The DiscoverEEG System, Model DE-401 is intended to be used for measuring and recording the electrical activity of a subject's brain, obtained by placing non-invasive electrodes on the head. The DiscoverEEG, DE-401 is indicated for use in acquiring electroencephalographic (EEG) signals in the OR, ICU, ER, clinical settings and at home and for clinical research. The medical use of data acquired by the DiscoverEEG is to be performed under the direction and interpretation of a licensed medical professional. The DiscoverEEG, Model DE-401 does not provide any diagnostic conclusion about the subject's condition.

Device Description

The DiscoverEEG System, Model DE-401, is a wearable, medical-grade EEG device that acquires and stores up to four electroencephalograms (EEGs) obtained from noninvasive electrodes placed on a subject's head. The acquired EEG waveforms, as well as, processed EEG spectral variables are continuously stored by the system for later retrieval. The data can be transferred from the DiscoverEEG hardware to a computer for review. The DiscoverEEG System, Model DE-401 has four main components: Acquisition Module, Memory Module, Disposable Electrode Array, and Data Viewer Software.

AI/ML Overview

The provided text does not contain specific acceptance criteria for performance metrics (like sensitivity, specificity, accuracy) related to the interpretation of EEG signals by the DiscoverEEG System, Model DE-401 for diagnostic purposes. This is explicitly stated in the Indications for Use: "The DiscoverEEG, Model DE-401 does not provide any diagnostic conclusion about the subject's condition."

Instead, the non-clinical testing sections focus on the device meeting its design and functional requirements, safety standards (UL, IEC60601-1, IEC60601-1-11, IEC60601-2-26), and electromagnetic compatibility (IEC60601-1-2). The substantial equivalence claim is based on similar intended use, technological characteristics, and principles of operation to predicate devices, with bench testing demonstrating functional performance without providing specific quantitative metrics for diagnostic accuracy.

Therefore, for the aspects requested, here's what can be extracted from the document:

1. A table of acceptance criteria and the reported device performance

The document does not provide a table of performance-based acceptance criteria (e.g., sensitivity, specificity) for diagnostic accuracy. The "reported device performance" is primarily qualitative, stating that the device "meets its design and functional requirements" and "performed as expected."

Acceptance Criteria Category	Reported Device Performance
Design & Functional Requirements	Meets design and functional requirements; performed as expected; no unexpected behavior observed.
Safety Standards	Will comply with IEC60601-1, IEC60601-1-11, IEC60601-2-26, and UL medical electrical equipment standards.
Electromagnetic Compatibility	Will comply with IEC60601-1-2 and IEC60601-2-26.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. The document states "Laboratory testing, performed on identical hardware to the DiscoverEEG subject of this submission, demonstrated that the DiscoverEEG, Model DE-401 meets its design and functional requirements." This indicates bench testing rather than a clinical human subject test set. There's no mention of sample size or data provenance in this context.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. The testing described is non-clinical bench testing, not involving human interpretation for ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. There was no test set requiring expert adjudication for ground truth.

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

Not applicable. The device "does not provide any diagnostic conclusion about the subject's condition" and the submission states "further clinical data is not required to demonstrate performance for the DiscoverEEG, Model DE-401 for the indication for use subject to this submission." Therefore, no MRMC study was performed to assess human reader improvement with or without AI assistance.

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

Not applicable in the context of diagnostic performance. The device's function is to "measure and record the electrical activity of a subject's brain" and provide "processed EEG spectral variables." The medical use and interpretation are explicitly "to be performed under the direction and interpretation of a licensed medical professional." While the device itself processes signals, the "standalone" performance for diagnostic purposes is not claimed or evaluated. The non-clinical testing focused on hardware functionality and adherence to standards.

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

Not applicable. The testing described is non-clinical/bench testing against design specifications and functional requirements, not against clinical ground truth like expert consensus, pathology, or outcomes data.

8. The sample size for the training set

Not applicable. The document does not describe an AI/ML component that requires a training set for diagnostic or interpretative tasks. The device acquires and processes EEG signals, but its output is for interpretation by a medical professional, not a standalone diagnostic conclusion.

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

Not applicable, as there is no described training set.

Summary

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which consists of a stylized caduceus-like symbol with three human profiles facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the emblem.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 23, 2015

NeuroWave Systems Inc. Tatjana Zikov President 2490 Lee Blvd., Suite 300 Cleveland Heights, OH 44118

Re: K142834

Trade/Device Name: DiscoverEEG System, Model DE-401 Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: OLT, OMC Dated: May 10, 2015 Received: May 11, 2015

Dear Tatjana Zikov:

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. The general controls provisions of the Act include requirements for annual registration. Isting 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 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Felipe Aguel -S

Carlos L. Peña, PhD, MS for Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K142834

Device Name DiscoverEEG System, DE-401

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
区 Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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Contact Details 1.

