AMBULATORY EEG/SLEEP RECORDER AND ACCESSORIES, MODEL # SSR3201

K983072 · Nihon Kohden America, Inc. · OLV · Dec 1, 1998 · Neurology

Device Facts

• Record ID: K983072
• Device Name: AMBULATORY EEG/SLEEP RECORDER AND ACCESSORIES, MODEL # SSR3201
• Applicant: Nihon Kohden America, Inc.
• Product Code: OLV · Neurology
• Decision Date: Dec 1, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1400
• Device Class: Class 2

Intended Use

The SSR3201 Ambulatory EEG/Sleep Recorder is Intended for medical purposes to record electrical activity of the brain (EEG) and to record physiological data required for sleep studies (Polysomnography or PSG). These studies Including EEG, eye movement (EOG), respiratory signals such as air flow or air pressure and thoraco-abdominal movement, chin and armleg movement (EMG), body position, EKG and blood oxygen saturation. The device does not provide alarms and can not be used as an automated apnea monitor. This device is intended to record up to 24 hours of continuous patient data for freely-moving or sleeping patients both inside and outside of a medical facility. The SSR3201 is intended to record patient data for later review by a medical professional using a legally marketed digital EEG/PSG system to assist in diagnosing EEG related conditions such as epilepsy and sleep related conditions such as sleep related breathing disorders.

Device Story

Battery-powered ambulatory recorder; captures up to 24 hours of continuous physiological data including EEG, EOG, EMG, respiratory signals (airflow/pressure, thoraco-abdominal movement), body position, EKG, and blood oxygen saturation. Device utilizes isolated junction box for sensor/electrode connection. Operates as a data logger for later review by medical professionals; data transferred to legally marketed digital EEG/PSG system for clinical diagnosis. Used in clinical or home settings; patient-worn. Benefits include continuous monitoring of neurological and sleep-related conditions without requiring constant clinical supervision. No automated alarms or apnea monitoring capabilities.

Clinical Evidence

Bench testing only. No clinical data provided. Device performance verified through environmental, safety, and performance testing procedures, including software validation to confirm operation within specifications.

Technological Characteristics

Battery-powered (max 9V DC); isolated junction box for patient sensors/electrodes. Non-contacting materials. Portable form factor for ambulatory use. Not sterile. Software-based data recording.

Indications for Use

Indicated for patients requiring EEG or polysomnography (PSG) monitoring for diagnosis of conditions including epilepsy and sleep-related breathing disorders. Suitable for freely-moving or sleeping patients in or out of medical facilities. Not for use as an automated apnea monitor.

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

• Bio-logic Systems Corporation's Sleepscan Traveler (K862103)
• Oxford Instruments (K970177)

Submission Summary (Full Text)

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NIHON KOHDEN AMERICA, INC. September 1, 1998 DEC 510(k) NOTIFICATION SSR3201 Ambulatory EEG/Sleep Recorder

1 1998

K 983072

SECTION 2 - 510(K) SUMMARY

Name and Address of Applicant Nihon Kohden America, Inc. Attn: Regulatory Affairs 2601 Campus Drive Irvine, California 92812-1601 [phone]

The device has been classified as Class II by the Division of Cardiovascular, Respiratory, and Neurological Devices and the Neurology Device Classification Panel under 21 CFR Part and Nethological Devices and the Norther States of Che Anesthesion Panel of 882.1400 Electroencephalograph per of ex Cfrical of Crising, and by the Cardiovascular
under 21 CFR Part 868.2375 Ventiliatory Enrt Recorder per 73 MAR, and by the Cardiovasc under 21 Of K Part 000.201 under 21 CFR Part 870.2700 Oximeter per OLJ,

Common names for the SSR3201 device include Electroencephalograph, Ambulatory EEG Recorder and Ambulatory Sleep Recorder.

The predicate devices are Bio-logic Systems Corporation's Sleepscan Traveler per 510(K) # = The predicate devices are Blo-Dogo dated August 22, 1986 and Oxford Instruments #K862103, commercial distribution certification dated Negover Freeting dated January 17, 1997.

The SSR3201 is intended for medical purposes to record electively of the brain (EEG) and other blo-potential signals and to record physiological data required for sleep studies (Polysomnography or PSG) including EEG, eye movement (EOG), respiratory signals such as also (Polysomnography of PSG) Molding LCC, oyo nevent, chinand amovement (EMG), body position, EKG and blood oxygen saturation. The device does not provide alarms and can not be used as an automated apnea monitor.

This device is intended to record up to 24 hours of continuous patient data for freely moving or sleeping patients both inside and outside of a medical facility. The SSR3201 is intended to of sleeping patients Don miside and Outsier of a medical reciments of legally marketed digital EEG/PSG system.

To date, no performance standards or special controls are known or established for this device as required by Section 514 of the Food, Drug and Cosmetic Act and implemented by 21 CFR Part 861.

The SSR3201 device is not intended to be sterile.

The device material components were determined to be non-contacting. Therefore, good laboratory practice studies were not required per 21 CFR part 58.

The SSR3201 is subjected to environmental, safety and performance testing procedures. Software validation is performed for the device software. These tests verify the operation and confirm that the device performs within specifications.

The SSR3201 is a battery-powered device with no voltage inside the unit greater than 9 volts DC. An isolated junction box connects electrodes and/or sensors to the patient. Because of the low voltage and isolated box comroomes of the device can cause serious patient injury.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular pattern around the eagle. The eagle is depicted in a simple, black and white design.

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

Mr. Gary Reasoner Director of Product Operations Nihon Kohden America, Inc. 2601 Campus Drive Irvine, California 92612-1601

APR - 9 2012

Re: K983072

Trade/Device Name: SSR3201 Ambulatory EEG/Sleep Recorder Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: II Product Code: OLV, GWQ Dated (Date on orig SE ltr): September 1, 1998 Received (Date on orig SE 1tr): September 2, 1998

Dear Mr. Reasoner:

This letter corrects our substantially equivalent letter of December 1, 1998.

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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Page 2 - Mr. Gary Reasoner

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.

Kesia Alexana

Sincerely vours.

Malvina B. Evdelman, 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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Page 1 of 1

510(k) Number (if known): K983072

SSR3201 Ambulatory EEG/Sleep Recorder Device Name:

Indications For Use:

(Per 21 CFR 801.109)

The SSR3201 Ambulatory EEG/Sleep Recorder is Intended for medical purposes to record electrical activity of the brain (EEG) and to record physiological data required for sleep studies (Polysomnography or PSG). These studies Including EEG, eye movement (EOG), respiratory signals such as air flow or air pressure and thoraco-abdominal movement, chin and armleg movement (EMG), body position, EKG and blood oxygen saturation. The device does not provide alarms and can not be used as an automated apnea monitor.

This device is intended to record up to 24 hours of continuous patient data for freely-moving or sleeping patients both inside and outside of a medical facility. The SSR3201 is intended to record patient data for later review by a medical professional using a legally marketed digital EEG/PSG system to assist in diagnosing EEG related conditions such as epilepsy and sleep related conditions such as sleep related breathing disorders.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number. K983072

Prescription Use X OR Over-The-Counter Use

(Optional Formal 1-2-96)