Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes automated detection algorithms for seizures and spikes but does not mention AI, ML, or any related concepts like training or test sets, which are typical for AI/ML-based devices. The performance studies focus on functional and comparison testing against predicate devices, not on AI/ML model performance metrics.

Therapeutic

No
The device is EEG software that displays and analyzes physiological signals to assist qualified clinical practitioners in the assessment of EEG traces. It is used for diagnostic assistance rather than direct treatment or therapy.

Diagnostic

No

The "Intended Use / Indications for Use" section explicitly states, "This device does not provide any diagnostic conclusion about the patient's condition to the user." While it assists in the assessment of EEG traces, it does not make a diagnosis itself.

SaMD (Software as a Medical Device)

No

The device description explicitly states that the software platform is designed to work with specific Natus amplifiers (headboxes), indicating a dependency on hardware components for signal acquisition.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an In Vitro Diagnostic (IVD).

Here's why:

IVDs analyze samples taken from the human body. The intended use and device description clearly state that Natus NeuroWorks is EEG software that displays and analyzes physiological signals acquired directly from the patient's brain via electrodes. It does not process biological samples like blood, urine, or tissue.
The analysis is of electrical activity, not biological components. EEG measures the electrical activity of the brain, which is a physiological signal, not a biological component of a sample.

Therefore, Natus NeuroWorks falls under the category of a medical device that analyzes physiological signals, not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

Product codes (comma separated list FDA assigned to the subject device)

OMB, OMA, OLT

Device Description

Natus NeuroWorks is electroencephalography (EEG) software that displays physiological signals. The software platform is designed to work with Xltek and other select Natus amplifiers (headboxes). Software add-ons and optional accessories let you customize your system to meet your specific clinical EEG monitoring needs.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Brain (EEG recordings obtained with full scalp montage according to the standard 10/20 system)

Indicated Patient Age Range

Adult (greater than or equal to 18 years)

Intended User / Care Setting

Qualified medical practitioner trained in Electroencephalography. Hospital or medical environment, including the operating room, intensive care unit, emergency room, and clinical research settings.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Software validation and verification were performed according to a robust software development process and applicable guidance documents/standards.
Bench and performance testing confirmed functional testing of supported Amplifiers, NeuroWorks Workflows, Peripheral Components, Interoperability between NeuroWorks amplifiers and Physiological Monitoring units, Functional and bench testing of Trend data, and Comparison testing of Trend data between NeuroWorks and a predicate device (NicoletOne software).
Results indicate that the Natus NeuroWorks software complies with its predetermined specifications and applicable standards, and that it is as safe, as effective, and performs as well as or better than the predicate devices.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K180421, K173366, K080217

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 882.1400 Electroencephalograph.

(a)
Identification. An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.(b)
Classification. Class II (performance standards).

Summary

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

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3

510(k) SUMMARY

Submission Date:	25 April 2020
Submitter:	Natus Medical Incorporated DBA Excel-Tech Ltd. (XLTEK)
2568 Bristol Circle
Oakville, Ontario, L6H 5S1
Canada
Submitter and
Application
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)
2568 Bristol Circle
Oakville, Ontario, L6H 5S1
Canada
Trade Name:	Natus NeuroWorks
Common and
Classification
Name:	Electroencephalograph
Classification
Regulation:	21 CFR §882.1400
Product Code:	OMB (primary), OMA, OLT

