The NeuroFAST Monitoring System, Model NF-201 is intended to be used for measuring and recording the electrical activity of a patient's brain, obtained by placing electrodes on the head. The NeuroFAST NF-201 is indicated for use in acquiring electroencephalographic (EEG) signals in the OR, ICU, ER, clinical settings and for clinical research. The NeuroFAST Monitor is to be used under the direction and interpretation of a licensed medical professional. The NeuroFAST Monitoring System, Model NF-201 does not provide any diagnostic conclusion about the patient's condition.

Device Description

The NeuroFAST Monitoring System, Model NF-201, is an EEG monitor that records and displays electroencephalograms (EEGs) obtained from noninvasive electrodes placed on a patient's head. The acquired EEG waveforms and processed EEG variables are continuously displayed by the system for interpretation by the licensed medical professional. The NeuroFAST Monitoring System, Model NF-201 has three main components: Display Module (DM-201), Patient Module (PM-201), and EasyPrep Sensor Kit (EK-701).

AI/ML Overview

The NeuroFAST Monitoring System, Model NF-201, is an EEG monitor. The provided 510(k) summary focuses on demonstrating substantial equivalence to predicate devices rather than establishing novel safety and effectiveness through specific clinical performance criteria. Therefore, the information regarding acceptance criteria and a study proving device performance as typically understood for new medical devices with specific performance claims (e.g., diagnostic accuracy) is not present in the same way it would be for analytical or clinical performance studies.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

Since this 510(k) is for an EEG monitor, the "acceptance criteria" are primarily related to its technical specifications and compliance with relevant standards, demonstrating that it functions equivalently to existing devices. There aren't specific diagnostic performance metrics (e.g., sensitivity, specificity) listed as acceptance criteria that a study would then "prove" the device meets.

Instead, the acceptance criteria are implicitly met by showing the device's technical specifications and intended use are similar to predicate devices and that it complies with relevant safety and technical standards.

Feature / Standard	Acceptance Criteria (Implied)	Reported Device Performance (NeuroFAST NF-201)
Intended Use	Consistent with 21 CFR 882.1400 (Electroencephalograph)	Measuring and recording electrical activity of the brain, acquiring EEG signals in OR, ICU, ER, clinical settings, and for clinical research. No diagnostic conclusion provided.
Modalities	EEG	EEG
Environment of Use	Hospitals and Clinics	Operating room, intensive care unit, emergency room, and clinical settings where EEG monitoring is used.
Sensing Electrodes	Standard EEG electrodes	Silver-silver chloride disposable EEG electrodes (EasyPrep Sensor Kit)
Screen Display	Raw EEG waveforms and spectral parameters	Displays: Raw EEG Waveforms, Spectral Parameters (EEG power spectrum and frequency bands, 50% Median Edge Frequency (MEF), and 95% Spectral Edge Frequency (SEF))
Stored EEG data	Yes	Yes - through removable storage
EEG Channels	Multiple channels, typically 2 or more for EEG monitoring	2 bilateral frontal channels viewed concurrently
Real Time Display	Yes	Yes
Processed Bandwidth	Appropriate for EEG	User Selectable: Low Filter: 0.125 or 0.5 Hz, High Filter: 30 or 70 Hz
Automatic Artifacting	Yes	Yes
Amplifier CMRR	≥ 100 dB	≥100 dB
Amplifier Input Impedance	≥ 50 Meg Ohms (Predicate: ≥ 100 Meg Ohms)	≥50 Meg Ohm
Electrode Impedance Test	Yes	Yes - Continuous and on demand
Derived/Processed EEG Measures	Power spectrum parameters common to EEG monitors	Power spectrum parameters derived from FFT: Power spectrum (Density Spectral Array), 95% Spectral Edge Frequency (SEF), Median Edge Frequency (MEF), Spectral Powers in EEG frequency bands (α, β1, β2, δ, θ and γ)
Patient Isolation	Electrical isolation for patient safety	Yes - Patient module (analog-to-digital converter) provides 6kV electrical isolation of the patient from the monitor.
Safety Standards	Compliance with Medical Electrical Equipment and Electroencephalograph Standards (IEC/UL)	Complies with IEC60601-1, IEC60601-1-4, IEC60601-2-26. Will meet UL medical electrical equipment standards for safety.
EMC Standards	Compliance with Electromagnetic Compatibility Standards (IEC)	Complies with IEC60601-1-2, IEC60601-2-26.
Functional Requirements	Meets design and functional requirements; performs as expected.	Laboratory testing on identical hardware demonstrated that the NeuroFAST Monitoring System, Model NF-201 meets its design and functional requirements, including IFCN Guidelines for electroencephalographs. Actual device functions and features were evaluated against the device specifications and in all instances the NeuroFAST NF-201 performed as expected and no unexpected behavior was observed.

