EPI-SCAN, MODEL P 100

K032935 · Edx Epi-Scan, Inc. · GZO · Nov 20, 2003 · Neurology

Device Facts

• Record ID: K032935
• Device Name: EPI-SCAN, MODEL P 100
• Applicant: Edx Epi-Scan, Inc.
• Product Code: GZO · Neurology
• Decision Date: Nov 20, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.1540
• Device Class: Class 2

Intended Use

For the measurement of galvanic skin response.

Device Story

Epi-Scan P100 is a noninvasive, painless instrument for quantitative measurement of Selective Tissue Conductance. Device applies a weak DC electrical signal to a restricted surface area of biological tissue for a selected duration. Principle of operation relies on electrophysiological effects of sweat gland innervation, sharing neuroanatomic reflex pathways with sympathetic skin activity tests. Device measures tissue conductance; output provides quantitative data for clinical assessment of regional perspiration levels. Used by clinicians to evaluate sympathetic skin activity.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological comparison to the predicate device.

Technological Characteristics

Galvanic skin response measurement device; noninvasive; applies weak DC electrical signal to tissue surface. Measures selective tissue conductance based on sweat gland innervation. Class II device (Product Code: GZO).

Indications for Use

Indicated for the measurement of galvanic skin response in patients.

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.

Predicate Devices

• Epi-Scan Selective Tissue Conductance Meter (K874850)

Submission Summary (Full Text)

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EDA Epi Scan

k032935 1/2

NOV 2 0 2003

## EDX Epi-Scan

130 Main Road Huntsville, AL 35811 256-858-6666

## SUMMARY

| Submitter's name: | EDX Epi-Scan |
|-------------------|----------------------|
| Address: | 130 Main Road |
| | Huntsville, AL 35811 |
| Phone: | 256-858-6666 |

Greg Holland Requlatory Specialists. Inc 3722 Ave. Sausalito Irvine, CA 92606 Phone: [phone] fax: [phone]

Date the summary was prepared: September 4, 2003

Name of the device: Trade or proprietary name: Common or usual name:

Classification name:

Name of contact person:

EDX Epi-Scan EDX Epi-Scan Galvanic Skin Response Measurement Device Galvanic Skin Response Measurement Device

The legally marketed device to which we are claiming equivalence [807.92(a)(3)]:

> K874850. Epi-Scan Selective Tissue Conductance Meter submitted by EDX Epi-Scan Inc

Description of the device:

The development of the Epi-Scan P100 has been based on the combined principles of instrumentation and the electrophysiological effects of innervation of the sweat glands. This provides a noninvasive, painless instrument system fore the quantitative measurement of Selective Tissue Conductance, which has been operationally defined as "…the relative ability of biological tissue to conduct a weak (DC) electrical signal, which is applied for a selected period of time to a selected, limited and restricted surface area of that tissue ... " and which shares those same neuroanatomic reflex

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K032935

pathways as other tests of sympathetic skin activity or regional perspiration levels.

Indications:

For the measurement of galvanic skin response.

Summary of the technological characteristics of our device compared to the predicate device:

The Epi-Scan Selective Tissue Conductance Meter, K874850 and Epi-Scan P100 were compared in the following areas and found to have similar technological characteristics and to be equivalent.

Indications for use Skin conductance range Display Components Standards met Software

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NOV 2 0 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

EDX Epi-Scan c/o Mr. Greg Holland Regulatory Specialists, Inc. 3722 Avenue Sausalito Irvine, California 92606

Re: K032935

Trade/Device Name: Epi-Scan P100 Regulation Number: 21 CFR 882.1540 Regulation Name: Galvanic skin response measurement device Regulatory Class: II Product Code: GZO Dated: October 23, 2003 Received: October 31, 2003

Dear Mr. Holland:

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 clectronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050,

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## Page 2 - Mr. Greg Holland

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 vour 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 vours.

Miriam C. Provost

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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| 510(k) Number (if known): | K032935 |
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Device Name: _ Epi-Scan P100

Indications For Use:

For the measurement of galvanic skin response.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use (Optional Format 1-2-96)

Miriam C. Provost

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

K632935 510(k) Number_

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