(129 days)
No
The summary describes standard image processing and analysis techniques for calculating blood flow parameters from MR images. There is no mention of AI, ML, or related terms, and the performance studies focus on traditional software verification and validation.
No
The device is described as medical imaging software that provides tools for reading, interpreting, and treatment planning, specifically related to blood flow analysis. It is not intended to provide therapy or directly treat a condition.
Yes
The "Intended Use / Indications for Use" section states that the software provides "tools to aid them in reading, interpreting, and treatment planning," and specifically "provides the imaging and assessment tools of blood flow velocity and directions." This indicates that the device is used to interpret medical images and provide information that assists in diagnosis.
Yes
The device is explicitly described as a "software application" and its functions are entirely software-based, processing image data retrieved from other medical devices and PACS systems. It runs on a general-purpose computer and does not include any proprietary hardware components.
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 used with medical imaging software (Synapse 3D Base Tools) and provides tools to aid trained medical professionals in reading, interpreting, and treatment planning based on MR images. It analyzes blood flow velocity and direction from these images.
- Device Description: The description reinforces that the software works with image data retrieved from medical devices like MR scanners via the DICOM standard. It processes and displays this image data.
- Lack of Mention of In Vitro Samples: There is no mention of the device being used to analyze samples taken from the human body (like blood, urine, tissue, etc.) outside of the body. IVD devices are specifically designed for testing such samples.
The device is a medical imaging software tool that aids in the interpretation of in vivo imaging data (MR images of blood flow). This falls under the category of medical devices, but not specifically In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
Synapse 3D Blood Flow Analysis 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, and treatment planning. Addition to the tools in Synapse 3D Base Tools, Synapse 3D Blood Flow Analysis provides the imaging and assessment tools of blood flow velocity and directions based on multi-slice, multi-phase and velocity encoded MR images.
Product codes
LLZ
Device Description
Synapse 3D Blood Flow Analysis is a software application that is used to work with Synapse 3D Base Tools (cleared by via K120361 on 04/06/2012). Synapse 3D Base Tools (K120361) 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 (K120361), and the associated image-related information of the image data is registered in the database and used for display, image processing, analysis, etc.
Synapse 3D Blood Flow Analysis developed to calculate the blood flow volume and velocity for an arranged ROI. The software can display the images on a display monitor, or printed them on a hardcopy using a DICOM printer or a Windows printer. The main functions of Synapse 3D Blood Flow Analysis are shown below.
- Display vessel images.
- Display the parameters such as flow velocity and volume calculated from the selected ROI.
- · Display the time-intensity curve and the analysis result of the flow volume analysis and the flow velocity analysis.
- Display blood flow by flow velocity vector, streamlines and pathlines.
- · Print or save reports.
Synapse 3D Blood Flow Analysis 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
multi-slice, multi-phase and velocity encoded MR images.
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 Blood Flow Analysis 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.
- 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 Blood Flow Analysis 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, 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 functions implemented in Synapse 3D Blood Flow Analysis 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 Blood Flow Analysis 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.
Conclusion: Performance tests were conducted to test the functionality of the subject device, Synapse 3D Blood Flow Analysis. 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)
CAAS MR 4D Flow (K162376)
Reference Device(s)
Synapse 3D Base Tools (K120361)
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
October 18, 2019
Image /page/0/Picture/1 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 acronym along with the full name of the agency on the right. The FDA acronym is in a blue box, followed by the words "U.S. FOOD & DRUG" in a larger, bold font, and "ADMINISTRATION" in a smaller font below.
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: K191544
Trade/Device Name: Synapse 3D Blood Flow Analysis Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: September 9, 2019 Received: September 10, 2019
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 and Part 809); 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/combination-products/guidance-regulatory-information/postmarketing-safety-reporting
1
combination-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 medical devices and radiation-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
2
Indications for Use
510(k) Number (if known) K191544
Device Name Synapse 3D Blood Flow Analysis
Indications for Use (Describe)
Synapse 3D Blood Flow Analysis 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, and treatment planning. Addition to the tools in Synapse 3D Base Tools, Synapse 3D Blood Flow Analysis provides the imaging and assessment tools of blood flow velocity and directions based on multi-slice, multi-phase and velocity encoded MR images.
| Type of Use (Select one or both, as applicable) |
|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
| Date Prepared: | June 10, 2019 |
|---|---|
| Submitter's Information: | FUJIFILM Corporation |
| 26-30, NISHIAZABU 2-CHOME MINATO-KU | |
| TOKYO 106-8620 | |
| Telephone: 201-675-8947 | |
| Contact: Jeffrey Wan | |
| Device Trade Name: | Synapse 3D Blood Flow Analysis |
| 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: | CAAS MR 4D Flow (K162376) |
| Pie Medical Imaging B.V. |
4
1. Description of the Device
Synapse 3D Blood Flow Analysis is a software application that is used to work with Synapse 3D Base Tools (cleared by via K120361 on 04/06/2012). Synapse 3D Base Tools (K120361) 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 (K120361), and the associated image-related information of the image data is registered in the database and used for display, image processing, analysis, etc.
