Nihon Kohden Wireless Input Unit WEE-1200

K171124 · Nihon Kohden Corporation · GWQ · Aug 25, 2017 · Neurology

Device Facts

• Record ID: K171124
• Device Name: Nihon Kohden Wireless Input Unit WEE-1200
• Applicant: Nihon Kohden Corporation
• Product Code: GWQ · Neurology
• Decision Date: Aug 25, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1400
• Device Class: Class 2
• Attributes: Pediatric

Intended 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.

Device Story

WEE-1200 Wireless Input Unit acquires, stores, and transmits physiological signals (EEG, ECG, EMG, EOG, respiration, SpO2) for EEG and sleep studies. Electrodes connect to a mini junction box linked to a patient-worn or bedside telemetry unit (ZB-120A). Data transmits via wired or wireless LAN (IEEE 802.11a/b/g/n) to a Nihon Kohden electroencephalograph (e.g., EEG-1200A) for display. SpO2 data is also displayed on the telemetry unit LCD. Used by qualified medical personnel in hospitals or clinics. Output allows clinicians to visualize waveforms to aid in diagnosing neurological and sleep disorders. Enhanced transmission performance and dual-band operation compared to predicates.

Clinical Evidence

No clinical testing performed. Substantial equivalence established through bench testing, including software verification/validation (unit, integration, system tests), wireless performance validation (coexistence, network, operation), and compliance with safety standards (AAMI/ANSI ES 60601-1, IEC 60601-1-2, IEC 60601-2-26, ISO 80601-2-61).

Technological Characteristics

Telemetry unit (ZB-120A) with mini junction box (JE-125AK/225AK/922A). Wireless: IEEE 802.11a/b/g/n (2.4/5 GHz), WPA/WPA2 security. SpO2 adapter (JL-570T) uses two-wavelength light absorption. 16-bit A/D resolution. Input impedance 200M ohm. Battery-operated (10-30 hours). Standards: AAMI/ANSI ES 60601-1, IEC 60601-1-2, IEC 60601-2-26, ISO 80601-2-61.

Indications for Use

Indicated for acquisition, storage, recording, and transmission of cerebral and extracerebral activity for EEG and sleep studies. Used for patients of all ages (adult, neonate, infant, child, adolescent) in medical facilities for diagnosis of sleep disorders, epilepsies, and related conditions.

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

• Nihon Kohden Wireless Input Unit WEE-1000A (K033475)
• Nihon Kohden EEG-1200A with JE-120A Multi Channel Electrode Junction Box (K113117)

Reference Devices

• Nihon Kohden EEG-1200A (K080546)
• JL-550T1 SpO2 adapter (K113117)

Submission Summary (Full Text)

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Public Health Service

Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or movement. The logo is black and white.

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 [phone] or [phone] 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 [phone] or [phone] 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) | |
|-------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="font-size:16px">☒</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> <span style="font-size:16px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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# 510(k) Summary

