The Natus BrainWatch System including the Natus BrainWatch Headband, is intended to record and store EEG signals and present these signals visually to assist trained medical staff in making neurological diagnoses in patients aged 2 years and older.

The device does not provide any diagnostic conclusions about the subject's condition and does not provide any automated alerts of an adverse clinical event. The Natus BrainWatch System is intended for use within a professional healthcare facility or clinical research environment. The Natus BrainWatch Headband is intended for single-patient use.

Device Description

The Natus BrainWatch system is a reliable, mobile, and easy-to-use EEG device intended to record, store, and visually present EEG signals to assist trained medical staff in making neurological diagnoses in patients.

The system includes a touchscreen tablet as its primary interface. The Natus BrainWatch Headband is a single-use disposable headpiece with an integrated array of 10 passive electrodes that are applied to the patient's head to record EEG signals when connected to an amplifier.

The Natus BrainWatch System consists of the following components: Tablet, IV Pole Handle, Amplifier, Headband(s), Gel Pods and a Mobile Application:

Touchscreen Tablet with charger
Single-Use disposable elastic fabric headband with 10 electrodes (available in sizes Small, Medium, and Large) containing:
- Hydroflex patch with 2 built-in electrodes
- 8 electrodes attached to gel pods used to improve impedance levels labeled L1-L4, R1-R4
Wireless amplifier that attaches to the headband and connects to the tablet via Bluetooth
IV pole handle that holds the tablet for a hands-free experience
Gels pods attach to the electrodes to improve impedance levels

The Natus BrainWatch System is a portable 10-channel EEG monitoring system. 10 patient electrodes are used to record the 10 channels. Channels 1-5 should be used for the patient's left hemisphere, with channel 1 at the front of the patient's head and channel 5 at the back. Channels 6-10 should be used for the patient's right hemisphere, with channel 6 at the front of the patient's head and channel 10 at the back.

EEG recording files are transferred wirelessly to a computer from the Natus BrainWatch Tablet using a Wi-Fi connection. The EEG sessions from Natus BrainWatch are stored using a cloudbased solution which allows the end user to view studies at a later date. Recorded sessions can be reviewed remotely on a computer using the Neuroworks EEG software.

The device is a portable, 10-channel EEG monitoring system. The device connects to a headband consisting of 10 patient electrodes which are used to form the 10 channels and may be used with any scalp EEG electrodes.

The system acquires the EEG signals of a patient and presents the EEG signals in visual formats in real time. The EEG recordings are displayed on a computer or tablet using an EEG viewer software. The visual signals assist trained medical staff to make neurological diagnoses. It does not provide any diagnostic conclusion about the subject's condition and does not provide any automated alerts of an adverse clinical event.

Micro-USB cable is used to connect the Natus BrainWatch System to power adapter for charging. Bluetooth is used to connect amplifier with tablet to transfer EEG recording files. When the Natus BrainWatch System is connected to a power adapter of a computer, all EEG acquisition functions are automatically disabled.

AI/ML Overview

The Natus BrainWatch System is a portable 10-channel EEG monitoring system intended to record, store, and visually present EEG signals to assist trained medical staff in making neurological diagnoses in patients aged 2 years and older. It does not provide diagnostic conclusions or automated alerts of adverse clinical events.

Here's a breakdown of the acceptance criteria and the study verifying the device's performance:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text details the performance verification against various standards rather than specific quantitative acceptance criteria for clinical performance. The focus is on demonstrating safety and electrical performance equivalence to predicate devices.

