(287 days)
The Trex HD is an Electroencephalograph intended to be used to acquire, display, store and archive electroencephalographic signals, intended for electroencephalographic (EEG) or level 1-2 polysomnographic (PSG) recordings. The Trex HD amplifier is designed to be used with Natus NeuroWorks™or Natus SleepWorks™ software.
The Trex HD headbox is similar to the cleared Trex headbox (K042150). It contains a complete data acquisition system that has built-in amplifiers, A/D Converters, Digital Signal Processors, and storage devices. Trex HD, as the predicate device, is composed of 24 Referential Inputs, 2 DC Inputs, 3 Differential Inputs, Oximeter / Photic Connection, Patient Event Switch Connection, USB Connection, and Video Interface box. The wireless adapter is a part of Trex HD system. It connects to Camera (Camcorder) via LANC port. It is used to synchronize video frames with the EEG study recorded in Trex HD. It communicates wirelessly with the headbox and can store video synchronization internally in non-volatile memory in case the wireless communication is not possible. The Trex HD headbox is designed to work with an XLTEK computer system running NeuroWorks (K090019) or SleepWorks software (K090277). A camcorder can be used to record video. A (Trex HD) Video Interface Box is needed in order to synchronize video recording (on the camcorder) and EEG recording (on the Trex HD headbox).
This 510(k) summary describes a device, the Trex HD, which is substantially equivalent to a predicate device, the Trex (K042150). The primary change in the Trex HD is the addition of a Video Interface box for wireless video synchronization. The provided document does not contain a traditional performance study comparing the device against specific acceptance criteria with quantifiable metrics. Instead, it relies on demonstrating substantial equivalence to a predicate device and adherence to established medical device standards.
Here's an analysis based on the provided text, addressing your questions as much as possible:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly list acceptance criteria as quantifiable targets for a clinical performance study. Instead, the "acceptance criteria" are implied by the safety and performance specifications being "Same" as the predicate device (Trex K042150). The performance of the Trex HD is "reported" as Pass for specific verification tests.
| Acceptance Criterion (Implied by Predicate Spec) | Reported Device Performance (Trex HD) |
|---|---|
| Electrical Performance | |
| Referential Inputs: +/- 10mV | Same as predicate (+/- 10mV) |
| Referential Resolution: 16 bit A/D | Same as predicate (16 bit A/D) |
| Differential Inputs: +/- 10mV | Same as predicate (+/- 10mV) |
| Differential Resolution: 16 bit A/D | Same as predicate (16 bit A/D) |
| Common Mode Rejection Ratio: -113 dB @ 60 Hz | Same as predicate (-113 dB @ 60 Hz) |
| DC Removal: Infinite | Same as predicate (Infinite) |
| Common Mode Input Impedance: > 10 MOhms | Same as predicate (> 10 MOhms) |
| Input Noise (peak to peak): 6.4 µV | Same as predicate (6.4 µV) |
| Input Noise (RMS): 1.08 µV | Same as predicate (1.08 µV) |
| Input Bias Current: |
§ 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).