4

| Substantially
Equivalent Devices: | New Model | Predicate 510(k)
Number | Predicate
Manufacturer / Model |
|--------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|--------------------------------------------------------------------------------------------------------------------|
| | Natus Neuro Works | K180421 | Natus Medical Incorporated DBA Excel-Tech Ltd. (XLTEK)
2568 Bristol Circle
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
is designed to work with Xltek and other select Natus amplifiers (headboxes). Software add-ons and optional accessories
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
qualified medical practitioner trained in Electroencephalography who will exercise professional judgment in
using the information. | | |
| | The Natus NeuroWorks EEG software allows acquisition, display, archive, review and analysis of
physiological signals. | | |
| | • The Seizure Detection component of Natus 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 Natus 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 Edge and Spectral Entropy trending
functionalities included in Natus NeuroWorks are intended to assist the user while monitoring the state of the
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
K173366	Moberg CNS
K080217	Natus NeuroWorks
K180421	Natus NeuroWorks	Comments
Device Class	Class II	Class II	Class II	Class II	Identical
Class Name	EEG	EEG	EEG	EEG	Identical
Classifying
Regulation
(Primary)	882.1400	882.1400	882.1400	882.1400	Identical
Intended User	Medical
Professional	Medical Professional	Medical Professional	Medical Professional	Identical
Table 1: Substantial Equivalence, Trends and other features
	Predicate	Predicate	Primary Predicate	Subject Device
Feature	NicoletOne
K173366	Moberg CNS
K080217	Natus NeuroWorks
K180421	Natus NeuroWorks	Comments
Indications for
Use	The NicoletOne
EEG/PSG
software performs
recording,
displaying,
analysis, printing
and storage of
physiological
signals to assist in
the diagnosis of
various
neurological
disorders, sleep
disorders and
sleep related
respiratory
disorders. It is
intended to
monitor the state
of the brain by
recording and
displaying EEG
signals and can
receive and
display a variety
of third party
signals such as
ECG, EMG,
Oxygen Saturation
or Respiration for
patients of all
ages.
NicoletOne
software allows:	The Component
Neuromonitoring
System is intended to
monitor the state of
the brain by recording
and displaying EEG
signals, and can also
receive and display a
variety of vital signs
and other
measurements from
third-party monitoring
devices (such as ICP,
ECG, SpO2, and
others). It also has
the optional capability
to record and display
patient video.
The Component
Neuromonitoring
System is intended for
use by a physician or
other qualified
medical personnel. It
is intended for use on
patients of all ages
within a hospital or
medical environment,
including the
operating room,
intensive care unit,
emergency room, and	The Natus
NeuroWorks is EEG
software that displays
physiological signals.
The intended User of
this product is a
qualified medical
practitioner trained in
Electroencephalograph
y. This device is
intended to be used by
qualified medical
practitioners who will
exercise professional
judgment in using the
information.
The Natus
NeuroWorks EEG
software allows
acquisition, display,
archive, review and
analysis of
physiological signals.
The Seizure
Detection component
of Natus
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	The Natus NeuroWorks is
EEG software that displays
physiological signals. The
intended User of this
product is a qualified
medical practitioner trained
in Electroencephalography.
This device is intended to
be used by qualified
medical practitioners who
will exercise professional
judgment in using the
information.
The Natus NeuroWorks
EEG software allows
acquisition, display,
archive, review and
analysis of physiological
signals.
The Seizure Detection
component of Natus
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	Equivalent, for the following reasons:

