geko T-2 Neuromuscular Stimulator

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image contains the logo of the Department of Health & Human Services (HHS) of the United States. The logo features the stylized HHS symbol, which consists of three overlapping human profiles facing right, representing the department's focus on people and health. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the symbol, indicating the department's name and national affiliation. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 October 23, 2015 Firstkind Limited c/o Sheila Hemeon-Heyer President Heyer Regulatory Solutions, LLC 125 Cherry Lane Amherst. MA 01002 Re: K152677 Trade/Device Name: geko™ T-2 Neuromuscular Stimulator Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: IPF Dated: September 18, 2015 Received: September 24, 2015 Dear Ms. 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 27f 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 {1}------------------------------------------------ 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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 Small Manufacturers, International and Consumer Assistance 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. # 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K152677 Device Name geko T-2 Neuromuscular Stimulator Indications for Use (Describe) The geko T-2 Neuromuscular Stimulator 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) | <span style="font-family: DejaVu Sans, sans-serif">☑</span> Prescription Use (Part 21 CER 801 Subpart D) | |----------------------------------------------------------------------------------------------------------| | ☐ Over-The-Counter Use (21 CER 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. rachel.fallon@firstkindmedical.com | A. Submitter: | Firstkind Limited<br>Hawk House<br>Peregrine Business Park<br>High Wycombe, UK<br>HP13 7DL | |------------------|--------------------------------------------------------------------------------------------| | Contact:<br>Tel: | Rachel Fallon, Chief Technology Officer<br>+44 (0) 1494 572045 | - Date Prepared: B. September 18, 2015 Email: #### C. Device Name and Classification Information: | Trade Name: | geko™ T-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: K133638, geko™ T-1 Neuromuscular Stimulator #### ய் Device Description: The geko™ T-2 Neuromuscular Stimulator (geko™ T-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 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-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 stimulus intensity varies with the pulse width, which can be set to one of seven levels for the geko™ T-2. The asymmetric biphasic waveform results in a net {4}------------------------------------------------ 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™ T-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. {5}------------------------------------------------ ## H. Substantial Equivalence | Parameter | Predicate<br>geko™ T-1 | Proposed<br>geko™ T-2 | |-----------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------| | Intended Use and<br>Indications for Use | Increasing local blood<br>●<br>circulation<br>Immediate post-surgical<br>●<br>stimulation of the calf<br>muscles to prevent venous<br>thrombosis | Same | | Clinical application | Prescription use only for use in<br>a clinical or home use setting.<br>Single patient use for up to 30<br>hours<br>Disposable (cannot be reused) | Same | | Anatomical Sites | The electrodes are applied to<br>the posterior aspect of the knee<br>only for stimulation of the<br>peroneal nerve. | Same | | Shelf Life | 24 months | Same | | Power source | One CR2032 primary lithium<br>coin cell. Not replaceable by<br>user | Same | | -Method of Line<br>Current Isolation | N/A | N/A | | -Patient Leakage<br>Current | | | | -Normal Condition<br>-Single Fault<br>Condition | < 20μA | Same | | | < 20μA | Same | | # output modes | Single mode with seven<br>discrete stimulation settings<br>corresponding to the seven<br>pulse widths. | Same | | # output channels | Single channel | Same | | -Synchronous or<br>alternating | N/A (single channel) | Same | | -Method of channel<br>isolation | Capacitor | Same | | Parameter | Predicate<br>gekoTM T-1 | Proposed<br>gekoTM T-2 | | Regulated current or<br>regulated voltage | Current regulated | Same | | Microprocessor<br>controlled? | Yes | Same | | Automatic overload<br>trip | Yes | Same | | Automatic no-load<br>trip | Yes | Same | | Automatic shut-off | Yes | Same | | Patient over-ride<br>control | Yes | Same | | Indicator display | | | | - On/Off status | Yes | Same | | - Low battery | Yes (automatic off) | Same | | -Voltage / current<br>level | N/A (fixed constant current) | Same | | -Charge