Nihon Kohden QP-160AK EEG Trend Program

K163644 · Nihon Kohden Corporation · OMA · May 19, 2017 · Neurology

Device Facts

• Record ID: K163644
• Device Name: Nihon Kohden QP-160AK EEG Trend Program
• Applicant: Nihon Kohden Corporation
• Product Code: OMA · Neurology
• Decision Date: May 19, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1400
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The QP-160AK EEG Trend Program is a software-only device intended to calculate and display EEG data obtained from the Nihon Kohden specified host device. The QP-160AK is intended to be used by qualified medical practitioners, trained in electroencephalography, who will exercise professional judgment when using the information. The intended use is as follows: · The EEG and aEEG waveforms are intended to help the user monitor the state of the brain. · The user-defined Fast Fourier Transform (FFT) parameters of this software (FFT power) are intended to help the user analyze the EEG waveform. • The burst suppression parameters of this software (interval and bursts per minute) are intended to aid in the identification and characterization of areas of burst-suppression pattern in the EEG. • The seizure detection component of QP-160AK is intended to mark previously acquired EEG waveforms of adult (greater than or equal to 18 years) that may correspond to electrographic seizures in order to aid in identification of seizure events and help review and annotation of EEG traces by user. EEG should be recorded with full scalp montage at the standard 10/20 system. The notifications for seizure detection are provided. QP-160AK notifications cannot be used as a substitute for real time monitoring of the underlying EEG by a trained expert. This device does not provide any diagnostic conclusion about the patient's condition to the user. The device is intended for use by medical personnel in any location within a medical facility, laboratory, clinic or nursing home or outside of a medical facility under direct supervision of a medical professional.

Device Story

Software-only device; installed on Nihon Kohden neurology host systems. Inputs: EEG data (up to 64 channels), SpO2, ETCO2. Transforms: Calculates trends (aEEG, DSA, FFT, burst suppression, seizure detection) using signal processing algorithms. Outputs: Visual trends, seizure notifications, and annotated EEG traces. Used in medical facilities, clinics, or nursing homes by trained medical personnel. Healthcare providers review outputs to monitor brain state and identify potential seizure events; output serves as an aid to clinical review and annotation, not a diagnostic conclusion. Benefits: Assists in long-term EEG monitoring and identification of seizure events in adult patients.

Clinical Evidence

Bench testing only. Seizure detection performance evaluated using 556 hours of archived EEG data from 139 adult patients (≥18 years) in an Epilepsy Monitoring Unit. Ground truth established by three independent experts using a two-third majority rule. Results: Positive Percent Agreement (PPA) of 77.2% (95% CI: 69.0-83.5) and False Detection Rate (FDR) of 0.451 Fp/h (95% CI: 0.320-0.669).

Technological Characteristics

Software-only device. Operates on Nihon Kohden neurology host systems. Features: EEG/aEEG waveform display, FFT power, burst suppression ratio, seizure detection, SpO2/ETCO2 trend display. Connectivity: Integrates with Neuro Workbench software. User interface: Touch panel. Algorithm: Automated seizure detection and quantitative EEG analysis.

Indications for Use

Indicated for adult patients (≥18 years) to aid in the identification and characterization of burst-suppression patterns and to mark previously acquired EEG waveforms that may correspond to electrographic seizures. Intended for use by qualified medical practitioners trained in electroencephalography.

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 QP-160AK EEG Trend Program (K120485)
• Persyst 12 EEG Review and Analysis Software (K133793)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 19, 2017

Nihon Kohden Corporation % Tom Bento Sr. Vice President, Quality and Regulatory Nihon Kohden America, Inc. 15353 Barranca Parkway Irvine, California 92618

Re: K163644

Trade/Device Name: Nihon Kohden QP-160AK EEG Trend Program Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: OMB, OMA, OLT, ORT Dated: April 21, 2017 Received: April 21, 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 of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) 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 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 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) K163644

#### Device Name

Nihon Kohden QP-160AK EEG Trend Program

#### Indications for Use (Describe)

The QP-160AK EEG Trend Program is a software-only device intended to calculate and display EEG data obtained from the Nihon Kohden specified host device. The QP-160AK is intended to be used by qualified medical practitioners, trained in electroencephalography, who will exercise professional judgment when using the information. The intended use is as follows:

· The EEG and aEEG waveforms are intended to help the user monitor the state of the brain.

