The X-Series System is intended for prescription use in the home, healthcare facility, or clinical research environment to acquire, transmit, display and store physiological signals from patients ages 6 and older. The X-Series system requires operation by a trained technician. The X-Series System acquires, transmits, displays and stores electroencephalogram (EEG), electrooculogram (EOG), electrocardiogram (ECG), and/or electromyogram (EMG), and accelerometer signals. The X-Series System only acquires and displays physiological signals, no claims are being made for analysis of the acquired signals with respect to the accuracy, precision and reliability.

Device Description

The X-Series System is indicated for acquiring, transmitting, displaying and storing physiological data in patients. It can be used with ambulatory patients in the home, health care facility, or clinical research environment. The X-Series system requires operation by a trained technician. The X-Series System.is comprised the X10 and X24 Headsets and accessories, Synapse Cream, X-Series Basic Software and BT receiving unit. The X-Series Basic Software is also compatible with the Models X4-E, and X4-M (K130013) when used in wireless mode. The X-Series System combines hardware, firmware and software to acquire physiological signals. It acquires physiological data through a battery powered headset worn by the patient and provides a flexible platform for applying sensors using synapse cream and acquiring signals from multiple locations on the head or body, transmitting and recording the signals and providing visual indications to ensure high quality data are obtained. Model X24 provides for acquisition of twenty channels of electroencephalography (EEG) and four optional channels connected to two sensors via a dual-lead connector. Model X10 provides for acquisition of nine channels of electroencephalography (EEG) and an optional channel connected to two sensors via a dual-lead connector. Both models measure movement and position measured via a 3-D accelerometer. The device is designed so it can be affixed by a technician and displays the signals via a wireless connection during acquisition. The X-Series Basic software monitors signal quality to ensure that the sensors are properly applied and that high quality signals are being acquired. The X-Series Basic software provides a means to: a) initiate a study and track patient information, b) acquire and wirelessly transmit signals from the device, c) visually inspect the signal quality. The acquired signals are saved in a universal data format (European Data Format Plus, EDF+) that is intended to be analyzed by a Physician using FDA cleared third party software, i.e. Persyst Software (K011397).

AI/ML Overview

This document describes the X-Series System, an electroencephalograph device for acquiring, transmitting, displaying, and storing physiological data. The submission focuses on demonstrating substantial equivalence to a predicate device (K130013 X4 System) through non-clinical and limited clinical testing.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document leverages comparison to a predicate device and adherence to recognized standards as its primary acceptance criteria. Performance metrics are largely presented as being equivalent to the predicate.

