Natus NeuroWorks
Device Facts
| Record ID | K200878 |
|---|---|
| Device Name | Natus NeuroWorks |
| Applicant | Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) |
| Product Code | OMB · Neurology |
| Decision Date | May 18, 2020 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 882.1400 |
| Device Class | Class 2 |
| Attributes | Software as a Medical Device |
Indications for Use
Natus NeuroWorks is EEG software that displays physiological signals. The intended user of this product is a qualified medical practitioner trained in Electroencephalography who will exercise professional judgment in using the information. The NeuroWorks EEG software allows acquisition, display, archive, review and analysis of physiological signals. · The Seizure Detection component of NeuroWorks is intended to mark previously acquired sections of the adult (greater than or equal to 18 years) EEG recordings that may correspond to electrographic seizures, in order to assist qualified clinical practitioners in the assessment of EEG traces. EEG recordings should be obtained with full scalp montage according to the standard 10/20 system. · The Spike Detection component of NeuroWorks is intended to mark previously acquired sections of the adult (greater than or equal to 18 years) EEG recordings that may correspond to electrographic spikes, in order to assist qualified clinical practitioners in the assessment of EEG traces. EEG recordings should be obtained with full scalp montage according to the standard 10/20 system. · aEEG, Burst Suppression, Envelope, Alpha variability, Spectral Entropy trending functionalities included in NeuroWorks are intended to assist the user while monitoring the state of the brain. The automated event marking function of Neuroworks is not applicable to these analysis features. · Neuro Works also includes the display of a quantitative EEG plot, Density Spectral Array (DSA), which is intended to help the user to monitor and analyze the EEG waveform. The automated event marking function of NeuroWorks is not applicable to DSA. · This device does not provide any diagnostic conclusion about the patient's condition to the user.
Device Story
Natus NeuroWorks is EEG software for acquisition, display, storage, and analysis of physiological signals (EEG, EMG, respiration, etc.). It interfaces with Natus amplifiers and third-party physiological monitors. Used in clinical/research environments by qualified medical practitioners. The software provides automated event marking for seizures and spikes, and generates trend plots (aEEG, Burst Suppression, Envelope, Alpha variability, Spectral Entropy, DSA) to assist in monitoring brain state. Users review, accept, or reject automated markings based on professional judgment. The device does not provide diagnostic conclusions. It benefits patients by facilitating efficient review of long-term EEG recordings and monitoring of brain state changes, aiding clinicians in the assessment of neurological and sleep-related disorders.
Clinical Evidence
No clinical data or animal studies performed. Substantial equivalence supported by bench testing, including functional verification of software workflows, amplifier/peripheral interoperability, and comparative analysis of trend data against the NicoletOne predicate device.
Technological Characteristics
Software-only device; operates on standard computer hardware. Features include signal acquisition, display, and analysis algorithms for EEG/physiological data. Connectivity via proprietary amplifiers and third-party physiological monitoring ports. Implements various signal processing trends (aEEG, DSA, Burst Suppression, etc.).
Indications for Use
Indicated for adult patients (≥18 years) for the acquisition, display, archive, review, and analysis of EEG and physiological signals to assist qualified clinical practitioners in the assessment of EEG traces. Includes automated marking of potential electrographic seizures and spikes. Trending features (aEEG, Burst Suppression, Envelope, Alpha variability, Spectral Entropy) and quantitative EEG plots (DSA) assist in monitoring brain state. Not for diagnostic conclusions.
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
Submission Summary (Full Text)
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.
May 18, 2020
Natus Medical Incorporated DBA Excel-Tech Ltd. (XLTEK) Sanjay Mehta Director, Global Regulatory Affairs 2568 Bristol Circle Oakville, Ontario L6H 5S1 Canada
Re: K200878
Trade/Device Name: Natus NeuroWorks Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: OMB, OMA, OLT Dated: April 1, 2020 Received: April 2, 2020
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
{1}------------------------------------------------
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Jay Gupta Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
# Indications for Use
510(k) Number (if known)
Device Name Natus NeuroWorks
#### Indications for Use (Describe)
Natus NeuroWorks is EEG software that displays physiological signals. The intended user of this product is a qualified medical practitioner trained in Electroencephalography who will exercise professional judgment in using the information. The NeuroWorks EEG software allows acquisition, display, archive, review and analysis of physiological signals. · The Seizure Detection component of NeuroWorks is intended to mark previously acquired sections of the adult (greater than or equal to 18 years) EEG recordings that may correspond to electrographic seizures, in order to assist qualified clinical practitioners in the assessment of EEG traces. EEG recordings should be obtained with full scalp montage according to the standard 10/20 system.