Natus NeuroWorks 9.2 intended use is the
same as Primary predicate and
"NicoleOne" predicate devices.
Nicolet One and Moberg CNS and Natus
NeuroWorks all permit the recording of
EEG data from corresponding EEG
amplifiers.
Nicolet One and Moberg CNS and Natus
NeuroWorks all permit the receipt of data
from various third party physiological
monitoring devices utilizing the same
hardware ports these devices provide to
output data to external recording systems
such as Nicolet One, Moberg EEG, and
Natus NeuroWorks software. | |
| Table 1: Substantial Equivalence, Trends and other features | | | | | | |
| | Predicate | Predicate | Primary Predicate | Subject Device | | |
| Feature | NicoletOne
K173366 | Moberg CNS
K080217 | Natus NeuroWorks
K180421 | Natus NeuroWorks | Comments | |
| | - Automated
analysis of
physiological
signals that is
intended for use
only in adults.
An optional
Audio/visual alert
for user defined
threshold on
calibrated DC
input. These
alerts are not
intended for use
as life support
such as vital signs
monitoring or
continuous
medical
surveillance in
intensive care
units.
Sleep report
templates are
provided which
summarize
recorded and
scored sleep data
using simple
measures
including count,
average,
maximum and
minimum values | clinical research
settings. | - 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 Natus
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.
The aEEG
functionality | according to the standard
10/20 system.
The Spike Detection
component of Natus
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 Edge and
Spectral Entropy trending
functionalities included
in Natus NeuroWorks are
intended to assist the user
while monitoring the
state of the brain. The
automated event marking
function of Natus
NeuroWorks is not
applicable to these
analysis features. | | |
| Table 1: Substantial Equivalence, Trends and other features | | | | | | |
| | Predicate | Predicate | Primary Predicate | Subject Device | | |
| Feature | NicoletOne
K173366 | Moberg CNS
K080217 | Natus NeuroWorks
K180421 | Natus NeuroWorks | Comments | |
| | as well as data
ranges for
trended values.
This device does
not provide any
diagnostic
conclusion about
the patient's
condition and is
intended to be
used only by
qualified and
trained medical
practitioners, in
research and
clinical
environments. | as well as data
ranges for
trended values.
This device does
not provide any
diagnostic
conclusion about
the patient's
condition and is
intended to be
used only by
qualified and
trained medical
practitioners, in
research and
clinical
environments. | included in Natus
NeuroWorks is
intended to monitor
the state of the brain.
The automated event
marking function of
Natus NeuroWorks is
not applicable to
aEEG.
Natus NeuroWorks
also includes the
display of a
quantitative EEG
plot, Compressed
Spectrum Array
(CSA), 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
CSA.
This device does not
provide any diagnostic
conclusion about the
patient's condition to
the user. | - 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. | | |
| User input | Mouse/keyboard | Mouse/keyboard | Mouse/keyboard | Mouse/keyboard | Same | |
| Acquire,
display, store | Yes | Yes | Yes | Yes | Same | |
| Table 1: Substantial Equivalence, Trends and other features | | | | | | |
| | Predicate | Predicate | Primary Predicate | Subject Device | | |
| Feature | NicoletOne
K173366 | Moberg CNS
K080217 | Natus NeuroWorks
K180421 | Natus NeuroWorks | Comments | |
| and archive
EEG/PSG and
data from 3rd
party
physiological
monitoring
devices | | | | | | |
| Signal
digitized | By separate
proprietary
amplifier | Amplifier included as
part of the system | By separate
proprietary amplifier | By separate proprietary
amplifier | Equivalent | |
| Third party
pass-through
inputs | Yes
SaO2, heart rate | Yes
SaO2, heart rate,
RsO2 | Yes
Nonin Oximeter pass-
through for Oxymetry,
HR, and Pulse Wave | Yes
Nonin Oximeter pass-
through for Oxymetry, HR,
and Pulse Wave | Equivalent | |
| Power | NA | NA | NA | NA | Software operating on a computer. | |
| EEG Software Detectors | | | | | | |
| Spike
Detection | Yes
(Manual &
Computer
Assisted) | Yes
(Manual) | Yes
(Manual & Computer
Assisted) | Yes
(Manual & Computer
Assisted) | Same or better:
Natus NeuroWorks supports manual and
automatic detection like in NicoletOne
predicate device. The Moberg predicate
device only allows for Manual detection. | |
| Seizure
Detection | Yes
(Manual &
Computer
Assisted) | Yes
(Manual) | Yes
(Manual & Computer
Assisted) | Yes
(Manual & Computer
Assisted) | | |
| Burst
Suppression | Yes | Yes | No | Yes | Equivalent: | |
| Table 1: Substantial Equivalence, Trends and other features | | | | | | |
| | Predicate | Predicate | Primary Predicate | Subject Device | | |
| Feature | NicoletOne
K173366 | Moberg CNS
K080217 | Natus NeuroWorks
K180421 | Natus NeuroWorks | Comments | |
| | | | | | Feature added to Natus NeuroWorks Subject
device. With this implementation the Natus
NeuroWorks Subject device is now
equivalent to NicoletOne and Moberg
Predicate devices. | |
| Amplitude
Integrated
EEG (aEEG) | Yes | Yes | Yes | Yes | Same | |
| Power
Spectrum | Yes | Yes | Yes | Yes | Same | |
| Envelope
Trend | Yes | No | No | Yes | Equivalent:
Feature added to Natus NeuroWorks Subject
device. With this implementation the Natus
NeuroWorks Subject device is now
equivalent to NicoletOne Predicate devices. | |
