WIRELESS INPUT UNIT, MODEL WEE-1000A SERIES

K033475 · Nihon Kohden America, Inc. · OLV · Jan 7, 2004 · Neurology

Device Facts

• Record ID: K033475
• Device Name: WIRELESS INPUT UNIT, MODEL WEE-1000A SERIES
• Applicant: Nihon Kohden America, Inc.
• Product Code: OLV · Neurology
• Decision Date: Jan 7, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1400
• Device Class: Class 2
• Attributes: Pediatric

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).

Device Story

Wireless Input Unit (WEE-1000A) is an ambulatory recording system for EEG and sleep studies. It collects physiological data including EEG, EOG, ECG, EMG, respiration, periodic limb movement, snore, SpO2, and sleep position. The system consists of an electrode junction box, a telemetry unit, and an access point (ZR-101AA). The telemetry unit transmits data to the access point, which interfaces with existing Nihon Kohden EEG machines. Used by medical personnel in medical facilities, nursing homes, or physician offices; provides data for clinicians to aid in the diagnosis of sleep disorders and epilepsy. Benefits include ambulatory monitoring capability for patient physiological assessment.

Clinical Evidence

Bench testing only. No clinical data provided. Device operation was verified and validated using the same test methods as existing cleared devices.

Technological Characteristics

Ambulatory telemetry system comprising electrode junction box, telemetry unit, and access point. Communicates with existing EEG machines. Non-sterile. Uses standard patient-contacting electrodes consistent with legally marketed accessories.

Indications for Use

Indicated for all patient populations, including pediatrics, for the acquisition, storage, and transfer of biophysical parameters to EEG machines to assist in the diagnosis of neurological and sleep disorders, including epilepsy.

Regulatory Classification

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.

Predicate Devices

• Siesta system by Compumedix (K003175)

Reference Devices

• EEG-1100A (K992742)
• EEG-9100A (K011204)

Submission Summary (Full Text)

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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: [phone] Fax: [phone]

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 [phone] or [phone] 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

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510(k) Number K033475