Synapse 3D Blood Flow Analysis 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, and treatment planning. Addition to the tools in Synapse 3D Base Tools, Synapse 3D Blood Flow Analysis provides the imaging and assessment tools of blood flow velocity and directions based on multi-slice, multi-phase and velocity encoded MR images.

Device Description

Synapse 3D Blood Flow Analysis is a software application that is used to work with Synapse 3D Base Tools (cleared by via K120361 on 04/06/2012). Synapse 3D Base Tools (K120361) is connected through DICOM standard to medical devices such as CT, MR, CR, US, NM, PT, XA, etc. and to a PACS system storing data generated by these medical devices, and retrieves image data via network communication based on the DICOM standard. The retrieved image data are stored on the local disk managed by Synapse 3D Base Tools (K120361), and the associated image-related information of the image data is registered in the database and used for display, image processing, analysis, etc.

Synapse 3D Blood Flow Analysis developed to calculate the blood flow volume and velocity for an arranged ROI. The software can display the images on a display monitor, or printed them on a hardcopy using a DICOM printer or a Windows printer. The main functions of Synapse 3D Blood Flow Analysis are shown below.

Display vessel images.
Display the parameters such as flow velocity and volume calculated from the selected ROI.
Display the time-intensity curve and the analysis result of the flow volume analysis and the flow velocity analysis.
Display blood flow by flow velocity vector, streamlines and pathlines.
Print or save reports.

Synapse 3D Blood Flow Analysis runs on Windows standalone and server/client configuration installed on a commercial general-purpose Windows-compatible computer. It offers software tools which can be used by trained professionals, such as radiologists, clinicians or general practitioners to interpret medical images obtained from various medical devices to create reports or develop treatment plans.

AI/ML Overview

The provided document is a 510(k) summary for the Synapse 3D Blood Flow Analysis software. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving performance against specific acceptance criteria for a new clinical claim. Therefore, much of the requested information regarding acceptance criteria, study design, ground truth, and expert involvement is not present in this document.

Here's a breakdown of what can be extracted based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table of quantitative acceptance criteria for clinical performance (e.g., accuracy, sensitivity, specificity for specific diagnostic tasks) or directly report performance against such criteria. The "Testing and Performance Information" section describes the software development process and verification/validation activities, stating:

"benchmark performance testing was conducted using actual clinical images to help demonstrate that the semi-automatic or automatic segmentation, detection functions implemented in Synapse 3D Blood Flow Analysis 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 passed successfully according to the design specifications."

However, the specific "expected accuracy performance," the actual "test results," or the "Pass/Fail criteria" are not quantified or presented. The document focuses on functional and technical equivalence.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not specified. The document mentions "actual clinical images" were used for benchmark performance testing but does not provide the number of cases or subjects.
Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). It only states "actual clinical images."

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

This information is not provided in the document. The document describes the software's tools to "aid them [trained medical professionals] in reading, interpreting, and treatment planning," but it does not detail how ground truth was established for performance testing.

4. Adjudication Method for the Test Set

This information is not provided in the document.

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 was not explicitly mentioned or described. The document states: "The subject of this 510(k) notification, Synapse 3D Blood Flow Analysis does not require clinical studies to support safety and effectiveness of the software." This indicates that the regulatory pathway did not necessitate a clinical efficacy study comparing human performance with and without the AI.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

The document implies that "benchmark performance testing" was conducted for "semi-automatic or automatic segmentation, detection functions," suggesting an assessment of the algorithm's performance on its own. However, the exact methodology and metrics of this "standalone" assessment are not detailed. It's generally assumed that software like this would have undergone internal standalone validation.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

This information is not provided. While "actual clinical images" were used, the method for establishing the "ground truth" or reference standard for those images (e.g., expert consensus, comparison to another gold standard) is not described.

8. The Sample Size for the Training Set

This information is not provided. The document focuses on verification and validation testing, not the training of a machine learning model, even though the device includes "semi-automatic or automatic segmentation, detection functions."

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

This information is not provided, as the document does not discuss the training set or its ground truth.

Summary of what is present and what is missing:

The 510(k) summary primarily focuses on:

Describing the device's functions and intended use.
Demonstrating technical and functional equivalence to a predicate device (CAAS MR 4D Flow).
Outlining the software development process, risk management, and cybersecurity measures.
Stating that verification and validation activities were performed and passed "according to the design specifications" but without providing quantitative results or detailed study methodologies.

The document does not contain the detailed clinical study information (acceptance criteria, specific performance metrics, sample sizes for training/test sets, ground truth methodology, expert qualifications, or MRMC study results) that would be expected for a device making new clinical claims requiring such evidence. The statement "does not require clinical studies to support safety and effectiveness of the software" reinforces that the 510(k) pathway for this device relied on substantial equivalence rather than a new clinical performance study.

Summary

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October 18, 2019

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FUJIFILM Corporation % Mr. Jeffrey Wan Senior Regulatory Affairs Specialist FUJIFILM Medical Systems U.S.A., Inc. 81 Hartwell Avenue, Suite 300 LEXINGTON MA 02421

Re: K191544

Trade/Device Name: Synapse 3D Blood Flow Analysis Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: September 9, 2019 Received: September 10, 2019

Dear Mr. Wan:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting

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combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K191544

Device Name Synapse 3D Blood Flow Analysis

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

Date Prepared:	June 10, 2019
Submitter's Information:	FUJIFILM Corporation26-30, NISHIAZABU 2-CHOME MINATO-KUTOKYO 106-8620Telephone: 201-675-8947Contact: Jeffrey Wan
Device Trade Name:	Synapse 3D Blood Flow Analysis
Device Common Names:	Picture Archiving and Communications System (PACS)
Device Clasification Name:	System, Image Processing, Radiological
Product Code:	LLZ
Regulation Number:	21 CFR 892.2050
Device Class:	Class II
Panel:	Radiology
Predicate Devices:	CAAS MR 4D Flow (K162376)Pie Medical Imaging B.V.