· The Spike Detection component of NeuroWorks is intended to mark previously acquired sections of the adult (greater than or equal to 18 years) EEG recordings that may correspond to electrographic spikes, in order to assist qualified clinical practitioners in the assessment of EEG traces. EEG recordings should be obtained with full scalp montage according to the standard 10/20 system.
· aEEG, Burst Suppression, Envelope, Alpha variability, Spectral Entropy trending functionalities included in NeuroWorks are intended to assist the user while monitoring the state of the brain. The automated event marking function of Neuroworks is not applicable to these analysis features.
· Neuro Works also includes the display of a quantitative EEG plot, Density Spectral Array (DSA), which is intended to help the user to monitor and analyze the EEG waveform. The automated event marking function of NeuroWorks is not applicable to DSA.
· This device does not provide any diagnostic conclusion about the patient's condition to the user.
| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------|---------------------------------------------------------------------------------|
| <div> <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |
### 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}------------------------------------------------
# 510(k) SUMMARY
| Submission Date: | 25 April 2020 |
|-----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|
| Submitter: | Natus Medical Incorporated DBA Excel-Tech Ltd. (XLTEK)<br>2568 Bristol Circle<br>Oakville, Ontario, L6H 5S1<br>Canada |
| Submitter and<br>Application<br>Correspondent | Mr. Sanjay Mehta |
| | Phone: +1 (905) 287-5055 |
| | Fax: +1 (905) 829-5304 |
| | Email: sanjay.mehta@natus.com |
| Manufacturing Site: | Natus Medical Incorporated DBA Excel-Tech Ltd. (XLTEK)<br>2568 Bristol Circle<br>Oakville, Ontario, L6H 5S1<br>Canada |
| Trade Name: | Natus NeuroWorks |
| Common and<br>Classification<br>Name: | Electroencephalograph |
| Classification<br>Regulation: | 21 CFR §882.1400 |
| Product Code: | OMB (primary), OMA, OLT |
{4}------------------------------------------------
| Substantially<br>Equivalent Devices: | New Model | Predicate 510(k)<br>Number | Predicate<br>Manufacturer / Model |
|--------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|--------------------------------------------------------------------------------------------------------------------|
| | Natus Neuro Works | K180421 | Natus Medical Incorporated DBA Excel-Tech Ltd. (XLTEK)<br>2568 Bristol Circle<br>Oakville, Ontario, L6H 5S1 Canada |
| | NicoletOne | K173366 | Natus Nurology Inc. |
| | Moberg CNS | K080217 | Moberg. |
| Device Description: | Natus NeuroWorks is electroencephalography (EEG) software that displays physiological signals. The software platform<br>is designed to work with Xltek and other select Natus amplifiers (headboxes). Software add-ons and optional accessories<br>let you customize your system to meet your specific clinical EEG monitoring needs. | | |
| Intended Use: | Natus NeuroWorks is EEG software that displays physiological signals. The intended user of this product is a<br>qualified medical practitioner trained in Electroencephalography who will exercise professional judgment in<br>using the information. | | |
| | The Natus NeuroWorks EEG software allows acquisition, display, archive, review and analysis of<br>physiological signals. | | |
| | • The Seizure Detection component of Natus NeuroWorks is intended to mark previously acquired sections of<br>the adult (greater than or equal to 18 years) EEG recordings that may correspond to electrographic seizures, in<br>order to assist qualified clinical practitioners in the assessment of EEG traces. EEG recordings should be<br>obtained with full scalp montage according to the standard 10/20 system. | | |
| | • The Spike Detection component of Natus NeuroWorks is intended to mark previously acquired sections of<br>the adult (greater than or equal to 18 years) EEG recordings that may correspond to electrographic spikes, in<br>order to assist qualified clinical practitioners in the assessment of EEG traces. EEG recordings should be<br>obtained with full scalp montage according to the standard 10/20 system. | | |
| | • aEEG, Burst Suppression, Envelope, Alpha variability, Spectral Edge and Spectral Entropy trending<br>functionalities included in Natus NeuroWorks are intended to assist the user while monitoring the state of the<br>brain. The automated event marking function of Natus NeuroWorks is not applicable to these analysis | | |
{5}------------------------------------------------
features.
