(87 days)
No
The document describes standard image processing and analysis tools, with no mention of AI or ML algorithms. The nodule detection is based on user-specified locations, not automated detection using AI/ML.
No
The device is medical imaging software that aids in reading, interpreting, reporting, and treatment planning by providing tools for nodule analysis, measurements, and comparisons. It does not directly 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 specifically mentions "nodule analysis" and "temporal comparison of nodule images," which are diagnostic activities.
Yes
The device description explicitly states that Synapse 3D Nodule Analysis is an "optional software module" that runs on a "commercial general-purpose Windows-compatible computer." It processes medical images obtained from other medical devices (CT and PT) and provides software tools for analysis and reporting. There is no indication of proprietary hardware being part of the device itself.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body. They are used to detect diseases, conditions, or infections.
- Device function: The description clearly states that Synapse 3D Nodule Analysis is medical imaging software that processes and analyzes medical images acquired from CT and PT. It provides tools for reading, interpreting, reporting, and treatment planning based on these images.
- No mention of biological samples: There is no indication that this software interacts with or analyzes any biological samples from a patient. Its input is image data.
Therefore, since the device operates on medical images and not biological samples, it falls outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Synapse 3D Nodule 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. Synapse 3D Nodule Analysis accepts DICOM compliant medical images acquired from CT and PT.
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 Nodule Analysis is intended to;
- use non-contrast and contrast enhanced computed tomography (CT) images, provide custom workflows and Ul, and reporting functions for nodule analysis including boundary detection of nodules based on the location specified by the user, measurement of nodules, temporal comparison of nodule images, and fusion of a CT nodule image on a PT nodule image.
- use positron emission tomography (PT) images, provide custom workflows and UI, and reporting functions for nodule analysis including SUV measurement of nodules with sphere VOI based on the location specified by the user, temporal comparison of nodule images, and fusion of a PT nodule image on a CT nodule image.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
Synapse 3D Nodule Analysis is an optional software module that works with Synapse 3D Base Tools (V3.0) (K120361, cleared on April 6, 2012). Synapse 3D Nodule Analysis, Synapse 3D Base Tools (V3.0), as well as other optional software modules, all belong to the Synapse 3D product family.
Synapse 3D is the medical application software running on Windows server/client configuration installed on a commercial general-purpose Windows-compatible computer. It offers software tools which can be used by trained medical professionals to interpret medical images obtained from various medical devices, to create reports, or to develop treatment plans.
The key features in Synapse 3D Nodule Analysis include boundary detection of nodules, measurement of nodules, temporal comparison of nodule images, and fusion of CT and PT nodule images on the non-contrast and contrast enhanced CT or PT images.
Synapse 3D Nodule Analysis offers physicians the following clinical applications in addition to the features available from Synapse 3D Base Tools (V3.0) to analyze the image data retrieved from CT and PT devices.
- Response Evaluation Criteria in Solid Tumors (RECIST) Tracker Use non-contrast and contrast enhanced computed tomography (CT) images, provide custom workflows, user interface (UI), and reporting functions for nodule analysis including boundary detection of nodules (based on the location specified by the user), measurement of nodules, temporal comparison of nodule images, and fusion of a CT nodule image on a PT nodule image.
- Positron Emission Response Criteria in Solid Tumors (PERCIST) Tracker . Use positron emission tomography (PT) images, provide custom workflows user interface (UI), and reporting functions for nodule analysis including standardized uptake value (SUV) measurement of nodules with sphere VOI (based on the location specified by the user), temporal comparison of nodule images, and fusion of a PT nodule image on a CT nodule image.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT, PT
Anatomical Site
Nodules (lung nodules implied by RECIST/PERCIST and general lung analysis context of predicate)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Trained medical professionals
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)
Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of the Synapse 3D Nodule Analysis software, which is found to be safe and effective and substantially equivalent to the currently-cleared predicate device.
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.
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.
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
FUJIFILM Medical Systems U.S.A., Inc. Synapse 3D Nodule Analysis 510(k)
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 Nodule Analysis
Device Common Name:
Medical Image Processing and Analysis Software
Requlation 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
JUN - 1 2012
1
FUJIFILM Medical Systems U.S.A. Synapse 3D Nodule Analysis 510(k)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
· Advantage Windows Lung Analysis: GE Healthcare (GE Medical Systems) (K042694).