Synapse 3D Blood Flow Analysis developed to calculate the blood flow volume and velocity for an arranged ROI. The software can display the images on a display monitor, or printed them on a hardcopy using a DICOM printer or a Windows printer. The main functions of Synapse 3D Blood Flow Analysis are shown below.
- Display vessel images.
- Display the parameters such as flow velocity and volume calculated from the selected ROI.
- · Display the time-intensity curve and the analysis result of the flow volume analysis and the flow velocity analysis.
- Display blood flow by flow velocity vector, streamlines and pathlines.
- · Print or save reports.
Synapse 3D Blood Flow Analysis 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.
2. Indications for Use
Synapse 3D Blood Flow Analysis 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.
Addition to the tools in Synapse 3D Base Tools, Synapse 3D Blood Flow Analysis provides the imaging and assessment tools of blood flow velocity and directions based on multi-slice, multi-phase and velocity encoded MR images.
5
3. Substantial Equivalence Comparison
Synapse 3D Blood Flow Analysis has the same intended use, similar labeling, and clinical application tools as those of the cleared predicate device CAAS MR 4D Flow (K162376). The device features and technical characteristics comparison with predicates is shown as Table 1 Device Features and Technical Characteristics Comparison Matrix.
Table 1 Device Features and Technical Characteristics Comparison Matrix
| Device Parameters | Synapse 3D Blood Flow
Analysis
(This submission) | CAAS MR 4D Flow
(K162376)
(Predicate device) |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------|----------------------------------------------------|
| Images supported
(DICOM 3.0; Enhanced DICOM;
Cardiovascular images: multi-slice,
multi-phase and velocity encoded MR
images) | Yes | Yes |
| 2D Viewing | Yes | Yes |
| Image Communication (DICOM SCU) | Yes | Yes |
| DICOM Interface (SCP/SCU) | Yes | Yes |
| Printing (DICOM SCU) | Yes | Yes |
| Measurements (2D and 3D) | Yes | Yes |
| Annotations - Standardized and Free Text | Yes | Yes |
| Reporting | Yes | Yes |
| Volume Rendering and 3D Viewing | Yes | Yes |
| MPR
-orthogonal / oblique / curved
Multi-Planar Reconstructions (MPR),
-Sector and rectangular shape MPR
image viewing
-Multiple MPR images along an object
(Slicer) | Yes | Yes |
| Image display and manipulation
-Pan/Zoom;
-Magnify;
-Maximize and minimize, scroll through
slice stack;
-Adjust window level, contrast,
brightness;
-Single image ROI placement;
-Automated 2D ROI;
-Propagate/copy/edit functions;
-2D velocity color map | Yes | Yes |
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| Automatic Vessel segmentation | Yes | Yes |
|---|---|---|
| Blood flow visualization | ||
| -Streamlines | ||
| -Vector fields | Yes | Yes |
| Blood flow visualization | ||
| -Pathlines | Yes | Yes |
| Blood flow parameters | ||
| -Blood velocity | ||
| -Regurgitation fraction | ||
| -Blood flow volume | Yes | Yes |
| Storage of results | ||
| -Text files (CSV) | ||
| -DICOM report | ||
| -PDF report | ||
| -Image snapshot bitmaps | ||
| -Animation for streamlines and vector | ||
| fields | ||
| -Snapshot for reanalysis | Yes | Yes |
| Storage of results | ||
| -Animation for pathlines | Yes | Yes |
| Hardware Platform | Windows PC | Windows PC |
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4. Safety Information
Synapse 3D Blood Flow 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 Blood Flow Analysis 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 Blood Flow Analysis 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.
- 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 Blood Flow Analysis 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, 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 functions implemented in Synapse 3D Blood Flow Analysis 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 Blood Flow Analysis software have been stress tested to ensure that the system as a
8
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 Blood Flow Analysis 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 Blood Flow Analysis 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 Blood Flow Analysis 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 62304:2006, Medical Device Software Software Life Cycle Processes.
- · 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 Blood Flow Analysis. Results of all conducted testing were acceptable in supporting the claim of substantial equivalence.