(56 days)
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.
The device does not provide any diagnostic conclusions about the subject's condition and does not provide any automated alerts of an adverse clinical event. The Natus BrainWatch System is intended for use within a professional healthcare facility or clinical research environment. The Natus BrainWatch Headband is intended for single-patient use.
The Natus BrainWatch system is a reliable, mobile, and easy-to-use EEG device intended to record, store, and visually present EEG signals to assist trained medical staff in making neurological diagnoses in patients.
The system includes a touchscreen tablet as its primary interface. The Natus BrainWatch Headband is a single-use disposable headpiece with an integrated array of 10 passive electrodes that are applied to the patient's head to record EEG signals when connected to an amplifier.
The Natus BrainWatch System consists of the following components: Tablet, IV Pole Handle, Amplifier, Headband(s), Gel Pods and a Mobile Application:
- Touchscreen Tablet with charger
- Single-Use disposable elastic fabric headband with 10 electrodes (available in sizes Small, Medium, and Large) containing:
- Hydroflex patch with 2 built-in electrodes
- 8 electrodes attached to gel pods used to improve impedance levels labeled L1-L4, R1-R4
- Wireless amplifier that attaches to the headband and connects to the tablet via Bluetooth
- IV pole handle that holds the tablet for a hands-free experience
- Gels pods attach to the electrodes to improve impedance levels
The Natus BrainWatch System is a portable 10-channel EEG monitoring system. 10 patient electrodes are used to record the 10 channels. Channels 1-5 should be used for the patient's left hemisphere, with channel 1 at the front of the patient's head and channel 5 at the back. Channels 6-10 should be used for the patient's right hemisphere, with channel 6 at the front of the patient's head and channel 10 at the back.
EEG recording files are transferred wirelessly to a computer from the Natus BrainWatch Tablet using a Wi-Fi connection. The EEG sessions from Natus BrainWatch are stored using a cloudbased solution which allows the end user to view studies at a later date. Recorded sessions can be reviewed remotely on a computer using the Neuroworks EEG software.
The device is a portable, 10-channel EEG monitoring system. The device connects to a headband consisting of 10 patient electrodes which are used to form the 10 channels and may be used with any scalp EEG electrodes.
The system acquires the EEG signals of a patient and presents the EEG signals in visual formats in real time. The EEG recordings are displayed on a computer or tablet using an EEG viewer software. The visual signals assist trained medical staff to make neurological diagnoses. It does not provide any diagnostic conclusion about the subject's condition and does not provide any automated alerts of an adverse clinical event.
Micro-USB cable is used to connect the Natus BrainWatch System to power adapter for charging. Bluetooth is used to connect amplifier with tablet to transfer EEG recording files. When the Natus BrainWatch System is connected to a power adapter of a computer, all EEG acquisition functions are automatically disabled.
The Natus BrainWatch System is a portable 10-channel EEG monitoring system intended to record, store, and visually present EEG signals 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.
Here's a breakdown of the acceptance criteria and the study verifying the device's performance:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text details the performance verification against various standards rather than specific quantitative acceptance criteria for clinical performance. The focus is on demonstrating safety and electrical performance equivalence to predicate devices.
| Acceptance Criteria Category | Reported Device Performance (Summary) |
|---|---|
| Electrical Safety | Verified in accordance with IEC 60601-1-6:2010/AMD2:2020, IEC 60601-1:2005/AMD2:2020, and IEC 80601-2-26:2019. |
| Electromagnetic Compatibility | Verified in accordance with IEC 60601-1-2 Ed 4.1. Underwent Wireless Coexistence testing per ANSI C63.27-2021. FCC Part 15 certified. |
| Packaging & Handling | Successfully passed verification as per ASTM D4169-22. |
| Bench Verification & Validation (Functional/Performance) | Successfully passed performance verification and validation in accordance with internal requirements and specifications. Met defined acceptance criteria for functional and performance characteristics. |
| EEG Specific Performance | Met requirements for basic safety and essential performance of electroencephalographs per IEC 80601-2-26. Met Performance Criteria of FDA Guidance "Cutaneous Electrodes for Recording Purposes - Performance Criteria for Safety and Performance Based Pathway". |
| Battery Safety | Tested per IEC 62133. |
| Biocompatibility | Patient contacting components (including conductive electrolyte gel) verified with Irritation, Sensitization, and Cytotoxicity testing per ISO 10993-5:2009, ISO 10993-23:2021, and ISO 10993-10:2021. |
| Shelf-life | Shelf-life testing performed. |
| Wireless Technology | Utilizes Bluetooth 5.0 technology (similar to reference device CGX Quick-20m K203331). No interference with other electronic devices; coexists well in a typical medical environment. |
| Analogue-to-Digital Conversion | 24-Bit Delta-Sigma (Same as Predicate 1). |
| Sampling Rate | 250 Hz (Same as Predicate 1). |
2. Sample size used for the test set and the data provenance
The document does not specify a separate "test set" in the context of clinical data for algorithmic performance. The testing described is primarily bench and engineering verification against international standards. Therefore, information about sample size, country of origin, or retrospective/prospective nature of a clinical test set is not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as the provided information does not describe a study involving clinical ground truth establishment by experts for a test set. The device assists trained medical staff in making diagnoses but does not provide diagnostic conclusions itself.
4. Adjudication method for the test set
Not applicable, as there is no described clinical study involving a test set and ground truth adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No MRMC comparative effectiveness study is described. The device is a data acquisition and visualization tool; it does not explicitly feature AI for interpretation or diagnostic assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The "Natus BrainWatch System" is an electroencephalograph (EEG) device that records and visually presents signals for trained medical staff to interpret. It does not provide any diagnostic conclusions or automated alerts, meaning it is not a standalone diagnostic algorithm.
7. The type of ground truth used
Not applicable. The testing focuses on engineering performance, safety, and functional compliance rather than diagnostic accuracy against a clinical ground truth (e.g., pathology, outcomes data, or expert consensus).
8. The sample size for the training set
Not applicable, as the document does not describe the development or validation of an AI algorithm with a training set. The device's function is to capture and display raw EEG signals.
9. How the ground truth for the training set was established
Not applicable, as there is no described training set or AI algorithm for which ground truth would need to be established.
§ 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).