Acceptance Criteria Category	Reported Device Performance (Summary)
Electrical Safety	Verified in accordance with IEC 60601-1-6:2010/AMD2:2020, IEC 60601-1:2005/AMD2:2020, and IEC 80601-2-26:2019.
Electromagnetic Compatibility	Verified in accordance with IEC 60601-1-2 Ed 4.1. Underwent Wireless Coexistence testing per ANSI C63.27-2021. FCC Part 15 certified.
Packaging & Handling	Successfully passed verification as per ASTM D4169-22.
Bench Verification & Validation (Functional/Performance)	Successfully passed performance verification and validation in accordance with internal requirements and specifications. Met defined acceptance criteria for functional and performance characteristics.
EEG Specific Performance	Met requirements for basic safety and essential performance of electroencephalographs per IEC 80601-2-26. Met Performance Criteria of FDA Guidance "Cutaneous Electrodes for Recording Purposes - Performance Criteria for Safety and Performance Based Pathway".
Battery Safety	Tested per IEC 62133.
Biocompatibility	Patient contacting components (including conductive electrolyte gel) verified with Irritation, Sensitization, and Cytotoxicity testing per ISO 10993-5:2009, ISO 10993-23:2021, and ISO 10993-10:2021.
Shelf-life	Shelf-life testing performed.
Wireless Technology	Utilizes Bluetooth 5.0 technology (similar to reference device CGX Quick-20m K203331). No interference with other electronic devices; coexists well in a typical medical environment.
Analogue-to-Digital Conversion	24-Bit Delta-Sigma (Same as Predicate 1).
Sampling Rate	250 Hz (Same as Predicate 1).

2. Sample size used for the test set and the data provenance

The document does not specify a separate "test set" in the context of clinical data for algorithmic performance. The testing described is primarily bench and engineering verification against international standards. Therefore, information about sample size, country of origin, or retrospective/prospective nature of a clinical test set is not provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable, as the provided information does not describe a study involving clinical ground truth establishment by experts for a test set. The device assists trained medical staff in making diagnoses but does not provide diagnostic conclusions itself.

4. Adjudication method for the test set

Not applicable, as there is no described clinical study involving a test set and ground truth adjudication.

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 MRMC comparative effectiveness study is described. The device is a data acquisition and visualization tool; it does not explicitly feature AI for interpretation or diagnostic assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. The "Natus BrainWatch System" is an electroencephalograph (EEG) device that records and visually presents signals for trained medical staff to interpret. It does not provide any diagnostic conclusions or automated alerts, meaning it is not a standalone diagnostic algorithm.

7. The type of ground truth used

Not applicable. The testing focuses on engineering performance, safety, and functional compliance rather than diagnostic accuracy against a clinical ground truth (e.g., pathology, outcomes data, or expert consensus).

8. The sample size for the training set

Not applicable, as the document does not describe the development or validation of an AI algorithm with a training set. The device's function is to capture and display raw EEG signals.

9. How the ground truth for the training set was established

Not applicable, as there is no described training set or AI algorithm for which ground truth would need to be established.

Summary

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November 19, 2024

Natus Medical Incorporated DBA Excel-Tech Ltd. (XLTEK) % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114

Re: K242930

Trade/Device Name: Natus BrainWatch System Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: OMC, GXY Dated: November 12, 2024 Received: November 12, 2024

Dear Prithul Bom:

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 (the 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 available 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

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Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 medical devices and radiation-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

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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,

Patrick Antkowiak -S 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

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Indications for Use

Submission Number (if known)

Device Name

Natus BrainWatch System (Natus BrainWatch System)

Indications for Use (Describe)

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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510K Summary

Date: November 5, 2024

Submitted by: Natus Medical Incorporated DBA Excel-Tech Ltd. (XLTEK) 2568 Bristol Circle Oakville, Ontario Canada L6H 5S1

Contact Person: Behsa Khoshnevis Senior Regulatory Affairs Specialist Natus Medical Incorporated Tel.: (905) 287 5055 Fax.: (905) 829-5304 E-mail: behsa.khoshnevis@natus.com

Proprietary Name: Natus BrainWatch™ System

Common Name: Electroencephalograph

Regulation Number: 21 CFR 882.1400

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Classification Name: Reduced montage standard electroencephalograph

Product code: OMC, GXY

Device Class: II

Predicate Device: Ceribell Pocket EEG Device (K170363), Ceribell Instant EEG Headband (210805)

Description:

Overview: Natus BrainWatch System

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The Natus BrainWatch System consists of the following components: Tablet, IV Pole Handle, Amplifier, Headband(s), Gel Pods and a Mobile Application:

· Touchscreen Tablet with charger
Single-Use disposable elastic fabric headband with 10 electrodes (available in sizes Small, . Medium, and Large) containing:
- · Hydroflex patch with 2 built-in electrodes
- · 8 electrodes attached to gel pods used to improve impedance levels labeled L1-L4, R1-R4
· Wireless amplifier that attaches to the headband and connects to the tablet via Bluetooth™
IV pole handle that holds the tablet for a hands-free experience 。
Gels pods attach to the electrodes to improve impedance levels .

