Natus Brain Monitor Amplifier

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo, which features a stylized caduceus. To the right is the FDA logo, which is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue. June 14, 2018 Natus Medical Incorporated DBA Excel-Tech Ltd. (Xltek) Sanjay Mehta Director, Quality Assurance & Regulatory Affairs 2568 Bristol Circle Oakville, ON L6H 5S1 Canada Re: K180290 Trade/Device Name: Natus Brain Monitor, Embla Dx series Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: GWO. OLV Dated: March 15, 2018 Received: March 16, 2018 Dear Sanjay Mehta: 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, listing 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 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 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); {1}------------------------------------------------ ## Page 2 - Sanjay Mehta and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, # Jay R. Gupta -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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K180290 Device Name Natus Brain Monitor, Embla Dx series ### Indications for Use (Describe) 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. | Type of Use (Select one or both, as applicable) | |-------------------------------------------------| |-------------------------------------------------| | Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-size: 20px;">☑</span> | |----------------------------------------------|-----------------------------------------| | Over-The-Counter Use (21 CFR 801 Subpart C) | <span style="font-size: 20px;">☐</span> | ### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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." {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for Natus Neurology. The word "natus" is in a teal color and in a larger font. Below that, the word "neurology" is in a smaller, black font. There is a registered trademark symbol to the right of the word "natus". # 510K Summary ### Date: May 24, 2018 - Submitted by: Natus Medical Incorporated DBA Excel-Tech Ltd. (XLTEK) 2568 Bristol Circle Oakville, Ontario Canada L6H 5S1 - Contact Person: Sanjay Mehta Director, Quality and Regulatory Affairs Natus Medical Incorporated Tel.: (905) 829-5300 ext 388 Fax.: (905) 829-5304 E-mail: sanjay.mehta@natus.com Proprietary Name: Natus Brain Monitor, Embla Dx series (includes models Embla NDx & Embla SDx) Common Name: Electroencephalograph Regulation Number : 21CFR 882.1400 Classification Name: Standard Polysomnograph with Electroencephalograph Product code: GWQ, OLV Device Class: II Predicate Device: Natus Quantum (K143440); N7000 System (K111742), Comet-Plus (K172711) ## Description: #### 1. Overview: Natus Brain Monitor 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. {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for Natus Neurology. The word "natus" is in a teal sans-serif font, with a registered trademark symbol to the right of the "s". Below "natus" is the word "neurology" in a smaller, italicized, black sans-serif font. The logo is simple and clean, with a focus on the company name. #### 2. Operating Principle of the Quantum Amplifier 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. Image /page/4/Picture/5 description: The image shows two Natus neurology devices, one labeled as a "Brain Monitor" and the other as "Embla". The Brain Monitor device has a screen displaying the Natus neurology logo and the words "Brain Monitor". Next to it is a smaller device with numerous buttons and connection points, also bearing the Natus logo. The Embla device is similar in appearance to the Brain Monitor, with a screen displaying the word "Embla". #### 2.1. Brain Monitor Image /page/4/Picture/7 description: The image shows three Natus Neurology medical devices. The device in the center is a larger, square-shaped monitor with a screen displaying the text "Embla NDx". The device on the right is a smaller, rectangular monitor with various buttons and indicators. The device on the left is similar to the one on the right, but only a portion of it is visible. 