(76 days)
No
The document describes image processing and analysis software for liver segmentation and analysis, but there is no mention of AI, ML, or related terms like deep learning or neural networks. The description focuses on providing tools for trained professionals to perform analysis.
No.
The device is medical imaging software intended to aid professionals in reading, interpreting, reporting, and treatment planning by providing tools for liver analysis, not to directly provide therapy.
No
Explanation: The "Intended Use / Indications for Use" section states that the device provides "tools to aid them in reading, interpreting, reporting, and treatment planning" and "is not intended for use with or for the primary diagnostic interpretation." This indicates that it assists in the diagnostic process but does not provide a diagnosis itself.
Yes
The device is described as "medical imaging software" and an "application" that uses existing CT images. It integrates with other software platforms (Synapse Workstation, Synapse Cardiovascular) and relies on previously cleared software (Synapse 3D Basic Tools). There is no mention of accompanying hardware or hardware components included with the device itself.
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: Synapse 3D Liver Analysis is medical imaging software that processes and analyzes medical images (CT scans) acquired from the human body. It does not perform tests on samples taken from the body.
- Intended Use: The intended use clearly states it's for aiding medical imaging professionals in reading, interpreting, reporting, and treatment planning based on medical images.
- Input: The input is DICOM compliant medical images from CT, not biological samples.
Therefore, Synapse 3D Liver Analysis falls under the category of medical imaging software, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
Synapse 3D Liver 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 Liver 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 Liver Analysis uses contrast enhanced computed tomographic images of the body and provides custom workflows and UI, and reporting functions for liver analysis including, liver segmentation, tumor segmentation, segmentation of intrahepatic vessels as well as the approximation of vascular territories.
Product codes (comma separated list FDA assigned to the subject device)
90-LLZ, LLZ
Device Description
Synapse 3D Liver Analysis is an application which uses the intravenous contrasted CT study of a liver to segment the liver and various blood vessels and to perform 3D display of the results. Using the information of segmented liver, hepatic vessels, tumors, and the morphological structure of vessel system and blood supply volume of each vessel, the user can analyze the liver, vessels and tumors and plan the treatment.
Synapse 3D Liver 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 Liver Analysis is intended to provide trained medical imaging professionals, including Physicians and Radiologists, with tools to aid them in reading, interpreting, and treatment planning and accepts DICOM compliant medical images.
Synapse 3D Liver 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 Liver 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
Liver
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
APR - 7 2011
5. 510(k) Summary
Date Prepared:
January 20, 2011
Submitter's Information:
FUJIFILM Medical Systems USA, Inc. 419 West Avenue Stamford, Connecticut 06902
Telephone: (203) 602-3665 Fax: (203) 251-7863 Kimerly A. Sharp Contact:
Device Trade Name:
Synapse 3D Liver 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
1
FUJIFILM Medical Systems U.S.A. Inc., Synapse 3D Liver Analysis 510(k)
Decision Date:
TBD
Decision:
TBD
Predicate Devices:
- IQQA-Liver Software (K061696), EDDA Technology .
Description of the Device
Synapse 3D Liver Analysis is an application which uses the intravenous contrasted CT study of a liver to segment the liver and various blood vessels and to perform 3D display of the results. Using the information of segmented liver, hepatic vessels, tumors, and the morphological structure of vessel system and blood supply volume of each vessel, the user can analyze the liver, vessels and tumors and plan the treatment.
Synapse 3D Liver 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 Liver Analysis is intended to provide trained medical imaging professionals, including Physicians and Radiologists, with tools to aid them in reading, interpreting, and treatment planning and accepts DICOM compliant medical images.
Synapse 3D Liver 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 Liver 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 Liver 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, and treatment planning. Synapse 3D Liver 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 Liver Analysis uses contrast enhanced computed tomographic images of the body and provides custom workflows and UI, and reporting
2
Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle. The eagle is depicted in a simple, abstract style, with thick, curved lines forming its body and wings. The text is in a sans-serif font and is evenly spaced around the circle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Ms. Kimerly A. Sharp Quality Assurance/Regulatory Affairs Associate FUJIFILM Medical System U.S.A., Inc. 419 West Avenue STAMFORD CT 06902
APR - 7 2011
Re: K110186
Trade/Device Name: Synapse 3D Liver Analysis Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: January 20, 2011 Received: January 21, 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
3
Page 2
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 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
4
Indications for Use
510(k) Number (if known):
Device Name: Synapse 3D Liver Analysis
Indications for Use:
Synapse 3D Liver 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 Liver 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 Liver Analysis uses contrast enhanced computed tomographic images of the body and provides custom workflows and UI, and reporting functions for liver analysis including, liver segmentation, tumor segmentation, segmentation of intrahepatic vessels as well as the approximation of vascular territories.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
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. Patel
(Division Sign-Off)
Office of In Vitro
510K K110186