The geko™ Plus R-2 Neuromuscular Stimulator (geko™ Plus R-2) is a disposable, fully integrated unit composed of a constant current pulse generator with embedded software and battery enclosed in an over-molded plastic casinq, 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 changes in the delivered pulse width. The geko™ Plus R-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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Geko™ Plus R-2 Neuromuscular Stimulator. This document focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a study to prove acceptance criteria with detailed performance metrics as would be found for an AI/ML device.

Therefore, many of the requested categories for AI/ML device studies are not applicable to this submission.

Here's a breakdown of the information that can be extracted and where the document falls short for AI/ML specific criteria:

1. A table of acceptance criteria and the reported device performance

The document does not provide specific acceptance criteria in terms of performance metrics (sensitivity, specificity, etc.) for the device's intended use (increasing local blood circulation, preventing venous thrombosis). Instead, it establishes substantial equivalence based on technical specifications and safety standards compared to a predicate device.

The table on pages 6-8 is a comparison of design parameters between the predicate device (geko™ T-2) and the proposed device (geko™ Plus R-2). It highlights technical specifications rather than clinical performance acceptance criteria.

Parameter	Predicate geko™ T-2 (Reference for Substantial Equivalence)	Proposed geko™ Plus R-2 (Reported Device Performance)
Intended Use and Indications for Use	• Increasing local circulation • Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis	Same
Clinical application	Prescription use only for use in a clinical or home use setting. Single patient use for up to 30 hours. Disposable.	Same
Anatomical Sites	Electrodes applied to the posterior aspect of the knee only for stimulation of the peroneal nerve.	Same
Shelf Life	24 months	Same
Power source	One CR2032 primary lithium coin cell. Not replaceable by user.	Same
-Method of Line Current Isolation	N/A	N/A
-Patient Leakage Current (Normal Condition)	< 20μΑ	Same
-Patient Leakage Current (Single Fault Condition)	< 20μΑ	Same
Output modes	Single mode with 7 discrete stimulation settings (pulse widths)	Single mode with 8 discrete stimulation settings (pulse widths)
Output channels	Single channel	Same
-Synchronous or alternating	N/A (single channel)	Same
-Method of channel isolation	Capacitor	Same
Regulated current or regulated voltage	Current regulated	Same
Microprocessor controlled?	Yes	Same
Automatic overload trip	Yes	Same
Automatic no-load trip	Yes	Same
Automatic shut-off	Yes	Same
Patient over-ride control	Yes	Same
Indicator display (On/Off status)	Yes	Same
Indicator display (Low battery)	Yes (automatic off)	Same
Indicator display (Voltage / current level)	N/A (fixed constant current)	Same
Indicator display (Charge level (pulse width))	Yes, number of LED flashes indicate stimulation level	Same
Timer range in minutes	1800 minutes maximum (device disabled after 30 hours battery run time)	Same
Compliance with voluntary standards	IEC 60601-1:2005, IEC 60601-2-10:2012, EN 60601-1-2:2007, ISO 10993-1	Same
Compliance with 21 CFR 898	N/A (electrodes are integral with the device, no separate leads)	Same
Weight	10 g	Same
Dimensions	7.8" x 1.2" x 0.4"	Same
Housing material and construction	Plastic injection molding	Same
Waveform	Biphasic (asymmetrical biphasic with zero net DC) Rectangular, with charge balancing second phase	Same
Maximum output voltage	13.5 V @ 500 Ω 54 V @ 2000 Ω 255 V @ 10,000 Ω	27 V @ 500 Ω 108 V @ 2000 Ω 255 V @ 10,000 Ω
Maximum output current	27 mA @ 500 Ω 27 mA @ 2000 Ω 25.5 mA @ 10,000 Ω	54 mA @ 500 Ω 54 mA @ 2000 Ω 25.5 mA @ 10,000 Ω
Pulse width	50, 70, 100, 140, 200, 280, 400 μs	50, 70, 100, 140, 200, 280, 400, 560 μs
Frequency	1 Hz	Same
For interferential modes only: -beat Frequency (Hz)	N/A	Same
Multiphasic waveforms -Symmetrical phases	No	Same
-Phase duration	50-400 µs for positive phase, second (negative) phase is an exponential decay with a 0.1 s time constant	50-560 µs for positive phase, second (negative) phase is an exponential decay with a 0.1 s time constant
Net charge	0 µC at 500 Ω	Same
-How achieved	Capacitor coupling	Same
Maximum phase charge*	10.8 µC at 500 Ω	30.2 µC at 500 Ω
Maximum current density*	5.5 mA/cm²	11.0 mA/cm²
Average (r.m.s.) current density*	0.11 mA/cm²	0.26 mA/cm²
Maximum power density (averaged over the duty cycle)*	0.000000012 W/cm²	0.000000093 W/cm²
Burst mode (a,b,c,d)	N/A (single pulse, no pulse train or burst)	Same
ON Time (seconds) OFF Time (seconds)	N/A Stimulation is delivered at 1 Hz, with single pulses of 50μs to 400μs	N/A Stimulation is delivered at 1 Hz, with single pulses of 50μs to 560μs
Electrodes	Hydrogel applied to silver electrode. Biocompatibility for the hydrogel has been established.	Same
Cables/ connectors	Integrated device: no separate cables	Same
Patient-contact	Contact is made through integrated self-adhesive electrodes.	Same

