Natus BrainWatch System
Natus Medical Incorporated DBA Excel-Tech Ltd. (XLTEK)The Natus BrainWatch System is a portable EEG monitoring device that records and visually presents EEG signals to assist trained medical personnel in neurological diagnosis for patients aged 2 years and older. It features a disposable headband with integrated electrodes, wireless connectivity, and cloud storage, enabling rapid and convenient EEG monitoring in healthcare settings.
Intended Use
The Natus BrainWatch System including the Natus BrainWatch Headband, is intended to record and store EEG signals and present these signals visually to assist trained medical staff in making neurological diagnoses in patients aged 2 years and older. It does not provide diagnostic conclusions or automated alerts of adverse clinical events. It is intended for use within professional healthcare or clinical research, with the headband for single-patient use.
Technology
The system includes a single-use disposable headband with 10 integrated electrodes, a wireless amplifier connecting via Bluetooth to a touchscreen tablet for acquisition and display of EEG signals, and cloud-based storage and review with Neuroworks EEG software. It operates with 10 EEG channels and uses conductive gel for electrodes. The system transmits data wirelessly and is portable for bedside use.
Performance
The device passed verification and validation testing including electrical safety (IEC 60601-1-6, IEC 60601-1, IEC 80601-2-26), electromagnetic compatibility (IEC 60601-1-2), battery safety (IEC 62133), and biocompatibility testing per ISO 10993 standards. Bench testing confirmed compliance with FDA guidance on cutaneous electrodes and wireless coexistence standards. Packaging and shipping tests per ASTM D4169-22 were also completed successfully.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
9/24/2024
1 month - 2
FDA Approval
11/19/2024
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