(218 days)
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.
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
Here is an analysis of the acceptance criteria and supporting study for the WR19 System, based on the provided document:
Acceptance Criteria and Device Performance
The document does not explicitly present a table of acceptance criteria with corresponding performance metrics in a single, clear format as might be desired for a device performance study. Instead, it describes performance testing outcomes and comparisons to a predicate device. The primary performance criteria are implicitly related to the ability of the WR19 System to acquire EEG signals comparably to a legally marketed predicate device (XLTEK EMU40EX) and meet established electrical and safety standards.
Here's an attempt to synthesize the acceptance criteria and stated performance based on the "510(k) Summary" and "PERFORMANCE DATA" sections, particularly "8. CLINICAL PERFORMANCE TESTING":
| Acceptance Criteria Category | Specific Criteria (Implicit or Explicit) | Reported Device Performance (WR19 System) |
|---|---|---|
| EEG Signal Quality | Comparable EEG signal quality to XLTEK EMU40EX (K163163). | "The subject device was found to perform at least as well as the comparator device based on predefined acceptance criteria." Evaluated via: Qualitative waveform comparisons, Likert scoring, spectral correlation, and SNR comparisons. |
| Setup Time | Not explicitly stated but evaluated. | "Results of time to setup... were analyzed to assess device performance." (Implied comparable or better than predicate, otherwise would be noted as a deficiency). |
| Artifact and Error Generation Handling | Ability to handle sources of artifact and/or error. | Healthy volunteers were "asked to generate sources of artifact and/ or error," and performance was assessed. (Implied satisfactory handling, as it contributed to the overall positive performance conclusion). |
| Functionality of Optional Auxiliary Signals | Verification of functionality for infrared receiver/transmitter, external optical input, photic trigger detector, ECG input, accelerometer, video capture, contact quality detection. | Testing confirmed functionality. |
| Electrical Safety | Conformance to ANSI / AAMI 60601-1:2005 + A1:2012. | "The WR19 System was evaluated and the device was found to conform to ANSI / AAMI 60601-1:2005 + A1:2012." |
| Electromagnetic Compatibility (EMC) | Conformance to IEC 60601-1-2:2014 and wireless coexistence testing per FDA guidance. | "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..." |
Study Details
-
Sample size used for the test set and the data provenance:
- Test Set Sample Size: 7 subjects.
- 2 cohorts: EEG patients and healthy volunteers.
- Recording durations: 15-30 minutes for 2 subjects (EEG patients and healthy volunteers) and 2 hours for 3 healthy volunteers.
- Data Provenance: The study was conducted "at a United States hospital." This indicates prospective data collection for this specific study.
- Test Set Sample Size: 7 subjects.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document does not specify the number of experts used to establish ground truth or their qualifications. The phrase "qualitative waveform comparisons" suggests expert review, but details are absent.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- The document does not describe any specific adjudication method for the test set.
-
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This was not an MRMC comparative effectiveness study involving AI assistance for human readers. The study compared the signal quality of the WR19 System (which is an EEG acquisition device) to another EEG acquisition device. There is no mention of AI in the context of improving human reader performance.
-
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, in essence, but not in the context of an "AI algorithm." The "standalone" performance here refers to the device's ability to acquire and produce EEG signals. The clinical performance testing ("8. CLINICAL PERFORMANCE TESTING") evaluates the device's inherent signal quality and functionality (e.g., contact quality detection feature, various auxiliary signals). This is a standalone evaluation of the device's performance characteristics.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the clinical performance study was established by comparing the WR19 System's EEG signals to those obtained from a "common EEG device cleared in K163163 - XLTEK EMU40EX." This implies a comparison to an established, legally marketed predicate device's output considered to be the standard for EEG signal quality. The evaluation metrics included "qualitative waveform comparisons, Likert scoring, and spectral correlation and SNR comparisons." This suggests expert qualitative review and quantitative signal analysis relative to the predicate.
