The VEEGix EEG System, is intended to be used for measuring and recording the electrical activity of a patient's brain, obtained by placing electrodes on the forehead and wirelessly transmitting the electroencephalographic (EEG) signals for storage and display.

The VEEGix EEG System, is intended for use in the acquisition of EEG signals, displaying them in real time and storing them for later review and analysis.

The VEEGix EEG System, is intended for use in a hospital Operating Room. Post Anesthesia Care Unit, Intensive Care Unit, Emergency Department, or in other medical facilities such as inpatient and outpatient (ambulatory) surgery settings.

The VEEGix EEG System is indicated for use on patients 18 years of age or older and is to be used by licensed medical professionals who have been adequately trained in the use and interpretation of EEG data for determination of brain state.

The VEEGix EEG System does not provide any diagnostic conclusion about the patient's condition.

The VEEGix EEG System is not to be used as a stand-alone in the evaluation or diagnosis of a disease or other condition.

The VEEGix EEG System is not intended for use in life support systems.

Device Description

The VEEGix™ EEG system (subject device) is a Electrocochleographic (EEG) device to allow healthcare practitioners, nurses, neurologists and qualified technicians working in hospital Operating Room, Post Anesthesia Care Unit, Intensive Care Unit, Emergency Department, or in other medical facilities such as inpatient and outpatient (ambulatory) surgery settings to observe a patient's EEG signals and its derivatives.

The use of the subject device is a straight-forward procedure of applying the VEEGix Electrode, which is a lightweight band, onto the patient's scalp in which the electrodes acquire the patient's EEG signals. Those signals are transmitted via the VEEGix EEG module) to the VEEGix iOS app (application) which display the patient's EEG measurements in real-time to allow healthcare practitioners, nurses, neurologists and qualified technicians to monitor and record those EEG measurements.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study details for the VEEGix EEG System, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly list a table of quantitative acceptance criteria with corresponding performance values for the software component of the device. Instead, the "Technology Comparison" table highlights specific technical characteristics where the VEEGix EEG System aligns with or exceeds its predicates, implying these are the implicit acceptance criteria for technical equivalence. The clinical performance section describes the methodology used to demonstrate comparable EEG signal quality to a conventional clinical EEG system, which serves as the overarching performance goal.

Implicit Acceptance Criteria and Reported Device Performance (based on "Technology Comparison" and "Clinical Performance Testing" sections):

Acceptance Criteria (Implied)	Reported Device Performance (VEEGix EEG System)	Reference/Context
Technical Equivalence
Classification Regulation	Class II per 882.1400	Same as primary predicate
Product Code(s)	OLT, OMC, ORT, GXY	Same as primary predicate
Indications for Use	Subset of primary, same as secondary predicate	No new safety/effectiveness questions
Modalities	EEG	Same as predicates
Environment of Use	Hospital OR, PACU, ICU, ED, inpatient/outpatient surgery settings	Same as primary predicate, included in secondary
Number of EEG Channels	1 bipolar	Same as secondary predicate, substantially equivalent to primary
Number of Electrodes	3 (Fp1, Fpz, Fp2)	Same as secondary predicate, substantially equivalent to primary
Sensing Electrodes	Silver, disposable	Substantially equivalent
Power Source	Battery	Same as predicates
System Components	Electrode Array, Sensor module, acquisition, Tablet for memory and data viewing	Same as primary predicate, similar to secondary
Screen Display Details	Raw EEG Waveforms; Signal Quality (Channel Connection, Artifact, Noise, Interference); Spectral Parameters (EEG power spectrum, SEF 95%, DSA, α, Β, δ, θ, γ)	Substantially equivalent to primary (missing 10/20 Hz markers, B band division not raising new questions), secondary display capabilities included
Storage for offline recording	Yes, in the tablet display	Same as primary predicate
Electrode Impedance	Yes	Same as primary predicate
Detection for Leads Off	Yes	Same as predicates
File output capability	Yes	Same as predicates
Real-time EEG Display	Yes, wireless to tablet	Same as predicates
Processed EEG Bandwidth	0.5 Hz to 80 Hz	Substantially equivalent as primary predicate (0.5 Hz to 45 Hz)
Automatic Artifact Identification	Yes	Same as primary predicate
Common Mode Rejection	> 100 dB	Substantially equivalent as primary predicate (> 90 dB)
Amplifier Input Impedance	200 GΩ	Substantially equivalent as primary predicate (> 500 M Ohm)
Electrode Impedance Test	Yes	Same as primary predicate
Patient Contains Isolation	Reinforced Insulation (2 MOPP), battery powered	Substantially equivalent as primary predicate
Event Markers	Yes, artifact detection	Same as primary predicate
Burst Suppression Display	Yes, Suppression Ratio (%)	Substantially equivalent as primary predicate (Burst Suppression Probability)
Display Interface	Tablet display indicates connection and operation	Same as primary predicate
Biocompatibility	Tested per ISO 10993 (cytotoxicity, irritation, sensitization)	Substantially equivalent
Clinical Performance
Comparable EEG signal quality to conventional clinical EEG systems	Pearson's correlation coefficient (r=0.84, p<0.0001) between time-aligned NS and N1 waveforms. Substantial overlap visually.	Bench testing in ICU setting

