(130 days)
The WEE-1200 Wireless Input Unit is intended to acquire, store, record, and transmit the cerebral and extracerebral activity for EEG and sleep studies. The device should be used together with Nihon Kohden specified electroencephalograph via wired or wireless communication to display EEG on the electroencephalograph screen. These data may be used by the clinician in sleep disorder, epilepsies and other related disorders as an aid in diagnosis. The WEE-1200 Wireless Input Unit is designed for use by qualified medical facility such as a hospital or clinic on all patient populations including adult, neonate, infant, child and adolescent subgroups.
The WEE-1200 Wireless Input Unit is a system that can be used in routine EEG testing, epilepsy monitoring, or PSG testing to send the measured EEG waves, ECG waves, EMG waves, EOG waves, and respiration waves from the electroencephalograph by wired or wireless LAN. The electrodes are connected to a mini junction box which is connected to the telemetry unit that is worn by patient or placed near patient.
The measured data can also be stored in the telemetry unit of the WEE-1200 Wireless Input Unit.
Additionally, by connecting a SpO2 sensor and SpO2 adapter to the telemetry unit, SpO2 value and waveform can be measured and displayed on both the electroencephalograph screen and the telemetry unit LCD display.
The provided text describes the regulatory submission for the Nihon Kohden Wireless Input Unit WEE-1200, primarily focusing on its substantial equivalence to predicate devices rather than proving its performance against specific acceptance criteria for diagnostic accuracy.
Therefore, many of the requested details about acceptance criteria, study design for proving device performance (like sample size, number of experts, adjudication methods, MRMC studies, standalone performance, and ground truth establishment), and training set information are not available in this document. This submission is for an Electroencephalograph (EEG) wireless input unit, which is a data acquisition and transmission device, not an AI-powered diagnostic tool. The "performance" being validated here relates to its technical functionality, safety, and electromagnetic compatibility.
However, I can extract information related to the non-clinical testing that was performed to demonstrate substantial equivalence and meet regulatory standards.
Here's a breakdown of the available information based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present specific diagnostic performance acceptance criteria (e.g., sensitivity, specificity, AUC) because it is a device for acquiring and transmitting physiological signals (EEG, ECG, EMG, EOG, respiration, SpO2), not a diagnostic algorithm. The acceptance criteria are based on functional performance, safety, and electromagnetic compatibility.
| Criterion Type | Specific Test | Acceptance Standard (Implicit/Explicit) | Reported Device Performance |
|---|---|---|---|
| Functional/Software | Software Unit Test | Code inspection and static analysis. | Tests performed and results indicate compliance (implied by "Software verification and validation testing for the WEE-1200 includes the following tests"). |
| Software Integration Test | Transfer of data and control across a program's internal and external interfaces. | Tests performed and results indicate compliance (implied by "Software verification and validation testing for the WEE-1200 includes the following tests"). | |
| System Test | Comprehensive testing of all required functionality of the device (hardware and software). | Tests performed and results indicate compliance (implied by "Software verification and validation testing for the WEE-1200 includes the following tests"). | |
| Wireless Performance | Wireless Coexistence Test | Performance validation in the presence of wireless emitters in the intended use environment (hardware and software) following FDA Guidance, "Radio Frequency Wireless Technology in Medical Device". | "The wireless transmission performance of the subject device is validated according to the FDA guidance..." indicating it met the requirements. |
| Wireless Network Test | Verify and validate the ability to securely operate in a mixed client enterprise 802.11a/b/g/n network, and to demonstrate the correct quality of service (hardware and software) following FDA Guidance, "Radio Frequency Wireless Technology in Medical Device". | "The wireless transmission performance of the subject device is validated according to the FDA guidance..." indicating it met the requirements. | |
| Wireless Operation Test | Verify and validate the Wi-Fi operation of the device (hardware and software) following FDA Guidance, "Radio Frequency Wireless Technology in Medical Device". | "The wireless transmission performance of the subject device is validated according to the FDA guidance..." indicating it met the requirements. | |
| Safety & EMC Standards | AAMI/ANSI ES 60601-1:2005/(R)2012 and A1:2012 | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance. | Tests performed and compliance stated (implied by inclusion in "Standards compliance testing on the device includes"). |
| IEC 60601-1-2:2007 | Medical electrical equipment Part 1-2: General requirements for safety and essential performance collateral standard: Electromagnetic compatibility - requirements and tests. | Tests performed and compliance stated (implied by inclusion in "Standards compliance testing on the device includes"). | |
| IEC 60601-2-26:2012 | Medical electrical equipment – Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs. | Tests performed and compliance stated (implied by inclusion in "Standards compliance testing on the device includes"). | |
