geko T-2 and geko Plus R-2

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains 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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. February 11, 2018 Firstkind Limited % Sheila Hemeon-Heyer President Heyer Regulatory Solutions LLC 125 Cherry Lane Amherst, Massachusetts 01002 Re: K180082 Trade/Device Name: geko™ T-2 and geko™ Pus R-2 Neuromuscular Stimulators Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: IPF Dated: January 10, 2018 Received: January 11, 2018 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 {1}------------------------------------------------ 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 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. 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. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. Vivek J. Pinto -S 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 {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K180082 Device Name geko™ T-2 and geko™ Plus R2 Neuromuscular Stimulators ### Indications for Use (Describe) - · Increasing local blood circulation - · Immediate post-surgical stimulation of the calf muscles to prevent venous thrombosis - · Edema reduction | Type of Use (Select one or both, as applicable) | |-------------------------------------------------| |-------------------------------------------------| | <div style="display:flex; align-items:center;"><div><span style="font-size:2em;">☑</span></div><div>Prescription Use (Part 21 CFR 801 Subpart D)</div></div> | |--------------------------------------------------------------------------------------------------------------------------------------------------------------| | <div style="display:flex; align-items:center;"><div><span>☐</span></div><div>Over-The-Counter Use (21 CFR 801 Subpart C)</div></div> | CONTINUE ON A SEPARATE PAGE IF NEEDED ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 510(k) Summary 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: | +44 (0) 845 2222 921 | | | | Email: | neil.buckley@firstkindmedical.com | | - B. Date Prepared: February 9, 2018 #### C. Device Name and Classification Information: | Trade Name: | geko™ T-2 and geko™ Plus R2 Neuromuscular<br>Stimulators | |----------------------|----------------------------------------------------------| | Classification Name: | Stimulator, Muscle, Powered | | Product Code, CFR: | IPF, 21 CFR 890.5850 | | Panel code: | 89 | | Class: | II | #### D. Predicate Device: K162987 for FlowAid FA100 SCCD #### Device Description: ن The geko™ T-2 and geko™ Plus R-2 Neuromuscular Stimulator devices were previously described in K152677 and K160299, respectively. There have been no changes to the design, technical specifications, or manufacturing of these devices since previously cleared. The devices are single patient use and disposable with fully integrated electronics composed of a constant current pulse generator with embedded software and a lithium-ion battery enclosed in a 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 {4}------------------------------------------------ the device output, which is achieved through changes in the delivered pulse width. The devices are 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 stimulus intensity varies with the pulse width, which can be set to one of seven levels for the geko™ T-2 (ranging from 50 usec to 400 usec) and one of eight levels for the geko™ Plus R-2 (ranging from 50 usec to 560 usec). The constant current output at each pulse width setting is nominally 27 mA for the geko™ T-2 and 54 mA 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 for both devices and is used to isometrically stimulate the leg and foot muscles with a cadence and energy similar to that of walking. ### F. Indications for Use: - Increasing local blood circulation - Immediate post-surgical stimulation of the calf muscles to prevent venous ● thrombosis - Edema reduction ● ## G. Technical Comparison with the Predicate Device and Discussion of Differences The purpose of this 510(k) is to add the indication for use of edema reduction to the previously cleared geko™ T-2 and geko™ Pus R-2 devices. There have been no changes to the device design, technical specifications, or operating principles. The geko devices are substantially equivalent to the FlowAid FA100 SCCD, which was cleared for use in edema reduction under K162987. The Table 1 below provides a technical comparison of the two geko models to the FA100 SCCD. Both the geko devices and the FlowAid FA100 SCCD are intended to increase blood flow using low frequency electrical stimulation of the lower limb. The main technological difference between the geko devices and the FlowAid FA100 SCCD is that the geko devices use a single electrode and a 1 Hz frequency, while the FA100 SCCD uses four electrodes that stimulate in a sequential pattern with a choice of three low frequencies (4 Hz, 9 Hz or 14 Hz). The availability of clinical data demonstrating that both devices are safe and effective in reducing edema supports the conclusion that these differences do not raise new questions of safety or effectiveness and, therefore, the geko devices can be found substantially equivalent for the indication of edema reduction. {5}------------------------------------------------ | Parameter | geko™ T-2 | geko ™ Plus R-2 | Predicate Device:<br>FlowAid FA100 SCCD | |------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for use | Increasing local blood circulation Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis Edema reduction | Increasing local blood circulation Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis Edema reduction | Increasing local blood circulation Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis Preventing or retarding disuse atrophy