Who is the manufacturer of WR19 System?

Zeto, Inc. filed the 510(k) submission for WR19 System (K172735).

What is the FDA product code for WR19 System?

GWQ. It is classified under 21 CFR 882.1400 as a Class 2 device in the Neurology panel.

What is the regulatory pathway for WR19 System?

510(k) clearance (submission type: Traditional).

What are the predicate devices for WR19 System?

X10 Headset with X-series Basic Software (K131383); X24 Headset with X-series Basic Software (K131383).

Who can help prepare an FDA 510(k) submission like WR19 System?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

WR19 System

K172735 · Zeto, Inc. · GWQ · Apr 17, 2018 · Neurology

Device Facts

Record ID	K172735
Device Name	WR19 System
Applicant	Zeto, Inc.
Product Code	GWQ · Neurology
Decision Date	Apr 17, 2018
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 882.1400
Device Class	Class 2
Attributes	Pediatric

Intended Use

The WR19 System is intended for prescription use in a health care facility or clinical research environment to acquire, transmit, display and store primarily EEG and optionally auxiliary signals for adults and children, not including newborns. The WR19 System requires operation by a healthcare professional familiar with EEG. The WR19 System acquires, transmits, displays and stores electroencephalogram (EEG), and optionally electrocardiogram (ECG), accelerometer, photic sensor, external trigger signals and video.

Device Story

The WR19 System is a wearable, semi-rigid headset designed for routine or outpatient EEG recording. It utilizes 19 dry signal electrodes and one ground/driven-right-leg electrode, positioned according to the 10-20 system. The device acquires EEG signals, along with optional auxiliary inputs (ECG, accelerometer, photic sensor, external triggers, and video). Data is transmitted via Wi-Fi to a cloud-based data center application for storage and display. A client application allows healthcare professionals to view waveforms, manage EEG sessions, and apply signal transformations (filters, montages). The device features real-time contact quality monitoring to ensure signal integrity. By eliminating the need for conductive gel/paste, the system facilitates rapid setup in clinical environments. The output assists clinicians in interpreting brain activity, aiding in the diagnosis and monitoring of neurological conditions.

Clinical Evidence

Clinical testing conducted at a US hospital with 7 subjects (EEG patients and healthy volunteers). Study compared WR19 signal quality to the XLTEK EMU40EX (K163163). Testing included 15-30 minute and 2-hour recording sessions, with healthy volunteers generating artifacts. Metrics included setup time, qualitative waveform comparison, Likert scoring, spectral correlation, and SNR. Results met predefined acceptance criteria, demonstrating performance comparable to the comparator device.

Technological Characteristics

Wearable semi-rigid headset (Polyamide PA12, ABS, Polyurethane, Polycarbonate). 19 active dry Ag/AgCl electrodes. 500 Hz sampling rate; 24-bit A/D conversion; >120dB CMRR; 1000 GOhm input impedance. Connectivity: 802.11 b/g/n Wi-Fi. Power: 3.7V Li-Ion battery. Software: Firmware-controlled headset, cloud-based data center, and client application for display/filtering. Sterilization: Non-sterile, reusable, cleaned via isopropyl alcohol. Standards: IEC 60601-2-26, IEC 60601-1, IEC 60601-1-2.

Indications for Use

Indicated for adults and children (excluding newborns) in healthcare or clinical research settings for the acquisition, transmission, display, and storage of EEG and auxiliary signals (ECG, accelerometer, photic sensor, external trigger, video). Requires operation by a healthcare professional familiar with EEG.

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

X10 Headset with X-series Basic Software (K131383)
X24 Headset with X-series Basic Software (K131383)

Reference Devices

g.Nautilus PRO (K171669)
XLTEK EMU40EX (K163163)

