Brainomix 360 Triage LVO

Brainomix Limited

510k9/28/2023

FDA #

K231837

Product Code

QAS

Panel

Radiology

Modality:CT Task:Triage Body Region:Neurological Target Condition:Large Vessel Occlusion

Brainomix 360 Triage LVO is an AI-powered software that analyzes CT angiogram images to detect suspected large vessel occlusions in the brain. It assists hospital clinicians by providing priority notifications and compressed image previews via a mobile app or web interface, helping specialists quickly identify and review critical cases in parallel with standard workflows. This tool supports faster triage but is not intended for diagnostic use on its own.

Intended Use

Brainomix Triage LVO is a notification-only, parallel workflow tool for use by hospital networks and trained clinicians to identify and communicate images of specific patients to a specialist, independent of standard of care workflow. The device analyzes CT angiogram images of the brain acquired in the acute setting, and sends notifications to a neurovascular specialist that a suspected large vessel occlusion (LVO) has been identified and recommends review of those images.

Technology

Brainomix 360 Triage LVO is a stand-alone software running on physical or virtual servers, using machine learning algorithms and advanced imaging to automatically identify suspected LVO on CT angiogram images. It integrates with DICOM-compliant imaging devices and provides notifications via mobile app and web interface. It sends compressed images for preview, while original images must be reviewed on diagnostic viewers.

Performance

A retrospective standalone performance evaluation was conducted on an independent dataset of 308 CTA scans from 14 US hospitals, showing sensitivity of 90% and specificity of 92.9% for detecting LVO, with an AUC of 91.4%. The device's time-to-notification was measured at less than 3.5 minutes, meeting regulatory criteria. Performance was consistent across different patient subgroups and scanner types.

View FDA documentation

Predicate Devices

No predicate devices specified

Device Timeline

1
Submission
6/22/2023
3 months
2
FDA Approval
9/28/2023

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