| K-number | K250239 |
| Device name | NeuroMatch |
| Applicant | LVIS Corporation |
| Product code | OLX |
| Device class | Class II |
| Decision date | May 23, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 882.1400 |
NeuroMatch is a cloud-based software that reviews, monitors, displays, and analyzes electroencephalogram (EEG) data from patients ≥18 years old. It includes seizure detection, spike detection, artifact reduction, quantitative EEG measures, source localization, and source localization trends to aid neurologists in EEG assessment. The device does not provide diagnostic conclusions and is not intended to substitute for real-time EEG monitoring.
NeuroMatch uses sLORETA source estimation algorithm with a Boundary Element Model (BEM) forward head model and an idealized brain model for visualization, compared to the predicate Epilog PreOp which also uses sLORETA with FDM. NeuroMatch adds three novel source localization trend metrics (Maximum Amplitude Projection, Node Visit Frequency, Node Transition Frequency) not present in the predicate. Both devices process 10-20 system EEG data and operate as cloud-based software.
Not stated in this summary. The document references International Standard 10-20 electrode placement for EEG recording but does not cite specific test standards (ISO, IEC, ASTM, etc.) used for device validation.
NeuroMatch is substantially equivalent because it has the same intended use as predicate Epilog PreOp (review and analysis of EEG with seizure and spike detection for patients ≥18 years). Head-to-head clinical validation comparing NeuroMatch source localization to both the CURRY reference device and PreOp predicate demonstrated non-inferior performance (90.7% vs 86% success rate vs CURRY; 91.7% vs 91.7% vs PreOp), with performance consistent across gender and age groups. The novel source localization trends are mathematical operations on previously cleared source localization functionality and were verified through software testing and clinician surveys confirming their utility. Technological differences (idealized vs individualized head models, BEM vs FDM, added trends) do not raise new safety or effectiveness questions because comparative testing demonstrates equivalent clinical performance.
View the full FDA submission: accessdata.fda.gov