HYDROSPOT EEG ELECTRODE MODEL 1501, HYDROSPOT LEADWIRE MODEL 1500

K960732 · Physiometrix, Inc. · GXY · Apr 15, 1996 · Neurology

Device Facts

• Record ID: K960732
• Device Name: HYDROSPOT EEG ELECTRODE MODEL 1501, HYDROSPOT LEADWIRE MODEL 1500
• Applicant: Physiometrix, Inc.
• Product Code: GXY · Neurology
• Decision Date: Apr 15, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1320
• Device Class: Class 2

Intended Use

The HydroSpots are intended as direct substitutes for existing reusable EEG electrodes.

Device Story

HydroSpot System (Models 1500/1501) comprises single-use, pre-gelled, silver/silver chloride EEG electrodes and leadwires; designed as disposable alternative to traditional reusable EEG electrodes. Electrodes utilize conductive hydrogel for signal transmission from skin surface to Ag/AgCl substrate; adhesive ring secures electrode to scalp. System mimics traditional electrode placement workflow; requires manual head measurement and marking. Used in clinical settings by technicians/clinicians for EEG monitoring; facilitates easier patient cleanup post-procedure compared to reusable electrodes. Device provides raw EEG signal transmission to external monitoring equipment; does not perform signal processing or analysis.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Materials: silver/silver chloride, conductive hydrogel, skin contact adhesive. Form factor: pre-gelled cup electrode with optional adhesive ring. Connectivity: wired connection to EEG monitoring equipment. Single-use, disposable. No software or active electronic components.

Indications for Use

Indicated for use as cutaneous electrodes for EEG signal acquisition in patients requiring neurophysiological 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

• HydroDot NeuroMonitoring System (K930080)

Submission Summary (Full Text)

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Physiometrix, Inc.
510(k), Premarket Notification
HydroSpot System, Model 1500 & 1501
K960732

# HYDROS/POTS
## SUMMARY OF SAFETY AND EFFECTIVENESS

| Date: | February 20, 1996 |
| --- | --- |
| Company: | Physiometrix, Inc.
Five Billerica Park
101 Billerica Avenue
N. Billerica, MA 01862 |
| Contact: | Dawn E. Frazer
Director, Regulatory Affairs & Quality Assurance
[phone]
[phone] |
| Subject Device: | Model 1501, HydroSpot EEG Electrodes
Model 1500, HydroSpot EEG Leadwires |
| Predicate Device: | K930080, HydroDot NeuroMonitoring System |
| Classification: | Class II, CFR 21 Part 882.1320, Cutaneous Electrodes |
| Description: | The HydroSpots are single-use, pre-gelled, disposable, silver/silver chloride EEG electrodes. They are designed to satisfy the customers who prefer the traditional electrode placement system that involves measuring the head, marking the electrode locations, and adhering electrodes to the head.

The HydroSpots have a similar form factor to the industry standard leadwire attached electrodes. The product design mimics the traditional electrode placement system while maintaining the other benefits provided by the heapiece electrodes that are listed below.

a. Ease of patient clean up. Both electrodes use a conductive adhesive gel to transmit the signal from the body's surface to the silver/silver chloride substrate. The hydrogel minimizes patient clean up as the hydrogel removes cleanly from the hair.

b. Ease of electrode clean up. The traditional electrodes have to be washed between patients while the HydroSpots and HydroDot electrodes are disposable. |
| Intended Use: | The HydroSpots are intended as direct substitutes for existing reusable EEG electrodes. |
| Design/Materials: | The HydroSpots are fabricated from a combination of materials that are widely used in the sensing electrode industry, silver/silver chloride, conductive hydrogel, and skin contact adhesive. |

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Physiometrix, Inc.
510(k), Premarket Notification
HydroSpot System, Model 1500 & 1501

The design features a pre-galled cup electrode with an optional adhesive ring that may be exposed and used to secure the electrode to the skin. The electrode is designed to mate with a wire such that the wire is reusable and the electrode which makes direct patient contact is disposable.

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