(86 days)
No
The document describes image processing and analysis techniques (tensor analysis, tractography, segmentation, measurement) but does not mention AI, ML, or related terms like neural networks or deep learning. The performance studies focus on accuracy and functionality, not AI/ML specific metrics.
No.
The device is medical imaging software intended for viewing, processing, and analyzing medical images for diagnostic purposes and treatment planning, not for administering therapy or directly treating a condition.
Yes
The device is medical imaging software that accepts, displays, and processes medical images for viewing local water diffusion properties, directional dependence of diffusion in white matter, and has functions for reporting, screening, and treatment planning, supporting a diagnostic workflow.
Yes
The device is explicitly described as an "optional software module" and "medical application software running on a Standalone PC or Windows server/client configuration installed on a commercial general-purpose Windows-compatible computer." It processes existing medical images and does not include any hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: The description clearly states that Synapse 3D Tensor Analysis is medical imaging software that processes and displays medical images acquired from MR, CT, XA, PET, and NM. It works with existing medical images, not with specimens taken from the body.
- Intended Use: The intended use is for viewing, processing, and analyzing medical images to aid trained medical professionals in reading, interpreting, reporting, screening, and treatment planning. This is a function related to image analysis and visualization, not the analysis of biological specimens.
Therefore, Synapse 3D Tensor Analysis falls under the category of medical imaging software, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Synapse 3D Tensor Analysis is medical imaging software used with Synapse 3D Base Tools to accept, display, and process DICOM compliant 2D and 3D medical images acquired from MR for the purpose of viewing of local water diffusion properties and directional dependence of the diffusion in the white matter. It is intended to be used by trained medical professionals in reading, interpreting, reporting, screening and treatment planning.
Addition to the general 2D and 3D image processing and measurement tools available in Synapse 3D Tensor Analysis provides custom workflows, UI, and reporting functions for tensor analysis with neck and head MR images. It includes display of diffusion and FA color map images, white matter tractography, dynamic review in MR, vessel and body visualization with registration of MR, CT, XA, PET and NM.
Product codes
LLZ
Device Description
Synapse 3D Tensor Analysis is an optional software module that works with Synapse 3D Base Tools, cleared by CDRH via K120361 on 04/06/2012. Synapse 3D Tensor Analysis, Synapse 3D Base Tools and other optional software modules consist of the Synapse 3D product family.
Synapse 3D is medical application software running on a Standalone PC or Windows server/client configuration installed on a commercial general-purpose Windows-compatible computer. It offers provides custom workflows, UI, and reporting functions for trained medical professionals to aid them in reading, interpreting, reporting, screening and treatment planning.
Synapse 3D Tensor Analysis supports the display of diffusion and Fractional anisotropy (FA) colormap images, white matter tractography, dynamic review, vessel and body visualization with registration of MR, CT, XA, PET and NM. Tensor Analysis tool enables tensor analysis from diffusion-weighted MR images and tractography-based extraction and observation of local water diffusion properties and directional dependence of the diffusion in the white matter. Additional images (mainly CT images) can be loaded, and skin, bone, brain parenchyma, tumor, and cerebral vessels can be extracted in craniotomy simulations.
The main functions are shown below.
- Display FA and diffusion colormap images
- Extract and observe white matter ●
- Calculate FA value, number of fibers, area, and volume in the specified ROI
- Simultaneous display of white matter and skin, bone, brain parenchyma, tumor, artery, . vein, and other reqions
- Craniotomy simulations involving cutting of skin and bone regions, brain surface clipping by depth, and tumor plane clipping
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MR, CT, XA, PET, NM
Anatomical Site
neck and head
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained medical professionals in reading, interpreting, reporting, screening and treatment planning.
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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. In addition, a comparative performance testing was conducted between the Synapse 3D Tensor Analysis and the predicate device, and the comparison test result supported the substantial equivalence of the devices' performance characteristics.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Visia 10 Neuro (K113701), Synapse 3D Base Tools (K120361), Ready View (K113456)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of three human profiles facing right, stacked on top of each other. The profiles are stylized and appear to be connected, forming a single, unified shape.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 3. 2014
FUJIFILM Medical Systems U.S.A. Inc. % Jyh-Shyan Lin, Ph. D. Senior Manager, Regulatory, Quality and Clinical Affairs 419 West Avenue STAMFORD, CT 06902
Re: K141514
Trade/Device Name: Synapse 3D Tensor Analysis Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: August 20, 2014 Received: August 22, 2014
Dear Dr. 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. 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 (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.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
for
Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K141514
Device Name Synapse 3D Tensor Analysis
Indications for Use (Describe)
Synapse 3D Tensor Analysis is medical imaging software used with Synapse 3D Base Tools to accept, display, and process DICOM compliant 2D and 3D medical images acquired from MR for the purpose of viewing of local water diffusion properties and directional dependence of the diffusion in the white matter. It is intended to be used by trained medical professionals in reading, interpreting, reporting, screening and treatment planning.