| Total Power
Trend | Yes | Yes | Yes | Yes | Same | |
| Band Power
Trend | Yes | Yes | Yes | Yes | Same | |
| DSA /
Spectrogram | Yes | Yes | Yes | Yes | Equivalent:
The feature was already available in Natus
NeuroWorks primary predicate device but
named "CSA". This feature is now called
DSA which is a more commonly used name.
In addition to the old color scale from the
CSA plot in previous Natus NeuroWorks
versions, additional color scales were taken | |
| Table 1: Substantial Equivalence, Trends and other features | | | | | | |
| Feature | Predicate | Predicate | Primary Predicate | Subject Device | | |
| | NicoletOne
K173366 | Moberg CNS
K080217 | Natus NeuroWorks
K180421 | Natus NeuroWorks | Comments | |
| Spectral edge/Median freq. Trends | Yes | Yes | No | Yes | provides better contrast improving the
performance of the feature. Spectral
resolution of 30Hz in Natus NeuroWorks 9.1
is improved in Natus NeuroWorks 9.2 to
64Hz (steps of 0.5Hz).
To summarize: DSA trend plots in Natus
NeuroWorks Subject device do not introduce
a new trend feature, but in terms of
performance it is now equivalent to
NicoletOne predicate device where is was
named "Spectrogram". | |
| Spectral edge/Median freq. Trends | Yes | Yes | No | Yes | Equivalent:
Feature added to Natus NeuroWorks Subject
device. With this implementation the Natus
NeuroWorks Subject device is now
equivalent to NicoletOne and Moberg
Predicate devices. | |
| Peak Frequency Trend | Yes | Yes | No | No | This feature is not implemented in Natus
NeuroWorks subject device because it is
rarely used. | |
| Spectral Entropy trend | Yes | Yes | No | Yes | Equivalent:
Feature added to Natus NeuroWorks Subject
device. With this implementation the Natus
NeuroWorks Subject device is now
equivalent to NicoletOne and Moberg
Predicate devices. | |
| Table 1: Substantial Equivalence, Trends and other features | | | | | | |
| | Predicate | Predicate | Primary Predicate | Subject Device | | |
| Feature | NicoletOne
K173366 | Moberg CNS
K080217 | Natus NeuroWorks
K180421 | Natus NeuroWorks | Comments | |
| | | | | | | |
| Frequency
Ratio Trend | Yes | No | Yes | Yes | Equivalent | |
| Alpha
Variation
Trend | Yes | Yes | No | Yes | Equivalent:
Feature added to Natus NeuroWorks Subject
device. With this implementation the Natus
NeuroWorks Subject device is now
equivalent to NicoletOne and Moberg
Predicate devices. | |
| Heart Rate
data trend &
summary | Yes | Yes | Yes | Yes | Same | |
| R-R interval
trend | Yes | No | No | Yes | Equivalent:
Feature added to Natus NeuroWorks Subject
device. With this implementation the Natus
NeuroWorks Subject device is now
equivalent to NicoletOne Predicate devices. | |
| Other features | | | | | | |
| Synchronized
patient video | Yes | Yes | Yes | Yes | Same | |
| Oximetry data
display and
reporting | Yes | Yes | Yes | Yes | Same | |
| Table 1: Substantial Equivalence, Trends and other features | | | | | | |
| | Predicate | Predicate | Primary Predicate | Subject Device | | |
| Feature | NicoletOne
K173366 | Moberg CNS
K080217 | Natus NeuroWorks
K180421 | Natus NeuroWorks | Comments | |
| Data storage | Local or remote,
hard disk | Local or remote, hard
disk | Local or remote, hard
disk | Local or remote, hard disk | Same | |
| Audio/ Visual
Alerts On
Calibrated
Channels | Yes | Yes | Yes | Yes | Same | |
| Signals
recorded
(output) | Respiratory Effort
(abdomen and
chest)
Airflow
Pressure
Snore
Body Position
Pulse Rate
Oximeter
ECG
EEG
EMG
EOG
DC
Leg Movement
and other signals
required for sleep
studies | Respiratory Effort
(abdomen and chest)
Airflow
Pressure
Snore
Body Position
Pulse Rate
Oximeter
ECG
EEG
EMG
EOG
DC
Leg Movement and
other signals required
for sleep studies | Respiratory Effort
(abdomen and chest)
Airflow
Pressure
Snore
Body Position
Pulse Rate
Oximeter
ECG
EEG
EMG
EOG
DC
Leg Movement | Respiratory Effort
(abdomen and chest)
Airflow
Pressure
Snore
Body Position
Pulse Rate
Oximeter
ECG
EEG
EMG
EOG
DC
Leg Movement | Equivalent | |
| Signals
recorded
(output) from
3rd party
physiological | SpO2 - Peripheral
Capillary Oxygen
Saturation
T - Temperature | Oxygen Saturation,
Pulse Rate,
Temperature,
Respiratory Rate, | Same | Same | Equivalent | |
| Table 1: Substantial Equivalence, Trends and other features | | | | | | |
| | Predicate | Predicate | Primary Predicate | Subject Device | | |
| Feature | NicoletOne
K173366 | Moberg CNS
K080217 | Natus NeuroWorks
K180421 | Natus NeuroWorks | Comments | |
| monitoring
devices | HR - Heart Rate
NIBPS - Non-
Invasive Blood
Pressure Systolic
NIPBD - Non-
Invasive Blood
Pressure Dystolic | Heart Rate,
Non-Invasive
Blood Pressure
Systolic,
Non-Invasive
Blood Pressure
Dystolic,
Non-Invasive
Blood Pressure
Mean, Invasive
Blood Pressure
Systolic,
Invasive Blood
Pressure Dystolic,
Invasive Blood
Pressure Mean,
Blood Flow
Perfusion,
Brain & Tissue
Oxygenation,
Intracranial
Pressure | | | | |
| Report
generation
including
counts indexes,
max / min/
average/
duration, range
based data | Yes, customizable
templates | Yes, customizable
templates | Yes, customizable
templates | Yes,
customizable templates | Same | |
| Table 1: Substantial Equivalence, Trends and other features | | | | | | |
| Feature | Predicate | Predicate | Primary Predicate | Subject Device | | |
| | NicoletOne
K173366 | Moberg CNS
K080217 | Natus NeuroWorks
K180421 | Natus NeuroWorks | Comments | |
| Numeric &
graphical
representations | | | | | | |