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The submission relies on design validation activities (electrical safety, EMC, hardware/firmware testing) rather than a clinical study with a "test set" in the context of AI/ML.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided and is not applicable, as no clinical "test set" and ground truth establishment by experts for AI/ML performance are described. The focus is on device specifications and adherence to standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided and is not applicable, as no clinical "test set" with expert adjudication is described.

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 information is not provided and is not applicable. The device is a neuromuscular stimulator, not an AI diagnostic or assistance tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This information is not provided and is not applicable. The device is a physical stimulator.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

This information is not provided and is not applicable. The assessment is based on physical device specifications and compliance with safety standards, not on "ground truth" for clinical outcomes as validated in AI studies. The "conclusion" on page 9 states that the device "performs as designed and intended," which is validated through engineering tests.

8. The sample size for the training set

This information is not provided and is not applicable, as this is not an AI/ML device requiring a training set.

9. How the ground truth for the training set was established

This information is not provided and is not applicable, as this is not an AI/ML device requiring a training set and its ground truth.

Summary of Device Performance and Substantial Equivalence:

The Geko™ Plus R-2 Neuromuscular Stimulator demonstrates substantial equivalence to its predicate device, the Geko™ T-2, primarily through a comparison of technical specifications and an affirmation that its design has been validated against relevant safety and performance standards.

Key Differences and Their Justification: The main change is the option for stronger stimulation, achieved by higher constant current (54 mA vs 27 mA) and a higher maximum pulse width setting (560 µs vs 400 µs). This change is justified by stating that the higher current and pulse width settings do not raise new safety or effectiveness concerns. The maximum voltage remains the same, and the maximum current density and power density remain well below established limits by IEC 60601-2-10:2012 and FDA guidance, respectively. The longer pulse width for the new device is also comparable to a previous predicate (geko™ T-1).
Design Validation Activities:
- Electrical Safety and Electromagnetic Compatibility Testing: The device was certified to comply with IEC 60601-1:2005 (General Safety), IEC 60601-2-10:2012 (Nerve and Muscle Stimulators), and IEC 60601-1-2:2007 (EMC).
- Hardware/Firmware Testing: Verification of output waveform characteristics (via oscilloscope tracings at different impedance levels) and validation of all hardware and firmware functionality were performed.
- Results: All test results demonstrated that the geko™ Plus R-2 meets the predefined device technical and functional requirements specifications.

In essence, the study presented here is a set of engineering verification and validation tests to ensure the device meets its design specifications and complies with regulatory safety standards, supporting the claim of substantial equivalence to its predicate. It is not a clinical study designed to measure diagnostic performance or AI effectiveness.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

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

April 8, 2016

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

Re: K160299

Trade/Device Name: Geko™ Plus R-2 Neuromuscular Stimulator Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: IPF Dated: March 10. 2016 Received: March 11, 2016

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. 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 device

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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/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

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) K160299

Device Name

geko(TM) Plus R-2 Neuromuscular Stimulator

Indications for Use (Describe)

The geko(TM) Plus R-2 is intended for:

Increasing local blood circulation; and
Immediate post-surgical stimulation of the calf muscles to prevent venous thrombosis.

