WAV SCAN EEG System is intended for the acquisition, display, and storage of electrical activity of a patient's brain including electroencephalograph (EEG) and event-related potentials (ERP) obtained by placing two or more electrodes on the head to aid in diagnosis.

Device Description

WAVi™ SCAN EEG system (WAVi™ SCAN 1.0) is intended for the acquisition, display, and storage of electrical activity of a patient's brain including electroencephalograph (EEG) and eventrelated potentials (ERP) obtained by placing two or more electrodes on the head to aid in diagnosis. The medical system includes the "WAVi™ EPU" (Electronic Processing Unit), an EEG amplifier intended to be used with EEG accessories cleared in K162460 and a computer (laptop computer or tablet device with internal battery and power cord). The hardware and ancillary components used in conjunction with WAVI™ SCAN 1.0 include an EEG cap, the WAVI™ EPU, headphones, a Subject Response Device and a Base Station laptop computer. The software on the Base Station laptop computer is intended for device programming. The WAVI EEG System's software includes electronic versions of standardized clinical assessment tools related to psychiatry and neuropsychological evaluation but are provided for convenience and are to be used in accordance with the assessment tools' specific general instructions. These tools do not interact with any other of the EEG system's hardware and software measures and are stand alone.

AI/ML Overview

The WAVi Scan EEG System has acceptance criteria primarily related to its electrical performance and adherence to established medical device standards. The study presented is a pre-market notification (510(k)) submission to the FDA, which demonstrates substantial equivalence to predicate devices rather than a comparative effectiveness study in the traditional sense of human reader improvement.

Here's a breakdown of the acceptance criteria and the study's proof of meeting them:

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria are derived from recognized international standards for electroencephalographs, particularly IEC 80601-2-26:2019, and general electrical safety and electromagnetic compatibility (EMC) standards. The study demonstrates conformance to these standards.

Acceptance Criteria (from IEC 80601-2-26:2019)	Reported Device Performance (Results)
Accuracy of signal reproduction: Input voltages in specified ranges reproduced with error ≤ ±20% of nominal output or ±10 µV, whichever is greater.	P (Pass)
Input dynamic range and differential offset voltage: With ±150mV DC offset and ±0.5mV varying input, output amplitude change ≤ ±10% over specified range.	P (Pass)
Input noise: Signal noise caused by amplifier and patient cable ≤ 6 µV peak-to-valley referred to input (RTI).	P (Pass) - Device noise reported as < 3.0 µVp-p, well within the 6 µVp-p requirement.
Frequency response: Bandwidth of at least 0.5 Hz to 50 Hz. Output at 0.5 Hz and 50 Hz within 71% to 110% of output at 5 Hz sine wave.	P (Pass) - Device band width is 0.5 to 40 Hz, which meets the 0.5Hz-<50Hz frequency response requirement.
Common mode rejection: 1V r.m.s. signal at mains frequency (50/60Hz) with 200pF source capacitance, connected between earth and all lead wires, produced output signal ≤ 100 µV peak-to-valley over 10s period.	P (Pass) - Measured output amplitude reported as not greater than 100 uV peak-to-valley.
Electrical Safety (ANSI AAMI 60601-1: 2005 +A1:2012)	Conforms
Electromagnetic Compatibility (IEC 60601-1-2:2014 - 4th Edition): Radiated Emissions (EN 55011:2009+A1:2010), ESD Immunity (IEC 61000-4-2:2008), Radiated Electromagnetic Field Immunity (IEC 61000-4-3:2006), Proximity Fields from RF Wireless (IEC 61000-4-3:2010), Magnetic Field Immunity (IEC 61000-4-8:2009)	Conforms

"P" indicates "Pass" in the provided document, meaning the device met the specified requirement. "Conforms" means the device passed the respective EMI/EMC tests.

2. Sample Size Used for the Test Set and Data Provenance

This document primarily describes a technical performance and safety evaluation for a 510(k) submission, not a clinical study with a "test set" of patient data in the typical sense for AI/diagnostic algorithms. The tests conducted were bench tests and electrical/EMC compliance tests performed by accredited laboratories.

