Intrasaccular Devices
Sim&Size
Indications for Use
Sim&Size enables visualization of cerebral blood vessels for preoperational planning and sizing for neurovascular interventions and surgery. Sim&Size also allows for the ability to computationally model the placement of neurointerventional devices. General functionalities are provided such as: • Segmentation of neurovascular structures • Automatic centerline detection • Visualization of X-ray based images for 2D review and 3D reconstruction • Placing and sizing tools • Reporting tools Information provided by the software is not intended in any way to eliminate, replace or substitute for, in whole or in part, the healthcare provider’s judgment and analysis of the patient’s condition.
Key Specifications
- Software modules: FDsize for flow-diverter devices, IDsize for intrasaccular devices, STsize for stent devices, and a common module for DICOM import and 3D vascular reconstruction
- Intended for use with 3D rotational angiography DICOM images
- Seven-step process: import images, select ROI, threshold validation, choose entry point, correct centerline, initialize implant, size implant
- Compatible operating systems: MS Windows and Mac OS
- Patient image import methods: external storage device (e.g., USB) or PACS connectivity (retrieve only)
- Output rendering: Local openGL rendering
- Supports computational modeling of specific FDA-approved IMDs in FDsize module: Medtronic Pipeline Flex (P100018/S015 and P100018/S026), Stryker Surpass Evolve (P170024/S003), MicroVention FRED (P180027) and FRED X (P180027/S002)
- Supports IDsize module: MicroVention WEB (P170032)
- Supports STsize module: Stryker Neuroform Atlas (P180031), MicroVention LVIS and LVIS Jr (P170013)
- Numerical solver: Sim&Cure Finite-Element (sacFE) in-house solver for braided and laser-cut stents
- Functionalities: Segmentation of neurovascular structures, automatic centerline detection, 2D/3D visualization, placing and sizing tools, reporting tools
- Software version: 1.1.2 (this submission)
- Predicate version: 1.0.6 (K202322)
- No patient contact
- Human intervention required for image interpretation
Description
The Sim&Size software is a medical device intended to provide a 3D view of the final placement of implants. It uses an image of the patient produced by 3D rotational angiography. It offers clinicians the possibility of computationally model neurovascular implantable medical devices (IMD) in the artery or in the aneurysm to be treated through endovascular surgery, IMD such as the flow-diverters (FD) and the intrasaccular devices (ISD). Sim&Size is a software designed with three modules. FDsize is the module that allows to pre-operationally plan the choice of size of flow-diverter devices. IDsize is the module that allows to pre-operationally plan the choice of size of intrasaccular devices. STsize is the module that allows to pre-operationally plan the choice of stent devices. Associated to these three modules, a common module is intended to import DICOM and to provide a 3D reconstruction of the vascular tree in the surgical area.