AMBULATORY EEG/SLEEP RECORDER AND ACCESSORIES, MODEL # SSR3201 by NIHON KOHDEN AMERICA, INC.

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 Description

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.

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.

AI/ML Overview

The provided text is a 510(k) summary for the NIHON KOHDEN AMERICA, INC. SSR3201 Ambulatory EEG/Sleep Recorder. It mainly focuses on demonstrating substantial equivalence to predicate devices and outlining the device's intended use and general characteristics.

Crucially, the document does NOT contain specific acceptance criteria, detailed study designs, or performance data that would allow for a comprehensive description of how the device meets such criteria. It mentions "environmental, safety and performance testing procedures" and "Software validation is performed for the device software" to "verify the operation and confirm that the device performs within specifications," but these specifications and the results are not provided.

Therefore, I cannot populate most of the requested table and study information. However, I can extract what is available and indicate where information is missing.

Acceptance Criteria and Device Performance (Based on available information)

Acceptance Criteria	Reported Device Performance
Specific performance criteria for EEG/PSG recording accuracy, signal quality, etc.	Not specified in the provided document. The document states "These tests verify the operation and confirm that the device performs within specifications," but the specifications themselves are not detailed.
Compliance with environmental, safety, and performance testing procedures.	"The SSR3201 is subjected to environmental, safety and performance testing procedures."
Software validation.	"Software validation is performed for the device software."
Non-contacting material components (for good laboratory practice studies).	"The device material components were determined to be non-contacting. Therefore, good laboratory practice studies were not required per 21 CFR part 58."
Low voltage and isolated junction box (for patient safety).	"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."
Ability to record up to 24 hours of continuous patient data.	"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."
Compatibility with legally marketed digital EEG/PSG systems for review.	"The SSR3201 is intended to record patient data for later review by a medical professional using a legally marketed digital EEG/PSG system."

Study Information (Based on available information)

Sample size used for the test set and the data provenance:
- Sample Size: Not specified.
- Data Provenance: Not specified. The document mentions "environmental, safety and performance testing procedures" but does not detail the nature of these tests in terms of patient data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified. The document focuses on regulatory compliance and the device's technical specifications, not a clinical validation study involving expert ground truth.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not specified.
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:
- No MRMC or comparative effectiveness study is mentioned. This device, being an ambulatory recorder from 1998, predates widespread AI integration in such devices. It is an EEG/PSG recording device, not an interpretation device.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No standalone performance study is explicitly described. The device is a data acquisition device, and its output is intended "for later review by a medical professional."
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not specified. Given the nature of the device as a recorder, its "ground truth" would likely relate to the accuracy and fidelity of the physiological signal acquisition compared to established measurement techniques, rather than diagnostic "ground truth" for disease states. However, details of such validation are not provided.
The sample size for the training set:
- Not applicable/Not specified. As a 1998 device and a recorder, it is highly unlikely it utilized machine learning models requiring a "training set" in the modern sense.
How the ground truth for the training set was established:
- Not applicable/Not specified.

Summary of Missing Information:

The provided 510(k) summary (from 1998) primarily focuses on demonstrating substantial equivalence to predicate devices and outlining the device's intended use and general system characteristics. It mentions that performance testing was conducted and software was validated, implying that there are internal specifications and acceptance criteria that were met. However, the document does not provide details on:

Specific quantitative acceptance criteria (e.g., signal-to-noise ratio, frequency response, accuracy of parameter measurements).
Any details of clinical studies or performance studies involving patient data, including sample sizes, ground truth establishment, expert involvement, or adjudication methods.
Any information related to artificial intelligence or machine learning components, which would require training and test sets as per modern standards.

This level of detail on performance data is not typically a requirement for 510(k) summaries, especially for devices from 1998 that are primarily data acquisition systems rather than diagnostic algorithms.

Summary

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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 (949) 250-3959

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.

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 (800) 638-2041 or (301) 796-7100 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)

(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)

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).