· Natus NeuroWorks also includes the display of a quantitative EEG plot. Density Spectral Array (DSA), which is intended to help the user to monitor and analyze the EEG waveform. The automated event marking function of Natus NeuroWorks is not applicable to DSA.
· This device does not provide any diagnostic conclusion about the patient's condition to the user.
## Comparison to Predicate Devices:
The Natus NeuroWorks software application is being compared to the software applications in the predicates NeuroWorks software (K180421) Nicoletone (K173366) and Moberg CNS (K080217). These software applications acquire, display, store, and archive electroencephalographic signals from the brain and other signals (such as electromyography, respirations) for Electroencephia and or Polysomnographic recordings. These devices also allow onscreen review, user-controlled annotation and user-controlled marking of data and generating summary reports.
| Table 1: Substantial Equivalence, Trends and other features | | | | | | |
|-----------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| | Predicate | Predicate | Primary Predicate | Subject Device | | |
| Feature | NicoletOne<br>K173366 | Moberg CNS<br>K080217 | Natus NeuroWorks<br>K180421 | Natus NeuroWorks | Comments | |
| Device Class | Class II | Class II | Class II | Class II | Identical | |
| Class Name | EEG | EEG | EEG | EEG | Identical | |
| Classifying<br>Regulation<br>(Primary) | 882.1400 | 882.1400 | 882.1400 | 882.1400 | Identical | |
| Intended User | Medical<br>Professional | Medical Professional | Medical Professional | Medical Professional | Identical | |
| Table 1: Substantial Equivalence, Trends and other features | | | | | | |
| | Predicate | Predicate | Primary Predicate | Subject Device | | |
| Feature | NicoletOne<br>K173366 | Moberg CNS<br>K080217 | Natus NeuroWorks<br>K180421 | Natus NeuroWorks | Comments | |
| Indications for<br>Use | The NicoletOne<br>EEG/PSG<br>software performs<br>recording,<br>displaying,<br>analysis, printing<br>and storage of<br>physiological<br>signals to assist in<br>the diagnosis of<br>various<br>neurological<br>disorders, sleep<br>disorders and<br>sleep related<br>respiratory<br>disorders. It is<br>intended to<br>monitor the state<br>of the brain by<br>recording and<br>displaying EEG<br>signals and can<br>receive and<br>display a variety<br>of third party<br>signals such as<br>ECG, EMG,<br>Oxygen Saturation<br>or Respiration for<br>patients of all<br>ages.<br>NicoletOne<br>software allows: | The Component<br>Neuromonitoring<br>System is intended to<br>monitor the state of<br>the brain by recording<br>and displaying EEG<br>signals, and can also<br>receive and display a<br>variety of vital signs<br>and other<br>measurements from<br>third-party monitoring<br>devices (such as ICP,<br>ECG, SpO2, and<br>others). It also has<br>the optional capability<br>to record and display<br>patient video.<br>The Component<br>Neuromonitoring<br>System is intended for<br>use by a physician or<br>other qualified<br>medical personnel. It<br>is intended for use on<br>patients of all ages<br>within a hospital or<br>medical environment,<br>including the<br>operating room,<br>intensive care unit,<br>emergency room, and | The Natus<br>NeuroWorks is EEG<br>software that displays<br>physiological signals.<br>The intended User of<br>this product is a<br>qualified medical<br>practitioner trained in<br>Electroencephalograph<br>y. This device is<br>intended to be used by<br>qualified medical<br>practitioners who will<br>exercise professional<br>judgment in using the<br>information.<br>The Natus<br>NeuroWorks EEG<br>software allows<br>acquisition, display,<br>archive, review and<br>analysis of<br>physiological signals.<br>The Seizure<br>Detection component<br>of Natus<br>NeuroWorks is<br>intended to mark<br>previously acquired<br>sections of the adult<br>(greater than or equal<br>to 18 years) EEG<br>recordings that may<br>correspond to<br>electrographic | The Natus NeuroWorks is<br>EEG software that displays<br>physiological signals. The<br>intended User of this<br>product is a qualified<br>medical practitioner trained<br>in Electroencephalography.