Foot Drop System (Model XFT-2001D)

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November 30, 2017 Shenzhen XFT Medical Limited Mrs. Jiang Xiaoying Manager RM 203, BLD1, 14 Jinhui Road, New District Shenzhen, Guangdong CN Re: K162718 Trade/Device Name: Foot Drop System, Model 2001-D Regulation Number: 21 CFR 882.5810 Regulation Name: External Functional Neuromuscular Stimulator Regulatory Class: Class II Product Code: GZI Dated: October 27, 2017 Received: October 31, 2017 Dear Mrs. Xiaoying: We have reviewed vour 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). 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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) K162718 Device Name Foot Drop System (Model XFT-2001D) #### Indications for Use (Describe) XFT-2001D Foot Drop System is intended to address the lack of ankle dorsiflexion in patients who have sustained damage to upper motor neurons or pathways to the spinal cord. During the swing phase of walking, the XFT-2001D electrically stimulates the appropriate muscles that cause ankle dorsiflexion and may thus improve the individual's gait. Medical benefits of Functional Stimulation (FES) may include prevention/retardation of disuse attophy, increased local blood flow, muscle re-education, and maintained or increased joint range of motion. | Type of Use (Select one or both, as applicable) | | |----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | <div> <span> <span style="font-size: 100%;"> <input checked="true" type="checkbox"/> </span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> <span style="font-size: 100%;"> <input type="checkbox"/> </span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> | ### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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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 In accordance with 21 CFR 807.92 the following summary of information is provided: | Date: | November 30, 2017 | |-----------------|----------------------------------------------------------------------------------------------------------------------------------------------------------| | Submitter: | Shenzhen XFT Medical Limited<br>Room203, Building 1, Biomedicine Innovations Industrial Park,<br>#14 Jinhui Road, Pingshan New District, Shenzhen, China | | Contact Person: | Mrs. Jiang Xiaoying | Co xfthr3@xft.cn Tel: +86-(0) 755-29888818 Device: Trade Name: Foot Drop System > Model: XFT-2001D series External Neuromuscular Functional Stimulator Classification Names: Product Code: GZI Regulation Number: 21 CFR 882.5810 Device Class: Class II Submission Purpose: New Device Predicate Device(s): K123972 {4}------------------------------------------------ - Nerve and Muscle Stimulator (Foot Drop System) is a battery-operated, Device Description: electrical stimulator that can be used for functional electrical stimulation (FES). > Nerve and Muscle Stimulator (Foot Drop System) is an external functional electrical stimulator. It is a small device that attaches to the leg just below the knee, near the head of the fibula. During a gait cycle, Nerve and Muscle Stimulator (Foot Drop System) stimulates the common peroneal nerve, which innervates the tibialis anterior and other muscles that cause dorsiflexion of the ankle. The Nerve and Muscle Stimulator (Foot Drop System) consists of the Patient Kit and the Clinician Kit. The Patient Kit comprises of all the components and accessories that the patient will take home and use. The Clinician System includes the Medical Records Management Software. - Intended Use: XFT-2001D Foot Drop System is intended to address the lack of ankle dorsiflexion in patients who have sustained damage to upper motor neurons or pathways to the spinal cord. During the swing phase of walking, the XFT-2001D electrically stimulates the appropriate muscles that cause ankle dorsiflexion and may thus improve the individual's gait. Medical benefits of Functional Electrical Stimulation (FES) may include prevention/retardation of disuse atrophy, increased local blood flow, muscle re-education, and maintained or increased joint range of motion. - Technology: Proposed device and predicate device use a small electrical signal to stimulate the nerves in the leg, causing the muscles contract and produce a movement that can help walking. The most common use of FES is as a treatment for foot drop where disruptions in the nerve pathways between the legs and brain which means the front of your foot cannot be lifted to the correct angle when walking. The Foot Drop System employs the same fundamental scientific technology as its predicate devices. {5}------------------------------------------------ Basis for Technological characteristics, features, specifications, materials and Substantial intended uses of the new device are substantially equivalent to the Equivalence: quoted predicated device. The parameters such as waveform, frequency, pulse width, output current and voltage, although not exactly identical to this particular predicate, do not raise any new questions of safety or effectiveness. Applicable performance and safety testing was performed to verify technological and functional characteristics including any design modification. The differences that exist between the devices are insignificant in terms of safety and effectiveness. The proposed device is Substantially Equivalent (SE) to the predicate device which is US legally market device. Therefore, the subject device is determined as safe and effectiveness. Table 1 Comparison between XFT-2001D and the predicate device {6}------------------------------------------------ | Specification | Predicate Device | Proposed device | |------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | K number | K123972 | K162718 | | Device name | WalkAide | XFT-2001D | | Manufacturer | Innovative Neurotronics, Inc. | Shenzhen XFT Medical Limited | | Intended Use/ Indications for<br>Use | The Innovative Neurotronics WalkAide<br>System is intended to address the lack of<br>ankle dorsiflexion in patients who have<br>sustained damage to upper motor<br>neurons or pathways to the spinal cord.