SUPERIOR STARBURST REUSABLE SELF-ADHERING TENS/NMES/FES STIMULATING ELECTRODE

K100418 · Covidien · GXY · Sep 3, 2010 · Neurology

Device Facts

• Record ID: K100418
• Device Name: SUPERIOR STARBURST REUSABLE SELF-ADHERING TENS/NMES/FES STIMULATING ELECTRODE
• Applicant: Covidien
• Product Code: GXY · Neurology
• Decision Date: Sep 3, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1320
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The proposed Superior Starburst Reusable Self-Adhering TENS/NMES/FES Stimulating Electrode is intended for over-the-counter use with transcutaneous electrical stimulation devices to provide the conductive interface between the stimulation device and the patient's skin. The starburst gradient pattern is designed to provide optimal current distribution during electrotherapy.

Device Story

Reusable self-adhering electrode for TENS, NMES, and FES applications. Device serves as conductive interface between electrical stimulation device and patient skin. Construction includes cover, reinforcement film, lead wire, glue, silver print, conductive member, conductive hydrogel, pressure-sensitive adhesive, and release liner. Starburst gradient pattern optimizes current distribution. Used in OTC settings; operated by patient. Device facilitates delivery of electrical current from stimulator to skin; benefits patient by enabling electrotherapy.

Clinical Evidence

Bench testing only; no clinical data required due to identical technological characteristics and design as the predicate device.

Technological Characteristics

Cutaneous electrode; components include cover, reinforcement film, lead wire, glue, silver print, conductive member, conductive hydrogel, pressure-sensitive adhesive, and release liner. Features starburst gradient pattern for current distribution. Passive device; no energy source or software.

Indications for Use

Indicated for use with transcutaneous electrical stimulation devices to provide a conductive interface between the device and the patient's skin for OTC 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

• Superior Starburst Reusable Self-Adhering TENS/NMES/FES Stimulating Electrode (K083350)
• TENS Reusable Electrode (K902195)

Submission Summary (Full Text)

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K100418

SEP 3 2010

#### 510(K) SUMMARY

#### 1. 510(k) Owner:

Covidien 15 Hampshire Street Mansfield, MA 02048 Telephone: (508) 261 - 6596 (508) 261 - 8461 Fax:

Contact: Mr. Wing Ng Title: Senior Regulatory Specialist Date Prepared: February 12, 2010

#### 2. Device:

Trade Name: Superior Starburst Reusable Self-Adhering TENS/NMES/FES Stimulating Electrode Common Name: Electrode Classification Name: Cutaneous Electrode Regulation Number: 21 CFR 882.1320 Product Code: GXY Classification: Class II

### 3. Predicate Devices:

- Superior Starburst Reusable Self-Adhering TENS/NMES/FES Stimulating . Electrode (K083350)
- TENS Reusable Electrode (K902195) .

#### 4. Device Description:

The Superior Starburst Reusable Self-Adhering TENS/NMES/FES Stimulating Electrode is a transcutaneous electrical nerve stimulation (TENS), neuromuscular electrical stimulation (NMES), functional electrical stimulation (FES) electrode. It is composed of a cover, reinforcement film, lead wire, glue, silver print, conductive member, conductive hydrogel, pressure sensitive adhesive, and a release liner. During electrotherapy, current from the electrical stimulation device is delivered through the lead wire, silver printed conductive member, conductive hydrogel, and to the patient's skin. Four finished electrodes are placed into a protective pouch. The pouches are sealed and boxed for shipping.

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#### 5. Intended Use:

The proposed Superior Starburst Reusable Self-Adhering TENS/NMES/FES Stimulating Electrode is intended for over-the-counter use with transcutaneous electrical stimulation devices to provide the conductive interface between the stimulation device and the patient's skin. The starburst gradient pattern is designed to provide optimal current distribution during electrotherapy.

#### 6. Technological Characteristics:

The OTC Superior Starburst Reusable Self-Adhering TENS/NMES/FES Stimulating Electrode exhibits identical technological characteristics as compared to the predicate prescription Superior Starburst Reusable Self-Adhering TENS/NMES/FES Stimulating Electrode (K083350). The electrode is composed of a cover, reinforcement film, lead wire, glue, silver print, conductive member, conductive hydrogel, pressure sensitive adhesive, and a release liner.

#### 7. Performance Data:

No performance data was required to support this premarket notification as the proposed OTC Superior Starburst Reusable Self-Adhering TENS/NMES/FES Stimulating Electrode has identical technological characteristics, including design and materials, as compared to the currently marketed predicate prescription Superior Starburst Reusable Self-Adhering TENS/NMES/FES Stimulating Electrode (K083350). This premarket notification supports a change to the product labeling only to allow the product to be sold for over-the-counter (OTC) use.

#### 8. Conclusion:

Based on an evaluation of the labeling for the proposed and predicate devices, Covidien believes that the proposed OTC Superior Starburst Reusable Self-Adhering TENS/NMES/FES Stimulating Electrode is suitable for over-the-counter use.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

Covidien Medical Supplies c/o Mr. Wing Ng 15 Hampshire St Mansfield, MA 02048

2010 SEP 3

Re: K100418

Trade/Device Name: Superior Starburst Reusable Self-Adhering TENS/NMES/FES Stimulating Electrodes

Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous electrode Regulatory Class: Class II Product Code: GXY Dated: August 27, 2010 Received: August 30, 2010

Dear Mr. Ng:

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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical)

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Page 2 - Mr. Wing Ng

device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Kesia Alexander

Image /page/3/Picture/7 description: The image contains a handwritten word, "for", in cursive script. The letter "f" has a descending loop that extends below the baseline, and the "o" and "r" are connected with a smooth, flowing line. The writing appears to be done with a pen or marker, and the strokes are clear and defined.

Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known): K100418

## Device Name: Superior Starburst Reusable Self-Adhering TENS/NMES/FES Stimulating Electrode

## Indications For Use:

The Superior Starburst Reusable Self-Adhering TENS/NMES/FES Stimulating Electrode is indicated for use with transcutaneous electrical stimulation devices to provide the conductive interface between the stimulation device and the patient's skin.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use × (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Aen.

(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number k100418