Reusable, self-adhering Neurostimulation Electrodes are indicated for use with transcutaneous electrical stimulation devices. Some common types of transcutaneous stimulation devices include, but are not limited to, transepithelial nerve stimulation (TENS) and electrical muscle stimulation (EMS) devices. Transcutaneous Neurostimulation Electrodes are passive devices serving as an interface between a user's skin and a neurostimulation device.

Device Description

The FlexStim Neurostimulation Electrode is used as a transcutaneous electrical nerve stimulation electrode in conjunction with an electrical stimulator for TENS or EMS and available in backing materials such as, non-woven cloth and PE foam, conductive carbon film (low impedance and standard impedance) with lead wire and snap connection configurations. The device functions as a passive device by carrying an electrical signal from a neurostimulation device through the device cable and electrode lead wire or snap button to the user's skin.

AI/ML Overview

Here's an analysis of the acceptance criteria and supporting study for the FlexStim Neurostimulation Electrodes, based on the provided document:

Device: FlexStim Neurostimulation Electrodes (Model Numbers: 5050ROC1S, 5050ROC1W, 5050ROC2S, 5050ROC2W, 5050SQC1S, 5050SQC1W, 5050SQC2S, 5050SQC2W)

This document is a 510(k) Summary, which is a premarket notification to demonstrate that the device is substantially equivalent to a legally marketed predicate device. As such, it focuses on comparing the new device to existing ones rather than establishing novel acceptance criteria in a traditional sense with specific numerical thresholds for effectiveness. Instead, the acceptance is based on demonstrating comparable safety and performance to the predicate devices through various tests.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) submission and not a clinical trial establishing effectiveness, the "acceptance criteria" are implied by the standards and predicate device characteristics, and performance is demonstrated through in-vitro and bench tests rather than clinical outcomes.

Acceptance Criteria Category	Specific Criteria (Implied from standards/predicate comparison)	Reported Device Performance
1. Biocompatibility	Safe for skin contact; non-cytotoxic, non-sensitizing, non-irritating (per ISO 10993-1).	The skin-contacting material (conductive hydrogel) was found to be biocompatible for its intended use based on tests for cytotoxicity, sensitization, and irritation, conducted in accordance with ISO 10993-1.
2. Electrical Performance	Conductive properties appropriate for intended use with neurostimulation devices; lead wire assembly compliant with FDA performance standards (21 CFR Part 898) and IEC 60601-1, sub-clause 56.3 (c).	Impedance testing performed with Surface Electrode Analysis Meter (SEAM 10) confirmed appropriate conductive properties. The lead wire assembly's Certificate of Compliance (CoC) confirmed compliance with FDA performance standard 21 CFR Part 898 (via IEC 60601-1, sub-clause 56.3 (c)).
3. Adhesive Performance	Ability to adhere to the patient's skin for a duration compatible with the intended use of the device.	Peel Test performed as per International Standard Afera 5001. Results concluded that the design ensures adherence to patient's skin for a duration compatible with intended use. (Specific peel strength values are not provided in this summary but were presumably met.)
4. Stability/Shelf-Life	Maintain electrical and adhesive performance over a specified shelf-life (e.g., 24 months when stored at 5°C - 30°C); hydrogel resists physical and chemical breakdown from electrical current and storage.	Accelerated shelf-life study (40°C ± 2°C, 75% ± 5% RH, tested at 0, 3, & 6 months) and ambient temperature study (25°C ± 2°C, 60% ± 5% RH, tested up to 11 months) demonstrated the product passes electrical (impedance) and adhesive performance tests. Concluded suitable for use up to 24 months when stored at 5°C - 30°C. Implies hydrogel stability against breakdown.
5. Substantial Equivalence	Demonstrably safe and effective as predicate devices (PROTENS Reusable Stimulating Electrodes (K142099) and Reusable Stimulating Electrodes (K111270)); identical indications for use, similar technological characteristics (design and materials), and comparable performance specifications; no new questions of safety and effectiveness.	The device states identical indications for use, similar technological characteristics (design, materials like backing, carbon film, hydrogel), and comparable performance specifications as the predicate devices. The performance data (biocompatibility, electrical, adhesive, stability) supports that the device is as safe and effective as the predicate devices, posing no new safety or effectiveness concerns. (The report highlights minor differences in backing materials and conductivity film type (carbon vs. carbon/silver), method of sale/supply, but asserts these do not raise new questions of safety/effectiveness).

