Philips Self-Adhesive Electrodes

K151033 · Philips Consumer Lifestyle · GXY · Jul 28, 2015 · Neurology

Device Facts

• Record ID: K151033
• Device Name: Philips Self-Adhesive Electrodes
• Applicant: Philips Consumer Lifestyle
• Product Code: GXY · Neurology
• Decision Date: Jul 28, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1320
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Philips Self-Adhesive Electrodes are intended for use with the PulseRelief device for applying Transcutaneous Electrical Nerve Stimulation (TENS) and Electrical Muscle Stimulation (EMS)

Device Story

Passive cutaneous electrodes serve as interface between user skin and Philips PulseRelief neurostimulation device. Device consists of metal target, rivet, textile adhesive, carbon layer, hydrogel, and backing sheet. Printed silver pattern ensures current distribution. Used in home or clinical settings; operated by patient or clinician. Electrodes conduct electrical signals from stimulator through hydrogel to skin. Magnetic button enables clamping to PulseRelief device. Benefits include safe, effective delivery of TENS/EMS therapy for nerve and muscle stimulation.

Clinical Evidence

Bench testing only. Includes biocompatibility testing (cytotoxicity, sensitization, irritation) per ISO 10993-1, electrical impedance testing, adhesion force testing, mechanical connection testing, and accelerated aging studies to ensure performance within expiration.

Technological Characteristics

Passive cutaneous electrode. Materials: metal target, rivet, textile adhesive, conductive carbon film, conductive hydrogel, backing sheet. Printed silver pattern for current distribution. Dimensions: 50mm x 50mm. Connectivity: magnetic button interface for PulseRelief device. Biocompatibility per ISO 10993-1.

Indications for Use

Indicated for use with the PulseRelief device for applying Transcutaneous Electrical Nerve Stimulation (TENS) and Electrical Muscle Stimulation (EMS).

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

• ValuTrode® Neurostimulation Electrodes (K130987)

Submission Summary (Full Text)

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

July 28, 2015

Philips Consumer Lifestyle Marta Walker Sr. Safety, Compliance & Regulatory Manager 1600 Summer Street Stamford, Connecticut 06905

Re: K151033

Trade/Device Name: Philips Self-adhesive Electrodes Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous Electrode Regulatory Class: Class II Product Code: GXY Dated: April 7, 2015 Received: April 17, 2015

Dear Marta Walker:

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 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Carlos L. Pena -S 同Δ

Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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| Form Approved: OMB No. 0910-0120 |
|-----------------------------------|
| Expiration Date: January 31, 2017 |
| See PRA Statement below. |

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

**Indications for Use**

| 510(k) Number (if known) | |
|--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | Philips Self-Adhesive Electrodes |
| Indications for Use (Describe) | The Philips Self-Adhesive Electrodes are intended for use with the PulseRelief device for applying Transcutaneous Electrical Nerve Stimulation (TENS) and Electrical Muscle Stimulation (EMS) |

| Type of Use (Select one or both, as applicable) | |
|-----------------------------------------------------------------------|---------------------------------------------------------------------------------|
| <input type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) | <input checked="" type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) |

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FORM FDA 3881 (8/14)

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PSC Publishing Services (101) 14-6740 EF

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Department of Health and Human Services Centre of Device and Radiological Health Office of Device Evaluation Traditional 510(k) section

## 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION as required by section 21 CFR 807.92

## 1. SUBMITTER OF 510(K):

| Company name: | Philips Consumer Lifestyle |
|----------------------|------------------------------------------------------|
| Registration number: | 3009181561 |
| Address: | 1600 Summer Street<br>Stamford, CT 06905 USA |
| Phone: | [phone] |
| email | [e-mail] |
| Correspondent: | Marta Walker,<br>Sr. Safety, Compliance & Regulatory |
| Date of Preparation: | July 21st, 2015 |

# 2. DEVICE:

| Trade/Proprietary Name: | Philips Self-Adhesive Electrodes |
|-------------------------|----------------------------------|
| Common/Usual Name: | Electrodes |
| Regulation Name: | Electrodes, Cutaneous |
| Classification Name: | Neurological Diagnostic Devices |
| Classification: | 21CFR 882.1320 Class II |
| Product Code: | GXY |

# 3. PREDICATE DEVICE

Our new device is based on the legally marketed device cited in the table below:

| Manufacturer | Device | 510(k) # |
|--------------------------------------------------------------------------------------|----------------------------------------|----------|
| Axelgaard<br>Manufacturing Co.<br>LTD, 520 Industrial<br>Way, Fallbrook, CA<br>92028 | ValuTrode® Neurostimulation Electrodes | K130987 |

Table 1: Predicate device

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# 4. DEVICE DESCRIPTION

The Philips Self-Adhesive Electrodes is used as a transcutaneous electrical nerve stimulation electrode in conjunction with the Philips PulseRelief device which is an electrical stimulator for TENS or EMS.

