g.Estim FES

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October 29, 2020 g.tec medical engineering GmbH Christoph Guger CEO Siemingerstrasse 14 Schiedlberg, 4521 Austria Re: K200088 Trade/Device Name: g.Estim FES Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: IPF, GZI Dated: July 29, 2020 Received: July 31, 2020 Dear Dr. Guger: 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. 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 {1}------------------------------------------------ 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 (OS) 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 mediation-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, Amber Ballard, PhD Assistant Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ #### Indications for Use 510(k) Number (if known) K200088 Device Name g.Estim FES Indications for Use (Describe) Neuromuscular electronic stimulator indical supervision for adjunctive therapy in the treatment of medical diseases and conditions. As powered muscle stimulator: - · Temporary Relaxation of muscle spasms - · Prevention or retardation of disuse atrophy - · Increasing local blood flow in the treatment area - Muscle re-education - Prevention of post-surgical phlebo-thrombosis through immediate stimulation of calf muscles - · Maintaining or increasing range of motion As external functional neuromuscular stimulator: - · Helps to relearn voluntary motor functions of the extremities The device must be used by trained and qualified personnel. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------| | <div> <span style="text-decoration: overline;">X</span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <span>☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </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 The following 510(k) summary has been prepared pursuant to requirements specified in 21CFR 807.92(a). 807.92(a)(1) #### Submitter Information g.tec medical engineering GmbH Sierningstrasse 14 4521 Schiedlberg Austria | Phone: | ++43 (7251) 22240-12 | |--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------| | Fax: | ++43 (7251) 22240-39 | | Contact Person: | Christoph Guger | | Date: | 28.10.2020 | | 807.92(a)(2) | | | Trade Name: | g.Estim FES | | Common Name: | Electrical muscle stimulator | | Classification Names(s): | Powered muscle stimulator<br>(per 21 CFR section 21 CFR 890.5850)<br>External functional neuromuscular stimulator<br>(per 21 CFR section 21 CFR 882.5810) | | Product Code: | IPF, GZI | 807.92(a)(3) #### Predicate Devices/ Reference Devices | | Secondary Predicate | Reference | Primary Predicate | |--------------------------------|-----------------------------|------------------------|--------------------------------------| | Manufacturer: | Mettler Electronics<br>Corp | Thought Technology Ltd | Otto Bock Healthcare<br>Product GmbH | | Trade Name | SYS*STIM 208/208A | MyoTRac Infiniti | STIWELL med 4 | | 510(k) document control number | K031017 | K053266 | K080950 | g.tec medical engineering GmbH, Sierningstrasse 14, 4521 Schiedlberg, Austria, Europe, Tel .: +43 7251 22240, Fax: +43 7251 22240-39, office@gtec.at, www.gtec.at {4}------------------------------------------------ 807.92(a)(4) #### Device Description The g.Estim FES is a constant-current powered muscle stimulator that can deliver rectangular electrical pulses with alternating polarities, lengths and amplitudes, or trains of such pulses. The device is battery supplied and can be connected via USB to a computer. It can be triggered via software or with a hand or foot switch. The programmable parameters of the stimulator are: frequency, current, pulse width, ramp up and down and session length. The phase width and the stimulation current can be changed during stimulation; the other parameters can only be changed when the stimulator is stopped. Stimulation can be started and stopped using a configurable ramp for smooth on- and offsets. A LED shows the stimulus onset. The system consists of the stimulator, a USB connector cable to connect the device to a host computer, patient cables for electrode connection and a software package including the driver and a graphical user interface. Optional trigger out cables and trigger in cables as well as a hand switch and foot switch to trigger the stimulator are available. The device stops stimulation if an over-load is detected or the electrodes are disconnected. A foot switch or hand switch can be used to trigger the stimulator. The device can perform an impedance measurement to check the electrodes impedance before the stimulation is done and can measure the actual stimulation current when a stimulation is done. The impedance measurement is done quickly so that the stimulation can rapidly be performed. If a high impedance is detected the stimulator does not stimulate. g.Estim FES works in the same manner as the approved predicate devices. {5}------------------------------------------------ 807.92(1)(5) #### Indications for Use Neuromuscular electronic stimulator indicated for use under medical supervision for adjunctive therapy in