(68 days)
No
The document describes standard medical image processing and analysis tools based on established algorithms (like Agatston score) and does not mention AI or ML.
No.
The device is medical imaging software intended to aid in reading, interpreting, reporting, and treatment planning, and provides tools for analysis and quantification of medical images; it does not directly treat or diagnose a disease or condition.
Yes
The device provides tools for reading, interpreting, reporting, and treatment planning based on medical images, and calculates functional and quantitative values such as ejection fraction, volumes, and calcium scores, which are all part of diagnostic processes.
Yes
The device description explicitly states that Synapse 3D Cardiac Tools is "medical imaging software" and is used "with Fujifilm's Synapse 3D Basic Tools" and can be "integrated with our cleared Fujifilm's Synapse Workstation". It processes DICOM images from various modalities. There is no mention of accompanying hardware components 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 or other conditions.
- Device Function: Synapse 3D Cardiac Tools is medical imaging software that processes and analyzes medical images (CT, MR, NM, XA) acquired from imaging devices. It does not perform tests on biological samples.
- Intended Use: The intended use clearly states that the software is used with medical images to aid in reading, interpreting, reporting, and treatment planning. It focuses on analyzing anatomical structures and functional characteristics based on imaging data.
Therefore, Synapse 3D Cardiac Tools falls under the category of medical imaging software, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
Synapse 3D Cardiac Tools 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 Cardiac Tools accepts DICOM compliant medical images acquired from a variety of imaging devices including, CT, MR, NM, and XA.
This product is not intended for use with or for the primary diagnostic interpretation of Mammography images.
Addition to the tools with Synapse 3D Basic Tools, Synapse 3D Cardiac Tools provides the tools for specific clinical applications which provide targeted workflows. custom UI, targeted measurements and reporting functions including:
- Functional cardiac analysis for CT left ventriculography images: which is intended to evaluate the functional characteristics of heart
- Functional cardiac analysis for non contrasted MR heart images: which is intended to evaluate the functional characteristics of heart
- Coronary artery analysis for CT coronary arteriography images: which is intended for the qualitative and quantitative analysis of coronary arteries
- Calcium scoring for non contrasted CT heart images: which is intended for non invasive identification and quantification of calcified atherosclerotic plaques in the coronary arteries using tomographic medical image data and clinically accepted calcium scoring algorithms
- Cardiac Fusion: which is intended to analyze cardiac anatomy and pathology with a fused image of functional data (e.q. NM imaqe. Bulls eye) and anatomical data.
Product codes (comma separated list FDA assigned to the subject device)
90-LLZ, LLZ
Device Description
Synapse 3D Cardiac Tools is with Fujifilm's Synapse 3D Basic Tools (K101662, cleared by CDRH on July 26, 2010) and can be integrated with our cleared Fujifilm's Synapse Workstation, version 3.1.0 and above as a part of a Synapse system. Synapse 3D Cardiac Tools also can be integrated with Fujifilm's Synapse Cardiovascular for cardiology purposes.
Synapse 3D Cardiac Tools offers physicians the following clinical applications in addition to the features available from our cleared Synapse 3D Basic Tools (K101662) to analyze the image data retrieved from various connected devices.
Functional cardiac analysis (CT) is an application for cardiac function evaluation which obtains the boundary between left ventricle and cardiac wall from CT left ventriculography images retrieved from multiple time phases and calculates ejection fraction, end-diastolic volume, endsystolic volume, stroke volume, etc.
Functional cardiac analysis (MR) is an application for cardiac function evaluation which obtains the boundary between left ventricle and cardiac wall from non-contrasted MR images retrieved from multiple time phases and calculates ejection fraction, end-diastolic volume, end-systolic volume, output volume per beat, etc.
Coronary artery analysis is an application using CT coronary arteriography images to extract the path of the target blood vessels and to perform coronary artery evaluation.
The calcium scoring is an application which uses non-contrasted CT images to display the calcification area in the coronary artery with color separation and calculates the calcification quantitative values using the Agatston score method.
Cardiac fusion is an application to create an image having the mutual characteristics of source images of heart. Source images could be original image of CT, MR or NM and the functional image derived from the original image.
Mentions image processing
Medical Image Processing and Analysis Software
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT, MR, NM, XA
Anatomical Site
Heart, coronary arteries
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)
Not Found
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
JAN 3 1 2011
5. 510(k) Summary
Date Prepared:
November 23, 2010
Submitter's Information:
FUJIFILM Medical Systems USA, Inc. 419 West Avenue Stamford, Connecticut 06902
Telephone: (203) 602-3774 Facsimile: (203) 363-3813 Contact: Debra A. Peacock
Device Trade Name:
Synapse 3D Cardiac Tools
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
1
Decision Date:
TBD
Decision:
TBD
Predicate Devices:
- · Voxar 3D Enterprise with CardiaMetrix, K061326
- · ZIO Soft MR Cardiac Function Analysis, K091262
- · GE CardIQ Fusion, K061370
Description of the Device
Synapse 3D Cardiac Tools is with Fujifilm's Synapse 3D Basic Tools (K101662, cleared by CDRH on July 26, 2010) and can be integrated with our cleared Fujifilm's Synapse Workstation, version 3.1.0 and above as a part of a Synapse system. Synapse 3D Cardiac Tools also can be integrated with Fujifilm's Synapse Cardiovascular for cardiology purposes.