Applicant Name:	NeuroWave Systems Inc.2490 Lee Blvd., Suite 300Cleveland Heights, OH 44118(216) 361-1591 (telephone)(216) 361-1554 (fax)
Contact:	Tatjana Zikov,Presidenttzikov@neurowavesystems.com
Date Prepared:	September 29, 2014

2. Device Name

Trade Name:	DiscoverEEG System, Model DE-401
Common/Usual Name:	EEG Monitor
Classification Name:	Electroencephalograph
Product Code:	OMC
Regulation Number:	21 CFR 882.1400
Device Class:	Class II
Classification Panel:	Neurology

Legally Marketed Predicate Device 3.

510(k)Number	ProductCode	Trade Name	Manufacturer
K092477	OMC	NeuroFAST MonitoringSystem, Model NF-201	NeuroWave Systems, Inc.
K101830	OLV,OMC	Zmachine	Consolidated Research ofRichmond, Inc.

4. Description of Device

The DiscoverEEG System, Model DE-401 has four main components:

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. Acquisition Module: contains the circuitry for acquisition of the EEG signals through connections to the electrodes placed on the subject's head. The acquired signals are digitized and then passed to the Memory Module, for signal processing and storage.
. Memory Module: provides power to the system and contains memory and EEG processing circuitry (impedance check, lead off check, pre-processing incl. artifact removal, processed spectral variables). Includes LED indicators for assurance of proper operation and other user interface elements. May contain a wireless option for data transfer to Data Viewer Software in realtime.
. Disposable Electrode Array: contains noninvasive, disposable, single patient electrodes (5 electrodes, 4 EEG channels) and skin preparation materials. The packaging will guide the user on how to prepare the subject's skin and how to place the electrodes.
. Data Viewer Software: PC based software used for retrieving and reviewing acquired raw EEG waveforms (as well as processed data) from the DiscoverEEG hardware. This software will also be capable of converting the retrieved EEG data files to standard formats (i.e. EDF+, tab-delimited). Such converted data files can then be reviewed using off-the-shelf bio-signal review software that accepts the converted format.

5. Intended Use

The intended use of DiscoverEEG System, Model DE-401 is consistent with the classification 21 CFR 882.1400, Electroencephalograph:

"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."

6. Substantial Equivalence Comparison

The technology of the DiscoverEEG DE-401 device is equivalent to other EEG monitor devices. The EEG signal is acquired in analog format, digitized, processed and saved for later user interpretation. An Electrode (Sensor) Array is provided with the system for the convenience of the user in applying the acquisition electrodes. The Electrode Array is made of the materials that have been shown to pass cytotoxicity, primary skin irritation and sensitization as required (refer to section 15 for addition details).

