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

This product is not intended for use with or for the primary diagnostic interpretation of Mammography images. Synapse 3D Base Tools provides several levels of tools to the user:

Basic imaging tools for general images, including 2D viewing, volume rendering and 3D volume viewing, orthogonal / oblique / curved Multi-Planar Reconstructions (MPR), Average (RaySum) and Minimum (MinIP) Intensity Projection. 4D volume viewing, image subtraction, surface rendering, sector and rectangular shape MPR image viewing, MPR for dental images, creating and displaying multiple MPR images along an object, time-density distribution, basic image processing, CINE, measurements, annotations, reporting, storing, distribution, and general image management and administration tools, etc.

-Tools for regional segmentation of anatomical structures within the image data, path definition through vascular and other tubular structures, and boundary detection.

-Image viewing tools for modality specific images, including CT PET fusion and ADC image viewing for MR studies. -Imaging tools for CT images including virtual endoscopic viewing.

-Imaging tools for MR images including delayed enhancement image viewing, diffusion-weighted MRI data analysis.

Device Description

The 3D image analysis software Synapse 3D Base Tools (V6.1) is medical application software running on Windows server/client configuration installed on commercial general-purpose Windows-compatible computers. It offers software tools which can be used by trained professionals to interpret medical images obtained from various medical devices, to create reports, or to develop treatment plans.

Synapse 3D Base Tools 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 it retrieves image data via network communications based on the DICOM standard. The retrieved image data are stored on the local disk managed by Synapse 3D Base Tools (V6.1), and the associated image-related information of the image data is registered in its database and is used for display, image processing, analysis, etc. Images newly created by Synapse 3D Base Tools (V6.1) not only can be displayed on a display, but also can be printed on a hardcopy using a DICOM printer or a Windows printer.

Synapse 3D Base Tools (V6.1) is a basic software module that works with other cleared clinical applications, including Synapse 3D Cardiac Tools (K200973), Synapse 3D Perfusion Analysis (K162287), Synapse 3D Lung and Abdomen Analysis (K130542), Synapse 3D Liver and Kidney Analysis (K142521), Synapse 3D Nodule Analysis (K120679), Synapse 3D Colon Analysis (K123566), Synapse 3D Tensor Analysis (K141514) and Synapse 3D Blood Flow Analysis (K191544). All these software modules consist of the Synapse 3D product family.

Synapse 3D Base Tools can be integrated with Fujifilm's Synapse PACS, and can be used as a part of a Synapse system. Synapse 3D Base Tools also can be integrated with Fujifilm's Synapse Cardiovascular for cardiology purposes.

AI/ML Overview

The provided text describes Synapse 3D Base Tools v6.1, a medical imaging software. However, it does not include specific acceptance criteria or a detailed study proving the device meets particular performance metrics. Instead, the document focuses on regulatory compliance, substantial equivalence to a predicate device, and general software development and testing procedures.

Here's an analysis of what can be extracted and what information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

No specific acceptance criteria or quantitative performance metrics are provided in the document. The text generally states that "Test results showed that all tests passed successfully according to the design specifications," but it does not detail what those design specifications or acceptance criteria were.

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

Sample Size for Test Set: Not specified. The document mentions "benchmark performance testing was conducted using actual clinical images," but the number of images or cases used is not provided.
Data Provenance: Not specified. It only mentions "actual clinical images" without details on country of origin, whether the data was retrospective or prospective, or other demographic information.

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

Not specified. The document does not describe the establishment of a ground truth for a test set, nor does it mention the involvement or qualifications of experts for this purpose.

4. Adjudication Method for the Test Set

Not applicable/Not specified. Since the document doesn't detail a test set with ground truth established by experts, an adjudication method is not mentioned.

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

No MRMC comparative effectiveness study is mentioned. The submission focuses on device functionality and equivalence, not human reader performance with or without AI assistance.

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

The document states that "benchmark performance testing was conducted using actual clinical images to help demonstrate that the semi-automatic or automatic segmentation, detection, and registration functions implemented in Synapse 3D Base Tools achieved the expected accuracy performance." This implies some form of standalone evaluation of the algorithm's performance for these specific functions. However, no quantitative results or specific metrics for this standalone performance are provided.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

Not specified. While "benchmark performance testing" is mentioned for segmentation, detection, and registration, the method for establishing the "ground truth" against which these algorithms were benchmarked is not detailed.