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: The document does not specify the exact sample sizes used for each of the performance tests (Biocompatibility, Electrical Performance, Adhesive Performance, Stability). It refers to "samples" being tested.
Data Provenance: The studies appear to be conducted by or for Medico Electrodes International Ltd. in India ("Manufactured by Medico Electrodes International Ltd., India"). The studies are in-vitro and bench testing, not human clinical trials. Thus, there is no "country of origin of the data" in terms of patient population, nor is it retrospective or prospective in the clinical sense. It's pre-clinical, lab-based data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This section is not applicable to this document. The "ground truth" for these types of tests (biocompatibility, electrical, adhesive, stability) is established by adherence to recognized international standards (ISO 10993-1, Afera 5001, IEC 60601-1) and comparison with predicate devices. There wouldn't be "experts" establishing a clinical ground truth for a test set in a 510(k) bench study. The "truth" is objective measurement against engineering and material science standards.

4. Adjudication Method for the Test Set

This section is not applicable. Adjudication typically refers to expert review of clinical cases. These are bench tests against predetermined standards. The results of the tests either meet the standard/predicate comparison or they don't.

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

This section is not applicable. The device is an inanimate neurostimulation electrode, not an AI-powered diagnostic or assistive tool for human readers. There is no AI component, and thus no MRMC study performed to evaluate human reader improvement.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This section is not applicable. The device is a passive neurostimulation electrode, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the performance data presented is derived from:

International Standards: e.g., ISO 10993-1 for biocompatibility, IEC 60601-1 for electrical safety, Afera 5001 for adhesive performance.
Predicate Device Characteristics: Comparison of technical specifications and performance to legally marketed predicate devices (PROTENS Reusable Stimulating Electrodes (K142099) and Reusable Stimulating Electrodes (K111270)).
Engineering Specifications: Internal design and material specifications that define acceptable ranges for electrical impedance, adhesion strength, and material composition.

8. The Sample Size for the Training Set

This section is not applicable. The device is a physical medical device, not an AI model that requires a training set. The manufacturing process is validated (which is akin to "training" in a broad sense for consistent product quality), but this is not discussed in terms of a "training set" here.

9. How the Ground Truth for the Training Set Was Established

This section is not applicable for the same reasons as point 8.

Summary

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

October 30, 2016

Medico Electrodes International Ltd. Amit Seth Vice President Plot 142A/11, 12, 27, 28 &29, Noida Special Economic Zone Noida, Uttar Pradesh 201305 India

Re: K161282

Trade/Device Name: FlexStim Neurostimulation Electrodes Model Numbers: 5050ROC1S, 5050ROC1W, 5050ROC2S, 5050ROC2W, 5050SQC1S, 5050SQC1W, 5050SQC2S, 5050SQC2W Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous Electrode Regulatory Class: Class II Product Code: GXY Dated: September 8, 2016 Received: September 28, 2016

Dear Amit Seth:

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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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 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/Resourcesfor You/Industry/default.htm. 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 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.

Michael J. Hoffmann -A

for 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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Indications for Use

510(k) Number (if known) K161282

Device Name

FlexStim Neurostimulation Electrodes Model Numbers: 5050ROC1S, 5050ROC1W, 5050ROC2W, 5050SQC1S, 5050SQC1W, 5050SQC1W, 5050SQC2S, 5050SQC2W

Indications for Use (Describe)

Reusable, self-adhering neurostimulation electrodes are indicated for use with transcutaneous electrical stimulation devices. Some common types of transcutaneous stimulation devices include, but are not limited to, transepithelial nerve stimulation (TENS) and electrical muscle stimulation (EMS) devices. Transcutaneous neurostimulation electrodes are passive devices serving as an interface between a user's skin and a neurostimulation device.

