MSAS-VANTAGE

K053004 · Biomeridian, Int. · GZO · Jan 13, 2006 · Neurology

Device Facts

• Record ID: K053004
• Device Name: MSAS-VANTAGE
• Applicant: Biomeridian, Int.
• Product Code: GZO · Neurology
• Decision Date: Jan 13, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.1540
• Device Class: Class 2

Intended Use

The MSAS -- Vantage intended use is for the measurement of Galvanic Skin Response.

Device Story

MSAS-Vantage measures Galvanic Skin Response (GSR); device captures electrical skin conductance data via electrodes; processes signals to provide quantitative GSR measurements; used in clinical settings by healthcare professionals; output assists clinicians in assessing physiological responses; device provides objective data for clinical evaluation.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Galvanic skin response measurement device; 21 CFR 882.1540; Class II; Product Code GZO.

Indications for Use

Indicated for the measurement of Galvanic Skin Response (GSR).

Regulatory Classification

Identification

A galvanic skin response measurement device is a device used to determine autonomic responses as psychological indicators by measuring the electrical resistance of the skin and the tissue path between two electrodes applied to the skin.

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 882.9.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 3 2006

Mr. Gene Swift Vice President, Compliance Biomeridian, Int. 12411 South 265 West, Suite F Draper, Utah 84020

Re: K053004

Trade/Device Name: MSAS - Vantage Regulation Number: 21 CFR 882.1540 Regulation Name: Galvanic skin response measurement device Regulatory Class: II Product Code: GZO Dated: December 12, 2005 Received: December 15, 2005

Dear Mr. Swift;

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 - Mr. Swift

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 yours,

Mark N. Mellor

Mark N. Melkerson Section Acting 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 (if known):

K053004

Device Name:

MSAS - Vantage

Indications for Use:

The MSAS -- Vantage intended use is for the measurement of Galvanic Skin Response.

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ AND/OR Prescription Use (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

510(k) Number_Ko53004

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