ABR-2000

K020360 · Meridian Co., Ltd. · GZO · Aug 29, 2002 · Neurology

Device Facts

• Record ID: K020360
• Device Name: ABR-2000
• Applicant: Meridian Co., Ltd.
• Product Code: GZO · Neurology
• Decision Date: Aug 29, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1540
• Device Class: Class 2

Intended Use

The ABR-2000 intended use is for the meas orement of galvanic skin response.

Device Story

ABR-2000 is a galvanic skin response (GSR) measurement device. It measures electrical skin conductance to assess physiological responses. The system utilizes electrodes applied to the patient to capture skin signals. It incorporates electrical isolation (4000Vac) between patient-applied parts and live parts, using an isolation transformer and reinforced/double insulation for safety. The device is intended for clinical use. Output is provided to the healthcare provider to assist in physiological assessment. The device is designed to prevent accidental connection to AC power outlets via unique electrode connectors.

Clinical Evidence

Bench testing only. The device underwent electrical safety testing to confirm conformance with EN 60601-1 (IEC 601-1) and EN 60601-1-2 standards.

Technological Characteristics

Galvanic skin response measurement device. Features reinforced/double insulation and 4000Vac electrical isolation between patient-applied parts and live parts. Includes an isolation transformer. Electrode connectors are uniquely designed to prevent AC power outlet connection. Complies with EN 60601-1 and EN 60601-1-2 standards.

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

• MERIDIAN-II
• MERIDIAN-Plus

Submission Summary (Full Text)

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AUG 2 9 2002

MERIDIAN CO., LTD.

# MERIDIAN CO., LTD.

9FI., Seoil Bldg., 222, Jamsilbon-Dong, Songpa-Gu, SEOUL, KOREA Fax : [phone] Tel : [phone]

### SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION

| APPLICANT'S<br>NAME/ADDRESS : | MERIDIAN CO., LTD.<br>9FI., Seoil Bldg.,<br>222, Jamsilbon-Dong,<br>Songpa-Gu,<br>Seoul, Korea |
|-------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT PERSON : | Soo-Rang Lee |
| COMMON/USUAL NAME : | Galvanic Skin Response Measurement |
| CLASSIFICATION NAME : | Galvanic Skin Response Measurement |
| OWNER/OPERATOR<br>NUMBER : | 9038705 |
| CLASSIFICATION : | The Galvanic Skin Response<br>Measurement Device is classified into Class<br>II under 21 code of Federal Regulation 82.<br>1540 |
| PERFORMANCE<br>STANDARD : | MERIDIAN CO., LTD. is not aware of any<br>Special Controls or Performance Standards<br>established for Galvanic Skin Response<br>Measurement Device under Section 513 and<br>514 respectively of the Food and Drug and |

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#### Cosmetics Act.

MERIDIAN CO., LTD. believes the SUBSTANTIAL ABR-2000 is substantially equivalent to the EQUIVALENCE : MERIDIAN-II and MERIDIAN-Plus.

Electrical safety of the ABR-2000 are achieved by means of reinforced or double insulated parts. Electrical isolation of at least 4000Vac between Applied Part(patient circuit) and Live Part. An isolation transformer isolates the primary line current from the secondary electronics of the system when the AC power cord is connected to the system. The connectors of the electrodes are uniquely designed to prevent accidental connection to an AC power outlet.

The ABR-2000 system underdone various electrical safety tests and certify the conformance to the following standards (See Attachment 3) :

- 1. EN 60601-1(IEC 601-1), Safety of Medical Electrical Equipment, Part 1, General Requirements for Safety, including Amendment 1 and 2.
- 2. EN 60601-1-2 first edition, Standard for Electromagnetic Compatibility.

In summary the ABR-2000 meets or exceeds all the safety requirements for a medical device in its class. Our dedication to safety is evidenced in the many extra steps we have taken to insure a safe product.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 .

AUG 2 9 2002

Meridian Company, LTD. Soo-Rang Lee 9F1., Seoil Building 222 Jamsilbon-Dong Songpa-Gu Seoul, Korea

Re: K020360

Trade/Device Name: ABR-2000 Regulation Number: 882.1540 Regulation Name: Galvanic Skin Response Measurement Regulatory Class: Class II Product Code: GZO Dated: May 30, 2002 Received: June 3, 2002

Dear Mr. Lee:

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. Soo-Rang Lee

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,

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) Premarket Notification

MERIDIAN CO., LTD.

States of the states

## Indications for Use Statement

PMN 510(k) Number : K 020360

Device Name : ABR-2000

(Galvanic Skin Response Measurement Device)

Indication for Use :

The ABR-2000 intended use is for the meas orement of galvanic skin response.

(Division Sign Off) Division of General, Restorative and Neurological Devices KOZOJ60 510(k) Number ________________________________________________________________________________________________________________________________________________________________