FLASH EVD System (10-0002)

The FLASH EVD System is a stereotactic image guidance system designed to assist surgeons in placing external ventricular drainage (EVD) catheters by providing real-time spatial positioning and orientation of neurosurgical instruments during cranial surgery. It uses preoperative imaging combined with intraoperative tracking to guide instrument placement without requiring rigid patient fixation or instrument guide fixation.

FLASH EVD employs the same core technology as its predicate: registration between preoperative tomographic imaging and intraoperatively captured Structured Light scanner data, real-time tracking of navigated instruments, and display of instrument position relative to patient anatomy. Both systems achieve <2.0 mm linear placement error and <2° angular placement error at 99% confidence. Key differences include FLASH EVD using single-use presterilized procedural kits versus the predicate's reusable multi-use tools, and FLASH EVD requiring no cranial fixation modality while the predicate uses a skull clamp.

ISO 10993-1 (biocompatibility), ISO 11607-1/2 (packaging validation), ISO 11137-1/2 (sterilization), IEC 62366-1 (usability engineering), ANSI/AAMI HE75 (human factors), ASTM F2554-10 (positional accuracy measurement), IEC 62304 (software lifecycle), IEC 60601-1/1-2/1-6 (electrical safety and electromagnetic compatibility), and ISO 14971 (risk management).

FLASH EVD is substantially equivalent because it performs the identical surgical function—image-guided neurosurgical instrument positioning—using the same fundamental technology (preoperative imaging registration plus intraoperative Structured Light tracking) with equivalent accuracy specifications as the predicate K192945. Although FLASH EVD uses single-use kits and requires no patient/instrument fixation (versus the predicate's reusable tools and skull clamp), these are design differences that do not raise new safety or effectiveness questions, as the core guidance mechanism, workflow, and performance characteristics remain substantially the same.