NXPRO Neuromuscular Electrical Stimulation Device

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October 11, 2019 NeuX Technologies, Inc. % Christopher Devine, PhD President Devine Guidance International, Inc. 4730 South Fort Apache Road, Suite 300 Las Vegas, Nevada 89147 Re: K191181 Trade/Device Name: NXPRO Neuromuscular Electrical Stimulation Device Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: NGX Dated: July 12, 2019 Received: July 17, 2019 Dear Dr. Christopher Devine: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. {1}------------------------------------------------ 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. For Vivek Pinto, Ph.D. Director (Acting) DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K191181 Device Name NXPRO Neuromuscular Electrical Stimulation Device #### Indications for Use (Describe) The Neux NXPRO Neuromuscular Electrical Stimulation Device is intended for the stimulation of healthy muscles in order to improve or facilitate muscle performance. The Neux NXPRO is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind. The NeuX NXPRO is not designed for use on injured or ailing muscles and its use on such muscles is contraindicated. The NeuX NXPRO's electrical impulses allow triggering action potential on motor nerves (excitations). These excitations of motor neurons are transmitted to the motor endplate where they generate mechanical muscle fiber responses that correspond to muscle work. Depending on the parameters of the electrical impulses (pulse frequency, duration of contraction, duration of rest, & total session duration), different types of muscle work can be imposed on the stimulated muscles. The various types of muscle work that the NeuX NXPRPO can impose on the stimulated muscles are able to improve or facilitate muscle performance. The NeuX NXPRO is considered a technique of muscle training. Type of Use (Select one or both, as applicable) | <span></span> | Prescription Use (Part 21 CFR 801 Subpart D) | <span></span> | Over-The-Counter Use (21 CFR 801 Subpart C) | |---------------|----------------------------------------------|---------------|---------------------------------------------| | <span></span> | <div></div> | <span></span> | <div></div> | #### 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}------------------------------------------------ # Section Five (5) - 510(k) Summary # 510(k) SUMMARY [As Required by 21 CFR 807.92(c)] | Submitter's Name & Address: | NeuX Technologies, Inc.<br>3802 Spectrum Blvd.<br>Suite 112F<br>Tampa, FL 33612 | |-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------| | Contact Person: | Christopher J. Devine, Ph.D.<br>Telephone (702) 939-5507<br>Mobile (702) 917-0585<br>Chris.devine@devineguidanceinternational.com | | Date Summary Prepared: | 11 October 2019 | | Device Name: | Trade/Proprietary Name - NXPRO Neuromuscular<br>Electrical Stimulation Device | | | Common/Usual Name – Powered Muscle Stimulator | | | Classification Name - Powered Muscle Stimulator<br>(890.5850), Product Code NGX | | | Predicate Device – ARP Manufacturing – ARP Sport<br>Device (K093999) | | | Reference Device - N/A | {4}------------------------------------------------ # Device Description The NeuX NXPRO Neuromuscular Electrical Stimulation Device generates electrical impulses the result in a triggering action potential on motor neurons of motor nerves (excitations). These excitations of motor neurons are transmitted to the muscle fibers through the system electrodes where they generate mechanical muscle fiber responses that correspond to muscle work. Depending on the parameters of the electrical impulses: (a) pulse frequency; (b) duration of muscle contraction; (c) duration of rest; and (d) total session duration; different types of muscle work can be imposed on the stimulated muscles. The various types of muscle work that the NXPRO can impose on the stimulated muscles are able to improve or facilitate muscle performance. Note: the application of the NXPRO is considered a technique of muscle training. #### Intended Use The NeuX NXPRO Neuromuscular Electrical Stimulation Device is intended for the stimulation of healthy muscles in order to improve or facilitate muscle performance. The NeuX NXPRO is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind. The NeuX NXPRO is not designed for use on injured or ailing muscles and its use on such muscles is contraindicated. The NeuX NXPRO's electrical impulses allow triggering action potential on motor neurons of motor nerves (excitations). These excitations of motor neurons are transmitted to the muscle fibers via the motor endplate where they generate mechanical muscle fiber responses that correspond to muscle work. Depending on the parameters of the electrical impulses (pulse frequency, duration of contraction, duration of rest, & total session duration), different types of muscle work can be imposed on the stimulated muscles. {5}------------------------------------------------ The various types of muscle work