-
The sample size for the training set:
- The document does not mention a training set in the context of the clinical performance study. The WR19 System is an EEG acquisition device, not a diagnostic AI algorithm that typically requires a large training dataset. The software components are described as firmware, client application, and data center application, performing functions like presenting waveforms, controlling sessions, and standard EEG transformations (filters, montages), not complex pattern recognition that would necessitate a traditional "training set."
-
How the ground truth for the training set was established:
- Not applicable as no training set (in the AI/machine learning sense) is described for the clinical performance study.
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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 AveSanta Clara, CA 95050 |
| Submitter Tel. Number | (408) 658-0737 |
| Contact Person | Donna-Bea Tillman, Ph.D.Senior ConsultantBiologics Consulting Groupdtillman@biologicsconsulting.comPhone: (410) 531-6542Fax: (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 Headsetwith 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 DeviceWR19 SystemK172735 | Predicate Device X-Series SystemK131383 | Remarks | |
|---|---|---|---|
| UserInterface | Operator control, visualindicators | Operator control,visual indicators | Same |
| SystemComponents | • 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 thecloud, it uses a data centerapplication, as opposed tojust using client software |
| Subject DeviceWR19 SystemK172735 | Predicate Device X-Series SystemK131383 | Remarks | |
| SignalsAcquired | • Scalp EEG• Accelerometer• Optional non-EEGsignals: | • Scalp EEG• 3-Dactigraphy(accelerometer based)• Optional non-EEG signals: | Same in measuring EEGsignals, but the subjectdevice offers a differentsubset of optional auxiliaryfeatures. |
| PowerSupply | 1 x 2050mAh 3.7VLithium Ion battery | 2 to 4 x 240mAh 3.7Li- Ion batteries | No significant difference.WR19 uses a bigger batterybecause a higher samplingrate generates more data andrequires more power. |
| BatteryCharging | Via USB connectorconnected to USB wallcharger. | Via JED Connectorconnected to USB portor USB wall charger | Same |
| TypicalChargingTime | 0.5-6.0 hours | 0.5-5.0 hours | Same |
| OperatingTime | 6-7 hours | Monitoring Daysafter Charge/Hoursof Use• 0-4 Days: 16 to17 hours• 5-10 Days: 14 to15 hours | No significantdifference |
| Typical useduration | 20 - 60 minutes | Not specified | Comparison not available;however, the typical useduration of the subjectdevice is standard foroutpatient / routine EEGrecording |
| Subject DeviceWR19 SystemK172735 | Predicate Device X-Series SystemK131383 | Remarks | |
| Dimensions | 8.5 x 10.8 x 5.7" or214 x 274 x 144 mm(Complete headset withelectrodes) | 5.0" long, 2.25" wide,1.0" deep(Electronics box) | No significant difference.WR19 System contains aheadset worn like a bikehelmet. The electronics areintegrated into the headset.Predicate has flexibleelectrode strips that attachto Velcro bands that hold anelectronics housing. Hencedimensions vary. |
| Weight | < 650g or 23oz withbattery (Completeheadset with electrodes) | 3.9oz with twobatteries (Electronicsbox) | No significantdifference. Refer torow above forcomparison ofdimensions. |
| Cleaning | Cleaned and disinfectedby rubbing withisopropyl alcohol | Cleaned and disinfectedby rubbing withisopropyl alcohol | No significant difference.Unlike predicate, WR19uses dry electrodes that donot require gel/paste tooperate. Hence, a gel/pasteresidue 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 DeviceWR19 SystemK172735 | PredicateDeviceX-Series SystemK131383 | Remarks | |
|---|---|---|---|
