EEG ELECTRODES MODEL 445 SERIES

• K Number: K982053
• Device Name: EEG ELECTRODES MODEL 445 SERIES
• Manufacturer: CLASS A ENT.
• Date Cleared: 1999-04-20 ( 313 days)
• Product Code: GXY
• Regulation Number: 882.1320
• Type: Traditional
• Panel: Neurology
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

EEG Electrodes Model "445 Series" will be used to record the surface EEG potentials of the brain.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for EEG Electrodes Model "445 Series". It confirms that the device is substantially equivalent to legally marketed predicate devices. However, this type of document typically does not contain the detailed information about acceptance criteria or a study proving device performance as requested.

510(k) submissions primarily focus on demonstrating substantial equivalence to a predicate device, and while they include performance data, the public letter does not detail the specific acceptance criteria, study methodologies, or outcomes in the granular way you've asked for.

Therefore, I cannot extract the following information from the provided text:

1. A table of acceptance criteria and the reported device performance: This is not present.
2. Sample sizes used for the test set and data provenance: This is not present.
3. Number of experts used to establish ground truth and their qualifications: This is not present.
4. Adjudication method: This is not present.
5. MRMC comparative effectiveness study details (effect size): This is not present.
6. Standalone performance study details: This is not present.
7. Type of ground truth used: This is not present.
8. Training set sample size: This is not present.
9. How ground truth for the training set was established: This is not present.

The document only states the device name ("EEG Electrodes Model "445 Series"") and its intended use ("to record the surface EEG potentials of the brain"). It also confirms the regulatory class (II) and product code (GXY).

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol featuring three abstract human profiles or figures, arranged in a row and connected by flowing lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 0 1999

Ms. Janice A. Audi Class A Enterprises 7607 Lucerne Vista Yucca Valley, California 92284

Re: K982053 Trade Name: EEG Electrodes Model "445 Series" Regulatory Class: II Product Code: GXY Dated: October 13, 1998 Received: January 20, 1999

Dear Ms. Audi:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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This letter will allow you to begin marketing your device as described in your 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 vour device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

fi

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

Radiological Health

Enclosure

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Class A Enterprises - 510 (k) #K982053

Device Name: EEG Electrodes Model "445 Series"

Indications For Use:

EEG Electrodes Model "445 Series" will be used to record the surface EEG potentials of the brain.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X or Over-The-Counter Use __

(Division Sign-Off)
Division of General Restorative Devices K982053
510(k) Number__

20 .. 9

Regulation Number and Section

§ 882.1320 Cutaneous electrode.

(a)
Identification. A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.(b)
Classification. Class II (performance standards).