Sample Size for Test Set: Not applicable in the context of patient data. The "sample" here refers to the number of devices or test setups used in laboratory conditions, which is typically one or a small number for device verification.
Data Provenance: The data provenance for the performance testing is from accredited testing laboratories that conducted the electrical safety and EMC tests. These are laboratory-generated data, not patient-derived data from specific countries. The document does not specify if the testing was retrospective or prospective in the clinical sense, as it refers to device performance under controlled conditions.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This type of submission for an EEG amplifier (WAVi Scan EEG System) does not involve experts establishing ground truth for a test set of clinical images or signals for diagnostic performance in the way typically seen for AI-driven diagnostic aids. The "ground truth" for the performance testing is the objective measurement against the specifications listed in the IEC standards. These measurements are performed by qualified technicians/engineers at the accredited testing laboratories, not by medical experts like radiologists.

4. Adjudication Method for the Test Set

Not applicable. There's no human interpretation or subjective assessment of a test set that would require adjudication. The results are objective measurements against predefined engineering and performance standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This 510(k) submission is for an EEG acquisition, display, and storage system. The purpose is to demonstrate substantial equivalence to existing legally marketed EEG devices (predicates) based on technical characteristics, intended use, and safety/performance. It is not an AI-based diagnostic device that assists human readers, and therefore, a study on human reader improvement with AI assistance is not relevant to this submission.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done

No, not in the context of an AI algorithm making diagnostic interpretations. This device is an EEG system that acquires and displays physiological signals. While it has software for processing and analyzing EEG/ERP data (e.g., qEEG outputs like Coherence, power bands), its primary function is data acquisition and display "to aid in diagnosis." It does not present as a device that performs standalone diagnostic interpretations requiring performance metrics like sensitivity/specificity for an AI algorithm without human input. The "algorithm" here refers to the device's firmware and software for data handling and signal processing, not a diagnostic AI.

7. The Type of Ground Truth Used

The "ground truth" for this submission is based on:

International Consensus Standards: Specifically, IEC 80601-2-26:2019 for electroencephalographs and IEC 60601-1 series for general safety and electromagnetic compatibility.
Technical Specifications: The device's performance metrics (e.g., noise, frequency response, input dynamic range) are measured against the objective requirements dictated by these standards.

It is not based on expert consensus (clinical opinion), pathology, or outcomes data, as this is a technical device clearance, not a diagnostic or prognostic claim verified by clinical evidence.

8. The Sample Size for the Training Set

Not applicable. This device is an EEG acquisition system and does not describe or rely on an AI model trained on a "training set" of clinical data in the manner of deep learning algorithms for image classification or anomaly detection. The software components relate to data acquisition, display, storage, and basic signal processing, not de novo AI model training.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no mention of an AI model with a "training set" in the context of this 510(k) submission.

Summary

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May 6, 2022

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left side of the logo is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

WAVi Co. David Jones Consultant 3459 Ringsby Ct. Ste. #305 Denver. Colorado 80216

Re: K213900

Trade/Device Name: WAVi SCAN EEG System and Accessories Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: GWQ, GWJ, OLT Dated: December 13, 2021 Received: December 14, 2021

Dear David Jones:

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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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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 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

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Indications for Use

510(k) Number (if known) K213900

Device Name WAVi SCAN EEG System and Accessories

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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K213900 WAVi™ SCAN EEG System Traditional 510(K) Summary

Submitted by:	WAVi Co.3459 Ringsby Ct. Ste. #305Denver, CO 80216720-203-6970
Contact Person:	David Jones(281)989-8515djones3016@hotmail.com
Date Prepared:	May 5, 2022
Trade Name:	WAVi™ SCAN EEG System and Accessories (Accessories are the WAVi™Headset and WAVi™ eSoc™ Single Use Electrode Contacts, K162460)
Common Name:	EEG Amplifier
Product Code(s):	GWQ (Primary - full-montage standard electroencephalograph),GWJ (stimulator, auditory, evoked response)OLT (non-normalizing quantitative electroencephalograph software)
Regulation:	21 CFR § 882.1400
Classification:	Class II
Classification Name:	Electroencephalograph

Predicate Devices:

510(k) Number	Trade Name
K171781	eVox SystemEvoke Neuroscience200 Valencia Dr. Suite 109Jacksonville. NC 28546
K143233	Mitsar-EEGNova Tech EEG8503 E. Keats AvenueMesa, AZ 85209
K141316	COGNISION™ EEG/EP SYSTEMNeuronetrix Solutions1044 E. ChestnutLouisville KY, 40204

Device Description:

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The medical system includes the "WAVi™ EPU" (Electronic Processing Unit), an EEG amplifier intended to be used with EEG accessories cleared in K162460 and a computer (laptop computer or tablet device with internal battery and power cord).