8. The Sample Size for the Training Set

Not specified. The document mentions that some segmentation applications use a "Fully Convolutional Network" (a deep learning method), which implies a training set. However, the size of this training set is not provided.

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

Not specified. For the deep learning segmentation features, the method of establishing ground truth for the training data is not described.

Summary of what is present in the document:

Synapse 3D Base Tools v6.1 is an updated version of previously cleared software.
It provides various image viewing, processing, and analysis tools for trained medical professionals.
It accepts DICOM images from multiple modalities (CT, MR, CR, US, NM, PT, XA).
It is not for primary diagnostic interpretation of mammography images.
Some segmentation features are implemented using deep learning (Fully Convolutional Network).
Nonclinical testing included standard software development processes (hazard analysis, risk management, requirements analysis, design, integration testing, system testing, etc.).
"Benchmark performance testing was conducted using actual clinical images to help demonstrate that the semi-automatic or automatic segmentation, detection, and registration functions implemented in Synapse 3D Base Tools achieved the expected accuracy performance."
All tests passed according to design specifications.
Cybersecurity measures are in place.

Summary of what is missing/not specified in the document regarding acceptance criteria and performance study details:

Quantitative acceptance criteria for any specific function.
Detailed quantitative performance results (e.g., accuracy, precision, recall, Dice score for segmentation).
Specific sample sizes for test sets or training sets.
Details on data provenance (e.g., demographics, disease prevalence, acquisition parameters).
Information on expert involvement in ground truth establishment (number or qualifications).
Details on ground truth methodology (e.g., expert consensus, pathology reports).
Results from any MRMC comparative effectiveness studies.
Specific metrics or results for standalone algorithm performance.

The document appears to be a 510(k) summary focused on demonstrating substantial equivalence primarily through technical comparison and general software validation, rather than a detailed performance study with explicit acceptance criteria and corresponding results for specific AI/ML components.

Summary

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February 9, 2021

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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: K203103

Trade/Device Name: Synapse 3D, Synapse 3D Base Tools v6.1 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: December 14, 2020 Received: December 16, 2020

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); medical device reporting of medical device-related adverse events) (21 CFR 803) for

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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-reportingcombination-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 mediation-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)

K203103

Device Name Synapse 3D, Synapse 3D Base Tools v6.1

Indications for Use (Describe)

This product is not intended for use with or for the primary diagnostic interpretation of Mammography images. Synapse 3D Base Tools provides several levels of tools to the user:

-Tools for regional segmentation of anatomical structures within the image data, path definition through vascular and other tubular structures, and boundary detection.

-Image viewing tools for modality specific images, including CT PET fusion and ADC image viewing for MR studies. -Imaging tools for CT images including virtual endoscopic viewing.

-Imaging tools for MR images including delayed enhancement image viewing, diffusion-weighted MRI data analysis.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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Section 5 510(K) Summary

This Section contains:

510(k) Summary (per 21 CFR 807.92)

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510(k) Summary

K203103

Date Prepared:	Aug. 15, 2020
Submitter's Information:	FUJIFILM Corporation26-30,NISHIAZABU 2-CHOME MINATO-KUTOKYO 106-8620Telephone: (781) 323-5315Contact: Tommy San
Device Trade Name:	Synapse 3D, Synapse 3D Base Tools v6.1
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:	Synapse 3D Base Tools (K120361)FUJIFILM Medical Systems U.S.A., Inc.

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1. Description of the Device

Synapse 3D Base Tools (V6.1) (this submission) is updated software of previously-cleared Synapse 3D Base Tools (V3.0) (cleared by CDRH via K120361 on 04/06/2012).

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2. Indications for Use

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

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

Synapse 3D Base Tools provides several levels of tools to the user:

Basic imaging tools for general images, including 2D viewing, volume rendering and 3D volume viewing, orthogonal / oblique / curved Multi-Planar Reconstructions (MPR), Maximum (MIP), Average (RaySum) and Minimum (MinIP) Intensity Projection, 4D volume viewing, image fusion, image subtraction, surface rendering, sector and rectangular shape MPR image viewing, MPR for dental images, creating and displaying multiple MPR images along an object, time-density distribution, basic image processing, CINE, measurements, annotations, reporting, printing, storing, distribution, and general image management and administration tools, etc.