Note: The network must support WiFi Protected Access (WPA/WPA2) security.

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Operating Principle of Natus BrainWatch System

Natus BrainWatch System Features

· Rapid Setup: The Natus BrainWatch system can be set up quickly, typically within minutes.
Portability: The device features an integrated electrode headband and a compact amplifier that connects wirelessly to a tablet, ensuring high portability and convenience for bedside use.

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System Setup Overview

The Natus BrainWatch System setup involves several steps to ensure proper operation and accurate data capture. First, power on the tablet, followed by turning on the amplifier to the tablet via Bluetooth. Prepare the amplifier and headband by attaching the amplifier to the headband and placing the headband on the patient's head. Adjust the electrodes until the green light is displayed on the Electrode Page, indicating proper electrode placement. Enter patient demographic information into the system to ensure accurate data association. Once setup is complete, the system is ready for recording and monitoring EEG signals. When finished, stop the recording to conclude the session.

Device-patient interaction Accessories List:

The Headband will be in contact with the hair and skin of the patient's head throughout the study.

Accessories:

Item	Model Number
Hanger Assembly (TabletHanger)	045276
Carry Case	046863

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Indications for Use

The device does not provide any diagnostic conclusions about the subject's condition and does not provide any automated alerts of an adverse clinical event. The Natus BrainWatch System is intended for use within a professional healthcare facility. The Natus BrainWatch Headband is intended for singlepatient use.

Comparison to the Predicate Device:

There are 2 predicates: Ceribell Pocket EEG Device (K170363) and Ceribell Instant EEG Headband (K210805)

There is one reference device; CGX Quick (K203331) which is used for referring wireless amplifier technology. Both the subject device and the reference device use Bluetooth 5.9 technology.

The SE comparison table below is provided to compare the similarities and differences in the indications for use (intended use environment, intended use population) and the technological characteristics of the subject device and the predicates.

