geko T-3 Neuromuscular Stimulator

{0}------------------------------------------------ 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, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath in a smaller font. Mav 23, 2018 Firstkind Limited % Sheila Hemeon-Heyer President Heyer Regulatory Solutions LLC 125 Cherry Lane Amherst, Massachusetts 01002 Re: K181059 Trade/Device Name: geko™ T-3 Neuromuscular Stimulator Regulation Number: 21 CFR 890.5850 Regulation Name: Powered muscle stimulator Regulatory Class: Class II Product Code: IPF Dated: April 23, 2018 Received: April 23, 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 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 {1}------------------------------------------------ 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) K181059 Device Name geko™ T-3 Neuromuscular Stimulator ### 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) | | | | |--------------------------------------------------|---------------------------------------------|--|--| | X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) | | | 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) 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 Limited<br>Hawk House<br>Peregrine Business Park<br>High Wycombe, UK<br>HP13 7DL | |----------------|--------------------------------------------------------------------------------------------| | Contact: | Neil Buckley<br>Head of Quality and Regulatory Affair | | Tel:<br>Email: | +44 (0) 845 2222 921<br>neil.buckley@firstkindmedical.com | - B. Date Prepared: May 23, 2018 #### Device Name and Classification Information: C. | Trade Name: | geko™ T-3 Neuromuscular Stimulators | |----------------------|-------------------------------------| | Classification Name: | Stimulator, Muscle, Powered | | Product Code, CFR: | IPF, 21 CFR 890.5850 | | Panel code: | 89 | | Class: | II | - D. Predicate Devices: K180082 for geko™ T-2 and geko™ Plus R-2 #### Device Description: ய் The geko™ T-3 Neuromuscular Stimulator (geko™ T-3) is 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 the device output, which is achieved through changes in the delivered pulse width. The geko™ T-3 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 stimulus intensity varies with the pulse width, which can be set to one of 11 levels: 35, 50, 70, 100, 140, 200 or 280 @ 27 mA; 280 or 400 @ 38 mA; and 400 or 560 @ 54 mA. The asymmetric {4}------------------------------------------------ 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 calf 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 geko™ T-3 Neuromuscular Stimulator device incorporates the stimulus output levels of the geko™ T-2 and geko™ Pus R-2 into a single device. | Parameter | Predicate<br>geko™ T-2 | Predicate<br>geko™ Plus R-2 | Proposed<br>geko™ T-3 | |-----------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for use | • Increasing local blood circulation<br>• Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis<br>• Edema reduction | • Increasing local blood circulation<br>• Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis<br>• Edema reduction | • Increasing local blood circulation<br>• Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis<br>• Edema reduction | | Number of output modes | 1 | 1 | 1 | | Number of output channels | 1 | 1 | 1 | | - Synchronous or alternating?<br>- Method of channel isolation? | N/A | N/A | N/A | | Method of stimulus regulation | Current regulated | Current regulated | Current regulated | | Microprocessor controlled? | Yes | Yes | Yes | | Automatic overload trip | Yes | Yes | Yes | | Parameter | Predicate<br>geko™ T-2 | Predicate<br>geko ™ Plus R-2 | Proposed<br>geko™ T-3 | | Automatic no-load<br>trip | Yes | Yes | Yes | | Automatic shut-<br>off | Yes | Yes | Yes | | Patient over-ride<br>control | Yes | Yes | Yes | | Indicator displays<br>- On/Off status | | | | | - Low battery | Yes | Yes | Yes | | - Stimulus level | Yes (device switches off) | Yes (device switches off) | Yes (device switches off) | | | Yes. Stimulation level<br>(pulse width) is indicated<br>by the number of times<br>the LED flashes in<br>sequence, e.g., a single<br>flash for Level 1 (50<br>$\u03bcs$ /27 mA) up to 7<br>flashes for Level 7 (400<br>$\u03bcs$ /27 mA) | Yes. Stimulation level<br>(pulse width) is indicated<br>by the number of times<br>the LED flashes in<br>sequence, e.g., a single<br>flash