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Feature	DiscoverEEG System, ModelDE-401	NeuroFAST MonitoringSystem,Model NF-201(092477)	Zmachine(101830)
Indications forUse	The DiscoverEEG System,Model DE-401 is intended tobe used for measuring andrecording the electricalactivity of a subject's brain,obtained by placing non-invasive electrodes on thehead. The DiscoverEEG, DE-401 is indicated for use inacquiringelectroencephalographic(EEG) signals in the OR, ICU,ER, clinical settings and athome and for clinical research.The medical use of dataacquired by the DiscoverEEGis to be performed under thedirection and interpretation ofa licensed medicalprofessional. TheDiscoverEEG, Model DE-401does not provide anydiagnostic conclusion aboutthe subject's condition.	The NeuroFAST Monitor NF-201 is intended to be used formeasuring and recording theelectrical activity of apatient's brain, obtained byplacing electrodes on thehead. The NeuroFAST NF-201 is indicated for use inacquiringelectroencephalographic(EEG) signals in the OR, ICU,ER, clinical settings and forclinical research. TheNeuroFAST Monitor is to beused under the direction andinterpretation of a licensedmedical professional. TheNeuroFAST Monitor NF-201does not provide anydiagnostic conclusion aboutthe patient's condition.	The CR1 Zrnachine is asingle-channel EEGacquisition and analysissystem, designed for use inthe home or clinicalenvironments. This deviceis intended to be used byqualified healthcarepractitioners to monitor thewake and sleep states ofadult patients and as anadjunct to their diagnosisof sleep disorders.
Modalities	EEG	EEG	EEG
Environmentof Use	Operating room, intensive careunit, emergency room, clinicalsettings and At Home whereEEG monitoring is used.	Operating room, intensivecare unit, emergency room,and clinical settings whereEEG monitoring is used.	In the home or clinicalenvironment
Power Source	Battery	120 Volt 60Hz AC power	Li Ion Battery
SystemComponents	Electrode (Sensor) Array,Acquisition and MemoryModules, Data ViewerSoftware	Patient Module, Patient Cable,Display Module, Data Cableand EasyPrep Electrode Kit	Zmachine device, EEGsensors, Sensor cable, wallcharger
SensingElectrodes	Silver-silver chloridedisposable EEG electrodes	Silver-silver chloridedisposable EEG electrodes	Silver-silver chloridedisposable electrodes
Feature	DiscoverEEG System, ModelDE-401	NeuroFAST MonitoringSystem,Model NF-201(092477)	Zmachine(101830)
ScreenDisplayDetails	Data Viewer Software:1) Raw EEG Waveforms2) Signal Qualityinformation: ChannelConnection flags,Impedance values,Artifact Detection flags,Noise Level3) Spectral Parameters: EEGpower spectrum andfrequency bands, 50%50% Median EdgeFrequency (MEF), and95% Spectral EdgeFrequency (SEF)	Displays:1) Raw EEG Waveforms2) Signal Qualityinformation: ChannelConnection flags,Impedance values,Artifact Detection flags,Noise Level3) Spectral Parameters: EEGpower spectrum andfrequency bands, 50%50% Median EdgeFrequency (MEF), and95% Spectral EdgeFrequency (SEF)	Displays:Sleep/Wake Statistics
Stored EEGdata available	Yes - SD Card	Yes – through removablestorage	Yes - microSD
EEGChannels/Montage	Up to 4 channels (2 fronto-temporal channels, and 2temporal channels)	2 bilateral fronto-temporalchannels viewed concurrently	1 channel, differentialmastoid
Real TimeEEG Display	Yes, if wireless option ispresent	Yes	No
ProcessedEEGBandwidth	User Selectable in DataViewer softwareLow Filter: 0.125 or 0.5 HzHigh Filter: 30 or 70 Hz	User SelectableLow Filter: 0.125 or 0.5 HzHigh Filter: 30 or 70 Hz	0.5-380 Hz
AutomaticArtifacting	Yes	Yes	Unknown
AmplifierCommonModeRejectionRation(CMRR)	≥110 dB	≥100 dB	Unknown
AmplifierInputImpedance	≥100 Meg Ohm	≥50 Meg Ohm	10 Gig Ohms
ElectrodeImpedanceTest	Yes	YesContinuous and on demand bythe user	Yes
Feature	DiscoverEEG System, ModelDE-401	NeuroFAST MonitoringSystem,Model NF-201(092477)	Zmachine(101830)
Derived /ProcessedEEG Measures	Power spectrum parametersderived from FFT:	Power spectrum parametersderived from FFT:	Wake/Sleep Determination
	1) Power spectrum displayedas Density Spectral Array(DSA)	1) Power spectrumdisplayed as DensitySpectral Array (DSA)
	2) 95% Spectral EdgeFrequency (SEF)	2) 95% Spectral EdgeFrequency (SEF)
	3) Median Edge Frequency(MEF)	3) Median Edge Frequency(MEF)
	4) Spectral Powers in EEGfrequency bandstraditionally used toquantify EEG signals (α,β1, β2, δ, θ and γ)	4) Spectral Powers in EEGfrequency bandstraditionally used toquantify EEG signals (α,β1, β2, δ, θ and γ)
	Signal Quality information(Channel connection flags,Impedance values, ArtifactDetection flags, Noise Level)	Signal Quality information(Channel connection flags,Impedance values, ArtifactDetection flags, Noise Level)
Containspatientisolation	Battery powered, thus noconnection between patientand mains	Yes - Patient module(analog-to digital converter)provides 6kV electricalisolation of the patient fromthe monitor	Battery powered, thus noconnection between patientand mains
DisplayInterface	Yes, LEDs to ensure propersystem connection andoperation.	Yes - High-resolution, color,graphical user interface andtouch screen	Yes, To ensure propersystem connection andoperation.
Event Markers	Yes, artifact detection andsignal quality eventsUser selectable eventsincluded in Data Viewersoftware	Yes, user selectable	Yes, Sleep/Wake Events

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Non-clinical Testing 7.

Laboratory testing, performed on identical hardware to the DiscoverEEG subject of this submission, demonstrated that the DiscoverEEG, Model DE-401 meets its design and functional requirements. Actual device functions and features were evaluated against the device specifications and in all instances the DiscoverEEG, Model DE-401 performed as expected and no unexpected behavior was observed.

Prior to commercial introduction, the device will meet the requirements of UL medical electrical equipment standards for safety and the IEC particular standard for electroencephalographs.

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To ensure safety, the DiscoverEEG, Model DE-401 will comply with all applicable requirements of IEC60601-1 and IEC60601-1-11, and will also comply with the particular requirements for the safety of electroencephalographs established in IEC60601-2-26.

To ensure electromagnetic compatibility, the DiscoverEEG, Model DE-401 will comply with all applicable requirements of IEC60601-1-2, and will also comply with the particular requirements for the safety of electroencephalographs established in IEC60601-2-26.

8. Clinical Testing

The DiscoverEEG, Model DE-401 device is an electroencephalographic device comprised of hardware that has been bench tested to assess safety and effectiveness and to establish substantial equivalence with the predicate devices. We believe further clinical data is not required to demonstrate performance for the DiscoverEEG, Model DE-401 for the indication for use subject to this submission.

9. Conclusion

The DiscoverEEG, Model DE-401, when compared to its predicate devices, has the similar intended use and technological characteristics and principles of operation. The nonclinical tests demonstrate that the device is safe, as effective, and performs at least as safely and effectively as the legally marketed devices. Thus, in indications, intended use and technology, the DiscoverEEG, Model DE-401 is substantially equivalent to the predicated devices. Minor technological difference as documented in the Substantial Equivalence Comparison table above, raise no new questions of safety or effectiveness.

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).