the treatment of medical diseases and conditions. As powered muscle stimulator: - Temporary Relaxation of muscle spasms . - Prevention or retardation of disuse atrophy . - Increasing local blood flow in the treatment area . - · Muscle re-education - . Prevention of post-surgical phlebo-thrombosis through immediate stimulation of calf muscles - Maintaining or increasing range of motion . As external functional neuromuscular stimulator - · Helps to relearn voluntary motor functions of the extremities The device must be used by trained and qualified personnel. {6}------------------------------------------------ #### 807.92(a)(6) #### Technological Characteristics | | Item | g.tec medical engineering<br>GmbH<br>g.Estim FES<br>this Submission | Mettler Electronics Corp.<br>SYS*STIM 208/208A<br>K031017 for IPF<br>(secondary) | Thought Technology Ltd<br>MyoTrac Infiniti K053266<br>for IPF (reference) | Otto Bock Healthcare<br>Product GmbH<br>STIWELL med4 K080950<br>for IPF and GZI (primary) | Comments | 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| 1. | Intended use | Neuromuscular electronic<br>stimulator indicated for use<br>under medical supervision for<br>adjunctive therapy in the<br>treatment of medical diseases<br>and conditions. | Powered Muscle Stimulation | Muscle Stimulation and EMG<br>Biofeedback | Neuromuscular electronic<br>stimulator indicated for use<br>under medical supervision for<br>adjunctive therapy in the<br>treatment of medical diseases<br>and conditions | Equivalent with predicate<br>K080950, which covers all<br>indications claimed also by this<br>submission (including the<br>indications of the other<br>predicate devices).<br>Indications for product code | | 2. | Indication for<br>use | As powered muscle<br>stimulator:<br>• Temporary Relaxation<br>of muscle spasms<br>• Prevention or retardation<br>of disuse atrophy<br>• Increasing local blood<br>flow in the treatment<br>area<br>• Muscle re-education<br>• Prevention of post-<br>surgical phlebo-<br>thrombosis through<br>immediate stimulation<br>of calf muscles<br>• Maintaining or<br>increasing range of<br>motion<br>As external functional<br>neuromuscular stimulator:<br>• Helps to relearn<br>voluntary motor<br>functions of the<br>extremities<br>The device must be used by<br>trained and qualified personnel. | • Temporary Relaxation<br>of muscle spasms<br>• Prevention or retardation<br>of disuse atrophy<br>• Increasing local blood<br>flow in the treatment<br>area<br>• Muscle re-education<br>• Prevention of post-<br>surgical phlebo-<br>thrombosis through<br>immediate stimulation<br>of calf muscles<br>• Maintaining or<br>increasing range of<br>motion<br>• Symptomatic relief of<br>chronic intractable pain,<br>acute post traumatic<br>pain or acute post<br>surgical pain | • Relaxation of muscle<br>spasms<br>• Prevention or retardation<br>of disuse atrophy<br>• Increasing local blood<br>circulation<br>• Muscle re-education<br>• Immediate post-surgical<br>stimulation of calf<br>muscles to prevent<br>venous thrombosis<br>• Maintaining or<br>increasing range of<br>motion<br>• Biofeedback, Relaxation<br>& Muscle Re-Education | As powered muscle<br>stimulator:<br>• Relaxation of muscle<br>spasm<br>• Prevention or retardation<br>of disuse atrophy<br>• Increasing local blood<br>circulation<br>• Muscle re-education<br>• Immediate post-surgical<br>stimulation of calf<br>muscles to prevent<br>venous thrombosis<br>• Maintaining or<br>increasing range of<br>motion<br>As external functional<br>neuromuscular stimulator:<br>• Helps to relearn<br>voluntary motor<br>functions of the<br>extremities<br>As a transcutaneous<br>electrical nerve stimulator<br>for pain relief:<br>• Symptomatic relief and<br>management of chronic<br>(long-term), intractable<br>pain | IPF (green) are equivalent in<br>safety and effectiveness.<br>Indications for product code<br>GZI (blue) are identical.<br>Additional product codes of the<br>predicate devices not claimed<br>by the current submission<br>(orange) are:<br>• reduction of pain (GZJ),<br>• biofeedback (HCC)<br>• incontinence treatments<br>(KPI) | | Item | g.tec medical engineering<br>GmbH<br>g.Estim FES | Mettler Electronics Corp.<br>SYS*STIM 208/208A<br>K031017 for IPF | Thought Technology Ltd<br>MyoTrac Infiniti K053266<br>for IPF | Otto Bock Healthcare<br>Product GmbH<br>STIWELL med4 K080950 | Comments | | | | this Submission | | | for IPF and GZI | | | | | | | | Adjunctive treatment in<br>the management of post-<br>surgical pain and post<br>traumatic acute pain<br>As a biofeedback device: Biofeedback, relaxation<br>and muscle re-education<br>purposes<br>As a nonimplanted electrical<br>continence device: Acute and ongoing<br>treatment of stress, urge<br>or mixed urinary<br>incontinence and where<br>the following results<br>may improve urinary<br>control: Inhibition of the<br>detruser muscles<br>through reflexive<br>mechanisms and<br>strengthening of pelvic<br>floor muscles Incontinence treatment<br>for assessing EMG<br>activity of the pelvic<br>floor and accessory<br>muscles such as the<br>abdominal and the<br>gluteus muscles | | | | | Item | g.tec medical engineering<br>GmbH<br>g.Estim FES<br>This Submission | Mettler Electronics Corp.