for Level 1 (50<br>$\u03bcs$ /54 mA) up to 8 flashes<br>for Level 8 (560 $\u03bcs$ /54<br>mA). | Yes. Stimulation level<br>(pulse width) is indicated<br>by the number of times<br>the LED flashes in<br>sequence, e.g., a single<br>flash for Level 1 (35<br>$\u03bcs$ /27 mA) up to 11<br>flashes for Level 11 (560<br>$\u03bcs$ /54 mA). | | Waveform | Asymmetrical, biphasic,<br>rectangular waveform<br>with charge balancing<br>second phase | Asymmetrical, biphasic,<br>rectangular waveform with<br>charge balancing second<br>phase | Asymmetrical, biphasic,<br>rectangular waveform<br>with charge balancing<br>second phase | | 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%) | 27.0 V @ 500 Ω<br>108 V @ 2000 Ω<br>255 V @ 10,000 Ω<br>All voltages (±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%) | 54 mA @ 500 Ω<br>54 mA @ 2000 Ω<br>54 mA @ 10,000 Ω<br>All currents (±15%) | | Pulse widths ( $\u03bcs$ )<br>(@ current<br>setting) | 50, 70, 100, 140, 200,<br>280, 400 (@ 27 mA) | 50, 70, 100, 140, 200,<br>280, 400, 560 (@ 54 mA) | 35, 50, 70, 100, 140,<br>200, 280 (@ 27 mA);<br>280, 400 (@ 38 mA);<br>400, 560 (@ 54 mA) | | Frequency | 1 Hz, fixed | 1 Hz, fixed | 1 Hz, fixed | | Net charge | 0 µC at 500Ω, capacitor<br>coupled | 0 µC at 500Ω, capacitor<br>coupled | +/- 0.1 µC at 500Ω,<br>phase balancing | | Maximum phase<br>charge | 18.3 µC at 500 Ω | 40 µC at 500 Ω | 40 µC at 500 Ω | | Parameter | Predicate<br>geko™ T-2 | Predicate<br>geko™ Plus R-2 | Proposed<br>geko™ T-3 | | Maximum current<br>density | 6.67 mA/cm² | 13.3 mA/cm² | 13.3 mA/cm² | | Maximum power<br>density | 0.000044 W/cm² | 0.000088 W/cm² | 0.000088 W/cm² | | Timer range in<br>minutes | 1800 min max (30 hr run<br>time) | 1800 min max (30 hr run<br>time) | 1800 min max (30 hr run<br>time) | | Power source | One 3V lithium coin cell | One 3V lithium coin cell | One 3V lithium coin cell | | Weight | 10 g | 10 g | 10 g | | Dimensions | 7.8" x 1.2" x 0.4" | 7.8" x 1.2" x 0.4" | 7.8" x 1.2" x 0.4" | | Patient contacting<br>materials | Hydrogel (KM10T) | Hydrogel (KM10T) | Hydrogel (KM10T) | | Housing material | Polypropylene<br>Plastic injection molding | Polypropylene<br>Plastic injection molding | Polypropylene<br>Plastic injection molding | {5}------------------------------------------------ {6}------------------------------------------------ The differences between the proposed geko™ T-3 and the predicate geko models are: - More stimulus levels are available to the user: 11 in the geko™ T-3 as . compared to 7 in the geko™ T-2 and 8 in the geko™ Plus R-2. - The qeko T-3 offers three constant current levels: 27 mA, 38 mA, and 54 mA; . however, these are within the ranges available on the predicate models. - . The geko T-3 offers one additional short pulse width (35 µs) that is below the lowest pulse width available on the predicate models. - . The geko™ T-3 uses a different method of charge balancing; however, the net charge to the user remains essentially zero. Otherwise, as can be seen from the Technical Comparison Table, the indications for use and technical specifications for the geko™ T-3 are the same as for the predicate models. None of the changes are associated with any new risks, nor do they change the risk levels previously identified in the geko risk analysis. ## 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: Electrical Safety and Electromagnetic Compatibility Testing - The geko™ T-3 has been certified to comply with the applicable clauses of the following standards: {7}------------------------------------------------ - . IEC 60601-1:2005 +A1(2012) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance - . IEC 60601-1-11:2015 Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment - . IEC 60601-2-10:2012 +A1(2016) Medical electrical equipment - Part 2-10: Particular requirements for the safety of nerve and muscle stimulators - . EN 60601-1-2:2015 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests Hardware/Firmware Testing - The geko™ T-3 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™ T-3 hardware and firmware functionality #### Conclusion l. The information and testing presented in this 510(k) demonstrated that the geko™ T-3 is substantially equivalent to the predicate geko devices, models T-2 and Plus R-2, for the intended uses of increasing local circulation, immediate post-surgical prevention of venous thrombosis, and edema reduction.