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.

Device Description

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

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.

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 .

AI/ML Overview

The Nihon Kohden QP-160AK EEG Trend Program is a software-only device intended to be installed on the EEG-1200A series electroencephalograph to record, calculate, and display EEG data. It assists qualified medical practitioners in monitoring brain state, analyzing EEG waveforms using FFT power, and identifying/characterizing burst-suppression patterns. The device does not provide diagnostic conclusions.

Here's an analysis of the acceptance criteria and the study performed, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative "acceptance criteria" for the QP-160AK EEG Trend Program in terms of specific performance metrics (e.g., accuracy, sensitivity, specificity) for its outputs (aEEG, burst suppression parameters, FFT power). Instead, the performance testing focuses on conformance to design requirements and comparative equivalence to predicate devices.

The "acceptance criteria" are implied to be that the device:

Performs within its specifications (which are not detailed beyond its functional description).
Demonstrates substantial equivalence in calculation and display of burst suppression ratio and aEEG compared to predicate devices.

Acceptance Criterion (Implied)	Reported Device Performance
Conformance to all design requirements	"The QP-160AK EEG Trend Program has undergone validation and verification testing to ensure conformance to all design requirements."
Performance within specifications	"These tests verified that the device performed within specifications." (Specific specifications are not provided in this document).
Substantial equivalence in calculation and display of burst suppression ratio and aEEG to predicate devices	"Additionally, the system has undergone comparison testing to ensure the substantial equivalence of the calculation and display of the burst suppression ratio and aEEG." The conclusion of substantial equivalence states: "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."

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the number of EEG recordings or the sample size used for the performance or comparison testing. It also does not mention the country of origin of the data or whether the data was retrospective or prospective.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

The document does not specify the number of experts used to establish ground truth or their qualifications. The device is intended to be used by "qualified medical practitioners, trained in Electroencephalography, who will exercise professional judgment." This implies that expert judgment would be the basis for evaluating results, but the specifics of an expert panel for testing are not detailed.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1) used for establishing ground truth or evaluating the device's performance.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or reported in this 510(k) summary. The study described focuses on standalone performance and comparison to predicate devices, not on the improvement of human readers with AI assistance.

6. Standalone (Algorithm Only) Performance Study

Yes, a standalone performance assessment was done. The document states: "The QP-160AK EEG Trend Program was subjected to safety and performance testing procedures. The QP-160AK EEG Trend Program has undergone validation and verification testing to ensure conformance to all design requirements." This implies that the algorithm's functionality was evaluated on its own merits as designed. Additionally, comparison testing to ensure substantial equivalence of calculations and display to predicate devices also falls under a standalone assessment of the device's output.

7. Type of Ground Truth Used

The type of ground truth used is implicitly expert assessment and comparison to established predicate device outputs, rather than pathology, outcomes data, or a formalized consensus panel. The device is intended to "help the user monitor," "help the user analyze," and "aid in the identification and characterization," suggesting that the "truth" is what expert clinicians would interpret from similar data or how predicate devices present the same information.

8. Sample Size for the Training Set

The document does not specify any sample size for a training set. This is consistent with the device type, which is a trend program for an existing EEG system, rather than a machine learning model that typically requires a large training dataset. Its functionality appears to be based on established signal processing algorithms for aEEG, FFT, and burst suppression.

9. How Ground Truth for the Training Set Was Established

Since a distinct "training set" for a machine learning model is not applicable or mentioned, the method for establishing ground truth for such a set is also not described. The device's performance validation relies on conformance to design requirements and comparison to predicate devices, implying that its underlying algorithms are based on established physiological principles and methods.

Summary

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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 (949) 580-1555 ex. 3325 Fax: (949) 580-1550

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 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

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 SuppressionRatio	Yes (BurstSuppression Ratio)	Yes (BurstSuppressionIndex)	No	Yes (percentSuppression)

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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(Alpha /Delta)	Yes (Alpha to Delta)	Yes (FFT bands trends)	No	Yes (EEG Band Power Percentages)
DC Trend includinganalog input	Yes (Generic trend)	Yes (DCChannel 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 electronicmedia	Incorporate in theMonitor	CD ROM orelectronicmedia	CD ROM orelectronicmedia	Incorporate in theMonitor

C. Target Population

Nihon KohdenOP-160 Trends	CarefusionNervusMonitor	GrassNeuroTracIII	NatusNeuroworks	Day OneMedicalCNS Monitor
1. Any location within a medicalfacility, physician's office,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 (800) 638-2041 or (301) 796-7100 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 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

Regulation Number and Section

§ 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).