(133 days)
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.
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.
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.
Here's a breakdown of the acceptance criteria and study information for the Natus Brain Monitor, based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria in a pass/fail threshold format for each performance metric. Instead, it provides a comparison to predicate devices, implying that performance comparable to or better than the predicates is acceptable. The performance is reported in the "Comparison to Predicate Device" table.
| Specification | Predicate Device (K143440, K111742, K172711) | Subject Device (Natus Brain Monitor - Natus Brain Monitor, Embla NDx, Embla SDx) |
|---|---|---|
| Referential Channels | 256 (K143440), 32 (K111742), 32 (K172711) | 40 (programmable to up to 64), 16 (Embla SDx Model) |
| Bipolar Channels | 16 (K143440), 8 (K111742), 8 (K172711) | 12, 4 (Embla SDx Model) |
| DC Inputs | 16 (+/-5Vdc or +/-2.5Vdc) | 16 (+/-5Vdc), 8 (+/-5Vdc) - For Embla SDx model |
| SpO2, Pulse Rate, Plethysmogram | Yes (all predicates, some with PPG) | Yes (with PPG) |
| Body Position | Uses universal sensor via DC input or integrated proprietary | Integrated proprietary, or uses universal sensor via DC input |
| Resolution | 24 bit, 22 bit, 16 bit | 24 bit (16 bit stored) |
| EEG Channels | 64-256, 40, 32 | 64, 20 (Embla SDx) |
| Reference Channels | Dedicated separate reference and ground, Dedicated ground | Dedicated separate reference and ground |
| Input Impedance | >1000 MOhm, >20MΩ, ≥20 ΜΩ | >1000 MOhm |
| Input Noise | < 1.5uV pk to pk @ .1-100Hz bandwidth (K143440), < 1µVrms or <2µVrms (K111742), <2uV pk to pk (K172711) | ≤ 2 uV pk-to-pk (0.1Hz to 100 Hz) |
| Input Signal Range | 20mV pk-to-pk, +/-350mV, 4 mV peak to peak full-scale | 20mV pk-to-pk, +/-0.3VDC |
| Input Bias Current | <1nA, < 5nA, <4 nA | <1nA |
| Maximum Operational DC input voltage electrode offset | ±300mV, ±1V, ±500 mV | ±300mV |
| Common mode Rejection Ratio | >110dB@60Hz, >80dB, >80 dB (signal ref), > 100 dB (earth ref) | >106db@60Hz |
| Sampling Frequency | 256-16384 Hz, 64-512 Hz, 200-800 Hz | 256, 512, 1024, 2048, 4096 (256, 512Hz for Embla SDx) |
| Sampling Resolution - EEG channels | 24 bits, 22 bits, 16 bits | 24 bits |
| Sampling Quantization - EEG channels | 305nV, N/A, 0.06 µV/bit | 305nV |
| Storage Resolution - EEG channels | 16 bits | 16 bits |
| Impedance Check | <2.5 to <50kΩ, 0 to 100kΩ, <2 to <20 kΩ | 2.5kΩ, 5kΩ, 10kΩ, 25kΩ |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document describes bench testing for performance validation rather than a clinical study with a "test set" of patient data. Therefore, details about sample size (patients) or data provenance are not applicable in the context of this submission. The testing was performed internally by the manufacturer.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable. The device is an electroencephalograph, and the testing described is technical performance validation against engineering and safety standards, not a diagnostic or AI-driven system requiring expert-adjudicated ground truth from patient studies.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as there was no patient "test set" with ground truth requiring adjudication. The testing involved measurements against predetermined technical specifications and compliance with standards.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No such study was conducted or reported. This device is a hardware amplifier for acquiring physiological signals, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This refers to an algorithm's performance without human intervention, typically in AI/software. This is not applicable to the Natus Brain Monitor, which is a hardware device for signal acquisition.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the performance testing was technical specifications, engineering requirements, and international standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-26, IEC 62366, ISO 80601-2-61). The device's performance was measured against these predefined technical benchmarks, rather than clinical outcomes or expert labels.
8. The sample size for the training set
Not applicable. This device is a hardware amplifier, not an AI/machine learning system that requires a "training set."
9. How the ground truth for the training set was established
Not applicable for the same reason as above.
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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);
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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
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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) | ☑ |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) | ☐ |
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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.
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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
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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
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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.