The hardware and ancillary components used in conjunction with WAVI™ SCAN 1.0 include an EEG cap, the WAVI™ EPU, headphones, a Subject Response Device and a Base Station laptop computer. The software on the Base Station laptop computer is intended for device programming.

The WAVI EEG System's software includes electronic versions of standardized clinical assessment tools related to psychiatry and neuropsychological evaluation but are provided for convenience and are to be used in accordance with the assessment tools' specific general instructions. These tools do not interact with any other of the EEG system's hardware and software measures and are stand alone.

Intended Use:

WAVI™ SCAN is intended for the acquisition, display, and storage, of electrical activity of a patient's brain including electroencephalograph (EEG) and event-related potentials (ERP) obtained by placing two or more electrodes on the head to aid in diagnosis.

Technological Characteristics:

WAViTM SCAN EEG system consists of two software components:

· Base Station laptop computer software: pre-loaded WAVi™ SCAN 1.0, and
· Firmware running on the WAVi™ EPU ((PN SW-MSP43)).

The Base Station laptop is running on a Windows Operating System and is paired with the EPU through a USB cable. WAVI™ SCAN software runs on the Base Station computer and has a graphic user interface that allows the clinician to set up a patient and create a new patient record, conduct a study to collect EEG and ERP data, view live EEG and ERP data on the Base Station monitor, and export recorded data to a file.

Firmware for WAVi™ SCAN resides on the EPU. The purpose of the firmware is to acquire electrophysiology data from the patient and transmit it to the Base Station.

The EPU operational mode is controlled via the WAVi™ SCAN software. In addition to 19 channels of EEG recording the device includes a mode to measure the cap electrode impedances. This is useful for determining if the electrodes are making a good electrical connection with the scalp at each electrode location.

The primary software outputs are EEG and ERP data files. These data files are written as floating point numbers in binary format, which represent the electrical potential on each of the 19 EEG channels in microvolts. WAVI's qEEG outputs includes Coherence, delta, theta, alpha, beta Power, Audio P300 Delay and Voltage, and Physical Reaction Time.

The EPU amplifier device does not come in direct contact with patients. Accessories that contact patients such as the EEG electrode cap are the same as used with legally marketed devices or are comprised of the same materials as legally marketed accessories.

WAVITM SCAN is intended for prescription use in any healthcare, medical, or athletic or sports clinics, or outside of medical facilities such as in the sports arena under the supervision of a physician.

The device is not sterile.

Substantial Equivalence

The WAVI™ SCAN EEG system is a portable, non-invasive, non-radiation emitting, point of care, electroencephalogram (EEG) devices, and is intended for the acquisition, display, and

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storage, of electrical activity of a patient's brain including electroencephalograph (EEG) and eventrelated potentials (ERP) obtained by placing two or more electrodes on the head to aid in diagnosis.

The WAVi™ SCAN EEG system is substantially equivalent to the predicate devices in the following manner:

Same intended use
Same operating principle .
Same fundamental scientific technology .
Same or substantially equivalent materials, including headset and electrodes. .

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There are no technological differences between the WAVI™ SCAN EEG system and the predicates that raise and effectiveness, and the proposed differences have been addressed via performance testing. The WAVI™ SCAN EEG system is substantially equivalent to the predicate device.

