Biopotential skin electrodes will be used by the Bio Medical community in both clinical and research applications of the acquisition of all surface biopotentials, standards, and reference, i.e. Electroencephalograph (EEG), Electrocardiograph (ECG), Electromyography (EMG), Electrooculograph (EOG).

Device Description

This specific device is comprised of a sintered Ag-AgCl electrode with a 99.99% Silver wire. Some of the electrodes are to be sold as bare electrodes. Some are set and sealed in an epoxy or silicone housing with a PVC, Silicone or other TPE insulated, tinseled copper lead wire attached. The device is then sealed with either silicone or Epoxy. They have a smooth, non-porous finish on all surfaces with no cracks, seams, or bubbles. It is then considered waterproof and cold sterilizable. There is a recess in the underside of the housing surrounding the exposed electrode surface to allow for the placement of an electroconductive gel. The gel establishes contact between the Ag-AgCl electrode and the subject surface to be measured. The gel improves electro conductivity between the subject surface and the Ag-AgCl electrode surface for a more sensitive and accurate reading of the Biopotential. The lead wires are either unterminated or terminate with a 1.5 DIN safety socket, snap, or pinch connector.

AI/ML Overview

The provided text is a 510(k) summary for "Cutaneous Electrodes" from DocXS, LLC. This document focuses on the regulatory clearance process for a medical device and does not contain information about acceptance criteria or a study proving that the device meets those criteria, as typically found in clinical validation or performance studies.

Instead, it's a submission for a "substantial equivalence" determination to a legally marketed predicate device. This means the manufacturer is asserting their device is as safe and effective as another device already on the market, rather than presenting a performance study with acceptance criteria.

Therefore, I cannot fulfill the request to describe acceptance criteria and a study proving the device meets them based solely on the provided text. The document does not contain the information required for:

A table of acceptance criteria and reported device performance.
Sample size used for the test set or data provenance.
Number of experts used to establish ground truth or their qualifications.
Adjudication method for the test set.
MRMC comparative effectiveness study results or effect sizes.
Standalone (algorithm-only) performance results.
Type of ground truth used.
Sample size for the training set.
How ground truth for the training set was established.

The text describes the device (Ag-AgCl electrodes), its intended use ("acquisition of all surface biopotentials"), and the regulatory process (510(k) submission, substantial equivalence to a predicate device). It explicitly states that the 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."

In summary, the provided document does not contain the information requested regarding a study or acceptance criteria for device performance.

Summary

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SEP 2 6 2002

DOCXS LI Bio Medical products Ag-AgCl Electrodes Vascular Occluders

510(k) Summary -

Cutaneous Electrodes

Biopotential Electrodes, various types

Date of Application: 3/15/02

Company name: DocXS, LLC Address: 564 S. Dora, Unit A #1 Ukiah, CA 95482 Mailing Address: 12200 Pine Ave. Potter Valley, CA 95469 Phone: 707-743-1365 E-mail: DocXS@pacific.net FDA Reg. #: Submitted application and waiting for response Submitted by: Richard A. Rizzolo, Principle Address: 12200 Pine Ave., Potter Valley, CA 95469 Phone: 707-743-1365

Signature:

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Description of Device

Product Description: Biopotential Electrodes, various types and models Proprietary Device name: B series electrodes Common\Generic Name: Biopotential electrodes, various types and models Trade Name: Cutaneous electrodes FDA Classification Name: Cutaneous electrodes Device Class: 2 Product Code: GXY Regulation Number: 882.1320 Medical Specialty/Panel: NEUROLOGY Manufacture of original device: NA Establishment Operations: manufacturer

The lead wires are either unterminated or terminate with a 1.5 DIN safety socket, snap, or pinch connector. Exasple . Je ctron

Labeling

Labeling: Package Label, see sample label below

Instructions for use, Promotional material, Specific intended use statement, included with device, example page ... Section 4 page 3 $ 4
Warnings, contradictions, or limitations: included with device, . example page... Sec ... Sec 4 -- 1 --Page 3 14

Sample Label:

Manufactured by	DocXS, LLC
	564 S. Dora, Ukiah, CA 95482 707-743-1365

Biopotential Surface Electrodes

Contents: One Ag-AgCl electrode, 8mm X 1mm in Epoxy

Model: B-224-LS, 40" red

Indicated for use in acquisition of surface biopotentials

Refer to instructions before use	Batch #:	non-sterile
----------------------------------	----------	-------------

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features an abstract image of an eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle. The seal is black and white and appears to be a scanned image.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 6 2002

Mr. Richard Rizzolo DocXS, LLC 564 South Dora, Suite A-1 Ukiah, California 95482

Re: K020903

Trade/Device Name: DocXS B Series Electrodes Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous Electrode Regulatory Class: Class II Product Code: GXY Dated: August 13, 2002 Received: August 23, 2002

Dear Mr. Rizzolo:

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. Richard Rizzolo

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" (21CFR 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,

A. Celia M. Witten, Ph.D., MD

Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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EU,STFood and Drig Administration, Center for Devices and Radiotograaf Realithy

510(k) Number (if known): K020903

Device Name:

Indications for Use:

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurence of CDRH, Office of Device Evaulation (ODE) (Division Sign-Off)

Division of General, Restorative and Neurological Devices

(Optional Format 3-10-98)

510(k) Number K070903

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).