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.

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, 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).

AI/ML Overview

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: < 10 pA	Same as predicate (< 10 pA)
Channel Crosstalk: 56 dB	Same as predicate (56 dB)
Electrode Connections: Safety Touch	Same as predicate (Safety Touch)
Non-Isolated DC Inputs: +/- 5 Volts	Same as predicate (+/- 5 Volts)
Non-Isolated DC Resolution: 16 bit A/D	Same as predicate (16 bit A/D)
Impedance: <2.5, <5, <10, <25 kOhm	Same as predicate (<2.5, <5, <10, <25 kOhm)
Channel Test Signal: Software selectable	Same as predicate (Software selectable)
Sampling Frequency: 200 Hz, 256 Hz, 512 Hz	Same as predicate (200 Hz, 256 Hz, 512 Hz)
*Physical/Functional Performance*
Oximeter/Photic Stim Connection	Same as predicate (Yes)
Patient Event Button	Same as predicate (Yes)
Interface Cable: USB 2.0	Same as predicate (USB 2.0)
USB Cable Length	Same as predicate (Standard: 68 inches, Max: 15 feet)
Main Unit Weight: 300g	Same as predicate (300g)
Main Unit Size: 10 x 15.5 x 2.5 (h x w x d) cm	Same as predicate (10 x 15.5 x 2.5 (h x w x d) cm)
Batteries: 2 AA	Same as predicate (2 AA)
*Safety Performance*
Leakage Current: <10 µA with 240 VAC	Same as predicate (<10 µA with 240 VAC)
*Non-Clinical Tests*	*Results*
Trex HD Signal Quality Verification Test	Pass
Trex Functionality Verification Test	Pass
Video Synchronization Verification Test	Pass
Compliance with various safety and EMC standards	Full compliance with listed standards (e.g., IEC 60601-1, IEC 60601-2-26, IEC 60601-1-2, various IEC 61000 series, CISPR 11)
*Wireless Transceiver*
Protocol	Bluetooth V2.0 EDR
Operating frequency	2.402 - 2.480 GHz
Transmission power	8dBm
Modulation	GFSK
FCCID	R47F2M03GL

2. Sample Size Used for the Test Set and Data Provenance

The document states: "Non-clinical: Testing of the Natus Trex_HD was performed in compliance with Natus Corporation design control process." It then lists three verification tests that "Pass."

Sample Size: The document does not specify a quantitative sample size for any of the verification tests. It implies that these tests were conducted on a sufficient number of devices or components to demonstrate compliance with design control processes.
Data Provenance: The tests are non-clinical, implying they were conducted in a laboratory or engineering setting by the manufacturer, Natus Medical Incorporated DBA Excel-Tech Ltd. (XLTEK) in Oakville, Ontario, Canada. This is retrospective in the sense that the testing was performed during the development and verification phase of the device before submission for regulatory clearance. It is not clear if any data from humans was used for "Signal Quality Verification".

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Number of Experts: This information is not provided.
Qualifications of Experts: This information is not provided.

Given that this is a non-clinical submission for an EEG amplifier and video synchronization system, and not an AI/diagnostic device that interprets medical images/signals, the concept of "ground truth established by experts" as in a clinical setting is not applicable here. The "ground truth" for these engineering verification tests would likely be established by comparing device output against known input signals or reference measurements using calibrated equipment.

4. Adjudication Method for the Test Set

This information is not provided, and it's generally not applicable for non-clinical engineering verification tests of this type. Adjudication methods like "2+1" or "3+1" are relevant for clinical studies involving human interpretation or subjective assessment where consensus building is required.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

Was an MRMC study done? No, an MRMC comparative effectiveness study was not done. The submission explicitly states: "Clinical: Clinical testing was not required to ensure safety and effectiveness of the modified device."
Effect Size: Not applicable, as no MRMC study was performed.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done

The device is an Electroencephalograph (EEG) and a video interface, not an AI algorithm. "Standalone performance" in this context would refer to the technical performance of the device hardware and its synchronization capabilities. The document reports "Pass" for "Trex HD Signal Quality Verification Test," "Trex Functionality Verification Test," and "Video Synchronization Verification Test." These are essentially standalone performance tests of the device's technical specifications.