| ISO 80601-2-61:2011 | Medical electrical equipment – Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment (for the SpO2 adapter). | Tests performed and compliance stated (implied by inclusion in "Standards compliance testing on the device includes"). | |
| Technical Specifications | Noise, Rejection Ratio, Low/High Cut Filter, Input Impedance, Sampling Frequency (compared to predicates) | Predicate device performance or equivalent (e.g., Noise: < 2.0 micro Vp-p, Rejection ratio: > 105dB, Input impedance: 200M ohm, Max Sampling Frequency: 4000Hz (wired) / 2000Hz) as detailed in the "Technological Characteristics - Substantial Equivalence Discussion" table. | The WEE-1200's specifications are listed in the comparative table, showing performance within acceptable ranges and often improvements over the predicate (e.g., Noise < 2.0 micro Vp-p vs. WEE-1000A's < 3.0 micro Vp-p; Max Sampling Freq: 4000Hz vs. WEE-1000A's 200Hz). Its wireless LAN security uses 802.11 WPA/WPA2, an enhancement from the predicate's original protocol. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable in the context of diagnostic accuracy for an AI/ML model on a specific dataset of patient cases. The tests described are non-clinical, involving hardware and software validation, and compliance with technical standards.
- Data Provenance: Not applicable for patient data. The tests are laboratory-based, ensuring the device's technical specifications and compliance with standards.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
- Not applicable. This device is a data acquisition and transmission unit, not an AI diagnostic tool that requires ground truth established by medical experts for diagnostic accuracy claims. The "ground truth" here is the adherence to engineering specifications and regulatory standards, evaluated through technical validation tests.
4. Adjudication Method for the Test Set
- Not applicable. No human adjudication of medical findings is involved in the validation described.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No. This is not an AI-assisted diagnostic device, so MRMC studies were not performed. The submission explicitly states "No clinical testing on the subject device was necessary to show substantial equivalence to the predicate."
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was Done
- Not applicable. This device is hardware for signal acquisition and transmission, not a standalone diagnostic algorithm.
7. The Type of Ground Truth Used
- Technical Specifications and Regulatory Standards: The "ground truth" for this device's performance validation is its adherence to established electrical, safety, electromagnetic compatibility, and wireless communication standards and the functional specifications demonstrated through engineering tests.
8. The Sample Size for the Training Set
- Not applicable. This device is not an AI/ML model trained on a dataset of patient cases.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. No training set for an AI/ML model is mentioned or relevant for this device.
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Public Health Service
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 25, 2017
Nihon Kohden Corporation % Tom Bento Sr. Vice President, Quality and Regulatory Nihon Kohden America, Inc. 15353 Barranca Parkway Irvine, California 92618
Re: K171124
Trade/Device Name: Nihon Kohden Wireless Input Unit WEE-1200 Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: GWQ, OLV Dated: July 31, 2017 Received: August 1, 2017
Dear Mr. Bento:
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
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related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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 Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Michael J. Hoffmann -S
for
Carlos L. Peña, PhD, MS 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) K171124
Device Name Nihon Kohden Wireless Input Unit WEE-1200
Indications for Use (Describe)
The WEE-1200 Wireless Input Unit is intended to acquire, store, record, and transmit the cerebral and extracerebral activity for EEG and sleep studies. The device should be used together with Nihon Kohden specified electroencephalograph via wired or wireless communication to display EEG on the electroencephalograph screen. These data may be used by the clinician in sleep disorder, epilepsies and other related disorders as an aid in diagnosis. The WEE-1200 Wireless Input Unit is designed for use by qualified medical facility such as a hospital or clinic on all patient populations including adult, neonate, infant, child and adolescent subgroups.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☒ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
Nihon Kohden Wireless Input Unit WEE-1200
| Submitter: | Nihon Kohden Corporation |
|---|---|
| Address: | 1-31-4 Nishiochiai, Shinjuku-KuTokyo, Japan 161-8560 |
| Phone number: | 81-3-5996-8020 |
| Contact person: | Tom Bento |
| Phone number: | (949) 680-9048 |
| Fax number: | (913) 273-0732 |
| Date prepared: | April 14, 2017 |
| Device name: | Nihon Kohden Wireless Input Unit WEE-1200 |
| Common name: | Electroencephalograph (EEG) |
| Primary product codes: | GWQ, OLV |
| Regulation numbers: | 21 CFR 882.1400 |
| Substantial equivalence claimed to: | Nihon Kohden Wireless Input Unit WEE-1000A (K033475)Nihon Kohden EEG-1200A with JE-120A Multi ChannelElectrode Junction Box (K113117) |
Description:
The WEE-1200 Wireless Input Unit is a system that can be used in routine EEG testing, epilepsy monitoring, or PSG testing to send the measured EEG waves, ECG waves, EMG waves, EOG waves, and respiration waves from the electroencephalograph by wired or wireless LAN. The electrodes are connected to a mini junction box which is connected to the telemetry unit that is worn by patient or placed near patient.
