Neuronaute is a system intended to acquire, display, store, archive, and periodically transmit EEG signals from the brain using a full montage array to enable review at a physician's office, hospital, or other remote locations. It allows remote access by users via the Neuronaute N-CLOUD which receives EEG signals from Neuronaute Head Module which sends transmissions to the cloud. Neuronaute and its associated software are intended to assist in the diagnosis of neurological disorders. Neuronaute and its components do not provide any diagnostics conclusions or automated alerts of an adverse clinical event about a patient's clinical condition.

The device is for use by trained medical professionals for patients under medical supervision. The device is intended for use on adults (ages 18 and above). Neuronaute is not intended to replace direct communication with healthcare providers. The system data should not be used alone, but should be used along with all other clinical data and exams to come to a diagnosis.

Device Description

Neuronaute allows up to 24 channels EEG monitoring. It includes the following components: Neuronaute Head Module, Neuronaute High Capacity Battery Module, Neuronaute BioAdapter, Neuronaute Mobile App, Neuronaute N-CLOUD, Neuronaute N-DEO, Neuronaute N-WAY, Neuronaute IceCap.

AI/ML Overview

The provided text describes the Neuronaute device, an electroencephalograph (EEG) system, and its substantial equivalence to a predicate device (AE-120A EEG Head Set, K183529) for FDA clearance. However, it does not contain a specific study demonstrating that the device meets numerically defined acceptance criteria for diagnostic performance (e.g., sensitivity, specificity, accuracy for a particular condition). Instead, the submission focuses on demonstrating substantial equivalence through non-clinical performance testing against recognized standards.

Therefore, many of the requested items (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance) are not applicable or cannot be extracted from this document, as a clinical performance study with such metrics was not submitted.

Here's a breakdown of the information that can be extracted or inferred:

1. Table of Acceptance Criteria and Reported Device Performance

As a clinical performance study with specific diagnostic metrics (like sensitivity, specificity, or accuracy) was not submitted, there isn't a table of acceptance criteria for diagnostic performance against specific disease states. Instead, the acceptance is based on meeting technical and safety standards, and demonstrating signal quality, all of which are considered "performance" in this context.

Performance Characteristic	Acceptance Criteria (Met by adherence to standards)	Reported Device Performance (Demonstrated by testing)
Safety & Electrical	AAMI/ANSI ES 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-26	Met all listed standards requirements.
Electromagnetic Compatibility	IEC 60601-1-2	Met standard requirements.
EEG Signal Quality	IEC 60601-2-26 requirements for input noise; comparison to "EEG gold standards."	Met IEC 60601-2-26 requirements. Signal quality demonstrated (implied to be acceptable through comparison).
Software Verification & Validation	IEC 62304, FDA Guidance "General Principles for Software Validation"	Met all listed standards and guidance requirements.
Usability	IEC 62366, FDA Guidance "Applying Human Factors and Usability Engineering to Medical Devices (2016)"	Met all listed standards and guidance requirements. No new questions of safety or effectiveness identified.
Biocompatibility	ISO 10993-5, ISO 10993-10 (for IceCap and electrode gel paste)	Conforms to ISO 10993-5 and ISO 10993-10.
Input Dynamic Range & Differential Offset Voltage	IEC 60601-2-26 requirements	±400mV (device); conforms to IEC 60601-2-26.
ADC Resolution	Not explicitly defined as an acceptance criterion for comparison, but described as "improved"	24 bits
ADC Common Mode Rejection Rate (CMRR)	IEC 60601-2-26 requirements	> 105 dB (device); conforms to IEC 60601-2-26.
Input Impedance	IEC 60601-2-26 requirements	> 1 Gohm (device); conforms to IEC 60601-2-26.
Input Noise	IEC 60601-2-26 requirements	< 6µVp-p over 0.1-50Hz (device); conforms to IEC 60601-2-26.

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

Sample Size (Test Set): Not applicable. No clinical performance testing with a patient test set was submitted for diagnostic accuracy. The testing performed was non-clinical (bench, software V&V, usability).
Data Provenance: Not applicable. No clinical patient data was submitted for performance testing.

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

Number of Experts: Not applicable. No clinical performance testing with expert-established ground truth was submitted.
Qualifications of Experts: Not applicable.

4. Adjudication method for the test set

Adjudication Method: Not applicable. No clinical performance testing requiring adjudication was submitted.

