Brainomix 360 e-CTA

Brainomix 360 e-CTA is medical image processing software for visualizing, analyzing, and post-processing CT angiography (CTA) images. It runs on standard off-the-shelf hardware and processes DICOM-compliant images, allowing trained professionals such as physicians and medical technicians to perform image viewing and analysis to support clinical decision-making. The software is not intended for mobile diagnostic use.

The proposed device introduces three new features compared to the primary predicate: (1) an AI/ML algorithm to distinguish bone from vessels and reduce image grain, improving vessel detection; (2) accessible posterior MIP views for focused visualization of posterior large vessels; and (3) a 3D-colored transparency overlay to visualize MCA hemisphere vessel density asymmetry. These features are similar to the secondary predicate's technological approach but differ in presentation (e.g., transparency scale versus multi-colored scale).

ISO 14971:2019 (risk management), FDA Cybersecurity Guidance, and IEC 81001-5-1 (cybersecurity). The device was designed and verified in compliance with 21 CFR Part 820.30 (design controls).

The proposed device has identical intended use to the primary predicate (CTA image processing) and performs the same basic functions. Although it introduces an AI/ML algorithm and new visualization features, digital phantom testing demonstrates the algorithm reduces mean absolute error without raising new safety or effectiveness questions, and the added views and overlay are visualization enhancements that do not alter clinical workflow. The secondary predicate (Rapid) similarly uses AI/ML and colored overlays for vessel density analysis, establishing that these technological improvements are established in the market and do not require new performance evidence beyond the comparison study of 308 clinical CTA scans, which showed consistent performance across patient subgroups, scanner manufacturers, and clinical sites.