ClearPoint System (Software Version 3.0)

The ClearPoint System is a stereotactic guidance platform that helps surgeons plan and perform neurological procedures such as biopsies, electrode insertion, and deep brain stimulation (DBS) lead placement. It uses MRI and/or CT imaging to create three-dimensional maps of brain anatomy, identify target structures automatically, and guide the placement of surgical instruments with high precision during operating room procedures.

The primary technological difference from the predicate device is the addition of full software support for intraoperative CT-guided surgical workflows, whereas the predicate (v2.2) supported only MRI-guided procedures. ClearPoint 3.0 introduces automatic segmentation of hardware components from CT images, improved image fusion tools, enhanced post-insertion workflow features, and visualization of frame adjustments prior to mounting. The hardware components remain identical to the predicate device.

Not stated in this summary.

ClearPoint 3.0 is substantially equivalent because its hardware is identical in design and technological characteristics to the predicate device (K233243). The software modifications are enhancements and extensions of existing capabilities rather than fundamental changes to the device's intended purpose: both provide stereotactic guidance using MRI and now CT imaging with equivalent accuracy specifications for MRI workflows (mean positional error 0.14–0.56 mm) and validated CT accuracy (mean 0.81 mm positional error). All non-clinical testing met acceptance criteria, demonstrating that CT-guided functionality does not raise different questions of safety or effectiveness compared to the established MRI-only predicate.