The measured data can also be stored in the telemetry unit of the WEE-1200 Wireless Input Unit.
Additionally, by connecting a SpO2 sensor and SpO2 adapter to the telemetry unit, SpO2 value and waveform can be measured and displayed on both the electroencephalograph screen and the telemetry unit LCD display.
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Indications for Use:
The WEE-1200 Wireless Input Unit is intended to acquire, store, record, and transmit the cerebral and extracerebral activity for EEG and sleep studies. The device should be used together with Nihon Kohden specified electroencephalograph via wired or wireless communication to display EEG on the electroencephalograph screen. These data may be used by the clinician in sleep disorder, epilepsies and other related disorders as an aid in diagnosis. The WEE-1200 Wireless Input Unit is designed for use by qualified medical personnel in a medical facility such as a hospital or clinic on all patient populations including adult, neonate, infant, child and adolescent subgroups.
Technological Characteristics - Substantial Equivalence Discussion
The WEE-1200, just like its predicate WEE-1000A (K033475), is a device intended to be used together with Nihon Kohden electroencephalographs such as EEG-1200A (K080546) to transmit the measured data via wired LAN. The WEE-1200 has same measuring parameters as the predicates.
The new SpO2 adapter, JL-570T, that can be used with the subject device for SpO2 measurement is substantially equivalent to the previously cleared SpO2 adapter. JL-550T1 (K113117, EEG-1200A with JE-120A), with only a few minor differences that do not raise any new safety and effectiveness issues.
When compared with the WEE-1000A (K033475), the subject device has an enhanced transmission performance: the maximum transmission throughput is increased and dualband operation (IEEE802.11 a/b/g/n) is available on the subject device. The wireless LAN security adopted on the predicate device was Nihon Kohden original protocol while the subject device utilizes 802.11 WPA/WPA2. The wireless transmission performance of the subject device is validated according to the FDA guidance "Radio Frequency Wireless Technology in Medical Devices" for its co-existence features and network performance.
| EEG-1200A with JE-120A Junction BoxPredicate Device(K113117) | WEE-1000AWireless Input UnitPredicate Device(K033475) | WEE-1200Wireless Input UnitNew Device | |
|---|---|---|---|
| Indications for Use | EEG-1200 seriesNeurofax is intended torecord, measure anddisplay cerebral andextraccrebral activity forEEG and Sleep Studies.These data may be usedby the clinician in sleepdisorder, epilepsies andother related disorders asan aid in diagnosis.The device is intended foruse by medical personnelin any location within a | The device is intended toacquire, store, andtransfer biophysicalparameters to EEGmachines for the purposeof assisting the diagnosisof neurological and sleepdisorders, measurementand display of cerebraland extracerebral activityfor EEG and sleepstudies. These data maybe used by clinician in | The WEE-1200 WirelessInput Unit is intended toacquire, store, record, andtransmit the cerebral andextracerebral activity for EEGand sleep studies. Thedevice should be usedtogether with Nihon Kohdenspecifiedelectroencephalograph viawired or wirelesscommunication to displayEEG on theelectroencephalographscreen. These data may be |
| EEG-1200A with JE-120A Junction Box | WEE-1000AWireless Input Unit | WEE-1200Wireless Input Unit | |
| Predicate Device(K113117) | Predicate Device(K033475) | New Device | |