	K213900Subject DeviceWAVi Scan	K171781eVox System	K143233MITSAR-EEG	K141316Cognision EEG/EPSystem	Remarks
Principle ofOperation	The WAVi Scan deviceis used for acquisition ofphysiological signalsusing two or morechannels ofelectroencephalography(EEG) from the scalp. Itconsists of the WAViScan amplifier (EPU), alaptop or tablet computer(base station), a patientEEG cap accessory,subject response button,earphones, and acharging cord. TheWAVi Scan EPU andsoftware provide ameans to:a) initiate a study, trackuser EEG and ERP dataand enter text orquestionnaireinformation,b) acquire and savesignals to the memory ofthe device,	The eVox Systemdevice is used foracquisition ofphysiological signalsusing two or morechannels ofelectroencephalography(EEG) from the scalp.It consists of an eVoxamplifier, a laptopcomputer (base station),a patient EEG cap,subject response button,ear buds, and acharging cord. TheeVox amplifier andsoftware provide ameans to:a) initiate a study, trackuser EEG and ERP dataand enter text orquestionnaireinformation,b) acquire and savesignals to the memoryof the device,	The Mitsar EEGconsists of biosignalamplifier, USBcable, USB dongleand software. Themedical systemincludes "MitsarEEG" device andcomputer (stationaryPC withuninterruptiblepower supply (UPS)or laptop withinternal battery).The Mitsar EEGdevice is anamplifier whichreceives patientEEG data from apatient EEG cap orEEG electrodes.	The COGNISIONEEG/EP System is acombination devicefor reduced montagerecording and displayofelectroencephalographic (EEG) andevoked potentials(EP) test data. Thesystem uses elasticbands to accuratelyposition 10 electrodepods around the head.EEG signalamplification,conditioning, andA/D conversion isperformed byelectronic circuitsclosely coupled to theelectrode podsthrough short flexibleprinted wires. Theheadset is connectedby a cable to ahandheld control unitand data acquisition	Similar;All of these devices:-use skin couplingmethods throughelectrodes whichtransmits patient EEG andERP from the surface ofthe scalp to an amplifier,-use a wired connectionbetween the amplifier andelectrodes, -convert theanalog data into digitaldata which aretransmitted to a basestation (computer),-transmit data to a basestation computer,display and store thedata on the base stationand allow the user toexport the data to a file.
	K213900Subject DeviceWAVi Scan	K171781eVox System	K143233MITSAR-EEG	K141316Cognision EEG/EPSystem	Remarks
	c) transmit signal datafrom the device,d) Visually inspect theacquired signal.e) Manage Event relatedPotentials (EEG) fromthe scalp.	c) transmit signal datafrom the device,d) Visually inspect theacquired signal.e) Manage Eventrelated Potentials(EEG) from the scalp.	c) transmit signal datafrom the device,	box (HCU). TheHCU communicatesvia awireless data link to aWindow PC tostream EEG data.Software on the PC isused to setup the testsand view andevaluate the resultanttest data usingstandard EEG/EPdisplay methods.
Patient population	All age groups	All age groups	All age groups	Adults	Similar
Use environment	Intended for use in anyhealthcare, medical, orathletic or sports clinics,or outside of medicalfacilities such as in thesports arena under thesupervision of aphysician.Also, investigations canbe performed outside ofhealthcare facilities, aslong as they are led byqualified medicalpersonnel.	Intended for use in anyhealthcare, medical, orathletic or sportsclinics, or outside ofmedical facilities suchas in the sports arenaunder the supervisionof a physician.Also, investigations canbe performed outside ofhealthcare facilities, aslong as they are led byqualified medicalpersonnel.	Intended for use inFunctionaldiagnostics wardsand departments atout-patient clinics,hospitals, healthresearch institutes,health centers andother medicalinstitutions. Also,investigations can beperformed outside ofhealthcare facilities,as long as they areled by qualifiedmedical personnel.	Physicians' Offices	Similar
