The NeuroSENSE Monitoring System, Model NS-901, is intended for monitoring the brain state of adult and pediatric patients (18 years of age and older) in the operating room and other clinical settings by acquiring electroencephalographic (EEG) signals.

The WAVCNs index, a quantifier of EEG activity calculated and displayed by the NeuroSENSE NS-901 Monitor, may be used as an aid in monitoring the hypnotic effect of anesthetics. The anesthetics include inhaled anesthetics and propofol in combination with opioids. The NeuroSENSE Monitor is intended to be used under the direction and interpretation of a qualified medical professional.

Device Description

The NeuroSENSE Monitoring System, Model NS-901, is a 2-channel bilateral processed Electroencephalograph (EEG) monitor for brain function monitoring in the operating room and other clinical settings. The acquired EEG waveforms and processed EEG variables are continuously displayed by the system for interpretation by a qualified medical professional and for use as a supplement to the anesthesia standard of care. The user interacts with the system via a touch screen interface.

The NS-901 System consists of the following main components:

Display Module (DM-901) processes acquired EEG signals, displays EEG waveforms . and processed EEG variables, and archives them for later review
EEG Module (EM-901)
1. acquires analog EEG signals through the integrated Patient Cable connected to electrodes on a patient's forehead,
1. converts acquired analog EEG signals into digital EEG signals, and
1. sends the digital EEG signals to the Display Module through the integrated Data Cable
EasyPrep Sensor Kit (EK-901) Noninvasive, disposable, single-use patient electrodes ● for acquiring the EEG signal

The NeuroSENSE Monitoring System displays EEG waveforms and the following EEG processed variables and plots for each EEG channel:

Wavelet-based Anesthetic Value for Central Nervous System (WAVCNS) ●
. Electromyogram (EMG)
Suppression Ratio (SR) ●
Spectral parameters: Density Spectral Array (DSA), Median Edge Frequency (MEF), ● Spectral Edge Frequency (SEF), and spectral powers in different EEG frequency bands

For improved reliability, the NeuroSENSE employs circuitry and algorithms for automatic detection, removal and/or filtering of physiological and environmental artifacts that commonly contaminate EEG signals. The NS-901 System also performs self-tests, automatic calibration of the amplifiers and continuous check of the electrode-skin contacts to ensure proper operation and optimal signal quality. Signal quality indicators (electrode status, 50/60 Hz noise level, artifact status) as well as system alarms, notifications and other related messages are displayed by the system. The system also provides protection for the operator and patient during cardiac defibrillation.

AI/ML Overview

The provided text describes the NeuroSENSE Monitoring System, Model NS-901, and its substantial equivalence to a predicate device. While it details several performance characteristics and the clinical study conducted, it does not explicitly state acceptance criteria in a quantitative, pass/fail manner. Instead, the performance is described in terms of "correlation," "discrimination," and "agreement" with clinical observations and the predicate device.

Given this, I will infer relevant performance measures from the text and present them as "reported device performance." I will also explicitly state when information requested is not present in the provided document.

Acceptance Criteria and Device Performance

The NeuroSENSE Monitoring System, Model NS-901, was evaluated to demonstrate its substantial equivalence to the predicate device in monitoring brain function during anesthesia. While explicit, numeric acceptance criteria are not presented in a traditional table format in the provided text, the document describes the purpose of the validation and the outcomes that supported the substantial equivalence claim.

Based on the provided information, the implicit acceptance criteria are related to the device's ability to:

Discriminate clinical endpoints related to consciousness.
Correlate with changes in anesthetic dosing.
Demonstrate an appropriate range for general anesthesia for its proprietary index (WAVCNS).
Show excellent agreement with the predicate device for a specific parameter (SR).

