Legend Pro DMA

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. October 21, 2021 Pollogen, Ltd % Amaya De Levie RA Director Benjamin L. England and Associates 810 Landmark Dr. Suite 126 Glen Burnie, Maryland 21061 Re: K200545 Trade/Device Name: Legend Pro DMA Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: NGX Dated: September 14, 2021 Received: September 22, 2021 Dear Amaya De Levie: 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 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. Vivek Pinto, PhD 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) K200545 Device Name Legend Pro DMA #### Indications for Use (Describe) Legend Pro DMA is intended for muscle conditioning to stimulate healthy muscles. Legend Pro DMA is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind. Legend Pro DMA is intended to be operated by a trained professional who is present to monitor treatment | Type of Use (Select one or both, as applicable) | |--------------------------------------------------------------------------------------------------------| | <label><input checked="checked" type="checkbox"/> Prescription Use (Part 21 CFR 201 Subpart D)</label> | | <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 201 Subpart C)</label> | > 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) SUMMARY #### K200545 | Applicant Name: | Udi Russo<br>Pollogen Ltd.<br>6 Kaufman Street<br>Tel Aviv, Tel-Aviv, ISRAEL 6801298<br>Phone: +972 3 5104110<br>Fax: +972 3 5104112 | |----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person: | Amaya De Levie<br>Lumenis Ltd.<br>6 Hakidma Street PO Box 240,<br>Yokneam Industrial Park<br>Yokneam 2069204<br>Israel<br>Phone: +972-549599073<br>E-mail: Amaya.delevie@gmail.com | | Date Prepared: | October 20, 2021 | | Trade Name: | Legend Pro DMA | | Classification Name: | Stimulator, Muscle, Powered, For Muscle Conditioning | | Product Code: | NGX | | Device Class: | Class II | | Regulation Number: | 21 CFR 890.5850 | | Panel: | Physical Medicine | | Predicate Device: | Body System (K182440) | | Reference Device | AK Body Toning Device (K152420) | #### Intended Use/ Indications for Use: Legend Pro DMA is intended for muscle conditioning to stimulate healthy muscles. Legend Pro DMA is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind. Legend Pro DMA is intended to be operated by a trained professional who is present to monitor treatment. {4}------------------------------------------------ # Device Description: The Legend Pro DMA generates a sequence of electrical pulses which are delivered to the skin overlaying the muscles intended to be stimulated. The Legend Pro DMA consists of a floormounted, rolling System Console that generates voltage output delivered though metal electrodes in the three different DMA Applicators. The System Console generates electrical pulses, and delivers modulated low frequency rectangular biphasic waveforms via electrodes incorporated in different Applicators connected to the System Console: - . LP DMA Applicator No. 1 for large Areas (includes 6 stainless-steel equidistant electrodes) - . LP DMA Applicator No. 2 for Medium areas (includes 3 stainless-steel equidistant electrodes) - LP DMA Applicator No. 3 for Small Areas (includes 3 stainless-steel equidistant ● electrodes) The Legend Pro DMA is controlled by a proprietary embedded SW. The system SW provides the treatment parameters. The hardware (HW) then implements the actual pulse generation according to the parameters provided by the software. Via the GUI in the System Console, the physician selects the Applicator according to the size of the area being treated and the treatment parameters (Frequency, % Height/Amplitude, pulse width and Treatment Duration). During the treatment session, the operator moves the Applicator across the skin that is lubricated with glycerine. | Parameter | Legend Pro DMA | Principal<br>Predicate Device | Reference Device | Same/<br>Similar/Different | |---------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) Number | K200545 | K182440 | K152420 | N/A | | Device Name<br>and Model | Legend Pro DMA | Body System | AK Body Toning<br>Device | N/A | | Manufacturer | Pollogen | A-1 Engineering | AK Beauty Enterprises,<br>LLC | | | Product Code | NGX | NGX | NGX | Same | | Type of Use | Prescription Use<br>(Part 21 CFR 801<br>Subpart D) | Prescription Use<br>(Part 21 CFR 801<br>Subpart D) | Over-The-Counter Use<br>(21 CFR 801 Subpart<br>C) | Same | | Intended Use | Legend Pro DMA is<br>intended for<br>muscle<br>conditioning