NIGHTRON POLYSOMNOGRAPHY SYSTEM

K022249 · Telediagnostic Systems, Inc. · OLV · Dec 31, 2002 · Neurology

Device Facts

• Record ID: K022249
• Device Name: NIGHTRON POLYSOMNOGRAPHY SYSTEM
• Applicant: Telediagnostic Systems, Inc.
• Product Code: OLV · Neurology
• Decision Date: Dec 31, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1400
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The device is used in the assessment of sleep related disorders by recording a range of physiologic parameters during sleep. These parameters are presented graphically on a computer screen for diagnostic review, similar in application to the use of a traditional paper based polygraph recorder. This device does not provide alarms, is not intended for use as an automated apnea monitor, and does not provide automated diagnostic analysis.

Device Story

Nightron Polysomnography System records physiologic parameters during sleep; functions as digital replacement for traditional paper-based polygraph recorders. Device captures signals; displays data graphically on computer screen for clinician review. Used in clinical settings under physician order and supervision. Does not provide alarms, automated apnea monitoring, or automated diagnostic analysis. Clinician reviews raw graphical data to assess sleep disorders; output supports clinical decision-making regarding patient sleep health.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Digital polysomnography system; records physiologic parameters; graphical display on computer screen; no automated analysis or alarm capabilities.

Indications for Use

Indicated for use upon the order of a physician and under the supervision of a qualified health care professional for the assessment of sleep-related disorders in patients requiring physiologic parameter recording during sleep.

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.

Submission Summary (Full Text)

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

TeleDiagnostic Systems. Inc. Larry Woodard President 1757 East bayshore Road, #24 Redwood City, California 94063

APR

Re: K022249

Trade/Device Name: Nightron polysomnography System™ Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: II Product Code: OLV Dated (Date on orig SE ltr): September 27, 2002 Received (Date on orig SE ltr): October 2, 2002

Dear Mr. Woodard:

This letter corrects our substantially equivalent letter of December 31, 2002.

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. Larry Woodard

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/CDRH/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.

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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

Enclosure

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Nightron Polysomnography System 510(K) Submission page:

K02 2249

## Indications For Use

K022249 510(k) Number:

## Nightron Polysomnography System Device Name:

This is a diagnostic device for use upon the order of a Indications For Use: physician and under the supervision of qualified health care professional.

> The device is used in the assessment of sleep related disorders by recording a range of physiologic parameters during sleep. These parameters are presented graphically on a computer screen for diagnostic review, similar in application to the use of a traditional paper based polygraph recorder.

> This device does not provide alarms, is not intended for use as an automated apnea monitor, and does not provide automated diagnostic analysis.

Mark N. Mellema
for Richard Stone

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

510(k) Number K022249