(287 days)
No
The summary describes a data acquisition system for EEG/PSG recordings and associated software for display, storage, and archiving. There is no mention of AI or ML algorithms being used for analysis, interpretation, or any other function.
No.
The "Intended Use" states that the device is "intended to be used to acquire, display, store and archive electroencephalographic signals", which describes a diagnostic rather than a therapeutic function.
Yes
The intended use explicitly states that it is an electroencephalograph for acquiring, displaying, storing, and archiving electroencephalographic signals for EEG or polysomnographic (PSG) recordings, which are diagnostic procedures.
No
The device description explicitly details hardware components such as amplifiers, A/D Converters, Digital Signal Processors, storage devices, inputs, connections, a wireless adapter, and a headbox. While it works with software, it is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used to acquire, display, store, and archive electroencephalographic signals for EEG and PSG recordings. This involves measuring electrical activity from the body (specifically the scalp/face and body), not analyzing samples taken from the body (like blood, urine, or tissue).
- Device Description: The description details a system for acquiring physiological signals (EEG and PSG) and synchronizing them with video. It does not mention any components or processes related to analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any reagents, assays, or procedures typically associated with in vitro diagnostics.
In summary, the Trex HD is a device for measuring and recording physiological signals directly from the patient, which falls under the category of in vivo diagnostics or physiological monitoring, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
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.
Product codes
GWQ, OLV
Device Description
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 1
- 2 DC Inputs
- 3 Differential Inputs
- Oximeter / Photic Connection 4
- 5 Patient Event Switch Connection
- USB Connection
- Video Interface box
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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical: Testing of the Natus Trex_HD was performed in compliance with Natus Corporation design control process.
Tests performed:
- Trex HD Signal Quality Verification Test: Pass
- Trex Functionality Verification Test: Pass
- Video Synchronization Verification Test: Pass
Clinical: Clinical testing was not required to ensure safety and effectiveness of the modified device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Trex (K042150)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Image /page/0/Picture/0 description: The image shows the logo for "xltek", which is written in lowercase letters. Above the word "xltek" is a black graphic that looks like a mountain range. Below the word "xltek" is the phrase "a division of natus".
510K Summary
Date: Dec 27, 2013
FEB 1 4 2014
Submitted by: Natus Medical Incorporated DBA Excel-Tech Ltd. (XLTEK) 2568 Bristol Circle Oakville, Ontario Canada L6H 5S1
Contact Person: Sanjay Mehta Quality and Regulatory affairs Manager Natus Medical Incorporated Tel.: (905) 829-5300 ext 388 Fax .: (905) 829-5304 E-mail: sanjay mehta@natus.com
Propietary Name: Trex_HD
Common Name: Electroencephalograph
Classification Name; Full-montage standard electroencephalograph
Product code: GWQ, OLV
Device Class: II
Predicate Device: Trex (K042150)
Prior Submissions for the same device:
We reference K042150 as the predicate device only. There are no other submissions for the same device as presented here or any other communication from FDA related to it.
Description of the Modified (subject) device
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 1
- 2 DC Inputs
- 3 Differential Inputs
- Oximeter / Photic Connection 4
Same as predicate Same as predicate Same as predicate Same as predicate Same as predicate
- 5 Patient Event Switch Connection
1
Image /page/1/Picture/0 description: The image shows the logo for "xltek, a division of natus". The logo consists of a stylized "X" shape to the left of the word "xltek". Below the word "xltek" is a horizontal line, and below that is the text "a division of natus". The logo is simple and professional.
- 0
7 USB Connection
Video Interface box
Same as predicate New
Image /page/1/Picture/5 description: The image shows a Natus Xltek Trex HD device with several labeled components. The labels point to various parts of the device, including indicators for 'study in progress', connector ports, and electrode input locations. The device also features a 'Patient event' section with labeled DC inputs and a USB port.
| Trex HD Amplifier | |
|---|---|
| 1 | Power LED |
| 2 | Status LED |
| 3 | Oximeter / Photic Connection |
| 4 | Reference Input (forward) |
| 5 | Common Input (rear) |
| 6 | 24 Referential Inputs (two rows) |
| 7 | Patient Event Switch Connection |
| 8 | DC Inputs (rear row) |
| 9 | Differential Inputs (forward row) |
| 10 | USB Connection (bottom) |
Trex HD Video Interface Features
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.
2
Image /page/2/Picture/0 description: The image shows the logo for "xltek", which is described as a division of natus. The logo features a small triangle pointing upwards to the left of the word "xltek". The text is in a simple, sans-serif font and is black and white.
Image /page/2/Picture/2 description: The image shows a black Natus monitor. The monitor is rectangular with rounded edges and has a silver screw on top. The word "Natus" is printed in white on the side of the monitor.