level (pulse<br>width) | Yes, number of LED flashes<br>indicate stimulation level | Same | | Timer range in<br>minutes | 1800 minutes maximum<br>(device is disabled after 30<br>hours battery run time) | Same | | Compliance with<br>voluntary standards | Yes<br>IEC 60601-1:1998 A1, A2<br>IEC 60601-2-10:1987, A1<br>EN 60601-1-2:2007<br>ISO 10993-1 | Yes<br>IEC 60601-1:2005, 3rd ed<br>IEC 60601-2-10:2012, 2nd ed<br>EN 60601-1-2:2007, 3rd ed<br>ISO 10993-1 | | Compliance with 21<br>CFR 898 | N/A (electrodes are integral<br>with the device, there are no<br>separate leads) | Same | | Weight | 18 g | 10 g | | Dimensions | 6" x 1.6" x 0.43" | 7.8" x 1.2" x 0.4" | | Housing material and<br>construction | Plastic injection molding | Same | | Waveform | Biphasic (asymmetrical<br>biphasic with zero net DC)<br>Rectangular, with charge<br>balancing second phase | Same | | Parameter | Predicate<br>geko™ T-1 | Proposed<br>geko™ T-2 | | Maximum output<br>voltage | 13.5 V @ 500 Ω<br>54 V @ 2000 Ω<br>110 V @ 10,000 Ω | 14.0 V @ 500 Ω<br>53.5 V @ 2000 Ω<br>255 V @ 10,000 Ω | | Maximum output<br>current | 27 mA @ 500 Ω<br>27 mA @2000 Ω<br>11 mA @ 10,000 Ω | 27.9 mA @ 500 Ω<br>26.8 mA @2000 Ω<br>25.5 mA @ 10,000 Ω | | Pulse width | 70, 100, 140, 200, 280, 400,<br>560 μs | 40, 70, 100, 140, 200, 280,<br>400 μs | | Frequency | 1 Hz | Same | | For interferential<br>modes only:<br>-beat Frequency (Hz) | N/A | Same | | Multiphasic<br>waveforms | | | | -Symmetrical phases | No | Same | | -Phase duration | 70-560 µs for positive phase,<br>second (negative) phase is an<br>exponential decay with a 0.1 s<br>time constant | 50-400 µs for positive phase,<br>second (negative) phase is<br>an exponential decay with a<br>0.1 s time constant | | Net charge | 0 µC at 500 Ω | Same | | -How achieved | Capacitor coupling | Same | | Maximum phase<br>charge | 18.3 µC at 500 Ω | Same | | Maximum current<br>density | 6.67 mA/cm² | Same | | Maximum power<br>density | 0.000044 W/cm² | Same | | Burst mode | N/A (single pulse, no pulse<br>train or burst) | Same | | a) Pulses per burst | | | | b) Bursts per second | | | | c) Burst duration<br>(seconds) | | | | d) Duty Cycle [Line<br>(b) x Line (c)] | | | | ON Time (seconds) | N/A Stimulation is delivered at<br>1 Hz, with single pulses of<br>70µs to 560µs | N/A Stimulation is delivered<br>at 1 Hz, with single pulses of<br>50µs to 400µs | | OFF Time (seconds) | | | | Parameter | Predicate<br>geko™ T-1 | Proposed<br>geko™ T-2 | | Electrodes | Hydrogel applied to silver<br>electrode. Biocompatibility for<br>the hydrogel has been<br>established. | Same | | Cables/ connectors | Integrated device: no separate<br>cables | Same | | Patient-contact | Contact is made through<br>integrated self-adhesive<br>electrodes. The geko™ T-1 is a<br>single channel device. | Same | {6}------------------------------------------------ {7}------------------------------------------------ {8}------------------------------------------------ #### Discussion of differences The geko™ device has been redesigned for more efficient current delivery, enabling shorter pulse widths at each stimulus level. Replacing the one button design of the geko™ T-1 with a two button design in the geko™ T-2 improves ease of use. The changes resulting in the geko™ T-2 device do not alter the device intended use, indications for use or fundamental scientific technology, and none of the changes significantly affect the safety or effectiveness of the device. #### 1. Nonclinical Data: 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-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, 3td 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. {9}------------------------------------------------ ## Hardware/Firmware Testing As with the predicate device, the geko™ T-2 hardware and firmware work together and need to be 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 - Measurements to compare the geko™ T-2 output currents to those of the ● geko™ T-1 under loads ranging from 500Ω to 10kΩ - Validation of all geko™ T-2 hardware and firmware functionality - Usability evaluations by healthy volunteers ● - Clinical evaluations of the ability to achieve adequate stimulation (calf and . foot twitches) in patients immediately post-operative following elective total hip replacement at a hospital in the United Kingdom All test results demonstrated that the geko™ T-2 meets the predefined device technical and functional requirements specifications. ### I. Conclusions The information and testing presented in this 510(k) demonstrated that that the geko™ T-2 performs as designed and intended and is substantially equivalent to the predicate device, the geko™ T-1, for increasing local circulation and immediate postsurgical prevention of venous thrombosis.