EEG- 1200A Series Neurofax is intended to record, measure and display cerebral and extracerebral 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 PE-210AK Switch Box is an optional accessory for the EEG-1200A device. It is used with the EEG-1200A to switch between EEG recording and cortical stimulation using the same cortical electrode. The software is used for functional brain mapping to support diagnostic and surgical epilepsy procedures.

The device is intended for use within a hospital or medical facility under direct supervision of a medical professional

Device Description

The PE-210A Switch Box is an optional accessory for the EEG-1200A device cleared under 510k # K080546. The PE-210AK Hardware is made up of electronic switches inside a box enclosure and cable connections on the outside of the box enclosure. The PE210AK Hardware switch box does not have any controls or adjustment for the operator. All settings, controls, and adjustments are made using the PE-210AK software installed on the EEG's (off the shelf) PC. Utilizing the EEG's CPU. Data storage, keyboard, mouse, and display, the PE-210AK switch box software allows the user switch electrode stimulation sites between the EEG recording and the cortical stimulator. The PE-210AK software allows the user to query the data recorded on the EEG's PC and create a report of the stimulation sites, including duration and intensity settings.

AI/ML Overview

The Nihon Kohden PE-210AK Switch Box for EEG-. 1200A is an accessory that facilitates switching electrodes between an electroencephalograph (EEG) and a cortical stimulator, primarily for functional brain mapping in the context of diagnostic and surgical epilepsy procedures. The 510(k) submission K110376 does not explicitly detail acceptance criteria in a quantitative manner as would be expected for a diagnostic or AI-powered device. Instead, the "acceptance criteria" are implied by the demonstration of substantial equivalence to a predicate device, the Excel Tech EMU 128s Switch Matrix (K040360), and verified through design validation and various testing procedures.

The provided document describes the device's functional capabilities and compares them to the predicate device to establish substantial equivalence. The "study" proving the device meets these criteria is a design validation that confirmed the operation of the software and hardware according to design specifications, along with electromagnetic, environmental, safety, and performance testing. However, there is no information provided about a clinical study involving human subjects, diagnostic accuracy metrics (e.g., sensitivity, specificity, AUC), or a comparison against a defined ground truth for specific clinical outcomes.

Here's an attempt to structure the information based on your request, understanding that the given document focuses on functional equivalence rather than quantitative performance metrics for diagnostic accuracy.

Acceptance Criteria and Device Performance

Acceptance Criteria (Implied from Substantial Equivalence and Design Validation)	Reported Device Performance
Functional Equivalence to Predicate Device:	Met: The PE-210AK Switch Box performs the core functions of switching electrode output from a stimulation unit to EEG electrodes connected to the patient and EEG instrument, similar to the Excel Tech EMU 128s Switch Matrix.
- Software Capabilities (e.g., electrode arrangement, stimulation site selection, data display, report generation)	- Met: The software allows electrodes to be arranged on a brain map, selection of STIM SITE (+) and STIM REF (-) electrodes, display of selected electrode names, and creation/saving/printing of functional mapping reports and stimulation event tables. Minor differences (e.g., zoom feature, display of current values) were noted as not impacting safety or effectiveness.
- Hardware Characteristics (e.g., electronic switch, trigger out)	- Met: The device utilizes an electronic switch and provides trigger out for external stimulator, consistent with the predicate.
Operational Conformance to Design Specifications:	Met: Design validation confirmed the operation of both software and hardware in accordance with design specifications.
Safety and Effectiveness:	Met: Electromagnetic, environmental, safety, and performance testing procedures were conducted, and these tests "verified the proper operation of the device." The manufacturer asserts that features differing from the predicate (e.g., zoom feature, check-up program for switch/trigger signals) have "no impact on patient safety or effectiveness of device." The device is non-sterile and does not contact patients.
Intended Use Fulfillment:	Met: The device is used with the EEG-1200A to switch between EEG recording and cortical stimulation using the same cortical electrode, and its software supports functional brain mapping for diagnostic and surgical epilepsy procedures, as intended.

Study Details Proving Acceptance Criteria

The provided 510(k) summary does not detail a clinical study with human subjects, diagnostic performance metrics, or specific quantitative acceptance criteria that would typically be associated with an AI or diagnostic device. Instead, the "study" is a collection of engineering tests and a comparison to a predicate device to establish substantial equivalence.

