TAYLOR GENERAL PURPOSE MONITORING ELECTRODE

K954951 · Taylor Industries, Inc. · GZJ · May 30, 1996 · Neurology

Device Facts

• Record ID: K954951
• Device Name: TAYLOR GENERAL PURPOSE MONITORING ELECTRODE
• Applicant: Taylor Industries, Inc.
• Product Code: GZJ · Neurology
• Decision Date: May 30, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Taylor TENS electrode is designed to be used in monitoring/ stimulating applications. This type of application places the emphasis on the patient's comfort. We recommend that the patient's skin be clean, dry, and shaved, if necessary. It has been shown that a mild abrasion with a prep pad or with fine sandpaper will reduce the inter electrode impedance imbalance, which can cause the pickup of 60 cycle noise, known as baseline hum. This means that the way a patient's skin is prepared for the electrode, will affect the quality of how the users ECG tracings come out and the performance during stimulation procedures. The Taylor TENS electrode is for Health Care Professionals only. It is intended for single patient use only.

Device Story

Device is a cutaneous electrode for ECG monitoring and electrical stimulation; consists of silver/silver chloride conductive coated carbon-filled polymer with attached leadwire and hypo-allergenic hydrogel adhesive. Used by healthcare professionals in clinical settings. Applied to patient skin to facilitate electrical signal transmission for monitoring or stimulation. Performance depends on proper skin preparation (cleaning/shaving/abrasion) to minimize inter-electrode impedance and baseline hum. Single-patient use.

Clinical Evidence

Bench testing only. Comparative performance testing conducted against the predicate device (Classic ECG/ Stimulating No. 1700 Series Electrode) to evaluate accuracy and electrical performance.

Technological Characteristics

Materials: Silver/Silver Chloride conductive coated carbon-filled polymer; hypo-allergenic hydrogel adhesive. Meets applicable AAMI standards. Form factor: Electrode with attached leadwire. Energy: Passive conductive interface for electrical stimulation/ECG monitoring.

Indications for Use

Indicated for use by healthcare professionals for ECG monitoring and electrical stimulation applications on patients requiring such procedures.

Regulatory Classification

Identification

A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.

Predicate Devices

• Classic ECG/ Stimulating No. 1700 Series Electrode (K900519)

Submission Summary (Full Text)

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K954951

# 510(k) Summary of Safety and Effectiveness

## Manufacturer/ Submitter
Taylor Industries, Inc.
2995 S. Moorland Road
New Berlin, WI 53151 USA

## Contact Name/ Telephone Number
Michael Ballard
President
Taylor Industries, Inc.

Phone [phone]

Date October 23, 1995

## General Device Information

### Common/ Usual Name
This device is commonly known as a stimulation electrode.

### Trade/ Proprietary Name
Taylor Industries, Inc.'s trade/ proprietary name for this device is the Taylor TENS (Transcutaneous Electrical Nerve Stimulator) Electrode.

### Classification Name(s)
The Taylor TENS Electrode's classification name, classification panel, and regulation citation is:

21 CFR 882.1320
Cutaneous Electrode
84GXY

## Device Classification
Similar devices have been determined to be Class II devices according to the Neurological Devices Classification Panel. It is believed that this electrode will be considered to be a Class II device.

## Performance Standards
Performance standards (Section 514 of the Act) have not yet been established for the device that is the subject of this premarket notification submission.

## Legally Marketed Predicate Device
The Taylor TENS Electrode is substantially equivalent, with similar indications for use to the following devices which are currently legally marketed and in commercial distribution:

*K900519
Classic Medical Products
Classic ECG/ Stimulating No. 1700 Series Electrode

## Device Description
The Taylor TENS Electrode is intended to be used as an ECG or stimulating electrode. The electrode is a Silver/ Silver Chloride conductive coated carbon filled polymer, with an attached leadwire. The adhesive that is being used is a hypo-allergenic hydrogel which allows for an adequate hold to the patient. This product meets all of the applicable AAMI Standards.

## Intended Use
The Taylor TENS electrode is designed to be used in monitoring/ stimulating applications. This type of application places the emphasis on the patient's comfort. We recommend that the patient's skin be clean, dry, and shaved, if necessary. It has been shown that a mild abrasion with a prep pad or with fine sandpaper will reduce the inter electrode impedance imbalance, which can cause the pickup of 60 cycle

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neise, known as baseline hum. This means that the way a patient's skin is prepared for the electrode, will affect the quality of how the users ECG tracings come out and the performance during stimulation procedures.

The Taylor TENS electrode is for Health Care Professionals only. It is intended for single patient use only.

## Conclusion

Comparative testing was done on Taylor TENS electrode and the Classic ECG/ Stimulating No. 1700 Series electrode. Test results indicate that the Taylor TENS electrode provides an equivalent level or better in performance when compared to the legally marketed predicate device when tested to the accuracy requirements as specified in the contents of the premarket notification submission.

Taylor Industries, Inc. feels that the Taylor TENS Electrode is as safe and effective, and performs substantially equivalent to the legally marketed predicate device.