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

The document states: "Bench testing was performed in hospital to compare the quality and medical EEG feature similarity of electroencephalography (EEG) signals obtained by the NeuroServo (NS) device and those recorded with a conventional clinical EEG system (N1) (NicoletOne, Natus Medical Inc., Pleasanton, CA) in an ICU setting."

Sample Size for Test Set: Not explicitly stated as a number of patients or recordings. The description focuses on signal processing and comparison, implying data was collected from one or more patients, but a specific count is missing.
Data Provenance:
- Country of Origin: Not explicitly stated, but the study was performed "in hospital" in an "ICU setting," suggesting prospective data collection.
- Retrospective or Prospective: Prospective, as the testing was described as being "performed in hospital" to compare signals.

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

The document mentions "experts" in the context of "10-second epochs as this is a common temporal range used by experts for the offline or online visualization of data." However, it does not state the number of experts used to establish the ground truth for the test set, nor their specific qualifications. The comparison was primarily quantitative (Pearson's correlation) and visual ("substantial overlap between the waveforms").

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

No explicit adjudication method (e.g., 2+1 or 3+1 for clinical consensus on ground truth) is mentioned for the test set. The comparison relies on a quantitative statistical measure (Pearson's correlation coefficient) and visual assessment of waveform overlap against a predicate device.

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

No multi-reader multi-case (MRMC) comparative effectiveness study involving human readers or AI assistance effect size is reported. The VEEGix EEG System "does not provide any diagnostic conclusion about the patient's condition" and "is not to be used as a stand-alone in the evaluation or diagnosis of a disease or other condition." Its purpose is to measure, record, and display EEG signals for interpretation by licensed medical professionals.

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

The clinical performance test described is a standalone (algorithm only) performance evaluation, although it's comparing the VEEGix system's signal acquisition and processing directly against a predicate system. The study quantified the similarity of EEG signals obtained by the VEEGix system with a conventional clinical EEG system (NicoletOne, N1) using Pearson's correlation coefficient. The output of the VEEGix system (processed EEG signals) was directly compared to the output of the N1 system.

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

The "ground truth" for the clinical performance testing was the EEG signals obtained from a "conventional clinical EEG system (NicoletOne, Natus Medical Inc., Pleasanton, CA)". This predicate device's output served as the reference standard against which the VEEGix device's signal quality was compared.

8. The sample size for the training set

The document does not provide any information regarding a training set sample size. The VEEGix EEG System appears to be a signal acquisition and display system without explicit mention of deep learning or AI models that would require a dedicated training set in the conventional sense. The "Automatic Artifact Identification" feature might implicitly involve some learned algorithms, but no details on training data are provided.

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

As no training set is mentioned or detailed, there is no information provided on how ground truth for a training set was established.

Summary

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August 23, 2024

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, 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.

NeuroServo Inc. Nicolas Tremblay CEO 2065 Parthenais. Suite 416 Montreal, QC H2K3T1 Canada

Re: K240593

Trade/Device Name: VEEGix EEG System Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: OLT, OMC, ORT, GXY Dated: March 1, 2024 Received: March 1, 2024

Dear Nicolas Tremblay:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

Patrick Antkowiak -S for

Jay Gupta Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional, and

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Center for Devices and Radiological Health

Enclosure

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Indications for Use

Submission Number (if known)

K240593

Device Name

VEEGix EEG System

Indications for Use (Describe)

The VEEGix EEG System, is intended for use in the acquisition of EEG signals, displaying them in real time and storing them for later review and analysis.