Tools for regional segmentation of anatomical structures within the image data, path definition through vascular and other tubular structures, and boundary detection.
Image viewing tools for modality specific images, including CT PET fusion and ADC image viewing for MR studies.
Imaging tools for CT images including virtual endoscopic viewing.
Imaging tools for MR images including delayed enhancement image viewing, diffusion-weighted MRI data analysis.

3. Substantial Equivalence Comparison

Synapse 3D Base Tools has the same intended use, similar labeling, and clinical application tools as those of the cleared predicate device Synapse 3D Base Tools (K120361). The device features and technical characteristics comparison with predicates is shown as Table 1 Device Features and Technical Characteristics Comparison Matrix.

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Device Parameters	Synapse 3D Base Tools(V6.1)(This submission)	Synapse 3D BaseTools(V3.0)(K120361)(Primary predicatedevice)
Basic features and basic imaging tools
2D Viewing	Yes	Yes
Image Storing (DICOMSCP)	Yes	Yes
Image Communication(DICOM SCU)	Yes	Yes
DICOM Interface(SCP/SCU)	Yes	Yes
Printing (DICOM SCU)	Yes	Yes
Measurements (2D and3D)	Yes	Yes
Annotations -Standardized and FreeText	Yes	Yes
Reporting	Yes	Yes
Cine	Yes	Yes
Volume Rendering and3D Viewing	Yes	Yes
MPR• orthogonal / oblique /curved Multi-PlanarReconstructions (MPR),• Sector and rectangularshape MPR imageviewing• MPR for dental images• Multiple MPR imagesalong an object (Slicer)	Yes	Yes
Maximum, Average,Minimum Intensity	Yes	Yes
Device Parameters	Synapse 3D Base Tools (V6.1) (This submission)	Synapse 3D Base Tools(V3.0) (K120361) (Primary predicate device)
Projection
4D viewing	Yes	Yes
Image fusion	Yes	Yes
Surface rendering	Yes	Yes
Image subtraction (3D)	Yes	Yes
Time-density distribution	Yes	Yes
General image data management and administration tools	Yes	Yes
In-depth analysis tools
Segmentation	Yes (Some segmentation applications are implemented using a deep learning method called as “Fully Convolutional Network”)	Yes
Path definition	Yes	Yes
Boundary detection	Yes	Yes
Modality specific imaging tools
CT PET fusion	Yes	Yes
ADC image viewing (MRI)	Yes	Yes
Virtual Endoscopic Simulator	Yes	N/A
Diffusion-weighted MRI Data Analysis	Yes	N/A
Delayed Enhancement Image Viewing	Yes	N/A
Product characteristics
Device Parameters	Synapse 3D Base Tools(V6.1)(This submission)	Synapse 3D BaseTools(V3.0)(K120361)(Primary predicatedevice)
Product Availability	Software Product	Software Product
Hardware Platform	Windows PC	Windows PC

Table 1 Device Features and Technical Characteristics Comparison Matrix

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The main differences as in-depth analysis tools are shown as follows.

1. The new segmentation features implemented using an algorithm "graph cuts" same as the algorithm used in our previously cleared Synapse 3D Basic Tools (K120361).
1. The old segmentation features that had existed in our previously cleared Synapse 3D Basic Tools (K120361) are implemented using a new algorithm called as "Fully Convolutional Network" - a new deep learning-based algorithm.
1. The new segmentation features are implemented using a new algorithm called as "Fully Convolutional Network" - a new deep learning-based algorithm.

The main differences presented as new features of modality specific imaging tools are shown as follows.

1. Virtual Endoscopic Simulator (CT).
1. Diffusion-weighted MRI Data Analysis (MRI).
1. Delayed Enhancement Image Viewing (MRI).

4. Safety Information

Synapse 3D Base Tools 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 Base Tools 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 Bae Tools 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.

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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 Base Tools 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, labeling 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, and registration functions implemented in Synapse 3D Base Tools 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 Base Tools software have been stress tested to ensure that the system as a 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 Base Tools 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 Base Tools 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 Base Tools 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 62304:2015, Medical Device Software Software Life Cycle Processes.
• ISO 14971 Second Edition 2007-03-01, Medical Devices Application of Risk Management to Medical Devices.

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6. Conclusion

Performance tests were conducted to test the functionality of the subject device, Synapse 3D Base Tools. 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).