RegulatoryClassification	Class II	Class II	Class II	Class II
	K213900Subject DeviceWAVi Scan	K171781eVox System	K143233MITSAR-EEG	K141316Cognision EEG/EPSystem	Remarks
Biocompatibility	N/A	Per ISO 10993-1	Per ISO 10993-1	Per ISO 10993-1	Similar; The patient-contacting componentshave been previouslycleared in K162460 andISO 10993-1 for thesecomponents was coveredin that submission
Intended Use	WAVi Scan is intendedfor the acquisition,display, and storage, ofelectrical activity of apatient's brain includingelectroencephalograph(EEG) and Event-relatedPotentials (ERP)obtained by placing twoor more electrodes onthe head to aid indiagnosis.	The eVox System isintended for theacquisition, display,and storage, ofelectrical activity of apatient's brainincludingelectroencephalograph(EEG) and Event-related Potentials (ERP)obtained by placing twoor more electrodes onthe head to aid indiagnosis.	The Mitsar-EEG isintended to acquire,display and store theelectrical activity ofa patient's brain byplacing two or moreelectrodes on thehead to aid indiagnosis.	The COGNISIONsystem is acombination devicefor reduced montagerecording and displayofelectroencephalograph (EEG) and evokedpotentials (EP) testdata.	Same
ERP StimulusModality	Auditory	Auditory; Visual	None	Auditory	Similar
SystemComponents	WAVi Scan EEGSystem consists of:• a laptop computer(base station),• an amplifier (WAViEPU),	eVox System consistsof:• an eVox amplifier,• a laptop computer(base station),• a patient EEG cap,	"Mitsar EEG"consists of:•biosignal amplifier,• computer(stationary PC withuninterruptiblepower supply (UPS)	COGNISIONTMconsists of:• Headset• Auditory stimulator• Handheld ControlUnit	Similar
	K213900Subject DeviceWAVi Scan	K171781eVox System	K143233MITSAR-EEG	K141316Cognision EEG/EPSystem	Remarks
	• subject responsebutton,• WAVi SCAN EEGsoftware,• earphones, and• charging cord.Accessories: WAVi Capand eSoc K162460	• subject responsebutton,• ear buds,• and a charging cord.	• or laptop withinternal battery)• USB cable,• USB dongle• and software	(HCU) includingInterfaceSoftware• Connecting Headsetcable between theheadset and thehandheld control unit
ERP Paradigm(Auditory andVisual Stimuli)	P300 Oddball- Single Stimulus- Single Deviant	P300 Oddball- Single Stimulus- Single Deviant- 2 Deviant- Active and Passive	None	P300 Oddball- Single Stimulus- Single Deviant- 2 Deviant- Active and Passive	Similar
ERP TaskResponse	User Buttons	User Buttons	None	User Buttons	Similar
Skin Coupling	N/A	Custom Electrode Bandand Gel	Custom ElectrodeBand and Gel	HydroDot Biosensor	Similar; WAVi SCANcan be used with any510(k) cleared EEG gel
Sterile	No	No	No	No	Similar
Single Use	No	No	No	No	Similar
Shelf life	Durable Good	Durable good	Durable good	Durable good	Similar
TypicalBiopotentialSignals Recorded	Electroencephalography(EEG), EP/ERP	Electroencephalography (EEG), EP/ERP	Electroencephalography (EEG)	Electroencephalography (EEG), EP/ERP	Similar; WAVi Scan,eVox and Cognisionrecord EEG and EP/ERP.Mitsar does not haveEP/ERP modality.
	K213900Subject DeviceWAVi Scan	K171781eVox System	K143233MITSAR-EEG	K141316Cognision EEG/EPSystem	Remarks
Number of SignalRecordingChannels	Up to 21	Up to 21	Up to 21	Up to 10	Similar