The following table provides a substantial equivalson of the Natus NeuroWorks software application under review to three predicate devices.

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Detailed description of new Trend features:

	NicoletOne K173366 (Predicate device)	Natus NeuroWorks (subject device)	Comments
Description of
Burst
Suppression
trend	The Burst Suppression Trend is an analyzer
that has been developed to identify Burst
Suppression Pattern in the EEG. It is
recognized by a periodic pattern of low voltage
(less than 10 μν) and relatively shorter patterns
of higher amplitude complexes.

Three types of burst channels are available in
the Calculated Channels editor:

Burst rate: average n° of segments with
higher-amplitude and mixed-frequency
activity over the analysis window length
% Suppression, "Burst Suppression
ratio", or "BSR": % of (sum of duration
of suppression during analysis window /
analysis window length). The default
analysis window is 10 min
IBI, "Inter-burst interval": Duration of the
last complete suppression period (will
be detected 1 – 2 seconds after arrival
of burst ending the suppression...)
In addition to the trends, these BS values can
be displayed in the Heads-Up toolbar from
Natus NeuroWorks. | The Burst Suppression Trend is an analyzer
that has been developed to identify Burst
Suppression Pattern in the EEG. It is
recognized by a periodic pattern of low voltage
(less than 10 µv) and relatively shorter patterns
of higher amplitude complexes.