· The user-defined Fast Fourier Transform (FFT) parameters of this software (FFT power) are intended to help the user analyze the EEG waveform.

• The burst suppression parameters of this software (interval and bursts per minute) are intended to aid in the identification and characterization of areas of burst-suppression pattern in the EEG.

• The seizure detection component of QP-160AK is intended to mark previously acquired EEG waveforms of adult (greater than or equal to 18 years) that may correspond to electrographic seizures in order to aid in identification of seizure events and help review and annotation of EEG traces by user. EEG should be recorded with full scalp montage at the standard 10/20 system. The notifications for seizure detection are provided. QP-160AK notifications cannot be used as a substitute for real time monitoring of the underlying EEG by a trained expert.

This device does not provide any diagnostic conclusion about the patient's condition to the user.

The device is intended for use by medical personnel in any location within a medical facility, laboratory, clinic or nursing home or outside of a medical facility under direct supervision of a medical professional.

| Type of Use (Select one or both, as applicable) |
|------------------------------------------------------------------------------------------|
| <div> <span> <span></span>Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> |
| <div> <span> <span></span>Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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## 510(k) Summary for Nihon Kohden EEG Trend Program QP-160AK

| Submitter: | Nihon Kohden Corporation | |
|-------------------------------------|-----------------------------------------------------------------------------------------------------------|--|
| Address: | 1-31-4 Nishiochiai, 1-Chome, Shinjuku-Ku<br>Tokyo, Japan 161-8560 | |
| Phone number: | 81-2-59968020 | |
| Contact person: | Tom Bento | |
| Phone number: | [phone] | |
| Fax number: | [phone] | |
| Date prepared: | December 21, 2016 | |
| Device name: | Nihon Kohden QP-160AK EEG Trend Program | |
| Common name: | Electroencephalograph (EEG) | |
| Primary product codes: | OMB, OLT, ORT, OMA | |
| Regulation numbers: | 21 CFR 882.1400 | |
| Substantial equivalence claimed to: | Nihon Kohden QP-160AK EEG Trend Program (K120485<br>Persyst 12 EEG Review and Analysis Software (K133793) | |

#### Description:

The QP-160AK EEG Trend Program is a software-only device. When installed in Nihon Kohden neurology products with EEG measurement function, the device calculates and displays EEG data obtained from the neurology product's system. In addition, the QP-160AK EEG Trend Program identifies trends in the EEG data over extended periods of time in order for trained healthcare professionals to observe changes over time. Below is an illustration of how the device interacts with the Medical Personnel and Patient.

The program's existing main features are listed below:

- Calculate and display aEEG, DSA, FFT and burst suppression ratio trend .
- Display up to 64 channel EEG ●
- . Display SpO2 and ETCO2 trends
- Operation by touch panel buttons
- . Data management with Neuro Workbench software

The modification is to add:

- Seizure detection and notification .

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### Indications for Use:

The QP-160AK EEG Trend program is a software-only device intended to calculate, and display EEG data obtained from the Nihon Kohden specified host device. The QP-160AK is intended to be used by qualified medical practitioners, trained in Electroencephalography, who will exercise professional judgment when using the information.