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Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health and Human Services logo. The logo on the right is the Food and Drug Administration logo. The FDA logo is in blue and contains the words "FDA U.S. FOOD & DRUG ADMINISTRATION". April 17, 2018 Zeto, Inc. % Donna-Bea Tillman, PhD Team Leader and Senior Consultant, Medical Devices Biologics Consulting Group 1555 King Street, Suite 300 Alexandria, Virginia 22314 Re: K172735 Trade/Device Name: WR19 System Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: GWO. GXY Dated: March 16, 2018 Received: March 19, 2018 Dear Dr. Tillman: 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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); {1}------------------------------------------------ and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). > Sincerely, Michael J. Hoffmann -S Carlos L. Peña. PhD. MS for Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K172735 Device Name WR19 System Indications for Use (Describe) The WR19 System is intended for prescription use in a health care facility or clinical research environment to acquire, transmit, display and store primarily EEG and optional auxiliary signals for adults and children, not including newborns. The WR19 System requires operation by a healthcare professional familiar with EEG. The WR19 System acquires, transmits, displays and stores electroencephalogram (EEG), and optionally electrocardiogram (ECG), accelerometer, photic sensor, external trigger signals and video. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|--| |-------------------------------------------------|--| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 510(k) Summary # K172735 | Submitter Name | Zeto, Inc. | |-----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------| | Submitter Address | 2336 Park Ave Santa Clara, CA 95050 | | Submitter Tel. Number | (408) 658-0737 | | Contact Person | Donna-Bea Tillman, Ph.D. Senior Consultant Biologics Consulting Group dtillman@biologicsconsulting.com Phone: (410) 531-6542 Fax: (703) 548-745 | | Date Prepared | April 16th, 2018 | | Trade Name | WR19 System | | Common Name | Full-montage standard electroencephalograph | | Classification Name | Electroencephalograph 21 CFR 882.1400 | | Product Codes | GWQ, GXY | | Primary Predicate | K131383 X10 Headset with X-series Basic Software, X24 Headset with X-series Basic Software | | Reference Predicate | K171669 g.Nautilus PRO | #### DEVICE DESCRIPTION 1. The WR19 System is primarily intended to acquire, transmit, display and store EEG and optionally do so for auxiliary signals. WR19 headset is designed to perform Routine or Outpatient EEG using 19 dry signal electrodes and 1 dedicated dry ground/driven-right-leg (DRL) electrode, adjusted and placed to comply with the 10-20 EEG system. The device consists of the following components: - . Headset - Electrodes (affixed to the underside of the headset) ● - Charger - Charging cable . - Software ● - Headset firmware - - Client application - - Data center application {4}------------------------------------------------ #### 2. INTENDED USE The WR19 System is intended for prescription use in a health care facility or clinical research environment to acquire, transmit, display and store primarily EEG and optionally auxiliary signals for adults and children, not including newborns. The WR19 System requires operation by a healthcare professional familiar with EEG. The WR19 System acquires, transmits, displays and stores electroencephalogram (EEG), and optionally electrocardiogram (ECG), accelerometer, photic sensor, external trigger signals and video. #### SUBSTANTIAL EQUIVALENCE DISCUSSION 3. The primary predicate device is the X-Series System (models X10 and X24) (cleared in K131383). The reference device for dry electrodes is the g.Nautilus PRO (cleared in K171669). #### 3.1. Technological Comparison to Predicate Device The following tables provide comparisons of technological characteristics between the WR19 System and the X-Series System. #### 3.1.1. Comparison - Overview The following tables provide a comparison of the technological characteristics between the WR19 System and the X-Series System: | | Subject Device WR19 System K172735 | Predicate Device X- Series System K131383 | Remarks | |-----------------------------|-------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | User Interface | Operator control, visual indicators | Operator control, visual indicators | Same | | System Components | • Headset • Electrodes • Charger • Charging cable • Software | • Headset (Electronics box) • Electrode strip • Electrodes • Neoprene Strap • Charger • Charging cable • Software | No significant difference. Since WR19 works via the cloud, it uses a data center application, as opposed to just using client software | | | Subject Device WR19 System K172735 | Predicate Device X- Series System K131383 | Remarks | | Signals Acquired | • Scalp EEG • Accelerometer • Optional non-EEG signals: | • Scalp EEG • 3-D actigraphy (acceleromet er based) • Optional non- EEG signals: | Same in measuring EEG signals, but the subject device offers a different subset of optional auxiliary features. | | Power Supply | 1 x 2050mAh 3.7V Lithium Ion battery | 2 to 4 x 240mAh 3.7 Li- Ion batteries | No significant difference. WR19 uses a bigger battery because a higher sampling rate generates more data and requires more power. | | Battery Charging | Via USB connector connected to USB wall charger. | Via JED Connector connected to USB port or USB wall charger | Same | | Typical Charging Time | 0.5-6.0 hours | 0.5-5.0 hours | Same | | Operating Time | 6-7 hours | Monitoring Days after Charge/Hours of Use • 0-4 Days: 16 to 17 hours • 5-10 Days: 14 to 15 hours | No significant difference | | Typical use duration | 20 - 60 minutes | Not specified | Comparison not available; however, the typical use duration of the subject device is standard for outpatient / routine EEG recording | | | Subject Device WR19 System K172735 | Predicate Device X- Series System K131383 | Remarks | | Dimensions | 8.5 x 10.8 x 5.7" or 214 x 274 x 144 mm (Complete headset with electrodes) | 5.0" long, 2.25" wide, 1.0" deep (Electronics box) | No significant difference. WR19 System contains a headset worn like a bike helmet. The electronics are integrated into the headset. Predicate has flexible electrode strips that attach to Velcro bands that hold an electronics housing. Hence dimensions vary. | | Weight | < 650g or 23oz with battery (Complete headset with electrodes) | 3.9oz with two batteries (Electronics box) | No significant difference. Refer to row above for comparison of dimensions. | | Cleaning | Cleaned and disinfected by rubbing with isopropyl alcohol | Cleaned and disinfected by rubbing with isopropyl alcohol | No significant difference. Unlike predicate, WR19 uses dry electrodes that do not require gel/paste to operate. Hence, a gel/paste residue is not left behind. | {5}------------------------------------------------ {6}------------------------------------------------ {7}------------------------------------------------ #### 3.1.2. Comparison – Data Transfer and Storage The following tables provide a comparison of data transfer and storage characteristics between the WR19 System and the X-Series System: | | Subject Device WR19 System K172735 | Predicate Device X-Series System K131383 | Remarks | |---------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Internal data Storage | SD card, Minimum 8GB memory capacity | Not used. The X- Series system does not include a recording mode where data is stored on the recorder. | No significant difference. WR19 has built-in memory buffer capacity to smooth temporary slowing of data communication, but WR19 also offers a backup solution during total loss of communication. | | File Size per 8 hr. recording | 1.5 GB | 512 MB | No significant difference. WR19 uses higher sampling rate and hence file size is higher. | | Wireless Data Transfer | 802.11 b/g/n Wi-Fi | Bluetooth 2.0 | No significant difference. The nature of the data transmission protocol yields a higher data throughput and more reliable connection. | | Maximum wireless transfer distance | Headset includes commercially available, FCC-certified, Wi-Fi module that works for standard transfer distance from Wi-Fi Router, typically up to 30 meters. | Transfer distance 10 m line of sight, maximum transfer rate 3 Mbaud | No significant difference. WR19 offers a longer data transfer range. | | | Subject Device WR19 System K172735 | Predicate Device X-Series System K131383 | Remarks | | Definition | Up to 19 referential channels | Up to 20 differential or referential channels | Same as predicate. WR19 does not offer differential variations in hardware but can be changed with software montages, typical of Full Montage EEG systems. | | Signal Processing Techniques | Sampling Rate: 500 s/s | Sampling Rate: 256 s/s | No significant difference. WR19 provides higher temporal signal resolution. | | | No hardware LPF/HPF/Notch filters. | Hardware filters: 0.1Hz HPF, 100Hz LPF | No significant difference. WR19 does not limit the operator/EEG reviewer as it does not use any hardwired filters. | | | Software Filtering: Following are optional: LPF and HPF (Cutoff frequency selectable by operator), 50Hz, 60Hz notch | Software Filtering: 50, 60 Hz notch | Same as predicate. WR19 also offers a wider range of operator selectable filters. | | | Subject Device WR19 System K172735 | Predicate Device X-Series System K131383 | Remarks | | Accuracy, Performance | Sampling rate: 500 Hz Dynamic range: +/- 375 mV Resolution: 0.044 μV Peak to peak noise: 4 µV (typical) Common Mode Rejection Ratio: > 120dB (typical) Input Impedance: 1000 GOhm Noise: 1µV RMS A/D Conversion: 24 Bit | Sampling rate: 256 Hz Dynamic range: +/- 1000μV Resolution: 0.03μV Peak to peak noise: 3.7 µV (typical) Common Mode Rejection