geko™ W-2

K193045 · Firstkind Limited · IPF · Jan 18, 2020 · Physical Medicine

Device Facts

• Record ID: K193045
• Device Name: geko™ W-2
• Applicant: Firstkind Limited
• Product Code: IPF · Physical Medicine
• Decision Date: Jan 18, 2020
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 890.5850
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Increasing local blood circulation. Edema reduction.

Device Story

The geko™ W-2 is a disposable, battery-powered neuromuscular stimulator. It consists of a constant current pulse generator, lithium coin-cell battery, and a silver electrode with hydrogel coating. The device is applied behind the knee over the common peroneal nerve. It delivers electrical pulses to stimulate calf muscle contraction, mimicking the cadence and energy of walking to increase local blood circulation and reduce edema. The device is operated by the patient or clinician using two buttons to toggle power and adjust intensity across 10 settings. It provides two 6-hour treatment sessions with a mandatory 6-hour rest period between them. The device output is an asymmetrical, biphasic, rectangular waveform. It is intended for use in clinical or home settings.

Clinical Evidence

No clinical data. Bench testing only. Biocompatibility testing (ISO 10993-5, ISO 10993-10) confirmed the KM40A hydrogel is safe. EMC testing performed per IEC 60601-1-2:2014. Performance testing verified device durability, adhesion, and output waveform characteristics across various load impedances (500Ω, 2kΩ, 10kΩ).

Technological Characteristics

Disposable neuromuscular stimulator; polypropylene housing; silver electrode with KM40A hydrogel. Powered by 3V lithium coin cell. Constant current, asymmetrical biphasic rectangular waveform. Frequency fixed at 1 Hz. 10 intensity levels (pulse widths 25-560 μs). Complies with IEC 60601-1-2:2014 for EMC.

Indications for Use

Indicated for increasing local blood circulation and edema reduction in patients requiring neuromuscular stimulation.

Regulatory Classification

Identification

A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.

Predicate Devices

• geko™ Plus R-2 (K180082)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

January 18, 2020

Firstkind Limited % Sheila Hemeon-Heyer President Heyer Regulatory Solutions LLC 125 Cherry Lane Amherst, MA 01002

Re: K193045

Trade/Device Name: geko™ W-2 Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: IPF Dated: December 19, 2019 Received: December 19, 2019

Dear Sheila Hemeon-Heyer:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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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 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

For Vivek Pinto, Ph.D. Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K193045

Device Name geko™ W-2

Indications for Use (Describe)

- Increasing local blood circulation

- Edema reduction

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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### 510(k) Summary - K193045

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.

| A. Submitter: | Firstkind Limited<br>Hawk House<br>Peregrine Business Park<br>High Wycombe, UK<br>HP13 7DL |
|----------------|--------------------------------------------------------------------------------------------|
| Contact: | Neil Buckley<br>Head of Quality and Regulatory Affairs |
| Tel:<br>Email: | [phone]<br>[e-mail] |

- B. Date Prepared: November 1, 2019
#### C. Device Name and Classification Information:

| Trade Name: | geko™ W-2 |
|----------------------|-----------------------------|
| Common Name: | Neuromuscular stimulator |
| Classification Name: | Stimulator, Muscle, Powered |
| Product Code, CFR: | IPF, 21 CFR 890.5850 |
| Panel code: | 89 |
| Class: | II |

- Predicate Devices: qeko™ Plus R-2 as cleared under K180082 D.
#### Device Description: E.

The geko™ W-2 neuromuscular stimulator is a disposable, fully integrated unit composed of a constant current pulse generator with embedded software, a lithium coin-cell battery enclosed in an over-molded plastic casing, and a silver electrode with a hydrogel coating which provides a means of attachment of the device and electrical contact with the patient. Two buttons are used to control the On/Off function and increase or decrease the intensity level of the device output, which is achieved through choosing one of 10 stimulus settings.

