(68 days)
No
The summary describes standard image processing and calculation of physiological parameters (CBV, CBF, MTT, TTP) based on dynamic imaging data. There is no mention of AI, ML, or any learning-based algorithms. The focus is on post-processing and visualization tools for trained medical professionals.
No
This device is medical imaging software that aids in reading, interpreting, reporting, and treatment planning by post-processing medical images to assess cerebral blood flow. It does not provide any direct therapy or treatment.
Yes
The device provides tools to aid in "reading, interpreting, reporting, and treatment planning" and helps "aid the assessment of cerebral blood flow" by calculating and mapping parameters like CBV, CBF, MTT, and TTP, which are crucial for diagnostic interpretation.
Yes
The device is described as "medical imaging software" and its function is to process and analyze existing medical images (CT and MR) to generate parameter images. It relies on other software (Synapse 3D Base Tools) and can be integrated with a workstation, but the core device itself is presented as a software application for post-processing and analysis. There is no mention of accompanying hardware components that are 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 taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device function: Synapse 3D Brain Perfusion is medical imaging software that processes and analyzes medical images (CT and MR) acquired from the patient's body. It does not perform tests on biological samples.
- Intended Use: The intended use clearly states it's for aiding trained medical professionals in reading, interpreting, reporting, and treatment planning based on medical images.
The device works with images acquired from the body, not with samples taken from the body for laboratory testing.
N/A
Intended Use / Indications for Use
Synapse 3D Brain Perfusion 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 Brain Perfusion accepts DICOM compliant medical images acquired from CT and MR.
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 Brain Perfusion provides the parameter images by post-processing with dynamic scanned CT cerebral arteriography images and magnetic resonance images (MR) with contrast agent to aid the assessment of cerebral blood flow. The parameter images are Cerebral Blood Volume (CBV), Cerebral Blood Flow (CBF), Mean Transit Time (MTT), and Time To Peak (TTP).
Product codes
LLZ
Device Description
Synapse 3D Brain Perfusion (V3.0) is the updated version of previously-cleared Synapse 3D Cerebral Analysis software (cleared by CDRH via K103687 on 03/04/2011).
Synapse 3D Brain Perfusion is used in addition to Synapse 3D Base Tools (K120361, cleared on April 6, 2012) to analyze the images acquired from CT and MR. Synapse 3D Brain Perfusion is intended to provide trained medical professionals with tools to aid them in reading, interpreting, reporting, and treatment planning of DICOM compliant medical images. This product is not intended for use with or for the primary diagnostic interpretation of mammography images.
Synapse 3D Cerebral Analysis (V3.0) is an application that analyzes the changes of the cerebral blood flow on the dynamic scanned CT cerebral arteriography and the MR images.
- Brain Perfusion (CT): Unchanged from the cleared version K103687 . Brain Perfusion is an application analyzing the changes of the cerebral blood flow on the dynamic scanned CT cerebral arteriography images. CBV (Cerebral Blood Volume), CBF (Cerebral Blood Flow), MTT (Mean Transit Time), and TTP (Time To Peak) are calculated and mapped on images.
· Brain Perfusion (MR):
Brain Perfusion is an application analyzing the changes of the cerebral blood flow on the magnetic resonance images (MR) with contrast agent. CBV (Cerebral Blood Volume), CBF (Cerebral Blood Flow), MTT (Mean Transit Time), and TTP (Time To Peak) are calculated and mapped on images.
Common image processing functions (such as window width and window level, zooming, panning, flip, rotate, adding annotations on an image, measurement of lengths, areas, etc.),are available to support the cerebral analysis of the CT and MR images. These functions belong to and are provided by Synapse 3D Base Tools (K120361) that is used with Synapse 3D Brain Perfusion (V3.0) (this submission).
The Brain Perfusion (CT) application is unchanged from the cleared version (K103465) and the Brain Perfusion (MR) is the added application.
Synapse 3D Brain Perfusion with Synapse 3D Basic/Base 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 Brain Perfusion also can be integrated with Fujifilm's Synapse Cardiovascular for cardiology purposes.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT, MR
Anatomical Site
Brain/Cerebral
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)
Synapse 3D Brain Perfusion 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 Brain Perfusion 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)
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).
