Synapse 3D Brain Perfusion 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 Brain Perfusion accepts DICOM compliant medical images acquired from CT and MR.

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

Addition to Synapse 3D Base Tools, Synapse 3D Brain Perfusion provides the parameter images by post-processing with dynamic scanned CT cerebral arteriography images and magnetic resonance images (MR) with contrast agent to aid the assessment of cerebral blood flow. The parameter images are Cerebral Blood Volume (CBV), Cerebral Blood Flow (CBF), Mean Transit Time (MTT), and Time To Peak (TTP).

Device Description

Synapse 3D Brain Perfusion (V3.0) is the updated version of previously-cleared Synapse 3D Cerebral Analysis software (cleared by CDRH via K103687 on 03/04/2011).

Synapse 3D Brain Perfusion is used in addition to Synapse 3D Base Tools (K120361, cleared on April 6, 2012) to analyze the images acquired from CT and MR. Synapse 3D Brain Perfusion is intended to provide trained medical professionals with tools to aid them in reading, interpreting, reporting, and treatment planning of DICOM compliant medical images. This product is not intended for use with or for the primary diagnostic interpretation of mammography images.

Synapse 3D Cerebral Analysis (V3.0) is an application that analyzes the changes of the cerebral blood flow on the dynamic scanned CT cerebral arteriography and the MR images.

Brain Perfusion (CT): Unchanged from the cleared version K103687 . Brain Perfusion is an application analyzing the changes of the cerebral blood flow on the dynamic scanned CT cerebral arteriography images. CBV (Cerebral Blood Volume), CBF (Cerebral Blood Flow), MTT (Mean Transit Time), and TTP (Time To Peak) are calculated and mapped on images.
· Brain Perfusion (MR):

Brain Perfusion is an application analyzing the changes of the cerebral blood flow on the magnetic resonance images (MR) with contrast agent. CBV (Cerebral Blood Volume), CBF (Cerebral Blood Flow), MTT (Mean Transit Time), and TTP (Time To Peak) are calculated and mapped on images.

Common image processing functions (such as window width and window level, zooming, panning, flip, rotate, adding annotations on an image, measurement of lengths, areas, etc.),are available to support the cerebral analysis of the CT and MR images. These functions belong to and are provided by Synapse 3D Base Tools (K120361) that is used with Synapse 3D Brain Perfusion (V3.0) (this submission).

The Brain Perfusion (CT) application is unchanged from the cleared version (K103465) and the Brain Perfusion (MR) is the added application.

Synapse 3D Brain Perfusion with Synapse 3D Basic/Base Tools can be integrated with our cleared Fujifilm's Synapse Workstation, version 3.2.1 and above, and can be used as a part of a Synapse system. Synapse 3D Brain Perfusion also can be integrated with Fujifilm's Synapse Cardiovascular for cardiology purposes.

AI/ML Overview

The provided text does not contain detailed information about specific acceptance criteria or the study that definitively proves the device meets those criteria in a quantitative, performance-based manner (e.g., sensitivity, specificity, accuracy).

Instead, the submission focuses on substantial equivalence to predicate devices. The "Testing" section mentions the device was "tested successfully with reference to its Software Requirements Specification, as well as design verification and validation documents and Traceability Matrix document." It concludes that "Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of the Synapse 3D Brain Perfusion software, which is found to be safe and effective and substantially equivalent to the currently-cleared predicate device."

This implies that the acceptance criteria are likely related to:

Functional correctness: The software performs the calculations (CBV, CBF, MTT, TTP) as designed and produces parameter maps.
Reliability: The software consistently produces these results.
Performance: The output is comparable to, or within acceptable limits of, the predicate devices.
Compatibility: It integrates correctly with Synapse 3D Base Tools and other Fujifilm systems.
Safety: No new safety or efficacy issues compared to predicates.

However, the specific quantitative metrics for these criteria (e.g., "CBV values must be within X% of a reference standard") are not provided in this document.

Therefore, many of the requested details about the study that proves the device meets acceptance criteria cannot be extracted directly from this 510(k) summary.

Here's a breakdown of what can be inferred or explicitly stated based on the provided text, with "N/A" where information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category (Inferred)	Reported Device Performance
Functional Correctness	- Calculates and maps CBV, CBF, MTT, and TTP from dynamic scanned CT cerebral arteriography images (unchanged from predicate K103465).- Calculates and maps CBV, CBF, MTT, and TTP from MR images with contrast agent (new addition).- Common image processing functions (window/level, zoom, pan, etc.) are available via Synapse 3D Base Tools.
Reliability	- "Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics..."
Compatibility/Integration	- Works with Synapse 3D Base Tools (K120361).- Integrates with Fujifilm's Synapse Workstation, version 3.2.1 and above.- Can integrate with Fujifilm's Synapse Cardiovascular.
Safety and Efficacy (Substantial Equivalence)	- "Introduces no new safety or efficacy issues other than those already identified with the predicate devices."- "Found to be safe and effective and substantially equivalent to the currently-cleared predicate device."
Software Requirements Conformance	- "Tested successfully with reference to its Software Requirements Specification, as well as design verification and validation documents and Traceability Matrix document."
Quantitative Performance Metrics (e.g., accuracy of CBF, CBV)	N/A (Specific quantitative metrics for acceptance and results are not detailed in this document. The focus is on demonstrating substantial equivalence to predicates for these types of calculations, which implies similar performance.)