Study Proving Device Meets Acceptance Criteria:

The key study mentioned is non-clinical bench testing.

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

Sample Size for Test Set: Not applicable in the traditional sense for a clinical performance study. The "test set" in this context refers to the device itself and its components undergoing engineering and functional verification. The summary states "Laboratory testing, performed on identical hardware to the NeuroFAST subject of this submission..." This implies testing was done on units of the device, not a sample of patient data.
Data Provenance: Not applicable. The testing described is hardware and functional verification, not data from patients. There is no mention of country of origin or retrospective/prospective nature as clinical data was not used.

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

Number of Experts: Not applicable. For hardware and functional testing, "ground truth" is typically established by engineering specifications, international standards, and comparison with predicate device functionalities, not through expert reading of data generated by the device.
Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set:

Adjudication Method: Not applicable. The testing described is objective measurement against specifications and visual verification of expected device behavior, not subjective interpretation requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not done. The summary explicitly states: "We believe further clinical data is not required to demonstrate performance for the NeuroFAST NF-201 for the indication for use subject to this submission." This indicates that the regulatory pathway relied on demonstrating substantial equivalence through technical specifications and non-clinical testing rather than proving improved human reader performance with or without AI assistance.
Effect Size: Not applicable as no such study was performed.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

No, a standalone algorithm performance study was not done. The NeuroFAST Monitoring System, Model NF-201 is described as an EEG monitor that records and displays EEGs for interpretation by a licensed medical professional. It "does not provide any diagnostic conclusion about the patient's condition." This means it's a data acquisition and display device, not an AI-powered diagnostic algorithm. Its performance is intrinsically tied to its ability to accurately acquire and present physiological signals, not to generate a standalone interpretation.

7. Type of Ground Truth Used:

Ground Truth: For the non-clinical testing, the "ground truth" was the device's own design and functional requirements, IFCN Guidelines for electroencephalographs, device specifications, and relevant international safety and EMC standards (IEC60601-1, IEC60601-1-4, IEC60601-2-26, IEC60601-1-2). The performance was evaluated against these predetermined engineering and regulatory benchmarks.

8. Sample Size for the Training Set:

Sample Size for Training Set: Not applicable. This device is an EEG monitor, not an AI/ML algorithm that requires a training set in the conventional sense. Its function is to acquire and display biological signals, not to learn patterns from data.

9. How the Ground Truth for the Training Set Was Established:

How Ground Truth for Training Set Was Established: Not applicable, as there is no training set for this type of device.

Summary

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K092477

510(k) SUMMARY

1. Contact Details

Applicant Name:	Neuro Wave Systems Inc.2490 Lee Blvd., Suite 300Cleveland Heights, OH 44118OCT 29 2010(216) 361-1591 (telephone)(216) 361-1554 (fax)
Contact:	Tracie Capozzio,Quality Assurance and Regulatory Compliancetcapozzio@neurowavesystems.com
Date Prepared:	October 19, 2010
Device Name
Trade Name:	NeuroFAST Monitoring System, Model NF-201
Common/Usual Name:	EEG Monitor
Classification Name:	Electroencephalograph
Product Code:	OMC

21 CFR 882.1400 Class II Neurology

Legally Marketed Predicate Device 3.