The VEEGix EEG System does not provide any diagnostic conclusion about the patient's condition.

The VEEGix EEG System is not to be used as a stand-alone in the evaluation or diagnosis of a disease or other condition.

The VEEGix EEG System is not intended for use in life support systems.

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

Prescription Use (Part 21 CFR 801 Subpart D)

The-Counter Use (21 CFR 801 Subpart C)

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Image /page/4/Picture/0 description: The image shows the logo for Neuroservo. The logo consists of a black circle with a white waveform inside. Below the circle, the word "NEUROSERVO" is written in a sans-serif font, with "NEURO" in black and "SERVO" in gray.

VEEGix™ EEG System Traditional 510(k) Summary K240593

510(k) Summary:

This summary of 510(k)-safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92

Applicant Information:

NeuroServo Inc. 2065 Parthenais Street, Suite 416 Montréal, Québec Canada H2K 3T1

Contact Information:

Nicolas Tremblay CEO Telephone: +1 514 536-0250 E-mail: ntremblay@neuroservo.com

Date Prepared:

June 27, 2024, updated: August 22, 2024

Subject Device Information:

510(k) Number:	K240593 (Pre-Market)
Trade Name:	VEEGix EEG System
Manufacturer:	NeuroServo, Inc.
Classification Name:	Electroencephalograph, 21 CFR 882.1400
Device Class:	Class II
Product Code:	OLT – Sec. OMC, ORT, GXY

Primary Predicate Device Information:

510(k) Number:	K213299
Trade Name:	Wireless EEG System
Manufacturer:	Pascall Systems, Inc.
Classification Name:	Electroencephalograph, 21 CFR 882.1400
Device Class:	Class II
Product Code:	OLT - Sec. OMC, ORT, GXY

Secondary Predicate Device Information:

510(k) Number:	K221563
Trade Name:	Neurosteer EEG Recorder
Manufacturer:	Neurosteer Inc.
Classification Name:	Electroencephalograph, 21 CFR 882.1400
Device Class:	Class II
Product Code:	OMC, GXY

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Image /page/5/Picture/0 description: The image shows the logo for Neuroservo. The logo consists of a black circle with a white waveform inside. Below the circle, the word "NEUROSERVO" is written in a sans-serif font, with the "S" in "SERVO" being slightly larger and a different shade of gray.

Device Description:

Indications for Use:

The VEEGix EEG System is intended to be used for measuring the electrical activity of a patient's brain, obtained by placing electrodes on the forehead and wirelessly transmitting the electroencephalographic (EEG) signals for storage and display.

The VEEGix EEG System is intended for use in the acquisition of EEG signals, displaying them in real time and storing them for later review and analysis.

The VEEGix EEG System is intended for use in a hospital Operating Room, Post Anesthesia Care Unit, Intensive Care Unit, Emergency Department, or in other medical facilities such as inpatient (ambulatory) surgery settings.

The VEEGix EEG System does not provide any diagnostic conclusion about the patient's condition.

The VEEGix EEG System is not to be used as a stand-alone in the evaluation or diagnosis of a disease or other condition.

The VEEGix EEG System is not intended for use in life support systems.

Summary of substantial equivalence

The primary predicate device is Wireless EEG System, manufactured by Pascall Systems, and cleared under K213299. The secondary predicate device, Neurosteer EEG Recorder System by Neurosteer Inc., cleared under K221563 is cited for the intent for use and same number of electrodes.

The indications for use of the subject device are a subset of (narrower than and encompassed by) the primary (Wireless EEG System by Pascall Systems, Inc) predicate device's indications and falls within the same intended use as that of the secondary predicate device (Neurosteer EEG Recorder). All three devices

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Image /page/6/Picture/1 description: The image shows the logo for Neuroservo. The logo consists of a black circle with a white waveform inside, above the word "NEUROSERVO" in a sans-serif font. The "NEURO" part of the word is in a darker gray than the "SERVO" part.

are intended to monitor the brain by real-time data acquisition and processing of electroencephalograph signals.

Same as for the primary predicate, the subject device is intended to be used with adult patients 18 years of age or older. Both the subject and primary predicate devices are intended to be used in a hospital Operating Room, Post Anesthesia Care Unit, Intensive Care Unit, Emergency Department, or in other medical facilities such as inpatient and outpatient (ambulatory) surgery settings.

