📋 FDA Reference
Brightmatter Guide with Surface Trace Registration
Synaptive Medical
Summary: The BrightMatter Guide with Surface Trace Registration is a medical device used in neurosurgery to assist with tumor ablation procedures. It is primarily used by neurosurgeons to enhance precision and safety during surgery.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K153281 ↗
Decision Date ?
March 30, 2016
Product Code ?
HAW
Device Class ?
Class 2
Evidence ?
0 studies
The BrightMatter Guide with Surface Trace Registration was cleared through the FDA 510(k) pathway on March 30, 2016. Manufactured by Synaptive Medical, it is classified as a Class 2 device under product code HAW.
What It Is
The BrightMatter Guide with Surface Trace Registration is a sophisticated surgical navigation system designed to assist neurosurgeons during brain tumor ablation procedures. It integrates advanced imaging and surface trace registration technology to provide real-time, 3D visualization of the brain. This helps surgeons navigate complex brain structures with enhanced accuracy and safety.
FDA-Cleared Indications
- Used to assist with the ablation of brain tumors during neurosurgical procedures.
- Provides image-guided navigation and surface trace registration to help the surgeon localize and approach the treatment target.
Clinical Applications
- Image-guided navigation during surgical ablation of brain tumors.
- Surface trace registration to correlate the patient's anatomy with preoperative or intraoperative imaging.
- Neurosurgical localization of a brain tumor and the planned ablation pathway.
- Assistance with targeting while helping the surgeon avoid intended critical brain structures.
Practical Considerations
- The system requires appropriate setup, patient registration, and calibration before use.
- Use depends on compatible imaging, navigation, and neurosurgical equipment; compatibility should be confirmed with the manufacturer and facility.
- The device should be used by trained neurosurgical personnel familiar with image-guided surgery.
- MRI safety depends on the specific system components and the imaging environment; do not bring components into an MRI scanner unless their labeling specifically permits it.
- Navigation supports surgical decision-making but does not replace direct visualization, clinical judgment, or the surgeon's assessment of anatomy.
Frequently Asked Questions
What is BrightMatter Guide with Surface Trace Registration used for?
It is used to assist neurosurgeons in the precise ablation of brain tumors by providing real-time, 3D visualization and navigation.
What specialties typically use this device?
This device is primarily used by neurosurgeons in the field of neurosurgery.
What are the FDA-cleared indications?
The device is indicated for use in assisting with the ablation of brain tumors, providing enhanced visualization and navigation during surgical procedures.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.