PreOp v3

PreOp V3 is medical device software that combines EEG data and MRI images to visualize recorded brain electrical activity in 3D. It is intended for use by trained EEG technologists or physicians on adult and pediatric patients at least 3 years old to visualize human brain function by fusing EEG information with individualized head models and MRI images.

PreOp V3 uses sLORETA source estimation and Finite Difference Model (FDM) forward head modeling, like the predicate. Key improvements include integration with Persyst EEG software for direct access within a single interface, support for both idealized and patient-specific MRI models, automated preprocessing and spike detection with enhanced morphology and topography-based clustering, modernized cloud-native microservices architecture, and 3D visualization capabilities for head models and electrode positioning.

Software verification and validation testing conducted in accordance with IEC 62304:2006 + A1:2015 (Medical device software – Software life-cycle processes, FDA Recognition Number 13-79). Testing followed FDA's 2023 guidance on 'Content of Premarket Submissions for Device Software Functions.'

PreOp V3 is substantially equivalent to the predicate PreOp (K172858) because it maintains identical intended use, patient population (adults and pediatric subjects ≥3 years), same core functional principles (sLORETA source estimation and FDM modeling), and same prescription-only classification. The technological enhancements represent workflow, architectural, and performance improvements without changing the fundamental technology or operational principles.