(411 days)
The EEG NeuroAmp II.5s is intended to acquire, display, store and archive the electroencephalographic (EEG) signals from a patient's brain obtained by placing two or more electrodes on the head. It must be used in combination with appropriate software and computer. The EEG NeuroAmp II.5s is also intended to be used to provide stimulation and recording of visual and auditory evoked response potentials with appropriate software, computer, and accessories.
The EEG NeuroAmp II.5s can also be used for biofeedback and relaxation purposes of this training task, information for feedback may be derived from the electroencephalographic signals and from as many as eight channels of peripheral physiology measures such as are conventionally used in biofeedback.
The EEG NeuroAmp II.5s is intended to be used only by trained professionals who can ensure sound handling practices. The device is intended for use in clinical environments (not surgical or emergency environments) as well as in medical and therapeutic practices. It can be used with patients of all ages but is not designed for fetal use.
The device does not draw any diagnostic conclusion. Recorded data of electroencephalogram (EEG) signals or event related potentials (ERPs) need to be interpreted by a clinical expert. The results of such interpretation must be considered only in conjunction with other clinical findings.
The EEG NeuroAmp II.5s is a user-friendly high-performance interface between client and clinician computer. It can be used in two different functionalities: In an EEG/ERP measurement and in an EEG biofeedback (neurofeedback) and/or peripheral biofeedback setting. The EEG NeuroAmp 11.5s device itself contains three function blocks:
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- EEG amplifier, two channels, interface for 23- or 39-channel EEG recording front-end
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- Impedance meter function
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- peripheral channels for additional sensors, ERP synchronization and biofeedback
Apart from the EEG-biofeedback functionality, together with the x23/x39 accessories, it is possible to utilize the equipment as an EEG/ERP measurement device. A 23- or 39-channel EEG can be measured with conventional EEG caps, which are not part of the device, according to the standard 10-20 system. The device does not draw any diagnostic conclusions and does not invite the clinician to do so. Recorded data of electroencephalogram (EEG) signals need to be interpreted by a clinical expert. The results of such interpretation must be considered in conjunction with other clinical findings to provide context. There is no therapeutic effect of the EEG NeuroAmp II.5s used in this setting.
The NeuroAmp x23/x39 devices are a full 23-/39-channel digital EEG recording front-end with integrated impedance meter. They are an accessory to the EEG NeuroAmp 11.5s and work only in conjunction with it.
The Corscience EEG NeuroAmp II.5s is an electroencephalograph device that functions for EEG/ERP measurement and biofeedback. The device received 510(k) clearance based on substantial equivalence to predicate devices, demonstrating its safety and effectiveness through performance testing against relevant IEC and ISO standards.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the EEG NeuroAmp II.5s are implicitly defined by its performance against the specified technical requirements, which are shown to be equivalent or superior to predicate devices. The "Discussion on safety and effectiveness" column in the comparative table effectively serves as the acceptance criteria and performance review.
| Specification | Acceptance Criteria (from predicate comparison) | Reported Device Performance (EEG NeuroAmp II.5s) |
|---|---|---|
| EEG/ERP Measurement Functionality | ||
| Indications for Use (short version) | Acquire, display, store, and archive electrical activity of a patient's brain (Mitsar EEG and Natus Brain Monitor also allow stimulation and recording of evoked response potentials). | Acquire, display, store and archive the electroencephalographic (EEG) signals from a patient's brain obtained by placing two or more electrodes on the head incl. stimulation and recording of visual and auditory evoked response potentials. |
| Common name, Product code, Regulation number | GWQ, 21 CFR 882.1400 (Mitsar EEG); GWQ & OLV, 21 CFR 882.1400 (Natus Brain Monitor) | EEG/ERP measurement & biofeedback device, GWQ, GWE, GWJ, OLV & HCC, 21 CFR 882.1400, 21 CFR 882.5050, 21 CFR 882.1890 & 21 CFR 882.1900 |
| Power supply | Primarily USB port for power, with galvanic isolation (for EEG NeuroAmp, presumed for Mitsar EEG). | Power supply via USB port (galvanic isolation according to IEC 60601-1) |
| Software | EEG Studio (Mitsar EEG); Natus NeuroWorks™/SleepWorks (Natus Brain Monitor) | ERPrec |
| Windows 10 and 7 compatible | Windows 7, perhaps also Windows 10 (Mitsar EEG); Yes (Natus Brain Monitor) | Yes |
| EEG channels | 21 + 4 active/reference pairs, one auxiliary channel (Mitsar EEG); 40 (Natus Brain Monitor) | up to 41 plus 8 peripheral channels |
| Resolution EEG channels | 16 bit (Mitsar EEG); 24 bit (16 bit stored) (Natus Brain Monitor) | 24 bit, stored loss-free 24bit and full sampling rate |
| Sampling frequency | 500 Hz per channel, multiplexed (Mitsar EEG); 256, 512, 1024, 2048, 4096 (Natus Brain Monitor) | 1Msample/second gross sampling rate, down sampled to 250 or 500 sps. synchronous sampling over all EEG- and peripheral channels |
| Common-Mode Rejection Ratio (CMRR) | at least 100 dB at 10 Hz (Mitsar EEG); >106db@60Hz (Natus Brain Monitor) | >130 dB |
| Notch filter | -30 dB at 50(60) Hz (Mitsar EEG); No data (Natus Brain Monitor) | 200 MΩ (Mitsar EEG); >1000 MOhm (Natus Brain Monitor) |
| Bandwidth (3dB) and sample rate | 0.16 – 70 Hz (Mitsar EEG); 0.1 Hz – 100 Hz (Natus Brain Monitor) | DC ... 100Hz/160Hz |
| Impedance measurement EEG electrodes (electrode contact quality) | Yes, 5kΩ – 40kΩ (Mitsar EEG); Yes, 2.5kΩ, 5kΩ, 10kΩ, 25kΩ (Natus Brain Monitor) | Yes, 0 ... 140kΩ |
| Input Noise |
§ 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).