The geko™ W-2 is applied so that the electrodes lie over the common peroneal nerve behind the knee. Stimulation of the common peroneal nerve causes contraction of the calf muscles through the direct activation of the motor neurons, resulting in increased blood flow. The pulse rate is fixed at a frequency of 1 Hz and is used to isometrically stimulate the calf and foot muscles with a cadence and energy similar to that of walking. Each geko™

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W-2 provides two 6-hour treatments with a 6 hour minimum rest period between treatments. Two optional accessories are available to hold the geko W-2 in place during treatment, if needed: a knee strap and an adhesive tape.

## F. Indications for Use:

- Increasing local blood circulation .
- Edema reduction ●

## G. Technical Comparison with the Predicate Device and Discussion of Differences

| Parameter | Proposed<br>gekoTM W-2 | Predicate<br>gekoTM Plus R-2 (K180082) |
|--------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for use | Increasing local blood circulation<br>• Edema reduction | Increasing local blood circulation<br>• Edema reduction<br>• Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis |
| # output modes | 1 | 1 |
| # output channels<br>- Synchronous or<br>alternating?<br>- Method of channel<br>isolation? | 1<br>N/A<br>N/A | 1<br>N/A<br>N/A |
| Method of stimulus<br>regulation | Current regulated | Current regulated |
| Microprocessor<br>controlled? | Yes | Yes |
| Automatic overload<br>trip | Yes | Yes |
| Automatic no-load<br>trip | Yes | Yes |
| Automatic shut-off | Yes | Yes |
| Patient over-ride<br>control | Yes | Yes |
| Parameter | Proposed<br>gekoTM W-2 | Predicate<br>gekoTM Plus R-2 (K180082) |
| Indicator displays | | |
| - On/Off status | Yes | Yes |
| - Low battery | Yes | Yes |
| - Stimulus level | Yes (device switches off) | Yes (device switches off) |
| | Yes. Stimulation level (pulse<br>width) is indicated by the number<br>of times the LED flashes in<br>sequence, e.g., a single flash for<br>Level 1 (25 $\mu$ s/54 mA) up to 10<br>flashes for Level 10 (560 $\mu$ s/54<br>mA). | Yes. Stimulation level (pulse<br>width) is indicated by the number<br>of times the LED flashes in<br>sequence, e.g., a single flash for<br>Level 1 (50 $\mu$ s/54 mA) up to 8<br>flashes for Level 8 (560 $\mu$ s/54<br>mA). |
| Waveform | Asymmetrical, biphasic,<br>rectangular waveform with charge<br>balancing second phase | Asymmetrical, biphasic,<br>rectangular waveform with charge<br>balancing second phase |
| Maximum output<br>voltage | 27.0 V @ 500 Ω | 27.0 V @ 500 Ω |
| | 108 V @ 2000 Ω | 108 V @ 2000 Ω |
| | 255 V @ 10,000 Ω | 255 V @ 10,000 Ω |
| | All voltages (±10%) | All voltages (±10%) |
| Maximum output<br>current | 54 mA @ 500 Ω | 54 mA @ 500 Ω |
| | 54 mA @ 2000 Ω | 54 mA @ 2000 Ω |
| | 25.5 mA @ 10,000 Ω | 25.5 mA @ 10,000 Ω |
| | All currents (±15%) | All currents (±15%) |
| Pulse widths | 25, 35, 50, 70, 100, 140, 200,<br>280, 400, 560 $\mu$ s | 50, 70, 100, 140, 200, 280, 400<br>and 560 $\mu$ s |
| Frequency | 1 Hz, fixed | 1 Hz, fixed |
| Net charge | 0 $\mu$ C at 500Ω, capacitor coupled | 0 $\mu$ C at 500Ω, capacitor coupled |
| Maximum phase<br>charge | 40 $\mu$ C at 500 Ω | 40 $\mu$ C at 500 Ω |
| Maximum current<br>density | 13.3 mA/cm² | 13.3 mA/cm² |
| Maximum power<br>density | 0.000088 W/cm² | 0.000088 W/cm² |
| Timer range in<br>minutes | 720 minutes max (two 6-hour run<br>times) | 1800 minutes max (one 30-hour<br>run time) |
| Power source | One 3V lithium coin cell | One 3V lithium coin cell |
| Weight | 10 g | 10 g |
| Dimensions | 7.8" x 1.2" x 0.4" | 7.8" x 1.2" x 0.4" |
| Patient contacting<br>materials | Hydrogel (KM40A) | Hydrogel (KM10T) |
| Parameter | Proposed<br>gekoTM W-2 | Predicate<br>gekoTM Plus R-2 (K180082) |
| Housing material | Polypropylene<br>Plastic injection molding | Polypropylene<br>Plastic injection molding |

