BIOSOMNIA

K021485 · Oxford Biosignals Limited · OMC · Sep 11, 2002 · Neurology

Device Facts

• Record ID: K021485
• Device Name: BIOSOMNIA
• Applicant: Oxford Biosignals Limited
• Product Code: OMC · Neurology
• Decision Date: Sep 11, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1400
• Device Class: Class 2

Intended Use

The Oxford BioSignals BioSomnia is a single channel ambulatory EEG with a software package designed for use as an adjunct for the physician in their diagnosis of sleep disorders and to quantify sleep and wakefulness on a second by second basis. The device is designed to be used overnight in the patient's home environment to assist the physician in diagnosing sleep disorders. Warning: Federal (U.S.A.) law restricts this device for use by or on the order of a physician.

Device Story

Biosomnia is a single-channel ambulatory EEG system; records brain activity during overnight home sleep sessions. Software processes recorded EEG data to quantify sleep and wakefulness states on a second-by-second basis. Physician uses output as an adjunct tool for diagnosing sleep disorders. Device operates via prescription; intended for home use by patients; data reviewed by clinicians to inform diagnostic decisions.

Technological Characteristics

Single-channel ambulatory EEG system. Includes hardware for signal acquisition and software for data analysis. Operates as a diagnostic aid for sleep disorder assessment.

Indications for Use

Indicated for patients requiring diagnosis of sleep disorders. Used overnight in home environments to assist physicians in quantifying sleep and wakefulness.

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

Oxford Biosignals Limited c/o E. J. Smith Smith Associates P.O. Box 4341 Crofton, Maryland 21114-4341

APR - 9 2012

Re: K021485

Trade/Device Name: Biosomnia Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: II Product Code: OMC, OLV Dated (Date on orig SE ltr): August 8, 2002 Received (Date on orig SE ltr): August 12, 2002

Dear Mr. Smith:

This letter corrects our substantially equivalent letter of September 11, 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. E. J. Smith

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/ResourcesforYou/Industry/default.htm.

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Kesia

Malvina B.
Director
Division of

Sincerely yours,

Malvina B. Eydelman, M.D. 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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510(k) Number: K021485

Device Name: Oxford BioSignals BioSomnia

Classification Panel:

Indications for Use:

The Oxford BioSignals BioSomnia is a single channel ambulatory EEG with a software package designed for use as an adjunct for the physician in their diagnosis of sleep disorders and to quantify sleep and wakefulness on a second by second basis.

The device is designed to be used overnight in the patient's home environment to assist the physician in diagnosing sleep disorders.

Warning: Federal (U.S.A.) law restricts this device for use by or on the order of a physician.

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

Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use: Over-the-Counter Use: Division of General, Restorative and Neurological Devices

510(k) Number K021485