Three types of burst channels are available in
the Calculated Channels editor:

Burst rate: average n° of segments
with higher-amplitude and mixed-
frequency activity over the analysis
window length
% Suppression, "Burst Suppression
ratio", or "BSR": % of (sum of duration
of suppression during analysis window
/ analysis window length). The default
analysis window is 10 min
IBI, "Inter-burst interval": Duration of
the last complete suppression period
(will be detected 1 - 2 seconds after
arrival of burst ending the
suppression...)
In addition to the trends, these BS values can
be displayed in the Heads-Up toolbar from
Natus NeuroWorks. | Same |

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Image /page/17/Figure/0 description: The image shows examples of Burst Suppression trends in NicoletOne and Natus NeuroWorks. The text explains that the Burst Suppression features eliminate the need to manually count bursts and also show trend plots and values for Bursts, % Suppression, and Inter-Burst Interval (IBI). The programming code and drawing algorithm for Burst Suppression was taken over from NicoletOne software, a product owned by Natus. The trend plots for Burst Suppression in Natus NeuroWorks are shown on the same study data, and the resulting graphs are identical.

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Image /page/18/Figure/0 description: The image shows a description of the envelope trend, which is a line graph representing variations in the amplitude of EEG activity. The algorithm slices the EEG into blocks of a specific length, ideally 20-30 seconds, for better elimination of movement artifacts. For each block, all waves in the EEG are detected, and the peak-to-peak amplitude is calculated in each wave. The waves are then lined up by size, and the median peak-to-peak amplitude in the block is found, which is the numerical value of the envelope.

Page 16 of 25

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Image /page/19/Figure/0 description: The image shows two examples of envelope trends in NicoletOne and Natus NeuroWorks. The text states that the programming code and drawing algorithm for Envelope was taken over from NicoletOne software, a product owned by Natus. The following examples show trend plots for Envelope trend in Natus NeuroWorks on the same study data as the example for Nicoletone, and consequently the resulting graphs are identical. The graphs show the envelope trend over time, with the x-axis representing time and the y-axis representing the envelope trend.

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| Description of Spectral Entropy (SEN) trend | Spectral Entropy shows a line graph representing the "complexity" or "regularity" of a signal.
SEN can take values from 0 (if the signal is completely regular, e.g. a sine wave) to 100 (if the spectrum is that of uncorrelated white noise).
Example of a spectral Entropy trend in Nicoletone:
|
|---------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Spectral Entropy shows a line graph representing the "complexity" or "regularity" of a signal.
SEN can take values from 0 (if the signal is completely regular, e.g. a sine wave) to 100 (if the spectrum is that of uncorrelated white noise).
The programming code and the drawing algorithm for Spectral Entropy was taken over from NicoletOne software, a product owned by
Natus.
The following example show the trend plot for Spectral Entropy_in Natus NeuroWorks on the same study data as the example for Nicoletone. Consequently the resulting graphs are identical:
|
| | Same |

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Image /page/21/Figure/0 description: The image shows two identical graphs that describe the spectral edge trend. The 95% spectral edge is the frequency below which one finds 95% of the total power. The spectral edge and median frequencies are derived from the power spectrum from a block of EEG. The algorithm for spectral edge was taken over from NicoletOne software, a product owned by Natus.

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| | The following example show the trend plot for
Spectral Edge trend in Natus NeuroWorks on the
same study data as the example for Nicoletone.
Consequently the resulting graphs are identical:
| | |
|-------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|
| Description of
Alpha Variability | Alpha variability is the analysis of the change
in power in the 6Hz to 14Hz band (including
alpha) compared to the wide band power
between 1Hz and 20Hz.
The Alpha Variability Trend/Relative Alpha,
takes a moving average of the spectrum. The
moving average contains 60 blocks of data
where one block is typically 2 seconds.
$Alpha variability = \frac{BandPower(6Hz, 14Hz)}{BandPower(1Hz, 20Hz)}$ | Alpha variability is the analysis of the change
in power in the 6Hz to 14Hz band (including
alpha) compared to the wide band power
between 1Hz and 20Hz.
The Alpha Variability Trend/Relative Alpha,
takes a moving average of the spectrum. The
moving average contains 60 blocks of data
where one block is typically 2 seconds.
$Alpha variability = \frac{BandPower(6Hz, 14Hz)}{BandPower(1Hz, 20Hz)}$ | Same |

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Image /page/23/Figure/0 description: The image shows examples of Alpha Variability trends in NicoletOne. The algorithm for Alpha Variability was taken over from NicoletOne software, a product owned by Natus. The following examples show trend plots for Alpha Variability trend in NicoletOne and in Natus NeuroWorks on the same study data as the example for NicoletOne, and consequently the resulting graphs are identical. There are three trend plots shown in the image.