Edema reduction | | Number of output modes | Single mode with seven discrete pulse width settings (50-400 μs) which define the stimulation level | Single mode with eight discrete pulse width settings (50-560 μs) which define the stimulation level | Single mode with three frequency settings and user adjusted stimulus level | | Number of output channels<br>- Synchronous or alternating? | 1<br>N/A | 1<br>N/A | 4<br>Sequential stimulation of electrode pairs: | | Method of channel isolation? | N/A | N/A | Capacitor isolated | | Method of stimulus regulation | Current regulated | Current regulated | Current regulated | | Microprocessor controlled? | Yes | Yes | Yes | | Automatic overload trip | Yes | Yes | Yes | | Automatic no-load trip | Yes | Yes | Yes | | | | | | | | Table 1. Technical Comparison of geko™ T-2 and geko™ Plus R-2 to Predicate Device | |--|--|--|--|--|--|-----------------------------------------------------------------------------------| |--|--|--|--|--|--|-----------------------------------------------------------------------------------| {6}------------------------------------------------ | Parameter | geko™ T-2 | geko™ Plus R-2 | Predicate Device:<br>FlowAid FA100 SCCD | |---------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------| | Automatic shut-off | Yes | Yes | Yes | | Patient over-ride<br>control | Yes | Yes | Yes | | Indicator displays<br>- On/Off status<br>- Low battery<br>-Stimulus level | Yes<br>Yes (device switches off)<br>Yes. Stimulation level (pulse<br>width) is indicated by the flashing<br>LED. The number of times LED<br>flashes in sequence indicates the<br>level of stimulation, i.e., a single<br>flash for Level 1 (50 µs pulse<br>width) up to seven flashes in<br>sequence for Level 7 (400 µs<br>pulse width). | Yes<br>Yes (device switches off)<br>Yes. Stimulation level (pulse<br>width) is indicated by the flashing<br>LED. The number of times LED<br>flashes in sequence indicates the<br>level of stimulation, i.e., a single<br>flash for Level 1 (50 µs pulse<br>width) up to eight flashes in<br>sequence for Level 8 (560 µs<br>pulse width). | Yes<br>Yes<br>Yes - numerical indication of<br>signal intensity (voltage value) | | Waveform | Asymmetrical, biphasic,<br>rectangular waveform with charge<br>balancing second phase for 0 net<br>DC | Asymmetrical, biphasic,<br>rectangular waveform with charge<br>balancing second phase for 0 net<br>DC | Symmetrical, bi-phasic,<br>rectangular wave with 0 net DC | | Maximum output<br>voltage | 14.0 V @ 500 Ω<br>53.5 V @ 2000 Ω<br>255 V @ 10,000 Ω<br>All voltages (±10%) | 27.0 V @ 500 Ω<br>108 V @ 2000 Ω<br>255 V @ 10,000 Ω<br>All voltages (±10%) | 80 V (±10%) | | Maximum output<br>current | 27 mA @ 500 Ω<br>27 mA @2000 Ω<br>25.5 mA @ 10,000 Ω<br>All currents (±15%) | 54 mA @ 500 Ω<br>54 mA @ 2000 Ω<br>25.5 mA @ 10,000 Ω<br>All currents (±15%) | 160 mA (±10%) | | Parameter | geko™ T-2 | geko™ Plus R-2 | Predicate Device:<br>FlowAid FA100 SCCD | | Pulse width | 50, 70, 100, 140, 200, 280, 400 μs | 50, 70, 100, 140, 200, 280, 400,<br>560 μs | Fixed – 500 µsec | | Frequency | 1 Hz, fixed | 1 Hz, fixed | Three setting options: 4 Hz, 9<br>Hz, or 14 | | Net charge | 0 μC at 500 Ω, capacitor coupled | 0 μC at 500 Ω, capacitor coupled | 0 µC, phase balancing | | Maximum phase charge | 18.3 µC at 500 Ω | 40 µC at 500 Ω | 8 μC | | Maximum current<br>density | 6.67 mA/cm² | 13.3 mA/cm² | 6.4 mA/cm² | | Maximum power<br>density | 0.000044 W/cm² | 0.000088 W/cm² | 0.000041 W/cm² | | Timer range in minutes | 1800 min maximum | 1800 min maximum | No timer<br>Device will operate until turned<br>off by user or battery depleted. | | Power source | One CR2032 primary lithium coin<br>cell. Not replaceable by user | One CR2032 primary lithium coin<br>cell. Not replaceable by user | Four 1.2VDC GP NiMH<br>battery cells | | Weight | 10 g | 10 g | 230 g, including batteries | | Dimensions | 7.8" x 1.2" x 0.4" | 7.8" x 1.2" x 0.4" | 2.8" x 5.1" x 1.1" | | Patient contacting<br>materials | Hydrogel (KM10T) | Hydrogel (KM10T) | Hydrogel applied to silver<br>electrode. | | Housing material | Polypropylene<br>Plastic injection molding | Polypropylene<br>Plastic injection molding | Injection molded plastic | {7}------------------------------------------------ {8}------------------------------------------------ ## H. Discussion of Performance Data A clinical study was conducted to demonstrate the safety and effectiveness of the geko devices in the reduction of edema. Twenty-six subjects undergoing total hip replacement surgery were randomized to receive either the geko™ device (n=14) or compression stockings (n=12). The randomized therapy was applied bilaterally immediately following the surgery and worn continuously until hospital discharge except while bathing or for other procedures. The geko™ devices were changed every 24 hours per the instructions for use. Circumference measurements were taken on both the operated and non-operated legs at the ankle, calf and thigh immediately prior to and following surgery and on each day post-surgery until hospital discharge. The circumference measurements were used to determine the total volume of each leg using a conical model. The results demonstrated less edema formation for the subjects treated with the geko™ devices as compared to compression stockings in both the operated and non-operated legs, which reached statistical significance by Day 1 post-op and continued until hospital discharge. No device-related adverse events or serious adverse events were reported for either the geko™ devices or compression stockings. #### l. Conclusion The clinical data presented in this 510(k) supports the safety and effectiveness of the geko™ devices when used for edema reduction. Therefore, this 510(k) is substantially equivalent for the new indication for use.