(102 days)
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)
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. It is composed of: 1. Metal target, 2. Rivet, 3. Textile adhesive layer, 4. Carbon layer, 5. Hydrogel layer, 6. Backing sheet. Proper current distribution is delivered via use of a printed silver pattern.
The provided text describes the acceptance criteria and performance data for the Philips Self-Adhesive Electrodes in the context of demonstrating substantial equivalence to a predicate device for FDA 510(k) clearance. This is not a study proving a device meets acceptance criteria for an AI/ML algorithm or a new medical device that requires clinical performance studies based on efficacy or accuracy.
The "acceptance criteria" here refers to the parameters assessed for substantial equivalence with a legally marketed predicate device (Axelgaard ValuTrode® Neurostimulation Electrodes K130987). The "study" refers to the performance data gathered to support this claim, primarily focusing on physical and electrical characteristics as well as biocompatibility, rather than clinical efficacy studies often associated with AI/ML devices.
Therefore, for most of the requested information points (especially those related to AI/MRMC studies, ground truth, experts, and data provenance related to clinical performance), the document does not provide the relevant data because this is a 510(k) submission for a simple medical device (electrodes), not an AI/ML diagnostic tool.
I will populate the table and answer the questions based only on the information available in the provided document, acknowledging where the information is not applicable or not present for this type of device submission.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (from predicate or general standards for electrodes) | Reported Device Performance (Philips Self-Adhesive Electrodes) |
|---|---|
| Biocompatibility: | |
| - Cytotoxicity test | Tested in accordance with FDA Blue Book Memorandum #G95-1 and ISO 10993-1. (Results implicitly positive, as the conclusion states the device is safe and effective). |
| - Sensitization test | Tested in accordance with FDA Blue Book Memorandum #G95-1 and ISO 10993-1. (Results implicitly positive, as the conclusion states the device is safe and effective). |
| - Irritation test | Tested in accordance with FDA Blue Book Memorandum #G95-1 and ISO 10993-1. (Results implicitly positive, as the conclusion states the device is safe and effective). |
| Electrical Performance: | |
| - Current distribution (equal) | Tested to assure the current is equally distributed. |
| - Impedance (proper electrical connection) | Tested for Impedance to assure proper electrical connection to the skin. |
| - Average power density (max 0.25 W/cm²) | Calculated average power density: 0.0026 W/cm². This is below the maximum value of 0.25 W/cm². (Calculation: Max current 60mA, Max voltage 60V, Surface area 25cm² (50x50mm). Worst case r.m.s. current in program 1: (2*90µs/10ms)*60mA = 1.08mA. Current density = 1.08mA/25cm² = 43µA r.m.s. Power = 43µA * 60V = 0.0026 W/cm².) |
| Mechanical Performance: | |
| - Initial adhesion force | Tested. (Results implicitly positive, as the conclusion states the device is safe and effective). |
| - Adhesion force after multiple uses | Tested. (Results implicitly positive, as the conclusion states the device is safe and effective). |
| - Connector/Magnetic clamping reliability (multiple use) | Tested to assure multiple use and to assure the TENS PulseRelief stays fixed to the Philips Self-Adhesive Electrode during use. (Results implicitly positive, as the conclusion states the device is safe and effective). |
| Packaging/Storage: | |
| - Storage conditions (41°F to 80.6°F / +5°C to +27°C) | Tested for storage conditions. (Results imply compliance with specified range). |
| - Accelerated aging (function as expected within expiration date) | Tested for accelerated aging in worst storage condition to assure function within the expiration date. (Results implicitly positive, as the conclusion states the device is safe and effective). |
2. Sample size used for the test set and the data provenance
The document does not specify the explicit sample sizes for the various performance tests (e.g., number of electrodes tested for electrical properties, adhesion, accelerated aging).
The data provenance is from tests conducted on the Philips Self-Adhesive Electrodes, which are manufactured by Axelgaard (the same manufacturer as the predicate device). The nature of the testing described (biocompatibility, electrical, mechanical, packaging) suggests it is prospective testing specifically for this device's submission. No geographical origin of the testing data is specified beyond the parent company being Philips Consumer Lifestyle, located in Stamford, Connecticut, USA.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable to this type of device submission. The tests performed are engineering, material, and safety tests, not clinical evaluations requiring expert interpretation or ground truth establishment in a diagnostic sense.
4. Adjudication method for the test set
This information is not applicable. Adjudication methods are typically used in clinical studies involving human interpretation or multi-reader scenarios, not for the direct physical/electrical testing described for this electrode.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No, an MRMC comparative effectiveness study was not done. This device is an electrode, not an AI-assisted diagnostic tool. Therefore, this section is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm performance study was not done. This device does not involve an algorithm.
7. The type of ground truth used
The "ground truth" for the performance tests outlined here is derived from engineering and material standards, electrical measurement principles, and established biocompatibility testing protocols (e.g., ISO 10993-1). It's based on objective quantifiable results against predefined acceptance limits, not expert consensus or direct clinical outcomes in the diagnostic sense.
8. The sample size for the training set
This information is not applicable. This device is not an AI/ML algorithm and therefore does not have a "training set."
9. How the ground truth for the training set was established
This information is not applicable, as there is no training set for this device.