7. The Type of Ground Truth Used

For the non-clinical tests ("Signal Quality Verification," "Functionality Verification," "Video Synchronization Verification"), the "ground truth" would be established by:

Known input signals: Introducing precisely calibrated electrical signals to the EEG inputs and verifying the accuracy and fidelity of the recorded output signals.
Reference timing standards: For video synchronization, comparing the timestamps generated by the device against a known, accurate time reference or by directly measuring synchronization accuracy between video frames and EEG datastreams.
Conformance to engineering specifications: The device's electrical characteristics (e.g., resolution, noise, CMRR) are compared against the established design specifications, which are themselves based on industry standards and the performance of the predicate device.

It is not "expert consensus, pathology, or outcomes data," as these are clinical ground truths.

8. The Sample Size for the Training Set

This information is not applicable. The Trex HD is a medical device hardware system for acquiring physiological signals, not an AI or machine learning algorithm that requires a "training set."

9. How the Ground Truth for the Training Set Was Established

This information is not applicable, as there is no training set for this type of device.

Summary

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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

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

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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.

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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.

	Wireless Transceiver - F2M03GLA
Protocol	Bluetooth V2.0 EDR
Operating frequency	2.402 - 2.480 GHz
Transmission power	8dBm
Modulation	GFSK
FCCID	R47F2M03GL

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.

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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.

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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.

	Subject Device	Predicate Device	Comment
	Trex HD	Trex (K042150)
Specification	Value
Indications for Use	The Trex HD is anElectroencephalographintended to be used toacquire, display, store andarchiveelectroencephalographicsignals, intended forelectroencephalographic(EEG) or level 1-2polysomnographic (PSG)recordings. The Trex HDamplifier is designed to beused with NatusNeuroWorks™ or NatusSleepWorks™ software.	The XLTEK TREX isintended to be used as anelectroencephalograph: toacquire, digitized, storeand archiveelectroencephalographicsignals.	NewdeviceIFUincludesreferenceto PSGrecordings. Thesetype ofrecordings, althoughused for adifferentpurposecomparedto EEGonly, it istechnicallysimilar tomultipleparameterEEGrecordings. Noimpact onsafety/effectivenessof thedevice
Technological Characteristics
Patient Electrical Connections
24 Referential Inputs(+ ground, +)	+/- 10 mV	+/- 10 mV	Same
	Subject DeviceTrex HD	Predicate DeviceTrex (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 ModeRejection Ratio	-113 dB @ 60 Hz	-113 dB @ 60 Hz	Same
DC Removal	Infinite	Infinite	Same
Common Mode InputImpedance	> 10 MOhms	> 10 MOhms	Same
Input Noise (peak topeak)	6.4 μV	6.4 μV	Same
Input Noise (RMS)	1.08 μV	1.08 μV	Same
Input Bias Current	< 10 pA	< 10 pA	Same
Channel Crosstalk	56 dB	56 dB	Same
Electrode Connections(including commoninput)	Safety Touch	Safety Touch	Same
4 Non-Isolated DCInputs	+/- 5 Volts	+/- 5 Volts	Same
Resolution	16 bit A/D	16 bit A/D	Same
Impedance (kOhm)	<2.5, <5, <10, <25	<2.5, <5, <10, <25	Same
Channel Test Signal	Software selectable	Software selectable	Same
Sampling Frequency	200 Hz, 256 Hz, 512 Hz	200 Hz, 256 Hz, 512 Hz	Same
	Physical Capabilities
	Subject DeviceTrex HD	Predicate DeviceTrex (K042150)	Comment
Specification	Value
Oximeter/Photic StimConnection	Yes (either/or)	Yes (either/or)	Same
Patient Event Button	Yes	Yes	Same
Interface Cable	USB 2.0	USB 2.0	Same
USB Cable Length	Standard Length: 68inches (~ 147 cm)Maximum Length: 15 feet(4.6 m)	Standard Length: 68inches (~ 147 cm)Maximum Length: 15 feet(4.6 m)
	Subject DeviceTrex HD	Predicate DeviceTrex (K042150)	Comment
Specification	Value
Main Unit Weight (g)	300	300	Same
Main Unit Size (cm)	10 x 15.5 x 2.5 (h x w x d)	10 x 15.5 x 2.5 (h x w x d)	Same
Batteries	2 AA	2 AA	Same
	Safety
Leakage Current	<10 μA with 240 VAC onall electrode inputs	<10 μA with 240 VAC onall electrode inputs	Same
	Operating Parameters
OperatingEnvironmental Limits	Temperature: 10°C to40°CHumidity 30%-75%Atmospheric Pressure: 700hP-1060 hP	Temperature: 10°C to40°CHumidity 30%-75% non-condensingAtmospheric Pressure:700 hP-1060 hP	Same
Transport and StorageTemperature Range	- 40°C to 70°C	- 40°C to 70°C	Same
Transport and StorageHumidity Range	10-100%, includingcondensation	10-100%, non-condensing	Same
Transport and StorageAtmospheric PressureRange	500 hPa-1060 hPa	500 hPa-1060 hPa	Same
	Wireless Transceiver - F2M03GLA
Protocol	Bluetooth V2.0 EDR	Not Available
Operating frequency	2.402 - 2.480 GHz	Not Available
Transmission power	8dBm	Not Available
Modulation	GFSK	Not Available
FCCID	R47F2M03GL	Not Available

