ClearPoint System (Software Version 3.0)
ClearPoint Neuro, Inc.The ClearPoint System (Software Version 3.0) is a software platform that assists neurosurgeons by providing precise stereotactic guidance during neurological procedures such as biopsies and deep brain stimulation lead placements. It integrates with MR and CT imaging to automatically identify and segment brain structures and hardware components, improving procedure planning and monitoring. This system enhances the clinician's ability to accurately navigate and operate within the brain, supporting safer and more effective interventions.
Intended Use
The ClearPoint System is intended to provide stereotactic guidance for the placement and operation of instruments or devices during planning and operation of neurological procedures within an operating room environment and in conjunction with MR and/or CT imaging. It also provides functionality for automatic identification, labeling, visualization, and quantification of segmentable brain structures from loaded MR images.
Technology
ClearPoint System 3.0 includes software modifications to support intraoperative CT imaging workflow in addition to MR imaging. It features automatic segmentation of hardware components from CT images, enhanced image fusion and registration tools, and clinical workflow improvements post device insertion. It integrates stereotactic guidance with a hardware platform consisting of adjustable frames and accessories providing trajectory guidance during neurosurgical procedures.
Performance
Extensive non-clinical verification and validation were performed, including automated verification, integrated system verification with MR imaging, regression testing, manual testing, and accuracy verification using CT imaging. Testing demonstrated positional and angular accuracy within clinically acceptable ranges, confirming the system's safety and effectiveness for MR- and CT-guided neurosurgical procedures.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
11/27/2024
1 month - 2
FDA Approval
1/24/2025
Other devices from ClearPoint Neuro, Inc.
- ClearPoint System (Software Version 2.2)2023 • 510K
- ClearPoint Maestro Brain Model2022 • 510K
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