<br>SYS*STIM 208/208A<br>K031017<br>(secondary predicate) | Thought Technology Ltd<br>MyoTrac Infiniti K053266<br>(reference) | Otto Bock Healthcare<br>Product GmbH<br>STIWELL med4 K080950<br>(primary predicate) | Comments | | 3. | Power sources | USB and battery, 2 x 9 V | 110V AC, 60Hz +-10% | not publicly available | Battery Pack Li-ion 11,1 V | g.Estim FES is powered by a<br>combination of batteries and<br>USB power. The applied part is<br>powered by conventional<br>batteries and fulfills IEC 60601-<br>1, therefore it is equivalent in<br>safety and effectiveness. | | 4. | Line current<br>isolation | The applied part is powered by<br>conventional batteries. The<br>applied part is isolated from the<br>rest of the circuit by 2 MOP<br>according to IEC 60601-1. | AC power supply is converted<br>to DC power supply through<br>transformer. Hence there is an<br>insulation of mains from<br>circuitry. From circuitry to<br>output again, there is insulation<br>through the transformer, there<br>by double separation between<br>mains and the human body. | not publicly available | Medical Class II Power<br>Adapter- Mascot (12,6 VDC-<br>15,1W)) | State of the art isolation strategy<br>- equivalent in safety and<br>effectiveness. | | 5. | Patient leakage<br>current | Type BF according to IEC<br>60601-1<br>NC max: < 1 μA<br>(IEC level NC <100 µA)<br>SFC max: 2.6 µA<br>(IEC level SFC <500 µA) | NC <100 µA<br>SFC < 300 µA | not publicly available | NC NA (Battery)<br>SFC NA (Battery) | Below IEC standard thresholds<br>and therefore equivalent in<br>safety and effectiveness. | | 6. | Number of<br>output modes | 1 | 3:<br>Tetanize<br>Surge<br>Pulse | not publicly available | 1 | g.Estim FES allows a similar<br>parameter range as MyoTrac<br>Infinity and STIWELL med 4<br>and is equivalent in safety and<br>effectiveness. | | 7. | Number of<br>output channels | 1 | 1 | not publicly available | 4 | g.Estim FES provides one<br>channel but is equivalent in<br>safety and effectiveness. | | 8. | Number of<br>EMG (input)<br>Channels | NA | NA | not publicly available | 2 | g.Estim FES provides no EMG<br>channel and does not claim<br>product category HCC, so<br>equivalent in safety and<br>effectiveness for claimed | | | Item | g.tec medical engineering<br>GmbH<br>g.Estim FES<br>This Submission | Mettler Electronics Corp.<br>SYS*STIM 208/208A<br>K031017 | Thought Technology Ltd<br>MyoTrac Infiniti K053266 | Otto Bock Healthcare<br>Product GmbH<br>STIWELL med4 K080950 | Comments | | 9. | EMG sensitivity | NA | NA | not publicly available | 1 μV | g.Estim FES provides no EMG<br>channel and does not claim<br>product category HCC, so<br>equivalent in safety and<br>effectiveness for claimed<br>product codes. | | 10. | EMG sampling<br>Rate | NA | NA | not publicly available | 3 kHz | g.Estim FES provides no EMG<br>channel and does not claim<br>product category HCC, so<br>equivalent in safety and<br>effectiveness for claimed<br>product codes. | | 11. | EMG detection<br>(bipolar/monop<br>olar) | NA | NA | Bipolar | Bipolar | g.Estim FES provides no EMG<br>channel and does not claim<br>product category HCC, so<br>equivalent in safety and<br>effectiveness for claimed<br>product codes. | | 12. | EMG range(μV) | NA | NA | 0-2000μV | 1-2000μV | g.Estim FES provides no EMG<br>channel and does not claim<br>product category HCC, so<br>equivalent in safety and<br>effectiveness for claimed<br>product codes. | | 13. | EMG bandwidth | NA | NA | 20-500Hz | 70-480Hz | g.Estim FES provides no EMG<br>channel and does not claim<br>product category HCC, so<br>equivalent in safety and<br>effectiveness for claimed<br>product codes. | | 14. | EMG signal<br>processing (eg.<br>RMS) | NA | NA | RMS (root mean square) | AVR (average reached value) | g.Estim FES provides no EMG<br>channel and does not claim<br>product category HCC, so<br>equivalent in safety and<br>effectiveness for claimed<br>product codes. | | 15. | Synchronous or<br>alternating<br>channels | NA | NA | not publicly available | Alternating | g.Estim FES provides one<br>channel but equivalent in safety<br>and effectiveness. | | | Item | g.tec medical engineering<br>GmbH<br>g.Estim FES<br>This Submission | Mettler Electronics Corp.<br>SYS*STIM 208/208A<br>K031017 | Thought Technology Ltd<br>MyoTrac Infiniti K053266 | Otto Bock Healthcare<br>Product GmbH<br>STIWELL med4 K080950 | Comments | | 16. | Method of<br>channel<br>isolation | The applied part is isolated<br>from the rest of the circuit by 2<br>MOP according to IEC 60601-<br>1. | In this system, all the outputs<br>are isolated from each other,<br>they have their own amplifiers<br>which are independent from<br>neighboring channels or<br>outputs. The only common<br>thing between the outputs is the<br>microprocessor and the power<br>supply. | not publicly available | Transformer inductive couplers | State of the art isolation strategy<br>- provides equivalent safety and<br>effectiveness. | | 17. | Regulated<br>current or<br>regulated<br>voltage | Regulated voltage, constant<br>current…