(597 days)
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.
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.
The provided text does not contain detailed acceptance criteria for the Legend Pro DMA device, nor does it describe a study that explicitly proves the device meets specific acceptance criteria in the format requested.
Instead, the document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than fulfilling specific, pre-defined acceptance criteria with a detailed study report. The "Performance Data" section lists various tests performed to establish safety and performance, which indirectly support the device's suitability for its intended use, but not against quantitative performance metrics.
Here's a breakdown of the requested information based on the provided text, highlighting where information is absent:
Acceptance Criteria and Reported Device Performance
The document does not explicitly state acceptance criteria in the typical sense of numerical thresholds or performance targets. Instead, it compares the Legend Pro DMA's technical specifications to those of its predicate devices to demonstrate similarity and equivalence.
| Parameter | Acceptance Criteria (Not explicitly stated in document, inferred from predicate comparison) | Reported Device Performance (Legend Pro DMA) |
|---|---|---|
| Intended Use | To be substantially equivalent to predicate (muscle conditioning to stimulate healthy muscles) | Intended for muscle conditioning to stimulate healthy muscles. |
| Waveform | Biphasic, similar to predicate's rectangular biphasic waveform. | Biphasic, Rectangular |
| Max Output Voltage | Similar to predicate (e.g., 58V@500Ω) but not higher than 10VRMS at 500Ω. | 60V@500Ω (3.95VRMS), 200V@2000Ω (12.3VRMS), 360V@10000Ω (17.6VRMS) |
| Max Output Current | Similar to predicate (e.g., 108mA@500 Ω) | 120mA@500Ω, 100mA@2000Ω, 36mA@10000Ω |
| Pulse Width | Within ranges that do not raise issues of safety or effectiveness compared to predicate. | 20 to 400 µsec (Different from predicate's 500 to 2500 µsec, but deemed not to raise issues of safety or effectiveness) |
| Frequency | Within ranges that do not raise issues of safety or effectiveness compared to predicate. | 0.78, 1.56, 3.13, 6.25, 12.5 Hz (Different from predicate's 200 to 1200 Hz, but similar to reference's 75 Hz; deemed not to raise issues of safety or effectiveness) |
| Net Charge per pulse | Zero net charge, similar to predicate. | 0 @ 500Ω, achieved by symmetrical biphasic waveforms. |
| Max Charge per Phase | Similar to predicate (e.g., 45 µC @ 500 Ω @ 200 Hz). | 24µC @ 500Ω @ 12.5Hz |
| Max Current Density | Similar to predicate (e.g., 5 mA / cm²). | 1.1mA/cm² @ 500Ω |
| Max Power Density | Similar to predicate (e.g., 0.012 W/cm²). | 0.0044 W/cm² @ 500Ω |
| Electrical Safety | Compliance with IEC 60601-1, IEC 60601-1-2 and IEC 60601-2-10. | Complies with IEC 60601-1, IEC 60601-1-2 and IEC 60601-2-10. |
| Software Safety | Compliance with IEC 62304 and FDA Guidance "Principles of Software Validation". | Complies with IEC 62304 and FDA Guidance "Principles of Software Validation". |
| Biocompatibility | Compliance with ISO 10993-1. | Complies with ISO 10993-1. |
Study Information
The document describes non-clinical performance data to support substantial equivalence, focusing on design verification and validation processes rather than a comparative effectiveness study.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not applicable in the context of device testing for substantial equivalence, as no patient-level test set data is described. The "Performance Data" section details engineering and laboratory testing on the device itself.
