BioTraceIO Precision (2.0)

BioTraceIO Precision is a software application that analyzes ultrasound images captured during liver ablation (radiofrequency or microwave) to provide physicians with adjunctive information about the ablation zone. It displays a Reference Ablation Zone (RAZ) during the procedure and generates a BioTrace Map (BTM) post-procedure that correlates with 24-hour contrast-enhanced CT imaging. The device is intended only as adjunctive information and is not for standalone prediction or diagnosis.

Both subject and predicate devices are stand-alone software applications using proprietary computational algorithms to analyze ultrasound images. The primary differences are: (1) BTM processing time optimized to display results 15 minutes post-procedure versus 30 minutes; (2) RAZ algorithm adapted to use the same architectural framework as BTM; (3) user interface improvements including button layout and reference frame selection; (4) cybersecurity enhancements including PHI encryption; (5) technical modifications including name change and software framework architecture changes.

Testing conducted in accordance with FDA 'Guidance on Software Contained in Medical Devices' and adherence to the DICOM standard. Design control process followed 21 CFR Part 820.30.

The device maintains identical intended use and principles of operation as the predicate device (BioTraceIO Lite). Algorithmic validation testing demonstrated equivalent performance with mean DICE coefficients of 84.7 for the optimized BTM versus 85.5 for predicate BTM (p=0.2408, non-significant), both compared to 24-hour post-ablation CECT. The optimized BTM showed significantly higher correlation to T=24 CECT versus T=0 CECT. Minor differences in processing time, UI, and architecture do not raise new safety or effectiveness issues. The device meets user needs and requirements substantially equivalent to the predicate.