to<br>stimulate healthy<br>muscles. | The Body System<br>is intended for<br>muscle<br>conditioning to<br>stimulate healthy<br>muscles. | The AK Body Toning<br>Device is intended for<br>use by healthy persons<br>to apply<br>transcutaneous<br>electrical muscle<br>stimulation<br>(EMS) through skin-<br>contact electrodes in<br>order to improve or<br>facilitate muscle<br>performance. | Same Intended use as<br>the Predicate. Similar<br>to the Reference | | | Legend Pro DMA is<br>not intended to be<br>used in conjunction<br>with therapy or | The Body System<br>is not intended to<br>be used in<br>conjunction with | | | | Parameter | Legend Pro DMA | Principal<br>Predicate Device | Reference Device | Same/<br>Similar/Different | | 510(k) Number | K200545 | K182440 | K152420 | | | Device Name<br>and Model | Legend Pro DMA | Body System | AK Body Toning<br>Device | N/A | | | treatment of<br>medical diseases<br>or medical<br>conditions. Legend<br>Pro DMA is<br>intended to be<br>operated by a<br>trained<br>professional who is<br>present to monitor<br>treatment. | therapy or<br>treatment of<br>medical diseases<br>or medical<br>conditions of any<br>kind. The Body<br>System is<br>intended to be<br>operated by a<br>trained<br>professional who<br>is present to<br>monitor treatment. | | | | Mode of<br>Operation | Application of<br>transcutaneous<br>electrical muscle<br>stimulation<br>(EMS) through skin-<br>contact electrodes | Application of<br>transcutaneous<br>electrical muscle<br>stimulation<br>(EMS) through<br>skin-contact<br>electrodes | Application of<br>transcutaneous<br>electrical muscle<br>stimulation<br>(EMS) through skin-<br>contact electrodes | Same mode of<br>operation as the<br>Predicate and<br>Reference | | Mode of<br>application | Metal (Stainless<br>steel) electrodes in<br>the System<br>Applicator emit<br>electric energy to the<br>skin while the system<br>applicator is rolled<br>across the treatment<br>area | Fixed self-<br>adhesive, gelled<br>pad applicators<br>attached to the skin<br>for muscle<br>conditioning. | Metal electrodes in the<br>device emit electric<br>energy to the skin<br>while the device is<br>rolled across the<br>treatment area | Different from the<br>predicate (moving<br>electrodes vs. fixed<br>electrodes) but similar<br>to the Reference<br>device. See Section<br>12.4. | | Body<br>Application<br>Areas | Body | Body | Not publicly available | | | Power Source(s) | 110-240 V<br>50-60 Hz | 110-240 vac (AC<br>wall plug-in)<br>50 - 60 Hz | Battery<br>3 x 1.5 V<br>AAA batteries | Same as the<br>Predicate. Different<br>from the Reference<br>device | | Method of Line<br>Current Isolation | Medical Power<br>Supply, Transformer<br>in output stage | Power Supply<br>isolation | N/A - Internal Power<br>Type BF | Similar to the<br>Predicate | | Patient Leakage<br>Current | | | | | | - Normal<br>Condition<br>(μΑ) | 1.5 μΑ | .05 μΑ | N/A (battery operated<br>device) | Similar to the Predicate | | - Single Fault<br>Condition<br>(μΑ) | 40 μΑ | 5 μΑ | N/A (battery operated<br>device) | Similar to the Predicate<br>and below 500<br>μΑ<br>value in guidance. | | Number of<br>Output Modes | 1 | 5 | 1 | Different. Modes are<br>comparable. No issues<br>of safety or<br>effectiveness | | Number of<br>Output<br>Channels: | 1 | 16 | 1 | Different. Each session<br>will use one of three<br>Applicators. No<br>difference in safety or<br>effectiveness. | | Parameter | Legend Pro DMA | Principal<br>Predicate Device | Reference Device | Same/<br>Similar/Different | | 510(k) Number | K200545 | K182440 | K152420 | | | Device Name<br>and Model | Legend Pro DMA | Body System | AK Body Toning<br>Device | N/A | | | | | | Applicator is moved to<br>cover entire treatment<br>area. | | Synchronous or<br>Alternating? | N/A Single output<br>channel. | Synchronous | N/A Single channel. | Different. Not required<br>for one output channel | | Method of<br>Channel<br>Isolation | N/A Single output<br>channel. | Power Supply<br>isolation | N/A Single channel. | Different. Single<br>channel does not<br>require channel<br>isolation. | | Regulated<br>Current or<br>Regulated<br>Voltage? | Voltage | Current and Voltage | Voltage | Similar to the<br>Predicate. Different<br>form the Reference<br>device | | Software/Firmwa<br>re/Microprocess<br>or Control? | Yes | No | No | Different. The software<br>is validated. The<br>output from each is<br>comparable. Does not<br>directly affect safety<br>and effectiveness. | | Automatic<br>Overload Trip? | No | Yes | No | Same as the<br>Reference. Different<br>from the predicate<br>device | | Automatic No-<br>Load Trip? | No | Yes | No | Same as the<br>Reference. Different<br>from the predicate<br>device | | Automatic Shut<br>Off? | No | Not publicly<br>available | Yes | Different. | | Patient Override<br>Control? | Yes | Not publicly<br>available | Yes | Similar to the<br>Reference device.