RecordingChannels Locationand PositioningSystems	10- 20 System	Fz,Cz,Pz,F3,P3,F4,P4Utilizing elastic bandsusing distance ratiosconsistent with the 10-20 System	Fz,Cz,Pz,F3,P3,F4,P4Utilizing elasticbands using distanceratios consistentwith the 10- 20System	Fz,Cz,Pz,F3,P3,F4,P4Utilizing elasticbands using distanceratios consistent withthe 10-20 System	Similar; WAVi Scan,eVox, Mitsar andCognision call for thesame electrode placementconfiguration
Impedance Test	Yes	Yes	Yes	Yes	Similar
Amplifier InputImpedance	>= $1 GΩ$	> $10 MΩ$	> $200 ΜΩ$	> $60 MΩ$	Similar
Analog to DigitalConversion	24 Bit	24 Bit	16 Bit	16 Bit	Similar
Sampling Rate	250 Hz	250 Hz	500 Hz	125/250 Hz	Similar
Common moderejection	>= 115 dB	>110 dB	>110 dB	>90 dB	Similar
Analysis Software	Embedded,commercially available,and user defined.	Embedded,commercially available,and user defined.	Embedded,commerciallyavailable, and userdefined.	Embedded,commerciallyavailable, and userdefined.	Similar
Interface withAmplifier	USB cable to PC	Class 2 Bluetooth®version 2.0 to PC	USB cable to PC	Bluetooth 2.0/4.0	Different; however, thelack of wirelessconnectivity does notraise different questionsof safety andeffectiveness
	K213900Subject DeviceWAVi Scan	K171781eVox System	K143233MITSAR-EEG	K141316Cognision EEG/EPSystem	Remarks
Power Supply	USB cable	Li-Ion Battery, withUSB cable for chargingthe battery.	USB cable	Li-Ion Battery	Similar
EEG inputterminals	up to 19 channels	up to 19 channels	up to 21 channels	up to 7 channels	Similar
Resolution	24 bits	24 bits	16 bits	16 bits	Similar
Band Width	0.5 to 40 Hz	0.1 to 50 Hz	0.162-70 Hz	0.4 to 40 Hz	Similar; WAVi Scanmeets the Frequencyrequirements of IEC80601-2-26:2019 (0.5Hz-50 Hz)
Noise	< 3.0 μVp-p	2-3 uVp-p	< 1.5μVp-p	<1 uV RMS	The measured noise of<3uVp-p for WAVi Scanis well within the IEC60601-2-26:2019requirement of 6 uVp-p.Substantially Equivalent
Event RelatedPotentials (ERP)Type	Tones	Burst (White Noise)	None	Tones	Similar; WAVi usestones, which is typical foroddball P300 and also hassubjects respond to targetstimuli that occurinfrequently andirregularly within a seriesof standard stimuli.
Duration for ERP	50ms	100ms	None	50ms	Similar; 50- 100ms is atypical length for evokingan ERP.
Ear Sides	Both	Both	None	Unknown	Similar
	K213900Subject DeviceWAVi Scan	K171781eVox System	K143233MITSAR-EEG	K141316Cognision EEG/EPSystem	Remarks
ERP Frequencyrange	1 kHz and 2.77 kHz,programmable from440Hz-16kHz forresearch purposes	440 Hz-16kHz	None	Unknown	Similar; The WAVi Scansystem generates a soundwith a frequency range of440Hz-16kHz which issufficiently wide enoughband for human hearing.
Intensity	0 to 85 dB	0 to 85dB	None	Unknown	Similar; The Maximumdecibel level is 85dB,well below 125dB (lowrisk to user)
Noise Patterns	16.7% occurrencerandomly distributedover a minimum of 4minutes	12.5% occurrencerandomly distributedover 10 minutes	None	10% occurrencewithin 10-60 minutes	Similar; This pattern isstandard to elicit thedesired number of ERPsas set by the user inselecting testing times.
Input VoltageRange	+/- 400mV	+/-150 mV	5 mV	Not stated	Similar
Safety StandardsCompliance	IEC 60601-1-2:2014IEC/EN 60601-1:2005+A1:2012IEC 80601-2-26:2019	IEC 60601-1: 2005 +CORR. 1:2006 +CORR. 2:2007 +AM1:2012 (or IEC60601-1: 2012 reprint)EN 60601-1-2:2012IEC 60601-2-26:2012	EN 60601-1:2005EN 60601-1-2:2005EN 60601-2-26	UL 60601-1:2003EN60601-1-2/A1:2007EN60601-1-2/A1:2007EN 60601-2-26IEC 60601-2-40	Similar
OperatingEnvironment	0 to +45 °C, Relativehumidity, 5% to 95%noncondensing	0 to +45 °C, Relativehumidity, 5% to 95%noncondensing	Not Published	60 to 90 °F	Similar
StorageEnvironment	-20° to 45° C. Relativehumidity, 5% to 95%noncondensing	-20° to 45° C. Relativehumidity, 5% to 95%noncondensing	Not Published	Not published	Similar

