(206 days)
The ABR-2000 intended use is for the meas orement of galvanic skin response.
Not Found
The provided text describes a 510(k) premarket notification for the ABR-2000, a Galvanic Skin Response Measurement device. The document primarily focuses on demonstrating substantial equivalence to predicate devices and adherence to electrical safety standards. It does not contain information about a study proving the device meets specific acceptance criteria related to its performance in measuring galvanic skin response, nor does it detail a study that would include the specific elements requested (e.g., sample size for test set, ground truth methods, MRMC studies, standalone performance).
Therefore, based on the provided text, I cannot complete a table of acceptance criteria versus reported device performance relevant to the measurement of galvanic skin response, nor can I provide information on sample sizes, ground truth establishment, or multi-reader studies.
The document indicates:
- Substantial Equivalence: The ABR-2000 is considered substantially equivalent to the MERIDIAN-II and MERIDIAN-Plus devices. This is the primary "acceptance criterion" in the context of a 510(k) submission where direct performance data might be deferred if equivalence to a legally marketed device is established for the same intended use.
- Electrical Safety: The device meets electrical safety requirements as per EN 60601-1 (IEC 601-1) and EN 60601-1-2. This is a safety-related acceptance criterion.
Based on the provided text, the specific information requested about a performance study is not available. The document focuses on regulatory compliance for electrical safety and substantial equivalence for its intended use, rather than a detailed performance study proving specific clinical or technical acceptance criteria for galvanic skin response measurement.
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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 : 82.2.2103.3333 Tel : 82.2.2103.3300
SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION
| APPLICANT'SNAME/ADDRESS : | MERIDIAN CO., LTD.9FI., Seoil Bldg.,222, Jamsilbon-Dong,Songpa-Gu,Seoul, Korea |
|---|---|
| CONTACT PERSON : | Soo-Rang Lee |
| COMMON/USUAL NAME : | Galvanic Skin Response Measurement |
| CLASSIFICATION NAME : | Galvanic Skin Response Measurement |
| OWNER/OPERATORNUMBER : | 9038705 |
| CLASSIFICATION : | The Galvanic Skin ResponseMeasurement Device is classified into ClassII under 21 code of Federal Regulation 82.1540 |
| PERFORMANCESTANDARD : | MERIDIAN CO., LTD. is not aware of anySpecial Controls or Performance Standardsestablished for Galvanic Skin ResponseMeasurement Device under Section 513 and514 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) :
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- EN 60601-1(IEC 601-1), Safety of Medical Electrical Equipment, Part 1, General Requirements for Safety, including Amendment 1 and 2.
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- 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 (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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 ________________________________________________________________________________________________________________________________________________________________
§ 882.1540 Galvanic skin response measurement device.
(a)
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.(b)
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.