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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Image /page/3/Picture/0 description: The image shows the logo for MEDICO ELECTRODES. The logo features a stylized letter "M" intertwined with other shapes in blue and gray. The text "MEDICO ELECTRODES" is written in blue, sans-serif font to the right of the symbol.

510(k) Summary

(As required by 21 CFR 807.92)

I. SUBMITTER

Medico Electrodes International Ltd. Plot 142A/11, 12, 27, 28 & 29, Noida Special Economic Zone, Noida - 201305, Uttar Pradesh, India

Phone: 91-120-3042984 Fax: 91-120-3042986

Contact Person: Amit Seth Date Prepared: Oct 28, 2016

II. DEVICE

Name of Device: FlexStim Neurostimulation Electrodes Model Numbers: 5050ROC1S 5050ROC1W 5050ROC2S 5050ROC2W 5050SQC1S 5050SQC1W 5050SQC2S 5050SOC2W Common or Usual Name: Neurostimulation Electrodes Classification Name: Cutaneous electrode (21 CFR 882.1320) Regulatory Class: II Product Code: GXY

III. PREDICATE DEVICE

PROTENS Reusable Stimulating Electrodes, K142099 (Predicate Device 1) Reusable Stimulating Electrodes, K111270 (Predicate Device 2)

These predicate devices had not been subject to a design-related recall. No reference devices were used in these submissions.

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Image /page/4/Picture/0 description: The image shows the logo for MEDICO ELECTRODES. The logo features a stylized "M" and "J" intertwined within a circle on the left. The text "MEDICO ELECTRODES" is written in a sans-serif font to the right of the symbol.

IV. DEVICE DESCRIPTION

1. Device Identification
  The FlexStim Neurostimulation Electrode is used as a transcutaneous electrical nerve stimulation electrode in conjunction with an electrical stimulator for TENS or EMS and available in backing materials such as, non-woven cloth and PE foam, conductive carbon film (low impedance and standard impedance) with lead wire and snap connection configurations.
1. Device Characteristics
- Software: Not Applicable ●
- Biologics: Not Applicable ●
- Drugs: Not Applicable
- Any patient-contacting materials: Conductive hydrogel ●
- Coatings: Not Applicable ●
- Additives: Not Applicable ●
- The electrodes are designed for single patient/multiple application use ●
- The device is not a sterile product, therefore sterilization is not required
1. Environment of Use:
- Healthcare facility/hospital .
- . Home
1. Description of the Device

The device functions as a passive device by carrying an electrical signal from a neurostimulation device through the device cable and electrode lead wire or snap button to the user's skin.

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Image /page/5/Picture/0 description: The image shows the logo for MEDICO ELECTRODES. The logo consists of a stylized graphic of the letters 'M' and 'J' intertwined, with the word 'MEDICO' in blue, sans-serif font to the right of the graphic. The word 'ELECTRODES' is also in blue, sans-serif font and is placed to the right of 'MEDICO'.

1. Materials of Use

S. No.	Component	Description/Material of Construction
1	Backing material(s)	Non-woven cloth/PE foam
2	Lead wire having insulation on female connector	Wire length: 114.3 mm or 4.5" (104.3 mm or 4.1" - 124.3 mm or 4.9")Din size: 2.0 mm
3	Stud/Snap (for electrodes without lead wire)	Stainless steel
4	Sensor/Eyelet (for electrodes without lead wire)	Glass filled ABS with Ag/AgCl coating
5	Carbon film	Conductive carbon film (low impedance and standard impedance)
6	Gel	Conductive hydrogel
7	Release liner	PET i.e., Polyethylene terephthalate

V. INDICATIONS FOR USE

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The FlexStim Neurostimulation Electrodes exhibit technological characteristics that are substantially equivalent to those of the predicate devices, as determined by both component usage and physical testing.