The intended use is as follows:

- . The EEG and aEEG waveforms are intended to help the user monitor the state of the brain.
- . The user-defined Fast Fourier Transform (FFT) parameters of this software (FFT power) are intended to help the user analyze the EEG waveform.
- . The burst suppression parameters of this software (interburst interval and bursts per minute) are intended to aid in the identification and characterization of areas of burstsuppression pattern in the EEG.
- . The seizure detection component of QP-160AK is intended to mark previously acquired EEG waveforms of adult (greater than or equal to 18 years) that may correspond to electrographic seizures in order to aid in identification of seizure events and help review and annotation of EEG traces by user. EEG should be recorded with full scalp montage at the standard 10/20 system. The notifications for seizure detection are provided. QP-160AK notifications cannot be used as a substitute for real time monitoring of the underlying EEG by a trained expert.

This device does not provide any diagnostic conclusion about the patient's condition to the user.

The device is intended for use by medical personnel within a medical facility, laboratory, clinic or nursing home or outside of a medical facility under direct supervision of a medical professional.

## Technological Characteristics - Substantial Equivalence Discussion

The Nihon Kohden QP-160AK EEG Trend Program is substantially equivalent to the predicate device of the same name (K120485) with the additional features of seizure detection and notification. For the seizure detection and notification, QP-160AK is substantially equivalent to the other listed predicate devices, Persyst 12 EEG Review and Analysis Software (K133793). Differences between the devices are minor and do not raise questions regarding safety or efficacy.

These differences include:

- 1. The QP-160AK EEG Trend Program is the same as the previous submission of QP-160AK cleared under K120485, but has two additional functions: seizure detection and notification of seizure detection.
- 2. For these new functions, we refer to Persyst 12 EEG Review and Analysis Software

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(K133793) as the predicate.

- 3. Other functions of QP-160AK remain the same as the previously cleared submission, K120485; thus QP-160AK of K120485 is referenced as the predicate for the functions other than seizure detection and notification of seizure detection.

