REUSABLE CUTANEOUS ELECTRODE

K121483 · Ampcare, LLC · GXY · Oct 15, 2012 · Neurology

Device Facts

• Record ID: K121483
• Device Name: REUSABLE CUTANEOUS ELECTRODE
• Applicant: Ampcare, LLC
• Product Code: GXY · Neurology
• Decision Date: Oct 15, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1320
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

AMPCARE 50709 Series of cutaneous electrodes are intended to be used to apply electrical stimulation current to the patient's skin. Example electrical stimulation current applications of these electrodes are: a) Transcutaneous Electrical Nerve Stimulation (TENS) for pain relief, b) Electrical muscle stimulation (EMS) for neck muscle stimulation, c) Functional electrical stimulation (FES), d) Galvanic stimulation, e) Microcurrent electrical nerve stimulation (MENS), f) Interferential (IF) stimulation, and g) Neuromuscular electrical stimulation (NMES), including for muscle re-education by application of external stimulation to the muscles necessary for pharyngeal contraction.

Device Story

AMPCARE 50709 Series are non-sterile, self-adhering, reusable cutaneous electrodes; available with pin/socket or snap connectors. Electrodes interface with external electrical stimulation devices to deliver current to patient skin. Used in clinical or home settings under prescription. Construction includes non-conductive top layer, conductive center layer, and adhesive bottom layer. Plastic liner removed prior to application. Electrodes facilitate various stimulation modalities (TENS, EMS, FES, etc.) for therapeutic purposes like pain relief or muscle re-education. Benefit derived from uniform current distribution, preventing 'hot spots' and patient discomfort during stimulation.

Clinical Evidence

Bench testing only. No clinical data. Testing included dispersion testing to verify uniform current distribution and absence of 'hot spots' compared to Columbia (K080386) and Uni-Patch (K915333) electrodes. Electrical impedance and impedance uniformity testing performed to demonstrate equivalence to predicate devices.

Technological Characteristics

Three-layer construction: non-conductive top layer, conductive center layer, adhesive bottom layer. Pin/socket or snap connectors; pin/socket version compatible with 21 CFR 898 lead wires. Non-sterile, self-adhering, reusable. No active electronic components; passive electrode.

Indications for Use

Indicated for patients requiring electrical stimulation therapy, including TENS for pain, EMS for neck muscles, FES, galvanic stimulation, MENS, IF stimulation, and NMES for muscle re-education (including pharyngeal contraction).

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

• Labeltape Meditect, Inc. (Uni-Patch / Covidien) (K915333)
• Columbia Scientific Development, LLC (K080386)
• Axelgaard Manufacturing Company, Ltd. (K852267)
• SelectiveMed Components, Inc. (Guardian) (K083756)

Submission Summary (Full Text)

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# AMPCARE

OCT 15 2012

## 5.510(k) SUMMARY - K121483

| Submitter: | AMPCARE, LLC<br>1201 Richardson Drive, Suite 280<br>Richardson, Texas 75080 | |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Russell Campbell<br>CEO / President<br>TEL: [phone]<br>FAX: [phone]<br>[e-mail] | |
| Date Prepared: | May 17, 2012 revised September 13, 2012 | |
| Trade Name: | Reusable Cutaneous Electrode | |
| Common Name: | Cutaneous Electrode | |
| Classification Name: | GXY 882.1320 | Electrode, Cutaneous |
| Predicate Devices: | K915333 GXY<br>K080386 GXY<br>K852267 GXY<br>K083756 GXY | Labeltape Meditect, Inc. (Uni-Patch / Covidien)<br>Columbia Scientific Development, LLC<br>Axelgaard Manufacturing Company, Ltd.<br>SelectiveMed Components, Inc. (Guardian) |
| Device Description: | The new AMPCARE 50709 Series Electrodes device is a family of cutaneous<br>electrodes with various shapes and sizes, which are similar in design and<br>construction to several predicate cutaneous electrodes. AMPCARE electrodes are<br>non-sterile, self-adhering, and are for multiple use by a single patient, available with | |

AMPCARE 50709 Series of cutaneous electrodes are intended to be used to apply Statement of electrical stimulation current to the patient's skin. Example electrical stimulation Intended Use: current applications of these electrodes are: a) Transcutaneous Electrical Nerve Stimulation (TENS) for pain relief, b) Electrical muscle stimulation (EMS) for neck muscle stimulation, c) Functional electrical stimulation (FES), d) Galvanic stimulation, e) Microcurrent electrical nerve stimulation (MENS), f) Interferential (IF) stimulation, and g) Neuromuscular electrical stimulation (NMES), including for muscle re-education by application of external stimulation to the muscles necessary for pharyngeal contraction.

either pin/socket or snap connections.

The new AMPCARE device is designed in accordance with the general design Summary of approach of the predicate devices referenced above. Specifically, each electrode in Technological the AMPCARE 50709 Series is constructed with a non-conductive top layer, Characteristics: conductive center layer and adhesive bottom layer. The plastic liner at the bottom of the electrode is peeled away just prior to placement on the patient, consistent with the four predicate devices. The pin/socket connector version of the new device will be provided with a lead wire that is 21 CFR 898 compatible, containing a female recessed socket for electrical connection.

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AMPCARE

Summary of Non-Clinical Testing: Dispersion testing has demonstrated that the new AMPCARE device has uniform current distribution with no evidence of "hot spots" that could cause patient discomfort or injury. The Columbia (K080386) and Uni-Patch (K915333) electrodes were included in the dispersion testing for comparison purposes. Additional comparison testing to predicate device electrodes was performed to demonstrate suitability of use for each example of electrical stimulation current applications given in the Indications for Use. Both electrical impedance testing and electrical impedance uniformity testing was performed on AMPCARE electrodes as well as predicate device electrodes to demonstrate substantial equivalence.

Conclusion:

AMPCARE considers the AMPCARE 50709 Series Electrodes to be substantially equivalent to the predicate devices listed above. This conclusion is based on the similarities in primary intended use, principles of operation, functional design, nonclinical test results, and established medical use.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, topped by a bird-like shape. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular fashion around the symbol.

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

OCT 15 2012

AMPCARE, LLC % Ms. Diane Rutherford Submissions Manager Ken Block Consulting 1201 Richardson Drive, Suite 280 Richardson, TX 75080

Re: K121483

Trade/Device Name: AMPCARE 50709 Series Electrodes Regulation Number: 21 CFR 882.1320 Regulation Name: Electrode, cutaneous Regulatory Class: Class II Product Code: GXY Dated: September 13, 2012 Received: September 14, 2012

Dear Ms. Rutherford:

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 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

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### Page 2- Ms. Diane Rutherford

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 (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.

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Sincerely yours,

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: K121483

Device Name: AMPCARE 50709 Series Electrodes

Indications for Use:

AMPCARE 50709 Series of cutaneous electrodes are intended to be used to apply electrical stimulation current to the patient's skin. Example electrical stimulation current applications of these electrodes are:

a) Transcutaneous Electrical Nerve Stimulation (TENS) for pain relief

b) Electrical muscle stimulation (EMS) for neck muscle stimulation.

- c) Functional electrical stimulation (FES)
- d) Galvanic stimulation.
- e) Microcurrent electrical nerve stimulation (MENS).
- Interferential (IF) stimulation. 0
- g) Neuromuscular electrical stimulation (NMES), including for muscle re-education by application of external stimulation to the muscles necessary for pharyngeal contraction.

Prescription Use X (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 CDHR, Office of Device Evaluation (ODE)

Callaway

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

510(k) Number K121483

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