PORTI 7 PHYSIOLOGICAL AMPLIFIER

K063599 · Tms International BV · GWL · Mar 22, 2007 · Neurology

Device Facts

• Record ID: K063599
• Device Name: PORTI 7 PHYSIOLOGICAL AMPLIFIER
• Applicant: Tms International BV
• Product Code: GWL · Neurology
• Decision Date: Mar 22, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.1835
• Device Class: Class 2

Intended Use

The Porti Physiological Amplifier is intended to be use by or under the directions of a physician for acquisition of EEG, polygraphy and polysomnography signals and transmission of the signals to a PC during recording of neuro-physical/physiological research and exams. Polygraphy and polysmnography may besides EEG, include physiological information such as EMG, ECG, EGG, EGG, PH, Respiration, Temperature and Oxygen Saturation.

Device Story

Porti Physiological Amplifier acquires physiological signals including EEG, EMG, ECG, EGG, PH, respiration, temperature, and oxygen saturation. Device transmits these signals to a PC for recording during neuro-physical/physiological research and clinical exams. Operated by or under direction of physician. Provides raw signal data to PC for display and analysis by healthcare provider to assist in clinical decision-making regarding neurological or physiological status.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Physiological signal amplifier; 21 CFR 882.1835; Class II; Product Code GWL. Connectivity: transmits signals to PC.

Indications for Use

Indicated for use by or under physician direction for acquisition and transmission of EEG, polygraphy, and polysomnography signals (including EMG, ECG, EGG, PH, respiration, temperature, and oxygen saturation) to a PC for neuro-physical/physiological research and exams.

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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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three overlapping curved lines, representing the human services aspect. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

TMS International BV c/o Mr. David W. Wagner Quality for Quality Consulting 7744 Swaps Trail Evergreen, CO 80439

MAR 2 2 2007

Re: K063599

Trade Name: Porti 7 Regulation Number: 21 CFR 882.1835 Regulation Name: Physiological signal amplifier Regulatory Class: II Product Code: GWL Dated: March 14, 2007 Received: March 19, 2007

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 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.

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Page 2 - Ms. Laetitia Cousin

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/industry/support/index.html.

Sincerely v

For
Mark N. Melkerson
Director

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 K063599

The Porti Physiological Amplifier is intended to be use by or under the directions of a physician for acquisition of EEG, polygraphy and polysomnography signals and transmission of the signals to a PC during recording of neuro-physical/physiological research and exams.

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

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

**510(k) Number** L063555

Prescription Use _____________________________________________________________________________________________________________________________________________________________

AND/OR

Over-the-counter use

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