The device is intended to acquire, store, and transfer biophysical parameters to EEG machines. The device is intended to acquire, store, 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 a diagnostic tool.

Device Description

The product is comprised of telemetry unit, Electrode junction box and access point to operate with our current commercially available EEG devices. The basic measurement data includes: EEG, EOG, ECG, EMG, respiration, periodic limb movement (PLM), snore, SpO2 and sleep position.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Nihon Kohden Wireless Input Unit (K033475):

Based on the provided text, the device K033475 is a Wireless Input Unit for Electroencephalographs (EEG). The information emphasizes that the device's technological characteristics are the same as the predicate device (Siesta system by Compumedix, K003175) and that it was verified and validated using the same test methods as with the existing device. This strongly suggests that the acceptance criteria are based on equivalence to the predicate device and established performance of existing Nihon Kohden EEG machines, rather than new, independently established performance metrics against a clinical ground truth.

Therefore, the requested information about device performance against specific acceptance criteria, sample sizes for test/training sets, expert adjudication, MRMC studies, or standalone performance against pathology/outcomes data is largely not applicable in the traditional sense of a de novo AI/medical device study. This is a 510(k) submission for a device demonstrating substantial equivalence to a predicate.

Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Functional Equivalence to Predicate Device (Siesta system by Compumedix, K003175) in acquiring, storing, measuring, and displaying physiological data for EEG and sleep studies.**	The device's technological characteristics are stated to be "the same as predicate." The device's function is to record, measure, and display (EEG, EOG, ECG, EMG, respiration, PLM, snore, SpO2, sleep position) and communicate data to existing cleared Nihon Kohden EEG machines, which have known performance.
Intended Use Equivalence to Predicate Device and existing cleared Nihon Kohden EEG-1100A and EEG-9100A.	The intended use for the Wireless Input Unit is stated as "the same intended use as previously cleared for the EEG-1100A, and EEG-9100A (per K992742 and K011204) as well as Siesta system (predicate)."
Safety - Non-contact with patient (device itself).	The device "does not directly contact patients."
Safety - Patient-contacting accessories (electrodes, sensors) made from same component materials as legally marketed accessories.	"New accessories that contact patients such as the EEG electrodes are made from the same component materials as similar legally marketed accessories."
Compliance with design controls and appropriate verification/validation.	"The device was developed in accordance with design controls and operation of the device was appropriately verified and validated using the same test methods as with the existing device."

Study Details

Given the nature of a 510(k) submission for substantial equivalence based on a predicate and existing devices, the "study" described is primarily one of verification and validation against established engineering and functional specifications, rather than a clinical trial to determine new performance metrics.

Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: Not explicitly stated as a clinical "test set" in the context of diagnostic performance against a ground truth. The text mentions "operation of the device was appropriately verified and validated." This typically refers to engineering testing (e.g., signal fidelity, wireless range, data transfer integrity, power consumption, software functionality) using test environments and perhaps a limited number of human subjects for usability and basic function checks. No specific number of patient samples is provided for a performance study.
- Data Provenance: Not applicable. The validation would be against technical specifications and existing device performance, not a specific dataset derived from a country of origin. The testing would have been conducted by Nihon Kohden America, Inc. or its affiliates.
Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
- Not applicable for this type of submission. Ground truth in the sense of expert consensus on clinical diagnoses (e.g., presence of epilepsy, sleep disorders) for a test set is not mentioned, as the device is an input/transfer unit, not a diagnostic algorithm itself. The "ground truth" for its operation would be defined by the technical specifications of the signals it acquires and transmits, and how accurately it correlates with the existing cleared EEG machines.
Adjudication Method for the Test Set:
- Not applicable. Since there's no mention of a diagnostic performance study against a clinical ground truth, no adjudication method would be required.
If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size:
- No, an MRMC study was not done. This type of study is relevant for diagnostic algorithms where human readers interpret medical images or data. The Wireless Input Unit is a data acquisition and transfer device; it doesn't involve human interpretation to arrive at a diagnosis.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, in essence, standalone technical verification was performed. The phrase "operation of the device was appropriately verified and validated using the same test methods as with the existing device" implies performance testing of the device's technical capabilities (signal acquisition, transmission, storage) independent of a human operator making diagnostic decisions. However, this is for the functionality of the unit, not for a diagnostic algorithm.
The type of ground truth used:
- Technical Specifications and Performance of Predicate/Existing Cleared Devices: The "ground truth" for this submission is the established and cleared performance characteristics of the predicate device (Siesta system) and other Nihon Kohden EEG machines (EEG-1100A, EEG-9100A) to which this wireless unit connects. The wireless unit is intended to perform identically in terms of data acquisition and transfer fidelity to these existing systems.
The sample size for the training set:
- Not applicable. This device does not involve machine learning or AI algorithms that require a "training set."
How the ground truth for the training set was established:
- Not applicable. See point 7.