Acceptance Criteria Category	Specific Criteria (from document)	Reported Device Performance (X-Series System)
Functional Equivalence	Equivalence to predicate device (X4 System) for electrophysiological (EEG, EOG, ECG, EMG), wireless acquisition, and actigraphy. Technologies used in the same manner.	EEG: Sampling Rate: 256 s/s, 0.1 Hz High Pass (hardware), 100 Hz Low Pass (hardware), Dynamic range: +/- 1000μV, Resolution 0.03 µV, Peak to peak noise: 3.7 µV (typical), 110dB Common Mode Rejection Ratio (typically), Input Impedance: 100GOhm (Equivalent to X4) Aux - EOG/EMG: Sampling rate 256 Hz, 0.1 Hz High Pass (hardware), 100 Hz Low Pass (hardware). EMG/EOG: Dynamic range: +/- 1000μV, Resolution 0.03 μV, Peak to peak noise: 3.7 μV (typical) (Equivalent to X4) Aux - ECG: Bandwidth: 0.1 to 100Hz -3dB, Notch Filters: 50, 60Hz (software), Common Mode Rejection Ratio: 110dB, Input Impedance: 100GOhm, Input Range: +/-4mV, Accuracy: 16 bits, Noise: <5μVpp (typically 4.2μVpp), Max Electrode DC Offset: +/-125mV, Dynamic range: +/- 2000μV, Resolution: 0.06 μV (Equivalent to X4) Accelerometer: Sampled 100Hz, downsampled to 10Hz; X x Y x Z @ 10 s/s, Resolution nominal 10 bit at 2g, Actual output range for -90 to 90 degrees is 12 bit. Position accuracy typically +/- 3.0 degrees, maximum +/- 5.0 degrees in the +/- 60 degrees range. Sensitivity: 10 bit / 2g, Non-linearity: +/-0.5 %FS, Cross-Axis: +/-1 %, Zero-Level: +/-0.35-0.4 mg, Sensitivity change due temperature: +/-0.01 LSB/°C (Equivalent to X4) Bench tests confirmed EEG and optional dual-lead (for ECG) analog signals were equivalent to predicate. Actigraph measures were equivalent.
Electrical Safety	Compliance with IEC 60601-2-26:2002 (Electroencephalographs) and IEC 60601-1-11: 2010 (Home healthcare environment)	All tests "passing demonstrating the compliance of the X-Series system to FDA recognized standards for electro-medical equipment."
Biocompatibility	Cytotoxicity, Sensitization, Irritation per ISO 10993 standards (for patient-contacting components).	Cytotoxicity (ISO 10993-5): No reactivity (grade 0) in all cultures. Concluded "Non-cytotoxic." Sensitization (ISO 10993-10): Irritation absent from all animals, animals gained weight, no overt toxicity, no skin reaction scores. Concluded "Non-sensitizer." Irritation (ISO 10993-10): No signs of erythema or edema at observation points. Test Primary Irritation Index (PII) was 0.0. Concluded "Non-irritant."
Cleaning & Disinfection	Acceptance criteria: ≥ log 3.0 reduction in bioburden after cleaning according to instructions, per AAMI TIR 12-94 and AAMI TIR 30: 2003.	"All tests passed and demonstrate that the cleaning methods are appropriate for ensuring the X-Series acquisition device is clean between uses."
Software Integrity	Verification and validation of specifications, function, and intended use, per FDA's Guidance for Premarket Submissions for Software Contained in Medical Devices (May 2005).	"The results of the verification and validation activities that have been performed demonstrate that the software meets requirements for safety, function, and intended use."
EEG Electrode Performance	Electrical performance acceptable, using applicable methods from AAMI/ANS1 EC12:2000 (R)2010.	"The results demonstrate electrical performance of the EEG electrodes used with the X-Series System is acceptable."
Clinical Performance (Ages 6+)	Ability to acquire appropriate EEG recordings in children aged 6-8, with equivalent data quality to adults.	100% of EEG sessions contained appropriate EEG recordings. Data quality from children was equivalent to an equivalent adult population. Technician setup was quick, and no discomfort or agitation was reported by subjects.

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

Non-clinical bench tests (EEG, ECG, Actigraph comparison): The sample size is not explicitly stated as 'n=X' but implies a sufficient number of measurements were taken from the X-Series and predicate devices to compare their performance in a jig and with an oscilloscope/signal generator.
Biocompatibility: The specific number of items/animals per test is mentioned in the results (e.g., "all the animals," "all test animals").
- Cytotoxicity: Mammalian cell cultures (mouse fibroblast L929).
- Sensitization: Albino guinea pigs.
- Irritation: New Zealand White rabbits.
Clinical tests (for ages 6+):
- Sample size: Seven children aged 6-8 and seven adults.
- Data provenance: "A subset of data from a research study was analyzed." This suggests the data was retrospective and likely collected in a clinical research environment (Country of origin not specified, but likely USA given the FDA submission).

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

Non-clinical tests: The document implies standard laboratory testing procedures and comparisons to the predicate, overseen by qualified personnel. No specific "experts" for ground truth establishment are mentioned as the tests rely on objective measurements and established standards.
Clinical tests (for ages 6+): The document states that the acquired EEG recordings "could be further examined in third-party software" by a Physician. While a physician would interpret the EEG, their role in establishing "ground truth" for the device's acquisition capabilities (the focus of this study) is not explicitly detailed. The acceptance criteria here are about the ability to acquire appropriate EEG recordings and data quality equivalence, which are evaluated directly from the device's output. The "ground truth" for this aspect is the objective quality of the signals themselves, compared between subject groups.

4. Adjudication Method for the Test Set:

No formal adjudication method (like 2+1 or 3+1) is mentioned for any of the studies.
The non-clinical tests rely on objective measurement against defined specifications or predicate device performance.
The clinical study for children's EEG acquisition focused on the presence of "appropriate EEG recordings" and data quality equivalence, which would likely be assessed by comparing signal characteristics.

