular (K120367), are medical application software running on Windows operating system installed on commercial general-purpose Windowscompatible computers. These devices are connected to CT and MR with DICOM standard and retrieve image data via network communications. These devices provide 3D image visualization and manipulation tools for medical images with various user interfaces and measurement tools for analysis of rendered images. Both the Synapse 3D Cardiac Tools and the predicate devices support the workflows, UI, and reporting for cardiac analysis and aortic valve analysis.

Synapse 3D Cardiac Tools introduces no new safety or efficacy issues other than those already indentified with the predicate devices. The results of the Hazard Analysis combined with the appropriate preventive measures taken indicate that the device is of moderate concern as per the May 11, 2005 issue of the "Guidance for the Content of Premarket Submission for Software Contained in Medical Devices."

Testing

Synapse 3D Cardiac Tools is tested successfully with reference to its Software Requirements Specification, as well as design verification and validation documents and Traceability Matrix document. Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of the Synapse 3D Cardiac Tools software, which is found to be safe and effective and substantially equivalent to the currently-cleared predicate devices.

{4}------------------------------------------------

Testing involved system level functionality test, segmentation accuracy test, measurement accuracy test, interfacing test, usability test, serviceability test, labeling test, as well as the test for risk mitigation method analyzed and implemented in the risk management process. In addition, we conducted the bench performance testing using actual clinical images to help demonstrate that the proposed device achieved the expected accuracy performance.

Pass/Fail criteria were based on the requirements and intended use of the product. Test results showed that all tests successfully passed.

Conclusion

This 510(k) premarket notification submission has demonstrated Substantial Equivalence as defined and understood in the Federal Food Drug and Cosmetic Act and various guidance documents issued by the Center for Devices and Radiological Health. We conclude the subject device to be as safe and effective as the predicate devices.

{5}------------------------------------------------

Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling an eagle or bird in flight, composed of three curved lines.

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

April 9, 2013

JYH-SHYAN LIN SENIOR MANAGER, REGULATORY, QUALITY AND CLINICAL AFFAIRS FUJIFILM MEDICAL SYSTEMS USA, INC. 419 WEST AVENUE STAMFORD CT 06902

Re: K130383

Trade/Device Name: Synapse 3D Cardiac Tools Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: February 5, 2013 Received: February 14, 2013

Dear Mr. Lin:

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 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.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

{6}------------------------------------------------

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Sm. h. P.

for

Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

{7}------------------------------------------------

Indications for Use

510(k) Number (if known): K130383

Device Name: Synapse 3D Cardiac Tools

Indications for Use:

A Functional cardiac analysis for CT left ventriculography images: which is intended to evaluate the functional characteristics of heart
A Functional cardiac analysis for non-contrast MR heart images: which is intended to evaluate the functional characteristics of heart
A Coronary artery analysis for CT coronary arteriography images: which is intended for the qualitative and quantitative analysis of coronary arteries
A Coronary artery analysis for MR heart images: which is intended for the qualitative and quantitative analysis of coronary arteries
A Calcium scoring for non-contrast CT heart images: which is intended for non-invasive identification and quantification of calcified atherosclerotic plaques in the coronary arteries using tomographic medical image data and clinically accepted calcium scoring algorithms
A Cardiac Fusion: which is intended to analyze cardiac anatomy and pathology with a fused image of functional data (e.g. NM image, Bulls eye) and anatomical data
A Aortic Valve Analysis for contrast CT heart images: which is intended for visualization of the heart, aorta regions, and contour of the aorta, measurement of the vicinity of the aortic valve, measurement of the calcification area in the aorta.

Prescription Use X	AND/OR	Over-The-Counter Use
(Part 21 CFR 801 Subpart D)		(21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health

K130383 510(k)

Page 1 of 1

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).