SignalNED System (Model RE)

The SignalNED System (Model RE) is a portable EEG machine that records and stores electroencephalogram signals and displays quantitative EEG (qEEG) measures including relative band power (alpha, beta, delta, theta) and band power asymmetry as z-scores compared to a normative database. The device is intended to help qualified medical and clinical professionals analyze EEG data in adults but does not provide any diagnostic conclusions about the patient's condition.

The device uses 10 electrodes forming 8 recording channels, an analog-to-digital converter, samples at 250Hz with a 0.5Hz–100Hz frequency band, features a 1.8GHz Quad Cortex-A53 NXP i.MX 8M Plus processor, is battery-powered, and uses integrated 2.4 GHz IEEE 802.11 b/g/n WiFi with integrated antenna. The primary difference from the predicate K242306 is the addition of one software feature for qEEG calculation; otherwise all hardware and core functionality are identical.

ISO 10993 (Biocompatibility), IEC 60601-1 (Electrical Safety), and IEC 60601-1-2 (Electromagnetic Compatibility). Additionally, Shapiro-Wilk normality testing, linear regression analysis, and z-score performance bench testing were performed to validate the software changes.

The Subject Device is substantially equivalent to Primary Predicate K242306 because both devices are identical in intended use, technology, hardware specifications, and performance characteristics—the only difference is one additional qEEG software feature. For the Normalizing Quantitative Electroencephalograph Software component (product code OLU), the device is substantially equivalent to Secondary Predicate K171414 as both display identical qEEG measures (power spectrum density, asymmetry z-scores, spectral analysis) with only minor differences in normative database sample size and age range that raise no additional safety or efficacy questions.