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The differences between the proposed geko™ W-2 and the predicate geko™ PWS R-2 model are:

- . More stimulus levels are available to the user: 10 in the geko™ W-2 as compared to 8 in the qeko™ Pus R-2. The qeko W-2 offers two additional short pulse widths (25 & 35 us) that are below the lowest pulse width available on the predicate models.
- . The geko™ W-2 provides two doses of 6 hours each, with an enforced rest of 6 hours minimum between the doses as compared to the single 30 hour run time for a geko™ Plus R-2.
- . The geko™ W-2 uses KM40A instead of KM10T hydrogel.

The reason for these changes is to provide a geko model for patients who only require a lower level or stimulation and/or have sensitive skin. The geko W-2 provides a full range of stimulus intensities including two levels below those currently available for the geko™ Plus R-2. In addition, the KMT40A hydrogel of the geko W-2 has a lower adhesive strength and may be less irritative to sensitive skin than the KMT10T hydrogel used in the other geko models, including the geko PMS R-2. Finally, the 6 hour off treatment protocol gives sensitive skin a chance to rest in between treatment sessions.

Because the geko™ W-2 is limited to 6 hour treatment durations with a minimum of 6 hour rest between treatments, the device is not indicated for prevention of venous thrombosis, which requires continuous (or near continuous) therapy for longer than 6 hours. Therefore, the indications for use of the geko™ W-2 are a subset of the prior geko models. Otherwise, as can be seen from the Technical Comparison Table, the indications for use, technical specifications, mechanism of action, and device operation for the geko™ W-2 are the same as for the predicate device.

## H. Design Validation Activities

The device changes described in this Special 510(k) were implemented under the company's design change procedures. A risk assessment of the changes resulted in the following verification and validation activities:

Biocompatibility testing for the new hydrogel for medical devices in contact with intact skin:

- Cytotoxicity testing according to ISO 10993-5 o
- Sensitization and Irritation testing according to ISO 10993-10 O

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The testing demonstrated that the KM40A hydrogel is biocompatible for its intended use contact.

Electrical safety testing was not needed as there are no changes in the geko W-2 as compared to the predicate geko™ Plus R-2 related to the electrical hardware.

Electromagnetic compatibility testing was conducted to IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests. Although no electronic hardware changes were made to the geko W-2 as compared to the geko™ Pus R-2, EMC testing was conducted to assure compliance to the current version of the standard. Testing included all requirements for a non-rechargeable, battery powered medical device. Testing was conducted with the device in continuous operating mode at the highest stimulus setting. All tests were passed.

Hardware/Firmware testing – As with the prior geko models, the geko™ W-2 hardware and firmware were tested together in order to verify the correct functioning of the device. All tests were passed. Testing included:

- . Verification of output waveform characteristics via oscilloscope output tracings at 500Ω, 2kΩ and 10kΩ
- Validation of all geko™ W-2 hardware and firmware functionality .

Performance testing - The durability of the device when used multiple times was verified under internal test protocols that included: 1) assessing the device operation when applied and removed from a test substrate 100 times; and 2) assessing device adhesion when applied and removed for a total of 10 use cycles. All test samples passed all repeat test cases.

#### l. Conclusion

The information and testing presented in this 510(k) demonstrated that the geko™ W-2 is substantially equivalent to the predicate geko device models, specifically the geko™ Plus R-2, for the indications for use of increasing local circulation and edema reduction.