2.2. Embla NDx {5}------------------------------------------------ Image /page/5/Picture/0 description: The image contains the logo for Natus Neurology. The word "natus" is in a teal color, with a registered trademark symbol to the right of the "s". Below "natus" is the word "neurology" in a dark red color. The logo is simple and modern. #### 2.3. Embla SDx Image /page/5/Picture/3 description: The image shows two Natus Neurology Embla SDx devices. The device on the left is larger and has a screen displaying the Embla SDx software interface. The device on the right is smaller and has a screen displaying a diagram of electrode placement on a human body. Both devices have the Natus Neurology logo. The Natus Brain Monitor and Natus Embla NDx are identical devices. The only difference is the brand name/label on the front face of the breakout box. The Natus Embla SDx is a limited functionality version of the Natus Embla NDx with fewer inputs and some features turned off. # Natus Brain Monitor features include - Up to 64 AC inputs (40 referential, and 24 referential/differential configurable) ● - Up to 16 DC channels (12 on Natus Base unit + 4 on Brain Monitor & Embla NDx Breakouts) ● - Integrated Pulse Oximeter including SpO2, Pulse Rate and Plethysmogram signals ● - Ability to initiate an impedance test, change the threshold, and view the results in the patient room - Digital Trigger Input ● - A small and lightweight breakout box ● - TCP/IP and USB connectivity - . Patient-event switch interface on both the breakout box and base units - Photic stimulator interface for EEG applications (excluding Embla SDx). - . Holster for cart mounting - Pouch for extended EEG studies {6}------------------------------------------------ Image /page/6/Picture/0 description: The image contains the logo for Natus Neurology. The word "natus" is in a teal sans-serif font, with a registered trademark symbol next to it. Below "natus" is the word "neurology" in a smaller, black, sans-serif font. # System Setup Overview The Natus Brain Moniotr family of amplifiers connects to the Natus NeuroWorks (K090019) & Natus SleepWorks (K090277) software for the acquisition storage, analysis, and review of Electroencephalographic & Polysomnographic data in conjunction with synchronized digital video. The system overview is as follows. Image /page/6/Figure/4 description: This image shows a diagram of a brain monitoring system. The diagram includes a patient connected to various devices such as electrodes, an oximeter, and thorax/abdominal belts. These devices are connected to a Natus Base, which includes a CPU and AC-DC converter, and a personal computer running NeuroWorks/SleepWorks software. The system also includes an isolation transformer, AC mains, and various isolation barriers to ensure patient safety. {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the logo for Natus Neurology. The word "natus" is in a teal sans-serif font, with the "us" connected. Below that, the word "neurology" is in a smaller, black, italicized sans-serif font. The logo is simple and modern. ## Device-patient interaction Accessories List: The table below lists all accessories to the subject device. Accessories (1) to (7) enter in contact with the patient. These sensors guarantees acquisition of the physiological signals and passively transfer them to the head box. Characteristics of the sensors vary and are described (cleared) under their respective 510K submissions (see table). | | Description | Body contact<br>location | Device connection/Usage | |----|-------------------------------------------------------------------------------|-------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 1 | Reusable gold disk<br>electrode (K982053) | Scalp (according to<br>10-20 & 10-10<br>system) | Referential and differential inputs<br>Usage: To record the EEG/EOG/EMG surface<br>potentials. | | 2 | Single Use Intracranial<br>Grids, Strips and<br>Depth Electrodes<br>(K082474) | Intracranial<br>recordings | Referential and differential inputs (labeled<br>numerically)<br>Usage: For the recording, monitoring and stimulation<br>of electrical signals. | | 3 | Xactrace (K043132) | Respiratory belts<br>Thorax/Abdomen | Sensor input<br>Usage: to measure respiratory effort signals | | 4 | Thermistor (K922112) | Nasal/Oral | DC input<br>Usage: to monitor breathing frequency | | 5 | Pulse Oximeter Sensor<br>(K092101) | Finger | Channel labeled “oximeter/photic”<br>Usage: non-invasive spot-checking and/or continuous<br>monitoring of adult and pediatric patients who are well<br>or poorly perfused | | 6 | Snoring microphone<br>(K941759) | Nasion/cheek/chin or<br>side of the neck | DC input<br>Usage: To monitor breathing frequency | | 7 | Cannula (K922112) | Nasal/Oral | Pressure input<br>Usage: To monitor breathing frequency | | 8 | Body position Pod<br>(K122516) | Thorax | Sensor input<br>Usage: Position or movement recording | | 9 | Photic Stimulator<br>(K991903) | None | Photic input (base unit)<br>Usage: For photic activation of the EEG in visual<br>evoked potential | | 10 | Holster/Mounting<br>arm/Roll Stand (510K<br>-Not applicable) | None<br>Back/shoulder straps | None<br>Usage: Used to attach Quantum breakout boxes in as a<br>backpack to keep them out of the way of the patient. | | 11 | Pouch (510K# Not<br>Applicable) | None | None<br>Usage: To keep the breakout and electrodes protected<br>and easy to move. | | 12 | XLTEK Trolley and<br>Carts (510K# Not<br>Applicable) | None | None<br>Usage: Cart optimized for sitting users on which the<br>recording computer resides | {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the logo for Natus Neurology. The word "natus" is in a teal sans-serif font, with a registered trademark symbol next to it. Below "natus" is the word "neurology" in a smaller, black sans-serif font. # Indications for Use 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. # Comparison to Predicate Device | Specification | Predicate Device | Predicate Device | Predicate Device | Subject Device | |----------------------------------------------------------------------|--------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------| | | Natus Quantum<br>(K143440) | N7000 System (K111742) | Comet-PLUS<br>(K172711) | Natus Brain Monitor<br>Model #1: Natus Brain<br>Monitor<br>Model #2: Natus<br>Embla NDx<br>Model #3: Natus<br>Embla SDx | | Manufacturer | Natus Medical<br>Incorporated<br>Dba. Excel Tech Ltd<br>(Xltek) | Embla Systems a<br>division of Natus Medical<br>Incorporated | Natus Medical<br>Incorporated<br>Dba. Excel Tech Ltd<br>(Xltek) | Natus Medical<br>Incorporated<br>Dba. Excel Tech Ltd<br>(Xltek) | | Referential<br>Channels | 256<br>128 per Breakout | 32 | 32 | 40 (programmable to up<br>to 64)<br>16 (Embla SDx Model) | | Bipolar<br>Channels | 16<br>8 per Breakout | 8 | 8 | 12<br>4 (Embla SDx Model) | | DC inputs | 16 (+/-5Vdc) | 8 (+/-5Vdc) | 8 (+/-2.5Vdc) | 16 (+/-5Vdc)<br>8 (+/-5Vdc) - For Embla<br>SDx model | | SpO2 | SpO2, Pulse Rate,<br>Plethsmogram | SpO2, Pulse Rate,<br>Plethsmogram | SpO2 Pulse Rate,<br>Plethsmogram, PPG | SpO2 Pulse Rate,<br>Plethsmogram, PPG | | Body Position | Uses a universal sensor via<br>DC input | Integrated Proprietary | Uses a universal sensor<br>via DC input | Integrated proprietary | | Resolution | 24 bit (16 bit stored) | 22 bit | 16 bit | 24 bit (16 bit stored) | | EEG Channels | 64-256 | 40 | 32 | 64<br>20 (Embla SDx) | | Reference<br>Channels | Dedicated separate<br>reference and ground | Dedicated ground | Dedicated separate<br>reference and ground | Dedicated separate<br>reference and ground | | | | | | | | Input<br>Impedance | >1000 MOhm | >20MΩ | ≥20 ΜΩ | >1000 MOhm | | Input Noise | < 1.5uV pk to pk @<br>.1....100Hz bandwidth<br>(<0.53uV rms@1....100Hz<br>bandwidth) | Referential channels:<br>Noise levels when<br>sampling at 200Hz is less<br>than 1µVrms<br>Noise levels when<br>sampling at 200Hz is less<br>than 2µVrms | <2uV pk to pk | ≤ 2 uV pk-to-pk (0.1Hz<br>to 100 Hz), | | Input signal<br>range | 20mV pk-to-pk | Vin = ±350mV on bipolar<br>channels,<br>Vin = ±75mV dynamic<br>range on referential<br>channels | 4 mV peak to peak full-<br>scale | 20mV pk-to-pk, +/-<br>0.3VDC | | Input Bias<br>Current | <1nA | < 5nA | <4 nA | <1nA | | Maximum<br>Operational<br>DC input<br>voltage<br>electrode<br>offset | ±300mV | ±1V | ±500 mV | ±300mV | | Common<br>mode<br>Rejection<br>Ratio | >110dB@60Hz | >80dB | >80 dB (signal ref), > 100<br>dB (earth ref) | >106db@60Hz | | Sampling<br>Frequency | 256, 512, 1024, 2048,<br>4096, 8192, 16384 Hz | 64, 128, 256, 512Hz | 200 Hz, 256 Hz, 400 Hz,<br>512 Hz, 800 Hz | 256, 512, 1024, 2048,<br>4096<br>256, 512Hz (Embla SDx) | | Sampling<br>Resolution -<br>EEG channels | 24 bits | 22 bits | 16 bits | 24 bits | | Sampling<br>Quantization -<br>EEG channels | 305nV | N/A | 0.06 µV/bit | 305nV | | Storage<br>Resolution - | 16 bits | 16 bits | 16 bits | 16 bits | | Impedance<br>Check | <2.5, <5, <10, <25,<br><50kΩ | 0 to 100kΩ | <2, <5, <10, <20 kΩ | 2.5kΩ, 5kΩ, 10kΩ, 25kΩ | {9}------------------------------------------------ Image /page/9/Picture/0 description: The image shows the logo for Natus Neurology. The word "natus" is written in a teal, sans-serif font, with a registered trademark symbol next to it. Below "natus" is the word "neurology" in a smaller, black, sans-serif font. {10}------------------------------------------------ Image /page/10/Picture/0 description: The image shows the logo for Natus Neurology. The word "natus" is in a teal sans-serif font, with a registered trademark symbol next to it. Below "natus" is the word "neurology" in a smaller, black, italicized sans-serif font. # Brief Summary of Performance Testing The Natus Brain Monitor was verified for performance in accordance with Electrical Safety the following standard: - . IEC 60601-1: 2005, Am1: 2012, Medical electrical equipment – Part 1: General requirements for basic safety and essential performance. Results indicate that the Natus Brain Monitor complies with the applicable standards. The Natus Brain Monitor was verified for performance in accordance Electromagnetic with the following standard: Compatibility - . IEC 60601-1-2Edition4.0 : 2014-02, Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility -Requirements and tests. - . IEC 60601-2-26: 2012, Medical electrical equipment – Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs. Results indicate that the Natus Brain Monitor complies with the applicable standards. {11}------------------------------------------------ Image /page/11/Picture/0 description: The image shows the title of a document, which is "510(K): NATUS BRAIN MONITOR". Below the title, it says "510K SUMMARY". The image also indicates that it is page 9 of 9. The text is in a clear, bold font, making it easily readable. The Natus Brain Monitor was verified for EEG hardware performance in Performance accordance with internal requirements and the applicable clauses of the Testing - Bench following standards: - . IEC 60601-1-6 Edition 3.1: 2013-10, Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance – Collateral standard: Usability. - . IEC 60601-2-26: 2012, Medical electrical equipment – Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs. - IEC 62366: 2007, Am1: 2014, Medical devices – Application of usability engineering to medical devices. - . ISO 80601-2-61 : 2011, Medical electrical equipment – Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment The bench testing was performed to confirm - . EEG hardware Signal Quality such as leakage, noise, signal range, offset, CMRR, input impedance and cross talk. - . Functional testing of the Amplifier with NeuroWorks/SleepWorks software - Device performance at extreme Environmental and storage limits - Functional testing of the Amplifier with various accessory such as various type of Electrodes, Xactace belts, Thermistor ,Photic stimulators etc. Results indicate that the Natus Brain Monitor complies with its predetermined specifications and the applicable standards. ## Conclusions The substantial equivalence of the Natus Brain Monitor with Natus Quantum. N7000 and Comet-Plus products was demonstrated by testing in compliance with the Design Control process. The intended use and technology of the Natus Brain Monitor is similar to that of the predicate device(s). Verification and Validation were performed to ensure no new questions of safety or effectiveness are raised. The results of these activities demonstrate that the Natus Brain Monitor is as safe, as effective, and performs as well as or better than the predicate devices.