- Data Provenance: Not applicable. The tests are on the device's components and systems, not clinical data from patients.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- This is not applicable as there is no mention of a "test set" requiring expert ground truth in the clinical sense (e.g., image interpretation). The "ground truth" for the engineering and safety tests would be the established international standards and regulatory requirements.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable as there is no clinical test set requiring adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No MRMC comparative effectiveness study was done or reported. The device is a powered muscle stimulator, not an AI-assisted diagnostic tool that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone performance data (algorithm only): The document mentions "Software verification and validation according to IEC 62304 and FDA Guidance 'Principles of Software Validation Guidance for Industry and FDA Staff, January 2002'." This confirms that the device's embedded software was validated as a standalone component, but it doesn't quantify its "performance" in the way one might for a diagnostic algorithm (e.g., sensitivity, specificity). Instead, it validates that the software functions as intended and meets safety requirements. There is no "human-in-the-loop" aspect to the software's direct operation regarding its core function of generating electrical pulses.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for the non-clinical tests is regulatory and international standards, such as:
- Risk analysis: ISO 14971
- Electrical, electromagnetic compatibility safety: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10
- Software verification and validation: IEC 62304 and FDA Guidance "Principles of Software Validation"
- Biocompatibility: ISO 10993-1
8. The sample size for the training set
- Not applicable. The device is a hardware and embedded software system, not a machine learning model that requires a "training set" in the conventional AI sense.
9. How the ground truth for the training set was established
- Not applicable for the reasons stated above.
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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.
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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
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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) |
|---|
| Prescription Use (Part 21 CFR 201 Subpart D) |
| Over-The-Counter Use (21 CFR 201 Subpart C) |
Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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510(K) SUMMARY
K200545
| Applicant Name: | Udi RussoPollogen Ltd.6 Kaufman StreetTel Aviv, Tel-Aviv, ISRAEL 6801298Phone: +972 3 5104110Fax: +972 3 5104112 |
|---|---|
| Contact Person: | Amaya De LevieLumenis Ltd.6 Hakidma Street PO Box 240,Yokneam Industrial ParkYokneam 2069204IsraelPhone: +972-549599073E-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.
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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 | PrincipalPredicate Device | Reference Device | Same/Similar/Different |
|---|---|---|---|---|
| 510(k) Number | K200545 | K182440 | K152420 | N/A |
| Device Nameand Model | Legend Pro DMA | Body System | AK Body ToningDevice | N/A |
| Manufacturer | Pollogen | A-1 Engineering | AK Beauty Enterprises,LLC | |
| Product Code | NGX | NGX | NGX | Same |
| Type of Use | Prescription Use(Part 21 CFR 801Subpart D) | Prescription Use(Part 21 CFR 801Subpart D) | Over-The-Counter Use(21 CFR 801 SubpartC) | Same |
| Intended Use | Legend Pro DMA isintended formuscleconditioning tostimulate healthymuscles. | The Body Systemis intended formuscleconditioning tostimulate healthymuscles. | The AK Body ToningDevice is intended foruse by healthy personsto applytranscutaneouselectrical musclestimulation(EMS) through skin-contact electrodes inorder to improve orfacilitate muscleperformance. | Same Intended use asthe Predicate. Similarto the Reference |
| Legend Pro DMA isnot intended to beused in conjunctionwith therapy or | The Body Systemis not intended tobe used inconjunction with | |||
