REFA, PHYSIOLOGICAL AMPLIFIER

K060374 · Tms International BV · GWL · May 30, 2006 · Neurology

Device Facts

• Record ID: K060374
• Device Name: REFA, PHYSIOLOGICAL AMPLIFIER
• Applicant: Tms International BV
• Product Code: GWL · Neurology
• Decision Date: May 30, 2006
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 882.1835
• Device Class: Class 2

Intended Use

The REFA Physiological Amplifier family is intended to be used by or under the direction of a physician for acquisition of EEG, polygraphy and polysomnography signals and transmission of the signals to a PC during recording of neurophysical/ physiological research and exams. Polygraphy and Polysomnography may besides EEG, include physiological information such as EMG, ECG, EOG, EGG, PH, Respiration, Temperature and Oxygen Saturation.

Device Story

REFA Physiological Amplifier acquires physiological signals including EEG, EMG, ECG, EOG, EGG, PH, respiration, temperature, and oxygen saturation; transmits signals to a PC for recording during neurophysiological/physiological research and exams. Used in clinical or research settings under physician direction. Output consists of digitized physiological data displayed on a PC for clinical review and decision-making. Benefits include comprehensive monitoring of multiple physiological parameters for diagnostic or research purposes.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Physiological signal amplifier; multi-channel acquisition for EEG, polygraphy, and polysomnography. Connectivity via transmission to a PC. Class II device (21 CFR 882.1835).

Indications for Use

Indicated for patients undergoing neurophysiological or physiological research and exams requiring acquisition of EEG, EMG, ECG, EOG, EGG, PH, respiration, temperature, and oxygen saturation signals. For use by or under the direction of a physician.

Regulatory Classification

Identification

A physiological signal amplifier is a general purpose device used to electrically amplify signals derived from various physiological sources (e.g., the electroencephalogram).

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 30 2006

TMS International BV % Mr. David W. Wagner U.S. Agent 7744 Swaps Trail Evergreen, Colorado 80439

Re: K060374

Trade/Device Name: REFA Physiological Amplifier Regulation Number: 21 CFR 882.1835 Regulation Name: Physiological signal amplifier Regulatory Class: II Product Code: GWL Dated: May 12, 2006 Received: May 12, 2006

Dear Mr. Wagner:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set

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## Page 2 - Mr. David W. Wagner

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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/dsma/dsmamain.html

Sincerely yours.

el-mee

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and

Radiological Health

Enclosure

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## Indications for Use

## 510(k) Number K060374:

Device Name: REFA Physiological Amplifier

The REFA Physiological Amplifier family is intended to be used by or under the direction of a physician for acquisition of EEG, polygraphy and polysomnography signals and transmission of the signals to a PC during recording of neurophysical/ physiological research and exams.

Polygraphy and Polysomnography may besides EEG, include physiological information such as EMG, ECG, EOG, EGG, PH, Respiration, Temperature and Oxygen Saturation.

Prescription Use _____________________________________________________________________________________________________________________________________________________________

AND/OR

Over-the-counter use _

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> (Division Sign-Off) 60-0 Division of General, Restorative and Neurological Devices

KO60374 510(k) Number_