(206 days)
MERIDIAN-II, MERIDIAN-Plus
Not Found
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and provides no other information suggesting the use of AI/ML.
No
The device is intended for the measurement of galvanic skin response, which is a diagnostic or monitoring function, not a therapeutic one.
No
The device measures galvanic skin response, which is a physiological measurement, but the provided information does not indicate it is used to diagnose a disease, condition, or state of health.
Unknown
The provided 510(k) summary lacks a "Device Description" section, which is crucial for determining if the device is software-only or includes hardware components. The intended use mentions "measurement of galvanic skin response," which typically requires a hardware sensor. Without a device description, it's impossible to confirm if the ABR-2000 is solely software processing data from an external sensor or if it includes its own hardware for measurement.
Based on the provided information, the ABR-2000 is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for the measurement of galvanic skin response." This is a physiological measurement taken directly from the body, not a test performed on a sample of biological material (like blood, urine, or tissue) outside of the body.
- Lack of IVD Indicators: The provided information does not mention any of the typical characteristics of an IVD, such as:
- Testing biological samples.
- Detecting or measuring substances in biological samples.
- Providing information for the diagnosis, monitoring, or treatment of diseases based on analysis of biological samples.
Galvanic skin response measurement is a technique used to assess changes in the electrical conductivity of the skin, often related to emotional or physiological states. This is a direct physiological measurement, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The ABR-2000 intended use is for the meas orement of galvanic skin response.
Product codes
GZO
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
MERIDIAN-II, MERIDIAN-Plus
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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'S
NAME/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/OPERATOR
NUMBER : | 9038705 |
| CLASSIFICATION : | The Galvanic Skin Response
Measurement Device is classified into Class
II under 21 code of Federal Regulation 82.
1540 |
| PERFORMANCE
STANDARD : | MERIDIAN CO., LTD. is not aware of any
Special Controls or Performance Standards
established for Galvanic Skin Response
Measurement Device under Section 513 and
514 respectively of the Food and Drug and |
1
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) :
-
- EN 60601-1(IEC 601-1), Safety of Medical Electrical Equipment, Part 1, General Requirements for Safety, including Amendment 1 and 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.
2
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.
3
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
4
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 ________________________________________________________________________________________________________________________________________________________________