| medical facility,laboratory, clinic ornursing home or outsideof a medical facility underdirect supervision of amedical professional. | sleep disorders,epilepsies and otherrelated disorders as adiagnostic tool.The device is intended foruse by medical personnelin any location within amedical facility,physician's office,laboratory, clinic ornursing home or outsideof a medical facility undersupervision of a medicalprofessional. The devicewill be available in allpopulations, includingpediatrics. | used by the clinician in sleepdisorder, epilepsies andother related disorders as anaid in diagnosis.The WEE-1200 WirelessInput Unit is designed for useby qualified medicalpersonnel in a medical facilitysuch as a hospital or clinic onall patient populationsincluding adult, neonate,infant, child and adolescentsubgroups. | |
| Product used with | Nihon Kohden EEG-1200A (K080546) | Nihon Kohden EEG-1200A (K080546) | Nihon Kohden EEG-1200A(K080546) |
| Measurement Parameters | EEG, ECG, EMG,EOG, SpO2 and CO2 | EEG, ECG, EMG, EOG,Respiration, and SpO2 | EEG, ECG, EMG, EOGrespiration, and SpO2 |
| Telemetry Unit | |||
| Telemetry Unit Model | N/A | ZB-101AA or ZB-102AA | ZB-120A |
| Wireless LAN | N/A | IEEE 802.11 b/g | IEEE 802.11a/b/g/n |
| Frequency band | N/A | 2.4GHz | 2.4 GHz or 5 GHz |
| Number of channels | N/A | 2.4 GHz: 11 channels (1to 11ch) | 2.4 GHz: 11 channels (1 to11ch)5 GHz: 24 channels (36, 40,44, 48, 52, 56, 60, 64, 100,104, 108, 112, 116, 120, 124,128, 132, 136, 140, 149, 153,157, 161, 165 ch) |
| Modulation | N/A | DSSS (BPSK/QPSK):1 & 2 MbpsDSSS (CCK):5 & 11 Mbps | Auto(DSSS (BPSK/QPSK/CCK)): 802.11bOFDM (BPSK/QPSK/16QAM/64QAM):802.11a/g/n(6/9/12/18/24/36/48/54Mbps, MCS0/1/2/3/4/5/67) |
| Transmission power | N/A | < 5mW/MHz | 2.4GHz< 10mW/MHz5GHz< 10mW/MHz |
| Wireless LAN security | N/A | NK Original | WEP, WPA, WPA2 |
| Battery operation time | N/A | 18 hours(Using 10s Intermittenttransfer mode) | 10 hours (using internalbattery only)30 hours (using internalBattery and Extension unit) |
| EEG-1200A with JE-120A Junction Box | WEE-1000AWireless Input Unit | WEE-1200Wireless Input Unit | |
| Predicate Device(K113117) | Predicate Device(K033475) | New Device | |
| Applied wirelesstransmission standardsand guidance | N/A | FCC 47CFR Part 15 | FCC 47CFR Part 15 Subpart C |
| Subpart BFCC 47CFR Part 15Subpart C | FCC 47CFR Part 15 Subpart B | ||
| (FCC ID: PVH0941) | |||
| FCC 47CFR Part 2 1093 | |||
| (FCC ID: B6B0941) | |||
| Electrode Junction Box | |||
| Junction Box Model | • Amplification unitJE-120A | • Amplification unitZB-101AA/102AA | • Amplification unitZB-120A |
| • Mini Junction BoxJE-125AK or JE-225AKAnd JE-226AK/227AK/228AK | • Mini Junction BoxJE-011A or JE-012A orJE-013A | • Mini Junction BoxJE-125AK or JE-225AKor JE-922A | |
| Electrode jacks | Up to 64 for EEGUp to 4 for bipolar inputZ electrodeCOM | Up to 62 for EEGZ electrode | Up to 64 for EEGUp to 4 for bipolar inputZ electrodeCOM |
| Reference electrode | A5 and A6 (C3 and C4)or COM | A5 and A6 (C3 and C4) | A5 and A6 (C3 and C4)or COM |
| Input impedance | 200M ohm | 200M ohm | 200M ohm |
| Noise | Less than 1.5 micro Vp-p | Less than 3.0 micro Vp-p | Less than 2.0 micro Vp-p |
| Rejection ratio | More than 110dB | More than 105dB | More than 105 dB |
| Low cut filter | 0.016Hz (TC 10 seconds)or 0.08Hz (TC 2 seconds) | 0.08Hz (TC 2 seconds) | 0.08Hz (TC 2 seconds) |
| High cut filter | 3000Hz (-18dB/oct) | 60Hz (-18dB/oct) | 1200Hz (-18dB/oct) |
| Electrode impedancecheck | Yes | Yes | Yes |
| A/D resolution | 16 bit (97nV/LSB) or16 bit (388nV/LSB) | 16 bit (97nV/LSB) | 16 bit (97nV/LSB) or16 bit (388nV/LSB) |
| Maximum Samplingfrequency | 10000 Hz | 200Hz | • 4000Hz(Wired mode: Without anyconditionWireless mode: limit of storageof 40ch electrode )• 2000Hz(without any condition) |
| Main Unit | |||
| Interface with EEG | 100Base-TX LAN(On the QI-123AK) | 100Base-TX LAN(On the ZR-101AK) | 100Base-TX LAN |
