Who is the manufacturer of TREZ_HD?

Excel-Tech Ltd. (Xltek) filed the 510(k) submission for TREZ_HD (K131266).

What is the FDA product code for TREZ_HD?

GWQ. It is classified under 21 CFR 882.1400 as a Class 2 device in the Neurology panel.

What is the regulatory pathway for TREZ_HD?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like TREZ_HD?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

TREZ_HD

K131266 · Excel-Tech Ltd. (Xltek) · GWQ · Feb 14, 2014 · Neurology

Device Facts

Record ID	K131266
Device Name	TREZ_HD
Applicant	Excel-Tech Ltd. (Xltek)
Product Code	GWQ · Neurology
Decision Date	Feb 14, 2014
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 882.1400
Device Class	Class 2

Intended 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.

Device Story

Trex HD is an electroencephalograph system for EEG and level 1-2 PSG recordings. It consists of a headbox with built-in amplifiers, A/D converters, digital signal processors, and storage. Inputs include 24 referential, 2 DC, 3 differential, and oximeter/photic connections. A new Video Interface Box enables wireless synchronization between EEG signals and external camcorder video frames via Bluetooth V2.0 EDR. The system connects to a computer running Natus NeuroWorks or SleepWorks software via USB. Used in clinical settings by healthcare professionals; the wireless video interface allows increased mobility for the camcorder within the recording room compared to the predicate. Output is displayed and stored on the host computer for clinical review, aiding in the diagnosis and monitoring of neurological or sleep-related conditions.

Clinical Evidence

No clinical data. Substantial equivalence was demonstrated through non-clinical bench testing, including signal quality verification, functionality verification, and video synchronization verification, alongside compliance with electrical safety (IEC 60601-1) and EMC standards.

Technological Characteristics

Headbox with 24 referential, 2 DC, and 3 differential inputs; 16-bit A/D resolution; sampling rates 200/256/512 Hz. Wireless interface uses Bluetooth V2.0 EDR (2.402-2.480 GHz, 8dBm, GFSK). Powered by 2 AA batteries. Connectivity via USB 2.0 to host PC. Software-selectable channel test signal. Compliant with IEC 60601-1, IEC 60601-2-26, and IEC 60601-1-2.

Indications for Use

Indicated for patients requiring electroencephalographic (EEG) or level 1-2 polysomnographic (PSG) recordings for signal acquisition, display, storage, and archiving.

Regulatory Classification

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.

Predicate Devices

Trex (K042150)

Reference Devices

NeuroWorks (K090019)
SleepWorks (K090019)

Related Devices

K162595 — Trex_HD · Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) · Nov 4, 2016
K163163 — XLTEK EMU40EX EEG Headbox · Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) · Dec 14, 2016
K220254 — Neuron-Spectrum-AM with Neuron-Spectrum.NET Software · Neurosoft , Ltd. · Nov 30, 2022
K172271 — Trackit T4 EEG Amplifier · Lifelines , Ltd. · May 4, 2018
K052066 — CEEGRAPH/SLEEPSCAN NETLINK TRAVELER · Bio-Logic Systems Corp. · Aug 26, 2005

Submission Summary (Full Text)