Neither devices provide any diagnostic conclusion about the patient's condition. However, the indication for use of VEEGix EEG System explicitly prohibits the use of device in life support systems and its standalone use in the evaluation or diagnosis of diseases or other conditions.

All three devices use an electrode array and sensor/amplifier to detect and communicate the electroencephalograph signals wirelessly to a display unit that provides raw EEG waveforms and a digital spectral analysis presentation to a clinical user.

All three devices use a reduced montage of disposable EEG Electrode to archive the indication for use. The primary predicate device uses 6 electrodes. The secondary predicate device uses 3 electrodes, same as the VEEGix EEG system. This difference does not affect the indication for use and do not affect safety nor effectiveness as all three devices has been successfully tested for essential performances of Electroencephalograph as per requirements defined in clause 201.4.3.101 in the IEC 80601-2-26 Standard.

The subject and the primary predicate devices both provide signal quality indications including electrode impedance alert in the case of poor electrode contact, noise (EMG) indicator and automatic artifact detection/marker.

The Processed EEG Bandwidth, common mode rejection, and amplifier input impedance of the VEEGix EEG System is substantially equivalent to the primary predicate device since the performance of the VEEGix EEG System on these technical characteristics points is better so it does not affect the safety or effectiveness of the device.

Like primary predicate device, the subject device displays a spectrogram and indicate 95% Spectral Edge Frequency (SEF) along with the quality indicators for artifact, electrode impedance, and EMG. The primary predicate device presents markers at 10 and 20 Hz on the 0 - 30 Hz scale as aids to identify the frequency components of the spectrogram while the VEEGix EEG System does not include these markers. Those markers were provided as aids by the predicate device while the VEEGix EEG System present 2 spectrograms with different time spans to help with identifying current frequency components. The difference in these data presentations does not affect safety and effectiveness as both of these devices provide an equivalent way to display frequency component.

Both the subject device and the primary predicate device display a presentation of burst suppression. The primary predicate device displays burst suppression probability that suppression varies smoothly in time and measures only those frequencies that are within a certain range. The VEEGix EEG System displays suppression ratio in % which is in accordance with the definition of the 2021 definition of the American Clinical Neurophysiology Society. These differences are not significant and do not affect safety and efficacy as both devices present a means of determining suppression percentage.

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Image /page/7/Picture/0 description: The image contains the logo for Neuroservo. The logo consists of a black circle with a white waveform inside, above the word "NEUROSERVO" in a sans-serif font. The "NEURO" part of the word is in a darker gray than the "SERVO" part.

Overall, all the three devices display additional tools for the medical professional. Those additional tools are aimed to help the medical professional in their overall appreciation of patient brain state. The primary predicate device adds a phase-amplitude modulogram who is a color-intensity display that promoted to help visualize the relationship between the amplitude of the high- frequency components of the EEG and the phase of the low-frequency components in the EEG signal. The VEEGix EEG System, on its side, incorporates an amplitude-integrated EEG, which have undergone bench testing against gold standards for the purpose. The differences in additional tools do not affect the indication for use or the safety and effectiveness of the subject device.

The skin-contacting components of all the three devices underwent evaluation according to the requirements outlined in ISO 10993 standards for cytotoxicity, skin irritation, and skin sensitization.

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Image /page/8/Picture/0 description: The image contains the logo for Neuroservo. The logo consists of a black circle with a white waveform inside, above the word "NEUROSERVO" in a sans-serif font. The waveform appears to represent brain activity or neural signals.

Technology Comparison:

