(84 days)
No
The summary describes standard medical imaging software tools and does not mention AI, ML, or related concepts. The performance testing focuses on traditional software verification and validation, not AI/ML model training or evaluation.
No
The device is medical imaging software intended to aid in reading, interpreting, reporting, and treatment planning, not to provide therapy.
Yes
The "Intended Use / Indications for Use" section states that the software is "intended to provide trained medical professionals, with tools to aid them in reading, interpreting, reporting, and treatment planning," and it "accepts DICOM compliant medical images acquired from a variety of imaging devices". The "Device Description" also mentions that the software offers tools "to interpret medical images obtained from various medical devices to create reports or develop treatment plans," all of which indicate a diagnostic purpose.
Yes
The device is explicitly described as an "optional software module" that works with existing software (Synapse 3D Base Tools) and runs on a commercial general-purpose computer. It provides imaging tools and analysis capabilities based on DICOM data, without mentioning any dedicated hardware components included with the device itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the software is for "reading, interpreting, reporting, and treatment planning" using medical images acquired from imaging devices like CT and MR. This is focused on analyzing images of the human body, not on testing samples taken from the body (like blood, urine, or tissue).
- Device Description: The description reinforces that the software works with medical imaging devices and PACS systems to retrieve and process image data. It provides tools for viewing and analyzing these images.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other components typically associated with in vitro diagnostics.
In summary, the Synapse 3D Optional Tools is a medical imaging software intended for the analysis and interpretation of medical images, which falls under the category of medical devices, but not specifically In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
Synapse 3D Optional Tools 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 Optional Tools accepts DICOM compliant medical images acquired from a variety of imaging devices including CT, MR. This product is not intended for use with or for the primary diagnostic interpretation of Mammography images. Addition to the tools in Synapse 3D Base Tools, Synapse 3D Optional Tools provides:
· Imaging tools for CT images including virtual endoscopic viewing.
· Imaging tools for MR images including delayed enhancement image viewing and diffusion-weighted MRI data analysis.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
Synapse 3D Optional Tools is an optional software module that works with Synapse 3D Base Tools (cleared by via K120361 on 04/06/2012). 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 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, and the associated information of the image data is registered in the database and used for display, image processing, analysis, etc.
Synapse 3D Optional Tools provides imaging tools for CT and MR images such as virtual endoscopic simulator (CT) (referred collectively as "Endoscopic Simulator"), diffusion-weighted MRI data analysis (MR) (referred collectively as "IVIM"), and delayed enhancement image viewing (MR) (referred collectively as "Delayed Enhancement"). The software can display the images on a display monitor, or printed them on a hardcopy using a DICOM printer or a Windows printer.
Synapse 3D Optional Tools 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.
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 professionals, such as radiologists, clinicians or general practitioners
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)
Nonclinical testing result: The purpose of Software Development Process for Synapse 3D Optional Tools is to carry out the activities relating to the establishment of the software development plan (or definitely conducting software hazard analysis, risk management 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 Optional Tools did not require clinical studies to support safety and effectiveness of the software.
Verification and Validation: The purpose of Software Development Process for Synapse 3D Optional Tools is to carry out the activities relating to the establishment of the software development plan (or definitely conducting software requirement analysis, architectural design, the detailed design, unit implementation and verification, software integration testing, software system test, software release, software maintenance. Testing involved system level functionality test, component testing, verification testing, integration 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 segmentation, detection, and registration functions implemented in Synapse 3D Optional 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 Optional 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.
Key results: Results of all conducted testing were acceptable in supporting the claim of substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Synapse 3D Base Tools (K120361), FUJIFILM Medical Systems U.S.A., Inc.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
REX™ (K021099), PointDx, Inc., Olea Sphere V3.0 (K152602), Olea Medical
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
September 25, 2018
FUJIFILM Corporation % Jeffrey Wan Specialist. Regulatory Affairs FUJIFILM Medical Systems U.S.A., Inc. 419 West Avenue STAMFORD, CT 06902
Re: K181773
Trade/Device Name: Synapse 3D Optional Tools Regulation Number: 21 CFR 892.2050 Regulation Name: Picture Archiving And Communications System Regulatory Class: Class II Product Code: LLZ Dated: September 6, 2018 Received: September 7, 2018
Dear Jeffrey 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
1
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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Hsl 2. Nils
for Robert A. Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
K181773
Device Name Synapse 3D Optional Tools
Indications for Use (Describe)
Synapse 3D Optional Tools 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 Optional Tools accepts DICOM compliant medical images acquired from a variety of imaging devices including CT, MR. This product is not intended for use with or for the primary diagnostic interpretation of Mammography images. Addition to the tools in Synapse 3D Base Tools, Synapse 3D Optional Tools provides:
· Imaging tools for CT images including virtual endoscopic viewing.
· Imaging tools for MR images including delayed enhancement image viewing and 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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| FUJIFILM Medical Systems U.S.A., Inc.,
| Synapse 3D Optional Tools (V5.2) 510(k) | ||
|---|---|---|
| 510(k) Summary | ||
| Date Prepared: | July 1, 2018 | |
| 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: | Jeffrey Wan | |
| Device Trade Name: | Synapse 3D Optional Tools | |
| 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 | |
| Primary Predicate Devices: | Synapse 3D Base Tools (K120361), FUJIFILM Medical | |
| Systems U.S.A., Inc. | ||
| Reference Predicate Devices: | REX™ (K021099), PointDx, Inc. | |
| Olea Sphere V3.0 (K152602), Olea Medical |
4
FUJIFILM Medical Systems U.S.A., Inc., Synapse 3D Optional Tools (V5.2) 510(k)
1. Description of the Device
Synapse 3D Optional Tools is an optional software module that works with Synapse 3D Base Tools (cleared by via K120361 on 04/06/2012). 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 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, and the associated information of the image data is registered in the database and used for display, image processing, analysis, etc.
