X10 HEADSET WITH X-SERIES BASIC SOFTWARE, X24 HEADSET WITH X-SERIES BASIC SOFTWARE

K131383 · Advanced Brain Monitoring, Inc. · GWQ · Nov 27, 2013 · Neurology

Device Facts

• Record ID: K131383
• Device Name: X10 HEADSET WITH X-SERIES BASIC SOFTWARE, X24 HEADSET WITH X-SERIES BASIC SOFTWARE
• Applicant: Advanced Brain Monitoring, Inc.
• Product Code: GWQ · Neurology
• Decision Date: Nov 27, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1400
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

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 Story

X-Series System (X10/X24) is a physiological data acquisition platform. Input: EEG, EOG, ECG, EMG, and 3-D accelerometer signals via battery-powered headset. Operation: Trained technician applies sensors using synapse cream; device transmits signals wirelessly (Bluetooth 2.0) to a receiving unit. Software: X-Series Basic Software monitors signal quality during acquisition to ensure proper sensor application. Output: Signals saved in EDF+ format for analysis by third-party software (e.g., Persyst). Context: Used in home, clinic, or research environments. Benefit: Enables ambulatory physiological monitoring; provides high-quality signal acquisition for subsequent physician review.

Clinical Evidence

Clinical study included 14 subjects (7 children ages 6-8, 7 adults). Technicians performed setup and resolved impedance issues using software indicators. Results: 100% of sessions yielded appropriate EEG recordings; data quality in children was equivalent to adults. No discomfort or agitation reported. Bench testing confirmed equivalence to predicate for EEG, ECG, and actigraphy performance.

Technological Characteristics

Battery-powered headset (Li-Ion); 9 (X10) or 20 (X24) EEG channels; 3-D accelerometer; Bluetooth 2.0 wireless connectivity. Materials: X-Series Strip, disposable foam, synapse cream, enclosure (biocompatible per ISO 10993). Hardware filtering: 0.1-100 Hz bandpass. Software filtering: 50/60 Hz notch. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-26.

Indications for Use

Indicated for patients ages 6 and older requiring acquisition, transmission, display, and storage of EEG, EOG, ECG, EMG, and accelerometer signals in home, healthcare, or clinical research settings. Requires operation by a trained technician.

Regulatory Classification

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.

Predicate Devices

• X4 System (K130013)

Reference Devices

• Persyst Software (K011397)
• Model 4310 PSarray2 EEG electrode (K020670)

Submission Summary (Full Text)

{0}------------------------------------------------

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

{1}------------------------------------------------

#### 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).

#### INTENDED USE:

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.

{2}------------------------------------------------

## 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 for<br>Use | 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 |
| Patient<br>Population | Ages 6 and older | Adults |
| User | Trained Technician | Trained technician or patient for recording of sleep data. |
| Anatomical<br>Sites | Scalp/Chest | Forehead/Chest |
| Environment of<br>Use | Home (data acquisition)<br>Healthcare facility (data acquisition, analysis and reporting)<br>Clinical Research Environment | Home (data acquisition)<br>Healthcare facility (data acquisition, and analysis.)<br>Clinical Research |

## TABLE 1 COMPARISON OF X-SERIES TO PREDICATE DEVICE

{3}------------------------------------------------

| Specification | X-Series System | X4 System (K120447) |
|---------------------------------|----------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| User Interface | User control, visual indicators | User control, visual and audio<br>indicators |
| Accessories | EEG and ECG electrodes. | EEG and ECG electrodes. |
| Signals<br>Acquired | Scalp EEG 3-D actigraphy Optional channels<br>ECG/EEG/EOG/EMG | Scalp EEG Infra-red (IR) optical signal Microphone 3-D actigraphy Optional channel<br>ECG/EEG/EOG/EMG |
| Acquisition<br>modes | 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 |
| Battery<br>Charging | Via JED Connector connected to USB<br>port or USB wall charger | Via USB cable connected to USB port<br>or USB wall charger |
| Typical<br>Charging Time | 0.5-5.0 hours | 0.5 - 3.0 hours |
| Operating<br>Time | Monitoring Days after Charge Hours<br>of Use 0-4 Days: 16 to 17 hours 5-10 Days: 14 to 15 hours | Recording Days after Charge Hours<br>of Use 0-4 Days: 13.0 to 15.5 hours 5-10 Days: 11.5 to 14.8 hours Monitoring Days after Charge Hours<br>of 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 does<br>not include a record mode where<br>data is stored on the recorder. | 2 GB Micro-SD memory card |
| File size per 8<br>hr 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 |

.