Device comparison:
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Comparison of SpO2 adapters:
| JL-550T1(K113117) | JL-570T(New) | |
|---|---|---|
| Measurement Parameters | Saturated oxygen (SpO2), Pulse rate (PR) | |
| SpO2 measuring specification | ||
| Measuring method | Two wavelength light absorption method | |
| Measuring Range | 0 to 100%SpO2 | |
| Measuring accuracy (rms) | ±2 %SpO2 (80 %SpO2 ≤ SpO2 ≤ 100 %SpO2 )±3 %SpO2 (70 % SpO2 ≤SpO2 < 80 %SpO2 )SpO2 accuracy is guaranteed at surrounding temperature of 18 to40°C (64.4 to 104°F). | |
| Pulse rate measuring specification | ||
| Measuring Range | 30 to 300 beats/min | |
| Measuring accuracy (rms) | ±3% ± 1 1/min (30 to 300 beats/min) | |
| Dimensions and Weight | Width 34±10mm × Height 18±10mm × Depth 117±10mm2500±100mm95g±10% | 600mm±100mm55±10g |
| Degrees of protection provided by enclosure | IPX1 | |
| Temperature(Operating) | 10~40°C | |
| Temperature(Storage/Transportation) | -20~65°C | |
| Humidity(Operating) | 30~85%RH | |
| Humidity(Storage/Transportation) | 10~95%RH | |
| Voltage input | 5V±5% | 3.3V±5% |
| Power consumption | 250mWTyp. | 30mWTyp. |
| Hardware specification of SpO2 measurement board | ||
| 1) LED driver | Peak current 0 to 60 mA | Peak current 0 to 40 mA |
| 2) I/V converter | Transform current from the photodiode to voltage | |
| 3) Filter | Band pass filter | |
| 4) Amplifier | Variable DC amplifier | |
| 5) Demodulation | Demodulate R signal and IR signal separately with low pass filter | |
| 6) A/D converter | Convert analog DC signals to digital ΔΣ-A/D 24 bit | |
| 7) CPU | ARM 7 |
Test Summary:
-
i) Non-Clinical Testing
The software verification and validation testing for the WEE-1200 includes the following tests – -
Software Unit Test: Code inspection and static analysis .
-
. Software Integration Test: transfer of data and control across a program's internal and external interfaces
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-
System Test: Comprehensive testing of all required functionality of the device (hardware and software)
The following tests on wireless technology performance of the device were performed following FDA Guidance, "Radio Frequency Wireless Technology in Medical Device". -
Wireless Coexistence Test: Performance validation in the presence of wireless . emitters in the intended use environment (hardware and software)
-
Wireless Network Test: Verify and validate the ability to securely operate in a mixed . client enterprise 802.11a/b/g/n network, and to demonstrate the correct quality of service (hardware and software)
-
Wireless Operation Test: Verify and validate the Wi-Fi operation of the device (hardware and software)
Standards compliance testing on the device includes:
- AAMI/ANSI ES 60601-1:2005/(R)2012 and A1:2012 Medical electrical equipment -● Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-2:2007 Medical electrical equipment Part 1-2: General requirements . for safety and essential performance collateral standard: Electromagnetic compatibility - 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 80601-2-61:2011 Medical electrical equipment – Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment
- ii) Clinical Testing
No clinical testing on the subject device was necessary to show substantial equivalence to the predicate.
Conclusion:
Device comparison and the results of the above listed performance testing indicate that the Nihon Kohden Wireless Input Unit WEE-1200 is substantially equivalent to the predicate devices, the Nihon Kohden Wireless Input Unit WEE-1000A (K033475) and Nihon Kohden EEG-1200A with JE-120A Multi Channel Electrode Junction Box (K113117), and raises no safety or effectiveness issues.
§ 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).