MICROEEG SYSTEM

K112817 · Bio-Signal Group Corporation · GWQ · Jun 19, 2012 · Neurology

Device Facts

• Record ID: K112817
• Device Name: MICROEEG SYSTEM
• Applicant: Bio-Signal Group Corporation
• Product Code: GWQ · Neurology
• Decision Date: Jun 19, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1400
• Device Class: Class 2

Intended Use

The microEEG® system is a portable 26 channel digital electroencephalography (EEG) collection and wireless data transfer device that is designed for use in hospitals and other medical environments. The system digitizes analogue EEG signals collected by 3rd party electrodes, amplifies them, and uses Bluetooth® wireless connectivity to transfer the EEG data to a dedicated host computer. It is important to note that the microEEG® system collects and manages EEG data only. The system does not analyze or interpret EEG data in any manner. Rather, all such EEG analysis and interpretation is performed by a medical professional/clinician.

Device Story

Portable 26-channel digital EEG collection and wireless data transfer system; used in hospitals and medical environments. Device digitizes analog EEG signals from 3rd-party electrodes; amplifies signals; transmits data via Bluetooth to a dedicated host computer. Operated by medical professionals/clinicians. System performs no analysis or interpretation of EEG data; data management only. Clinicians review raw EEG data on host computer to support clinical decision-making. Benefits include portable EEG acquisition and wireless data transmission.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Portable 26-channel digital EEG system; utilizes 3rd-party electrodes; Bluetooth wireless connectivity; signal amplification and digitization; host computer interface.

Indications for Use

Indicated for use in hospitals and medical environments for the collection and wireless transfer of EEG data. Intended for use by medical professionals/clinicians for EEG data management; no patient population restrictions specified.

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

Bio-Signal Group Corporation c/o Anderson I. Micu Chief Operations Officer 760 Parkside Avenue Brooklyn. NY 11226

K112817 Re:

> Trade/Device Name: MicroEEGTM System Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: GWQ Dated: May 31, 2012 Received: June 1, 2012

JUN 1 9 2012

Dear Mr. Micu:

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.

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 or comply with all the Act's requirements, including, but not limited to: registration and listing (21

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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/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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

E. le. Krum MD
Malvina B. Eydelman, M/D

Malvina B. Eydelman, M 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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## Indications for Use

510(k) Number (if known):

K112817

Device Name:

microEEG® system

Indications For Use:

The microEEG® system is a portable 26 channel digital electroencephalography (EEG) collection and wireless data transfer device that is designed for use in hospitals and other medical environments. The system digitizes analogue EEG signals collected by 3rd party electrodes, amplifies them, and uses Bluetooth® wireless connectivity to transfer the EEG data to a dedicated host computer.

It is important to note that the microEEG® system collects and manages EEG data only. The system does not analyze or interpret EEG data in any manner. Rather, all such EEG analysis and interpretation is performed by a medical professional/clinician.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number K112817

Concurrence of CDRH, Office of Device Evaluation (ODE) Page 1 of 1