Here's an analysis based on the available information:

Sample size used for the test set and the data provenance: This information is not provided. The document states "Design validation confirmed the operation of the software and hardware of the device is in accordance to the design specifications" and "The device was subjected to electromagnetic, environmental, safety and performance testing procedures. These test verified the proper operation of the device." These are internal engineering and verification tests, not typically clinical trials with defined test sets of patient data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not provided. As the "study" described is a design validation and technical testing, there's no mention of expert-established ground truth in the context of clinical accuracy or a diagnostic outcome.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: This information is not applicable/not provided. There is no indication of a clinical test set requiring adjudication of findings.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: This information is not applicable/not provided. The Nihon Kohden PE-210AK Switch Box is an accessory for switching electrodes and assisting with functional brain mapping, not an AI-powered diagnostic tool that directly interprets data or assists human readers in a diagnostic task in a way that would warrant an MRMC study comparing AI-assisted vs. non-assisted performance.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: This information is not applicable/not provided. The device is an accessory controlled by software and is intended for use by medical professionals; it does not operate as a standalone algorithm without human interaction or supervision.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): This information is not provided/not explicitly defined in a clinical context. For the design validation, the "ground truth" would be the engineering and functional specifications that the device's hardware and software were designed to meet. The verification tests confirmed conformance to these specifications.
The sample size for the training set: This information is not applicable/not provided. The device is not an AI/ML-based system that requires a "training set" of data in the conventional sense. Its software performs control and display functions based on predefined logic and parameters, rather than learning from data.
How the ground truth for the training set was established: This information is not applicable/not provided for the same reasons as point 7.

Summary

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K110376

510(K) SUMMARY

, ...

ﻧﮯ

JUL 2 9 2011

Name and Address of Applicant .

Nihon Kohden America, Inc. 90 Icon Street Foothill Ranch, Ca 92610

Telephone: (949) 580-1555 Ext. 3325 Fax: (949) 580-1550 Attn: Steve Geerdes, Director of Regulatory Affairs

Date: July 20th , 2011

Name/Trade Name of the Device: Nihon Kohden PE-210AK Switch Box for EEG-. 1200A
The common or usual Name: Electroencephalograph (EEG) .
The Classification: The device has been classified as Class II by the Neurology Device . Classification Panel under 21 CFR Part 882.1400 Electroencephalograph per GWO.
. The legally marketed equivalence: The predicate device is the Excel Tech EMU 128s Switch Matrix commercial distribution March 12, 2004 cleared under 510k # K040360
A description of the device: .

The PE-210AK Software Program contains the following capabilities:

(1) Acquisition

Electrodes can be arranged on the brain map image.
Image files (JPEG/BMP/TIF) can be used for the brain map image.
STIM SITE (+) and STIM REF (-) electrodes switched for stimulation can be selected.
Identification when the stimulation electrodes are selected:
- STIM SITE (+) -> Red
- STIM REF (-) -> Blue

Names of the selected electrodes are displayed outside the brain map image.

Zoom display of electrode frames and electrode names
Current value (intensity) of stimulation of the electric stimulator can be set for the stimulation event.

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Duration time for switching electrodes for stimulation (train duration, max 300sec) can be set.
Switching electrodes for stimulation can be started or stopped with the mouse or the space key.
State of being stimulating can be easily recognized by the START button highlighted in fluorescent color.
Comments can be entered and stimulation events can be registered.
The table of stimulation events including names of the selected stimulation electrodes and current values can be displayed.
Trigger signal (stimulation rate/trigger pulse width/train) can be set.
Equipped with the symbols for the functional map and the functional mapping report can be created simultaneously.
Symbols can be added arbitrarily by a user.
The functional mapping report and the table of stimulation events can be saved in a file.
Equipped with the automatic file backup function
The functional mapping report and the table of stimulation events can be printed.

(2) Review

The functional mapping report can be edited.
Comments can be entered and stimulation events can be reviewed and edited.
The table of stimulation events including names of the selected stimulation electrodes and current values can be displayed.
The functional mapping report and the table of stimulation events can be printed.

(3) Others

Operation method is based on Windows (GUI/mouse/keyboard).
Files can be read and written on the network.
Equipped with the check-up program for the switch/trigger signals

Intended Use .

The device is intended for use within a hospital or medical facility under direct supervision of a medical professional

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

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The new PE-210AK Switch Box is connected between the multi-channel electrode junction box (JE-0011/0012/0013 and switches the connection destination of signal lines of electrodes between the electroencephalograph and the external stimulation unit (only one pair of electrodes can be switch at a time). The switch box is controlled by the switch box software which is installed on the electroencephalograph (EEG). Both the EMU128s and the PE-210AK have a hardware switch box and software controls that allow electrodes to be switched between the stimulation unit and the EEG device.

