(133 days)
The Natus Brain Monitor Amplifier is intended to be used as an electroencephalograph: to acquire, display, store and archive electrophysiological signals. The amplifier should be used in conjunction with Natus NeuroWorks™/ SleepWorks™ software to acquire scalp and intracranial electroencephalographic (EEG) signals as well as polysomnographic (PSG) signals. The Natus Brain Monitor Amplifier is intended to be used by trained medical professionals, and is designed for use in clinical environments such as hospital rooms, epilepsy monitoring units, intensive care units, and operating rooms. It can be used with patients of all ages, but is not designed for fetal use.
The Natus Brain Monitor family of amplifiers are intended to be used as an electroencephalograph: to acquire, display, store and archive electrophysiological signals. The amplifier should be used in conjunction with Natus NeuroWorks™/SleepWorks™ software to acquire electroencephalographic (EEG) signals as well as polysomnographic (PSG) signals. The Natus Brain Monitor family of amplifiers are intended to be used by trained medical professionals, and are designed for use in clinical environments such as hospital rooms, clinics, epilepsy monitoring units, intensive care units, and operating rooms. It can be used with patients of all ages, but is not designed for fetal use.
The Natus Brain Monitor (Natus Embla NDx, Natus Embla SDx) are comprised of a base unit and a breakout box. It is part of a system that is made up of a personal computer, software, a photic stimulator, an isolation transformer, video and audio equipment, networking equipment, and mechanical supports. EEG and other physiological signals from electrodes placed on the head and body as well as other accessories such as pulse oximeters, respiratory effort and airflow sensors can be acquired by the amplifiers. The amplifiers include sensor inputs for respiratory effort and airflow as well as snoring. The amplifiers include an integrated pressure sensor and pulse oximeter module. These signals are digitized and transmitted to the personal computer running the Natus NeuroWorks/SleepWorks software. The signals are displayed on the personal computer and can be recorded to the computer's local storage or to remote networked storage for later review.
Here's a breakdown of the acceptance criteria and study information for the Natus Brain Monitor, based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria in a pass/fail threshold format for each performance metric. Instead, it provides a comparison to predicate devices, implying that performance comparable to or better than the predicates is acceptable. The performance is reported in the "Comparison to Predicate Device" table.
| Specification | Predicate Device (K143440, K111742, K172711) | Subject Device (Natus Brain Monitor - Natus Brain Monitor, Embla NDx, Embla SDx) |
|---|---|---|
| Referential Channels | 256 (K143440), 32 (K111742), 32 (K172711) | 40 (programmable to up to 64), 16 (Embla SDx Model) |
| Bipolar Channels | 16 (K143440), 8 (K111742), 8 (K172711) | 12, 4 (Embla SDx Model) |
| DC Inputs | 16 (+/-5Vdc or +/-2.5Vdc) | 16 (+/-5Vdc), 8 (+/-5Vdc) - For Embla SDx model |
| SpO2, Pulse Rate, Plethysmogram | Yes (all predicates, some with PPG) | Yes (with PPG) |
| Body Position | Uses universal sensor via DC input or integrated proprietary | Integrated proprietary, or uses universal sensor via DC input |
| Resolution | 24 bit, 22 bit, 16 bit | 24 bit (16 bit stored) |
| EEG Channels | 64-256, 40, 32 | 64, 20 (Embla SDx) |
| Reference Channels | Dedicated separate reference and ground, Dedicated ground | Dedicated separate reference and ground |
| Input Impedance | >1000 MOhm, >20MΩ, ≥20 ΜΩ | >1000 MOhm |
| Input Noise | 110dB@60Hz, >80dB, >80 dB (signal ref), > 100 dB (earth ref) | >106db@60Hz |
| Sampling Frequency | 256-16384 Hz, 64-512 Hz, 200-800 Hz | 256, 512, 1024, 2048, 4096 (256, 512Hz for Embla SDx) |
| Sampling Resolution - EEG channels | 24 bits, 22 bits, 16 bits | 24 bits |
| Sampling Quantization - EEG channels | 305nV, N/A, 0.06 µV/bit | 305nV |
| Storage Resolution - EEG channels | 16 bits | 16 bits |
| Impedance Check |
§ 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).