<br>Patient-Controlled<br>Manual Switch used as<br>a patient control in the<br>case of discomfort that<br>stop power<br>transmission<br>immediately after the<br>patient presses the<br>button | | - Indicator<br>Display: | | | | | | - On/Off Status | Yes | Yes | Yes | Similar to Predicate<br>and Reference | | - Low Battery | N/A | N/A | No | N/A | | - Voltage/Curr<br>ent Level | Voltage | Yes | Proportional Voltage<br>level indicator | Similar to the<br>Predicate and<br>Reference<br>Controlled/displayed<br>via GUI | | - Timer Range<br>(minutes) | 1-99 min | None | 5 min | Similar to Predicate<br>and Reference | | Parameter | Legend Pro DMA | Principal<br>Predicate Device | Reference Device | Same/<br>Similar/Different | | 510(k) Number | K200545 | K182440 | K152420 | | | Device Name<br>and Model | Legend Pro DMA | Body System | AK Body Toning<br>Device | N/A | | Compliance with<br>Voluntary<br>Standards? | Yes<br>IEC60601-1<br>IEC60601-1-2<br>IEC60601-2-10<br>IEC62304<br>ISO 10993 | Yes<br>Electrical Safety:<br>Comply with IEC<br>60601-1 and IEC<br>60601-2-10<br>EMC: Comply with<br>IEC 60601-1-2<br>Biocompatibility:<br>ISO10993-5 and<br>ISO10993-10 | Yes<br>IEC 60601-1<br>IEC 60601-1-2<br>UL 60601-1 (2003)<br>CSA C22.2 No. 601.1<br>IEC 60601-2-10 | Similar to Predicate<br>and Reference. | | Compliance with<br>21 CFR 898 | Yes | Yes | N/A (electrodes are<br>integral with the device,<br>there are no separate<br>leads) | Compliant with 60601-<br>1 | | Weight (lbs., oz.) | ~30 Kg; 66 lbs | Not publicly<br>available | 800 g | N/A | | Dimensions (in.)<br>[W x H x D] | 45 x 110 x 45 cm<br>17.7 x 43.3 x 17.7 in | Not publicly<br>available | 3.12 x 3.51x 7.0 (IN) | N/A | | Housing<br>Materials and<br>Construction | Metal, Plastics | Aluminium | ABS | N/A | # Summary of Technological Characteristics {5}------------------------------------------------ {6}------------------------------------------------ {7}------------------------------------------------ #### OUTPUT SPECIFICATIONS | Parameter | Legend Pro DMA | Principal<br>Predicate Device | Reference Device | Similar/Different | |-----------------------------------------------------------------|--------------------------------|----------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) Number | K200545 | K182440 | K152420 | | | Device Name and<br>Model | Legend Pro DMA™ | Body System | AK Body Toning<br>Device | N/A | | Waveform (e.g.,<br>pulsed<br>monophasic,<br>biphasic) | Biphasic | Biphasic | Monophasic | Similar to Predicate<br>and different from<br>Reference | | Shape (e.g.,<br>rectangular,<br>spike, rectified<br>sinusoidal) | Rectangular | Rectangular | Rectangular | Similar to Predicate<br>and Reference | | Maximum Output<br>Voltage (volts) (+/-<br>10%) | 60V@500Ω<br>3.95VRMS@500Ω | 58V@500 Ω<br>VRMS not publicly available<br>but not higher than 10VRMS<br>to meet 60601-2-10 | 10.4V@500Ω<br>VRMS not publicly available<br>but not higher than 10VRMS<br>to meet 60601-2-10 | Similar to Predicate | | | 200V@2000Ω<br>12.3VRMS@2000Ω | 88V@2000Ω<br>VRMS not publicly<br>available | 35.6V@2000Ω<br>VRMS not publicly<br>available | Different from<br>predicate but not<br>higher than 10VRMS<br>@500 Ω<br>to meet 60601-2-10 | | | 360V@10000Ω<br>17.6VRMS@10000Ω | Not publicly available | 88.0V@10000Ω<br>VRMS not<br>publicly<br>available | Predicate information<br>not publicly<br>available. Different<br>from reference but<br>not higher than<br>10VRMS @500 Ω<br>to meet 60601-2-10 | {8}------------------------------------------------ | Parameter | Legend Pro DMA | Principal<br>Predicate Device | Reference Device | Similar/Different | |-------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|--------------------------|-------------------------------------------------------------------------------------------| | 510(k) Number | K200545 | K182440 | K152420 | | | Device Name and<br>Model | Legend Pro DMA™ | Body System | AK Body Toning<br>Device | N/A | | Maximum Output<br>Current (mA@ Ω)<br>(+/- 10%) | 120mA@500Ω | 108mA@500 Ω | 22 mA@500Ω | Similar to the<br>predicate | | | 100mA@2000Ω | Not publicly available | 18 mA@2000Ω | Predicate information<br>not publicly available | | | 36mA@10000Ω | Not publicly