# Nihon Kohden Wireless Input Unit WEE-1200

| Submitter: | Nihon Kohden Corporation |
|-------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | 1-31-4 Nishiochiai, Shinjuku-Ku<br>Tokyo, Japan 161-8560 |
| Phone number: | 81-3-5996-8020 |
| Contact person: | Tom Bento |
| Phone number: | [phone] |
| Fax number: | [phone] |
| 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)<br>Nihon Kohden EEG-1200A with JE-120A Multi Channel<br>Electrode 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-<br>120A Junction Box<br>Predicate Device<br>(K113117) | WEE-1000A<br>Wireless Input Unit<br>Predicate Device<br>(K033475) | WEE-1200<br>Wireless Input Unit<br>New Device |
|------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | EEG-1200 series<br>Neurofax is intended to<br>record, measure and<br>display cerebral and<br>extraccrebral activity for<br>EEG and Sleep Studies.<br>These data may be used<br>by the clinician in sleep<br>disorder, epilepsies and<br>other related disorders as<br>an aid in diagnosis.<br>The device is intended for<br>use by medical personnel<br>in any location within a | The device is intended to<br>acquire, store, and<br>transfer biophysical<br>parameters to EEG<br>machines for the purpose<br>of assisting the diagnosis<br>of neurological and sleep<br>disorders, measurement<br>and display of cerebral<br>and extracerebral activity<br>for EEG and sleep<br>studies. These data may<br>be used by clinician in | The WEE-1200 Wireless<br>Input Unit is intended to<br>acquire, store, record, and<br>transmit the cerebral and<br>extracerebral activity for EEG<br>and sleep studies. The<br>device should be used<br>together with Nihon Kohden<br>specified<br>electroencephalograph via<br>wired or wireless<br>communication to display<br>EEG on the<br>electroencephalograph<br>screen. These data may be |
| | EEG-1200A with JE-<br>120A Junction Box | WEE-1000A<br>Wireless Input Unit | WEE-1200<br>Wireless Input Unit |
| | Predicate Device<br>(K113117) | Predicate Device<br>(K033475) | New Device |
| | medical facility,<br>laboratory, clinic or<br>nursing home or outside<br>of a medical facility under<br>direct supervision of a<br>medical professional. | sleep disorders,<br>epilepsies and other<br>related disorders as a<br>diagnostic tool.<br>The device is intended for<br>use by medical personnel<br>in any location within a<br>medical facility,<br>physician's office,<br>laboratory, clinic or<br>nursing home or outside<br>of a medical facility under<br>supervision of a medical<br>professional. The device<br>will be available in all<br>populations, including<br>pediatrics. | used by the clinician in sleep<br>disorder, epilepsies and<br>other related disorders as an<br>aid in diagnosis.<br>The WEE-1200 Wireless<br>Input Unit is designed for use<br>by qualified medical<br>personnel in a medical facility<br>such as a hospital or clinic on<br>all patient populations<br>including adult, neonate,<br>infant, child and adolescent<br>subgroups. |
| Product used with | Nihon Kohden EEG-<br>1200A (K080546) | Nihon Kohden EEG-<br>1200A (K080546) | Nihon Kohden EEG-1200A<br>(K080546) |
| Measurement Parameters | EEG, ECG, EMG,<br>EOG, SpO2 and CO2 | EEG, ECG, EMG, EOG,<br>Respiration, and SpO2 | EEG, ECG, EMG, EOG<br>respiration, 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 (1<br>to 11ch) | 2.4 GHz: 11 channels (1 to<br>11ch)<br>5 GHz: 24 channels (36, 40,<br>44, 48, 52, 56, 60, 64, 100,<br>104, 108, 112, 116, 120, 124,<br>128, 132, 136, 140, 149, 153,<br>157, 161, 165 ch) |
| Modulation | N/A | DSSS (BPSK/QPSK):<br>1 & 2 Mbps<br>DSSS (CCK):<br>5 & 11 Mbps | Auto<br>(DSSS (BPSK/QPSK/<br>CCK)): 802.11b<br>OFDM (BPSK/QPSK/<br>16QAM/64QAM):<br>802.11a/g/n<br>(6/9/12/18/24/36/48/54<br>Mbps, MCS0/1/2/3/4/5/6<br>7) |
| Transmission power | N/A | < 5mW/MHz | 2.4GHz<br>< 10mW/MHz<br>5GHz<br>< 10mW/MHz |
| Wireless LAN security | N/A | NK Original | WEP, WPA, WPA2 |
| Battery operation time | N/A | 18 hours<br>(Using 10s Intermittent<br>transfer mode) | 10 hours (using internal<br>battery only)<br>30 hours (using internal<br>Battery and Extension unit) |
| | EEG-1200A with JE-<br>120A Junction Box | WEE-1000A<br>Wireless Input Unit | WEE-1200<br>Wireless Input Unit |
| | Predicate Device<br>(K113117) | Predicate Device<br>(K033475) | New Device |
| Applied wireless<br>transmission standards<br>and guidance | N/A | FCC 47CFR Part 15 | FCC 47CFR Part 15 Subpart C |
| | | Subpart B<br>FCC 47CFR Part 15<br>Subpart 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 unit<br>JE-120A | • Amplification unit<br>ZB-101AA/102AA | • Amplification unit<br>ZB-120A |
| | • Mini Junction Box<br>JE-125AK or JE-225AK<br>And JE-226AK/227AK/<br>228AK | • Mini Junction Box<br>JE-011A or JE-012A or<br>JE-013A | • Mini Junction Box<br>JE-125AK or JE-225AK<br>or JE-922A |
| Electrode jacks | Up to 64 for EEG<br>Up to 4 for bipolar input<br>Z electrode<br>COM | Up to 62 for EEG<br>Z electrode | Up to 64 for EEG<br>Up to 4 for bipolar input<br>Z electrode<br>COM |
| Reference electrode | A5 and A6 (C3 and C4)<br>or COM | A5 and A6 (C3 and C4) | A5 and A6 (C3 and C4)<br>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)<br>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 impedance<br>check | Yes | Yes | Yes |
| A/D resolution | 16 bit (97nV/LSB) or<br>16 bit (388nV/LSB) | 16 bit (97nV/LSB) | 16 bit (97nV/LSB) or<br>16 bit (388nV/LSB) |
| Maximum Sampling<br>frequency | 10000 Hz | 200Hz | • 4000Hz<br>(Wired mode: Without any<br>condition<br>Wireless mode: limit of storage<br>of 40ch electrode )<br>• 2000Hz<br>(without any condition) |
| Main Unit | | | |
| Interface with EEG | 100Base-TX LAN<br>(On the QI-123AK) | 100Base-TX LAN<br>(On the ZR-101AK) | 100Base-TX LAN |

## Device comparison:

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## Comparison of SpO2 adapters:

| | JL-550T1<br>(K113117) | JL-570T<br>(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 )<br>±3 %SpO2 (70 % SpO2 ≤SpO2 < 80 %SpO2 )<br>SpO2 accuracy is guaranteed at surrounding temperature of 18 to<br>40°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±10mm<br>2500±100mm<br>95g±10% | 600mm±100mm<br>55±10g |
| Degrees of protection provided by enclosure | IPX1 | |
| Temperature<br>(Operating) | 10~40°C | |
| Temperature<br>(Storage/Transportation) | -20~65°C | |
| Humidity<br>(Operating) | 30~85%RH | |
| Humidity<br>(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.