<br>During the swing phase of gait, the<br>WalkAide electrically stimulates the<br>appropriate muscles that cause ankle<br>dorsiflexion and may thus improve the<br>patient's gait. Medical benefits of<br>Functional Electrical Stimulation (FES)<br>may include prevention/retardation of<br>disuse atrophy, increased local blood<br>flow, muscle re-education, and<br>maintained or increased joint range of<br>motion. | XFT-2001D Foot Drop System is<br>intended to address the lack of ankle<br>dorsiflexion in patients who have<br>sustained damage to upper motor<br>neurons or pathways to the spinal<br>cord. During the swing phase of<br>walking, the XFT-2001D electrically<br>stimulates the appropriate muscles<br>that cause ankle dorsiflexion and may<br>thus improve the individual's gait.<br>Medical benefits of Functional<br>Electrical Stimulation (FES) may include<br>prevention/retardation of disuse<br>atrophy, increased local blood flow,<br>muscle re-education, and maintained<br>or increased joint range of motion. | | Contraindications | Do not use on persons with implanted<br>demand type cardiac pacemakers or<br>defibrillators. | Do not use on persons with implanted<br>demand type cardiac pacemakers or<br>defibrillators | | | Do not place the electrodes in the<br>carotid sinus region (throat). | Do not place the electrodes in the<br>carotid Sinus region (throat). | | | Laryngeal or pharyngeal spasms placed<br>across the throat or in the mouth. | Laryngeal or pharyngeal spasms may<br>occur when the electrodes are placed<br>across the throat or in the mouth. | | | Do not place the electrodes over<br>malignant tumors. | Do not place the electrodes over<br>malignant tumors. | | | Do not place the electrodes over areas in<br>which symptoms of existing thrombosis<br>are present. | Do not place the electrodes over areas<br>in which symptoms of existing<br>thrombosis are present. | | | Do not use if person has a history of<br>seizure disorder. | Do not use if person has a history of<br>seizure disorder. | | Patient Population | Adult | Adult | | Power Source(s) | 1.5 AA Battery (not rechargeable) | DC3.7V, 400mAh, rechargeable lithium<br>battery (Stim Unit & Remote control) | | Patient Leakage Current | -Normal condition: 0.5mA | -Normal condition: 0.5mA | | Specification | Predicate Device | Proposed Device | | Number of Output Modes | 2 modes: gait mode and training<br>mode | 2 modes: gait mode and training<br>mode | | Number of Output Channels | 1 | 1 | | Regulated Current or<br>Regulated Voltage | Voltage | Current | | Software/Firmware/Microproc<br>essor | Microprocessor | Microprocessor | | Auto Overload Trip? | No | No | | Auto No-Load Trip? | No | Yes | | Auto Shut Off? | No | Yes | | Patient Override Control? | Yes | Yes | | Indicator Display | | | | On/Off Status? | Yes | Yes | | Low Battery?<br>Voltage/Current Level? | Yes | Yes | | Timer Range (minutes) | 30 minutes | 20 minutes | | ON Time (seconds) | 1-5 sec in 1 sec steps | 1-5 sec in 0.5 sec steps | | OFF Time (seconds) | 1-10 sec in 1 sec steps | 2-10 sec in 1 sec steps | | Net Charge (µC per pulse) | 16.7-33Hz | 16.7-33Hz | | | 25-300 microseconds | 100-300 μS | | Frequency (Pulses per second) | Pules width adjustable in following<br>discrete steps:<br>25/50/100/150/200/250/300μS | Pules width adjustable in following<br>discrete<br>steps:100/150/200/250/300uS | | Pulse width | 25-300 microseconds | 100-300 μS | | | Pules width adjustable in following<br>discrete steps:<br>25/50/100/150/200/250/300μS | Pules width adjustable in following<br>discrete steps:<br>100/150/200/250/300uS | | | 41.2µC @ 500 ohm | 27.0μC @ 500 ohm | | Max Phase Charge(μC) | 28µC @ 1K ohm | 27.0µC @ 1K ohm | | Max Current Density,<br>(mA/cm²) | 1.8mA/cm² (500 ohm) | 0.7mA/cm² (500 ohm) | | Maximum Power Density,<br>(W/cm²) | 0.0128W/cm² (500 ohm) | 0.005W/cm² (500 ohm) | | Specification | Predicate Device | Proposed Device | | Max Output Voltage | unknown@ 500 ohm | 45V @ 500 ohm | | | 121V@ 1 K ohm | 90V @ 1 K ohm | | | unknown @ 2 K ohm | 156V @ 2 K ohm | | | unknown @ 10 K ohm | 158V@ 10 K ohm | | Max Output Current | 20.7mA rms@ 500 ohm | 14mA rms@ 500 ohm | | | unknown @ 2 K ohm | 11mA rms@ 2 K ohm | | | unknown @ 10 K ohm | 2.2mA rms@10 K ohm | | Burst Mode | | | | -Pulses per burst | Burst length and PPS dependent | Burst length and PPS dependent | | -Bursts per second | Depends on ON and OFF times | Depends on ON and OFF times | | -Burst duration<br>(seconds)<br>-Duty Cycle [Line (b) x Line (c)] | 1 to 5 sec in 1 sec steps Depends on<br>ON and OFF times | 1 to 5 sec in 1 sec steps Depends on<br>ON and OFF times | | Stimulation Trigger Source | Tilt Sensor or Foot Sensor | Tilt Sensor | | Anatomical Sites | Limb | Limb…