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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510(k) Summarv

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 LimitedHawk HousePeregrine Business ParkHigh Wycombe, UKHP13 7DL
Contact:Tel:Email:	Rachel Fallon, Chief Technology Officer+44 (0) 1494 572045rachel.fallon@firstkindmedical.com

Date Prepared: B. April 8, 2016

C. Device Name and Classification Information:

Trade Name:	gekoTM Plus R-2 Neuromuscular Stimulator
Common/usual Name:	Powered Muscle Stimulator
Classification Name:	Stimulator, Muscle, Powered
Product Code, CFR:	IPF, 21 CFR 890.5850
Panel code:	89
Class:	II

D. Predicate Device: K152677, geko™ T-2 Neuromuscular Stimulator

ய் Device Description:

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The stimulus intensity varies with the pulse width, which can be set to one of eight levels for the geko™ Pus R-2. The asymmetric biphasic waveform results in a net charge of zero to the patient during each pulse cycle. The pulse rate is fixed at a frequency of 1 Hz and is used to isometrically stimulate the leg and foot muscles with a cadence and energy similar to that of walking.

Electrical contact is made with the patient through a hydrogel layer applied during manufacture to the integrated electrode. The patient contacting materials have been previously tested per the requirements of ISO 10993-1 and shown to be biocompatible for prolonged (up to 30 days) contact with intact skin. There are no separate electrode leads or electrodes.

F. Indications for Use:

The geko™ Plus R-2 is intended for:

Increasing local blood circulation, and ●
Immediate post-surgical stimulation of the calf muscles to prevent venous ● thrombosis.

G. Contraindications

Powered muscle stimulators should not be used on patients with cardiac demand pacemakers.

Powered muscle stimulators should not be used on patients with recently diagnosed deep vein thrombosis.

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H. Substantial Equivalence

Parameter	PredicateTM gekoTM T-2	ProposedTM gekoTM Plus R-2
Intended Use andIndications for Use	• Increasing local bloodcirculation• Immediate post-surgicalstimulation of the calfmuscles to prevent venousthrombosis	Same
Clinical application	Prescription use only for use ina clinical or home use setting.Single patient use for up to 30hoursDisposable (cannot be reused)	Same
Anatomical Sites	The electrodes are applied tothe posterior aspect of the kneeonly for stimulation of theperoneal nerve.	Same
Shelf Life	24 months	Same
Power source	One CR2032 primary lithiumcoin cell. Not replaceable byuser	Same
-Method of LineCurrent Isolation	N/A	N/A
-Patient LeakageCurrent-Normal Condition	< 20μΑ	Same
-Single FaultCondition	< 20μΑ	Same
# output modes	Single mode with 7 discretestimulation settingscorresponding to the 7 pulsewidths.	Single mode with 8 discretestimulation settingscorresponding to the 8 pulsewidths.
# output channels	Single channel	Same
-Synchronous oralternating	N/A (single channel)	Same
-Method of channelisolation	Capacitor	Same
Parameter	Predicategeko™ T-2	Proposedgeko™ Plus R-2
Regulated current orregulated voltage	Current regulated	Same
Microprocessorcontrolled?	Yes	Same
Automatic overloadtrip	Yes	Same
Automatic no-loadtrip	Yes	Same
Automatic shut-off	Yes	Same
Patient over-ridecontrol	Yes	Same
Indicator display
- On/Off status	Yes	Same
- Low battery	Yes (automatic off)	Same
-Voltage / currentlevel	N/A (fixed constant current)	Same
-Charge level (pulsewidth)	Yes, number of LED flashes indicate stimulation level	Same
Timer range inminutes	1800 minutes maximum(device is disabled after 30hours battery run time)	Same
Compliance withvoluntary standards	YesIEC 60601-1:2005, 3rd edIEC 60601-2-10:2012, 2nd edEN 60601-1-2:2007, 3rd edISO 10993-1	Same
Compliance with 21CFR 898	N/A (electrodes are integralwith the device, there are noseparate leads)	Same
Weight	10 g	Same
Dimensions	7.8" x 1.2" x 0.4"	Same
Housing material andconstruction	Plastic injection molding	Same
Waveform	Biphasic (asymmetricalbiphasic with zero net DC)Rectangular, with chargebalancing second phase	Same
Parameter	Predicategeko™ T-2	Proposedgeko™ Plus R-2
Maximum outputvoltage	13.5 V @ 500 Ω54 V @ 2000 Ω255 V @ 10,000 Ω	27 V @ 500 Ω108 V @ 2000 Ω255 V @ 10,000 Ω
Maximum outputcurrent	27 mA @ 500 Ω27 mA @2000 Ω25.5 mA @ 10,000 Ω	54 mA @ 500 Ω54 mA @2000 Ω25.5 mA @ 10,000 Ω
Pulse width	50, 70, 100, 140, 200, 280, 400 μs	50, 70, 100, 140, 200, 280,400, 560 μs
Frequency	1 Hz	Same
For interferentialmodes only:-beat Frequency (Hz)	N/A	Same
Multiphasicwaveforms-Symmetrical phases	No	Same
-Phase duration	50-400 µs for positive phase,second (negative) phase is anexponential decay with a 0.1 stime constant	50-560 µs for positive phase,second (negative) phase isan exponential decay with a0.1 s time constant
Net charge	0 µC at 500 Ω	Same
-How achieved	Capacitor coupling	Same
Maximum phasecharge*	10.8 µC at 500 Ω	30.2 µC at 500 Ω
Maximum currentdensity*	5.5 mA/cm²	11.0 mA/cm²
Average (r.m.s.)current density*	0.11 mA/cm²	0.26 mA/cm²
Maximum powerdensity (averagedover the duty cycle)*	0.000000012 W/cm²	0.000000093 W/cm²
Burst modea) Pulses per burstb) Bursts per secondc) Burst duration(seconds)d) Duty Cycle [Line(b) x Line (c)]	N/A (single pulse, no pulsetrain or burst)	Same
Parameter	Predicate gekoTM T-2	Proposed gekoTM Plus R-2
ON Time (seconds)OFF Time (seconds)	N/A Stimulation is delivered at1 Hz, with single pulses of50μs to 400μs	N/A Stimulation is deliveredat 1 Hz, with single pulses of50μs to 560μs
Electrodes	Hydrogel applied to silverelectrode. Biocompatibility forthe hydrogel has beenestablished.	Same
Cables/ connectors	Integrated device: no separatecables	Same
Patient-contact	Contact is made throughintegrated self-adhesiveelectrodes.	Same

