TENS/NMES/FES STIMULATING ELECTRODE

K083350 · Covidien LP · GXY · Apr 21, 2009 · Neurology

Device Facts

• Record ID: K083350
• Device Name: TENS/NMES/FES STIMULATING ELECTRODE
• Applicant: Covidien LP
• Product Code: GXY · Neurology
• Decision Date: Apr 21, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1320
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Superior Starburst Reusable Self-adhering TENS/NMES/FES Stimulating Electrodes are indicated for use with transcutaneous electrical stimulation devices as non-sterile. Latex free, reusable device for single patient use only. The electrodes provide the conductive interface between the stimulation device and the patient's skin. The starburst gradient pattern provides optimal current distribution.

Device Story

Device is a cutaneous electrode for TENS/NMES/FES stimulation. Input: electrical current from stimulation device. Output: conductive interface to patient skin. Construction: top cover, reinforcement film, silver-printed conductive member, conductive hydrogel (with Aloe Vera/green pigment), and wire. Starburst gradient pattern optimizes current distribution. Used in clinical or home settings by patients or clinicians. Benefits: provides electrical path for therapy; reusable for single patient.

Clinical Evidence

Bench testing only. Biocompatibility, physical, and functional performance evaluations were conducted to demonstrate substantial equivalence to the predicate device.

Technological Characteristics

Cutaneous electrode; materials include top cover, reinforcement film, silver-printed conductive member, conductive hydrogel with Aloe Vera and green pigment, and wire. Features starburst gradient pattern for current distribution. Non-sterile, latex-free, single-patient reusable. No software or electronic components.

Indications for Use

Indicated for use with transcutaneous electrical stimulation devices (TENS/NMES/FES) as a non-sterile, latex-free, reusable interface for single-patient use.

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

• Covidien Reusable Self-adhering TENS/FES/NMES Stimulating Electrodes (K083350)

Submission Summary (Full Text)

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Covidien, LP 15 HAMPSHIRE STREET, MANSFIELD, MASSACHUSETTS 02048 • (508) 261-80

510(k) Premarket Notification - Superior Starburst Reusable Self-adhering TENS/NMES/FES Stimulating Electrodes

# Section B - 510(K) Summary

Date Summary Was Prepared: Submitter's Information:

November 11th, 2008

Covidien, LP 15 Hampshire Street Mansfield, MA 02048 Phone: [phone] APR 9 1 2009

Contact:

Wei Zhao Manager, Regulatory Affairs Covidien, LP Telephone: [phone] Fax: [phone]

Device Trade

Name:

Superior Starburst Reusable Self-adhering TENS/NMES/FES Stimulating Electrodes

Device Common Name:

Cutaneous Electrode

Classification Panel:

Neurology

### Legally Marketed Devices To Which Substantial Equivalence Is Claimed:

The proposed Covidien Superior Starburst Reusable Self-adhering TENS/NMES/FES Stimulating Electrodes are substantially equivalent to the currently marketed Covidien Reusable Self-adhering TENS/FES/NMES Stimulating Electrodes in intended use, physical characteristics, and performance characteristics. The predicate device is classified as Class II device.

### Device Description:

The proposed electrode composes of a top cover, a reinforcement film, a conductive member with printed Silver, conductive hydrogel which contains Aloe Vera and green pigment, a release liner which protects the conductive hydrogel before use and during storage, and a wire secured in between reinforcement film and conductive member. The wire connects the electrode to the transcutaneous electrical stimulation devices. Four finished electrodes are placed into a protective pouch. The pouches are sealed and boxed for shipping.

### Intended Use:

The Superior Starburst Reusable Self-adhering TENS/NMES/FES Stimulating Electrodes are indicated for use with transcutaneous electrical stimulation devices as non-sterile. Latex free, reusable device for single patient use only. The electrodes provide the conductive interface

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510(k) Premarket Notification – Superior Starburst Reusable Self-adhering TENS/NMES/FES Stimulating Electrodes

between the stimulation device and the patient's skin. The starburst gradient pattern provides optimal current distribution.

## Performance Data:

Performance data for the proposed electrodes are compared to that of the predicate device. Results from biocompatibility study, physical and functional performance evaluation demonstrate that the proposed device is substantially equivalent to the legally marketed device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an image of an eagle.

Public Health Service

APR 2 1 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Covidien, LP % Ms. Wei Zhao 15 Hampshire Street Mansfield, Massachusetts 02048

Re: K083350

Trade/Device Name: Superior Starburst Reusable Self-adhering Stimulating Electrodes Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous electrode Regulatory Class: II Product Code: GXY Dated: April 9, 2009 Received: April 13, 2009

Dear Ms. Zhao:

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.

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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- Ms. Wei Zhao

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours

Sincerely yours,

Mark N. Melkerson

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

Enclosure

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## Indication for Use

# 510(k) Number (if known):K083350

#### Device Name:

Superior Starburst Reusable Self-adhering TENS/NMES/FES Stimulating Electrodes

#### Indication For Use:

The Superior Starburst Reusable Self-adhering TENS/NMES/FES Stimulating The Superior other of for use with transcutaneous electrical stimulation devices as non-sterile, Latex free, reusable device for single patient use only. The electrodes non blomb, and interface between the stimulation device and the patient's skin.

Prescription Use × (21 CFR Part 801 Subpart D) And/Or

Over the Counter Use (21 CFR Part 801 Subpart C)

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Division Sign Off

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

**510(k) Number** L083350