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

MRMC Study: No. The device "Neuronaute" is an EEG data acquisition, display, storage, and transmission system. It is explicitly stated that "Neuronaute and its components do not provide any diagnostics conclusions or automated alerts of an adverse clinical event about a patient's clinical condition." Therefore, it does not include AI for diagnostic assistance, and an MRMC study comparing human readers with and without AI assistance is not relevant to this device's current claims.

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

Standalone Performance: No. As noted above, the device does not provide diagnostic conclusions or automated alerts, implying no standalone diagnostic algorithm. Its primary function is to collect and transmit EEG signals for review by a physician.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Type of Ground Truth: Not applicable for diagnostic performance. For the technical performance aspects (e.g., signal quality, electrical safety), the "ground truth" would be the specifications and requirements of the referenced industry standards (e.g., IEC 60601-2-26) or "EEG gold standards" referenced in the text.

8. The sample size for the training set

Sample Size (Training Set): Not applicable. As the device does not provide diagnostic conclusions or automated alerts, it does not appear to involve a machine learning model that would require a patient-based training set for diagnostic classification.

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

Ground Truth for Training Set: Not applicable. See explanation for #8.

Summary

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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, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

December 10, 2020

Bioserenity SAS Julien DUPONT Ouality and Regulatory Affairs Director ICM-iPEPS 47 Boulevard de l'Hopital 75013 Paris, France

Re: K202334

Trade/Device Name: Neuronaute Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: GWO. GXY Dated: July 30, 2020 Received: September 11, 2020

Dear Julien DUPONT:

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

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statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) 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 (QS) 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 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 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 Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K202334

Device Name Neuronaute

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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K202334 Neuronaute

Traditional 510(k) Summary

Prepared in accordance to the content and format outlined in 21 CFR 807.92

Submitter Information

Submitter's Name:	BioSerenity SAS
Submitter's Address:	ICM-iPEPS47 Boulevard de l'Hôpital75013 Paris, France
Telephone:Fax:	+33 683 970 625+33 186 953 093
Contact Person:	Julien DUPONTE-mail: julien.dupont@bioserenity.com
US Contact Person:	Joe COTYE-mail: joe.coty@bioserenity.com

US Telephone:	(803)466-2436
Date of Summary Preparation:	December 09, 2020

Subject Device Information

Trade Name:	Neuronaute
Common Name:	Electroencephalograph (EEG)
Classification Name:	Electroencephalograph
Primary Product Code:	GWQ - Full-montage standard electroencephalograph
Intended Use:	The subject device is intended to acquire, display, store,and archive EEG signals from the brain using a fullmontage array (i.e., 16 or more electrodes) and user-specified locations in order to assist in the diagnosis ofneurological disorders by a physician.
Regulation Number:	21 CFR 882.1400, Electroencephalogram
Device Class:	II

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Predicate Device Information

K183529
Device Name	AE-120A EEG Head Set
Manufacturer	Nihon Kohden Corporation
Primary Product Code	OMC; reduced- montage standardelectroencephalograph
Regulation number	21 CFR 882.1400
Device Class	II
Clearance Date	03/19/2019

Subject Device Description

Neuronaute allows up to 24 channels EEG monitoring. It includes the following components:

Neuronaute Head Module

removable recorder composed of an electronic card in a plastic case. It connects to the Neuronaute BioAdapter using snap buttons located on its rear. The data from the Head Module is uploaded to a secure cloud platform. The data acquired during a recording is stored locally on the Head Module recorder.

Neuronaute High Capacity Battery Module

removable and rechargeable electronic device. The battery is recharged using the Neuronaute Battery charger. The Neuronaute High Capacity Battery module connects to the Neuronaute Bio-Adapter using snap buttons located on its rear.

Neuronaute BioAdapter

enables the connection of the Neuronaute Head Module and the Neuronaute High Capacity battery module to the Neuronaute IceCap or a specific set of reusable cup electrodes manufactured with Ag/AgCl discs connected to a lead wire. The wire is insulated and terminates with a touch proof connector (DIN 42802) - equivalent to the reusable cup electrodes from Technomed Europe, FDA cleared under the 510k number K072016 in order to record and transmit data to the cloud platform.

Neuronaute Mobile App

The mobile application associated with the system which enables healthcare professionals to access and manage the prescribed recording sessions. It is compatible with iOS systems.

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Neuronaute N-CLOUD

A web-based information system that receives the EEG signals from the recorder through a paired Wi-Fi connection. The cloud platform enables long-term storage and display of the recorded signals. The physician, who prescribes the use of the Neuronaute system, should monitor its use and confirm the proper functioning of signal recording through the Neuronaute Cloud by testing this connection and use as outlined in the user manual.