Electrodes are passive devices serving as an interface between a user's skin and a neurostimulation device.

### 4.1 Technical characteristics

It is composed of :

- 1. Metal target
- 2. Rivet
- 3. Textile adhesive layer
- 4. Carbon layer
- 5. Hydrogel layer
- 6. Backing sheet

See picture below:

Image /page/4/Picture/12 description: The image shows an exploded view of a multi-layered object. There are six distinct layers labeled with numbers 1 through 6. Layers 1 and 5 have circular features, while layer 2 has a raised circular feature. The layers are arranged in a stack, with layer 1 at the top and layer 6 at the bottom.

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Proper current distribution is delivered via use of a printed silver pattern.

Axelgaard manufactures both the Philips Self-Adhesive Electrodes and the predicate electrodes K130987, with the same conductive hydrogel (tested for biocompatibility), conductive carbon film, printed silver pattern and electrode carrier liner

## 5. INDICATION FOR USE

The Philips Self-Adhesive Electrodes are intended for use with the PulseRelief device for applying Transcutaneous Electrical Nerve Stimulation (TENS) and Electrical Muscle Stimulation (EMS).

## 6. SUMMARY OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

| Topic | Self-Adhesive Electrodes | ValuTrode® Neurostimulation Electrodes |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K# | K130987 |
| Manufacturer | Philips Consumer Lifestyle | Axelgaard |
| Regulation<br>Number | 882.1320 | 882.1320 |
| Product Code | GXY | GXY |
| Indication of use | The Philips Self-Adhesive Electrodes<br>are intended for use with the<br>PulseRelief device for applying<br>Transcutaneous Electrical Nerve<br>Stimulation (TENS) and Electrical<br>Muscle Stimulation (EMS). | ValuTrode®) reusable, self-<br>adhering, over-the-counter<br>Neurostimulation<br>Electrodes are indicated for<br>use with transcutaneous<br>electrical stimulation<br>devices. Some common<br>types of transcutaneous<br>stimulation devices<br>include, but are not limited to,<br>transepithelial nerve<br>stimulation (TENS) and<br>electrical muscle stimulation<br>(EMS) devices.<br>Transcutaneous<br>Neurostimulation Electrodes<br>are passive devices serving<br>as an interface<br>between a user's skin and a<br>neurostimulation device |