| Internal dataStorage | SD card, Minimum 8GBmemory capacity | Not used. The X-Series systemdoes not include arecording modewhere data isstored on therecorder. | No significant difference.WR19 has built-in memorybuffer capacity to smoothtemporary slowing of datacommunication, but WR19also offers a backup solutionduring total loss ofcommunication. |
| File Sizeper 8 hr.recording | 1.5 GB | 512 MB | No significant difference.WR19 uses higher samplingrate and hence file size ishigher. |
| WirelessDataTransfer | 802.11 b/g/n Wi-Fi | Bluetooth 2.0 | No significant difference. Thenature of the data transmissionprotocol yields a higher datathroughput and more reliableconnection. |
| Maximumwirelesstransferdistance | Headset includescommercially available,FCC-certified, Wi-Fimodule that works forstandard transfer distancefrom Wi-Fi Router,typically up to 30 meters. | Transferdistance 10 mline of sight,maximumtransfer rate 3Mbaud | No significant difference.WR19 offers a longer datatransfer range. |
| Subject DeviceWR19 SystemK172735 | PredicateDeviceX-Series SystemK131383 | Remarks | |
| Definition | Up to 19 referentialchannels | Up to 20 differentialor referential channels | Same as predicate.WR19 does not offerdifferential variations inhardware but can bechanged with softwaremontages, typical ofFull Montage EEGsystems. |
| Signal ProcessingTechniques | Sampling Rate: 500s/s | Sampling Rate: 256s/s | No significantdifference. WR19provides highertemporal signalresolution. |
| No hardwareLPF/HPF/Notchfilters. | Hardware filters:0.1Hz HPF, 100HzLPF | No significantdifference. WR19 doesnot limit theoperator/EEG revieweras it does not use anyhardwired filters. | |
| Software Filtering:Following areoptional: LPF andHPF (Cutofffrequency selectableby operator), 50Hz,60Hz notch | Software Filtering:50, 60 Hz notch | Same aspredicate. WR19 alsooffers a wider range ofoperator selectablefilters. | |
| Subject DeviceWR19 SystemK172735 | PredicateDeviceX-Series SystemK131383 | Remarks | |
| Accuracy,Performance | Sampling rate: 500 HzDynamic range: +/- 375 mVResolution: 0.044 μVPeak to peak noise: 4 µV (typical)Common Mode Rejection Ratio: > 120dB (typical)Input Impedance: 1000 GOhmNoise: 1µV RMSA/D Conversion: 24 Bit | Sampling rate: 256 HzDynamic range: +/- 1000μVResolution: 0.03μVPeak to peak noise: 3.7 µV (typical)Common Mode Rejection Ratio: 110dB (typical)Input Impedance: 100 GOhmNoise: RMS not specified | No significant difference |
| Headset material | Semi-rigid andflexible polymermaterial (e.g.,Polyamide PA12,ABS, Polyurethaneand Polycarbonate) | Neoprene strap,flexible plastic typestrips that hold foamelectrodes filled withgel, rear electronicscasing (material notspecified) | No significant difference.Both devices passedapplicableBiocompatibility testsoutlined in relevantstandards. |
| Electrode type | Active, dry | Passive, wet | No significant difference |
| Contactquality/Impedancemeasurement | Contact qualitymonitoringperformed real timethroughout therecording/ test | Impedancemeasurementperformed by operatorbefore the start ofEEG test during 'TestImpedance' mode | No significant difference |
| Subject DeviceWR19 SystemK172735 | Predicate DeviceX-Series SystemK131383 | Remarks | |
| Channels | Single Differential ECGusing non-active (passive),electrodes (optional)(ECG lead wire andelectrodes not included) | Single Differential ECG(optional)(ECG cable included) | No significantdifference |
| Accuracy,performance | Sampling rate: 500 HzDynamic range: +/- 3900 mVResolution: 0.536 µVPeak to peak noise: 4 µVCommon Mode RejectionRatio: > 110dB (typical)Input Impedance: 500 MOhmA/D Conversion: 24 BitNoise: 1 µV RMS | Sampling rate: 256 HzDynamic range: +/- 2000 µVResolution: 0.06 µVPeak to peak noise: 4.2 µVCommon Mode RejectionRatio: > 110dB (typical)Input Impedance: 100 GOhmA/D Conversion: 16 BitNoise: not specified | No significantdifferences.The amplitudesof heartbeatelectricalsignals are ofthe order ofmillivolts. |