Acceptance Criteria (Inferred from study goals)	Reported Device Performance
WAVCNS Index: Discriminate effectively between clinical endpoints (LOS, ROC).	The WAVCNS index was shown to discriminate effectively between clinical endpoints such as loss of consciousness during propofol induction and return of consciousness during emergence from inhalational anesthesia.
WAVCNS and SR: Correlate with changes in inhalational anesthetic dosing.	Both the WAVCNS and SR were shown to correlate with changes in inhalational anesthetic dosing.
WAVCNS Index: Appropriate range for general anesthesia.	The WAVCNS range of 40 to 60 was found to be appropriate for general anesthesia.
SR: Excellent agreement with predicate device's SR calculation.	The re-processed data from the clinical trial to compare the SR parameter calculated by the subject device with that calculated by the predicate showed an excellent agreement between the two SR measures in this patient population.
Safety: No new questions of safety or effectiveness compared to predicate.	Clinical data collected in the operating room showed no adverse effects or complications. The nonclinical and clinical performance data demonstrate the subject device is as safe and effective as the predicate device. Additionally, the device complies with electromagnetic compatibility (EMC), electrical safety, and other safety standards (IEC 60601-1, 60601-2-26, 60601-1-2, 60601-1-8, 62133, etc.).
Overall: Substantial equivalence to predicate for intended use.	The study concluded that the subject device is substantially equivalent to its predicate for use as an aid in monitoring the hypnotic effect of anesthetics, as its indications for use are a subset of (narrower than and encompassed by) the predicate device's indications, and no new questions of safety or effectiveness arise.

Study Details:

Sample Size used for the Test Set and Data Provenance:
- Sample Size: 75 adult surgical patients.
- Patient Age: 18-71 years.
- Gender: 18 male / 57 female.
- ASA Classification: I-III.
- Data Provenance: The study was a "prospective clinical study." While the country of origin is not explicitly stated, the context of an FDA 510(k) submission generally implies the study adheres to U.S. regulatory standards, often conducted in the U.S. or under international standards acceptable to the FDA. The data was collected "in the operating room."
Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
- This information is not provided in the text. The ground truth ("clinical observations" and "drug information") was seemingly captured during standard clinical practice by the operating medical professional(s), but the number and specific qualifications of the adjudicating or ground truth-establishing experts are not specified.
Adjudication Method for the Test Set:
- This information is not provided in the text. The "clinical observations" and "drug information" that served as ground truth appear to be direct clinical records, but details on how these observations were adjudicated (e.g., by multiple experts, consensus, etc.) are absent.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC comparative effectiveness study was not explicitly mentioned or described. The study focused on the device's performance in relation to clinical observations and comparison to a predicate device's calculated parameter, rather than evaluating human reader improvement with or without AI assistance.
- Effect Size of Human Readers Improvement: Not applicable, as no MRMC study was described.
Standalone Performance (Algorithm-only without human-in-the-loop performance):
- Yes, in essence. The study evaluated the device's calculated indices (WAVCNS, SR) against clinical observations and anesthetic dosing, as well as the agreement of the device's SR calculation with that of the predicate. The device generates these values automatically. While the interpretation of the NeuroSENSE Monitor's output and its use as an aid is "under the direction and interpretation of a qualified medical professional," the performance evaluation described (e.g., discrimination of endpoints, correlation with dosing, agreement of SR) refers to the algorithmic output's accuracy and utility.
Type of Ground Truth Used:
- The ground truth relied on clinical observations (e.g., loss of consciousness (LOC) and return of consciousness (ROC)) and drug information (anesthetic dosing). Comparison for SR was against the SR calculated by a predicate device. This implies a form of clinical outcome/physiological measurement-based ground truth, observed by medical professionals during actual procedures.
Sample Size for the Training Set:
- This information is not provided in the text. The document describes the "validation" study as a "prospective clinical study in 75 adult surgical patients." It does not specify whether this dataset was used for training, testing, or exclusively for validation, nor does it mention the size of a separate training set if applicable. The focus of this 510(k) is on the validation data that supports substantial equivalence.
How Ground Truth for the Training Set Was Established:
- This information is not provided in the text, as details on a distinct training set are absent. If part of the 75-patient dataset was used for training (which is unlikely for a validation study unless it was a hold-out set for final performance evaluation), the ground truth would have been established via clinical observations and drug information as described for the evaluation.