Neuronaute N-DEO

A camera enabling the visualization of the patient during a recording. The IP camera provides HD resolution video sequence at 1080p, with advanced night mode and WDR technology.

Neuronaute N-WAY

a router module enabling flexible connectivity for remote monitoring and data transmission to the cloud platform.

Neuronaute IceCap

a single-use headset containing 21 electrodes which is connected to the Neuronaute Head Module via the IceAdapter, the DB25 cable, and the Neuronaute BioAdapter.

Target population

The target patient population for the Neuronaute is adult patients, ages 18 and above.

Comparison to Predicate Device

The Neuronaute and the predicate device, AE-120A EEG Head Set, have the same intended use. Both devices use an integrated array of cutaneous electrodes to obtain a recording of EEG signals to aid clinicians in the diagnosis of neurological disorders. The characteristics of the subject device and the predicate device are summarized in the following table and differences in technological characteristics do not raise different questions of safety and effectiveness.

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The table below provides a summary of the technological characteristics of the subject device in comparison to those of the predicate device.

Item of Comparison	Subject DeviceK202334	Predicate DeviceK183529	Comment
Trade Name	Neuronaute	AE-120A EEG HeadSet
Manufacturer	BioSerenity SAS	Nihon KohdenCorporation
510(k) Number	K202334	K183529
Primary ProductCode	GWQ; Full montagestandard EEG (16 ormore electrodes)	OMC; Reducedmontage standardEEG (less than < 16electrodes)	Similar; both productcodes fall under thesame regulation882.1400
Secondary ProductCode	GXY	GXY (cutaneouselectrode)	Same
Indications for Use			Similar
Neuronaute is a systemintended to acquire,display, store, archive, andperiodically transmit EEGsignals from the brainusing a full montage arrayto enable review at aphysician's office,hospital, or other remotelocations. It allows remoteaccess by users via theNeuronaute N-CLOUDwhich receives EEGsignals from NeuronauteHead Module which sendstransmissions to the cloud.Neuronaute and itsassociated software areintended to assist in thediagnosis of neurologicaldisorders. Neuronaute andits components do notprovide any diagnosticsconclusions or automatedalerts of an adverseclinical event about apatient's clinical condition.The device is for use bytrained medicalprofessionals for patientsunder medical supervision.The device is intended foruse on adults (ages 18 andabove). Neuronaute is notintended to replace directcommunication with	The AE-120A EEG HeadSet is intended to amplify,capture, and wirelesslytransmit electrical activityof the brain for review bya trained medicalprofessional using thepreviously cleared andvalidated Nihon Kohdenelectroencephalographsystems (EEG-1200Aseries and EEG-9100) toassist in the diagnosis ofneurological disorders.The AE-120A EEG HeadSet and its associated EEGSoftware do not provideany diagnostic conclusionor automated alerts of anadverse clinical eventabout a patient's condition.The device is intended foruse by trained medicalprofessionals in a medicalfacility such as aphysician's office,laboratory, or clinic. Thedevice is intended for useon adults (ages 18 andabove)		Wording differencesthat includedescriptions of thedevice functions donot change theintended use
Item of Comparison	Subject DeviceK202334	Predicate DeviceK183529	Comment
	healthcare providers. Thesystem data should not beused alone but should beused along with all otherclinical data and exams tocome to a diagnosis.

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Item of Comparison	Subject DeviceK202334	Predicate DeviceK183529	Comment
Intended User(s)	Trained healthcareprofessionals: doctors,polysomnogramtechnicians, andnurses	Trained medicalprofessionals	SimilarBoth devices are usedby trained healthcareusers. The subjectdevice has passed theusability tests for theintended users
Type of use	Prescription	Prescription	Same
Environment of use	Physician's office,hospital or otherremote locationsunder medicalsupervision.	Medical facility suchas a physician'soffice, laboratory, orclinic	SimilarBoth devices areintended to be used inan environment thatincludes medical andtrained supervision.