available | 9mA@10000Ω | Predicate information<br>not publicly available | | Pulse Width<br>(µsec) | 20 to 400 µsec | 500 to 2500 µsec | 1000 µsec | Different from<br>predicate but does<br>not raise issues of<br>safety or<br>effectiveness | | Phase duration | 10 to 200 µsec | Not publicly available | Not publicly available | N/A | | Frequency (Hz) | 0.78, 1.56, 3.13, 6.25;<br>12.5 Hz | 200 to 1200 Hz | 75 Hz | Different from<br>Predicate, similar to<br>Reference | | Net Charge<br>(microcoulombs<br>(µC) per pulse)<br>(If zero, state<br>method of<br>achieving zero net<br>charge.) | 0 @ 500Ω<br>biphasic waveform<br>Zero net charge is<br>achieved by<br>symmetrical<br>biphasic<br>waveforms | 0 @ 500 Ω<br>Zero net charge is<br>achieved by using<br>symmetrical<br>biphasic<br>waveforms | 22.5 µC @500Ω | Similar to Predicate | | Maximum charge<br>per Phase, (µC) | 24µC @ 500Ω<br>@12.5Hz | 45 µC @ 500 Ω @<br>200 Hz | 22.5 µC @500Ω | Similar to Predicate<br>and Reference | | Maximum Current<br>Density, (mA/cm²) | 1.1mA/cm² @ 500Ω | 5 mA / cm² | 4.17 mA/cm² @500Ω | Similar to Predicate<br>and Reference | | Maximum Power<br>Density (W/cm²), | 0.0044 W/cm² @<br>500Ω | 0.012 W/cm² | 0.0089W/cm² @<br>500Ω | Similar to Predicate<br>and Reference | | Burst Mode (i.e.,<br>pulse trains): | N/A no burst mode | Not publicly available | N/A, no burst mode | Similar to Reference | {9}------------------------------------------------ # Substantial Equivalence The Legend Pro DMA shares with its principal predicate, the Body System (K182440), exactly the same intended use: Legend Pro DMA is substantially equivalent to another legally marketed device, the Body System (K182440). The subject device, Legend Pro DMA, has the same general intended use and similar indications, technological characteristics, and principles of operation as the previously cleared predicate, the Body System (K182440). The Legend Pro DMA, similarly, to the Body System, is an electrical Muscle Stimulator for prescription use with a biphasic rectangular waveform, is voltage regulated and uses similar underlying technology and performance envelope. In addition, the Legend Pro DMA, meets the same safety standards, including biocompatibility and electrical safety. Provided as a reference, the AK Body Toning Device (K152420) was also included in the comparison tables in order to support the mode of the energy application to the target, as it uses non-stationary electrodes, similar to the electrodes and applicators used in the Legend Pro DMA. Overall, these three systems have the same principle of operation, applying transcutaneous electrical muscle stimulation (EMS) through skin-contact electrodes, and they all share the same intended use. # Performance Data The Legend Pro DMA has been tested to establish its safety and performance. The following design verification and validation processes were performed according to the FDA Guidance Document for Powered Muscle Stimulator 510(k)s Document issued on: June 9, 1999 and based on the Predicate device, the Body System, K182440: - Risk analysis per ISO 14971 ● - . Electrical, electromagnetic compatibility safety testing according to IEC 60601-1, IEC 60601-1-2 and IEC 60601-2-10. - Software verification and validation according to IEC 62304 and FDA Guidance ● "Principles of Software Validation Guidance for Industry and FDA Staff, January 2002". - Performance testing (e.g., energy measurements, including Output Waveforms). - Reprocessing evaluation according to FDA's guidance "Reprocessing Medical ● Devices in Health Care Settings: Validation Methods and Labeling FDA Guidance (2015, Updated June 9, 2017)". - . Biocompatibility evaluation according to ISO 10993-1 and FDA Guidance "Use of International Standard ISO 10993-1, "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing with a Risk Management Process, September 2020 and "Select Updates for Biocompatibility of Certain Devices in Contact with Intact Skin DRAFT", October 2020 {10}------------------------------------------------ #### Clinical Testing Not applicable. # Conclusion Based on the intended use/Indications for use, design, materials, principle of operation, energy used and materials, the Legend Pro DMA is substantially equivalent to the legally marketed predicate device the Body System (K182440). The non-clinical performance data according to the FDA Guidance Document for Powered Muscle Stimulator 510(k)s Document issued on June 9, 1999, supports the substantial equivalence and includes an analysis of output waveforms.