Regulation Number:

Classification Panel:

Device Class:

510(k)Number	ProductCode	Trade Name	Manufacturer
K082886	OLT	ZOOM-100DC	Brainscope Company, Inc.
K072382	GWQ	Model I-2000 Monitor	Infinite Biomedical Technologies

4. Description of Device

The NeuroFAST Monitoring System, Model NF-201 has three main components:

Display Module (DM-201) processes acquired digital EEG signals, displays . EEG waveforms and processed EEG variables, and archives them for later review

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Patient Module (PM-201) acquires analog EEG signals through the Patient . Cable, and converts them into digital EEG signals
. EasyPrep Sensor Kit (EK-701) - Noninvasive, disposable, single patient electrodes for acquiring the EEG signal

The NeuroFAST NF-201 system also includes the following cables:

Patient Cable (PC-201) connects the Patient Module to four (4) noninvasive . electrodes
USB Data Cable (DC-201) sends acquired digital EEG signals from the . Patient Module to the Display Module

5. Intended Use

The intended use of NeuroFAST Monitoring System, Model NF-201 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."

The NeuroFAST Monitoring System, Model NF-201 is intended to be used for measuring and recording the electrical activity of a patient's brain, obtained by placing electrodes on the head. The NeuroFAST NF-201 is indicated for use in acquiring electroencephalographic (EEG) signals in the OR, ICU, ER, clinical settings and for The NeuroFAST Monitor is to be used under the direction and clinical research. interpretation of a licensed medical professional. The NeuroFAST Monitoring System, Model NF-201 does not provide any diagnostic conclusion about the patient's condition.

Substantial Equivalence Comparison 6.

The technology of the NeuroFAST NF-201 device is equivalent to other EEG monitor devices. The EEG signal is acquired in analog format, digitized, processed and presented to the user for interpretation. An EasyPrep Sensor Kit is provided for the convenience of the user in applying the monitoring electrodes. The EasyPrep Sensor Kit is made of the same materials used in the manufacture of several medical sensors listed under 510(k) #781430 (refer to section 15 for addition details).

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Feature	NeuroFAST MonitoringSystem,Model NF-201(K092477)	ZOOM-100DC(082886)	Model I-2000 Monitor(072382)
Indications forUse	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 ZOOM-100DC is usedto measure and record theelectrical activity of apatient's brain. The ZOOM-100DC is intended to monitorthe state of the brain byacquisition and display ofelectroencephalogram (EEG)signals and by the calculationof standard quantitative EEG(qEEG) parameters.	The I-2000 Monitor isintended to be used formeasuring and recording theelectrical activity of apatient's brain, obtained byplacing electrodes on thehead.The I-2000 Monitor isindicated for use inmonitoring the state of thebrain by acquisition ofelectroencephalogram(EEG) signals, in researchand clinical environments.
Modalities	EEG	EEG	EEG
Environmentof Use	Operating room, intensivecare unit, emergency room,and clinical settings whereEEG monitoring is used.	Hospitals and Clinics	Hospitals and Clinics
Power Source	120 Volt 60Hz AC power	Li Ion Battery	Battery120 Volt 60Hz AC power
SystemComponents	Patient Module, Patient Cable,Display Module, Data Cableand EasyPrep Electrode Kit	ZOOM-100DC, ExternalPatient Interface Cable,External Audio Cable,Compact Flash Card, BatteryCharger	Table PC, Battery Poweredwireless headbox, headboxcharger, power conditioner
SensingElectrodes	Silver-silver chloridedisposable EEG electrodes	Standard off-the-shelf EEGelectrodes	Unknown type of EEGelectrodes
Feature	NeuroFAST Monitoring System, Model NF-201 (K092477)	ZOOM-100DC (082886)	Model I-2000 Monitor (072382)
Screen Display Details	Displays:1) Raw EEG Waveforms2) Spectral Parameters: EEG power spectrum and frequency bands, 50% 50% Median Edge Frequency (MEF), and 95% Spectral Edge Frequency (SEF)	Displays:1) Raw EEG Waveform	Displays:1) Raw EEG waveforms2) Spectral Parameters: EEG power spectrum 95% Spectral Edge Frequency (SEF)
Stored EEG data available	Yes - through removable storage	Yes - through Compact Flash card	Yes - through removable storage
EEG Channels/ Montage	2 bilateral frontal channels viewed concurrently	Up to 5 channels viewed concurrently8 single-ended channels corresponding to 8 electrodes placed anywhere on the head, including but not limited to, all locations defined by the International 10/20 system. (5 different channels can be viewed concurrently)	2 channels
Real Time EEG Display	Yes	Yes	Yes
Processed EEG Bandwidth	User SelectableLow Filter: 0.125 or 0.5 HzHigh Filter: 30 or 70 Hz	0.5-50 Hz	Unknown
Automatic Artifacting	Yes	Yes	Unknown
Amplifier Common Mode Rejection Ration (CMRR)	≥100 dB	≥ 100 dB	Unknown
Amplifier Input Impedance	≥50 Meg Ohm	≥ 100 Meg Ohms	Unknown
Electrode Impedance Test	YesContinuous and on demand by	Yes	Yes
Feature	NeuroFAST MonitoringSystem,Model NF-201(K092477)	ZOOM-100DC(082886)	Model I-2000 Monitor(072382)
Derived /ProcessedEEG Measures	Power spectrum parametersderived from FFT:1) Power spectrumdisplayed as DensitySpectral Array (DSA)2) 95% Spectral EdgeFrequency (SEF)3) Median Edge Frequency(MEF)4) Spectral Powers in EEGfrequency bandstraditionally used toquantify EEG signals ( $\alpha$ ,$\beta$ 1, $\beta$ 2, $\delta$ , $\theta$ and $\gamma$ )	Power spectrum parametersderived from FFT:1) Absolute Powera. Monopolar Powerb. Bipolar Power2) Relative Powera. Relative Monopolar Powerb. Relative Biopolar Power3) Mean frequency variables(univariate and multivariate)a. Monopolar MeanFrequencyb. Biopolar Mean Frequency4) Coherencea. Monopolar Coherenceb. Bipolar Coherence5) Asymmetrya. Monopolar Asymmetryb. Bipolar Asymmetry	Power spectrum parametersderived from FFT:1) Power spectrumdisplayed as a linegraph for each of thefour frequency bandstraditionally used toquantify EEG signals[Delta (0-4 Hz), Theta(4-8Hz), Alpha (8-13Hz) and Beta (13-30Hz)]2) 95% spectral edgefrequency (SEF)
Containspatientisolation	Yes - Patient module(analog-to digital converter)provides 6kV electricalisolation of the patient fromthe monitor	Battery powered, thus noconnection between patientand mains	Yes - Wireless Bluetoothcommunication provideselectrical isolation of thepatient from the monitor
DisplayScreen	Yes - High-resolution, color,graphical user interface andtouch screen	Yes	Yes - Graphical userinterface and touch screentablet PC
Event Markers	Yes, user selectable	Unknown	Yes