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Item of Comparison	Subject DeviceK202334	Predicate DeviceK183529	Comment
Video	Optional; The subjectdevice includes acomponent videocamera called N-DEO	No	DifferentThe subject devicecan be used with acamera which is notthe case for thepredicate device.The subject devicehas passed theessential performanceand usabilityrequirements toaccount for theintroduction of thistechnologicalcharacteristic.
Electrode Components
Type of patientContactingcomponentsincluded with thedevice	Electrodes and gelcontact patient's scalp	Electrodes and gelcontact patient's scalp	Same
Item of Comparison	Subject DeviceK202334	Predicate DeviceK183529	Comment
Electrodes	Up to 21 electrodes:• 19 EEG electrodes• 1 FpZ used for ground connection• An Oz electrode is used as a reference for EEG calculation	10 electrodes (8 EEGelectrodes, 1reference electrode, 1Z electrode)	SimilarBoth devices havesufficient number ofelectrodes for EEGmonitoring. Thesubject device meetsthe performancerequirements outlinedin IEC 60601-2-26(input noise) toaccount for thisdifference.
MaterialComposition	Silver & polyimide	Ag/AgCl electrodes	SimilarThe subject devicemeets thebiocompatibilityrequirements outlinedin ISO 10993-1 toaccount for thisdifference.
Electrodes; single orreusable?	Single use, non-sterile	Single use, non-sterile	IdenticalBoth devices aresingle use, non-sterileand disposable.
Montage	10/20 System	10/20 System	Same
Item of Comparison	Subject DeviceK202334	Predicate DeviceK183529	Comment
Able toaccommodatedifferent patienthead sizes	The material of theNeuronaute IceCapstretches such that itcan fits on thepatient's head, similarto a sock	AE-120A EEG HeadSet has flexiblearms that are adjustedto fit differentadult patient headsizes along withadjustments from thebelts/ straps (chin)	Similar
ConductiveElectrolyte gel	Conductiveelectrolyte paste putin the central hole ofeach electrode,cleared in K860210Elefix.	Conductiveelectrolyte paste isincludedin a packet gelreservoir integratedintoeach electrode. Userinserts electrodeinto the electrodeattachment position inHead Set with paste

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Item of Comparison	Subject DeviceK202334	Predicate DeviceK183529	Comment
EEG channels	Up to 24 channels	8	SimilarBoth devices havesufficient number ofEEG channels forEEG monitoring.CDRH has clearedother EEG systemswith 24 Channelsunder 882.1400:K170441andK010460.
Data format	EDF	Nihon Kohdenoriginal format	SimilarThe subject deviceprovides the data inthe standard formatused by the healthcare.Therefore,thisdifference does notraise any differentquestions of safety oreffectiveness.

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Item of Comparison	Subject DeviceK202334	Predicate DeviceK183529	Comment
Sampling Rate	250 or 500 Hz	200 Hz	SimilarThe subject deviceacquisition frequencyis higher than thepredicate device.Consequently, thesubject device has abetter accurate signal.Therefore, thisdifference does notraise any differentquestions of safety oreffectiveness.
		Recorder Component
Wireless Output	WiFi 2,4GHzBluetooth 2,4GHz	Bluetooth 2.4 GHz	SimilarBoth devices includewirelesscommunication.The subject deviceconforms with IEC60601-1, IEC 60601-2 and FCC PART15B requirements.
Item of Comparison	Subject DeviceK202334	Predicate DeviceK183529	Comment
Input dynamic rangeanddifferential offsetvoltage	±400mV	±500 mV or more	SimilarThe subject deviceconforms with IEC60601-2-26requirements toaccount for thisdifference.
ADC Resolution	24 bits	12 bits	SimilarThe subject devicehas an improved ADCresolution.
ADC CommonMode Rejection Rate(CMRR)	> 105 dB	90 dB or more	SimilarThe subject deviceconforms with the60601-2-26requirements and hasa better ADC CMRRto account for thisdifference.
Input Impedance	> 1Gohm	1200 Mohms	SimilarThe subject deviceconforms with the60601-2-26requirements.
Item of Comparison	Subject DeviceK202334	Predicate DeviceK183529	Comment
Input noise	$< 6µVp-p over 0.1-50Hz$	$5 µVp-p$ or less (0.53 to 60 Hz)	SimilarThe subject device conforms with the 60601-2-26 requirements.
Electrode impedance check	Yes	Yes	Same
General System Characteristics
Power source	Battery	Same
Type of battery	Rechargeable LiPo(Lithium Polymer)3.7-volt, 2.4 Ah	2 AA (LR6) alkaline batteries(not rechargeable)	SimilarThe subject device conforms with FDA-recognized electrical safety standards.
Battery dimensions	Neuronaute High Capacity Battery module: 199,5 x 170,6 x 27,2 mm	56 W x 43 H × 151 D mm	SimilarThe batterie subject device is used with the BioAdapter. The battery dimensions have no impact in the use of device for the patient.

