The EEG-1100A 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 Disorders, 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, I list or nursing home or outside of a medical facility under direct supervision of a medical professional.

Device Description

Common names for the EEG-1100A device include Electroencephalograph (EEG) and Polysomnograph (PSG). Nihon Kohden's, model number EEG-1100A intended to record, measure and display the physiological data required for EEG and sleep studies (Polysomnography or PSG). These data, may be used by the clinician in Sleep Disorders, Epilepsies and other disorders as an aid in diagnosis.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the NIHON KOHDEN AMERICA, INC. EEG-1100A EEG/PSG Recorder:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria/Test	Reported Device Performance
Safety and Standards Compliance	IEC 601-1 subclause 56.3(c) (Electrode Lead Wires and Patient Cables)	"The device complies with IEC 601-1 subclause 56.3(c)..."
Electromagnetic Compatibility (EMC)	Not explicitly stated (implied)	"The EEG-1100A was subjected to electromagnetic... testing procedures. These tests verified the operation of the device."
Environmental Performance	Not explicitly stated (implied)	"...environmental... testing procedures. These tests verified the operation of the device."
General Safety	Not explicitly stated (implied)	"...safety... testing procedures. These tests verified the operation of the device."
Performance (Hardware)	Ability to record, measure, and display physiological data	"...performance testing procedures. These tests verified the operation of the device."
Software Functionality	Acquiring, processing, displaying, and recording of all functions	"Software validation tested the operation of the software functions of acquiring, processing, displaying and recording of all functions of the device. The results confirmed that the device performed within specifications."

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

The provided text does not explicitly mention a "test set" in the context of clinical data for performance evaluation. The device appears to have undergone engineering and software validation testing, but not a study involving patient data with a defined test set.

Sample Size: Not applicable/not stated for a clinical test set.
Data Provenance: Not applicable/not stated for a clinical test set.

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

This information is not applicable as the document does not describe a study involving a "test set" of clinical cases where ground truth would need to be established by experts for diagnostic performance evaluation. The "experts" implied are those involved in the engineering validation and software testing of the device itself, rather than medical experts evaluating diagnostic output.

4. Adjudication Method for the Test Set

This is not applicable as no clinical test set requiring adjudication is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, the provided document does not describe a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. This type of study would typically involve human readers (e.g., clinicians) evaluating cases with and without AI assistance to measure the effect size of AI on their performance. The EEG-1100A is described as a recorder and display device, not an AI-assisted diagnostic tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The device is an EEG/PSG recorder and display system, not an algorithm providing a diagnostic output needing standalone performance evaluation. The "performance" described is the device's ability to accurately record, measure, display, and process physiological data. "Software validation" was done to confirm these functions "performed within specifications." This could be interpreted as a form of standalone performance for the software functions, but not in the context of an AI algorithm's diagnostic accuracy.

7. The Type of Ground Truth Used

For the engineering and software validation, the "ground truth" would be the device specifications and functional requirements. For example, software validation confirmed functions "performed within specifications," meaning the expected output (the "ground truth") was met by the observed output. It is not expert consensus, pathology, or outcomes data, as those relate to diagnostic accuracy, which is not the focus of the described testing.

8. The Sample Size for the Training Set

Not applicable. The EEG-1100A is a medical device for recording and displaying physiological data, not an AI/ML model that requires a "training set" of data.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As the device is not an AI/ML model, there is no training set or corresponding ground truth to establish.

Summary

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NIHON KOHDEN AMERICA, INC. August 12, 1999

510(k) NOTIFICATION EEG-1100A EEG/PSG Recorder

992742

SECTION 2 - 510(K) SUMMARY

Name and Address of Applicant Nihon Kohden America, Inc. 2601 Campus Drive Irvine, California 92612-1601 Phone: (949) 250-3959 Fax: (949) 250-3210

Primary Contact: Bonnie Bishop, Regulatory Affairs Manager (949) 250-3959 ext. 4401

Alternate Contact: Gary Reasoner, Director of Product Operations (949) 250-3959 ext. 3387

The device has been classified as Class 2 by the Neurology Device Classificaiton Panel under 21 CFR Part 882.1400 "Electroencephalograph" per GWQ1. DLV

Common names for the EEG-1100A device include Electroencephalograph (EEG) and Polysomnograph (PSG).

The predicate marketed device is the Nihon Kohden EEG-2100 per 510(k) # K944678, commercial distribution certification dated 5/22/98.

Nihon Kohden's, model number EEG-1100A intended to record, measure and display the physiological data required for EEG and sleep studies (Polysomnography or PSG). These data, may be used by the clinician in Sleep Disorders, Epilepsies and other disorders as an aid in diagnosis. This device is intended for use by medical personnel. The device will be available for use within a medical facility, laboratory, clinic or nursing home or outside of a medical facility under direct supervision of a medical professional.

The device complies with IEC 601-1 subclause 56.3(c) as implemented by 21 CFR Part 898 Performance Standard for Electrode Lead Wires and Patient Cables. No other special controls or performance standards are known or established for this device.

The EEG-1100A device is not sterile.

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 materials 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-1100A 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 of acquiring, processing, displaying and recording of all functions of the device. The results confirmed that the device performed within specifications.

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SECTION 3 - PROPOSED LABELING

Intended Use A. The EEG-1100A is intended for medical purposes to record, measure and display cerebral and The CLO-1 room is intoneca for meetics. These data, may be used by the clinician in Sleep Disorders, Epilepsies and other related disorders as an aid in diagnosis.

Device/Package Labels B.

The proposed product labels for the device is located in Attachment 1.

Proposed Packaging C. Packaging for the EEG-1100A is depicted in Attachment 2.

D. Instructions for Use The proposed instructions for use are provided with each packaged device and are presented in Attachment 9.

Advertisement/Promotional Literature E. To date no advertisement or promotional literature has been created for the EEG-1100A for distribution in the United States.

Contraindications, Precautions & Warnings F. Warnings and cautions are listed in the Operator's Manual as shown in Attachment 3.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three human figures within its body. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular fashion around the eagle.

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

Ms. Bonnie Bishop Regulatory Affairs Manager NIHON KOHDEN AMERICA, INC. 2601 Campus Drive Irvine, California 92612

APR - 9 2012

Re: K992742

Trade/Device Name: Neurofax Model EG-1100A Electroencephalograph Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: II Product Code: OLV, GWQ Dated (Date on orig SE ltr): August 13, 1999 Received (Date on orig SE ltr): August 16, 1999

Dear Ms. Bishop:

This letter corrects our substantially equivalent letter of October 14, 1999.

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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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 (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/CDRH0ffices/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 vours.

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

for

Enclosure

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NIHON KOHDEN AMERICA, INC. August 12, 1999

510(k) NOTIFICATION EEG-1100A EEG/PSG Recorder

G. Indications for Use Statement

. 510(k) Number (if known):

K992742

Device Name: EEG-1100A

Indications for Use:

hcdeslaB

(Division Sign-Off) Division of General Restorative Devices 510(k) Number .

Prescription Use
X
(Per 21 CFR 801.109)

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).