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 MRMC comparative effectiveness study was done.
The X-Series System is a data acquisition device; it explicitly states, "The X-Series System only acquires and displays physiological signals, no claims are being made for analysis of the acquired signals with respect to the accuracy, precision and reliability." It is not an AI-assisted diagnostic tool.

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

Not applicable. This device is purely for data acquisition and display, to be interpreted by a physician using separate (third-party) software. There is no algorithm providing diagnostic or analytical output within the X-Series System itself.

7. The Type of Ground Truth Used:

Non-clinical/Bench tests: Objective measurements (e.g., signal generator output, oscilloscope readings, defined angles for actigraph, standard test methods for biocompatibility and cleaning). The comparison to the predicate device serves as a de facto "ground truth" for performance equivalence where applicable.
Clinical tests (for ages 6+): The "ground truth" for this specific study was the presence of "appropriate EEG recordings" and subjectively assessed "equivalent data quality" for the acquired signals between age groups. This relies on the qualitative assessment of electrical signal characteristics typically reviewed by trained professionals.

8. The Sample Size for the Training Set:

Not explicitly stated, nor is a dedicated "training set" relevant for this device. The X-Series System is a data acquisition device, not a machine learning model that requires a training set. The clinical study for ages 6+ was a validation of its acquisition capabilities, not for training an algorithm.

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

Not applicable, as no training set was used for a machine learning algorithm.

Summary

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K131383

510(k) Summary

In accordance with 21 CFR 807.92 the following summary of information is provided:

DATE: November 26, 2013

SUBMITTER:

Advanced Brain Monitoring 2237 Faraday Avenue, Suite 100 Carlsbad, CA 92008 T 760.720.0099 . F 760.720.3337

NOV 27 2013

PRIMARY CONTACT PERSON:

Adrienne Lenz, RAC Member Pathway Regulatory Consulting, LLC T 262-290-0023

SECONDARY CONTACT PERSON:

Dan Levendowski President and Co-founder Advanced Brain Monitoring, Inc.

DEVICE:

TRADE NAME: X-Series System

COMMON/USUAL NAME: X10 / X24

CLASSIFICATION NAMES: 882.1400 Electroencephalograph

PRODUCT CODE: GWQ, OMC

PREDICATE DEVICE(S):

K130013 X4 System

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DEVICE DESCRIPTION:

The X-Series System.is comprised the X10 and X24 Headsets and accessories, Synapse Cream, X-Series Basic Software and BT receiving unit. The X-Series Basic Software is also compatible with the Models X4-E, and X4-M (K130013) when used in wireless mode.

The X-Series System combines hardware, firmware and software to acquire physiological signals. It acquires physiological data through a battery powered headset worn by the patient and provides a flexible platform for applying sensors using synapse cream and acquiring signals from multiple locations on the head or body, transmitting and recording the signals and providing visual indications to ensure high quality data are obtained.

Model X24 provides for acquisition of twenty channels of electroencephalography (EEG) and four optional channels connected to two sensors via a dual-lead connector. Model X10 provides for acquisition of nine channels of electroencephalography (EEG) and an optional channel connected to two sensors via a dual-lead connector. Both models measure movement and position measured via a 3-D accelerometer. The device is designed so it can be affixed by a technician and displays the signals via a wireless connection during acquisition. The X-Series Basic software monitors signal quality to ensure that the sensors are properly applied and that high quality signals are being acquired.

The X-Series Basic software provides a means to: a) initiate a study and track patient information, b) acquire and wirelessly transmit signals from the device, c) visually inspect the signal quality.

The acquired signals are saved in a universal data format (European Data Format Plus, EDF+) that is intended to be analyzed by a Physician using FDA cleared third party software, i.e. Persyst Software (K011397).

INTENDED USE:

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TECHNOLOGY:

The X-Series System uses the same fundamental technology as the X4 System for most features including the electrophysiological (EEG, EOG, ECG, EMG, ), wireless acquisition, and actigraphy. The technologies used in the X-Series are used in the same manner as the predicate products · and do not raise new questions of safety and effectiveness.