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Item of Comparison	Subject DeviceK202334	Predicate DeviceK183529	Comment
Weight	• Neuronaute HighCapacity Batterymodule: 147 g	240 g (without thebelts, forehead padand batteries)	SimilarThe battery subjectdevice is used withthe BioAdapter. Thebattery weight has noimpact in the use ofdevice for the patient.

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●	Neuronaute Head Module
●	Neuronaute IceCap
●	Neuronaute IceAdapter
●	Neuronaute BioAdapter
●	Neuronaute Battery
●	Neuronaute N-WAY	N-
●	Neuronaute N-DEO	N-
●	Neuronaute® N-CLOUD	N-
●	Neuronaute® Mobile APP
●	Standard cup electrodes to be used with the BioAdapter (not

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Item of Comparison	Subject DeviceK202334	Predicate DeviceK183529	Comment
	supplied byBioSerenity).BioSerenityrecommends theuse of FDAcleared EEG cupelectrodes only
EEG Software	The NeuronauteSystem contains asoftware whichenables collecting andcommunicating EEGdata.	AE-120A EEG HeadSet comes withEEG-compatiblesoftware forinteraction with andviewing of EEG data	SimilarThe subject devicehas been developed inaccordance with theIEC 62304 andusabilityrequirements.
Connectors	Snap buttons on the Neuronaute Head Module and the battery Neuronaute IceAdapter DB25 cable Touch proofs	Single connector ofelectrodes to AE-120A Head Set	Similar
Item of Comparison	Subject DeviceK202334	Predicate DeviceK183529	Comment
Electrical Safety &EMC	• IEC 60601-1• IEC 60601-1-2• IEC 60601-1-11• IEC 60601-2-26	• IEC 60601-1• IEC 60601-1-2• IEC 60601-2-26	SimilarBoth devices conformto the relevantstandards. As thesubject device can beused at home undersupervision of ahealthcareprofessional, IEC60601-1-11requirements havebeen added to allowfor use in thisenvironment.
Biocompatibility	Neuronaute IceCapand electrode gelpaste (K860210)conform to ISO10993-5 and ISO10993-10	Patient contactingcomponents verifiedwith Cytotoxicity,Sensitization, andIrritation per ISO10993-5 and ISO10993-10 (or previousclearance orprevious use ofmaterial/processingfor same patientcontact and duration).These componentsinclude: electrodes,electrode gel, paste	SameThe subject devicemeets thebiocompatibilityrequirements outlinedin 10993-1 relevant tothe patient contactingtype, according to therisk profile of thedevice.

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Performance Testing

Non-clinical Performance Testing

In order to demonstrate the substantial equivalence between Neuronaute and the predicate, bench testing was carried out on the following characteristics:

Electromagnetic compatibility (EMC) -
Electrical safety testing -
-EEG signal quality
Software verification and validation testing -
Usability testing -
-Biocompatibility

Neuronaute was tested and meets the requirements of following:

AAMI/ANSI ES 60601-1:2005/(R)2012 and A1:2012 Medical electrical equipment Part 1: General requirements for basic safety and essential performance
-IEC 60601-1-2:2007 Medical electrical equipment - Part 1-2: General requirements for safety and essential performance collateral standard: Electromagnetic compatibility - requirements and tests
IEC 60601-1-11 Edition 2.0 2015-01 Medical electrical equipment Part 1-11: -General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
EC 60601-2-26:2012 Medical electrical equipment Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs

In order to demonstrate the signal quality, BioSerenity has compared the Neuronaute device with EEG gold standards.

The firmware in Neuronaute Head Module, Neuronaute mobile application and Neuronaute Cloud have been tested through verification and validation procedures according to the IEC 62304: 2006/A1:2016 standard and as per the FDA Guidance "General Principles for Software Validation". The results of the verification and validation activities demonstrate that the software meets the requirements for safety, functionnal and intended use.

BioSerenity has carried tests according to the IEC 62366 standard and FDA guidance "Applying Human Factors and Usability Engineering to Medical Devices (2016)". The objective was to assess the usability within the overall human factors engineering process and to identify any potential risks related to the use of the device. The tests have

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demonstrated all the points listed above do not raise any new questions of safety or effectiveness for the Neuronaute intended purposes.

Clinical Performance Testing

No clinical testing was submitted to determine substantial equivalence.

Conclusion

Neuronaute and the predicate device, K183529 AE-120A EEG Head Set, have the same intended use. Differences in technological characteristics do not raise different questions of safety and effectiveness to achieve the intended use and the performance testing submitted to evaluate these differences are acceptable to demonstrate substantial equivalence to 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).