:

:

・

·

{4}------------------------------------------------

:

:

・

.

| Specification | X-Series System | X4 System (K120447) |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Cleaning | Cleaned and disinfected by rubbing<br>with isopropyl alcohol. | Cleaned and disinfected by rubbing<br>with isopropyl alcohol. |
| Wireless data<br>transfer | Blue tooth 2.0 | Blue tooth 2.0 |
| Maximum<br>Bluetooth<br>wireless<br>transfer<br>distance and<br>rate | Transfer distance 10 meters line of<br>sight, maximum transfer rate 3<br>Mbaud | Transfer distance 10 meters line of<br>sight, maximum transfer rate 3<br>Mbaud |
| EEG | | |
| Definition | Up to 20 differential or referential<br>channels | 3 or 4 differential or referential<br>channels |
| Signal<br>processing<br>techniques<br>(e.g. filtering,<br>etc.) | Sampling Rate: 256 s/s<br><br>0.1 Hz High Pass, hardware<br>100 Hz Low Pass, hardware | Sampling Rate: 256 s/s<br><br>0.1 Hz High Pass, hardware<br>100 Hz Low Pass, hardware |
| Accuracy,<br>variance and<br>error of<br>measurements,<br>in comparison<br>to standard<br>techniques of<br>measuring<br>identical<br>physiologic<br>variables | Sampling rate: 256Hz<br><br>Dynamic range: +/- 1000μV<br>Resolution 0.03 µV<br><br>Peak to peak noise: 3.7 µV (typical)<br><br>110dB Common Mode Rejection<br>Ratio (typically)<br><br>Input Impedance: 100GOhm | Sampling rate: 256Hz<br><br>Dynamic range: +/- 1000μV<br>Resolution 0.03 µV<br><br>Peak to peak noise: 3.7 µV (typical)<br><br>110dB Common Mode Rejection<br>Ratio (typically)<br><br>Input Impedance: 100GOhm |

.

1. September 19.

.

.

.

。

{5}------------------------------------------------

:

| Specification | X-Series System | X4 System (K120447) |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Aux - EOG/EMG | | |
| Definition | Up to 4 optional single channel<br>either dual lead electrooculogram<br>(EOG) or electromyogram (EMG) | Optional single channel either dual<br>lead electrooculogram (EOG) or<br>electromyogram (EMG) |
| Signal<br>processing<br>techniques<br>(e.g. filtering,<br>etc.) | Sampling rate 256 Hz<br>0.1 Hz High Pass, hardware<br>100 Hz Low Pass, hardware | Sampling rate 256 Hz<br>0.1 Hz High Pass, hardware<br>100 Hz Low Pass, hardware |
| Accuracy,<br>variance and<br>error of X4<br>System<br>measurements,<br>in comparison<br>to standard<br>techniques of<br>measuring<br>identical<br>physiologic<br>variables | ECG:<br>Dynamic range: +/- 2000μV<br>Resolution: 0.06 μV<br>Peak to peak noise: 4.2 μV<br>EMG/EOG:<br>Dynamic range: +/- 1000μV<br>Resolution 0.03 μV<br>Peak to peak noise: 3.7 μV (typical) | EOG:<br>Dynamic range: +/- 2000μV<br>Resolution: 0.06 μV<br>Peak to peak noise: 4.2 μV<br>EMG:<br>Dynamic range: +/- 1000μV<br>Resolution 0.03 μV<br>Peak to peak noise: 3.7 μV (typical) |

.

:

.

{6}------------------------------------------------

.

| 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 -3dB<br>bandwidth | Bandwidth: 0.1 to 100Hz -3dB<br>bandwidth |
| | Notch Filters: 50, 60Hz, software | Notch Filters: 50, 60Hz, software |
| | Common Mode Rejection Ratio:<br>110dB | Common Mode Rejection Ratio:<br>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: +/-<br>125mV | Maximum Electrode DC Offset: +/-<br>125mV |
| Signal<br>processing | Hardware filtering: 0.1Hz -100Hz<br>bandpass | Hardware filtering: 0.1Hz -100Hz<br>bandpass |
| techniques<br>(e.g. filtering,<br>etc.) | Software Filtering: 50, 60Hz,<br>software | Software Filtering: 50, 60Hz,<br>software |
| Accuracy, | Noise: typical 4.2μVpp | Noise: typical 4.2μVpp |
| variance and<br>error of X4 | Dynamic range: +/- 2000μV | Dynamic range: +/- 2000μV |
| System<br>measurements,<br>in comparison | Resolution: 0.06 μV | Resolution: 0.06 μV |
| to standard<br>techniques of<br>measuring<br>identical | | |
| physiologic<br>variables | | |

. '