Synapse 3D Optional Tools provides imaging tools for CT and MR images such as virtual endoscopic simulator (CT) (referred collectively as "Endoscopic Simulator"), diffusion-weighted MRI data analysis (MR) (referred collectively as "IVIM"), and delayed enhancement image viewing (MR) (referred collectively as "Delayed Enhancement"). The software can display the images on a display monitor, or printed them on a hardcopy using a DICOM printer or a Windows printer.
Synapse 3D Optional Tools 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.
Indications for Use 2.
Synapse 3D Optional Tools 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 Optional Tools accepts DICOM compliant medical images acquired from a variety of imaging devices including CT, MR. This product is not intended for use with or for the primary diagnostic interpretation of Mammography images. Addition to the tools in Synapse 3D Base Tools, Synapse 3D Optional Tools provides:
- · Imaging tools for CT images including virtual endoscopic viewing.
- · Imaging tools for MR images including delayed enhancement image viewing and diffusionweighted MRI data analysis.
Substantial Equivalence Comparison 3.
Synapse 3D Optional Tools has the same intended use, similar labeling, and clinical application tools as those of the cleared primary predicate device Synapse 3D Base Tools (K120361).and reference predicate devices REX, VERSION 1.0 (K021099) and Olea Sphere V3.0 (K152602). The device features and technical characteristics comparison with predicate and reference devices is shown as Table 1.
5
Table 1 Device Features and Technical Characteristics Comparison Matrix
| Device Parameters | Synapse 3D Optional
Tools
(This submission) | Synapse 3D Base Tools
(K120361)
(Primary predicate device) | REX™
(K021099)
(Reference device) | Olea Sphere V3.0
(K152602)
(Reference device) |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------|------------------------------------------------------------------|-----------------------------------------|-----------------------------------------------------|
| 2D Viewing | Yes | Yes | Yes | Yes |
| Image Storing (DICOM
SCP) | Yes | Yes | N/A | Yes |
| Image Communication
(DICOM SCU) | Yes | Yes | Yes | Yes |
| DICOM Interface
(SCP/SCU) | Yes | Yes | Yes | Yes |
| Printing (DICOM SCU) | Yes | Yes | N/A | N/A |
| Measurements (2D and 3D) | Yes | Yes | Yes | Yes |
| Annotations - Standardized
and Free Text | Yes | Yes | Yes | Yes |
| Reporting | Yes | Yes | Yes | Yes |
| Cine | Yes | Yes | N/A | N/A |
| Volume Rendering and 3D
Viewing | Yes | Yes | Yes | Yes |
| MPR
orthogonal / oblique /
curved Multi-Planar
Reconstructions (MPR),
Sector and rectangular
shape MPR image
viewing
Multiple MPR images | Yes | Yes | Yes | Yes |
| along an object (Slicer) | | | | |
| Maximum, Average,
Minimum Intensity
Projection | Yes | Yes | N/A | N/A |
| 4D viewing | Yes | Yes | N/A | N/A |
| Image fusion | Yes | Yes | N/A | N/A |
| Surface rendering | Yes | Yes | N/A | N/A |
| Image subtraction (3D) | Yes | Yes | N/A | N/A |
| Time-density distribution | Yes | Yes | N/A | N/A |
| General image data
management and
administration tools | Yes | Yes | Yes | Yes |
| Real time display of
endoscopic view | Yes | N/A | Yes | N/A |
| Internal and external
viewing of any hollow
structure | Yes | N/A | Yes | N/A |
| Visualizing the diffusion
properties (IVIM map) from
the analysis of
diffusion-weighted MRI data | Yes | N/A | N/A | Yes |
| Display of delayed
enhancement MR images | Yes | N/A | N/A | N/A |
| Hardware Platform | Windows PC | Windows PC | Windows PC | Windows PC |
6
FUJIFILM Medical Systems U.S.A., Inc., Synapse 3D Optional Tools (V5.2) 510(k)
7
FUJIFILM Medical Systems U.S.A., Inc., Synapse 3D Optional Tools (V5.2) 510(k)
4. Safety Information
Synapse 3D Optional Tools introduces no new safety or efficacy issues other than those already indentified with the predicate devices. The Risk Management and 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 Optional 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 Optional Tools is to carry out the activities relating to the establishment of the software development plan (or definitely conducting software hazard analysis, risk management 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 Optional Tools did not require clinical studies to support safety and effectiveness of the software.
Verification and Validation:
The purpose of Software Development Process for Synapse 3D Optional Tools is to carry out the activities relating to the establishment of the software development plan (or definitely conducting software requirement analysis, architectural design, the detailed design, unit implementation and verification, software integration testing, software system test, software release, software maintenance. Testing involved system level functionality test, component testing, verification testing, integration 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
05- 6 510(K) Summary
8
FUJIFILM Medical Systems U.S.A., Inc.,
Synapse 3D Optional Tools (V5.2) 510(k)
demonstrate that the semi-automatic segmentation, detection, and registration functions implemented in Synapse 3D Optional 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 Optional 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 Optional 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 Optional 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 communication based on the DICOM standard. Therefore Synapse 3D Optional Tools assure 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 CycleProcesses.
- · 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 Optional Tools. Results of all conducted testing were acceptable in supporting the claim of substantial equivalence.