Description of the Device
Synapse 3D Nodule Analysis is an optional software module that works with Synapse 3D Base Tools (V3.0) (K120361, cleared on April 6, 2012). Synapse 3D Nodule Analysis, Synapse 3D Base Tools (V3.0), as well as other optional software modules, all belong to the Synapse 3D product family.
Synapse 3D is the medical application software running on Windows server/client configuration installed on a commercial general-purpose Windows-compatible computer. It offers software tools which can be used by trained medical professionals to interpret medical images obtained from various medical devices, to create reports, or to develop treatment plans.
The key features in Synapse 3D Nodule Analysis include boundary detection of nodules, measurement of nodules, temporal comparison of nodule images, and fusion of CT and PT nodule images on the non-contrast and contrast enhanced CT or PT images.
Synapse 3D Nodule Analysis offers physicians the following clinical applications in addition to the features available from Synapse 3D Base Tools (V3.0) to analyze the image data retrieved from CT and PT devices.
- . Response Evaluation Criteria in Solid Tumors (RECIST) Tracker Use non-contrast and contrast enhanced computed tomography (CT) images, provide custom workflows, user interface (UI), and reporting functions for nodule analysis including boundary detection of nodules (based on the location specified by the user), measurement of nodules, temporal comparison of nodule images, and fusion of a CT nodule image on a PT nodule image.
- Positron Emission Response Criteria in Solid Tumors (PERCIST) Tracker . Use positron emission tomography (PT) images, provide custom workflows user interface (UI), and reporting functions for nodule analysis including standardized uptake value (SUV) measurement of nodules with sphere VOI (based on the location specified by the user), temporal comparison of nodule images, and fusion of a PT nodule image on a CT nodule image.
Indication for Use
Synapse 3D Nodule 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. Synapse 3D Nodule Analysis accepts DICOM compliant medical images acquired from CT and PT.
2
FUJIFILM Medical Systems U.S.A., Inc Synapse 3D Nodule Analysis 510(k)
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 Nodule Analysis is intended to:
- use non-contrast and contrast enhanced computed tomography (CT) images, provide A custom workflows and UI. and reporting functions for nodule analysis including boundary detection of nodules based on the location specified by the user, measurement of nodules, temporal comparison of nodule images, and fusion of a CT nodule image on a PT nodule image.
- 公 use positron emission tomography (PT) images, provide custom workflows and UI, and reporting functions for nodule analysis including SUV measurement of nodules with sphere VOI based on the location specified by the user, temporal comparison of nodule images, and fusion of a PT nodule image on a CT nodule image.
Technological Characteristics
Synapse 3D Nodule Analysis 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 Nodule 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 Nodule Analysis 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 consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized design featuring three abstract shapes that resemble human figures or birds in flight.
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, Quality and Clinical Affairs FUJIFILM Medical Systems, U.S.A., Inc. 419 West Avenue STAMFORD CT 06902
JUN - 1 2012
Re: K120679
Trade/Device Name: Synapse 3D Nodule Analysis 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 6, 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
4
medical device-related adverse events) (21 CFR 803); and good manufacturing practice mourements 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 with anony four to FDA finding of substantial equivalence of your device to a legally marketed nonication. The I Drivinant ssification 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 11 Jul deen before 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 Tou may 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
5
Indications for Use
510(k) Number (if known):
Device Name: Synapse 3D Nodule Analysis
Indications for Use:
Synapse 3D Nodule 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. Synapse 3D Nodule Analysis accepts DICOM compliant medical images acquired from CT and PT.
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 Nodule Analysis is intended to;
-
use non-contrast and contrast enhanced computed tomography (CT) images, provide custom workflows and Ul, and reporting functions for nodule analysis including boundary detection of nodules based on the location specified by the user, measurement of nodules, temporal comparison of nodule images, and fusion of a CT nodule image on a PT nodule image.
- use positron emission tomography (PT) images, provide custom workflows and UI, and A reporting functions for nodule analysis including SUV measurement of nodules with sphere VOI based on the location specified by the user, temporal comparison of nodule images, and fusion of a PT nodule image on a CT nodule image.
Prescription Use x 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 of Radiological Devices Office of In 510K
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