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

August 5, 2021

NeuroWave Systems Inc. Tatjana Zikov President 2490 Lee Blvd. Ste 300 Cleveland Heights, Ohio 44118

Re: K202621

Trade/Device Name: NeuroSENSE Monitoring System, Model NS-901 Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: OLW, OMC, ORT, OLT, GXY Dated: July 8, 2021 Received: July 9, 2021

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. 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/cdrl/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.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 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.

Todd Courtnev Assistant Director DHT1C: Division of ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory. ENT and Dental 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) K202621

Device Name NeuroSENSE Monitoring System, Model NS-901

Indications for Use (Describe)

The WAVcns Index, a quantifier of EEG activity calculated and displayed by the NeuroSENSE NS-901 Monitor, may be used as an aid in monitoring the hypnotic effect of anesthetics include inhaled anesthetics and propofol in combination with opioids.

The NeuroSENSE Monitor is intended to be used under the direction and interpretation of a qualified medical professional.

Type of Use (Select one or both, as applicable)
-------------------------------------------------

|X Prescription Use (Part 21 CFR 801 Subpart D)

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

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K202621

Image /page/3/Picture/1 description: The image shows the logo for NeuroWave. The logo consists of a blue wave-like symbol on the left, followed by the word "NeuroWave" in a bold, purple font. Below the word "NeuroWave" is the tagline "HARNESSING THE POWER OF EEG". The text "Page 1 of 7" is located in the upper right corner of the image.

5. 510(K) SUMMARY

Company Name:	NeuroWave Systems Inc.25825 Park Science Dr, Ste 250Beachwood, OH 44122(216) 361-1591
Contact:	Tatjana Zikov,President
Phone:Fax No:	(216) 472-6337(216) 361-1554
Date:	August 4, 2021

5.1 Device Name

Trade Name:	NeuroSENSE Monitoring System, Model NS-90
Common/Usual Name:	EEG Monitor
Classification Name:	Electroencephalograph
Regulation Number:	21 CFR 882.1400
Product Code:	OLW
Subsequent Product Codes:	OMC, OLT, ORT, GXY
Device Class:	Class II

5.2 Predicate Device

510(k) Number:	K072286
Manufacturer:	Aspect Medical Systems Inc.
Trade Name:	BIS EEG VISTA MONITOR SYSTEM

5.3 Description of Device

The NS-901 System consists of the following main components:

Display Module (DM-901) processes acquired EEG signals, displays EEG waveforms . and processed EEG variables, and archives them for later review
EEG Module (EM-901) ●

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1. acquires analog EEG signals through the integrated Patient Cable connected to electrodes on a patient's forehead,
1. converts acquired analog EEG signals into digital EEG signals, and
1. sends the digital EEG signals to the Display Module through the integrated Data Cable
EasyPrep Sensor Kit (EK-901) Noninvasive, disposable, single-use patient electrodes ● for acquiring the EEG signal

The NeuroSENSE Monitoring System displays EEG waveforms and the following EEG processed variables and plots for each EEG channel:

Wavelet-based Anesthetic Value for Central Nervous System (WAVCNS) ●
. Electromyogram (EMG)
Suppression Ratio (SR) ●
Spectral parameters: Density Spectral Array (DSA), Median Edge Frequency (MEF), ● Spectral Edge Frequency (SEF), and spectral powers in different EEG frequency bands

5.4 Performance Characteristics of the Device

The device specifications are shown in the table below:

