K Number
K171124
Device Name
Nihon Kohden Wireless Input Unit WEE-1200
Date Cleared
2017-08-25

(130 days)

Product Code
Regulation Number
882.1400
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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 facility such as a hospital or clinic on all patient populations including adult, neonate, infant, child and adolescent subgroups.
Device 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.
More Information

EEG-1200A with JE-120A Junction Box (K113117), WEE-1000A (K033475), Nihon Kohden EEG-1200A (K080546)

No
The summary describes a device for acquiring, storing, recording, and transmitting physiological signals (EEG, ECG, EMG, EOG, respiration, SpO2). It focuses on hardware and data transmission capabilities. There is no mention of AI, ML, image processing, or any algorithms that would interpret or analyze the data using such technologies. The performance studies focus on software verification, wireless performance, and standards compliance, not on the performance of any analytical algorithms.

No
The device is intended to acquire, store, record, and transmit physiological data for diagnostic purposes, primarily as an aid in diagnosis and not for direct treatment or therapy.

Yes

Explanation: The "Intended Use / Indications for Use" section states that the data acquired by the device "may be used by the clinician in sleep disorder, epilepsies and other related disorders as an aid in diagnosis." This explicitly indicates a diagnostic purpose.

No

The device description explicitly mentions hardware components like a telemetry unit, mini junction box, electrodes, and a SpO2 sensor and adapter. It is a system that includes both hardware and software.

Based on the provided information, the WEE-1200 Wireless Input Unit is not an In Vitro Diagnostic (IVD).

Here's why:

  • IVDs are used to examine specimens from the human body. The WEE-1200 acquires physiological signals (EEG, ECG, EMG, EOG, respiration, SpO2) directly from the patient's body using electrodes and sensors. It does not analyze samples like blood, urine, or tissue.
  • The intended use describes acquiring, storing, recording, and transmitting physiological activity. This is consistent with a device that measures and processes bioelectrical signals, not one that analyzes biological samples.
  • The device description details connections to electrodes and sensors placed on or near the patient. This further supports its function as a physiological signal acquisition device.

Therefore, the WEE-1200 Wireless Input Unit falls under the category of a physiological monitoring or recording device, not an In Vitro Diagnostic.

N/A

Intended Use / 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 facility such as a hospital or clinic on all patient populations including adult, neonate, infant, child and adolescent subgroups.

Product codes

GWQ, OLV

Device 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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Cerebral and extracerebral activity

Indicated Patient Age Range

all patient populations including adult, neonate, infant, child and adolescent subgroups.

Intended User / Care Setting

qualified medical facility such as a hospital or clinic

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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
  • 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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

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

Reference Device(s)

EEG-1200A with JE-120A Junction Box (K113117), WEE-1000A (K033475), Nihon Kohden EEG-1200A (K080546)

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 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).

0

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

1

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

2

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-Ku
Tokyo, 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 Channel
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.

4

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 Box
Predicate Device
(K113117) | WEE-1000A
Wireless Input Unit
Predicate Device
(K033475) | WEE-1200
Wireless Input Unit
New Device |
|------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | EEG-1200 series
Neurofax is intended to
record, measure and
display cerebral and
extraccrebral activity for
EEG and Sleep Studies.
These data may be used
by the clinician in sleep
disorder, epilepsies and
other related disorders as
an aid in diagnosis.
The device is intended for
use by medical personnel
in any location within a | The device is intended to
acquire, store, and
transfer biophysical
parameters to EEG
machines for the purpose
of assisting the diagnosis
of neurological and sleep
disorders, measurement
and display of cerebral
and extracerebral activity
for EEG and sleep
studies. These data may
be used by clinician in | 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 |
| | EEG-1200A with JE-
120A Junction Box | WEE-1000A
Wireless Input Unit | WEE-1200
Wireless Input Unit |
| | Predicate Device
(K113117) | Predicate Device
(K033475) | New Device |
| | medical facility,
laboratory, clinic or
nursing home or outside
of a medical facility under
direct supervision of a
medical professional. | sleep disorders,
epilepsies and other
related disorders as a
diagnostic tool.
The device is intended for
use by medical personnel
in any location within a
medical facility,
physician's office,
laboratory, clinic or
nursing home or outside
of a medical facility under
supervision of a medical
professional. The device
will be available in all
populations, including
pediatrics. | 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. |
| 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, EOG
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
to 11ch) | 2.4 GHz: 11 channels (1 to
11ch)
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 Mbps
DSSS (CCK):
5 & 11 Mbps | Auto
(DSSS (BPSK/QPSK/
CCK)): 802.11b
OFDM (BPSK/QPSK/
16QAM/64QAM):
802.11a/g/n
(6/9/12/18/24/36/48/54
Mbps, MCS0/1/2/3/4/5/6
7) |
| Transmission power | N/A |