NIHON KOHDEN QP-160AK EEG TREND PROGRAM

K092573 · Nihon Kohden America, Inc. · OMA · Jul 9, 2010 · Neurology

Device Facts

• Record ID: K092573
• Device Name: NIHON KOHDEN QP-160AK EEG TREND PROGRAM
• Applicant: Nihon Kohden America, Inc.
• Product Code: OMA · Neurology
• Decision Date: Jul 9, 2010
• 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 Trend program is a software-only device intended to be installed on the EEG-1200A series electroencephalograph to record, calculate, and display EEG data obtained from the EEG-1200A system. This device is intended to be used by qualified medical practitioners, trained in Electroencephalography, who will exercise professional judgment when using the information. The intended use for each of the software's outputs 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. This device does not provide any diagnostic conclusion about the patient's condition to the user.

Device Story

Software-only program installed on Nihon Kohden EEG-1200A series electroencephalograph; records, calculates, and displays EEG data. Inputs: EEG waveforms from EEG-1200A system. Processing: Computes aEEG, burst suppression ratio/intervals, and FFT power parameters. Outputs: Trend displays of aEEG, burst suppression, and FFT trends; displayed on EEG-1200A monitor. Used in medical facilities, clinics, or nursing homes by trained medical practitioners. Provides data visualization to assist clinicians in monitoring brain state and identifying patterns; does not provide diagnostic conclusions. Benefits: Enables long-term trend observation and pattern identification to support clinical decision-making.

Clinical Evidence

Bench testing only. No clinical data. Validation and verification testing confirmed conformance to design requirements. Comparison testing performed against predicate devices to ensure equivalent calculation and display of burst suppression ratio and aEEG.

Technological Characteristics

Software-only device (distributed on CD-ROM/electronic media). Operates as an add-on to the EEG-1200A series electroencephalograph. Features include aEEG, burst suppression ratio, FFT power analysis, and DC trend display. Data management via NeuroWorkbench. Non-sterile; no patient contact.

Indications for Use

Indicated for use by qualified medical practitioners trained in EEG to monitor brain state, analyze EEG waveforms via FFT, and identify/characterize burst suppression patterns in patients undergoing EEG monitoring in medical facilities, clinics, or nursing homes.

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

• Nervus Monitor (K021185)
• Grass Technologies TWin Neurotrac-III (K081551)
• Natus Neuroworks (K092039)
• Day One Medical CNS Monitor (K080217)

Submission Summary (Full Text)

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K092573

# 510(K) SUMMARY - Nihon Kohden QP-160AK EEG Trend Program

JUL -- 9 2010

Name and Address of Applicant Nihon Kohden America, Inc. 90 Icon Street Foothill Ranch, CA 92610

Contact: Steve Geerdes Director, Regulatory Affairs [phone] ex. 3325 Fax: [phone]

Summary revised on 7/8/2010

#### Trade/Device Name:

Nihon Kohden QP-160AK EEG Trend Program

# Common or usual Name:

Electroencephalograph (EEG)

# Legally Marketed Predicate:

Nervus Monitor (K021185) commercial distribution certification dated July 12, 2002.

Grass Technologies TWin Neurotrac-III (K081551) commercial distribution certification dated December 241" 2008.

Natus Neuroworks (K092039) commercial distribution certification dated Febuary 2200 2009.

Day One Medical CNS Monitor (K080217) commercial distribution certification dated November 5th 2008.

#### Intended Use:

The QP-160AK Trend program is a software-only device intended to be installed on the EEG-1200A series electroencephalograph to record, calculate, and display EEG data obtained from the EEG-1200A system. This device is intended to be used by qualified medical practitioners, trained in Electroencephalography, who will exercise professional judgment when using the information.

The intended use for each of the software's outputs 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 burstsuppression pattern in the EEG.

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

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# Device Description

### Physical Description

The QP-160AK EEG Trend program is a software program stored on electronic media such as CD Rom.

### Principles of Operation

The EEG-1200A OP-160AK Trend program is a device which is installed on the electroencephalograph EEG-1200A Series and records the EEG waveforms and identifies trends in the EEG data over extended periods of time in order for trained health care professionals to observe changes over time.

### Design Features

The QP-160AK design features are as follows:

- Trend display of aEEG and Burst suppression ratio .
- Display of EEG waveform maximum of 64 channels
- DC Trend display including analog inputs .
- Operations of functions by control buttons adapted to touch panels .
- Data management by NeuroWorkbench .

# A summary of the technological characteristics of the device compared to the predicate device:

The main difference between the new QP-160AK EEG Trend program and the predicate the Nervus Monitor is a different time interval of trends.

The main difference between the new QP-160AK EEG Trend program and the predicate device " Grass Technologies Neurotrac III is a different time interval of trends

The main difference between the new QP-160AK EEG Trend program and the predicate device "Natus Neuroworks is the Natus only provides aEEG elements of the OP-160AK

The main difference between the new OP-160AK EEG Trend program and the predicate device "Day One Medical CNS Monitor is a stand alone product.

