(85 days)
No
The summary describes image processing and analysis tools for lung and abdomen CT scans, but there is no mention of AI, ML, or related concepts in the intended use, device description, or performance study sections.
No
The device is described as medical imaging software used to aid professionals in reading, interpreting, reporting, and treatment planning by providing tools for analysis and volume calculation. It does not actively treat or directly interact with the patient's body for therapeutic purposes.
Yes
The "Intended Use / Indications for Use" section states that the software provides "tools to aid them in reading, interpreting, reporting, and treatment planning" of medical images, and specifically mentions aiding in the detection and analysis of pulmonary nodes and fat areas, which are functions directly related to diagnosis.
Yes
The device is described as "medical imaging software" and an "application" that performs analysis on existing medical images. While it integrates with other systems (Synapse Workstation, Synapse Cardiovascular), the core device being described is the software itself, which processes data from CT scans. There is no mention of accompanying hardware being part of this specific device submission.
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 Lung and Abdomen Analysis software processes medical images (CT scans) acquired from the human body. It performs analysis on these images to aid medical professionals in interpretation and treatment planning. It does not analyze biological samples.
- Intended Use: The intended use clearly states it's for analyzing medical images to aid in reading, interpreting, reporting, and treatment planning.
- Input: The input is DICOM compliant medical images from CT scans, not biological samples.
Therefore, the device falls under the category of medical imaging software, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
Synapse 3D Lung and Abdomen Analysis is medical imaging software used with Synapse 3D Basic Tools 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. Synapse 3D Lung and Abdomen Analysis accepts DICOM compliant medical images acquired from CT.
This product is not intended for use with or for the primary diagnostic interpretation of Mammography images.
Addition to Synapse 3D Basic Tools, Synapse 3D Lung and Abdomen Analysis is intended to;
- use non-contrasted and contrast enhanced computed tomographic images of the lung, perform boundary detection and volume calculation for pulmonary nodes in the lung based on the location specified by the user and display low absorption areas.
- use non-contrasted CT images and calculate subcutaneous fat and visceral fat areas in 2D and both volumes in 3D.
Product codes
90-LLZ, LLZ
Device Description
Synapse 3D Lung and Abdomen Analysis is an application that can perform volume calculation for pulmonary nodes, display of low absorption areas, and other analysis for Lung contrasted and non-contrasted CT volume date. In addition, the application can calculate the area and volume (3D) of subcutaneous fat and visceral fat using abdomen CT images. The result can be displayed as a graph, and the fat quantity at each slice position can be presented.
Synapse 3D Lung and Abdomen Analysis is used in addition to the previously-cleared features available from Synapse 3D Basic Tools (K101662) to analyze the images acquired from CT. Synapse 3D Lung and Abdomen Analysis is intended to provide trained medical imaging professionals, including Physicians and Radiologists, with tools to aid them in reading, interpreting, reporting, and treatment planning and accepts DICOM compliant medical images.
Synapse 3D Lung and Abdomen Analysis with Synapse 3D Basic Tools can be integrated with our cleared Fujifilm's Synapse Workstation, version 3.2.1 and above, and can be used as a part of a Synapse system. Synapse 3D Lung and Abdomen Analysis also can be integrated with Fujifilm's Synapse Cardiovascular for cardiology purposes.
This product is not intended for use with or for the primary diagnostic interpretation of Mammography images.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT
Anatomical Site
Lung, Abdomen
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The Synapse 3D Lung and Abdomen Analysis software has undergone Verification and Validation Testing, as described in Section 18. Results: All planned verification and validation tests for Synapse 3D Lung and Abdomen Analysis have passed and the design validation has been successfully completed.
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).
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5. 510(k) Summary
Date Prepared:
MAR 1 6 2011
December 20, 2010
Submitter's Information:
FUJIFILM Medical Systems USA, Inc. 419 West Avenue Stamford, Connecticut 06902
Telephone: (203) 602-3665 (203) 251-7863 Fax: Kimerly A. Sharp Contact:
Device Trade Name:
Synapse 3D Lung and Abdomen 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 Communication System (PACS)
Panel:
Radiology
Product Code:
90-LLZ
Date Received:
TBD
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FUJIFILM Medical Systems U.S.A. Inc., Synapse 3D Lung and Abdomen Analysis 510(k)
Decision Date:
TBD
Decision:
TBD
Predicate Devices:
- Lung Nodule Assessment and Comparison Option (K023785), Philips .