The Substantial Equivalence summary is described below:

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Image /page/6/Picture/0 description: The image shows the logo for Medico Electrodes. The logo consists of a stylized letter "M" intertwined with other shapes, followed by the text "MEDICO ELECTRODES" in a sans-serif font. The color scheme is primarily blue, with some elements in a lighter shade of gray.

S. No.	Areas ofComparison	Subject DeviceFlexStimNeurostimulationElectrodes(Manufactured by MedicoElectrodes InternationalLtd., India)	Predicate Device 1PROTENS ReusableStimulating Electrodes(K142099)(Manufactured byBio Protech Inc., Korea)	Predicate Device 2Reusable StimulatingElectrodes (K111270)(Manufactured byBio Protech Inc., Korea)
1	Intended Use /Indications forUse	Reusable, self-adhering,Neurostimulation Electrodesare indicated for use withtranscutaneous electricalstimulation devices. Somecommon types oftranscutaneous stimulationdevices include, but are notlimited to, transepithelialnerve stimulation (TENS)and electrical musclestimulation (EMS) devices.TranscutaneousNeurostimulation Electrodesare passive devices servingas an interface between auser's skin and aneurostimulation device.	PROTENS reusable, self-adhering, over-the-counterCutaneous electrodes areindicated for use withelectrical stimulationdevice. Some commontypes of electricalstimulation device include,but are not limited to,transcutaneous nervestimulation (TENS),electrical musclestimulation (EMS) device,Neuromuscular ElectricalStimulation (NMES/FES)device and Microcurrentelectrical nerve stimulation(MENS), InterferentialStimulation (IF).Cutaneous electrodes arepassive devices serving asan interface between auser's skin and anelectrical stimulation	Bio Protech ReusableStimulating electrodes areintended to be used toapply electrical stimulationcurrent to the patient's skinor to record physiologicalsignals.Electrical stimulationcurrent applications ofthese electrodes are:a) TranscutaneousElectrical Nerve Stimulation(TENS) for pain reliefb) Electrical musclestimulation (EMS)c) Functional electricalstimulation (FES)d) Microcurrent electricalnerve stimulation (MENS)e) Interferential stimulation(IF)f) Neuromuscular electricalstimulation (NMES)
S. No.	Areas ofComparison	Subject DeviceFlexStimNeurostimulationElectrodes(Manufactured by MedicoElectrodes InternationalLtd., India)	Predicate Device 1PROTENS ReusableStimulating Electrodes(K142099)(Manufactured byBio Protech Inc., Korea)	Predicate Device 2Reusable StimulatingElectrodes (K111270)(Manufactured byBio Protech Inc., Korea)
2	Targetpopulation	Adults	device.	Adults
3	Anatomical site	Intact skin (refer IFU)	Intact skin (refer IFU)	Intact skin (refer IFU)
4	Where used	Hospital, clinic and homeuse environment	Hospital, clinic and homeuse environment	Hospital, clinic and homeuse environment
5	Design	Cutaneous electrode whichconducts an electrical signalfrom a neurostimulationdevice through a lead wireor snap button; which isdispersed from the wireacross a conductivesurface; then transmittedthrough the conductiveadhesive gel to the surfaceof the patient's skin.	Cutaneous electrode whichconducts an electricalsignal from aneurostimulation devicethrough a lead wire; whichis dispersed from the wireacross a conductivesurface; then transmittedthrough the conductiveadhesive gel to the surfaceof the patient's skin.	Cutaneous electrode whichconducts an electrical signalfrom a neurostimulationdevice through a lead wire;which is dispersed from thewire across a conductivesurface; then transmittedthrough the conductiveadhesive gel to the surfaceof the patient's skin.