{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 | < 10 pA | < 10 pA | Same | | Channel Crosstalk | 56 dB | 56 dB | Same | | Electrode Connections (including common input) | Safety Touch | Safety Touch | Same | | 4 Non-Isolated DC Inputs | +/- 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 Device Trex HD | Predicate Device Trex (K042150) | Comment | | Specification | Value | | | | Oximeter/Photic Stim Connection | 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: 68 inches (~ 147 cm) Maximum Length: 15 feet (4.6 m) | Standard Length: 68 inches (~ 147 cm) Maximum Length: 15 feet (4.6 m) | | | | Subject Device Trex HD | Predicate Device Trex (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 on all electrode inputs | <10 μA with 240 VAC on all electrode inputs | Same | | | Operating Parameters | | | | Operating Environmental Limits | Temperature: 10°C to 40°C Humidity 30%-75% Atmospheric Pressure: 700 hP-1060 hP | Temperature: 10°C to 40°C Humidity 30%-75% non- condensing Atmospheric Pressure: 700 hP-1060 hP | Same | | Transport and Storage Temperature Range | - 40°C to 70°C | - 40°C to 70°C | Same | | Transport and Storage Humidity Range | 10-100%, including condensation | 10-100%, non- condensing | Same | | Transport and Storage Atmospheric Pressure Range | 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 {6}------------------------------------------------ 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. {7}------------------------------------------------ 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. {8}------------------------------------------------ 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-M90 UL 60601-1:2003 IEC 60601-1:1988 + A1:1991 + A2:1995 (EN 60601-1:1990 +A1:1992 +A2:1995) | Medical Electrical Equipment Part 1: General Requirements for Safety | | CAN/CSA C22.2 No. 60601-2-26- 04 IEC 60601-2-26: 2002 (EN 60601-2-26:2003) | Medical Electrical Equipment - Part 2-26: Particular Requirements for the Safety of Electroencephalographs | | CAN/CSA C22.2 No. 60601-1-4- 02 IEC 60601-1-4: 1996 + A1: 1999 (EN 60601-1-4:2001) | Medical Electrical Equipment - Part 1-4: General Requirements for Safety - Collateral Standard: Programmable Electrical Medical Systems | | CAN/CSA C22.2 No. 60601-1-6- 05 IEC 60601-1-6: 2004 (EN 60601- 1-6:2004) | Medical Electrical Equipment - Part 1-6: General requirements for safety - Collateral Standard: Usability | | CAN/CSA C22.2 No. 60601-1-1- 02 IEC 60601-1-1: 2000 (EN 60601- 1-1:2001) | Medical Electrical Equipment - Part 1-1: General Requirements for Safety - Collateral Standard: Safety Requirements 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:General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests | {9}------------------------------------------------ | Image: logo | xltek | |---------------------|-------| | a division of natus | | | IEC 61000-4-2:2008 / EN 61000- 4-2:2009 | Electromagnetic Compatibility (EMC) Part 4-2: Testing and Measurement Techniques - Electrostatic Discharge 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: Testing and 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: Testing and Measurement Techniques - Electrical Fast Transient/Burst Immunity Test | | IEC 61000-4-5:2005 / EN 61000- 4-5:2006 | Electromagnetic Compatibility (EMC) Part 4-5: Testing and Measurement Techniques - Surge Immunity Test | | IEC 61000-4-6:2008 / EN 61000- 4-6:2009 | Electromagnetic Compatibility (EMC) Part 4-6: Testing and Measurement Techniques - Immunity to Conducted Disturbances, Induced by Radio-frequency Fields | | IEC 61000-4-8:2009 / EN 61000- 4-8:2010 | Electromagnetic Compatibility (EMC) Part 4-8: Testing and Measurement Techniques - Power Frequency Magnetic Field Immunity Test | | IEC 61000-4-11:2004 / EN 61000-4-11:2004 | Electromagnetic Compatibility (EMC) Part 4-11: Testing and Measurement Techniques - Voltage Dips, Short Interruptions 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 Fluctuations and Flicker in Public Low-voltage Supply Systems | | CISPR 11:2009 +A1:2010 / EN 55011:2009 +A1:2010 | Industrial, Scientific and Medical (ISM) Radio- Frequency Equipment - Electromagnetic Disturbance Characteristics - 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 . {10}------------------------------------------------ | | K131266: TREX_HD | |------------------------------------------|------------------| | Image: xitek logo a 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. {11}------------------------------------------------ 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 {12}------------------------------------------------ #### 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 {13}------------------------------------------------ #### 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 {14}------------------------------------------------ This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW." The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."