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1. Description of the Device

Display vessel images.
Display the parameters such as flow velocity and volume calculated from the selected ROI.
· Display the time-intensity curve and the analysis result of the flow volume analysis and the flow velocity analysis.
Display blood flow by flow velocity vector, streamlines and pathlines.
· Print or save reports.

2. Indications for Use

Addition to the tools in Synapse 3D Base Tools, Synapse 3D Blood Flow Analysis provides the imaging and assessment tools of blood flow velocity and directions based on multi-slice, multi-phase and velocity encoded MR images.

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3. Substantial Equivalence Comparison

Synapse 3D Blood Flow Analysis has the same intended use, similar labeling, and clinical application tools as those of the cleared predicate device CAAS MR 4D Flow (K162376). The device features and technical characteristics comparison with predicates is shown as Table 1 Device Features and Technical Characteristics Comparison Matrix.

Table 1 Device Features and Technical Characteristics Comparison Matrix

Device Parameters	Synapse 3D Blood FlowAnalysis(This submission)	CAAS MR 4D Flow(K162376)(Predicate device)
Images supported(DICOM 3.0; Enhanced DICOM;Cardiovascular images: multi-slice,multi-phase and velocity encoded MRimages)	Yes	Yes
2D Viewing	Yes	Yes
Image Communication (DICOM SCU)	Yes	Yes
DICOM Interface (SCP/SCU)	Yes	Yes
Printing (DICOM SCU)	Yes	Yes
Measurements (2D and 3D)	Yes	Yes
Annotations - Standardized and Free Text	Yes	Yes
Reporting	Yes	Yes
Volume Rendering and 3D Viewing	Yes	Yes
MPR-orthogonal / oblique / curvedMulti-Planar Reconstructions (MPR),-Sector and rectangular shape MPRimage viewing-Multiple MPR images along an object(Slicer)	Yes	Yes
Image display and manipulation-Pan/Zoom;-Magnify;-Maximize and minimize, scroll throughslice stack;-Adjust window level, contrast,brightness;-Single image ROI placement;-Automated 2D ROI;-Propagate/copy/edit functions;-2D velocity color map	Yes	Yes

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Automatic Vessel segmentation	Yes	Yes
Blood flow visualization-Streamlines-Vector fields	Yes	Yes
Blood flow visualization-Pathlines	Yes	Yes
Blood flow parameters-Blood velocity-Regurgitation fraction-Blood flow volume	Yes	Yes
Storage of results-Text files (CSV)-DICOM report-PDF report-Image snapshot bitmaps-Animation for streamlines and vectorfields-Snapshot for reanalysis	Yes	Yes
Storage of results-Animation for pathlines	Yes	Yes
Hardware Platform	Windows PC	Windows PC

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4. Safety Information

Synapse 3D Blood Flow Analysis introduces no new safety or efficacy issues other than those already indentified with the predicate devices. The Risk Management and 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." The Synapse 3D Blood Flow Analysis labeling contains instructions for use and necessary cautions, warnings and notes to provide the safe and effective use of the device.

5. Testing and Performance Information

Nonclinical testing result:

The purpose of Software Development Process for Synapse 3D Blood Flow Analysis is to carry out the activities relating to the establishment of the software development plan (or plans) for definitely conducting software hazard analysis, risk management, requirement analysis, architectural design, the design specification, unit implementation and verification, software integration and integration testing, software system test, software release, software maintenance. The main activities in software development process are described as follows.

Software development plan .
Software hazard analysis and risk management ●
Software requirements analysis/specification ●
Software architectural design ●
Software detailed design specification ●
Software unit module implementation and verification
. Software integration and system testing

Clinical tests:

The subject of this 510(k) notification, Synapse 3D Blood Flow Analysis does not require clinical studies to support safety and effectiveness of the software.

Verification and Validation:

Testing for verification and validation involved system level functionality test, component testing, verification testing, integration testing, usability testing, installation/upgrade testing, as well as the testing for risk mitigations associated with the risk management process. In addition, benchmark performance testing was conducted using actual clinical images to help demonstrate that the semi-automatic or automatic segmentation, detection functions implemented in Synapse 3D Blood Flow Analysis 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 passed successfully according to the design specifications. All of the different components of the Synapse 3D Blood Flow Analysis software have been stress tested to ensure that the system as a

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whole provides all the capabilities necessary to operate according to its intended use and in a manner substantially equivalent to the predicate devices.

Cybersecurity:

The confidentiality, integrity and availability are maintained by Synapse 3D Blood Flow Analysis in accordance with Section 6 of the Content of Premarket Submissions for Management of Cybersecurity in Medical Devices; Guidance for Industry and Food and Drug Administration Staff (October 2, 2014).

Synapse 3D Blood Flow Analysis is connected through DICOM standard to medical devices and to a PACS system storing data generated by these medical devices, and it retrieves image data via network communication based on the DICOM standard. Therefore Synapse 3D Blood Flow Analysis assures an adequate degree of protection for cybersecurity.

Performance standards:

· Digital Imaging and Communications in Medicine (DICOM) Set (PS 3.1 3.20) (2016).
· AAMI / ANSI / IEC 62304:2006, Medical Device Software Software Life Cycle Processes.
· ISO 14971 Second Edition 2007-03-01, Medical Devices Application of Risk Management to Medical Devices.

6. Conclusion

Performance tests were conducted to test the functionality of the subject device, Synapse 3D Blood Flow Analysis. Results of all conducted testing were acceptable in supporting the claim of substantial equivalence.

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).