| Parameter | Legend Pro DMA | PrincipalPredicate Device | Reference Device | Same/Similar/Different |
| 510(k) Number | K200545 | K182440 | K152420 | |
| Device Nameand Model | Legend Pro DMA | Body System | AK Body ToningDevice | N/A |
| treatment ofmedical diseasesor medicalconditions. LegendPro DMA isintended to beoperated by atrainedprofessional who ispresent to monitortreatment. | therapy ortreatment ofmedical diseasesor medicalconditions of anykind. The BodySystem isintended to beoperated by atrainedprofessional whois present tomonitor treatment. | |||
| Mode ofOperation | Application oftranscutaneouselectrical musclestimulation(EMS) through skin-contact electrodes | Application oftranscutaneouselectrical musclestimulation(EMS) throughskin-contactelectrodes | Application oftranscutaneouselectrical musclestimulation(EMS) through skin-contact electrodes | Same mode ofoperation as thePredicate andReference |
| Mode ofapplication | Metal (Stainlesssteel) electrodes inthe SystemApplicator emitelectric energy to theskin while the systemapplicator is rolledacross the treatmentarea | Fixed self-adhesive, gelledpad applicatorsattached to the skinfor muscleconditioning. | Metal electrodes in thedevice emit electricenergy to the skinwhile the device isrolled across thetreatment area | Different from thepredicate (movingelectrodes vs. fixedelectrodes) but similarto the Referencedevice. See Section12.4. |
| BodyApplicationAreas | Body | Body | Not publicly available | |
| Power Source(s) | 110-240 V50-60 Hz | 110-240 vac (ACwall plug-in)50 - 60 Hz | Battery3 x 1.5 VAAA batteries | Same as thePredicate. Differentfrom the Referencedevice |
| Method of LineCurrent Isolation | Medical PowerSupply, Transformerin output stage | Power Supplyisolation | N/A - Internal PowerType BF | Similar to thePredicate |
| Patient LeakageCurrent | ||||
| - NormalCondition(μΑ) | 1.5 μΑ | .05 μΑ | N/A (battery operateddevice) | Similar to the Predicate |
| - Single FaultCondition(μΑ) | 40 μΑ | 5 μΑ | N/A (battery operateddevice) | Similar to the Predicateand below 500μΑvalue in guidance. |
| Number ofOutput Modes | 1 | 5 | 1 | Different. Modes arecomparable. No issuesof safety oreffectiveness |
| Number ofOutputChannels: | 1 | 16 | 1 | Different. Each sessionwill use one of threeApplicators. Nodifference in safety oreffectiveness. |
| Parameter | Legend Pro DMA | PrincipalPredicate Device | Reference Device | Same/Similar/Different |
| 510(k) Number | K200545 | K182440 | K152420 | |
| Device Nameand Model | Legend Pro DMA | Body System | AK Body ToningDevice | N/A |
| Applicator is moved tocover entire treatmentarea. | ||||
| Synchronous orAlternating? | N/A Single outputchannel. | Synchronous | N/A Single channel. | Different. Not requiredfor one output channel |
| Method ofChannelIsolation | N/A Single outputchannel. | Power Supplyisolation | N/A Single channel. | Different. Singlechannel does notrequire channelisolation. |
| RegulatedCurrent orRegulatedVoltage? | Voltage | Current and Voltage | Voltage | Similar to thePredicate. Differentform the Referencedevice |
| Software/Firmware/Microprocessor Control? | Yes | No | No | Different. The softwareis validated. Theoutput from each iscomparable. Does notdirectly affect safetyand effectiveness. |
| AutomaticOverload Trip? | No | Yes | No | Same as theReference. Differentfrom the predicatedevice |
| Automatic No-Load Trip? | No | Yes | No | Same as theReference. Differentfrom the predicatedevice |
| Automatic ShutOff? | No | Not publiclyavailable | Yes | Different. |
| Patient OverrideControl? | Yes | Not publiclyavailable | Yes | Similar to theReference device.Patient-ControlledManual Switch used asa patient control in thecase of discomfort thatstop powertransmissionimmediately after thepatient presses thebutton |
| - IndicatorDisplay: | ||||
| - On/Off Status | Yes | Yes | Yes | Similar to Predicateand Reference |
| - Low Battery | N/A | N/A | No | N/A |
| - Voltage/Current Level | Voltage | Yes | Proportional Voltagelevel indicator | Similar to thePredicate andReferenceControlled/displayedvia GUI |
| - Timer Range(minutes) | 1-99 min | None | 5 min | Similar to Predicateand Reference |
| Parameter | Legend Pro DMA | PrincipalPredicate Device | Reference Device | Same/Similar/Different |
| 510(k) Number | K200545 | K182440 | K152420 | |