Specification	X-Series System	X4 System (K120447)
Indications forUse	The X-Series System is intended for prescription use in the home, healthcare facility, or clinical research environment to acquire, transmit, display and store physiological signals from patients ages 6 and older. The X-Series system requires operation by a trained technician. The X-Series System acquires, transmits, displays and stores electroencephalogram (EEG), electrooculogram (EOG), electrocardiogram (ECG), and/or electromyogram (EMG), and accelerometer signals. The X-Series System only acquires and displays physiological signals, no claims are being made for analysis of the acquired signals with respect to the accuracy, precision and reliability.	The X4 System is intended for prescription use in the home, healthcare facility, or clinical research environment to acquire, record, transmit and display physiological signals from adult patients. The X4 System acquires, records, transmits and displays electroencephalogram (EEG), electrooculogram (EOG), electrocardiogram (ECG), and/or electromyogram (EMG), accelerometer, acoustical and photoplethesmographic signals. The X4 system only acquires and displays physiological signals, no claims are being made for analysis of the acquired signals with respect to the accuracy, precision and reliability
PatientPopulation	Ages 6 and older	Adults
User	Trained Technician	Trained technician or patient for recording of sleep data.
AnatomicalSites	Scalp/Chest	Forehead/Chest
Environment ofUse	Home (data acquisition)Healthcare facility (data acquisition, analysis and reporting)Clinical Research Environment	Home (data acquisition)Healthcare facility (data acquisition, and analysis.)Clinical Research

TABLE 1 COMPARISON OF X-SERIES TO PREDICATE DEVICE

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Specification	X-Series System	X4 System (K120447)
User Interface	User control, visual indicators	User control, visual and audioindicators
Accessories	EEG and ECG electrodes.	EEG and ECG electrodes.
SignalsAcquired	Scalp EEG 3-D actigraphy Optional channelsECG/EEG/EOG/EMG	Scalp EEG Infra-red (IR) optical signal Microphone 3-D actigraphy Optional channelECG/EEG/EOG/EMG
Acquisitionmodes	Monitor only	Record or Monitor
Power Supply	2 to 4 240mAH 3.7 Li-Ion batteries	1 x 600 mAH 3.7V Li-ION battery
BatteryCharging	Via JED Connector connected to USBport or USB wall charger	Via USB cable connected to USB portor USB wall charger
TypicalCharging Time	0.5-5.0 hours	0.5 - 3.0 hours
OperatingTime	Monitoring Days after Charge Hoursof Use 0-4 Days: 16 to 17 hours 5-10 Days: 14 to 15 hours	Recording Days after Charge Hoursof Use 0-4 Days: 13.0 to 15.5 hours 5-10 Days: 11.5 to 14.8 hours Monitoring Days after Charge Hoursof Use 0-4 Days: 6.5 to 7.8 hours 5-10 Days: 6.0 to 7.3 hours
Data Storage	Not used. The X-Series system doesnot include a record mode wheredata is stored on the recorder.	2 GB Micro-SD memory card
File size per 8hr recording	512 MB	72 MB
Dimensions	5.0" long, 2.25"wide, 1.0" deep	2.1" long, 1.5"wide, 0.75" deep
Weight	3.9 ounces with two batteries	2.5 ounces with battery

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Specification	X-Series System	X4 System (K120447)
Cleaning	Cleaned and disinfected by rubbingwith isopropyl alcohol.	Cleaned and disinfected by rubbingwith isopropyl alcohol.
Wireless datatransfer	Blue tooth 2.0	Blue tooth 2.0
MaximumBluetoothwirelesstransferdistance andrate	Transfer distance 10 meters line ofsight, maximum transfer rate 3Mbaud	Transfer distance 10 meters line ofsight, maximum transfer rate 3Mbaud
EEG
Definition	Up to 20 differential or referentialchannels	3 or 4 differential or referentialchannels
Signalprocessingtechniques(e.g. filtering,etc.)	Sampling Rate: 256 s/s0.1 Hz High Pass, hardware100 Hz Low Pass, hardware	Sampling Rate: 256 s/s0.1 Hz High Pass, hardware100 Hz Low Pass, hardware
Accuracy,variance anderror ofmeasurements,in comparisonto standardtechniques ofmeasuringidenticalphysiologicvariables	Sampling rate: 256HzDynamic range: +/- 1000μVResolution 0.03 µVPeak to peak noise: 3.7 µV (typical)110dB Common Mode RejectionRatio (typically)Input Impedance: 100GOhm	Sampling rate: 256HzDynamic range: +/- 1000μVResolution 0.03 µVPeak to peak noise: 3.7 µV (typical)110dB Common Mode RejectionRatio (typically)Input Impedance: 100GOhm

September 19.