Ratio: 110dB (typical) Input Impedance: 100 GOhm Noise: RMS not specified | No significant difference | | Headset material | Semi-rigid and flexible polymer material (e.g., Polyamide PA12, ABS, Polyurethane and Polycarbonate) | Neoprene strap, flexible plastic type strips that hold foam electrodes filled with gel, rear electronics casing (material not specified) | No significant difference. Both devices passed applicable Biocompatibility tests outlined in relevant standards. | | Electrode type | Active, dry | Passive, wet | No significant difference | | Contact quality/Impedance measurement | Contact quality monitoring performed real time throughout the recording/ test | Impedance measurement performed by operator before the start of EEG test during 'Test Impedance' mode | No significant difference | | | Subject Device WR19 System K172735 | Predicate Device X-Series System K131383 | Remarks | | Channels | Single Differential ECG using non-active (passive), electrodes (optional) (ECG lead wire and electrodes not included) | Single Differential ECG (optional) (ECG cable included) | No significant difference | | Accuracy, performance | Sampling rate: 500 Hz Dynamic range: +/- 3900 mV Resolution: 0.536 µV Peak to peak noise: 4 µV Common Mode Rejection Ratio: > 110dB (typical) Input Impedance: 500 MOhm A/D Conversion: 24 Bit Noise: 1 µV RMS | Sampling rate: 256 Hz Dynamic range: +/- 2000 µV Resolution: 0.06 µV Peak to peak noise: 4.2 µV Common Mode Rejection Ratio: > 110dB (typical) Input Impedance: 100 GOhm A/D Conversion: 16 Bit Noise: not specified | No significant differences. The amplitudes of heartbeat electrical signals are of the order of millivolts. | {8}------------------------------------------------ #### 3.1.3. Comparison – EEG Measurements The following table provides a comparison of EEG measurement characteristics between the WR19 System and the X-Series System: {9}------------------------------------------------ {10}------------------------------------------------ #### 3.1.4. Comparison – ECG Measurements The following table provides a comparison of ECG measurement characteristics between the WR19 System and the X-Series System. #### 3.1.5. Comparison – Accelerometer The following table provides a comparison of accelerometer characteristics between the WR19 System and the X-Series System. | | Subject Device WR19 System K172735 | Predicate Device X-Series System K131383 | Remarks | |-----------------|----------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------| | Scope of use | Used primarily as an aid for motion detection and hence finding EEG artifacts | Used primarily as part of a 3-D actigraphy for monitoring rest/ non- specific activity cycles | No significant difference. WR19 intended scope is a subset of the predicate. | {11}------------------------------------------------ | Channels | Dynamic Range: -180° to 180° | Same as predicate device | |----------------------------------------------------------------------------|----------------------------------------------------------------------------|--------------------------| | Three channels (X, Y, Z) used by software to measure movement and position | Three channels (X, Y, Z) used by software to measure movement and position | | #### 3.1.6. Comparison - Software Characteristics The following table provides a comparison of software technological characteristics between the WR19 System and the X-Series System: | | Subject Device WR19 System K172735 | Predicate Device X-Series System K131383 | Remarks | |----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------| | Firmware | WR19 headset is controlled by a firmware. | X-series headset is controlled by a firmware (No more details specified) | Same as predicate device | | Data center application | WR19 sends data to the data center application in the cloud. | Not applicable. | No significant difference. Predicate is not a cloud solution. | | Client application | Client application presents waveforms, controls EEG session, and offers standard EEG transformations such as low-pass, high-pass and notch filters and montage transformations. | Client application presents waveforms (No more details specified) | No significant difference | | Client application | Client application records and retrieves EEG waveforms. | Client application presents waveforms (No more details specified) | No significant difference. Predicate uses 3rd party software to retrieve and display waveforms. | {12}------------------------------------------------ #### 3.2. Technological Comparison to Reference Device The following table provides a comparison of electrode technological characteristics between the WR19 System and the g.Nautilus PRO: | | Subject Device WR19 System K172735 | Reference Device g.Nautilus PRO K171669 | Remarks | |------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|-----------------------------------| | Electrode material | Ag/AgCl coated | Gold or Ag/AgCl coated | Same as reference