(79 days)
The MSAS -- Vantage intended use is for the measurement of Galvanic Skin Response.
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This document is a 510(k) clearance letter from the FDA for a device called "MSAS - Vantage." It states that the device is substantially equivalent to legally marketed predicate devices.
However, this letter does not contain the information required to answer your specific questions about acceptance criteria and study details.
Here's why and what you would typically look for in such a document or related submissions:
- Acceptance Criteria and Reported Device Performance: This letter only confirms that the device is "substantially equivalent" but does not detail the specific performance metrics used for that determination or the achieved results against acceptance criteria. A 510(k) submission would typically include a comparative analysis of the new device to a predicate device, often using metrics relevant to the device's function. For a galvanic skin response measurement device, this might include measures of accuracy, precision, or repeatability compared to a standard.
- Study Details (Sample Size, Data Provenance, Ground Truth, Experts, Adjudication, MRMC, Standalone, Training Set): None of this information is available in the provided FDA clearance letter. These details would be found in the actual 510(k) submission, specifically in the sections detailing the studies performed to demonstrate substantial equivalence.
In summary, based only on the provided text, I cannot complete the table or answer the specific questions. The document is a regulatory approval, not a technical report on the device's performance study.
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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 (240) 276-0115. 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 (800) 638-2041 or (301) 443-6597 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):
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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§ 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.