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Specification	X-Series System	X4 System (K120447)
Aux - EOG/EMG
Definition	Up to 4 optional single channeleither dual lead electrooculogram(EOG) or electromyogram (EMG)	Optional single channel either duallead electrooculogram (EOG) orelectromyogram (EMG)
Signalprocessingtechniques(e.g. filtering,etc.)	Sampling rate 256 Hz0.1 Hz High Pass, hardware100 Hz Low Pass, hardware	Sampling rate 256 Hz0.1 Hz High Pass, hardware100 Hz Low Pass, hardware
Accuracy,variance anderror of X4Systemmeasurements,in comparisonto standardtechniques ofmeasuringidenticalphysiologicvariables	ECG:Dynamic range: +/- 2000μVResolution: 0.06 μVPeak to peak noise: 4.2 μVEMG/EOG:Dynamic range: +/- 1000μVResolution 0.03 μVPeak to peak noise: 3.7 μV (typical)	EOG:Dynamic range: +/- 2000μVResolution: 0.06 μVPeak to peak noise: 4.2 μVEMG:Dynamic range: +/- 1000μVResolution 0.03 μVPeak to peak noise: 3.7 μV (typical)

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Specification	X-Series System	X4 System (K120447)
Aux.- ECG
Definition	Dual lead electrocardiogram	Dual lead electrocardiogram
	Number: Single Channel (optional)	Number: Single Channel (optional)
	Bandwidth: 0.1 to 100Hz -3dBbandwidth	Bandwidth: 0.1 to 100Hz -3dBbandwidth
	Notch Filters: 50, 60Hz, software	Notch Filters: 50, 60Hz, software
	Common Mode Rejection Ratio:110dB	Common Mode Rejection Ratio:110dB
	Input Impedance: 100GOhm	Input Impedance: 100GOhm
	Input Range: +/-4mV	Input Range: +/-4mV
	Accuracy: 16 bits over input range	Accuracy: 16 bits over input range
	Noise: <5μVpp (typically 4.2μVpp)	Noise: <5μVpp (typically 4.2μVpp)
	Maximum Electrode DC Offset: +/-125mV	Maximum Electrode DC Offset: +/-125mV
Signalprocessing	Hardware filtering: 0.1Hz -100Hzbandpass	Hardware filtering: 0.1Hz -100Hzbandpass
techniques(e.g. filtering,etc.)	Software Filtering: 50, 60Hz,software	Software Filtering: 50, 60Hz,software
Accuracy,	Noise: typical 4.2μVpp	Noise: typical 4.2μVpp
variance anderror of X4	Dynamic range: +/- 2000μV	Dynamic range: +/- 2000μV
Systemmeasurements,in comparison	Resolution: 0.06 μV	Resolution: 0.06 μV
to standardtechniques ofmeasuringidentical
physiologicvariables

. '

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Specification	X-Series System	X4 System (K120447)
Accelerometer
Definition	Three channels (X x Y x Z) used bysoftware to measure movement andpositionDynamic Range: -180° to 180°	Three channels (X x Y x Z) used bysoftware to measure movement andpositionDynamic Range: -180° to 180°
Signalprocessingtechniques(e.g. filtering,etc.)	-Sampled 100Hz, downsampled to10Hz- X x Y x Z @ 10 s/s- Resolution nominal 10 bit at 2g- Actual output range for -90 to 90degrees is 12 bit	-Sampled 100Hz, downsampled to10Hz- X x Y x Z @ 10 s/s- Resolution nominal 10 bit at 2g- Actual output range for -90 to 90degrees is 12 bit
Accuracy,variance anderror of X4Systemmeasurements,in comparisonto standardtechniques ofmeasuringidenticalphysiologicvariables	Position accuracy typically +/- 3.0degrees, maximum +/- 5.0 degreesin the +/- 60 degrees rangeParameterX-Series Sensitivity10 bit / 2g Non-linearity+/-0.5 %FS Cross-Axis+/-1 % Zero-Level+/-0.35-0.4 mg Sensitivitychange duetemperatureq+/-0.01 LSB/°C		Position accuracy typically +/- 3.0degrees, maximum +/- 5.0 degreesin the +/- 60 degrees rangeParameterX4 Sensitivity10 bit / 2g Non-linearity+/-0.5 %FS Cross-Axis+/-1 % Zero-Level+/-0.35-0.4 mg Sensitivitychange duetemperature+/-0.01 LSB/°C
Software	Software presents waveforms	Software presents waveforms