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Non-clinical Testing 7.

Laboratory testing, performed on identical hardware to the NeuroFAST subject of this submission, demonstrated that the NeuroFAST Monitoring System, Model NF-201 meets its design and functional requirements, including IFCN Guidelines for electroencephalographs. Actual device functions and features were evaluated against the device specifications and in all instances the NeuroFAST NF-201 performed as expected and no unexpected behavior was observed. The device will meet the requirements of UL medical electrical equipment standards for safety and the IEC particular standard for electroencephalographs.

To ensure safety, the NeuroFAST Monitoring System, Model NF-201 will comply with all applicable requirements of IEC60601-1 and IEC60601-1-4, and will also comply

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with the particular requirements for the safety of electroencephalographs established in IEC60601-2-26.

To ensure electromagnetic compatibility, the NeuroFAST NF-201 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 NeuroFAST NF-201 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 NeuroFAST NF-201 for the indication for use subject to this submission.

9. Conclusion

The NeuroFAST NF-201, when compared to its predicate devices, has the same intended use and similar 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 NeuroFAST NF-201 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.

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Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare, to the right of the text. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement around the caduceus. The caduceus is depicted with a simple, flowing design.

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

NeuroWave Systems, Inc. c/o Ms. Tracie Capozzio Quality Assurance and Regulatory Compliance 2490 Lee Blvd., Suite 300 Cleveland Heights, Ohio 44118

OCT 2 9 2010

Re: K092477

Trade/Device Name: NeuroWave NeuroFAST Monitoring System, Model NF-201 Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph (EEG) Regulatory Class: Class II Product Code: OMC Dated: October 19, 2010 Received: October 20, 2010

Dear Ms. Capozzio:

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. Iisting 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.

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Page 2 - Ms. Tracie Capozzio

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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 vours.

In A. Ramm
Melvin R. Felder, M.D.

Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE

510(k) Number (if known): K092477

OCT 2 9 2010

Device Name: NeuroFAST Monitoring System, Model NF-201

Indications For Use:

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

signature

(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number K092477

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).