Addition to the general 2D and 3D image processing and measurement tools available in Synapse 3D Tensor Analysis provides custom workflows, UI, and reporting functions for tensor analysis with neck and head MR images. It includes display of diffusion and FA color map images, white matter tractography, dynamic review in MR, vessel and body visualization with registration of MR, CT, XA, PET and NM.
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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FUJ}}FILM MEDICAL SYSTEMS U.S.A., Inc.
Synapse 3D Tensor Analysis
510(k) Summary
Date Prepared:
August 20, 2014
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 Tensor Analysis
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
4
FUJ}{FILM MEDICAL SYSTEMS U.S.A., Inc.
Synapse 3D Tensor Analysis
Description of the Device
Synapse 3D Tensor Analysis is an optional software module that works with Synapse 3D Base Tools, cleared by CDRH via K120361 on 04/06/2012. Synapse 3D Tensor Analysis, Synapse 3D Base Tools and other optional software modules consist of the Synapse 3D product family.
Synapse 3D is medical application software running on a Standalone PC or Windows server/client configuration installed on a commercial general-purpose Windows-compatible computer. It offers provides custom workflows, UI, and reporting functions for trained medical professionals to aid them in reading, interpreting, reporting, screening and treatment planning.
Synapse 3D Tensor Analysis supports the display of diffusion and Fractional anisotropy (FA) colormap images, white matter tractography, dynamic review, vessel and body visualization with registration of MR, CT, XA, PET and NM. Tensor Analysis tool enables tensor analysis from diffusion-weighted MR images and tractography-based extraction and observation of local water diffusion properties and directional dependence of the diffusion in the white matter. Additional images (mainly CT images) can be loaded, and skin, bone, brain parenchyma, tumor, and cerebral vessels can be extracted in craniotomy simulations.
The main functions are shown below.
- Display FA and diffusion colormap images
- Extract and observe white matter ●
- . Calculate FA value, number of fibers, area, and volume in the specified ROI
- Simultaneous display of white matter and skin, bone, brain parenchyma, tumor, artery, . vein, and other reqions
- Craniotomy simulations involving cutting of skin and bone regions, brain surface clipping by depth, and tumor plane clipping
Indication for Use
Synapse 3D Tensor Analysis is medical imaging software used with Synapse 3D Base Tools to accept, display, and process DICOM compliant 2D and 3D medical images acquired from MR for the purpose of viewing of local water diffusion properties and directional dependence of the diffusion in the white matter. It is intended to be used by trained medical professionals in reading, interpreting, reporting, screening and treatment planning.
Addition to the general 2D and 3D image processing and measurement tools available in Synapse 3D Base Tools, Synapse 3D Tensor Analysis provides custom workflows, UI, and reporting functions for tensor analysis with neck and head MR images. It includes display of diffusion and FA color map images, white matter tractography, dynamic review in MR, vessel and body visualization with registration of MR, CT, XA, PET and NM.
Predicate Devices:
- Visia 10 Neuro (K113701), MeVis Medical Solutions AG
- Synapse 3D Base Tools (K120361), FUJIFILM Medical Systems U.S.A., Inc. .
- Ready View (K113456), GE Healthcare
5
FUJIFILM MEDICAL SYSTEMS U.S.A., Inc.
Synapse 3D Tensor Analysis
Technological Characteristics
The proposed Synapse 3D Tensor Analysis and the predicate devices, i.e., Visia™ Neuro (K113701) and Synapse 3D Base Tools (K120361), are medical application software running on Windows operating system installed on commercial general-purpose Windows-compatible 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. The Synapse 3D Tensor Analysis and the predicate devices support the workflows, UI, and reporting functions for the Tensor Analysis and Craniotomy Simulations.
Safety Information
Synapse 3D Tensor 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 Tensor Analysis labeling contains instructions for use and necessary cautions, warnings and notes to provide the safe and effective use of the device.
Testing and Performance Information
Synapse 3D Tensor Analysis 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 Tensor Analysis software, which is found to be safe and effective and substantially equivalent to the predicate devices.
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. In addition, a comparative performance testing was conducted between the Synapse 3D Tensor Analysis and the predicate device, and the comparison test result supported the substantial equivalence of the devices' performance characteristics.
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.