AV Vascular

AV Vascular is a post-processing software application that visualizes, assesses, and quantifies blood vessels in CT angiography (CTA) and MR angiography (MRA) images. It is intended to help clinicians evaluate patients with suspected or diagnosed vascular disease and plan endovascular interventions, providing tools for 2D/3D visualization, automatic vessel segmentation, measurements, and pre-procedural planning.

AV Vascular includes advanced visualization (2D, MIP, MPR, curved MPR, 3D volume rendering), automatic bone removal and vessel segmentation for head/neck and body CTA, automatic centerline extraction with AI-based aorto-iliac outer wall segmentation, and ring marker placement for anatomical landmarks. Key differences from the predicate include automatic AI-based vessel contouring for the aorta and iliac arteries, automatic ring marker placement at specific ostia, and support for both CTA and MRA with a unified workflow.

Not stated in this summary.

AV Vascular is substantially equivalent to the 3mensio Structural Heart/3mensio Vascular predicate device because both are Class II medical image management and processing systems with similar intended use (visualization, assessment, and quantification of vascular anatomy for diagnostic and procedural planning). Performance testing demonstrated that the AI-based algorithms for aorto-iliac wall segmentation and ring marker placement met stringent acceptance criteria (DSC >0.9, MSD <1.0 mm) on a representative US patient population, showing the device is safe and effective. The minor technological differences (additional AI features and MRA support) do not raise new safety or effectiveness concerns.