| Specifications | Nihon Kohden QP-160AK | Persyst 12 EEG (Predicate device K133793) |
|----------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The QP-160AK EEG Trend program is a software-only device intended to calculate, and display EEG data obtained from the Nihon Kohden specified host device. The QP-160AK is intended to be used by qualified medical practitioners, trained in Electroencephalography, who will exercise professional judgment when using the information.<br>The intended use is as follows: The EEG and aEEG waveforms are intended to help the user monitor the state of the brain. The user-defined Fast Fourier Transform (FFT) parameters of this software (FFT power) are intended to help the user analyze the EEG waveform. The burst suppression parameters of this software (interburst interval and bursts per minute) are intended to aid in the identification and characterization of areas of burst-suppression pattern in the EEG. The seizure detection component of QP-160AK is intended to mark EEG waveforms of adult (greater than or equal to 18 years) | 1. Persyst 12 EEG Review and Analysis Software is intended for the review, monitoring and analysis of EEG recordings made by electroencephalogram (EEG) devices using scalp electrodes and to aid neurologists in the assessment of EEG. This device is intended to be used by qualified medical practitioners who will exercise professional judgment in using the information.<br>2. The Seizure Detection and Seizure Probability component of Persyst 12 is intended to mark previously acquired sections of adult (greater than or equal to 18 years) EEG recordings that may correspond to electrographic seizures, in order to assist qualified clinical practitioners in the assessment of EEG traces. EEG recordings should be obtained with a full scalp montage according to the standard 10/20 system.<br>3. The Spike Detection component of Persyst 12 is intended to mark previously acquired sections of the patient's EEG recordings that may correspond to spikes, in order to assist qualified clinical practitioners in the assessment of EEG traces. The Spike Detection component is intended to be used in patients at least one month old. Persyst 12 Spike |
| Specifications | Nihon Kohden QP-160AK | Persyst 12 EEG<br>(Predicate device<br>K133793) |
| | electrographic seizures in<br>order to aid in identification of<br>seizure events and help<br>review and annotation of EEG<br>traces by user. EEG should<br>be recorded with full scalp<br>montage at the standard<br>10/20 system. The<br>notifications for seizure<br>detection are provided. | Detection performance has not been<br>assessed for intracranial recordings. |
| | This device does not provide any<br>diagnostic conclusion about the<br>patient's condition to the user. | 4. Persyst 12 includes the calculation<br>and display of a set of quantitative<br>measures intended to monitor and<br>analyze the EEG waveform. These<br>include FFT, Automatic event marking<br>is not applicable to the quantitative<br>measures. These quantitative EEG<br>measures should always be<br>interpreted in conjunction with review<br>of the original EEG waveforms. |
| | The device is intended for use by<br>medical personnel within a medical<br>facility, laboratory, clinic or nursing<br>home or outside of a medical facility<br>under direct supervision of a medical<br>professional. | 5. The aEEG functionality included in<br>the Persyst 12 is intended to monitor<br>the state of the brain. The automated<br>event marking function of Persyst 12<br>is not applicable to aEEG. |
| | | 6. Persyst 12 provides notifications for<br>seizure detection, quantitative EEG<br>and aEEG that can be used when<br>processing a record during<br>acquisition. These include an on<br>screen display and the optional<br>sending of an email message. Delays<br>of up t several minutes can occur<br>between the beginning of a seizure<br>and when the Persyst 12 notifications<br>will be shown to a user. Persyst 12<br>notifications cannot be used as a<br>substitute for real time monitoring of<br>the underlying EEG by a trained<br>expert. |
| | | 7. Persyst AR (Artifact Reduction) is<br>intended to reduce EMG, eye<br>movement, and electrode artifacts in<br>a standard 10-20 EEG recording. AR<br>does not remove the entire artifact<br>signal, and is not effective for other<br>types of artifacts. AR may modify<br>portions of waveforms representing<br>cerebral activity. Waveforms must still<br>be read by a qualified medical |
| Specifications | Nihon Kohden QP-160AK | Persyst 12 EEG<br>(Predicate device<br>K133793)<br>practitioner trained in recognizing<br>artifact, and any interpretation or<br>diagnosis must be made with<br>reference to the original waveforms.<br><br>8. This device does not provide any<br>diagnostic conclusion about the<br>patient's condition to the user. |
| Identify Seizures | Yes | Yes |
| Provides Seizure<br>Notifications | Yes | Yes |
| Identify Spikes | No | Yes |
| Montage/Channel<br>Array | Scalp 10/20 Array | Scalp 10/20 Array |
| Number of EEG<br>Channels | Up to 32/64 EEG channels<br>(dependent on amplifier) | Up to 32/64 EEG channels<br>(dependent on amplifier) |
| Number of DC<br>Channels | Up to 8 channels (dependent on<br>amplifier) | Up to 8 channels (dependent on<br>amplifier) |
| Density Spectral<br>Array (DSA) Trend | Yes | Yes |
| Density Spectral<br>Array (DSA)<br>Asymmetry Trend | Yes | Yes |
| Spectral Edge<br>Frequency Trend<br>Amplitude | Yes | Yes |
| Integrated EEG<br>(aEEG) Trend | Yes | Yes |
| Burst Suppression<br>Ratio (BSR) Trend | Yes | Yes |
| Inter-Burst Interval<br>(IBI) Trend | Yes | No |
| Burst Per Minute<br>(BPM) Trend | Yes | No |
| FFT Power Trend | Yes | Yes |
| FFT Power<br>Asymmetry Trend | Yes | Yes |
| FFT Power ratio<br>(e.g. Alpha/Delta,<br>Alpha/Beta) Trend | Yes | Yes |
| External Input (DC<br>Input) Display | Yes | Yes |
| Number of Trends | More than 16 | More than 16 |
| User Selectable<br>Trend Group<br>(Panel) | Yes | Yes |
| Time Interval of<br>Trends | 1 minute/page to 24 hours/page,<br>1cm/hour to 300cm/hour | 1 minute/page to 24 hours/page,<br>1cm/hour to 60cm/hour |
| User Selectable<br>Trends Time Scale | Yes | No…