Characteristic	Specification
NeuroSENSE System (NS-901)
Safety/EMC	IEC 60601-1 & IEC 60601-2-26 / IEC 60601-1-2
Operating Conditions
Temperature	10°C to 40°C;
Humidity	30 to 75% RH;
Pressure	70 to 106 kPa
Storage Conditions
Temperature
Without batteries installed	-10°C to 60°C;
With batteries installed	0°C to 40°C;
Humidity	15 to 95% RH (non-condensing);
Pressure	50 to 106 kPa
Display of EEG Waveforms	Continuous display of 2 frontal, bilateral EEG channels;
	Time Scale: 1, 2, 4 or 8 s per division;
	Vertical Scale; 5, 25, 50, 100, or 250 µV per division;
	Notch Filter @ 50/60 Hz: On/Off

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Display Range [Resolution] for ProcessedEEG and Other Parameters
WAVCNS	0 to 100 [1];
EMG	20 to 80 dB [<1 dB];
SR	0 to 100% [1%];
Artifact Presence	0 to 100% [1%];
Electrode ImpedanceSEF/MEF	0 to 30 KΩ [0.1 KΩ];0 to 30 Hz [1 Hz];
DSA	Blue to red (20 to 60 dB), with respect to 0.0001 μV² [<1 dB];
Spectral Powers
Delta band (1-3 Hz)	20 to 60 dB, with respect to 0.0001 μV² [0.1 dB];
Theta band (4-7 Hz)	20 to 60 dB, with respect to 0.0001 μV² [0.1 dB];
Alpha band (8-12 Hz)	20 to 60 dB, with respect to 0.0001 μV² [0.1 dB];
First Beta band (13-19 Hz)	20 to 60 dB, with respect to 0.0001 μV² [0.1 dB];
Second Beta band (20-29 Hz)	20 to 60 dB, with respect to 0.0001 μV² [0.1 dB];
Gamma band (30-48 Hz)	20 to 60 dB, with respect to 0.0001 μV² [0.1 dB]
Display Module (DM-901)
Type	10.4" True Color High Contrast LCD with Touch Screen
Luminance	500 Max cd/m2
Viewing Angle	176°(H) / 176°(V)
IP Rating	IPX3;IPX4 - All surfaces except for the bottom surface
Weight	7.5 lb (3.4 kg) - Without batteries installed;
	8.0 lb (3.6 kg) - With 1 Smart Pack battery (SP-901) installed
	8.4 lb (3.8 kg) - With 2 Smart Pack batteries (SP-901) installed
Dimensions	11.5" x 9.75" x 3.0"
Mounting	VESA 75
Attachments	C clamp (provided) for attachment to I.V. poles or similar
Noise	40 dB (A)
Input Power Rating	100-240 V/50-60 Hz, 2A/1A
Power Consumption	26 VA
Earth Leakage Current	<5 mA
Power Supply MTBF	> 3,000,000 hrs operation at 40°C ambient
Touch Screen Lifetime	10 million activations
LCD Back Light MTBF	50,000 hrs
Audio Alarms	IEC 60601-1-8 compliant
Storage Capacity	256 GB
Mechanical Strength	Compliant with IEC 60601-1 requirements for portableequipment
Protection against electric shock	Type: Class I equipment;Degree: Not classified
Mode of Operation	Continuous
EEG Module (EM-901)
Inputs (Sensor Type)	External; pre-gelled snap electrodes
Input Channels	2 analog referential (4 leads)
Input Range	± 375 mV
High Pass Filter	0.125 Hz
Low Pass Filter	200 Hz
A/D Resolution	24 bits
Sampling Rates	896 samples/sec and per channel
DC Offset Rejection	300 mV (max)
In-band Input Impedance	>100 MΩ @ 10 Hz
Common Mode Rejection	> 110 (90) dB @ 60 Hz in isolation (direct) mode
Cross Talk	<-60 dB @ 10 Hz
Patient Isolation	5000 VDC
Patient Auxiliary Current	<10 μΑ DC / <100 μΑ AC
Patient Leakage Current	<10 μΑ
Impedance Check	On-demand & Continuous @ 165 Hz
Protection Circuitry	For the operator and patient during cardiac defibrillation;Circuitry for detection and minimization of electro-surgicalunit interference
Weight	10 oz (300 g) including cables
Size	4.75" x 2.9" x 0.75"
IP rating	IPX4
Attachments	Garment clip
Mechanical Strength	Compliant with IEC 60601-1 requirements for portableequipment
Protection against electric shock	Type: Class II equipment;Degree: Type BF
Mode of Operation	Continuous
Smart Pack Rechargeable Battery (SP-901)
Safety	IEC 62133 and UN 38.3Up to 2 (4) hr with 1 (2) Smart Packs SP-901 installed
Capacity (Standard Charge/Discharge)	6.0 Ah (44.4 Wh)
Nominal Voltage (Average for StandardCharge)	7.4 V
Standard Charge
Constant Current	3000 mA;
Constant Voltage	8.4 V;
End Condition (Cut Off)	100 mA
Fast Charge	3800 ± 200 mA
Maximum Charge Voltage	8.4 ± 0.5 V
Maximum Charge Current	3800 ± 200 mA
Standard Discharge
Constant Current	4500 mA;
End Voltage (Cut Off)	5.2 V
Fast Discharge	5000 ± 250 mA
Maximum Discharge Current	5000 ± 250 mA
Weight	7.4 oz (210 g)
Operating Temperature
Charge	10°C to 45°C;
Discharge	0°C to 65°C

