(77 days)
Not Found
Not Found
No
The summary describes standard image post-processing techniques (calculating CBV, CBF, MTT, TTP) from dynamic CT data, which are not inherently AI/ML. There is no mention of AI, ML, deep learning, training data, or performance metrics typically associated with AI/ML devices.
No.
The device is described as medical imaging software that aids in reading, interpreting, reporting, and treatment planning, rather than directly providing therapy.
Yes
The "Intended Use / Indications for Use" section states that the software provides "tools to aid them in reading, interpreting, reporting, and treatment planning." Interpretation of medical images for diagnostic purposes falls under the definition of diagnostic aid. The output includes "parameter images" (CBV, CBF, MTT, TTP) to "aid the assessment of cerebral blood flow," which is a diagnostic function.
Yes
The device is explicitly described as "medical imaging software" and its function is to process and analyze existing medical images (DICOM compliant CT images) to generate parameter images. There is no mention of any accompanying hardware or hardware components being part of 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: The description clearly states that Synapse 3D Cerebral Analysis is medical imaging software that processes CT images. It does not involve analyzing samples taken from the body.
- Intended Use: The intended use is to aid medical imaging professionals in reading, interpreting, reporting, and treatment planning based on medical images.
Therefore, this device falls under the category of medical imaging software, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Synapse 3D Cerebral 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 Cerebral 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 Cerebral Analysis provides the parameter images by post-processing with dynamic scanned CT cerebral arteriography images 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
Medical Image Processing and Analysis Software
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT
Anatomical Site
Cerebral
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)
Not Found
Reference Device(s)
Not Found
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
MAR - 4 2011
5. 510(k) Summary
Date Prepared:
December 16, 2010
Submitter's Information:
FUJIFILM Medical Systems USA, Inc. 419 West Avenue Stamford, Connecticut 06902
Telephone: (203) 602-3774 Fax: (203) 363-3813 Contact: Debra A. Peacock
Device Trade Name:
Synapse 3D Cerebral 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
Image /page/1/Picture/0 description: The image shows the logo for the Department of Health & Human Services. The logo includes the department's emblem on the left, followed by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in a clear, sans-serif font. A horizontal line is placed beneath the text, visually separating the department's name from any content that might follow.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Ms. Debbie Peacock Regulatory Affairs Manager FUJIFILM Medical Systems, USA Inc. 419 West Avenue STAMFORD CT 06902
MAR - 4 251
Re: K103687
Trade/Device Name: Synapse 3D Cerebral Analysis Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: December 17, 2010 Received: December 17, 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
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 5100%) premarket notification. The FDA finding of substantial equivalence of your device to a legally romarketed 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 Pastel
Mary Pastel, ScD. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known): ربع 63 (23 10 1 1
Device Name: Synapse 3D Cerebral Analysis
Indications for Use:
Synapse 3D Cerebral 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 Cerebral 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 Cerebral Analysis provides the parameter images by post-processing with dynamic scanned CT cerebral arteriography images 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_ X | A |
|---|---|
| (Part 21 CFR 801 Subpart D) |
ND/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)
| (Division Sign-Off) |
|---|
| Division of Radiological Devices |
| Office of In Vitro Diagnostic Device Evaluation and Safety |
| K103687 |
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