Attributes	Primary Predicate	Secondary Predicate	Subject Device	Comments
	Pascall Systems, Inc. Wireless EEG System (K213299)	Neurosteer EEG Recorder (K221563)	VEEGix EEG System
ClassificationRegulation	Class II per 882.1400	Class II per 882.1400	Class II per 882.1400	Same as primary predicate
Product Code(s)	OLT, OMC, ORT, GXY	OMC, GXY	OLT, OMC, ORT, GXY	Same as primary predicate
Indications for Use	The Pascall Systems, Inc. Wireless EEGSystem, is intended to be used formeasuring and recording the electricalactivity of a patient's brain, obtained byplacing electrodes on the forehead andwirelessly transmitting theelectroencephalographic (EEG) signals forstorage and display.The Pascall Systems, Inc. Wireless EEGSystem, is intended for use in theacquisition of EEG signals, displaying themin real time and storing them for later reviewand analysis.The Pascall Systems, Inc. Wireless EEGSystem, is intended for use in a hospitalOperating Room, Post Anesthesia CareUnit, Intensive Care Unit, EmergencyDepartment, or in other medical facilitiessuch as inpatient and outpatient(ambulatory) surgery settings.The Pascall Systems, Inc. Wireless EEGSystem is indicated for use on patients 18years of age or older and is to be used bylicensed medical professionals that havebeen adequately trained in the use andinterpretation of raw EEG data fordetermination of brain state duringanesthesia.The Pascall Systems, Inc. Wireless EEGSystem does not provide any diagnosticconclusion about the patient's condition.	The Neurosteer EEG Recorder isintended to record and store EEGsignals, and to present the EEGsignals in visual formats in real time.The visual signals assist trainedmedical staff to make neurologicaldiagnoses. The EEG Recorder doesnot provide any diagnostic conclusionabout the subject's condition anddoes not provide any automatedalerts of an adverse clinical event.The EEG Recorder is intended to beused in a professional healthcarefacility environment	The VEEGix EEG System, is intendedto be used for measuring and recordingthe electrical activity of a patient'sbrain, obtained by placing electrodeson the forehead and wirelesslytransmitting theelectroencephalographic (EEG) signalsfor storage and display.The VEEGix EEG System is intendedfor use in the acquisition of EEGsignals, displaying them in real timeand storing them for later review andanalysis.The VEEGix EEG System, is intendedfor use in a hospital Operating Room,Post Anesthesia Care Unit, IntensiveCare Unit, Emergency Department, orin other medical facilities such asinpatient and outpatient (ambulatory)surgery settings.The VEEGix EEG System is indicatedfor use on patients 18 years of age orolder and is to be used by licensedmedical professionals that have beenadequately trained in the use andinterpretation of EEG data fordetermination of brain state.The VEEGix EEG System does notprovide any diagnostic conclusionabout the patient's condition.The VEEGix EEG System is not to beused as a stand-alone in the evaluation	The indications for use ofthe subject device are asubset of (narrower thanand encompassed by) theprimary predicate device'sindications and falls withinthe same intended use asthat of the secondarypredicate. Thus, no new ordifferent questions ofsafety or effectivenessarise for the subject devicewhen used as labelled.
			or diagnosis of a disease or othercondition.The VEEGix EEG System is notintended for use in life support systems.
Modalities	EEG	EEG	EEG	Same
Environment of Use	Operating Room, Post Anesthesia CareUnit, Intensive Care Unit, EmergencyDepartment, or in other medical facilitiessuch as inpatient and outpatient(ambulatory) surgery settings	Professional healthcare facilityenvironment settings	Operating Room, Post AnesthesiaCare Unit, Intensive Care Unit,Emergency Department, or in othermedical facilities such as inpatient andoutpatient (ambulatory) surgerysettings	Same as primary predicateand included in theenvironment of thesecondary predicate
Number of EEGchannels	4 (2 frontotemporal channels, and2 temporal channels)	1 bipolar	1 bipolar	Same as the secondarypredicate and substantiallyequivalent as the primarypredicate
Number ofelectrodes	6 (4 measurement, 1 reference, 1 ground),single use	3 (Locations: Fp1, Fpz, Fp2)	3 (Locations: Fp1, Fpz, Fp2)	Same as the secondarypredicate and substantiallyequivalent as the primarypredicate
Sensing Electrodes	Silver/Silver chloride, disposable	Silver/Silver chloride, disposable	Silver, disposable	Substantially equivalent
Power Source	Battery	Battery	Battery	Same
System Components	Electrode Array (disposable patch), Sensormodule, acquisition, Tablet for memory anddata viewing	Electrode Array (disposable patch),Sensor module, acquisition, Tabletfor data viewing, and cloud platformfor data storage	Electrode Array (disposable patch),Sensor module, acquisition, Tablet formemory and data viewing	Same as primary predicateand similar as thesecondary predicate
ScreenDisplayDetails	• 4 Raw EEG Waveforms• Signal Quality information:Channel Connection flags, Impedancevalues(electrode contact signal strength),Artifact (ART),Noise Level (EMG)• Spectral Parameters: EEG powerspectrum and frequency bands including:Two horizontal lines at 10 and 20 Hzprovided as an aid to help identify thefrequency components of the spectrogram,SEF 95% Power spectrum displayed asDensity Spectral Array (DSA) SpectralPowers in EEG frequency bandstraditionally used to quantify EEG signals(α, β1, β2, δ, θ and γ)	• Raw EEG Waveforms• Spectrogram• Metrics and bar graph views	• Raw EEG Waveforms• Signal Quality information:Channel Connection flags, Artifact(ART), Noise Level (EMG) andInterference Level• Spectral Parameters: EEG powerspectrum and SEF 95%. Powerspectrum displayed as DensitySpectral Array (DSA) Spectral Powersin EEG frequency bands traditionallyused to quantify EEG signals (α, Β, δ, θand γ)	Substantially equivalent tothe primary predicate, themissing two horizontallines at 10 and 20 Hz in thesubject device, whichserve as aids to identify thefrequency components ofthe spectrogram anddivision of B Band into β1and β2, does not raise anynew questions of safety oreffectiveness.Secondary predicatedisplay capabilitiesincluded in the subjectdevice.

