FLASH EVD System (10-0002)
7D Surgical ULCThe FLASH EVD System is a stereotactic image-guided navigation tool designed to assist surgeons in the precise placement of external ventricular drain catheters during neurosurgery. It uses preoperative imaging and real-time tracking to improve accuracy and workflow during procedures that relieve intracranial pressure. This helps surgeons position instruments more accurately without rigidly fixing the patient or instruments.
Intended Use
FLASH EVD is a stereotactic image guidance system intended for the spatial positioning and orientation of neurosurgical instruments. It is indicated for cranial surgery where reference to a rigid anatomical structure can be identified, without requiring rigid fixation of the patient or navigated instrument guide.
Technology
The FLASH EVD System integrates preoperative tomographic imaging with intraoperative structured light scanning to provide spatial image registration. It tracks navigation tools in real time relative to the patient's anatomy, supported by software that links instrument position and orientation to preoperative image data. It uses a non-rigid fixation approach and single-use sterile navigation tools in procedural kits.
Performance
Comprehensive verification and validation activities were conducted including system, software, and instrumentation verification; surgical simulation on phantom models; sterilization and packaging validation; and conformity assessments to multiple relevant standards. Accuracy was tested using ASTM F2554-10 with clinical simulated phantom models evaluating target registration and angular trajectory errors. All accuracy and safety requirements were met. No clinical trial was required.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
8/21/2024
4 months - 2
FDA Approval
12/27/2024
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