6	Materials	Basic components:• Backing material(Non-woven cloth/PEfoam)• Lead wire and snapconnectionconfigurations	Basic components:• Backing material(Non-wovencloth/PEFoam/Tricot)• Lead wire and snapconnection	Basic components:• Backing material(Non-woven cloth/PEFoam/Tricot)• Lead wire and snapconnectionconfigurations
S. No.	Areas ofComparison	Subject DeviceFlexStimNeurostimulationElectrodes(Manufactured by MedicoElectrodes InternationalLtd., India)	Predicate Device 1PROTENS ReusableStimulating Electrodes(K142099)(Manufactured byBio Protech Inc., Korea)	Predicate Device 2Reusable StimulatingElectrodes (K111270)(Manufactured byBio Protech Inc., Korea)
		Conductive carbon film Hydrogel PET liner	configurations Conductive carbon/silver film Hydrogel Transparent PET liner	Conductive carbon/silver film Hydrogel Transparent PET liner
7	Performance	Based on successfulbiocompatibility testing ofthe skin contactingconductive hydrogel,impedance testing of theproduct, electricalperformance of theinsulated lead wirecomponents, adhesiveperformance and stability,the FlexStimNeurostimulation Electrodesare safe and effective whenused as an interfacebetween a user's skin andan approvedneurostimulation devices.	Based on successfulbiocompatibility testing ofthe skin contactingconductive hydrogel,impedance testing of theproduct, electricalperformance of theinsulated lead wirecomponents and adhesiveperformance, thePROTENS ReusableStimulating Electrodes aresafe and effective whenused as an interfacebetween a user's skin andan approvedneurostimulation devices.	Based on successfulbiocompatibility testing ofthe skin contactingconductive hydrogel,impedance testing of theproduct, electricalperformance of theinsulated lead wirecomponents and adhesiveperformance, the ReusableStimulating Electrodes aresafe and effective whenused as an interfacebetween a user's skin andan approvedneurostimulation devices.
8	Biocompatibility	The skin-contacting	Hydrogel	Hydrogel
S. No.	Areas ofComparison	Subject DeviceFlexStimNeurostimulationElectrodes(Manufactured by MedicoElectrodes InternationalLtd., India)	Predicate Device 1PROTENS ReusableStimulating Electrodes(K142099)(Manufactured byBio Protech Inc., Korea)	Predicate Device 2Reusable StimulatingElectrodes (K111270)(Manufactured byBio Protech Inc., Korea)
		material i.e., hydrogel wasfound to be biocompatiblefor its intended use as perISO 10993-1 standard.	Bio-Compatible High Adhesion	Bio-Compatible High Adhesion
9	Differences
	Intended Use	Intended to be used toapply electrical stimulationcurrent to the patient's skin	Intended to be used toapply electrical stimulationcurrent to the patient'sskin	Intended to be used toapply electrical stimulationcurrent to the patient's skinor to record physiologicalsignals.
	Materials	FlexStimNeurostimulationElectrodes use Non-woven cloth and PEfoam as the backingmaterials Conductive carbonfilm	Reusable Stimulating Electrodes use backingmaterials such as Non-woven cloth, PE Foam,Tricot Conductive film – carbon film or silver film	Reusable Stimulating Electrodes use backingmaterials such as Non-woven cloth, PE Foam,Tricot Conductive film – carbon film or silver film
	Method of saleand supply	We claim that theseelectrodes can be sold asOTC (21 CFR 801 SubpartC) as well as Prescription(21 CFR 801 Subpart D)medical devices.	The devices are currentlybeing sold as OTC medicaldevices.	The devices are currentlybeing sold as Prescriptionmedical devices.

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Image /page/7/Picture/0 description: The image shows the logo for Medico Electrodes. The logo features the letters 'M' and 'J' in a stylized design, with the word 'MEDICO' in bold blue letters and 'ELECTRODES' in a smaller font size next to it. The color scheme is primarily blue and gray.