Storage for offlinerecording	Yes, in the tablet display	Cloud storage	Yes, in the tablet display	Same as primary predicate
ElectrodeImpedance	Yes	Unknown	Yes	Same as primary predicate
Detection for LeadsOff	Yes	Yes	Yes	Same
File output capability	Yes	Yes	Yes	Same
Realtime EEGDisplay	Yes, wireless to tablet	Yes, wireless	Yes, wireless to tablet	Same
Processed EEGBandwidth	0.5 Hz to 45 Hz	Unknown	0.5 Hz to 80 Hz	Substantially equivalent asprimary predicate
Automatic ArtifactIdentification	Yes	Unknown	Yes	Same as primary predicate
Common ModeRejection	> 90 dB	Unknown	> 100 dB	Substantially equivalent asprimary predicate
Amplifier InputImpedance	> 500 M Ohm	Unknown	200 GΩ	Substantially equivalent asprimary predicate
ElectrodeImpedance Test	Yes	Unknown	Yes	Same as primary predicate
PatientContainsIsolation	Battery powered, thus no connectionbetween patients and mains power	Battery powered, thus no connectionbetween patients and mains power	Yes, the subject device has beendesigned with reinforced Insulation (2MOPP) and this isolation has beenvalidated by external agency testing.The subject device is battery poweredand can also be used while charging.	Substantially equivalent asprimary predicate
Event Markers	Yes, artifact detection	Unknown	Yes, artifact detection	Same as primary predicate
BurstSuppressionDisplay	Yes, Burst Suppression Probability	N/A	Yes, Suppression Ratio (%)	Substantially equivalent asprimary predicate
Display Interface	Tablet display indicates connection andoperation	Portable display monitor	Tablet display indicates connection andoperation.	Same as primary predicate
Biocompatibility	The Electrode Array patient contactmaterials have been tested and passed thetests per ISO 10993 for cytotoxicity, primaryskin irritation and sensitization as requiredfor patient contact < 24 hours duration.	The Electrode Strip was assessed inaccordance with ISO 10993-1and was tested in its final finishedform for the following endpoints:- Cytotoxicity (ISO MEM elutionmethod per ISO 10993-5:2009);- Irritation (rabbit irritation test per ISO10993-10:2010);- Sensitization (guinea pigmaximization per ISO 10993-	The Electrode Array patient contactmaterials have been tested per ISO10993 for cytotoxicity, primary skinirritation and sensitization as requiredfor patient contact < 24 hours duration.	Substantially equivalent

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Image /page/9/Picture/0 description: The image shows the logo for Neuroservo. The logo consists of a black circle with a white waveform inside, above the word "NEUROSERVO" in a sans-serif font. The word "NEURO" is in bold, while "SERVO" is in a lighter weight font.

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Image /page/10/Picture/0 description: The image shows the logo for Neuroservo. The logo consists of a black circle with a white waveform pattern inside. Below the circle, the word "NEUROSERVO" is written in a sans-serif font, with "NEURO" in a darker shade and "SERVO" in a lighter shade.