The following table compares the technological characteristics of WAVi Scan to those of the predicate Substantial Equivalence (SE).

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Substantial Equivalence Discussion:

The subject and predicate devices have the same intended use and have similar technological characteristics pertaining to hardware, operating systems, software, features, and functions. Thus, the WAVI™ SCAN EEG system is substantially equivalent to the predicate device(s).

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Performance Testing and Conformance to Standards

The WAVi™ SCAN 1.0 development and performance testing has met all performance specifications, product standards and national and international standards.

Extensive functional device testing and user testing has been performed with satisfactory results. Additionally, tests have been performed by accredited laboratories and show full compliance with standards IEC 80601-2-26:2019 Medical electrical equipment - Part 2: Particular requirements for the safety of electroencephalographs.

Clause	Requirement + Test	Results -Remarks
201.12.1.1 02	Accuracy of signal reproduction	P
	Input voltages in the ranges and varying at rates selected from"Scalp" and/or "Cerebral cortex or subdural locations" accordingto Table 201.102 ware reproduced on the output with an error of$\leq$ ±20 % of the nominal value of the output or ±10 µV, whicheveris greater	P
	Compliance checked according to Fig.201.104	P
201.12.1.1 03	Input dynamic range and differential offset voltage	P
	With a d.c. offset voltage in the range of ±150 mV anddifferential input signal voltages of ±0,5 mV that vary at rates upto 12 mV/s, when applied to any LEAD WIRE, the time-varyingoutput signal amplitude did not change by more than ±10 % overthe specified range of d.c. offset.	P
201.12.1.1 04	Input noise	P
	The signal noise caused by the EEG amplifier and PATIENTCABLE did not exceed 6 µV peak-to-valley referred to the input(RTI)	P
	Compliance checked according to Fig.201.105	P
201.12.1.1 05	Frequency response	P
	ME EQUIPMENT meets the requirement for a frequencyresponse (bandwidth) of at least 0,5 Hz to 50 Hz when tested withsinusoidal input signals.	P
	The output at 0,5 Hz and 50 Hz was within 71 % to 110 % of theoutput obtained with a 5 Hz sine wave input signal.	P
	Compliance checked according to Fig.201.104	P
201.12.1.1 06	Common mode rejection	P
	A 1 V r.m.s. signal at mains frequency (50 Hz/60 Hz) with 200pF source capacitance, connected between earth and all LEADWIRES connected together did not produce an output signalgreater than 100 uV peak-to-valley over a 10 s period.	P
	In series with each ELECTRODE was a 10 kΩ resistor in parallelwith a 47 nF capacitor and PATIENT CABLE specified by theMANUFACTURER were used.	P
	Compliance checked using Fig.201.105 with any mainsfrequency notch filter (if provided) turned off.	P
	The measured output amplitude was not be greater than 100 uVpeak-to-valley	P

{15}------------------------------------------------

Performance Testing

Electrical Safety & Electromagnetic Compatibility (EMC)

The tests have been performed by accredited laboratories and show full compliance with standards below: ANSI AAMI 60601-1: 2005 +A1:2012, Medical electrical equipment electrical equipment- Part 1: General requirements for basic safety and essential performance (FDA recognition # 19-4).

The tests have been performed by the accredited laboratories and show full compliance with standards below. The device under consideration has passed the tests according to IEC 60601-1 and IEC 60601-1-2:2014 (4th Edition) General requirements for basic safety and essential performance - Collateral Standard Electromagnetic disturbances – Requirements and tests (FDA recognition # 19-1)

Table II EMI Testing IEC 60601-1-2:2014 (4th Edition)
Test Description	Specification	Notes	Results
Radiated Emissions	EN 55011:2009+A1:2010	Class B30MHz – 1GHz	Conforms
Electrostatic DischargeImmunity	IEC 61000-4-2:2008	Contact discharge: ±8kV and AirDischarge: ±2kV, ±4kV, ±8kV,±15kV	Conforms
Radiated ElectromagneticField Immunity	IEC 61000-4-3:2006	80MHz to 2.7GHz @ 10V/m80% AM at 1kHz	Conforms
Proximity Fields from RFWireless	IEC 61000-4-3:2010	Table 9	Conforms
Magnetic Field Immunity	IEC 61000-4-8:2009	30A/m @ 50Hz or 60Hz	Conforms

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).