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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 DeviceWR19 SystemK172735 | Predicate DeviceX-Series SystemK131383 | Remarks | |
|---|---|---|---|
| Scope ofuse | Used primarily as an aidfor motion detection andhence finding EEGartifacts | Used primarily as part ofa 3-D actigraphy formonitoring rest/ non-specific activity cycles | No significantdifference. WR19intended scope is a subsetof 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 DeviceWR19 SystemK172735 | PredicateDeviceX-Series SystemK131383 | Remarks | |
|---|---|---|---|
| Firmware | WR19 headset is controlled by afirmware. | X-seriesheadset iscontrolled by afirmware (Nomore detailsspecified) | Same as predicatedevice |
| Data centerapplication | WR19 sends data to the data centerapplication in the cloud. | Not applicable. | No significantdifference.Predicate is not acloud solution. |
| Clientapplication | Client application presentswaveforms, controls EEG session,and offers standard EEGtransformations such as low-pass,high-pass and notch filters andmontage transformations. | Client applicationpresentswaveforms (Nomore detailsspecified) | No significantdifference |
| Clientapplication | Client application records andretrieves EEG waveforms. | Client applicationpresentswaveforms (Nomore detailsspecified) | No significantdifference.Predicate uses 3rdparty software toretrieve and displaywaveforms. |
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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 DeviceWR19 SystemK172735 | Reference Deviceg.Nautilus PROK171669 | Remarks | |
|---|---|---|---|
| Electrodematerial | Ag/AgCl coated | Gold or Ag/AgCl coated | Same asreferencepredicate |
| Type ofelectrodes | Active, dry | Active, wet or dry | Same asreferencepredicate |
| Electrodemountingmechanism | Semi-rigid wearable headsetwith certain electrodepositions. Electrode positionscan be adjusted to a limitedextent | Elastic EEG cap with chinstrap with certainelectrode positions | No significantdifference |
| Typical usagesetting | Intended for use for Routineclinical EEG where rapidplacement of EEG electrodesas per the 10-20 EEG systemis required | Intended for use in routineclinical settings whererapid placement of anumber of EEG electrodesis desired | Same asreferencepredicate |
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 60601-1:2005 + A1:2012 | Medical Electrical Equipment - Part 1: General Requirements for Basic Safetyand Essential Performance |
| IEC 60601-1-6:2010 +A1:2013 | Medical Electrical Equipment - Part 1-6: General Requirements for Basic Safetyand Essential Performance - Collateral Standard: Usability |
| IEC 60601-1-2:2014 | Medical Electrical Equipment - Part 1-2: General Requirements for Basic Safetyand Essential Performance - Collateral Standard: Electromagnetic Disturbances -Requirements and Tests |
| IEC 60601-2-26:2012 | Medical electrical equipment - Part 2-26: Particular requirements for the basicsafety and essential performance of electroencephalographs |
| ISO 14971:2007 | Medical Devices - Application of Risk Management to Medical Devices |
| ANSI/AAMI62304:2006 + A1:2015 | Medical Device Software - Software Life Cycle Processes |
| ISO 10993-1:2009 +TC:2010 | Biological Evaluation of Medical Devices - Part 1: Evaluation and TestingWithin a Risk Management Process |
| ISO 10993-5:2009 | Biological Evaluation of Medical Devices - Part 5: Tests For In VitroCytotoxicity |
| ISO 10993-10:2010 | Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and SkinSensitization |
| ANSI / AAMI62366:2007 + A1:2014 | Consolidated Version Medical Devices - Application Of Usability EngineeringTo 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.
§ 882.1400 Electroencephalograph.
(a)
Identification. An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.(b)
Classification. Class II (performance standards).