| Table 2: Substantial Equivalence Comparison Table | | |
|-------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | |
| Technology | Cutaneous electrode which conducts<br>an electrical signal from a<br>neurostimulation device through a<br>printed silver pattern; which is<br>dispersed from the wire across a<br>conductive surface; then transmitted<br>through the conductive adhesive gel<br>to the surface of the patient's skin | Cutaneous electrode which<br>conducts an electrical signal<br>from a neurostimulation<br>device through a printed<br>silver pattern; which is<br>dispersed from the wire<br>across a conductive surface;<br>then transmitted through the<br>conductive adhesive gel to<br>the surface of the patient's<br>skin |
| | Axelgaard manufactures both the<br>Philips Self-Adhesive Electrodes and<br>the predicate electrodes K130987,<br>with the same conductive hydrogel<br>(tested for biocompatibility),<br>conductive carbon film, printed silver<br>pattern and electrode carrier liner. | Axelgaard manufactures both<br>the Philips Self-Adhesive<br>Electrodes and the predicate<br>electrodes K130987, with the<br>same conductive hydrogel<br>(tested for biocompatibility),<br>conductive carbon film,<br>printed silver pattern and<br>electrode carrier liner. |
| Safety and<br>effectiveness | Based on the successful<br>biocompatibility testing of the skin<br>contacting surface, the Philips Self-<br>Adhesive Electrodes are safe and<br>effective when used as an interface<br>between a user's skin and the Philips<br>PulseRelief device | Based on successful<br>biocompatibility testing of the<br>skin contacting conductive<br>hydrogel, the electrical<br>performance of the insulated<br>lead wire components and<br>electrode current distribution<br>tests results, the Value Trode<br>neuro stimulation devices are<br>safe and effective when used<br>as an interface between a<br>user's skin and an approved<br>neuro stimulation devices |
| The average<br>power density<br>shall not exceed<br>0.25 watts per<br>square<br>centimeter of<br>electrode<br>conductive<br>surface area. | The maximum current of the device<br>is 60mA. The device is current-<br>controlled, so the current does not<br>depend on the load. The maximum<br>voltage is 60V. The size of the<br>electrodes is 50mmx50mm with an<br>equal current distribution.<br>The pulse shape is rectangular, so<br>the r.m.s. current is identical to the<br>average current. The worst case<br>r.m.s. current is in program 1, with<br>two phases of 90µs at a repetition<br>rate of 100Hz (10ms repetition<br>duration), this results in average | The Axelgaard electrode will<br>be used with different TENS<br>devices, which is not the case<br>for the Philips Self-Adhesive<br>electrode that is only to be<br>used with the PulseRelief and<br>thus guarantee the power<br>density of maximum of 0.0026<br>W/cm2 which is below the<br>maximum value. |
| | | |
| | current of (2*90µs/10ms)*60mA =<br>1.08mA. The surface of the<br>electrodes is 50x50mm = 25cm2.<br>The current density is<br>1.08mA/25cm2 = 43µA r.m.s. The<br>power is the product of the current<br>and the voltage, so the average<br>power is 43µA * 60V = 0.0026<br>W/cm2. | |
| Features/material | The electrode is composed of:<br>• Top cover material;<br>• Connection button;<br>• Conductive carbon film;<br>• Conductive hydrogel;<br>• Electrode carrier liner. | The electrode is composed<br>of:<br>• Top cover material;<br>• Connector lead wire or<br>snap;<br>• Conductive carbon film;<br>• Conductive hydrogel;<br>• Electrode carrier liner. |
| Size | 5 x 5 cm² (2in x 2in) | Several size including the<br>same 5x5 cm² (2in x2in) |
| Principles of<br>Operation | Philips Self-Adhesive electrode are<br>intended for use with TENS units as<br>OTC devices.<br>Some common type of neuro<br>stimulation devices include, but are<br>not limited to, TENS and EMS<br>devices.<br>TENS electrodes are passive<br>devices serving as an interface<br>between a user's skin and a neuro<br>stimulation device | Value Trodes are intended for<br>use with TENS units as OTC<br>devices.<br>Some common type of neuro<br>stimulation devices include,<br>but are not limited to, TENS<br>and EMS devices.<br>TENS electrodes are passive<br>devices serving as an<br>interface between a user's<br>skin and a neuro stimulation<br>device |
| Differences | Philips electrode has a metal button<br>that enables a magnetic clamping<br>with the Pulse Relief device | The ValueTrodes uses either<br>snap or lead wires to connect<br>with the TENS. |

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# 7. PERFORMANCE DATA

The following performance data are provided in support of the substantial equivalence determination:

## 7.1 Biocompatibility testing

The biocompatibility evaluation for the Philips Self-Adhesive Electrodes device was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing," May 1, 1995, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices -Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. As dictated by the application and duration of contact with the intact skin, the battery of testing included the following tests:

• Cytotoxicity

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- · Sensitization
- · Irritation

## 7.2 Other Performance Tests

The Philips Self-Adhesive Electrode is the same as the predicate device, the ValuTrode® Neurostimulation Electrodes from Axelgaard and it is manufactured by Axelgaard. Therefore the tests performed in the Neurostimulation Electrodes applies to the Philips Self-Adhesive Electrode.

### 1. Electrical & Impedance Tests

The Philips Self-Adhesive Electrode was tested to assure the current is equally distributed. The Philips Self-Adhesive Electrode was also tested for Impedance to assure proper electrical connection to the skin.

#### 2. Adhesion tests

The Philips Self-Adhesive Electrode was tested for initial adhesion force and adhesion force after using multiple times.

### 3. Connector & Mechanical tests

The TENS PulseRelief has a magnetic surface with the purpose to clamp the Philips Self-Adhesive Electrode. This connection was tested to assure multiple use and also to assure the TENS PulseRelief stay fixed to the Philips Self-Adhesive Electrode during use.

## 4. Packaging tests

The Philips Self-Adhesive Electrode was tested for storage conditions:

- The Philips Self-Adhesive Electrode should not be stored at temperatures lower than 41°F (+5°C) or higher than 80.6°F (+27°C).
## 5. Accelerated Aging

The Philips Self-Adhesive Electrode was tested for accelerate aging in worst storage condition to assure within the expiration date the electrode function as expected.

# 8. CONCLUSION

:

The performance testing presented above establishes that the device is safe and effective for its intended use. The comparison tabulated above demonstrates that the device is substantially equivalent to the predicate devices.