WR19 System
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 |
Indications for 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
Submission Summary (Full Text)
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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);
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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
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## 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)
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# 510(k) Summary
# K172735
| Submitter Name | Zeto, Inc. |
|-----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter Address | 2336 Park Ave<br>Santa Clara, CA 95050 |
| Submitter Tel. Number | (408) 658-0737 |
| Contact Person | Donna-Bea Tillman, Ph.D.<br>Senior Consultant<br>Biologics Consulting Group<br>dtillman@biologicsconsulting.com<br>Phone: (410) 531-6542<br>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<br>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
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#### 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<br>WR19 System<br>K172735 | Predicate Device X-<br>Series System<br>K131383 | Remarks |
|-----------------------------|-------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| User<br>Interface | Operator control, visual<br>indicators | Operator control,<br>visual indicators | Same |
| System<br>Components | • Headset<br>• Electrodes<br>• Charger<br>• Charging cable<br>• Software | • Headset<br>(Electronics box)<br>• Electrode strip<br>• Electrodes<br>• Neoprene Strap<br>• Charger<br>• Charging cable<br>• Software | No significant difference.<br>Since WR19 works via the<br>cloud, it uses a data center<br>application, as opposed to<br>just using client software |
| | Subject Device<br>WR19 System<br>K172735 | Predicate Device X-<br>Series System<br>K131383 | Remarks |
| Signals<br>Acquired | • Scalp EEG<br>• Accelerometer<br>• Optional non-EEG<br>signals: | • Scalp EEG<br>• 3-D<br>actigraphy<br>(acceleromet<br>er based)<br>• Optional non-<br>EEG signals: | Same in measuring EEG<br>signals, but the subject<br>device offers a different<br>subset of optional auxiliary<br>features. |
| Power<br>Supply | 1 x 2050mAh 3.7V<br>Lithium Ion battery | 2 to 4 x 240mAh 3.7<br>Li- Ion batteries | No significant difference.<br>WR19 uses a bigger battery<br>because a higher sampling<br>rate generates more data and<br>requires more power. |
| Battery<br>Charging | Via USB connector<br>connected to USB wall<br>charger. | Via JED Connector<br>connected to USB port<br>or USB wall charger | Same |
| Typical<br>Charging<br>Time | 0.5-6.0 hours | 0.5-5.0 hours | Same |
| Operating<br>Time | 6-7 hours | Monitoring Days<br>after Charge/Hours<br>of Use<br>• 0-4 Days: 16 to<br>17 hours<br>• 5-10 Days: 14 to<br>15 hours | No significant<br>difference |
| Typical use<br>duration | 20 - 60 minutes | Not specified | Comparison not available;<br>however, the typical use<br>duration of the subject<br>device is standard for<br>outpatient / routine EEG<br>recording |
| | Subject Device<br>WR19 System<br>K172735 | Predicate Device X-<br>Series System<br>K131383 | Remarks |
| Dimensions | 8.5 x 10.8 x 5.7" or<br>214 x 274 x 144 mm<br>(Complete headset with<br>electrodes) | 5.0" long, 2.25" wide,<br>1.0" deep<br>(Electronics box) | No significant difference.<br>WR19 System contains a<br>headset worn like a bike<br>helmet. The electronics are<br>integrated into the headset.<br>Predicate has flexible<br>electrode strips that attach<br>to Velcro bands that hold an<br>electronics housing. Hence<br>dimensions vary. |
| Weight | < 650g or 23oz with<br>battery (Complete<br>headset with electrodes) | 3.9oz with two<br>batteries (Electronics<br>box) | No significant<br>difference. Refer to<br>row above for<br>comparison of<br>dimensions. |
| Cleaning | Cleaned and disinfected<br>by rubbing with<br>isopropyl alcohol | Cleaned and disinfected<br>by rubbing with<br>isopropyl alcohol | No significant difference.<br>Unlike predicate, WR19<br>uses dry electrodes that do<br>not require gel/paste to<br>operate. Hence, a gel/paste<br>residue is not left behind. |
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#### 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<br>WR19 System<br>K172735 | Predicate<br>Device<br>X-Series System<br>K131383 | Remarks |
