Rapid CTA 360

Rapid CTA 360 is an AI/ML-based software that analyzes CT angiography images of the adult head to detect suspected large and medium vessel occlusions (LVO/MVO) in specific vascular segments including the internal carotid artery, middle cerebral artery, anterior cerebral artery, posterior cerebral artery, basilar artery, and vertebral artery. The device provides notifications with compressed preview images to assist clinicians in workflow triage and prioritization, operating in parallel with standard clinical image interpretation.

Rapid CTA 360 expands the predicate device (Rapid LVO K200941) from detecting only ICA and MCA-M1 occlusions to detecting Large and Medium Vessel Occlusions across six additional vascular segments (C1-C5, M1-M3, ACA, PCA, Basilar, Vertebral). The subject device uses AI/ML algorithms versus traditional software in the predicate. Both devices produce identical outputs (reports and DICOM secondary capture series), accept CTA input in DICOM format, target adult patients, and operate through the Rapid Platform with the same cybersecurity framework.

EN ISO 14971:2019 (Risk Management); IEC 62304:2006 (Software Lifecycle); IEC 62366:2015 (Usability Engineering); NEMA PS 3.1-3.20 (DICOM); UL 2900-1 (Cybersecurity); 21 CFR Part 820.20 (Verification and Validation).

The device does not raise new safety or effectiveness questions compared to the predicate because both are triage notification tools that do not alter original images and operate in parallel to standard care. Although Rapid CTA 360 detects additional vessel segments and uses AI/ML instead of traditional algorithms, the expanded clinical application follows the same fundamental workflow-support model with the same user responsibilities and outputs. The performance validation on 403 independent CTA cases demonstrated sensitivity of 92.1% and specificity of 89.0%, with confounders including high-grade stenosis and multiple comorbidities, supporting equivalent safety and effectiveness for the expanded intended use.