that the NeuX NXPRPO can impose on the stimulated muscles are able to improve or facilitate muscle performance. The NeuX NXPRO is considered a technique of muscle training. ## Technological Characteristics/Principles of Operation ## Technological Characteristics ## Storage and Transportation Conditions The NXPRO may be used either indoors or outdoors. However, if used outdoors, the NXPRO should not be exposed to rain, snow, condensing fog or condensing humidity, and should not be subjected to long-term exposure to direct sunlight. ## Storage Environmental Conditions: - - 10°C to +60°C - +5°C to +35°C at a relative humidity up to 90%, non-condensing ● - +35°C to 70°C at a water vapor pressure up to 50 hPa . ## Operating Environmental Conditions: - · +5°C to +40°C - Relative humidity range of 15% to 90%. non-condensing, but not requiring a . water vapor partial pressure greater than 50 hPa - Atmospheric pressure range of 700 hPa to 1060 hPa ## Disposal: - . Electronics must be disposed of in compliance with relevant national regulatory requirements. Note: the NeuX NXPRO device and components used in the manufacture of the NXPRO are RoHS compliant. ## Standards: {6}------------------------------------------------ - . The NXPRO complies with current medical standards. - The NXPRO also complies with the IEC 60601-1 standard on general safety . requirements for electro-medical devices, IEC 60601-1-11 general requirements for basic safety and essential performance, ty requirements for electro-medical devices, the IEC 60601-1-2 standard on electromagnetic compatibility, and the IEC 60601-2-10 standard on particular safety requirements for nerve and muscle stimulators. # Output Waveform: - A continuous, medium amplitude, sensory waveform, periodically broken by high . amplitude, rectangular stimulation pulses. Transformer isolation ensures that no direct current (DC) is present in the outputs. - Channels: 2 channels are electrically isolated from each other and floating. . # Output Specifications: - Main Pulse duration 400us . - . Main Pulse Shape: Rising and falling Exponential (RC) with a time constant of 50 microseconds - Main Pulse Frequency 50 to 250 pulses per second (manually adjustable) ● - Maximum Main Pulse Intensity: 75V peak-to-peak with 500-Ohm load - Waveform Ramp Up Time: 2.0 seconds ● - Waveform Ramp Down Time: 1.0 seconds - Output Power - 0.707 watts RMS Max with 500-Ohm load - Polarity Waveform polarity can be inverted . - Sensory Waveform Shape: Exponential (RC) ● - Sensory Waveform Frequency 10kHz (fixed) ● - Maximum Sensory Waveform Intensity: 14.0V peak-to-peak with 500-Ohm load . ## Unit Characteristics (without the stand): - Body: Plastic . - Weight: 1.59kg / 3.5lb . #### 510(k) Summary (NeuX – NXPRO Device) {7}------------------------------------------------ - . Length: 240mm / 9.45in - . Width: 160mm / 6.30in - Height: 40mm / 1.57in ● ## Power Supply - +12Vdc, 3A, AC to DC power supply. P/N: PEAMD36-12-B2 . ## Electromagnetic Compatibility (EMC) The NXPRO has been tested for EMC Class B emissions per IEC 60601-1-2:2014. The NXPRO is suitable for use in any establishment, including a private dwelling and a place connected directly to the low voltage mains, which powers residential buildings. Please observe the following precautions when operating the NXPRO. - Operation in close proximity to shortwave or microwave therapy may produce instability . in the output of the device. - . Simultaneous connection to high-frequency surgical equipment may result in burns at the site of stimulator electrodes and possible damage to the device. - . To ensure proper use and to mitigate the possibility of interference, avoid placing in close proximity to other electromagnetic devices. | Load Resistance | Output Voltage | Watt RMS to<br>Load | |-----------------|----------------|---------------------| | 500 ohm | 18.8 Vrms | 0.707W | | 2 Kohm | 33.7 Vrms | 0.568W | | 10 Kohm | 45.5 Vrms | 0.207W | ## Maximum Output Voltage & Power vs. Load Resistance ## Principles of Operation The principle of electrostimulation is to stimulate nerve fibers by means of electrical impulses transmitted by electrodes. Neuromuscular Electrical Stimulation (NMES) is applied to the muscles and specifically targets the motor nerve with electrical pulses that can activate the junction between the nerves and muscles being treated and produce a contraction of the muscle fibers. A stimulation-induced contraction can give an effective workout for the muscle. The electrical pulses generated by the NXPRO stimulator are high quality pulses - offering safety, 510(k) Summary (NeuX – NXPRO Device) {8}------------------------------------------------ comfort and efficiency. The quantity and the benefits obtained depend on the stimulation parameters. #### Non-Clinical Performance Testing Performance testing consisted of bench testing that has demonstrated that the output of the NeuX NXPRO Neuromuscular Electrical Stimulation Device provided the same performance characteristics as the