COMPARATIVE INFORMATION

New Device	Predicate
PE-210AK Switch Box	Excel Tech's EMU 128SSwitch Matrix
Switch output from a Stimulation Unit to EEGelectrodes connected to the patient and the EEGinstrument	Same
Stimulated site manually selected by user	Same
Data may be used by the clinician to aid in diagnosis.	Same
For use by medical personnel.	Same
For use functional mappingMeasurement.	Same
Electrodes can be arranged on the brain map image	Same
Image files (JPEG/BMP/TIF) can be used for the brainmap image	Same
STIM SITE (+) and STIM REF (-) electrodesswitched for stimulation can be selected	Same
Identification when the stimulation electrodes areselected:STIM SITE (+) -> RedSTIM REF (-) -> Blue	Same
Names of the selected electrodes are displayed outsidethe brain map image.	Same
Zoom display of electrode frames and electrodenames	No	This is just a zoom infeature. There is no impacton patient safety oreffectiveness of device.

Switching electrodes for stimulation can be started orstopped with the mouse or the space key.	Same
State of being stimulating can be easily recognized bythe START button highlighted in fluorescent color.	Same
Comments can be entered and stimulation events canbe registered.	Same
The table of stimulation events including names of theselected stimulation electrodes and current values canbe displayed.	No Current Values justelectrode Names	All values are registeredincluding Electrode names,Intensity and Duration
The functional mapping report and the table ofstimulation events can be saved in a file.	Same	Only when entered ascomment
Equipped with the automatic file backup function	Same
The functional mapping report and the table ofstimulation events can be printed.	Same	Only when entered ascomment
The functional mapping report can be edited inReview Mode.	Same	Only when entered ascomment
Comments can be entered and stimulation events canbe reviewed and edited.	Same
The table of stimulation events including names of theselected stimulation electrodes and current values canbe displayed	Same	Only when entered ascomment
The functional mapping report and the table ofstimulation events can be printed.	Same	Only when entered ascomment
Operation method is based on Windows(GUI/mouse/keyboard).	Same
Files can be read and written on the network.	Same	Only comments
Equipped with the check-up program for theswitch/trigger signals	No	This feature has No impacton effectiveness of device.Tool to assure properoperation.

Software Capabilities/ Characteristics

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ﺘﻪ ﻫ

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Physical (Hardware) Characteristics

PE-210AK Switch Box	EMU 128S Switch Matrix	Comments
Electronic Switch	Same	Controlled by software
Trigger out for external Stimulator is available.	Same

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Switch output from a Stimulation Unit to EEGelectrodes connected to the patient and the EEGinstrument.
Same
Creates report for functionalmapping. (Use a EEG PC Unit)
Same
Prints report for functionalmapping. (Printed by Printer with EEG's PC)
Same

Target Population

PE-210AK Switch Box	EMU 128S Switch Matrix	Comments
1. Any location within a medicalfacility, physician's office,Laboratory or clinic.	Same
2. May be used in the intensive careunit or operating room forMonitoring or recording.	Same
3. Any patient population (includingadults and children) as determined byTrained professionals.	Same

The device is not sterile.

The device is not contacting patients. Therefore, no good laboratory practice studies were required per 21 CFR 58.

Design validation confirmed the operation of the software and hardware of the device is in accordance to the design specifications.

The device was subjected to electromagnetic, environmental, safety and performance testing procedures. These test verified the proper operation of the device. Design validation confirmed the operation of the software and hardware of the device is in accordance to the design specifications.

Therefore based on the above, Nihon Kohden believes that the PE-210AK is substantially equivalent to the Excel Tech EMU 128s Switch Matrix cleared under 510k # K040360.

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Image /page/5/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is an abstract image of a bird-like figure, possibly representing an eagle or other national symbol. The image is in black and white.

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

Nihon Kohden Corporation c/o Steve Geerdes Director of Regulatory Affairs 90 Icon Street Foothill Ranch, CA 92610

JUL 2 9 2011

Re: K110376

Trade/Device Name: Nihon Kohden PE-210AK Switch Box for EEG 1200A Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: GWQ and GYC Dated: November 30, 2010 Received: February 09, 2011

Dear Mr. Geerdes:

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 device-related

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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 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/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 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Kesia Alexander

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):

Device Name: PE-210AK Switch Box

Indications for Use:

The device is intended for use within a hospital or medical facility under direct supervision of a medical professional

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

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

K110376

510(k) Number_

Division Sign-Off Office of Device Evaluation

510(k)________________________________________________________________________________________________________________________________________________________________________

Page 1 of

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).