DETERMINATION OF SUBSTANTIAL EQUIVALENCE:

SUMMARY OF NON-CLINICAL TESTS:

Support for the substantial equivalence of the X-Series System was provided as a result of risk management and testing which included electrical and biological safety, performance and software tests. Testing has provided reasonable assurance of safety and effectiveness for the intended use and supports a determination of substantial equivalence.

Bench tests were conducted using an oscilloscope and signal generator to compare performance of the X-Series to the predicate device. These comparison tests confirm the EEG

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and optional dual-lead (for ECG) analog signals between the X-Series and predicate devices were equivalent. The X-Series and X4 were placed in a jig that held the devices in eight unique angles to confirm that the measures obtained from the 3D actigraphs were equivalent. While the X-Series System is not a cardiac monitor as defined in the scope of ANSI/AAMI EC 13, the standard was referenced and requirements and test methods applicable to the electrocardiogram acquired and displayed by X-Series was applied. These tests demonstrated the equivalence of the X-Series system to the predicate device for EEG, ECG and actigraph performance.

The cleaning and disinfection procedures of the X-Series acquisition device have been validated by testing in accordance with AAMI TIR 12-94 Designing, Testing, and Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities: A Guide for Manufacturers and AAMI TIR 30: 2003 A Compendium of Processes, Materials, Test Methods, and Acceptance Criteria for Cleaning Reusable Medical Devices. Acceptance criteria established by Advanced Brain Monitoring and the TIR are ≥ log 3.0 reduction in bioburden after cleaning according to the instructions for use. All tests passed and demonstrate that the cleaning methods are appropriate for ensuring the X-Series acquisition device is clean between uses.

Biocompatibility was assessed following FDA Guidance "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing' (Replaces #G87-1 #8294) (blue book memo)". Per Table 1 of this guidance, the X-Series System is a Surface device with limited contact (Category A, less than 24 hours contact). As such, cytotoxicity, sensitization, and irritation or intracutaneous reactivity tests were selected. Test methods were in compliance with the corresponding standard from the ISO 10993 series for Biological Evaluation of Medical Devices. Test articles were comprised of all patient contacting components of the X-Series System, including the X-Series Strip with disposable foam and synapse cream, X-Series Strap and X-Series enclosure. Results of biocompatibility testing are summarized in table 2 and demonstrate that materials of the device in contact with the patient are biocompatible.

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ISO 10993Standard	Test	Results	Conclusions
ISO 10993-5	CytotoxicityAgar Diffusion Test - ISO DirectContactThe test article was applieddirectly to the surface of theagar of mammalian cell culture(mouse fibroblast L929) andthe cells were incubated for 48$\pm$ 2 hours at 37 $\pm$ 1°C. Thebiological reactivity of the cellsfollowing the exposure to thetest article was visuallyobserved with a microscope,and graded on a scale of 0 to 4.	None of the cultures testedwith the test articles showedany reactivity (grade 0).	Non-cytotoxic
ISO 10993-10	SensitizationBuehler Sensitization Test - ISODirect Contact.The test article, X SeriesSystem, was evaluated for itspotential to produce skinsensitization reactionsfollowing topical application toalbino guinea pigs.	Irritation (skin reaction scores)was absent from all the animals(albino guinea pigs). Allanimals gained weight duringthe course of the study. Noovert signs of toxicity wereevident in any of the animalsduring the course of the study.No skin reaction scores wereobserved in any of the testanimals. No skin reactionscores were evident in thenegative control group: Theincidence of the responsespost-challenge were calculatedto be 0% at 24 and 48 hours.	Non-sensitizer
ISO 10993Standard	Test	Results	Conclusions
10993-10	IrritationPrimary Skin Irritation Test -ISO Direct ContactThe X Series System wasevaluated for its potential toproduce Primary Skin Irritationafter a single topical 4 hourapplication to the skin of NewZealand White rabbits	All test animals gained bodyweight during the course of thestudy. No overt signs oftoxicity were evident in any ofthe animals during the courseof the study. No signs oferythema or edema werepresent at the 24, 48, or the 72hour observation point. Noneof the control sites of anyanimal at any of theobservation periods showedsigns of erythema or edema.The Test Primary Irritation Index(PII) was 0.0.	Non-irritant