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These predicate devices support features and technology equivalence of the Natus NeuroWorks software under review. As indicated, the Natus NeuroWorks software and the predicate devices are equivalent in features and technical characteristics.

The Natus NeuroWorks software and predicate devices are not life sustaining devices. The Natus NeuroWorks software is intended for use only by qualified and trained mactitioners in clinical and research environments, who evaluate the software output with their clinical experience and judgment to provide diagnostic conclusions about the patient's condition.

Similarly to the predicate devices, Natus North as the qualified users with computer assisted scoring of events which will mark sections of the recorded signals for subsequent review by the user. These functions are provided as computer-aded tools. Users are instructed to review, accept or reject the results of the assisted scoring tools in accordance with their professional judgment.

Natus NeuroWorks software and all predicates inclusition of synchronized video recording/review, audio/visual threshold based alerts for calibrated external devices (pulse oximeter) as well as trending of any collected data for summary review and reporting.

The differences between Natus NeuroWorks and the predicate devices are mainly related to user workflow. There are no major differences that significantly alter the intended use or raise of safety or effectiveness. The predicates devices NeuroWorks software (K18042), and NicoletOne (K173366), as well as the device under review, Natus NeuroWorks software, have equivalent intended use: to record and process EEGPSG and other physiological signals to assist in the diagnoss of various neurological disorders and sleep related respiratory disorders affecting patients in all age groups.

Brief Summary of Performance Tests:

BioCompatibility	Natus NeuroWorks is a software-only device. Biocompatibility testing is not applicable.
Electrical Safety and
EMC	Natus NeuroWorks is a software-only device. Electrical safety evaluation and EMC evaluation is not applicable.
Animal Study	There were no animal studies performed for this submission.
Clinical Study	There were no clinical studies performed for this submission.

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Software

The Natus NeuroWorks software was designed and developed according to a robust software development process, and was rigorously verified and validated. Software information is provided in accordance with internal requirements and the following FDA guidance documents and standards:

The content of premarket submissions for software contained in medical devices, 11 May 05. .
Off-the-shelf software use in medical devices, 09 Sep 99. .
General principles of software validation; Final guidance for industry and FDA staff, 11 Jan 02. .
Content of premarket submissions for management of cybersecurity in medical devices, 02 Oct 14. .
. Cybersecurity for networked medical devices containing off-the-shelf (OTS) software, 14 Jan 05
IEC 62304: 2006, Medical device software Software life cycle processes

Results indicate that the Natus NeuroWorks software complies with its predetermined specifications, the applicable guidance documents, and the applicable standards.

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Performance Testing – Bench The Natus NeuroWorks software was verified for performance in accordance with internal requirements and the applicable clauses of the following standards:

· IEC 62304: 2006, Medical device software Software life cycle processes
IEC 62366: 2007, Am1: 2014, Medical devices Application of usability engineering to medical devices .
IEC 60601-1-6 Medical electrical equioment-part 1-6 General requirements for basic safety and essential . performance -Collateral standard :Usability
ISO 14971: 2012, Medical devices Application of risk management to medical devices .

Results indicate that the Natus NeuroWorks software complies with its predetermined specifications and the applicable standards.

In addition , Bench and performance testing was performed to confirm

· Functional testing of the supported Amplifiers with NeuroWorks software
Functional testing of the supported Neuroworks Workflows within the software .
Functional testing of the supported Peripheral Components within the software .
Interoperability between the NeuroWorks amplifiers and Physiological Monitoring units. .
Functional and bench testing of the Trend data with Neuroworks software. .
Comparison testing of the Trend data between Neuroworks and Predicate device (NicoletOne . software)

Results indicate that the Natus NeuroWorks software complies with its predetermined specifications and the applicable standards.

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The substantial equivalence of the Natus Neuroworks software with the predicate devices was Conclusion demonstrated by testing in compliance with the Design Control process. The intended use and technology of the Natus Neuroworks software 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 Neuroworks software is as safe, as effective, and performs as well as or better than the predicate devices.