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Image /page/11/Picture/1 description: The image contains the logo for Neuroservo. The logo consists of a black circle with a white waveform inside, above the word "NEURO" in black and "SERVO" in gray. The waveform appears to be a stylized representation of brain activity or neural signals.

Each line from the above Technological Comparison table, the subject device has demonstrated substantially equivalent performance in comparison to the predicate device.

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Image /page/12/Picture/1 description: The image contains the logo for Neuroservo. The logo consists of a black circle with a white waveform pattern inside. Below the circle, the word "NEUROSERVO" is written in a sans-serif font, with "NEURO" in black and "SERVO" in a lighter color.

Performance Testing Summary

Tests were performed and verified with the VEEGix™ EEG system in accordance with performance standards for EGG devices for the environment use and the subject device's indications of use and those of the predicate device. Those test methods along with the verification results are detailed in the following table.

Non-clinical performance testing

Medical devices, Electrical Safety, Electromagnetic:

Applicable standards were used:

. 13485:2016 MDSAP Medical devices - Quality Management Systems - Requirements for regulatory purposes
. ANSI AAMI ES60601-1: Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance (IEC 60601-1:2005, MOD) (Consolidated Text) (Includes ANSI/AAMI ES60601-1:2005/(R)2012 And A1:2012, C1:2009/(R)2012 And A2:2010/(R)2012)
ANSI AAMI IEC 60601-1-2:2014 - Risk Management of Medical Electrical Equipment Package
IEC 80601-2-26:2019 Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs
. IEC 62133-2 Edition1.0 2017-02 Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells and for batteries made from them for use in portable applications - Part 2: Lithium systems
IEC 60529 Edition 2.2 2013-08 DEGREES OF PROTECTION PROVIDED BY ENCLOSURES (IP Code)
ANSI/AAMI/IEC 60601-1-2:2014 Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Disturbances - Requirements And Tests
AMMI TIR57:2019/(R) 2023 Principles For Medical Device Security Package

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Image /page/13/Picture/0 description: The image shows the logo for Neuroservo. The logo consists of a circular icon above the word "NEUROSERVO". The icon contains a stylized waveform pattern. The word "NEUROSERVO" is written in a sans-serif font, with "SERVO" in a lighter shade of gray.

Wireless Coexistence:

Applicable standards were used:

. AAMI TIR69:2017/(R)2020 Risk management of radio-frequency wireless coexistence for medical devices and systems
. IEEE ANSI USEMCSC C63.27-2021 American National Standard for Evaluation of Wireless Coexistence
. IEC 80001-1:2021 Application Of Risk Management For IT-Networks Incorporating Medical Devices - Part 1: Safety, Effectiveness And Security In The Implementation And Use Of Connected Medical Devices Or Connected Health Software

Verifications includes that wireless connectivity between the VEEGix module and the VEEGix iOS app as to support a continuous feed of EEG signals as to maintain a stable connectivity without loss of the EEG signal for a period of a 7 days.

Shelf Life:

The electrode component has a shelf life of 2 years. This is based on the shelf life of the tape adhesive manufacturer and the conductive fabric characteristic.

Whereas the rest of the subject device, excluding the electrode component, has a shelf life of 5 years. This is based on the following:

MTBF Analysis for components involved in essential performance and safety.
Enclosure IP67 Rating.
Quality and intended use of the internal battery.
Gold contact plating for all connections in the system.

Reference: "Estimated Useful Lives of Depreciable Hospital Assets," American Hospital Association

Biocompatibility:

Applicable standards were used:

. ISO 10993-1 Fifth edition 2018-08 Biological Evaluation Of Medical Devices - Part 1: Evaluation And Testing Within A Risk Management Process (ISO 10993-1:2018, Including Corrected Version 2018-10)
ISO 10993-5 Third edition 2009-06-01 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
ISO 10993-23 First edition 2021-01 Biological Evaluation Of Medical Devices Tests For Irritation
. ISO 10993-10 Fourth edition 2021-11 Biological evaluation of medical devices - Part 10: Tests for skin sensitization

Based on all the information evaluated as part of this submission, it is concluded that patient risk is negligible.

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Image /page/14/Picture/1 description: The image contains the logo for Neuroservo. The logo features a black circle with a white waveform-like design inside. Below the circle, the word "NEUROSERVO" is written, with "NEURO" in black and "SERVO" in light green.

