FFRangio System
CathWorks LtdThe FFRangio System is an AI-based software device used to analyze standard angiographic images (X-ray based) of coronary arteries. It generates a 3D computer model from these images to simulate blood flow and calculate FFRangio, a measure that helps clinicians assess coronary artery disease functionally. It aids in clinical decision-making by providing detailed physiological information during catheterization procedures without invasive measurements.
Intended Use
Software device for quantitative and qualitative analysis of angiography DICOM data to support functional evaluation of coronary artery disease.
Technology
The system uses standard DICOM angiographic images from X-ray imaging in the cath lab, constructs a 3D computer model of coronary arteries, and simulates blood flow to compute FFRangio, a derived physiological metric. Operated on a mobile cart with computer processing and user interface, it allows real-time analysis during procedures.
Performance
Performance testing included software verification and validation, hardware safety testing, electromagnetic compatibility, transportation, and extensive clinical validation in multicenter international trials comparing FFRangio results with invasive FFR measurements. The pivotal FAST-FFR study demonstrated high sensitivity (93.5%) and specificity (91.2%) indicating accurate, reliable functional assessment of coronary artery disease. Human factors studies confirmed usability and safety for intended users.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
8/8/2018
4 months - 2
FDA Approval
12/19/2018
Other devices from CathWorks Ltd
- FFRangio2019 • 510K
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