| Device Nameand Model | Legend Pro DMA | Body System | AK Body ToningDevice | N/A |
| Compliance withVoluntaryStandards? | YesIEC60601-1IEC60601-1-2IEC60601-2-10IEC62304ISO 10993 | YesElectrical Safety:Comply with IEC60601-1 and IEC60601-2-10EMC: Comply withIEC 60601-1-2Biocompatibility:ISO10993-5 andISO10993-10 | YesIEC 60601-1IEC 60601-1-2UL 60601-1 (2003)CSA C22.2 No. 601.1IEC 60601-2-10 | Similar to Predicateand Reference. |
| Compliance with21 CFR 898 | Yes | Yes | N/A (electrodes areintegral with the device,there are no separateleads) | Compliant with 60601-1 |
| Weight (lbs., oz.) | ~30 Kg; 66 lbs | Not publiclyavailable | 800 g | N/A |
| Dimensions (in.)[W x H x D] | 45 x 110 x 45 cm17.7 x 43.3 x 17.7 in | Not publiclyavailable | 3.12 x 3.51x 7.0 (IN) | N/A |
| HousingMaterials andConstruction | Metal, Plastics | Aluminium | ABS | N/A |
Summary of Technological Characteristics
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OUTPUT SPECIFICATIONS
| Parameter | Legend Pro DMA | PrincipalPredicate Device | Reference Device | Similar/Different |
|---|---|---|---|---|
| 510(k) Number | K200545 | K182440 | K152420 | |
| Device Name andModel | Legend Pro DMA™ | Body System | AK Body ToningDevice | N/A |
| Waveform (e.g.,pulsedmonophasic,biphasic) | Biphasic | Biphasic | Monophasic | Similar to Predicateand different fromReference |
| Shape (e.g.,rectangular,spike, rectifiedsinusoidal) | Rectangular | Rectangular | Rectangular | Similar to Predicateand Reference |
| Maximum OutputVoltage (volts) (+/-10%) | 60V@500Ω3.95VRMS@500Ω | 58V@500 ΩVRMS not publicly availablebut not higher than 10VRMSto meet 60601-2-10 | 10.4V@500ΩVRMS not publicly availablebut not higher than 10VRMSto meet 60601-2-10 | Similar to Predicate |
| 200V@2000Ω12.3VRMS@2000Ω | 88V@2000ΩVRMS not publiclyavailable | 35.6V@2000ΩVRMS not publiclyavailable | Different frompredicate but nothigher than 10VRMS@500 Ωto meet 60601-2-10 | |
| 360V@10000Ω17.6VRMS@10000Ω | Not publicly available | 88.0V@10000ΩVRMS notpubliclyavailable | Predicate informationnot publiclyavailable. Differentfrom reference butnot higher than10VRMS @500 Ωto meet 60601-2-10 |
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| Parameter | Legend Pro DMA | PrincipalPredicate Device | Reference Device | Similar/Different |
|---|---|---|---|---|
| 510(k) Number | K200545 | K182440 | K152420 | |
| Device Name andModel | Legend Pro DMA™ | Body System | AK Body ToningDevice | N/A |
| Maximum OutputCurrent (mA@ Ω)(+/- 10%) | 120mA@500Ω | 108mA@500 Ω | 22 mA@500Ω | Similar to thepredicate |
| 100mA@2000Ω | Not publicly available | 18 mA@2000Ω | Predicate informationnot publicly available | |
| 36mA@10000Ω | Not publicly available | 9mA@10000Ω | Predicate informationnot publicly available | |
| Pulse Width(µsec) | 20 to 400 µsec | 500 to 2500 µsec | 1000 µsec | Different frompredicate but doesnot raise issues ofsafety oreffectiveness |
| Phase duration | 10 to 200 µsec | Not publicly available | Not publicly available | N/A |
| Frequency (Hz) | 0.78, 1.56, 3.13, 6.25;12.5 Hz | 200 to 1200 Hz | 75 Hz | Different fromPredicate, similar toReference |
| Net Charge(microcoulombs(µC) per pulse)(If zero, statemethod ofachieving zero netcharge.) | 0 @ 500Ωbiphasic waveformZero net charge isachieved bysymmetricalbiphasicwaveforms | 0 @ 500 ΩZero net charge isachieved by usingsymmetricalbiphasicwaveforms | 22.5 µC @500Ω | Similar to Predicate |
| Maximum chargeper Phase, (µC) | 24µC @ 500Ω@12.5Hz | 45 µC @ 500 Ω @200 Hz | 22.5 µC @500Ω | Similar to Predicateand Reference |
| Maximum CurrentDensity, (mA/cm²) | 1.1mA/cm² @ 500Ω | 5 mA / cm² | 4.17 mA/cm² @500Ω | Similar to Predicateand Reference |
| Maximum PowerDensity (W/cm²), | 0.0044 W/cm² @500Ω | 0.012 W/cm² | 0.0089W/cm² @500Ω | Similar to Predicateand Reference |
| Burst Mode (i.e.,pulse trains): | N/A no burst mode | Not publicly available | N/A, no burst mode | Similar to Reference |
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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
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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.
§ 890.5850 Powered muscle stimulator.
(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(b)
Classification. Class II (performance standards).