Top view of the Video Interface Box
Image /page/2/Picture/4 description: The image shows a black Xltek Trex HD video interface device. The device has a clip on the top and a label with the text "REF 0057741". The device also has the words "Xltek Trex HD Video Interface" printed on the side. The device is sitting on a gray surface.
Bottom view of the Video Interface Box
| Wireless Transceiver - F2M03GLA | |
|---|---|
| Protocol | Bluetooth V2.0 EDR |
| Operating frequency | 2.402 - 2.480 GHz |
| Transmission power | 8dBm |
| Modulation | GFSK |
| FCCID | R47F2M03GL |
3
Image /page/3/Picture/0 description: The image shows the Xitek logo on the left side. On the right side, it shows the text "K131266: TREX HD", "510K SUMMARY", and "PAGE 4 of 11". The text indicates that this is page 4 of 11 of the 510K summary for TREX HD with the ID K131266.
Hardware Set Up
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).
Image /page/3/Figure/4 description: The image shows a diagram of a medical device setup. The diagram includes an XLTEK DT Computer connected via a USB to mini-USB cable to a camcorder and a USB 2.0 cable to a Trex HD Headbox. The camcorder is also connected to the Trex HD Video Interface Box via a LANC cable, and the Trex HD Headbox is connected to Patient Leads, with optional connections to a Patient Event Switch, Oximeter, and Photic Simulator.
4
Device-patient interaction. Accessories List:
The table below lists all accessories to the subject device. Accessories (1) to (8) enter in contact with the patient. Accessories (1) to (8) are to be connected at different regions of the scalpfface and body as illustrated on the image below. These sensors guarantees acquisition of the physiological signals and passively transfer them to the headbox. Characteristics of the sensors vary and are described (cleared) under their respective 510K submissions (see table).
Image /page/4/Figure/3 description: This image shows a diagram of a polysomnography (PSG) setup, which is a sleep study. The diagram includes various sensors attached to a person, such as EEG disc electrodes, body position sensors, respiratory effort sensor, and pulse oximeter sensor. The sensors are connected to a Trex HD Headbox, which is connected to a computer and other devices such as a camcorder and photic stimulator. A table provides descriptions and 510K numbers for the different components of the PSG setup.
5
Image /page/5/Picture/0 description: The image shows the text "K131266: TREX_HD 510K SUMMARY PAGE 6 of 11". The text is centered on the page. The text is in a sans-serif font. The text is black.
Image /page/5/Picture/1 description: The image shows the words "Indications for Use" in bold black font. The words are stacked on top of each other. The words are centered on the page.
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.
| Subject Device | Predicate Device | Comment | |
|---|---|---|---|
| Trex HD | Trex (K042150) | ||
| Specification | Value | ||
| Indications for Use | 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 XLTEK TREX is | ||
| intended to be used as an | |||
| electroencephalograph: to | |||
| acquire, digitized, store | |||
| and archive | |||
| electroencephalographic | |||
| signals. | New | ||
| device | |||
| IFU | |||
| includes | |||
| reference | |||
| to PSG | |||
| recordings | |||
| . These | |||
| type of | |||
| recordings | |||
| , although | |||
| used for a | |||
| different | |||
| purpose | |||
| compared | |||
| to EEG | |||
| only, it is | |||
| technically | |||
| similar to | |||
| multiple | |||
| parameter | |||
| EEG | |||
| recordings | |||
| . No | |||
| impact on | |||
| safety/effe | |||
| ctiveness | |||
| of the | |||
| device | |||
| Technological Characteristics | |||
| Patient Electrical Connections | |||
| 24 Referential Inputs | |||
| (+ ground, +) | +/- 10 mV | +/- 10 mV | Same |
| Subject Device | |||
| Trex HD | Predicate Device | ||
| Trex (K042150) | Comment | ||
| Specification | Value | ||
| reference) | |||
| Resolution | 16 bit A/D | 16 bit A/D | Same |
| 4 Differential Inputs | +/- 10 mV | +/- 10 mV | Same |
| Resolution | 16 bit A/D | 16 bit A/D | Same |
| Common Mode | |||
| Rejection Ratio | -113 dB @ 60 Hz | -113 dB @ 60 Hz | Same |
| DC Removal | Infinite | Infinite | Same |
| Common Mode Input | |||
| Impedance | > 10 MOhms | > 10 MOhms | Same |
| Input Noise (peak to | |||
| peak) | 6.4 μV | 6.4 μV | Same |
| Input Noise (RMS) | 1.08 μV | 1.08 μV | Same |
| Input Bias Current | Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov |
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