predicate device. The system successfully passed all tests required by IEC 60601-1, 3td Edition. #### Non-clinical Safety Tests The NeuX NXPRO Neuromuscular Electrical Stimulation Device has been designed and constructed to meet the following electrical and mechanical safety standards: - IEC 60601-1: Medical electrical equipment Part 1: General requirements o for basic safety and essential performance (3td edition) - IEC 60601-1-2: Medical electrical equipment Part 1-2: General o requirements for safety and essential performance - Collateral Standard: Electromagnetic disturbances - requirements and tests - IEC 60601-1-11: Medical electrical equipment Part 1-11: o 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: Medical equipment Part 2-10: O Particular requirements for the basic safety and essential performance of nerve and muscle stimulators There are no significant functional differences between the NXPRO Neuromuscular Electrical Stimulation Device and the ARP POV Sport Device. In accordance with FDA recommended guidance, NeuX Technologies has provided a detailed comparison of the NXPRO {9}------------------------------------------------ Neuromuscular Electrical Stimulation Device versus the previously cleared ARP POV Sport Device in Tables 5.1 and 5.2. | Device Name | NXPRO Device | Predicate<br>ARP Sport | Equivalency<br>Discussion | |-------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------| | 510(k) Number | - | K093999 | - | | Device Name, Model | NXPRO | POV Sport | - | | Manufacturer | NeuX Technologies | Arp Manufacturing | - | | Product Code | NGX | NGX | Identical | | Regulation | 890.5850 | 890.5850 | Identical | | Device Class | 2 | 2 | Identical | | Indications For Use | The NeuX NXPRO<br>Neuromuscular<br>Electrical Stimulation<br>Device is intended for<br>the stimulation of<br>healthy muscles in order<br>to improve or facilitate<br>muscle performance.<br><br>The NeuX NXPRO is not<br>intended to be used in<br>conjunction with<br>therapy or treatment of<br>medical diseases or<br>medical conditions of<br>any kind. The NeuX<br>NXPRO is not designed<br>for use on injured or<br>ailing muscles and its<br>use on such muscles is<br>contraindicated.<br><br>The NeuX NXPRO's<br>electrical impulses allow<br>triggering action<br>potential on motor | The ARP POV Sport is<br>intended to stimulate<br>healthy muscles in<br>order to improve or<br>facilitate muscle<br>performance.<br><br>The ARP POV Sport is<br>not intended to be used<br>in conjunction with<br>therapy or treatment of<br>medical diseases or<br>medical conditions of<br>any kind. The ARP POV<br>Sport is not designed<br>for use on injured or<br>ailing muscles and its<br>use on such muscles is<br>contraindicated.<br><br>The POV Sport's<br>electrical impulses<br>allow triggering action<br>potential on motor<br>neurons of | Equivalent | | Device Name | NXPRO Device | Predicate<br>ARP Sport | Equivalency<br>Discussion | | | neurons of motor | Motor nerves | | | | nerves (excitations). | (excitations). These | | | | These excitations of | excitations of motor | | | | motor neurons are | neurons are | | | | transmitted to the | transmitted to the | | | | muscle fibers via the | muscle fibers via the | | | | motor endplate where | motor endplate where | | | | they generate | they generate | | | | | mechanical muscle fiber mechanical muscle fiber | | | | responses that | responses that | | | | correspond to muscle | correspond to muscle | | | | | work. Depending on the work. Depending on the | | | | parameters of the | parameters of the | | | | electrical impulses | electrical impulses | | | | (pulse frequency, | (pulse frequency, | | | | | duration of contraction, duration of contraction, | | | | duration of rest, & total duration of rest, total | | | | | session duration), | session duration), | | | | different types of | different types of | | | | muscle work can be | muscle work can be | | | | imposed on the | imposed on the | | | | stimulated muscles. | stimulated muscles. | | | | The various types of | The various types of | | | | muscle work that the | muscle work that the | | | | NeuX NXPRPO can<br>impose on the | POV Sport can impose<br>on the stimulated | | | | stimulated muscles are | muscles are able to | | | | able to improve or | improve or facilitate | | | | facilitate muscle | muscle performance. | | | | performance. The NeuX The POV Sport is | | | | | NXPRO is considered a | considered a technique | | | | technique of muscle<br>training. | of muscle training. | | | Power Source(s) | External DC Power<br>Supply | Not Publically<br>Available | Equivalent | | - Method of Line Current Isolation | Power Supply Isolation | Not Publically<br>Available | Identical | | - Patient Leakage Current | <100μA | Not Publically<br>Available | Identical | | - Normal condition | <100μA | Not Publically | Identical | | Device Name | NXPRO Device | Predicate<br>ARP Sport | Equivalency<br>Discussion | | | | Available | | | - Single fault condition | $<100μA$ | Not Publically<br>Available…