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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
510K
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.
Clinical Applications
This device is commonly used in neurosurgical procedures, particularly for patients with brain tumors requiring precise ablation. It is utilized in both hospital and specialized surgical center settings. Neurosurgeons rely on this technology to improve surgical outcomes by minimizing damage to healthy brain tissue and enhancing the precision of tumor removal.
Indications for Use
The FDA-cleared indications for this device include its use in assisting with the ablation of brain tumors. It is intended for patients who require surgical intervention for tumor removal, providing enhanced visualization and navigation during the procedure.
Practical Considerations
The BrightMatter Guide is compatible with standard neurosurgical instruments and integrates seamlessly with existing imaging systems. Surgeons should be trained in its use to maximize the benefits of its advanced navigation capabilities. The system's setup and calibration are crucial for optimal performance during surgery.
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.