# COMPARATIVE INFORMATION

#### A. Intended Use

| Nihon Kohden | Carefusion | Grass | Natus | Day One Medical |
|----------------------------|----------------------------------|-------------------------------------|--------------|------------------------------|
| QP -160 Trends | Nervus Monitor | NeuroTrac III | Neuroworks | CNS Monitor |
| 510k Pending | K-021185 | K-081551 | K-090019 | K-080217 |
| | (07-12-02) | (12-24-08) | (02-22-10) . | (11-05-08) |
| aEEG | Yes (aEEG) | Yes (aEEG) | Yes (aEEG) | Yes (aEEG) |
| Burst Suppression<br>Ratio | Yes (Burst<br>Suppression Ratio) | Yes (Burst<br>Suppression<br>Index) | No | Yes (percent<br>Suppression) |

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| Inter-burst Interval | Yes (Burst Suppression) | Yes (Inter-Burst Interval) | No | Yes (Inter Burst Interval) |
|------------------------------------|----------------------------------|-----------------------------|----|----------------------------------|
| Burst per minute | Yes (Burst Suppression) | No | No | Unknown |
| FFT Power | Yes (Abs band power/Tower power) | Yes (FFT bands trends) | No | Yes (Total Power) |
| FFT Power Ratio<br>(Alpha /Delta) | Yes (Alpha to Delta) | Yes (FFT bands trends) | No | Yes (EEG Band Power Percentages) |
| DC Trend including<br>analog input | Yes (Generic trend) | Yes (DC<br>Channel Display) | No | Yes (Serial input) |

#### Physical Characteristics B.

| Nihon Kohden | Carefusion, | Grass | Natus | Day One Medical |
|-------------------------------|-------------------------------|----------------------------------|----------------------------------|-------------------------------|
| QP -160 Trends | Nervus Monitor | NeuroTrac III | Neuroworks | CNS Monitor |
| CD ROM or electronic<br>media | Incorporate in the<br>Monitor | CD ROM or<br>electronic<br>media | CD ROM or<br>electronic<br>media | Incorporate in the<br>Monitor |

#### C. Target Population

| Nihon Kohden<br>OP-160 Trends | Carefusion<br>Nervus<br>Monitor | Grass<br>NeuroTrac<br>III | Natus<br>Neuroworks | Day One<br>Medical<br>CNS Monitor |
|----------------------------------------------------------------------------------------------------------|---------------------------------|---------------------------|---------------------|-----------------------------------|
| 1. Any location within a medical<br>facility, physician's office,<br>laboratory, clinic or nursing home. | Same | Same | Same | Same |

# Performance Testing

- To date no special controls or performance standards are known or established for this . device as required by sections 513(b) and 514 of the Food, Drug and Cosmetic Act as implemented by 21 CFR Part 861.
- The device is not sterile. .
- . The device does not directly contact patients. Therefore, good laboratory practice studies were not required per 21 CFR Part 58.
- . The QP-160AK EEG Trend Program was subjected to safety and performance testing procedures. The QP-160AK EEG Trend Program has undergone validation and

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verification testing to ensure conformance to all design requirements. Additionally, the system has undergone comparison testing to ensure the substantial equivalence of the calculation and display of the burst suppression ratio and aEEG. These tests verified that the device performed within specifications.

# Conclusion of Substantial Equivalence:

- The comparison of technological characteristics and performance testing of the QP-. 160AK EEG Trend Program demonstrate that its safety, effectiveness, and performance are equivalent to the specified predicate devices. Therefore, Nihon Kohden believes that the device is substantially equivalent to the Nervus Monitor, Grass Neurotrac III, Natus Neuroworks, and the Day One Medical CNS Monitor predicate devices as stated.

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

Nihon Kohden America, Inc. c/o Mr. Steve Geerdes Director, Regulatory Affairs 90 Icon Street Foothill Ranch, CA 9261 0

APA - 5 2012

K092573 Re:

Trade/Device Name: Nihon Kohden QP-160AK EEG Trend Program for the Nihon Kohden EEG-1200A Series Neurofax Electroencephalograph Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: II Product Code: OMA, OLT, ORT Dated (Date on orig SE ltr): June 30, 2010 Received (Date on orig SE Itr): July 1, 2010

Dear Mr. Geerdes:

This letter corrects our substantially equivalent letter of July 9, 2010.

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.

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Page 2 - Mr. Geerdes

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-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Kesia Alexander

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Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear. Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### Indications for Use Form

510(k) Number (if known): _ K092573

#### Device Name: _Nihon Kohden QP-160AK EEG Trend Program

Indications for Use:

The QP-160AK Trend program is a software-only device intended to be installed on the EEG-1200A series electroencephalograph to record, calculate, and display EEG data obtained from the EEG-1200A system. This device is intended to be used by qualified medical practitioners, trained in Electroencephalography, who will exercise professional judgment when using the information.

The intended use for each of the software's outputs 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 burstsuppression pattern in the EEG.

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

Prescription Use × (Part 21 CFR 801 Subpart.D) AND/OR

Over-The-Counter Use (21 GFR 801 Subpart C).

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

R.C.

ion Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number K092573