Sim&Size

Sim&Size is a software-as-a-medical-device for planning neurovascular interventions and surgery. It visualizes cerebral blood vessels from 3D rotational angiography images and simulates placement and sizing of implantable devices (flow diverters, stents, intrasaccular devices, and coils) to support preoperational planning. The software provides segmentation, centerline detection, 2D/3D visualization, and sizing tools, but does not replace physician judgment.

Sim&Size is a standalone software running on Windows or Mac computers that processes DICOM images from 3D rotational angiography. It supports local file import and PACS connectivity. Key new features in K242124 include pull-down maneuver simulation for flow diverter deployment in fusiform aneurysms, compression indication assessment for intrasaccular devices, and addition of new implantable device models (Pipeline Vantage, Surpass Elite, LVIS EVO, and additional coil systems). Output formats expanded to include VTP format alongside DCM and PDF.

Not stated in this summary.

The subject device has identical intended use, indications, and core functionalities as the predicate (K222664). Both are non-contact software tools that do not control life support and require human interpretation. The added features (pull-down maneuver, compression indication, new device models, and VTP export) represent incremental enhancements to simulation capability that do not fundamentally change the device's purpose or mechanism. Verification, validation, bench testing, and retrospective in vivo testing all demonstrated the device performs as intended without raising new safety or effectiveness questions.