Feature	Subject DeviceNatus BrainWatchSytem	Predicate 1Ceribell Pocket EEGDevice, K170363	Predicate 2Ceribell Instant EEGHeadbandK210805	Comments
Device Class	Class II	Class II	Class II	Same aspredicate
Device Code	OMC, GXY	OMC	GXY	Same aspredicate
Feature	Subject DeviceNatus BrainWatchSytem	Predicate 1Ceribell Pocket EEGDevice, K170363	Predicate 2Ceribell Instant EEGHeadbandK210805	Comments
Class Name	Reduced montagestandardelectroencephalograph,Cutaneous Electrode	Reduced montagestandardelectroencephalograph,	Cutaneous electrode	Same aspredicate
ClassifyingRegulation	21 CFR 882.1400	21 CFR 882.1400	21 CFR 882.1320	Same asPredicate
Indications for Use	The BrainWatchSystem including theBrainWatch Headband,is intended to recordand store EEG signalsand present thesesignals visually to assisttrained medical staff inmaking neurologicaldiagnoses in patientsaged 2 years and older.The device does notprovide any diagnosticconclusions about thesubject's condition anddoes not provide anyautomated alerts of anadverse clinical event.The Natus BrainWatchSystem is intended foruse within aprofessional healthcarefacility. The NatusBrainWatch Headband	The Ceribell PocketEEG Device is intendedto record and storeEEG signals, and topresent the EEGsignals in visual andaudible formats in realtime. The visual andaudible signals assisttrained medical staff tomake neurologicaldiagnoses. The PocketEEG Device does notprovide any diagnosticconclusion about thesubject's condition anddoes not provide.any automated alerts ofan adverse clinicalevent. The Pocket EEGDevice is intended to beused in a professionalhealthcare facilityenvironment.	The Ceribell InstantEEG Headband is anelectroencephalogram(EEG) electrode arrayintended for singlepatient use in therecording of EEGs inpatients of 2 years andolder. The Instant EEGHeadband is intendedfor prescription use inthe home, healthcarefacility, or clinicalresearch	Similar topredicate butequivalent insafety andeffectivenessThe subjectdevice indicationsfor use statementis moredescriptive andclearer. Theclinical purpose ofthe predicate andsubject devices issame.
Feature	Subject DeviceNatus BrainWatchSytem	Predicate 1Ceribell Pocket EEGDevice, K170363	Predicate 2Ceribell Instant EEGHeadbandK210805	Comments
	is intended for single-patient use.
Where used	Professional healthcarefacility.	Professional healthcarefacility	Professionalhealthcare facility, inthe home or clinicalresearch	Same aspredicate
Sterility	Non-Sterile	Non-Sterile	Non-Sterile	Same aspredicate
DC Channel	All (10) channels arereferential	8 Differential only	N/A	Similar topredicate butequivalent insafety andeffectiveness.Identicalelectrodenumbers andcontact positions.Equivalent orbetter ineffectiveness, asthe subject devicecan capture either10 channels ofreferential signalsor 8 channels ofdifferentialsignals.
A/D Conversion	24-Bit Delta-Sigma	24-Bit Delta-Sigma	N/A	Same aspredicate
Feature	Subject DeviceNatus BrainWatchSytem	Predicate 1Ceribell Pocket EEGDevice, K170363	Predicate 2Ceribell Instant EEGHeadbandK210805	Comments
Sampling Rate	250 Hz	250 Hz	N/A	Same aspredicate
Batterychargingpower adapter	100-240V AC poweradapter	100-240V AC poweradapter	N/A	Same aspredicate
Bedside Unit-PCInterface	Bedside unit tocomputer using WiFi	Bedside unit tocomputer using WiFi orMicro-USB cable	N/A	Similar topredicate butequivalent insafety andeffectiveness.Predicate devicehas a Micro-USBcable as analternate option.
WiFifrequency/standard	2.4 GHz IEEE 802.11b/g/n	2.4 GHz IEEE 802.11b/g/n	N/A	Same aspredicate
Type of Applied Part	BF	BF	N/A	Same aspredicate
Type of PatientContact	Contacts patient scalp	N/A	Contacts patient scalp	Same aspredicate
Type of Use	Single use, non-sterile,disposable	N/A	Single use, non-sterile,disposable	Same aspredicate
Available Sizes	Small 45-51 cmMedium 50-56 cmLarge 55-62 cm	N/A	Small 45-51 cmMedium 50-56 cmLarge 55-62 cm	Same aspredicate
Number ofElectrodes	12 (Locations: Fp1, F7,T3,T5, O1, Fp2, F8, T4,T6, O2, Reference,Ground)	10 (Locations: Fp1, F7,T3, T5, O1, Fp2, F8,T4, T6, O2)	10 (Locations: Fp1, F7,T3, T5, O1, Fp2, F8,T4, T6, O2)	Similar topredicate butequivalent insafety andeffectiveness.
Feature	Subject DeviceNatus BrainWatchSytem	Predicate 1Ceribell Pocket EEGDevice, K170363	Predicate 2Ceribell Instant EEGHeadbandK210805	Comments
				The subjectdevice has 12electrodescompared to 10electrodes on thepredicate device.The locations areidenticalaccording to the10-20 system,with the referenceand ground beingthe 2 additionalelectrodes.
Type of Electrodes	Passive Ag/AgCl	N/A	Passive Ag/AgCl	Same aspredicate
ConductiveElectrolyte Gel	Conductive electrolytegel is included in sealedgel pods integrated intoeach electrodeassembly. User is alsoable to add additionalelectrolyte gel whenneeded using anothergel pod.	N/A	Conductive electrolytegel is included insealed gel packetsintegrated into eachelectrode assembly.User is also able toadd additionalelectrolyte gel whenneeded using asyringe.	Similar topredicate butequivalent insafety andeffectiveness.To add additionalgel to the subjectdevice, a new,fully filled gel podcan be replaced.For the predicatedevice, additionalgel is appliedusing a syringe.
Feature	Subject DeviceNatus BrainWatchSytem	Predicate 1Ceribell Pocket EEGDevice, K170363	Predicate 2Ceribell Instant EEGHeadbandK210805	Comments
Biocompatibility	Biocompatibility ofpatient contactingcomponents verifiedwith Irritation,Sensitization andCytotoxicity testing perISO 10993-5:2009, ISO10993-23:2021 and ISO10993-10:2021	Biocompatibility ofpatient contactingcomponents verifiedwith Irritation,Sensitization andCytotoxicity testing perISO 10993-5:2009 and ISO 10993-10:2010	Biocompatibility ofpatient contactingcomponents verifiedwith Irritation,Sensitization andCytotoxicity testing pertesting per ISO 10993-5:2009 and ISO10993-10:2010	Subject deviceand predicatedevice useconductiveelectrolyte gel toform an electricalconnectionbetween thepatient scalp andthe Ag/AgClelectrodes.Similar topredicate butequivalent tosafety andeffectiveness.Testing wasperformed tocurrent standards.

