The 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 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 Description

The EEG-1200A Electroencephalograph is the instrument to provide the information for intervention to utilize derivation, recording, analysis, or each combination of the brain's action potential. The instrument can measure the vital signal (including ECG waveform, EMG waveform, respiration waveform, ocular motility, SpO2 and CO2) in relation to EEG examination and display the waveform on the screen changing the montage and amplifier conditions. In addition, measurement data is available to file into the electric media. Changing the montage and amplifier conditions, then record to the printer, previews the measured data filed into the electric media. EEG data analysis is also executed to use the analysis software.

AI/ML Overview

The provided text describes the Nihon Kohden EEG-1200A Series Neurofax, an electroencephalograph (EEG) device. It includes a 510(k) summary, intended use, and a comparison to a predicate device. However, it does not contain information about specific acceptance criteria, a detailed study proving device performance against such criteria, sample sizes for test or training sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies for AI devices.

The "study" mentioned in the document refers to engineering verification and validation testing, not clinical performance studies with human subjects or AI-specific evaluations.

Therefore, I will extract relevant information from the provided text to construct the table and address the questions as much as possible, indicating when information is "Not provided" by the source.

Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Specified in 510(k) context as "Technological Characteristics" comparable to predicate)	Reported Device Performance (New Device: EEG-1200A Series Neurofax)
Number of channels	32
Noise Level (0.53 to 60 Hz)	< 1.5uV p-p
Frequency Response	0.08 to 300 Hz
High-pass Filter (Low-cut)	DC Standard
Power	120 V +/- 10% 50/60 Hz, 750 VA

Note: The "acceptance criteria" here are derived from the comparison table highlighting the technological characteristics of the new device relative to its predicate. The "study" proving these criteria were met is described as electromagnetic, environmental, safety, and performance testing, along with software validation.

Study Details

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not provided. The 510(k) summary mentions "electromagnetic, environmental, safety and performance testing procedures" and "Software validation tested the operation of the software functions," but it does not specify sample sizes for any test sets in a clinical or data-driven context. Given that this is a hardware device review, not an AI device, traditional "test sets" of patient data are not discussed in this submission.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not provided. As this is a hardware device submission, expert-established ground truth for clinical data is not a component of the described testing.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable / Not provided. Adjudication methods are typically relevant for human-read or AI-assisted interpretation of clinical data, which is not the focus of this 510(k) summary.
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:
- No. An MRMC study was not done, as this device is an electroencephalograph, not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is hardware for acquiring and displaying EEG data, not an algorithm for standalone interpretation. The software validation mentioned focuses on the correct operation of device functions (acquiring, processing, displaying, recording), not on diagnostic interpretation.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable / Not provided. The "ground truth" in the context of this submission refers to engineering specifications and verification that the device operates within those specifications (e.g., noise levels, frequency response), as opposed to clinical diagnoses.
The sample size for the training set:
- Not provided / Not applicable. This device is not an AI/ML product developed using training data in the conventional sense.
How the ground truth for the training set was established:
- Not applicable. This device does not have a "training set" in the context of machine learning. The "ground truth" for its operation is based on established engineering and safety standards, against which its performance was tested.

Summary

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NIHON KOHDEN AMERICA, INC.

SECTION 2- 510(K) SUMMARY

Name and Address of Applicant

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

AUG 2 9 2008 Contact: Jack Coggan Director, Regulatory Affairs (949) 580-1555 ex. 3325 Fax: (949) 580-1550

Trade/Device Name:

EEG-1200A Series Neurofax

Common or Usual Name:

Electroencephalograph (EEG)

Classification Name:

The device has been classified as Class 2 by the Neurology Device Classification Panel under 21 CFR Part 882.1400 Electroencephalograph per GWQ, OLLT C C V

Legally Marketed Predicate Device:

Nihon Kohden EEG-1100A Series and Accessories per 510(k) K992742 commercial distribution certification dated October 14, 1999.

Intended Use:

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.

A summary of the technological characteristics of the device compared to the predicate device: The new EEG-1200A Series Neurofax technological characteristics differences compared to the predicate device are:

Comparison	New Device	Predicate Device
Number of channels	32	40
Noise Level	< 1.5uV p-p(0.53 to 60 Hz)	< 3 uV p-p (0.53 to 60 Hz)
Frequency Response	0.08 to 300 Hz	0.016 to 300 Hz
High-pass Filter (Low-cut)	DC Standard	DC Option
Power	120 V +/- 10% 50/60 Hz750 VA	117 V +/- 10% 50/60 Hz550 VA

All other characteristics are of the device are the same.

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510(k) Summary:

The device is not sterile. ●
. The EEG-1200A Electroencephalograph is the instrument to provide the information for intervention to utilize derivation, recording, analysis, or each combination of the brain's action potential. The instrument can measure the vital signal (including ECG waveform, EMG waveform, respiration waveform, ocular motility, SpO2 and CO2) in relation to EEG examination and display the waveform on the screen changing the montage and amplifier conditions. In addition, measurement data is available to file into the electric media. Changing the montage and amplifier conditions, then record to the printer, previews the measured data filed into the electric media. EEG data analysis is also executed to use the analysis software.
The device does not directly contact patients. Accessories that contact patients, ● such as electrodes, are the same accessories as used with the predicate or are comprised of the same component material with the same design and manufacturing processes as the predicate accessories. The device may also use commercially available electrode and sensor products. Therefore, good laboratory practice studies were not required per 21 CFR Part 58.
. The EEG-1200A Series was subjected to electromagnetic, environmental, safety and performance testing procedures. These tests verified the operation of the device. Software validation tested the operation of the software functions for acquiring, processing, displaying and recording of all functions of the device. The results confirmed that the device performed within specifications.

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare, with a bird-like figure intertwined. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus. The logo is simple and recognizable, representing the department's role in public health and welfare.

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

Nihon Kohden America % Mr. Jack Coggan Director of Regulatory Affairs/Quality Assurance 90 Icon Street Foothill Ranch, California 92610

APR - 9 2012

Re: K080546

Trade/Device Name: EEG-1200A Series Neurofax Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: OLT, OLV, GWQ Dated (Date on orig SE ltr): July 29, 2008 Received: (Date on orig SE ltr): July 30, 2008

Dear Mr. Coggan:

This letter corrects our substantially equivalent letter of August 29, 2008

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

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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/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/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Kesia Alexander

Image /page/3/Picture/8 description: The image contains a handwritten word "for" in cursive script. The letter 'f' is elongated and loops downwards, while the 'o' and 'r' are connected with a smooth curve. The writing appears to be done with a pen or marker, and the background is plain white.

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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NIHON KOHDEN AMERICA, INC.

G. Indications for Use Statement:

510(k) Number (if known): KOSO546

Device Name: EEG-1200A Series Neurofax

Indication of Use:

The 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 oliar inn in Sleep Disorder, Epilepsies and other related disorders as an aid in diagnosis.

Mark M. Miller

(Division Sign-(Division Siga-o-al, Restorative, Division of Neurological Devices K080596

510(k) Number

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over The Counter Use (21 CFR 807 Subpart C)

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

CONCURRENCE OF CDRH, OFFICE OF DEVICE EVALUATION (ODE)

Page 8 of 22

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).