Comparison to Predicate Device

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Image /page/6/Picture/0 description: The image shows the logo for "xltek", with a stylized "X" symbol to the left of the text. Below the text is the phrase "a division of natus" in a smaller font. The logo is simple and uses a sans-serif font.

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Image /page/7/Picture/0 description: The image shows the logo for "xltek", which is a division of natus. The logo features a stylized "X" symbol to the left of the word "xltek". The word "xltek" is written in a bold, sans-serif font. Below the word "xltek" is the phrase "a division of natus" in a smaller font.

The only difference between the subject device and the predicate (K042150) is the addition of the Video Interface box. The Video Interface box is intended to allow time synchronization (via wireless communication) between video images recorded in a separate camcorder and the physiological signals recorded on the Trex_HD headbox.

The wireless communication capability has been added to give flexibility for data acquisition. On the cleared version of the device (K042150) the camcorder could only be connected by cable to the computer imposing restrictions in the video acquisition. Now, with the subject device, the camcorder can be moved around the recording room giving more flexibility for the recording set up. The addition of this part to the subject device has no impact on safety or effectiveness of the subject device compared to the predicate, as demonstrated by the results of extensive testing.

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Image /page/8/Picture/0 description: The image shows the logo for "xltek, a division of natus". The logo consists of a stylized "X" symbol to the left of the text "xltek". Below the text is the phrase "a division of natus" in a smaller font size. The logo is simple and modern, with a focus on the company name.

Brief Summary of Performance Tests

Non-clinical:

Testing of the Natus Trex_HD was performed in compliance with Natus Corporation design control process. Testing included:

Test	Results
Trex HD Signal Quality Verification Test	Pass
Trex Functionality Verification Test	Pass
Video Synchronization Verification Test	Pass

The device is in compliance with the following industrial standards

Safety Standard of Compliance and normative references

Standards	Title
CAN/CSA C22.2 No 601.1-M90UL 60601-1:2003IEC 60601-1:1988 + A1:1991 +A2:1995 (EN 60601-1:1990+A1:1992 +A2:1995)	Medical Electrical Equipment Part 1: GeneralRequirements for Safety
CAN/CSA C22.2 No. 60601-2-26-04IEC 60601-2-26: 2002 (EN60601-2-26:2003)	Medical Electrical Equipment - Part 2-26: ParticularRequirements for the Safety of Electroencephalographs
CAN/CSA C22.2 No. 60601-1-4-02IEC 60601-1-4: 1996 + A1: 1999(EN 60601-1-4:2001)	Medical Electrical Equipment - Part 1-4: GeneralRequirements for Safety - Collateral Standard:Programmable Electrical Medical Systems
CAN/CSA C22.2 No. 60601-1-6-05IEC 60601-1-6: 2004 (EN 60601-1-6:2004)	Medical Electrical Equipment - Part 1-6: Generalrequirements for safety - Collateral Standard: Usability
CAN/CSA C22.2 No. 60601-1-1-02IEC 60601-1-1: 2000 (EN 60601-1-1:2001)	Medical Electrical Equipment - Part 1-1: GeneralRequirements for Safety - Collateral Standard: SafetyRequirements for Medical Electrical Systems

EMC Standard of Compliance and normative references

Standards	Title
IEC 60601-1-2:2001 +A1:2004 /EN 60601-1-2:2001 +A1:2006	Medical Electrical Equipment Part 1-2:GeneralRequirements for Safety - Collateral Standard:Electromagnetic Compatibility - Requirements andTests

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Image: logo	xltek
a division of natus