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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle with three heads, representing the department's commitment to health, human services, and science. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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FORM FDA 3881 (8/14)
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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 StreetStamford, CT 06905 USA |
| Phone: | +31 6 319 78 546 |
| marta.walker@philips.com | |
| Correspondent: | Marta Walker,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) # |
|---|---|---|
| AxelgaardManufacturing Co.LTD, 520 IndustrialWay, Fallbrook, CA92028 | 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 :
-
- Metal target
-
- Rivet
-
- Textile adhesive layer
-
- Carbon layer
-
- Hydrogel layer
-
- 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 |
| RegulationNumber | 882.1320 | 882.1320 |
| Product Code | GXY | GXY |
| Indication of use | The Philips Self-Adhesive Electrodesare intended for use with thePulseRelief device for applyingTranscutaneous Electrical NerveStimulation (TENS) and ElectricalMuscle Stimulation (EMS). | ValuTrode®) reusable, self-adhering, over-the-counterNeurostimulationElectrodes are indicated foruse with transcutaneouselectrical stimulationdevices. Some commontypes of transcutaneousstimulation devicesinclude, but are not limited to,transepithelial nervestimulation (TENS) andelectrical muscle stimulation(EMS) devices.TranscutaneousNeurostimulation Electrodesare passive devices servingas an interfacebetween a user's skin and aneurostimulation device |
| Table 2: Substantial Equivalence Comparison Table | ||
|---|---|---|
| Technology | Cutaneous electrode which conductsan electrical signal from aneurostimulation device through aprinted silver pattern; which isdispersed from the wire across aconductive surface; then transmittedthrough the conductive adhesive gelto the surface of the patient's skin | Cutaneous electrode whichconducts an electrical signalfrom a neurostimulationdevice through a printedsilver pattern; which isdispersed from the wireacross a conductive surface;then transmitted through theconductive adhesive gel tothe surface of the patient'sskin |
| Axelgaard manufactures both thePhilips Self-Adhesive Electrodes andthe predicate electrodes K130987,with the same conductive hydrogel(tested for biocompatibility),conductive carbon film, printed silverpattern and electrode carrier liner. | Axelgaard manufactures boththe Philips Self-AdhesiveElectrodes and the predicateelectrodes K130987, with thesame conductive hydrogel(tested for biocompatibility),conductive carbon film,printed silver pattern andelectrode carrier liner. | |
| Safety andeffectiveness | Based on the successfulbiocompatibility testing of the skincontacting surface, the Philips Self-Adhesive Electrodes are safe andeffective when used as an interfacebetween a user's skin and the PhilipsPulseRelief device | Based on successfulbiocompatibility testing of theskin contacting conductivehydrogel, the electricalperformance of the insulatedlead wire components andelectrode current distributiontests results, the Value Trodeneuro stimulation devices aresafe and effective when usedas an interface between auser's skin and an approvedneuro stimulation devices |
| The averagepower densityshall not exceed0.25 watts persquarecentimeter ofelectrodeconductivesurface area. | The maximum current of the deviceis 60mA. The device is current-controlled, so the current does notdepend on the load. The maximumvoltage is 60V. The size of theelectrodes is 50mmx50mm with anequal current distribution.The pulse shape is rectangular, sothe r.m.s. current is identical to theaverage current. The worst caser.m.s. current is in program 1, withtwo phases of 90µs at a repetitionrate of 100Hz (10ms repetitionduration), this results in average | The Axelgaard electrode willbe used with different TENSdevices, which is not the casefor the Philips Self-Adhesiveelectrode that is only to beused with the PulseRelief andthus guarantee the powerdensity of maximum of 0.0026W/cm2 which is below themaximum value. |
| current of (2*90µs/10ms)*60mA =1.08mA. The surface of theelectrodes is 50x50mm = 25cm2.The current density is1.08mA/25cm2 = 43µA r.m.s. Thepower is the product of the currentand the voltage, so the averagepower is 43µA * 60V = 0.0026W/cm2. | ||
| Features/material | The electrode is composed of:• Top cover material;• Connection button;• Conductive carbon film;• Conductive hydrogel;• Electrode carrier liner. | The electrode is composedof:• Top cover material;• Connector lead wire orsnap;• Conductive carbon film;• Conductive hydrogel;• Electrode carrier liner. |
| Size | 5 x 5 cm² (2in x 2in) | Several size including thesame 5x5 cm² (2in x2in) |
| Principles ofOperation | Philips Self-Adhesive electrode areintended for use with TENS units asOTC devices.Some common type of neurostimulation devices include, but arenot limited to, TENS and EMSdevices.TENS electrodes are passivedevices serving as an interfacebetween a user's skin and a neurostimulation device | Value Trodes are intended foruse with TENS units as OTCdevices.Some common type of neurostimulation devices include,but are not limited to, TENSand EMS devices.TENS electrodes are passivedevices serving as aninterface between a user'sskin and a neuro stimulationdevice |
| Differences | Philips electrode has a metal buttonthat enables a magnetic clampingwith the Pulse Relief device | The ValueTrodes uses eithersnap or lead wires to connectwith 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.
§ 882.1320 Cutaneous electrode.
(a)
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.(b)
Classification. Class II (performance standards).