(42 days)
No
The document describes standard medical imaging processing and visualization tools, with no mention of AI or ML algorithms.
No
The device is medical imaging software intended for reading, interpreting, reporting, and treatment planning, but it does not directly provide therapy.
Yes
The software provides tools to aid medical imaging professionals in reading, interpreting, reporting, and treatment planning, which are all aspects of the diagnostic process. While it states it's not for primary diagnostic interpretation of mammography images, it clearly supports diagnostic interpretation for other modalities.
Yes
The device is described as "Synapse 3D Basic Tools Software" and its description focuses entirely on software functionalities, how it runs on general-purpose computers, and how it interacts with other medical devices and PACS systems via software protocols (DICOM). There is no mention of proprietary hardware components included with the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Synapse 3D Basic Tools Software is medical imaging software that processes and displays medical images acquired from various imaging modalities (CT, MR, etc.). It aids in the interpretation and analysis of these images, which are generated in vivo (within the living body).
- Lack of Biological Sample Analysis: The software does not interact with or analyze biological samples. Its input is image data, not biological specimens.
Therefore, the Synapse 3D Basic Tools Software falls under the category of medical imaging software, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Synapse 3D Basic Tools is medical imaging software that is intended to provide trained medical imaging professionals, including Physicians and Radiologists, with tools to aid them in reading, interpreting, reporting, and treatment planning. The Synapse 3D Basic 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.
The Synapse 3D Basic Tools Software provides several levels of tools to the user:
- Basic imaging tools for general images, such as 2D viewing, volume rendering and 3D volume A viewing, orthogonal / oblique / curved Multi-Planar Reconstructions (MPR), Maximum (MIP), Average (RaySum) and Minimum (MinIP) Intensity Projection, 4D volume viewing, image fusion, image subtraction, CT PET fusion, surface rendering, sector and rectangular shape MPR image viewing, 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 a through vascular and other tubular structures, and boundary detection.
Product codes
90-LLZ
Device Description
The Synapse 3D Basic Tools software 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 to develop treatment plans. The SYNAPSE 3D Basic Tools software runs on Windows Vista or Windows Server 2008 installed on commercial general-purpose Windowscompatible computers. SYNAPSE 3D Basic Tools is connected through DICOM standard to other medical devices such as CT, MR, CR, US, NM, PT, XA, etc. and to a PACS system storing data generated by these medial devices. Image data obtained from these devices are used for display, image processing, analysis, etc. SYNAPSE 3D Basic Tools cannot be used to interpret Mammography images.
SYNAPSE 3D Basic Tools can be integrated with Synapse Workstation (cleared by CDRH via K051553 on 07/07/2005) and can be used as a part of a SYNAPSE system.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT, MR, CR, US, NM, PT, XA
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained medical imaging professionals, including Physicians and Radiologists
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
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.
Pass/Fail criteria were based on the requirements and intended use of the product. Test results showed that all tests successfully passed.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of the proposed device.
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.
Pass/Fail criteria were based on the requirements and intended use of the product. Test results showed that all tests successfully passed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
FUJIFILM Medical Systems U.S.A. Inc., Synapse 3D Basic Tools 510(k)
K101662
5. 510(k) Summary
JUL 2 6 2010
Date Prepared:
May 27, 2010
Submitter's Information:
FUJIFILM Medical Systems USA, Inc. 419 West Avenue Stamford, Connecticut 06902
Telephone: (203) 602-3774 (203) 363-3813 Facsimile: Debra A. Peacock Contact:
Device Trade Name:
Synapse 3D Basic Tools
Device Common Name:
Medical Image Processing and Analysis Software
Requlation Number:
21 CFR 892.2050
Device Classification:
Class II
Device Classification Name
Picture Archiving Communication System (PACS)
Panel:
Radiology
Product Code:
90-LLZ
Date Received:
TBD
1
FUJIFILM Medical Systems U.S.A. Inc., Synapse 3D Basic Tools 510(k)
Decision Date:
TBD
Decision:
TBD
Predicate Devices:
- · Voxar 3D Enterprise with ColonMetrix and PET/CT Perfusion (Voxar) 510(k) #: K070831, cleared by CDRH on May 22, 2007.
- · Aquarius APS Server (iNtuition) (TeraRecon) 510(k) #: K061214, cleared by CDRH on May 15, 2006
Description of the Device
The Synapse 3D Basic Tools software 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 to develop treatment plans. The SYNAPSE 3D Basic Tools software runs on Windows Vista or Windows Server 2008 installed on commercial general-purpose Windowscompatible computers. SYNAPSE 3D Basic Tools is connected through DICOM standard to other medical devices such as CT, MR, CR, US, NM, PT, XA, etc. and to a PACS system storing data generated by these medial devices. Image data obtained from these devices are used for display, image processing, analysis, etc. SYNAPSE 3D Basic Tools cannot be used to interpret Mammography images.
SYNAPSE 3D Basic Tools can be integrated with Synapse Workstation (cleared by CDRH via K051553 on 07/07/2005) and can be used as a part of a SYNAPSE system.
Intended For Use
The Synapse 3D Basic Tools is medical imaging software that is intended to provide trained medical imaging professionals, including Physicians and Radiologists, with tools to aid them in reading, interpreting, reporting, and treatment planning. The Synapse 3D Basic 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.
2
FUJIFILM Medical Systems U.S.A. Inc., Synapse 3D Basic Tools 510(k)
The Synapse 3D Basic Tools provides several levels of tools to the user:
-
Basic imaging tools for general images, such as 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 subtraction, CT PET fusion, surface rendering, sector and rectangular shape MPR image viewing, 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.
Technological Characteristics
Synapse 3D Basic Tools introduces no new safety or efficacy issues other than those aiready 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
Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of the proposed device.
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.
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.
3
Image /page/3/Picture/0 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 featuring three abstract shapes that resemble human figures or flowing lines. The symbol is black, and the text is also in a dark color, likely black or a dark shade of blue.
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
Fuiifilm Medical Systems, USA, Inc. % Mr. Casey Conry Senior Project Engineer Underwriters Laboratories, Inc. 1285 Walt Whitman Rd. MELVILLE NY 11747
JUL 2 6 2010
Re: K101662
Trade/Device Name: Synapse 3D Basic Tools Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: June 30, 2010 Received: July 1, 2010 ·
, Dear Mr. Conry:
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
4
medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (OS) 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,
Donald J. St.Pierre Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known):
JUL 2 6 2010
Device Name: Synapse 3D Basic Tools
Indications for Use:
The Synapse 3D Basic Tools Software is medical imaging software that is intended to provide trained medical imaging professionals, including Physicians and Radiologists, with tools to aid them in reading, interpreting, reporting, and treatment planning. The Synapse 3D Basic 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.
The Synapse 3D Basic Tools Software provides several levels of tools to the user:
- Basic imaging tools for general images, such as 2D viewing, volume rendering and 3D volume A viewing, orthogonal / oblique / curved Multi-Planar Reconstructions (MPR), Maximum (MIP), Average (RaySum) and Minimum (MinIP) Intensity Projection, 4D volume viewing, image fusion, image subtraction, CT PET fusion, surface rendering, sector and rectangular shape MPR image viewing, 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 a through vascular and other tubular structures, and boundary detection.
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 Sign-Off)
(Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
510K K106.2
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Synapse 3D Basic Tools
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