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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 contactlocation | Device connection/Usage | |
|---|---|---|---|
| 1 | Reusable gold diskelectrode (K982053) | Scalp (according to10-20 & 10-10system) | Referential and differential inputsUsage: To record the EEG/EOG/EMG surfacepotentials. |
| 2 | Single Use IntracranialGrids, Strips andDepth Electrodes(K082474) | Intracranialrecordings | Referential and differential inputs (labelednumerically)Usage: For the recording, monitoring and stimulationof electrical signals. |
| 3 | Xactrace (K043132) | Respiratory beltsThorax/Abdomen | Sensor inputUsage: to measure respiratory effort signals |
| 4 | Thermistor (K922112) | Nasal/Oral | DC inputUsage: to monitor breathing frequency |
| 5 | Pulse Oximeter Sensor(K092101) | Finger | Channel labeled “oximeter/photic”Usage: non-invasive spot-checking and/or continuousmonitoring of adult and pediatric patients who are wellor poorly perfused |
| 6 | Snoring microphone(K941759) | Nasion/cheek/chin orside of the neck | DC inputUsage: To monitor breathing frequency |
| 7 | Cannula (K922112) | Nasal/Oral | Pressure inputUsage: To monitor breathing frequency |
| 8 | Body position Pod(K122516) | Thorax | Sensor inputUsage: Position or movement recording |
| 9 | Photic Stimulator(K991903) | None | Photic input (base unit)Usage: For photic activation of the EEG in visualevoked potential |
| 10 | Holster/Mountingarm/Roll Stand (510K-Not applicable) | NoneBack/shoulder straps | NoneUsage: Used to attach Quantum breakout boxes in as abackpack to keep them out of the way of the patient. |
| 11 | Pouch (510K# NotApplicable) | None | NoneUsage: To keep the breakout and electrodes protectedand easy to move. |
| 12 | XLTEK Trolley andCarts (510K# NotApplicable) | None | NoneUsage: Cart optimized for sitting users on which therecording computer resides |
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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(K143440) | N7000 System (K111742) | Comet-PLUS(K172711) | Natus Brain MonitorModel #1: Natus BrainMonitorModel #2: NatusEmbla NDxModel #3: NatusEmbla SDx | |
| Manufacturer | Natus MedicalIncorporatedDba. Excel Tech Ltd(Xltek) | Embla Systems adivision of Natus MedicalIncorporated | Natus MedicalIncorporatedDba. Excel Tech Ltd(Xltek) | Natus MedicalIncorporatedDba. Excel Tech Ltd(Xltek) |
| ReferentialChannels | 256128 per Breakout | 32 | 32 | 40 (programmable to upto 64)16 (Embla SDx Model) |
| BipolarChannels | 168 per Breakout | 8 | 8 | 124 (Embla SDx Model) |
| DC inputs | 16 (+/-5Vdc) | 8 (+/-5Vdc) | 8 (+/-2.5Vdc) | 16 (+/-5Vdc)8 (+/-5Vdc) - For EmblaSDx model |
| SpO2 | SpO2, Pulse Rate,Plethsmogram | SpO2, Pulse Rate,Plethsmogram | SpO2 Pulse Rate,Plethsmogram, PPG | SpO2 Pulse Rate,Plethsmogram, PPG |
| Body Position | Uses a universal sensor viaDC input | Integrated Proprietary | Uses a universal sensorvia 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 | 6420 (Embla SDx) |
| ReferenceChannels | Dedicated separatereference and ground | Dedicated ground | Dedicated separatereference and ground | Dedicated separatereference and ground |
| InputImpedance | >1000 MOhm | >20MΩ | ≥20 ΜΩ | >1000 MOhm |
| Input Noise | < 1.5uV pk to pk @.1....100Hz bandwidth(<0.53uV rms@1....100Hzbandwidth) | Referential channels:Noise levels whensampling at 200Hz is lessthan 1µVrmsNoise levels whensampling at 200Hz is lessthan 2µVrms | <2uV pk to pk | ≤ 2 uV pk-to-pk (0.1Hzto 100 Hz), |
| Input signalrange | 20mV pk-to-pk | Vin = ±350mV on bipolarchannels,Vin = ±75mV dynamicrange on referentialchannels | 4 mV peak to peak full-scale | 20mV pk-to-pk, +/-0.3VDC |
| Input BiasCurrent | <1nA | < 5nA | <4 nA | <1nA |
| MaximumOperationalDC inputvoltageelectrodeoffset | ±300mV | ±1V | ±500 mV | ±300mV |
| CommonmodeRejectionRatio | >110dB@60Hz | >80dB | >80 dB (signal ref), > 100dB (earth ref) | >106db@60Hz |
| SamplingFrequency | 256, 512, 1024, 2048,4096, 8192, 16384 Hz | 64, 128, 256, 512Hz | 200 Hz, 256 Hz, 400 Hz,512 Hz, 800 Hz | 256, 512, 1024, 2048,4096256, 512Hz (Embla SDx) |
| SamplingResolution -EEG channels | 24 bits | 22 bits | 16 bits | 24 bits |
| SamplingQuantization -EEG channels | 305nV | N/A | 0.06 µV/bit | 305nV |
| StorageResolution - | 16 bits | 16 bits | 16 bits | 16 bits |
| ImpedanceCheck | <2.5, <5, <10, <25,<50kΩ | 0 to 100kΩ | <2, <5, <10, <20 kΩ | 2.5kΩ, 5kΩ, 10kΩ, 25kΩ |
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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.
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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.
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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.
§ 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).