predicate | | Type of electrodes | Active, dry | Active, wet or dry | Same as reference predicate | | Electrode mounting mechanism | Semi-rigid wearable headset with certain electrode positions. Electrode positions can be adjusted to a limited extent | Elastic EEG cap with chin strap with certain electrode positions | No significant difference | | Typical usage setting | Intended for use for Routine clinical EEG where rapid placement of EEG electrodes as per the 10-20 EEG system is required | Intended for use in routine clinical settings where rapid placement of a number of EEG electrodes is desired | Same as reference predicate | #### 4. PERFORMANCE DATA The following performance testing was provided to support the substantial equivalence of the subject device: - EEG performance testing, as per IEC 60601-2-26:2012 ● - Testing of dry electrode input buffers (modified IEC 60601-2-26 testing) - Testing to verify functionality of optional auxiliary signals: . - -Infrared receiver - Infrared transmitter - - External optical input - - Photic trigger detector - - ECG input - - -Accelerometer - Video capture — - Contact quality detection feature - {13}------------------------------------------------ #### 5. STANDARDS The table below provides the complete list of standards that are used in the 510(k) to establish device performance and support substantial equivalence: | Standard | Title | |----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | ANSI / AAMI 60601- 1:2005 + A1:2012 | Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance | | IEC 60601-1-6:2010 + A1:2013 | Medical Electrical Equipment - Part 1-6: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Usability | | 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 | | IEC 60601-2-26:2012 | Medical electrical equipment - Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs | | ISO 14971:2007 | Medical Devices - Application of Risk Management to Medical Devices | | ANSI/AAMI 62304:2006 + A1:2015 | Medical Device Software - Software Life Cycle Processes | | ISO 10993-1:2009 + TC:2010 | Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process | | ISO 10993-5:2009 | Biological Evaluation of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity | | ISO 10993-10:2010 | Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Skin Sensitization | | ANSI / AAMI 62366:2007 + A1:2014 | Consolidated Version Medical Devices - Application Of Usability Engineering To Medical Devices | #### STERILIZATION, SHELF LIFE, CLEANING, REUSE 6. The WR19 System is neither shipped nor intended to be used sterile. The device is reusable, is intended for multi-patient use, and is intended to be cleaned and disinfected between uses. #### 7. BIOCOMPATIBILITY The patient-contacting materials of the WR19 System are all either limited duration (<24 h) skin or hair-contacting. Accordingly, cytotoxicity, maximization, and skin irritation testing were done as per ISO 10993-1:2009, ISO 10993-5:2009, and ISO 10993-10:2010. The results of all tests showed no evidence of toxic potential or adverse reactions. {14}------------------------------------------------ #### 8. CLINICAL PERFORMANCE TESTING Clinical testing was performed at a United States hospital to demonstrate that the WR19 System's electrode variations provide EEG signal quality that is comparable to a common EEG device cleared in K163163 - XLTEK EMU40EX. 7 subjects in 2 study cohorts (EEG patients and healthy volunteers) for 15-30 minutes of recording (2 cohorts, of EEG patients and healthy volunteers, 2 subjects each) and 2 hours (1 sub-cohort of healthy volunteers. 3 subjects). Healthy volunteers in both recording durations were asked to generate sources of artifact and/ or error. The results of time to setup, qualitative waveform comparisons, Likert scoring, and spectral correlation and SNR comparisons were analyzed to assess device performance. The subject device was found to perform at least as well as the comparator device based on predefined acceptance criteria. #### SOFTWARE DOCUMENTATION 9. Software documentation up to a Moderate Level of Concern device is provided in support of the WR19 System. #### ELECTRICAL SAFETY 10. The WR19 System was evaluated and the device was found to conform to ANSI / AAMI 60601-1:2005 + A1:2012. #### ELECTROMAGNETIC COMPATIBILITY 11. The WR19 System was evaluated and found to conform to IEC 60601-1-2:2014. In addition. wireless coexistence testing was conducted, per FDA's Guidance Document entitled "Radio Frequency Wireless Technology in Medical Devices issued on August 14, 2013. #### SUBSTANTIAL EQUIVALENCE CONCLUSION 12. Based on the comparison of intended use, technological characteristics to the previously cleared X-Series System (models X10 and X24) (K131383) as well as performance testing, and conformance with applicable standards, differences do not raise new questions of safety and effectiveness and the WR19 System is substantially equivalent to the predicate device.