Usability/ Human Factors:

Applicable standards were used:

IEC 62366-1 Edition 1.1 2020-06 CONSOLIDATED VERSION Medical devices Part 1: Application of usability engineering to medical devices

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Image /page/15/Picture/0 description: The image shows the logo for Neuroservo. The logo consists of a black circle with a white waveform inside, resembling brainwaves or a signal. Below the circle, the word "NEUROSERVO" is written in a sans-serif font, with "NEURO" in a slightly bolder typeface than "SERVO".

Clinical performance testing

Bench testing:

Bench testing was performed in hospital to compare the quality and medical EEG feature similarity of electroencephalography (EEG) signals obtained by the NeuroServo (NS) device and those recorded with a conventional clinical EEG system (N1) (NicoletOne, Natus Medical Inc., Pleasanton, CA) in an ICU setting.

To investigate the equivalency of the EEG signals acquired by NS and N1 systems, we conducted a visual comparison of the signals in the time domain. A point-by-point comparison of the amplitude of the waveforms requires precise temporal alignment of the signals obtained from NS and N1 systems were initially sampled in 2048 and 512 samples per second, respectively. Therefore, we downsampled the NS signal by decimation with a factor of 4 to ensure a point-by-point comparison. The signal then was band-pass filtered at corner frequencies at 0.5 and notch filtered at 58-62 Hz. Next, we used the prominent artifacts present in the data to roughly align the signals in the time domain. For precise alignment, we segmented the data int nonoverlapping 10-second epochs and used the crosscorrelation function "xcorr" in MATLAB (Mathworks, Natick, MA) to find the time lag (often less than 100 ms) with the highest correlation which then was used to realign the signals in time-domain. We used 10second epochs as this is a common temporal range used by experts for the offline or online visualization of data. Next, we repeated the same process for all segments to compensate for the occasional sample drifts in the data which could occur due to independent sampling clocks. An exemplar snippet of timealigned EEG signals obtained by N1 and NS systems is shown in Fig. 1A in blue and red traces, respectively. This example demonstrates a substantial overlap between the waveforms. To quantify the similarity, we computed Pearson's correlation coefficient between the two waveforms which demonstrated a high correlation coefficient between the two waveforms (Fig. 1B; r=0.84, p<0.0001).

Image /page/15/Figure/6 description: The image contains two plots, labeled A and B. Plot A shows the Fp1-Fp2 values over time, with the x-axis representing time in seconds from 10 to 20, and the y-axis representing the Fp1-Fp2 values from -20 to 20. Two lines are plotted, one for NicoletOne in blue and one for NeuroServo in red. Plot B is a scatter plot of NeuroServo versus NicoletOne, with both axes ranging from -20 to 20, and the title is Fp1-Fp2.

Figure 1. Visual comparison of waveforms obtained by NeuroServe (N1) systems. (A) The signals were time-aligned and overlayed for visual comparison. The bottom panel demonstrates a 10-second segment is selected (grey box) and exparied in the panel above. (B) The Pearson's correlation coefficient between the time-aligned signals is r=0.84 (p<0.0001)

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Image /page/16/Picture/0 description: The image shows the logo for Neuroservo. The logo consists of a circular icon above the word "NEUROSERVO". The icon contains a stylized waveform pattern, resembling brainwaves or neural activity. The word "NEUROSERVO" is written in a sans-serif font, with "NEURO" in a darker shade than "SERVO".

Conclusions:

Based on the test results provided above, and comparison to the predicate devices characteristics, the results show that the subject device is substantially equivalent to the predicate devices.

Based on the Performance Testing table, the subject device met all predetermined acceptance criteria. The conclusion from those verifications determines that its safe and effective use for the intended population and use environments.

Based on the clinical performance testing, our findings suggest that both the NS and N1 devices exhibit comparable EEG signal quality, indicating equivalence between the EEG signals recorded by the NS and N1 devices. These results are promising, as they suggest that the decision between the NS and N1 devices may depend on factors other than their core performance differences. Considerations such as cost, ease of use, and specific features could play a significant role in selecting the most suitable monitoring system for a particular clinical context. Importantly, the NS system emerges as a potentially more cost-effective and user-friendly option compared to the traditional EEG devices, which could make it preferable in certain scenarios.

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

The minor technological differences between the subject device and its predicate devices raise no new or different questions of safety or effectiveness. Consequently, the subject device is substantially equivalent.

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).