IEC 61000-4-2:2008 / EN 61000-4-2:2009	Electromagnetic Compatibility (EMC) Part 4-2: Testingand Measurement Techniques - ElectrostaticDischarge Immunity Test
IEC 61000-4-3:2006 +A1:2007+A2:2010 / EN 61000-4-3:2006+A1:2008 +A2:2010	Electromagnetic Compatibility (EMC) Part 4-3: Testingand Measurement Techniques - Radiated, Radio-frequency, Electromagnetic Field Immunity Test
IEC 61000-4-4:2004 +A1:2010 /EN 61000-4-4:2004 +A1:2010	Electromagnetic Compatibility (EMC) Part 4-4: Testingand Measurement Techniques - Electrical FastTransient/Burst Immunity Test
IEC 61000-4-5:2005 / EN 61000-4-5:2006	Electromagnetic Compatibility (EMC) Part 4-5: Testingand Measurement Techniques - Surge Immunity Test
IEC 61000-4-6:2008 / EN 61000-4-6:2009	Electromagnetic Compatibility (EMC) Part 4-6: Testingand Measurement Techniques - Immunity toConducted Disturbances, Induced by Radio-frequencyFields
IEC 61000-4-8:2009 / EN 61000-4-8:2010	Electromagnetic Compatibility (EMC) Part 4-8: Testingand Measurement Techniques - Power FrequencyMagnetic Field Immunity Test
IEC 61000-4-11:2004 / EN61000-4-11:2004	Electromagnetic Compatibility (EMC) Part 4-11: Testingand Measurement Techniques - Voltage Dips, ShortInterruptions and Voltage Variations Immunity Tests
IEC 61000-3-2:2005 +A1:2008+A2:2009 / EN 61000-3-2:2006+A1:2009 +A2:2009	Electromagnetic Compatibility (EMC) Part 3-2: Limits -Limits for Harmonic Current Emissions
IEC 61000-3-3:2008 / EN 61000-3-3:2008	Electromagnetic Compatibility (EMC) Part 3-3: Limits -Limitation of Voltage Changes, Voltage Fluctuationsand Flicker in Public Low-voltage Supply Systems
CISPR 11:2009 +A1:2010 / EN55011:2009 +A1:2010	Industrial, Scientific and Medical (ISM) Radio-Frequency Equipment - Electromagnetic DisturbanceCharacteristics - Limits and Methods of Measurement

Quality System Compliance:

. ISO 13485:2003 Medical devices - Quality management systems - Requirements for regulatory purposes.
SOR/98-282 Canadian Medical Device Regulations .
21 CFR Part 820 US Food and Drug Administration's Quality System Regulation .
. 93/42/EEG European Medical Device Directives
ISO 14971:2007 Medical Devices Application of Risk Management to Medical Devices .
EN 980:2008 Medical Devices Symbols for Use of fabeling of medical device ●
EN 1041:2008 Information supplied by the manufacturer of medical devices
ISO 15223-1:2012,Medical Devices Symbols to be Used With Medical Device Labels, . Labeling, and Information to be Supplied - Part 1: General requirements
IEC 62304:2006 Medical device software Software life-cycle processes .

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	K131266: TREX_HD
Image: xitek logoa division of natus	510k SUMMARY
	PAGE 11 of 11

Clinical: Clinical testing was not required to ensure safety and effectiveness of the modified device.

Based on the characteristics of the device as compared to the predicate and the results obtained during verification and other non-clinical testing we conclude that Trex HD is substantially equivalent to the predicate device.

Conclusions

The substantial equivalence of the Natus Trex HD with Trex amplifier was demonstrated by testing in compliance with the Design Control process. The intended use and technology of the Trex_HD is similar to that of the predicate device XLTEK-Trex. Validation was performed to ensure no new questions of safety or effectiveness are raised.

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Image /page/11/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, with three stylized wing-like shapes.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 14, 2014

Natus Medical Incorporated DBA Excel-Tech Ltd. (XLTEK) c/o Mr. Daniel Ramirez 2568 Bristol Circle Oakville, Ontario Canada L6H 5S1

Re: K131266

Trade/Device Name: Trex HD Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: GWQ Additional Product Code: OLV Dated: January 14, 2014 Received: January 17, 2014

Dear Mr. Ramirez:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act

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Page 2 - Mr. Daniel Ramirez

or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Joyce M. Whang -S

for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

510(k) Number (if known) K131266

Device Name Trex HD

Indications for Use (Describe)

The Trex HD is an Electroencephalograph intended to be used to acquire, display, store and archive electroencephic signals, intended for electroencephalographic (EEG) or level 1-2 polysomnographic (PSG) recordings. The Trex HD amplifier is designed to be used with Natus NeuroWorksTM or Natus SleepWorksTM software.

Type of Use (Select one or both, as applicable)

[x] Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

FORM FDA 3881 (1/14)

PSC Publishing Scrvices (301) 443-6740 EF

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*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."

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Regulation Number and Section

§ 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).