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ર્ડ Intended Use / Indications for Use

The proposed intended use / indications for use of NeuroSENSE NS-901 Monitor are as follows:

"The NeuroSENSE Monitoring System, Model NS-901, is intended for monitoring the brain state of adult and pediatric patients (18 years of age and older) in the operating room and other clinical settings by acquiring electroencephalographic (EEG) signals.

The indications for use of the subject device are a subset of (narrower than and encompassed by) the predicate device's indications and therefore fall within the same intended use as that of the predicate. Thus, no new questions of safety or effectiveness arise for the subject device when used as labeled.

5.6 Technological Characteristics

5.6.1 Theory of Operation

System, Model NS-901, is a reduced-montage The NeuroSENSE Monitoring electroencephalographic (EEG) device. Electroencephalographs are used by medical professionals to view and record the electrical activity of the brain to obtain insight into the patient's brain state or function.

The brain is the end-target organ of anesthetic drugs. Most general anesthetics produce dosedependent suppression of neuronal activity within the Central Nervous System (CNS), and consequently alter EEG activity in a dose-dependent manner. The NeuroSENSE System continuously calculates a proprietary processed EEG variable, referred to as WAV cys (Waveletbased Anesthetic Value for CNS), which relates to the hypnotic effect of anesthetic drugs on the patient's brain. The WAVCNs quantifies the level of patient's brain activity using wavelet analysis of the gamma frequency band of the normalized EEG signal and has been shown to correlate with changes in anesthetic drug dosing in adult patients.

The NeuroSENSE System continuously displays for each brain hemisphere the acquired EEG waveforms and related processed EEG variables including the WAVCNS, for interpretation by a clinician and for use as a supplement to the anesthesia standard of care.

5.6.2 Summary of Technological Characteristics of Subject Device Compared to Predicate Device

The subject device, NeuroSENSE Monitoring System, Model NS-901 and the predicate device, BIS VISTA Monitor System (K072286), have the following key similarities:

a) Both systems are reduced-montage EEG monitors.
b) Both systems display real-time EEG waveforms and processed EEG parameters on a touchscreen monitor, which also provides a graphical user interface.

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c) Both systems include a separate analog-to-digital converter module that acquires EEG signals and contains patient electrical isolation.
d) Both systems use single-patient use EEG electrodes placed on the patient's forehead to acquire fronto-frontotemporal EEG signals.
e) Both systems calculate and display an EEG-based proprietary index with a scale of 0 to 100 for use as an aid in monitoring the hypnotic effect of anesthetics on the brain of adult patients. An appropriate range for general anesthesia for both indexes is 40-60.
Both systems are capable of bilateral brain monitoring: bilateral EEG signals are acquired f) and displayed for each brain hemisphere, and further used for calculation and display of bilateral proprietary indexes, one per brain hemisphere.