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Feature	Subject DeviceNatus BrainWatch System	Reference DeviceCGX Quick-20m (K203331)
Device Class	Class II	Class II
Device Code	OMC, GXY	GWL, GXY
Class Name	Reduced montage standardelectroencephalograph, Cutaneous Electrode	Physiological Signal Amplifier
ClassifyingRegulation	21 CFR 882.1400, 21 CFR 882.1320	21 CFR 882.1835, 21 CFR 882.1320
Wireless	Amplifier to Tablet using Bluetooth 5.0	Amplifier to receiver (PC) using Bluetooth 5.0

Reference device for wireless amplifier technology:

Subject device is similar to Reference device but equivalent to safety and effectiveness. The Subject device and Reference device both use Bluetooth 5.0 technology. While the specific modules may differ in aspects such as power consumption, antenna design, or firmware capabilities, these differences are minor and do not impact the overall performance or safety of the devices.

The Subject device has been tested and certified under FCC Part 15 regulations. Additionally, the Subject device has undergone EMC compliance testing per IEC 60601-1-2 and Wireless Coexistence testing per ANSI C63.27-2021. These tests ensure that the Subject device's wireless amplifier does not interfere with other electronic devices and can coexist with them in a typical medical environment.

The Natus BrainWatch System and its predicates are substantially equivalent in features and technical characteristics. There are no major differences that significantly alter the intended use or raise new issues of safety or effectiveness.

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Brief Summary of Performance Testing

Electrical Safety

The Natus BrainWatch System was verified for performance in accordance with the following standard:

IEC 60601-1-6:2010/AMD2:2020, Medical electrical equipment Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
· EC 60601-1:2005/AMD2:2020-Medical electrical equipment Part 1: General requirements for basic safety and essential performance
· IEC 80601-2-26: 2019- Particular requirements for the basic safety and essential performance of electroencephalographs

Electromagnetic Compatibility

The Natus BrainWatch System was verified for performance in accordance with the following standard:

IEC 60601-1-2 Ed 4.1 Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance Collateral standard: Electromagnetic Disturbances – Requirements and tests.

Packaging and Handling Verification

The packaged Natus BrainWatch System components have successfully passed packaging and handling verification as per ASTM D4169-22

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Performance Testing - Bench Verification & Validation

The Natus BrainWatch System has successfully passed performance verification and validation in accordance with internal requirements and specifications at the system level.

The Bench testing verification and validation was performed to confirm device meets the functional and performance characteristics.

Additionally, Natus BrainWatch System has been tested and met defined acceptance criteria. The tests included:

· Requirements for the basic safety and essential performance of electroencephalographs per IEC 80601-2-26
· Electromagnetic Compatibility and Electrical Safety Testing performed to applicable requirements of IEC 60601-1 and IEC 60601-1-2
· Battery Safety Testing per IEC 62133
· Shipping/distribution and vibration testing per ASTM D4169-22
· Biocompatibility of patient contacting components verified with Cytotoxicity, Irritation, and Sensitization testing per ISO 10993-5:2009, ISO 10993-23:2021, and ISO 10993-10:2021
· Performance Criteria of FDA Guidance titled Cutaneous Electrodes for Recording Purposes -Performance Criteria for Safety and Performance Based Pathway, issued on August 14, 2020.
· Wireless Coexistence per ANSI C63.27-2021
· Shelf-life testing

Results indicate that the Natus BrainWatch System complies with its predetermined specifications and the applicable standards.

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Conclusions

The intended use and technology of the Natus BrainWatch System is similar to that of the predicate devices 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 BrainWatch System is as safe, as effective, and performs as well as or better than the predicate device

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).