X1-FFR

The SpectraWAVE X1-FFR Software is a standalone medical device used in catheterization labs to assess coronary artery blood flow using X-ray angiography images. It calculates coronary vessel dimensions, quantifies stenosis (narrowing), and measures pressure drops in coronary vessels to estimate Fractional Flow Reserve (FFR) without requiring adenosine injection or additional radiation, intended for use by or under supervision of a cardiologist.

The subject device accepts 2D X-ray angiography in display format (vendor-independent), uses AI-derived algorithms for vessel segmentation and analytical models for FFR calculations, and displays 2D X-ray images with automatic/manual calibration, vessel dimensions, stenosis assessment, and pressure drop measurement. The predicate device accepts broader data types (DICOM format, IVUS, OCT), supports 3D reconstruction, and provides additional capabilities like ventricular wall motion and stent analysis; the subject device represents a focused subset on coronary vessel assessment.

Software development and testing complied with IEC 62304 (medical device software lifecycle processes). Usability evaluation followed ANSI/AAMI/IEC 62366-1. Design verification and validation included software development, bench testing, and summative usability testing.

The X1-FFR Software is substantially equivalent to the Pie Medical CAAS Workstation predicate device because it performs an identical subset of the predicate's indications for use (coronary vessel dimension calculation, stenosis quantification, and pressure drop measurement), is regulated under the same FDA classification (21 CFR 892.1600, Class II), uses the same product codes (QHA, LLZ), and clinical validation data demonstrated equivalence to invasive FFR measurements with minimal bias (0.00) and tight agreement limits.