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Sample Size: N/A (Not specified in the document).
Data Provenance: N/A (Not specified in the document if clinical data was used for testing beyond internal software validation. It mentions "dynamic scanned CT cerebral arteriography images" and "MR images with contrast agent" but not their source or specifics).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Number of Experts: N/A (Not specified. The document primarily describes software testing and comparison to predicate functionality, not a clinical study involving experts for ground truth establishment).
Qualifications of Experts: N/A (Not specified).

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Adjudication Method: N/A (Not applicable, as no external expert review or adjudication process for establishing ground truth on a test set is mentioned).

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

MRMC Study: No, an MRMC comparative effectiveness study is not mentioned. This submission is for a medical image processing and analysis software that provides diagnostic aids, not an AI-assisted diagnostic tool in the sense of directly improving human reader performance quantified by an effect size. The device calculates parameters (CBV, CBF, MTT, TTP); it doesn't offer AI assistance in interpretation.
Effect Size: N/A (Not applicable, as no such study was performed or reported).

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

Standalone Performance: Yes, in essence, the "performance, functionality, and reliability characteristics" of the software itself (Synapse 3D Brain Perfusion) were established through "design verification and validation documents and Traceability Matrix document." The results of its calculations (CBV, CBF, MTT, TTP) are its standalone performance. The document states it was "tested successfully with reference to its Software Requirements Specification," indicating that the algorithm's output was verified against its design. However, specific metrics (like accuracy against a gold standard) for these calculations are not provided in this summary.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Type of Ground Truth: The document implies that the ground truth for validating the software's calculations would be based on engineering specifications and established algorithms for calculating cerebral perfusion parameters. For the new MR functionality, it would likely have been validated against:
- Mathematical/Computational correctness: Ensuring the algorithms correctly implement the physical models for perfusion.
- Comparison to existing methods/software: For the new MR capabilities, it would likely have been compared against outputs from similar, already validated algorithms or systems (potentially the predicate IB Neuro v1.0, though the text states IB Neuro is a predicate generally, not specifically for MR perfusion calculations).
- No mention of expert consensus, pathology, or outcomes data as direct ground truth for algorithm validation.

8. The sample size for the training set

Sample Size for Training Set: N/A (Not applicable, as this is not an AI/machine learning device that requires a "training set" in the typical sense. It's an algorithm-based image processing software. The development of the algorithms would be based on scientific and medical principles, not machine learning training data.)

9. How the ground truth for the training set was established

Ground Truth for Training Set: N/A (Not applicable for the same reasons as #8. The algorithms are based on established biophysical models for cerebral perfusion, not learned from a training set with established ground truth labels.)

Summary

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FUJIFILM Medical Systems U.S.A., Inc. Synapse 3D Brain Perfusion (V3.0) 510(k) 12120637

MAY - 8 2012

5. 510(k) Summary

Date Prepared:

February 28, 2012

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 Brain Perfusion

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

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FUJIFILM Medical Systems U.S.A., Inc. Synapse 3D Brain Perfusion (V3.0) 510(k)

Predicate Device:

. Synapse 3D Cerebral Analysis. FUJIFILM Medical Systems U.S.A., Inc. (K103687)
IB Neuro v1.0. Imaging Biometrics, LLC (K080762) �

Description of the Device.

Synapse 3D Brain Perfusion (V3.0) is the updated version of previously-cleared Synapse 3D Cerebral Analysis software (cleared by CDRH via K103687 on 03/04/2011).

Synapse 3D Cerebral Analysis (V3.0) is an application that analyzes the changes of the cerebral blood flow on the dynamic scanned CT cerebral arteriography and the MR images.

Brain Perfusion (CT): Unchanged from the cleared version K103687 . Brain Perfusion is an application analyzing the changes of the cerebral blood flow on the dynamic scanned CT cerebral arteriography images. CBV (Cerebral Blood Volume), CBF (Cerebral Blood Flow), MTT (Mean Transit Time), and TTP (Time To Peak) are calculated and mapped on images.
· Brain Perfusion (MR):

The Brain Perfusion (CT) application is unchanged from the cleared version (K103465) and the Brain Perfusion (MR) is the added application.

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FUJIFILM Medical Systems U.S.A., Inc. Synapse 3D Brain Perfusion (V3.0) 510(k)

Indication for Use

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

Technological Characteristics

Synapse 3D Brain Perfusion 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 Brain Perfusion 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 Brain Perfusion software, which is found to be safe and effective and substantially equivalent to the currently-cleared predicate device.

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.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the emblem.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

Mr. Jyh-Shyan Lin Senior Manager, Regulatory, Ouality and Clinical Affairs FUJIFILM Medical Systems, Inc. 419 West Avenue STAMFORD CT 06902

MAY - 8 2012

Re: K120637

Trade/Device Name: Synapse 3D Brain Perfusion Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: February 28, 2012 Received: March 1, 2012

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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of

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Page 2

medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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

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/cdrh/industry/support/index.html.

Sincerely Yours,

Janine M. Morris

Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

Device Name: Synapse 3D Brain Perfusion

Indications for Use:

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

Prescription Use × 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 Diagnostic Devices (OIVD)

Division of Radiological Device Office of in V

510K

Page 1 of

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).