BioTraceIO Vision (V1.7)

BioTraceIO Vision (V1.7) is a CT and MR image processing software package designed to assist physicians in planning and confirming ablation procedures. It imports medical images from CT/MR scanners and PACS systems, provides tools for segmenting anatomical structures and ablation targets, allows virtual needle placement planning for microwave and cryoablation procedures, and enables treatment confirmation through image registration and quantitative analysis of ablation zones.

The subject device expands the predicate device's functionality to support kidney ablation procedures (both MWA and cryoablation) in addition to liver ablation, adding kidney-specific segmentation algorithms and CT registration algorithms. It introduces cryoablation-specific user interface visualizations and ablation modality selection features. Both devices share the same six workflow steps, image processing functions, and core operational principles.

The submission references FDA 'Guidance on Software Contained in Medical Devices' and adherence to the DICOM standard. Testing was performed in accordance with the company's Design Control process compliant with 21 CFR Part 820.30.

The subject device is substantially equivalent because it maintains identical intended use, indications, and the same six distinct workflow steps as the predicate device (K240773). The primary technological difference—addition of kidney ablation support with adapted registration algorithms and new kidney segmentation algorithms—represents an extension of established functionality rather than fundamentally new features. Performance validation data (segmentation DICE scores, registration accuracy metrics) demonstrate equivalent safety and effectiveness, with kidney segmentation achieving 0.91 mean DICE and kidney registration achieving 3.06-4.61mm accuracy, comparable to liver results.