|---------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Internal data<br>Storage | SD card, Minimum 8GB<br>memory capacity | Not used. The X-<br>Series system<br>does not include a<br>recording mode<br>where data is<br>stored on the<br>recorder. | No significant difference.<br>WR19 has built-in memory<br>buffer capacity to smooth<br>temporary slowing of data<br>communication, but WR19<br>also offers a backup solution<br>during total loss of<br>communication. |
| File Size<br>per 8 hr.<br>recording | 1.5 GB | 512 MB | No significant difference.<br>WR19 uses higher sampling<br>rate and hence file size is<br>higher. |
| Wireless<br>Data<br>Transfer | 802.11 b/g/n Wi-Fi | Bluetooth 2.0 | No significant difference. The<br>nature of the data transmission<br>protocol yields a higher data<br>throughput and more reliable<br>connection. |
| Maximum<br>wireless<br>transfer<br>distance | Headset includes<br>commercially available,<br>FCC-certified, Wi-Fi<br>module that works for<br>standard transfer distance<br>from Wi-Fi Router,<br>typically up to 30 meters. | Transfer<br>distance 10 m<br>line of sight,<br>maximum<br>transfer rate 3<br>Mbaud | No significant difference.<br>WR19 offers a longer data<br>transfer range. |
| | Subject Device<br>WR19 System<br>K172735 | Predicate<br>Device<br>X-Series System<br>K131383 | Remarks |
| Definition | Up to 19 referential<br>channels | Up to 20 differential<br>or referential channels | Same as predicate.<br>WR19 does not offer<br>differential variations in<br>hardware but can be<br>changed with software<br>montages, typical of<br>Full Montage EEG<br>systems. |
| Signal Processing<br>Techniques | Sampling Rate: 500<br>s/s | Sampling Rate: 256<br>s/s | No significant<br>difference. WR19<br>provides higher<br>temporal signal<br>resolution. |
| | No hardware<br>LPF/HPF/Notch<br>filters. | Hardware filters:<br>0.1Hz HPF, 100Hz<br>LPF | No significant<br>difference. WR19 does<br>not limit the<br>operator/EEG reviewer<br>as it does not use any<br>hardwired filters. |
| | Software Filtering:<br>Following are<br>optional: LPF and<br>HPF (Cutoff<br>frequency selectable<br>by operator), 50Hz,<br>60Hz notch | Software Filtering:<br>50, 60 Hz notch | Same as<br>predicate. WR19 also<br>offers a wider range of<br>operator selectable<br>filters. |
| | Subject Device<br>WR19 System<br>K172735 | Predicate<br>Device<br>X-Series System<br>K131383 | Remarks |
| Accuracy,<br>Performance | Sampling rate: 500 Hz<br>Dynamic range: +/- 375 mV<br>Resolution: 0.044 μV<br>Peak to peak noise: 4 µV (typical)<br>Common Mode Rejection Ratio: > 120dB (typical)<br>Input Impedance: 1000 GOhm<br>Noise: 1µV RMS<br>A/D Conversion: 24 Bit | Sampling rate: 256 Hz<br>Dynamic range: +/- 1000μV<br>Resolution: 0.03μV<br>Peak to peak noise: 3.7 µV (typical)<br>Common Mode Rejection Ratio: 110dB (typical)<br>Input Impedance: 100 GOhm<br>Noise: RMS not specified | No significant difference |
| Headset material | Semi-rigid and<br>flexible polymer<br>material (e.g.,<br>Polyamide PA12,<br>ABS, Polyurethane<br>and Polycarbonate) | Neoprene strap,<br>flexible plastic type<br>strips that hold foam<br>electrodes filled with<br>gel, rear electronics<br>casing (material not<br>specified) | No significant difference.<br>Both devices passed<br>applicable<br>Biocompatibility tests<br>outlined in relevant<br>standards. |
| Electrode type | Active, dry | Passive, wet | No significant difference |
| Contact<br>quality/Impedance<br>measurement | Contact quality<br>monitoring<br>performed real time<br>throughout the<br>recording/ test | Impedance<br>measurement<br>performed by operator<br>before the start of<br>EEG test during 'Test<br>Impedance' mode | No significant difference |
| | Subject Device<br>WR19 System<br>K172735 | Predicate Device<br>X-Series System<br>K131383 | Remarks |
| Channels | Single Differential ECG<br>using non-active (passive),<br>electrodes (optional)<br>(ECG lead wire and<br>electrodes not included) | Single Differential ECG<br>(optional)<br>(ECG cable included) | No significant<br>difference |
| Accuracy,<br>performance | Sampling rate: 500 Hz<br>Dynamic range: +/- 3900 mV<br>Resolution: 0.536 µV<br>Peak to peak noise: 4 µV<br>Common Mode Rejection<br>Ratio: > 110dB (typical)<br>Input Impedance: 500 MOhm<br>A/D Conversion: 24 Bit<br>Noise: 1 µV RMS | Sampling rate: 256 Hz<br>Dynamic range: +/- 2000 µV<br>Resolution: 0.06 µV<br>Peak to peak noise: 4.2 µV<br>Common Mode Rejection<br>Ratio: > 110dB (typical)<br>Input Impedance: 100 GOhm<br>A/D Conversion: 16 Bit<br>Noise: not specified | No significant<br>differences.<br>The amplitudes<br>of heartbeat<br>electrical<br>signals are of<br>the order of<br>millivolts. |
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#### 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:
