(146 days)
The Neurosteer EEG Recorder is intended to record and store EEG signals, and to present the EEG signals in visual formats in real time. The visuals assist trained medical staff to make neurological diagnoses. The EEG Recorder does not provide any diagnostic conclusion about the subject's condition and does not provide any automated alerts of an adverse clinical event. The EEG Recorder is intended to be used in a professional healthcare facility environment.
The Neurosteer brain monitoring platform is a portable single-channel EEG that measures and records electrical activity of the brain. An adhesive electrode strip is affixed to the subject's forehead to capture the brain activity signal. The strip is attached to a sensing device that transmits the signal via low-energy Bluetooth (BLE) to a local brain activity monitor.
The brain activity monitor provides technical status indicators about the recording (such as battery level, connection status, and electrode disconnection alert). It can also be used to provide auditory prompt sequences (using an external speaker) during monitoring.
The signal is sent via a secure Internet connection to the cloud (either wireless Wi-Fi or physical Ethernet) where the data is stored according to HIPAA quidelines. Data processing performed in the cloud transforms the raw electrical brain activity signal into a display representation of the signal.
When the Internet connection is available, both the raw and processed data can be viewed in real-time on the brain activity monitor and through the web portal. When the connection is not available, only the raw data can be viewed in real-time on the brain activity monitor.
For the Neurosteer EEG Recorder (K221563), the acceptance criteria and the study proving the device meets these criteria are outlined below, primarily focusing on its technical performance rather than a diagnostic accuracy study involving human readers. This device is an EEG recorder, not a diagnostic AI tool, and thus the performance evaluation is centered on its ability to accurately record and present EEG signals.
1. Table of Acceptance Criteria and Reported Device Performance
The Neurosteer EEG Recorder's performance was assessed against established standards for EEG devices and electrodes. The table below summarizes the key acceptance criteria and the corresponding reported performance.
| Test Category | Specific Test / EC12 Clause | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Biocompatibility | ISO 10993-1 (Cytotoxicity, Irritation, Sensitization) | All endpoints (Cytotoxicity, Irritation, Sensitization) within acceptable limits. | All samples passed the acceptance criteria. |
| Electrical Safety | IEC 60601-1 (on Electrode Strip, Sensor, Brain Activity Monitor, charger, power adapter) | All electrical safety parameters within acceptable limits. | All samples passed the acceptance criteria. |
| Electromagnetic Compatibility (EMC) | IEC 60601-1-2 and ETSI EN 301 489-1 (on Electrode Strip and Sensor) | All EMC emissions and immunity parameters within acceptable limits. | All samples passed the acceptance criteria for each test. |
| Battery Safety | IEC 62133 (Sensor's rechargeable lithium-ion polymer battery) | All battery safety parameters within acceptable limits. | All samples passed the acceptance criteria. |
| EEG Essential Performance | IEC 80601-2-26 (on Sensor and Brain Activity Monitor) | All essential EEG performance parameters within acceptable limits. | All samples passed the acceptance criteria. |
| Electrode Performance (ANSI/AAMI EC12) | |||
| 5.2.2.1 (AC Impedance of electrode pairs) | ≤ 3,000 ohm | All samples passed the acceptance criteria. | |
| 5.2.2.2 (DC Offset Voltage of electrode pairs) | ≤ 100 mV (following a 1 min stabilization period) | All samples passed the acceptance criteria. | |
| 5.2.2.3 (Combined Offset Instability and Internal Noise) | ≤ 150 uV (peak-to-peak passband voltage, measured for 5 min after 1 min stabilization) | All samples passed the acceptance criteria. | |
| 5.2.2.4 (Defibrillation Overload Recovery) | - Discharge time to 2V ≤ 2,000ms |
- Recovery to
§ 882.1400 Electroencephalograph.
(a)
Identification. An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.(b)
Classification. Class II (performance standards).