Synapse 3D Cardiac Tools offers physicians the following clinical applications in addition to the features available from our cleared Synapse 3D Basic Tools (K101662) to analyze the image data retrieved from various connected devices.
Functional cardiac analysis (CT)
Functional cardiac analysis (CT) is an application for cardiac function evaluation which obtains the boundary between left ventricle and cardiac wall from CT left ventriculography images retrieved from multiple time phases and calculates ejection fraction, end-diastolic volume, endsystolic volume, stroke volume, etc.
Functional cardiac analysis (MR)
Functional cardiac analysis (MR) is an application for cardiac function evaluation which obtains the boundary between left ventricle and cardiac wall from non-contrasted MR images retrieved from multiple time phases and calculates ejection fraction, end-diastolic volume, end-systolic volume, output volume per beat, etc.
Coronary artery analysis (CT)
Coronary artery analysis is an application using CT coronary arteriography images to extract the path of the target blood vessels and to perform coronary artery evaluation.
2
Calcium Scoring
The calcium scoring is an application which uses non-contrasted CT images to display the calcification area in the coronary artery with color separation and calculates the calcification quantitative values using the Agatston score method.
Cardiac Fusion
Cardiac fusion is an application to create an image having the mutual characteristics of source images of heart. Source images could be original image of CT, MR or NM and the functional image derived from the original image.
Indication for Use
Synapse 3D Cardiac Tools 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, and treatment planning, Synapse 3D Cardiac Tools accepts DICOM compliant medical images acquired from a variety of imaging devices including, CT, MR, NM, and XA,
This product is not intended for use with or for the primary diagnostic interpretation of Mammography images.
Addition to the tools with Synapse 3D Basic Tools, Synapse 3D Cardiac Tools provides the tools for specific clinical applications which provide targeted workflows, custom UI, targeted measurements and reporting functions including:
-
Functional cardiac analysis for CT left ventriculography images: which is intended to evaluate the functional characteristics of heart
-
Functional cardiac analysis for non contrasted MR heart images: which is intended to evaluate the functional characteristics of heart
-
Coronary artery analysis for CT coronary arteriography images: which is intended for the qualitative and quantitative analysis of coronary arteries
-
Calcium scoring for non contrasted CT heart images: which is intended for non invasive identification and quantification of calcified atherosclerotic plaques in the coronary arteries using tomographic medical image data and clinically accepted calcium scoring algorithms
-
Cardiac Fusion: which is intended to analyze cardiac anatomy and pathology with a fused image of functional data (e.g. NM image, Bulls eye) and anatomical data.
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.
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. Debbie Peacock Sr. Regulatory Affairs Specialist FUJIFILM Medical Systems USA, Inc. 419 West Avenue STAMFORD, CT 06092
JAN 3 1 201
and the country of the country of the county of the county of
Re: K103465
Trade/Device Name: Synapse 3D Cardiac Tools Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: November 23, 2010 Received: November 24, 2010
Dear Ms. Peacock:
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 (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.
Mary S Postel
Mary Pastel. ScD. 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 Cardiac Tools
Indications for Use:
Synapse 3D Cardiac Tools 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 Cardiac Tools accepts DICOM compliant medical images acquired from a variety of imaging devices including, CT, MR, NM, and XA.
This product is not intended for use with or for the primary diagnostic interpretation of Mammography images.
Addition to the tools with Synapse 3D Basic Tools, Synapse 3D Cardiac Tools provides the tools for specific clinical applications which provide targeted workflows. custom UI, targeted measurements and reporting functions including:
-
Functional cardiac analysis for CT left ventriculography images: which is intended to evaluate the functional characteristics of heart
-
Functional cardiac analysis for non contrasted MR heart images: which is intended to evaluate the functional characteristics of heart
-
Coronary artery analysis for CT coronary arteriography images: which is intended for the qualitative and quantitative analysis of coronary arteries
-
Calcium scoring for non contrasted CT heart images: which is intended for non invasive identification and quantification of calcified atherosclerotic plaques in the coronary arteries using tomographic medical image data and clinically accepted calcium scoring algorithms
-
Cardiac Fusion: which is intended to analyze cardiac anatomy and pathology with a fused image of functional data (e.q. NM imaqe. Bulls eye) and anatomical data.
Prescription Use X Pressmption USD
(Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR (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)
(Division Sign-Off)
810K K103465
Synanse 3D Cardian Tools
Page 19 of 1101