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#### 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<br>WR19 System<br>K172735 | Predicate Device<br>X-Series System<br>K131383 | Remarks |
|-----------------|----------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|
| Scope of<br>use | Used primarily as an aid<br>for motion detection and<br>hence finding EEG<br>artifacts | Used primarily as part of<br>a 3-D actigraphy for<br>monitoring rest/ non-<br>specific activity cycles | No significant<br>difference. WR19<br>intended scope is a subset<br>of the predicate. |
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| 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<br>WR19 System<br>K172735 | Predicate<br>Device<br>X-Series System<br>K131383 | Remarks |
|----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|
| Firmware | WR19 headset is controlled by a<br>firmware. | X-series<br>headset is<br>controlled by a<br>firmware (No<br>more details<br>specified) | Same as predicate<br>device |
| Data center<br>application | WR19 sends data to the data center<br>application in the cloud. | Not applicable. | No significant<br>difference.<br>Predicate is not a<br>cloud solution. |
| Client<br>application | Client application presents<br>waveforms, controls EEG session,<br>and offers standard EEG<br>transformations such as low-pass,<br>high-pass and notch filters and<br>montage transformations. | Client application<br>presents<br>waveforms (No<br>more details<br>specified) | No significant<br>difference |
| Client<br>application | Client application records and<br>retrieves EEG waveforms. | Client application<br>presents<br>waveforms (No<br>more details<br>specified) | No significant<br>difference.<br>Predicate uses 3rd<br>party software to<br>retrieve and display<br>waveforms. |
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#### 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<br>WR19 System<br>K172735 | Reference Device<br>g.Nautilus PRO<br>K171669 | Remarks |
|------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|-----------------------------------|
| Electrode<br>material | Ag/AgCl coated | Gold or Ag/AgCl coated | Same as<br>reference<br>predicate |
| Type of<br>electrodes | Active, dry | Active, wet or dry | Same as<br>reference<br>predicate |
| Electrode<br>mounting<br>mechanism | Semi-rigid wearable headset<br>with certain electrode<br>positions. Electrode positions<br>can be adjusted to a limited<br>extent | Elastic EEG cap with chin<br>strap with certain<br>electrode positions | No significant<br>difference |
| Typical usage<br>setting | Intended for use for Routine<br>clinical EEG where rapid<br>placement of EEG electrodes<br>as per the 10-20 EEG system<br>is required | Intended for use in routine<br>clinical settings where<br>rapid placement of a<br>number of EEG electrodes<br>is desired | Same as<br>reference<br>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 -
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#### 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-<br>1:2005 + A1:2012 | Medical Electrical Equipment - Part 1: General Requirements for Basic Safety<br>and Essential Performance |
| IEC 60601-1-6:2010 +<br>A1:2013 | Medical Electrical Equipment - Part 1-6: General Requirements for Basic Safety<br>and Essential Performance - Collateral Standard: Usability |
| IEC 60601-1-2:2014 | Medical Electrical Equipment - Part 1-2: General Requirements for Basic Safety<br>and Essential Performance - Collateral Standard: Electromagnetic Disturbances -<br>Requirements and Tests |
| IEC 60601-2-26:2012 | Medical electrical equipment - Part 2-26: Particular requirements for the basic<br>safety and essential performance of electroencephalographs |
| ISO 14971:2007 | Medical Devices - Application of Risk Management to Medical Devices |
| ANSI/AAMI<br>62304:2006 + A1:2015 | Medical Device Software - Software Life Cycle Processes |
| ISO 10993-1:2009 +<br>TC:2010 | Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing<br>Within a Risk Management Process |
| ISO 10993-5:2009 | Biological Evaluation of Medical Devices - Part 5: Tests For In Vitro<br>Cytotoxicity |
| ISO 10993-10:2010 | Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Skin<br>Sensitization |
| ANSI / AAMI<br>62366:2007 + A1:2014 | Consolidated Version Medical Devices - Application Of Usability Engineering<br>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.
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#### 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.
