FFRangio
CathWorks LtdThe FFRangio System is a software tool that analyzes previously acquired angiographic images using 3D computer modeling to simulate blood flow in coronary arteries. It provides a mathematically derived value to support the functional assessment of coronary artery disease, helping clinicians evaluate artery physiology and make informed treatment decisions.
Intended Use
Clinical quantitative and qualitative analysis of previously acquired angiography DICOM data to provide a mathematically derived quantity (FFRangio) for functional evaluation of coronary artery disease.
Technology
FFRangio uses standard angiographic DICOM images to generate a 3D computer model of coronary arteries by user marking key features on images. Blood flow is simulated using this model to compute the FFRangio index. The system comprises a touchscreen console, a processing unit, optional 3D mouse, and connection box, supporting display on cath lab monitors.
Performance
Performance testing included software validation per FDA guidance and ISO 62304, electrical safety and electromagnetic compatibility testing per IEC standards, FCC compliance for wireless components, hardware verification, transportation and human factors usability testing. Clinical data was not required for this modification as algorithms remain unchanged. The device demonstrated 93.5% sensitivity and 91.2% specificity in prior pivotal clinical study.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
9/6/2019
3 months - 2
FDA Approval
12/9/2019
Other devices from CathWorks Ltd
- FFRangio System2018 • 510K
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