Sim&Size

Sim&Size is medical imaging software that visualizes cerebral blood vessels from 3D rotational angiography images to help surgeons plan neurovascular interventions and surgery. It allows clinicians to computationally simulate the placement and sizing of neurointerventional devices (flow diverters, stents, coils, intrasaccular devices) and provides tools for segmentation, centerline detection, 2D/3D visualization, device placement simulation, and reporting.

The subject device has the same intended use, patient contact status, operating systems (Windows, Mac OS), data management capabilities, DICOM support, and image display features as the predicate. New features in the subject device include relative sizing metrics, pore density calculation for flow diverters, and Spruce Index measurement for device deformation, plus DICOM format output for arterial reconstructions.

Not stated in this summary. The document references FDA guidance documents on 'Content of Premarket Submissions for Device Software Functions' and 'Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions' but does not cite specific ISO, IEC, or ASTM consensus standards.

The subject and predicate devices are substantially equivalent because they share the same intended use, technological characteristics, and general function. Both are software tools for preoperational planning and sizing of neurovascular devices. The new features added (relative sizing, pore density, Spruce Index) do not raise new questions of safety and effectiveness, and verification, validation, and bench testing demonstrate the device performs as intended.