·

24

{7}------------------------------------------------

| Specification | X-Series System | X4 System (K120447) | | | | | | | | | | | | | | | | | | | | | | | | |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|--|--|--|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|--|--|--|--|
| Accelerometer | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Definition | Three channels (X x Y x Z) used by<br>software to measure movement and<br>position<br>Dynamic Range: -180° to 180° | Three channels (X x Y x Z) used by<br>software to measure movement and<br>position<br>Dynamic Range: -180° to 180° | | | | | | | | | | | | | | | | | | | | | | | | |
| Signal<br>processing<br>techniques<br>(e.g. filtering,<br>etc.) | -Sampled 100Hz, downsampled to<br>10Hz<br>- X x Y x Z @ 10 s/s<br>- Resolution nominal 10 bit at 2g<br>- Actual output range for -90 to 90<br>degrees is 12 bit | -Sampled 100Hz, downsampled to<br>10Hz<br>- X x Y x Z @ 10 s/s<br>- Resolution nominal 10 bit at 2g<br>- Actual output range for -90 to 90<br>degrees is 12 bit | | | | | | | | | | | | | | | | | | | | | | | | |
| Accuracy,<br>variance and<br>error of X4<br>System<br>measurements,<br>in comparison<br>to standard<br>techniques of<br>measuring<br>identical<br>physiologic<br>variables | Position accuracy typically +/- 3.0<br>degrees, maximum +/- 5.0 degrees<br>in the +/- 60 degrees range<br><br>ParameterX-Series Sensitivity10 bit / 2g Non-linearity+/-0.5 %FS Cross-Axis+/-1 % Zero-Level+/-0.35-0.4 mg Sensitivity<br>change due<br>temperatureq+/-0.01 LSB/°C | | | | | | | | | | | | | Position accuracy typically +/- 3.0<br>degrees, maximum +/- 5.0 degrees<br>in the +/- 60 degrees range<br><br>ParameterX4 Sensitivity10 bit / 2g Non-linearity+/-0.5 %FS Cross-Axis+/-1 % Zero-Level+/-0.35-0.4 mg Sensitivity<br>change due<br>temperature+/-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

{8}------------------------------------------------

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.

{9}------------------------------------------------

| ISO 10993<br>Standard | Test | Results | Conclusions |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------|
| ISO 10993-5 | Cytotoxicity<br>Agar Diffusion Test - ISO Direct<br>Contact<br>The test article was applied<br>directly to the surface of the<br>agar of mammalian cell culture<br>(mouse fibroblast L929) and<br>the cells were incubated for 48<br>$\pm$ 2 hours at 37 $\pm$ 1°C. The<br>biological reactivity of the cells<br>following the exposure to the<br>test article was visually<br>observed with a microscope,<br>and graded on a scale of 0 to 4. | None of the cultures tested<br>with the test articles showed<br>any reactivity (grade 0). | Non-<br>cytotoxic |
| ISO 10993-10 | Sensitization<br>Buehler Sensitization Test - ISO<br>Direct Contact.<br>The test article, X Series<br>System, was evaluated for its<br>potential to produce skin<br>sensitization reactions<br>following topical application to<br>albino guinea pigs. | Irritation (skin reaction scores)<br>was absent from all the animals<br>(albino guinea pigs). All<br>animals gained weight during<br>the course of the study. No<br>overt signs of toxicity were<br>evident in any of the animals<br>during the course of the study.<br>No skin reaction scores were<br>observed in any of the test<br>animals. No skin reaction<br>scores were evident in the<br>negative control group: The<br>incidence of the responses<br>post-challenge were calculated<br>to be 0% at 24 and 48 hours. | Non-<br>sensitizer |
| ISO 10993<br>Standard | Test | Results | Conclusions |
| 10993-10 | Irritation<br>Primary Skin Irritation Test -<br>ISO Direct Contact<br>The X Series System was<br>evaluated for its potential to<br>produce Primary Skin Irritation<br>after a single topical 4 hour<br>application to the skin of New<br>Zealand White rabbits | All test animals gained body<br>weight during the course of the<br>study. No overt signs of<br>toxicity were evident in any of<br>the animals during the course<br>of the study. No signs of<br>erythema or edema were<br>present at the 24, 48, or the 72<br>hour observation point. None<br>of the control sites of any<br>animal at any of the<br>observation periods showed<br>signs of erythema or edema.<br>The Test Primary Irritation Index<br>(PII) was 0.0. | Non-irritant |

## TABLE 2 BIOCOMPATIBILITY RESULTS

27

.

.

{10}------------------------------------------------

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

{11}------------------------------------------------

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:<br>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: Electromagnetic<br>compatibility - 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 basic<br>safety and essential performance - Collateral Standard: Requirements for<br>medical electrical equipment and medical electrical systems used in the<br>home 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.

{12}------------------------------------------------

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

{13}------------------------------------------------

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 [phone] or [phone] 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 [phone] or [phone] 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

{14}------------------------------------------------

## Indications for Use

510(k) Number (if known): K131383

Device Name: X-Series System

Indications For Use:

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.

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