TABLE 2 BIOCOMPATIBILITY RESULTS

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The firmware in the X-Series System and the X-Series Basic software have been thoroughly tested through verification of specifications and validation, including software validation. Software documentation is available per FDA's Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices Document (May 11, 2005). The results of the verification and validation activities that have been performed demonstrate that the software meets requirements for safety, function, and intended use.

Electromagnetic compatibility and electrical safety testing of the X-Series was conducted following recognized standards Compliance to IEC 60601-2-26:2002 - Particular requirements for the safety of electroencephalographs was also demonstrated. The X-Series System has additionally been tested per IEC 60601-1-11: 2010 Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment to demonstrate operational and mechanical performance is not negatively affected by various mechanical and environmental hazards encountered in the home-use environment. All test results are passing demonstrating the compliance of the X-Series system to FDA recognized standards for electro-medical equipment as defined in Table 3.

The disposable EEG electrodes used with the X-Series System have been tested to demonstrate their electrical performance. While the scope of the standard does not cover EEG electrodes, testing using applicable methods defined in chapter 4 of AAMI/ANS1 EC12:2000 (R)2010 Disposable ECG electrodes has been conducted, similarly to other cleared EEG electrodes

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including Model 4310 PSarray2 EEG electrode (K020670). The results demonstrate electrical performance of the EEG electrodes used with the X-Series System is acceptable.

TABLE 3: FDA RECOGNIZED CONSENSUS STANDARDS AND VOLUNTARY STANDARDS THE
X-SERIES SYSTEM CONFORMS WITH:

Standard Number	Standard Title
IEC 60601-1-1:1988+A1:1991+A2: 1995	Medical Electrical Equipment - Part 1: General requirements for safety
IEC 60601-1-2: 2007	Medical Electrical Equipment Part 1-2: Collateral standard: Electromagneticcompatibility - requirements and tests
ISO 10993-1: 2009	Biological evaluation of medical devices Part 1
IEC 60601-1-11: 2010	Medical electrical equipment - Part 1-11: General requirements for basicsafety and essential performance - Collateral Standard: Requirements formedical electrical equipment and medical electrical systems used in thehome healthcare environment
IEC 60601-2-26:2002	Particular requirements for the safety of electroencephalographs

SUMMARY OF CLINICAL TESTS:

To provide additional support for use in ages 6 and older, a subset of data from a research study was analyzed to establish use of the X-10 and X-24 headsets to acquire EEG in this patient population. Data from seven children ages 6-8 were compared to data from seven adults. The subjects were set-up by a technician with the X-Series strip appropriate based on their head measurements as described in the labeling. Technicians were able to quickly set-up subjects and resolve any high impedance issues as displayed by the X-Series Software. None of the subjects complained of discomfort or agitation in wearing the strips and the sensors remained in contact with the scalp for the duration of testing. 100% of all EEG sessions contained appropriate EEG recordings that could be further examined in third party software, and when data acquired from children are compared to an equivalent adult population, the data quality were equivalent.

CONCLUSION:

Based on the results of the non-clinical and clinical tests performed, Advanced Brain Monitoring considers the X-Series System to be as safe, as effective, and substantially equivalent to the predicate devices.

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Image /page/12/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure with three stylized wings or feathers.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

November 27, 2013

Advanced Brain Monitoring, Inc. c/o Ms. Adrienne Lenz W324 S3649 County Road E Dousman. WI 53118

Re: K131383

Trade/Device Name: X-Series System Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: GWQ, OMC Dated: November 1, 2013 Received: November 5, 2013

Dear Ms. Lenz:

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, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 -Ms. Adrienne Lenz

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

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

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

You may obtain other general information on your responsibilities under the Act from the Division of 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 yours,

Joyce M. Whang -S

for

Victor Krauthamer, Ph.D. Acting Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K131383

Device Name: X-Series System

Indications For Use:

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

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of Center for Devices and Radiological Health (CDRH)

Joyce M. Whang -S

Page 1 of _ 1

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).