0
FUJIFILM Medical Systems U.S.A., Inc. Synapse 3D Brain Perfusion (V3.0) 510(k) 12120637
MAY - 8 2012
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 Brain Perfusion
Device Common Name:
Medical Image Processing and Analysis Software
Regulation 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
1
FUJIFILM Medical Systems U.S.A., Inc. Synapse 3D Brain Perfusion (V3.0) 510(k)
Predicate Device:
- . Synapse 3D Cerebral Analysis. FUJIFILM Medical Systems U.S.A., Inc. (K103687)
- IB Neuro v1.0. Imaging Biometrics, LLC (K080762) �
Description of the Device.
Synapse 3D Brain Perfusion (V3.0) is the updated version of previously-cleared Synapse 3D Cerebral Analysis software (cleared by CDRH via K103687 on 03/04/2011).
Synapse 3D Brain Perfusion is used in addition to Synapse 3D Base Tools (K120361, cleared on April 6, 2012) to analyze the images acquired from CT and MR. Synapse 3D Brain Perfusion is intended to provide trained medical professionals with tools to aid them in reading, interpreting, reporting, and treatment planning of DICOM compliant medical images. This product is not intended for use with or for the primary diagnostic interpretation of mammography images.
Synapse 3D Cerebral Analysis (V3.0) is an application that analyzes the changes of the cerebral blood flow on the dynamic scanned CT cerebral arteriography and the MR images.
- Brain Perfusion (CT): Unchanged from the cleared version K103687 . Brain Perfusion is an application analyzing the changes of the cerebral blood flow on the dynamic scanned CT cerebral arteriography images. CBV (Cerebral Blood Volume), CBF (Cerebral Blood Flow), MTT (Mean Transit Time), and TTP (Time To Peak) are calculated and mapped on images.
· Brain Perfusion (MR):
Brain Perfusion is an application analyzing the changes of the cerebral blood flow on the magnetic resonance images (MR) with contrast agent. CBV (Cerebral Blood Volume), CBF (Cerebral Blood Flow), MTT (Mean Transit Time), and TTP (Time To Peak) are calculated and mapped on images.
Common image processing functions (such as window width and window level, zooming, panning, flip, rotate, adding annotations on an image, measurement of lengths, areas, etc.),are available to support the cerebral analysis of the CT and MR images. These functions belong to and are provided by Synapse 3D Base Tools (K120361) that is used with Synapse 3D Brain Perfusion (V3.0) (this submission).
The Brain Perfusion (CT) application is unchanged from the cleared version (K103465) and the Brain Perfusion (MR) is the added application.
Synapse 3D Brain Perfusion with Synapse 3D Basic/Base 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 Brain Perfusion also can be integrated with Fujifilm's Synapse Cardiovascular for cardiology purposes.
2
FUJIFILM Medical Systems U.S.A., Inc. Synapse 3D Brain Perfusion (V3.0) 510(k)
Indication for Use
Synapse 3D Brain Perfusion 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 Brain Perfusion accepts DICOM compliant medical images acquired from CT and MR.
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 Brain Perfusion provides the parameter images by post-processing with dynamic scanned CT cerebral arteriography images and magnetic resonance images (MR) with contrast agent to aid the assessment of cerebral blood flow. The parameter images are Cerebral Blood Volume (CBV), Cerebral Blood Flow (CBF), Mean Transit Time (MTT), and Time To Peak (TTP).
Technological Characteristics
Synapse 3D Brain Perfusion 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 Brain Perfusion 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 Brain Perfusion 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.
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 forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the emblem.
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, Ouality and Clinical Affairs FUJIFILM Medical Systems, Inc. 419 West Avenue STAMFORD CT 06902
MAY - 8 2012
Re: K120637
Trade/Device Name: Synapse 3D Brain Perfusion 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 1, 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
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,
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 Brain Perfusion
Indications for Use:
Synapse 3D Brain Perfusion 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 Brain Perfusion accepts DICOM compliant medical images acquired from CT and MR.
This product is not intended for use with or for the primary diagn ostic interpretation of Mammography images.
Addition to Synapse 3D Base Tools, Synapse 3D Brain Perfusion provides the parameter images by post-processing with dynamic scanned CT cerebral arteriography images and magnetic resonance images (MR) with contrast agent to aid the assessment of cerebral blood flow. The parameter images are Cerebral Blood Volume (CBV), Cerebral Blood Flow (CBF), Mean Transit Time (MTT), and Time To Peak (TTP).
Prescription Use × 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 of Radiological Device Office of in V
510K
Page 1 of