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*Values are calculated using the device design specifications (i.e., nominal values).

Discussion of differences

The primary change from the predicate geko™ T-2 to the new geko™ Plus R-2 is that the new device model provides options for stronger stimulation to enable treatment for patients who do not achieve sufficient stimulation with the geko T-2. The stronger stimulation is achieved primarily by the higher constant current (54 mA vs 27 mA) along with a higher maximum pulse width setting (560 us vs 400 us). There are no changes to the indications for use, fundamental scientific principles, or operation of the device.

The higher current and pulse width settings do not raise new questions of safety or effectiveness. The maximum voltage is the same for both the new and predicate devices (255 V). The maximum current of the new device, although twice that of the predicate, is still low for a powered muscle stimulator, delivering an average (r.m.s) current density of 0.26 mA/cm2, well below the 2 mA/cm² maximum limit as set by IEC 60601-2-10:2012 (Medical electrical equipment: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators) and a maximum power density (averaged over the duty cycle) of 0.000000093 W/cm², well below the maximum limit of 0.25 W/cm² stated in FDA's Guidance Document for Powered Muscle Stimulator 510(k)s. The longer pulse width of 560 us for the new device is the same as the longest pulse width for the original geko™ T-1 device cleared under K133638, which served as the predicate device for the geko™ T-2.

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-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:

Electrical Safety and Electromagnetic Compatibility Testing – The geko™ Plus R-2 has been certified to comply with the applicable clauses of the following standards:

IEC 60601-1: Medical Electrical Equipment Part 1: General Requirements . for Safety, 3rd edition, 2005
IEC 60601-2-10: Medical electrical equipment Part 2-10: Particular . requirements for the safety of nerve and muscle stimulators, 2nd edition,
IEC 60601-1-2: Medical electrical equipment Part 1-2: General . requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests, 30 edition, 2007.

Hardware/Firmware Testing

As with the predicate device, the geko™ Plus R-2 hardware and firmware were tested together in order to verify the correct functioning of the device. Testing included the following:

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

All test results demonstrated that the geko ™ Pus R-2 meets the predefined device technical and functional requirements specifications.

I. Conclusions

The information and testing presented in this 510(k) demonstrated that the geko™ Plus R-2 performs as designed and intended and is substantially equivalent to the predicate device, the geko™ T-2, for increasing local circulation and immediate post-surgical prevention of venous thrombosis.

Regulation Number and Section

§ 890.5850 Powered muscle stimulator.

(a)
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.(b)
Classification. Class II (performance standards).