- . Aquarius Workstation (K011142), TeraRecon
Description of the Device
Synapse 3D Lung and Abdomen Analysis is an application that can perform volume calculation for pulmonary nodes, display of low absorption areas, and other analysis for Lung contrasted and non-contrasted CT volume date. In addition, the application can calculate the area and volume (3D) of subcutaneous fat and visceral fat using abdomen CT images. The result can be displayed as a graph, and the fat quantity at each slice position can be presented.
Synapse 3D Lung and Abdomen Analysis is used in addition to the previously-cleared features available from Synapse 3D Basic Tools (K101662) to analyze the images acquired from CT. Synapse 3D Lung and Abdomen Analysis is intended to provide trained medical imaging professionals, including Physicians and Radiologists, with tools to aid them in reading, interpreting, reporting, and treatment planning and accepts DICOM compliant medical images.
Synapse 3D Lung and Abdomen Analysis with Synapse 3D Basic Tools can be integrated with our cleared Fujifilm's Synapse Workstation, version 3.2.1 and above, and can be used as a part of a Synapse system. Synapse 3D Lung and Abdomen Analysis also can be integrated with Fujifilm's Synapse Cardiovascular for cardiology purposes.
This product is not intended for use with or for the primary diagnostic interpretation of Mammography images.
Indication for Use
Synapse 3D Lung and Abdomen Analysis is medical imaging software used with Synapse 3D Basic Tools 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. Synapse 3D Lung and Abdomen Analysis accepts DICOM compliant medical images acquired from CT.
This product is not intended for use with or for the primary diagnostic interpretation of Mammography images.
Addition to Synapse 3D Basic Tools, Synapse 3D Lung and Abdomen Analysis is intended to;
- use non-contrasted and contrast enhanced computed tomographic images of the lung, .
2
perform boundary detection and volume calculation for pulmonary nodes in the lung based on the location specified by the user and display low absorption areas.
- . use non-contrasted CT images and calculate subcutaneous fat and visceral fat areas in 2D and both volumes in 3D.
Technological Characteristics
Synapse 3D Lung and Abdomen 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 Lung and Abdomen Analysis is tested with reference to its Software Requirements Specification, as documented in Section 16.2 as well as design verification and validation documents and Traceability Matrix document included in this 510(k) filing. Functional testing is a part of the Product Development process, and also included in Section 16 of this filing.
The Synapse 3D Lung and Abdomen Analysis software has undergone Verification and Validation Testing, as described in Section 18. Results: All planned verification and validation tests for Synapse 3D Lung and Abdomen Analysis have passed and the design validation has been successfully completed.
Documentation provided in Section 18 demonstrates that our proposed Synapse 3D Lung and Abdomen Analysis software device is 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 seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is an abstract image of an eagle.
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
Ms. Kimberly A. Sharp Quality Assurance/Regulatory Affairs Associate FUJIFILM Medical Systems, USA Inc. 419 West Avenue STAMFORD CT 06902
MAR 1 6 2011
Re: K103720
Trade/Device Name: Synapse 3D Lung and Abdomen Analysis Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: December 20, 2010 Received: January 6, 2011
Dear Ms. Sharp:
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 (QS) regulation (2) CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 51010). THM sket notification. The FDA finding of substantial equivalence of your device to a legally manaketed predicate device results in a classification for your device and thus, permits your dry man 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 (01) 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.
Mary Pastel
Mary S. Pastel. Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): 七山37202
Device Name: Synapse 3D Lung and Abdomen Analysis
Indications for Use:
Synapse 3D Lung and Abdomen Analysis is medical imaging software used with Synapse 3D Basic Tools 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. Synapse 3D Lung and Abdomen Analysis accepts DICOM compliant medical images acquired from CT.
This product is not intended for use with or for the primary diagnostic interpretation of Mammography images.
Addition to Synapse 3D Basic Tools, Synapse 3D Lung and Abdomen Analysis is intended to;
- use non-contrasted and contrast enhanced computed tomographic images of the ● lung, perform boundary detection and volume calculation for pulmonary nodes in the lung based on the location specified by the user and display low absorption areas.
- use non-contrasted CT images and calculate subcutaneous fat and visceral fat . areas in 2D and both volumes in 3D.
Prescription Use X Prescription Use______________________________________________________________________________________________________________________________________________________________
ND/OR Over-The
(21 CFR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device (OIVD)
Mary S. Posth
510K K163220