The NeuroSENSE is different from the predicate device in the following ways:

a) The indications for use of the subject device are a subset of (narrower than and encompassed by) the predicate device's indications and fall within the same intended use as that of the predicate. Thus, no new or different questions of safety or effectiveness arise for the subject device when used as labeled.
There are some differences in weight, dimensions, battery backup life and environmental b) requirements between the two systems with no impact on safety or effectiveness since all the requirements for the subject device are adequate for its intended use.
The duration of the processed EEG epoch is 1 second for the NeuroSENSE, while the c) predicate device uses a 2-second epoch. This difference does not impact safety or effectiveness since the calculations of EEG parameters and their display by the NeuroSENSE are being updated as often as that of the predicate.
d) There is a difference in signal processing technology used by the subject device when compared to the predicate device (wavelets vs. bispectral analysis), which may lead to differences in the proprietary indexes of the two devices. Clinical and other data provided in this submission support substantial equivalence of the subject device's index for its intended use.

5.7 Nonclinical Performance Data

The following is a list of the non-clinical testing that was completed.

Electrical, Mechanical and Environmental Safety Testing per IEC 60601-1
Electrical Safety and Essential Performance Testing per IEC 80601-2-26
EMC Testing per IEC 60601-1-2 ●
Alarm Evaluation per IEC 60601-1-8
Usability Evaluation per IEC 60601-1-6 and IEC 62366-1:2015 ●
Software Verification and Validation per FDA Software Guidance
Risk Assessment per ISO 14971
Battery Safety Testing per IEC 62133
. bench testing for performance evaluation included: amplifier noise In-house level, common mode rejection, DC offset, input impedance, frequency response, linearity、 and crosstalk: impedance measurement accuracy; lead disconnection; electro-surgical unit (ESU) detection; capacitive coupling; patient electrical isolation, and water ingress protection.

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The results demonstrate that all requirements and performance specifications were met and that the subject device, like the predicate device, complies with the requirements for electro-encephalographic medical devices and is as safe and effective for brain function monitoring in clinical settings, thus supporting a substantial equivalence determination between the subject device and the predicate.

Clinical Performance Data 5.8

Validation of the subject device was performed in a prospective clinical study in 75 adult surgical patients (age: 18-71 years, male/female: 18/57. ASA: I-III). The proprietary WAVexs index was assessed against clinical observations and was shown to discriminate effectively between clinical endpoints such as loss of consciousness during propofol induction and return of consciousness during emergence from inhalational anesthesia. Both the SR were shown to correlate with changes in inhalational anesthetic WAVCNS and dosing. Also, the WAVCNs range of 40 to 60 was found to be appropriate for general anesthesia. The clinical data was collected in the operating room and no adverse effects or complications were observed. Clinical data used for the analysis included EEG WAVCNs index, index, SR, drug information and clinical observations. The signals. data from this trial was further re-processed to compare the SR parameter calculated by the subject device with that calculated by the predicate. The results showed an excellent agreement between the two SR measures in this patient population.

Clinical testing demonstrates that the subject device can be used as safely and as effectively as the predicate device to monitor the hypnotic effect of anesthetic drugs. The data thus support a substantial equivalence determination between the subject device and the predicate for use as an aid in monitoring the hypnotic effect of anesthetics.

5.9 Conclusion

Although there are some differences between the subject device and the predicate, the nonclinical and clinical performance data provided in this 510(k) submission demonstrate that the subject device is as safe and as effective in monitoring brain function and the hypnotic effect of anesthetics in clinical settings. The subject device is therefore substantially equivalent to its predicate.

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).