Summary

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K033475

JAN - 7 2004

SECTION 2 - 510(K) SUMMARY

November 2, 2003

Name and Address of Applicant Nihon Kohden America, Inc. Attn: Regulatory Affairs 90 Icon Street Foothill Ranch, California 92610 Phone: (949) 580-1555 Fax: (949) 580-1550

Trade name: Wireless Input Unit Common Name: Electroencephalograph Classification: II The Predicate: Siesta system by Compumedix, 510K No: K003175

The device is classified by the Neurology Panel under 21 CFR Part 882.1400 "Electroencephalograph" per GWQ, OLV

The device is intended to record, measure and display the physiological data required for EEG and sleep studies as an aid in diagnosis. The product is comprised of telemetry unit, Electrode junction box and access point to operate with our current commercially available EEG devices. The basic measurement data includes: EEG, EOG, ECG, EMG, respiration, periodic limb movement (PLM), snore, SpO2 and sleep position.

This device is intended for use by medical personnel and will be available for use within a medical facility or outside of a medical facility under direct supervision of a medical professional.

The device does not directly contact patients. New accessories that contact patients such as the EEG electrodes are made from the same component materials as similar legally marketed accessories. Therefore, good laboratory practice studies were not required per 21 CFR part 58. Electrodes and sensors from the patient are connected to telemetry unit through the electrode junction box. The telemetry unit communicates with Nihon Kohden Access point, ZR-101AA. The Access point is connected to other cleared Nihon Kohden EEG machines for all previously cleared indications of monitoring patients' physiological data.

The device is not sterile.

The device was developed in accordance with design controls and operation of the device was appropriately verified and validated using the same test methods as with the existing device.

The device technological characteristics are the same as predicate. The device Risk analysis and summary of Validation/Verification are attached.

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KO33475

SECTION 3 - PROPOSED LABELING

A. Intended Use

The device, a multi-functional ambulatory recording device, is intended for medical purposes to store, 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. This is the same intended use as previously cleared for the EEG-1100A, and EEG-9100A ( per K992742 and K 011204) as well as Siesta system (predicate).

B. Device/Package Labels

The proposed labels for the device are located in Attachment # 4.

C. Proposed Packaging

Packaging is similar to the packaging for the existing marketed device and is included in Attachment # 4.

D. Instructions for Use

The proposed instructions for use, including warnings and cautions, are provided with each packaged device and a draft is presented in Attachment # 2.

E. Advertisement/Promotional Literature

To date, no advertisement or promotional literature for the new device options has been created for distribution in the United States.

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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 stripes forming its wing and body. The eagle is enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is written around the circle.

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

Nihon Kohden America, Inc. c/o Ms. Serrah Namini Regulatory Affairs Associate Director 90 Icon Street Foothill Ranch, California 92610

APR - 9 2012

Re: K033475

Trade/Device Name: Wireless Input Unit; WEE-1000A Series Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: II Product Code: OLV, GWQ Dated (Date on orig SE Itr): November 1, 2003 Received (Date on orig SE ltr): November 3, 2003

Dear Ms. Namini:

This letter corrects our substantially equivalent letter of January 7, 2004.

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 (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/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

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

Ko33415 510(k) Number (if known):

Wireless Input Unit; WEE-1000A series Device Name:_

Indications For Use:

The device is intended to acquire, store, and transfer biophysical parameters to BBG machines I he device is mended to acquire, secreting the neurological and sleep disorders, measurement for the purpose of assisting the cases on activity for EBG and Sleep Studies. These data, may be and usplay of catolial and cannous volu. Epilepsies and other related disorders as a diagnostic tool.

The device is intended for use by medical personnel in any location within a medical facility, I he device is intention for as by inser nursing home or outside of a medical facility under physicial s office, aboratory, came of the device will be available on all patient populations, including pediatrics.

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)

Muriam C. Provost

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

Page 1 of

510(k) Number K033475

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).