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Image /page/8/Picture/0 description: The image shows the logo for Medico Electrodes. The logo features a stylized letter "M" in blue, intertwined with a gray element. The text "MEDICO ELECTRODES" is written in a sans-serif font to the right of the logo, with the words in all caps and in a matching blue color.

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Image /page/9/Picture/0 description: The image shows the logo for Medico Electrodes. The logo consists of a stylized letter "M" and "J" on the left side, with the text "MEDICO ELECTRODES" on the right side. The text is in a sans-serif font and is colored in a light blue color. The logo is simple and modern, and it is likely used to represent the company's brand.

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Image /page/10/Picture/0 description: The image shows the logo for MEDICO ELECTRODES. The logo consists of a stylized letter "M" in light blue, with a gray letter "J" behind it. To the right of the letters is the text "MEDICO ELECTRODES" in a sans-serif font, also in light blue. The logo is simple and modern, and the use of color is eye-catching.

VII. PERFORMANCE DATA

The following performance data is being provided in support of the substantial equivalence determination.

1. Biocompatibility

The biocompatibility evaluation for the FlexStim Neurostimulation Electrodes was conducted in accordance with the International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process", as recognized by FDA. The battery of testing included the following tests:

Cytotoxicity
· Sensitization
· Irritation

The skin-contacting material i.e., conductive hydrogel was found to be biocompatible for its intended use.

2. Electrical Performance

Impedance testing of the product was performed using the Surface Electrode Analysis Meter (SEAM 10). The equipment has been designed by CALM Technologies Inc., Canada to test the impedance of Neurostimulation Electrodes under a wide range of current pulse inputs, thereby assuring that the electrode has conductive properties appropriate to the device's intended use.

As per the Certificate of Compliance (CoC) received from the vendor of lead wire, the lead wire assembly is in compliance with the requirements of FDA performance standard 21 CFR Part 898 by testing under IEC 60601-1, sub-clause 56.3 (c).

3. Adhesive Performance

In order to assure that the electrode's adhesive performance is substantially equivalent to the predicate devices, the Peel Test was performed as per the International Standard Afera 5001. Based on the results, it was concluded that the design of the electrode ensures that it will adhere to the patient's skin for a duration of use compatible with the intended use of the device.

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Image /page/11/Picture/0 description: The image shows the logo for MEDICO ELECTRODES. The logo consists of a stylized letter "M" in light blue, intertwined with a gray shape. To the right of the symbol, the words "MEDICO ELECTRODES" are written in a bold, sans-serif font, also in light blue.

4. Stability

FlexStim electrode samples had undergone an accelerated shelf-life study when kept at 40°C ± 2°C and relative humidity of 75 % ± 5 % in a Calibrated Stability Chamber (SC-01) and tested at 0, 3 & 6 Months to monitor the critical parameters of finished device such as impedance and peel adhesion.
Apart from samples kept at accelerated ageing temperature, in parallel, samples were ● also kept at ambient temperature (25°C ± 2°C and relative humidity of 60 % ± 5 %) and tested for impedance & peel adhesion to demonstrate performance of the hydrogel for up to 11 months.
As per the accelerated and real time stability study results, it is concluded that the . product passes electrical (impedance testing) and adhesive performance test. The product is suitable for use up to 24 months when stored at 5°C - 30°C. This further implies that the hydrogel is stable and resist physical and chemical breakdown as a result of conducting electrical current and extended periods of storage over a range of environmental conditions.

VIII. CONCLUSIONS

Medico Electrodes International Ltd., India considers the FlexStim Neurostimulation Electrodes to be as safe and effective as the predicate devices PROTENS Reusable Stimulating Electrodes (K142099) and Reusable Stimulating Electrodes (K111270) as the subject device has identical indications for use, technological characteristics (including design and materials) and performance specifications as compared to the predicate devices already being legally marketed in the United States. Thus, the device is substantially equivalent to the predicates and any difference between the devices do not pose new questions of safety and effectiveness.

Regulation Number and Section

§ 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).