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 Disorder, Epilepsies and other related disorders as an aid in diagnosis.

Device Description

The EEG-1100A Switch Boxes product is connected between the multi-channel electrode junction boxes. JE-207A/209A/212A and a mini electrode junction box and switches the signal line of electrodes to EEG or stimulation unit. It corresponds to 65 to 128 channels and 129 to 192 channels. The new EEG-1100A Switch Boxes device has two switch boxes, the AAA-15919 switch box which is designed for the JE-207A, JE-209A, JE-212A electrode Junction Boxes and JE-208A, JE-210A, JE-214A, JE-214A, JE-2156A, JE-216A, JE-216A, JE-217A Mini Junction Boxes and the AAA-16060 192 channel Switch Box which is designed for the JE-212A Electrode Junction Box and JE-213A, JE-214A, JE-217A Mini Junction Boxes. The electrical stimulation signals from an electrical stimulation unit can be applied to each electrode through the switch box. The AAA-6060 192 channel switching is available by connecting to the AAA-15919 128 channel Switch Box.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study proving the device meets them, presented in the requested format:

The provided text focuses on a Special 510(k) Notification for EEG-1100A Switch Boxes by Nihon Kohden America, Inc. It details the device's classification, predicate device, intended use, and technological characteristics. However, the document primarily addresses regulatory aspects, substantial equivalence, and general testing categories. It does not contain detailed information about specific acceptance criteria or a dedicated study design with quantitative results in the way typically expected for a performance study of a device with diagnostic or analytical claims.

The “performance testing” mentioned is very general and focuses on verifying operation rather than demonstrating diagnostic accuracy against a ground truth.

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria Category	Specific Acceptance Criteria	Reported Device Performance
Safety	Device does not directly contact patients. Accessories that contact patients are the same as predicate or comprise same material/design/manufacturing.	Verified. (Implicitly, as no safety issues are reported, and accessories are deemed equivalent or commercially available.)
Environmental	Meets relevant environmental standards.	Verified. (Tests "verified the operation of the device.")
EMC (Electromagnetic Compatibility)	Meets relevant electromagnetic standards.	Verified. (Tests "verified the operation of the device.")
Performance (General Operation)	Device performs within specifications for acquiring, processing, displaying, and recording EEG/stimulation signals.	"The results confirmed that the device performed within specifications."
Software Validation	Software functions correctly for acquiring, processing, displaying, and recording all device functions.	"Software validation tested the operation of the software functions or acquiring, processing, displaying and recording of all functions of the device. The results confirmed that the device performed within specifications."
Sterility	Not applicable. Device is not sterile.	Device is not sterile.

Note: The document only provides high-level statements about testing being conducted and successfully meeting specifications. It does not provide specific numerical performance metrics, thresholds, or detailed pass/fail criteria for functionalities like signal integrity, accuracy, or specific clinical outcomes. This is typical for a 510(k) for an accessory device (switch box) that primarily enables functionality of a larger system (EEG) rather than performing a diagnostic function itself.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not describe a clinical "test set" in the context of patient data or samples. The testing described (electromagnetic, environmental, safety, performance, and software validation) would have been conducted on the device itself (prototypes or production units) rather than on patient data. Therefore, questions of sample size and data provenance for a test set of patient data are not applicable to the information provided.

3. 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 applicable. As no clinical "test set" requiring ground truth establishment is described, neither is the involvement of experts for this purpose.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No clinical "test set" and thus no adjudication method are described.

5. 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

Not applicable. The device is a switch box for an EEG system, not an AI-powered diagnostic or assistive tool. No MRMC study or AI assistance is mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. The device is hardware (switch boxes), not an algorithm or AI.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The concept of "ground truth" as typically applied to diagnostic or prognostic device performance studies is not directly applicable here. The "ground truth" for the device's performance would be engineering specifications and functional requirements against which the device's operational behavior (e.g., signal switching, signal integrity, electrical safety) was verified through technical testing.

8. The sample size for the training set

Not applicable. The device is a hardware accessory and does not involve machine learning algorithms that require training data.

9. How the ground truth for the training set was established

Not applicable. The device is a hardware accessory and does not involve machine learning algorithms that require training data or a ground truth for training.

Summary

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K073491

SPECIAL 510(k) NOTIFICATION EEG-1100A Switch Boxes

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

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

Trade/Device Name: EEG-1100A Switch Boxes

Common or Usual Name: Electroencephalograph (EEG)

JAN 1 1 2018

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 , OLV

Legally Marketed Predicate Device:

Nihon Kohden EEG-1100A and Accessories per 510(k) 992742 commercial distribution certification dated October 14, 1999.

Intended Use:

A summary of the technological characteristics of the device compared to the

predicate device: The new EEG-1100A Switch Boxes device has two switch boxes, the AAA-15919 switch box which is designed for the JE-207A, JE-209A, JE-212A electrode Junction Boxes and JE-208A, JE-210A, JE-214A, JE-214A, JE-2156A, JE-216A, JE-216A, JE-217A Mini Junction Boxes and the AAA-16060 192 channel Switch Box which is designed for the JE-212A Electrode Junction Box and JE-213A, JE-214A, JE-217A Mini Junction Boxes. The EEG-1100 predicate device did not previously control the electrical stimulation signals through a switch box. The electrical stimulation signals from an electrical stimulation unit can be applied to each electrode through the switch box. The AAA-6060 192 channel switching is available by connecting to the AAA-15919 128 channel Switch Box.

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510(k) Summary:

. The 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 material with the same design and manufacturing processes as the prodicate 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 Switch Boxes 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 or 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 shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol.

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. Jack Coggan Director, Regulatory Affairs 90 Icon Street Foothill Ranch, CA 92610

Re: K073491 Trade/Device Name: EEG-1100A Switch Boxes Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: II Product Code: OLV, GWQ Dated (Date on orig SE ltr): December 12, 2007 Received (Date on orig SE ltr): December 12, 2007

APR - 9 2012

Dear Mr. Coggan:

This letter corrects our substantially equivalent letter of January 11, 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 (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.

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. Jack Coggan

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/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 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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NIHON KOHDEN AMERICA, INC.

G. Indications for Use Statement:

510(k) Number (if known):

Device Name: EEG-1100A Switch Boxes

Indication of Use:

The device is intended for use by medical personnel in any location within a medical facility, laboratory, clinic or nursing home or outside or a medical facility under direct supervision of a medical professional.

Mark A. Melhusen

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number K073491

Prescription Use >< (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)

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).