AQUABOND ELECTRODE

K964433 · Medibond , Ltd. · GXY · Jan 27, 1997 · Neurology

Device Facts

• Record ID: K964433
• Device Name: AQUABOND ELECTRODE
• Applicant: Medibond , Ltd.
• Product Code: GXY · Neurology
• Decision Date: Jan 27, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1320
• Device Class: Class 2

Intended Use

The AQUABOND electrode is a disposable EEG cutaneous electrode that uses an aqueous, conductive adhesive to bond an Ag/AgCl disk to the skin.

Device Story

Disposable EEG cutaneous electrode; Ag/AgCl coated plastic base; aqueous conductive adhesive. Supplied dry; activated by wetting with tap water. Provides low impedance skin contact; suitable for application on hair-covered skin. Used in clinical settings for EEG signal acquisition. Replaces traditional electrode pastes/collodion; eliminates organic solvent odors; facilitates quick removal. Benefits patient/clinician via improved ease of use and reduced cleanup time.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Ag/AgCl coated plastic base; aqueous conductive adhesive. Disposable form factor. Activated by tap water. Low impedance interface.

Indications for Use

Indicated for use as a cutaneous EEG electrode for the acquisition of electroencephalographic signals in patients requiring EEG monitoring.

Regulatory Classification

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.

Predicate Devices

• Neurolink EEG/EP/EMG Surface Electrode
• Elefix Electrode Cream
• Collodion paste

Submission Summary (Full Text)

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JAN 27 1997
K964433

# SUMMARY OF SAFETY AND EFFECTIVENESS

This summary of safety and effectiveness information is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR 807.92.

## Submitter:

Medibond Ltd. 17 Aminadav St., Tel Aviv 67067, Israel
Tel: [phone]; Fax: [phone]

## Name of the Device:

AQUABOND

## Predicate Devices:

The AQUABOND is substantially equivalent to a combination of the Neurolink EEG/EP/EMG Surface Electrode, Elefix Electrode Cream and Collodion paste.

## Description of the Device:

The AQUABOND electrode is a disposable EEG cutaneous electrode that uses an aqueous, conductive adhesive to bond an Ag/AgCl disk to the skin. Because the adhesive is aqueous, removal is quick and unaccompanied by odors from organic solvents, as is the case with electrodes attached with pastes, such as Collodion. The AQUABOND electrode comprises a silver/silver chloride (Ag/AgCl) coated plastic base with an attached aqueous conductive adhesive component. The electrode is supplied in a dry state and when the conductive, adhesive component is wet with common tap water, it becomes sticky and can be attached to the skin, even in locations with hair, to provide a well adhering, low impedance electrode. The differences between the AQUABOND and the predicate devices raise no new issues of safety or effectiveness.

23. OCT. 1996
Date


Dr. Yoel Tsur, President

AQUABOND - 510(k) Application
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