NEUROFAX, MODEL EEG-1100A

K992742 · Nihon Kohden America, Inc. · OLV · Oct 14, 1999 · Neurology

Device Facts

• Record ID: K992742
• Device Name: NEUROFAX, MODEL EEG-1100A
• Applicant: Nihon Kohden America, Inc.
• Product Code: OLV · Neurology
• Decision Date: Oct 14, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1400
• Device Class: Class 2

Intended Use

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, clinic or nursing home or outside of a medical facility under direct supervision of a medical professional.

Device Story

EEG-1100A is an electroencephalograph and polysomnograph recorder. It acquires physiological signals (cerebral and extracerebral activity) via electrodes and sensors; processes, displays, and records data for clinical review. Used in medical facilities, laboratories, clinics, nursing homes, or home settings under direct medical supervision. Operated by medical personnel. Output provides diagnostic aid for sleep disorders, epilepsy, and related conditions. Device does not directly contact patients; uses standard electrodes/sensors. Bench testing verified electromagnetic, environmental, and safety performance; software validation confirmed acquisition, processing, and display functions.

Clinical Evidence

No clinical data. Bench testing only. Electromagnetic, environmental, safety, and performance testing procedures were conducted to verify device operation. Software validation confirmed the functionality of data acquisition, processing, display, and recording.

Technological Characteristics

Electroencephalograph/Polysomnograph. Complies with IEC 601-1 subclause 56.3(c) and 21 CFR Part 898 for electrode lead wires/cables. Non-sterile. Uses standard electrodes/sensors. Software-based acquisition, processing, and display. Connectivity via standard medical facility infrastructure.

Indications for Use

Indicated for patients requiring EEG or polysomnography (PSG) monitoring for the diagnosis of sleep disorders, epilepsies, and related neurological conditions. Intended for use by medical personnel in clinical, laboratory, or home settings under professional supervision.

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

• Nihon Kohden EEG-2100 (K944678)

Submission Summary (Full Text)

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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: [phone] Fax: [phone]

Primary Contact: Bonnie Bishop, Regulatory Affairs Manager [phone] ext. 4401

Alternate Contact: Gary Reasoner, Director of Product Operations [phone] 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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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 [phone] or [phone] 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:

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.

hcdeslaB

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

Prescription Use
X
(Per 21 CFR 801.109)