<br>This device is intended to<br>be used by qualified<br>medical practitioners who<br>will exercise professional<br>judgment in using the<br>information.<br>The Natus NeuroWorks<br>EEG software allows<br>acquisition, display,<br>archive, review and<br>analysis of physiological<br>signals.<br>The Seizure Detection<br>component of Natus<br>NeuroWorks is intended<br>to mark previously<br>acquired sections of the<br>adult (greater than or<br>equal to 18 years) EEG<br>recordings that may<br>correspond to<br>electrographic seizures,<br>in order to assist qualified<br>clinical practitioners in<br>the assessment of EEG<br>traces. EEG recordings<br>should be obtained with<br>full scalp montage | Equivalent, for the following reasons:<br>- Natus NeuroWorks 9.2 intended use is the<br>same as Primary predicate and<br>"NicoleOne" predicate devices.<br>- Nicolet One and Moberg CNS and Natus<br>NeuroWorks all permit the recording of<br>EEG data from corresponding EEG<br>amplifiers.<br>Nicolet One and Moberg CNS and Natus<br>NeuroWorks all permit the receipt of data<br>from various third party physiological<br>monitoring devices utilizing the same<br>hardware ports these devices provide to<br>output data to external recording systems<br>such as Nicolet One, Moberg EEG, and<br>Natus NeuroWorks software. | |
| Table 1: Substantial Equivalence, Trends and other features | | | | | | |
| | Predicate | Predicate | Primary Predicate | Subject Device | | |
| Feature | NicoletOne<br>K173366 | Moberg CNS<br>K080217 | Natus NeuroWorks<br>K180421 | Natus NeuroWorks | Comments | |
| | - Automated<br>analysis of<br>physiological<br>signals that is<br>intended for use<br>only in adults.<br>- An optional<br>Audio/visual alert<br>for user defined<br>threshold on<br>calibrated DC<br>input. These<br>alerts are not<br>intended for use<br>as life support<br>such as vital signs<br>monitoring or<br>continuous<br>medical<br>surveillance in<br>intensive care<br>units.<br>- Sleep report<br>templates are<br>provided which<br>summarize<br>recorded and<br>scored sleep data<br>using simple<br>measures<br>including count,<br>average,<br>maximum and<br>minimum values | clinical research<br>settings. | - seizures, in order to<br>assist qualified<br>clinical practitioners<br>in the assessment of<br>EEG traces. EEG<br>recordings should be<br>obtained with full<br>scalp montage<br>according to the<br>standard 10/20<br>system.<br>- The Spike Detection<br>component of Natus<br>NeuroWorks is<br>intended to mark<br>previously acquired<br>sections of the adult<br>(greater than or equal<br>to 18 years) EEG<br>recordings that may<br>correspond to<br>electrographic spikes,<br>in order to assist<br>qualified clinical<br>practitioners in the<br>assessment of EEG<br>traces. EEG<br>recordings should be<br>obtained with full<br>scalp montage<br>according to the<br>standard 10/20<br>system.<br>- The aEEG<br>functionality | according to the standard<br>10/20 system.<br>- The Spike Detection<br>component of Natus<br>NeuroWorks is intended<br>to mark previously<br>acquired sections of the<br>adult (greater than or<br>equal to 18 years) EEG<br>recordings that may<br>correspond to<br>electrographic spikes, in<br>order to assist qualified<br>clinical practitioners in<br>the assessment of EEG<br>traces. EEG recordings<br>should be obtained with<br>full scalp montage<br>according to the standard<br>10/20 system.<br>- aEEG, Burst<br>Suppression, Envelope,<br>Alpha variability,<br>Spectral Edge and<br>Spectral Entropy trending<br>functionalities included<br>in Natus NeuroWorks are<br>intended to assist the user<br>while monitoring the<br>state of the brain. The<br>automated event marking<br>function of Natus<br>NeuroWorks is not<br>applicable to these<br>analysis features. | | |
| Table 1: Substantial Equivalence, Trends and other features | | | |…
