(296 days)
The EVOLVE System with the Tone Applicator is an electro-muscle and transcutaneous nerve stimulation device for the treatment of different body areas.
The EVOLVE System with Tone Applicator is designed to operate in two modes - EMS and TENS.
In EMS mode it is used for:
- Relaxation of muscle spasms
- Prevention or retardation of disuse atrophy
- Increasing local blood circulation
- Muscle re-education
- Maintaining or increasing range of motion
- Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
And in TENS mode is intended for
- Symptomatic relief and management of chronic, intractable pain
- Post-surgical acute pain
- Post-trauma acute pain
The EVOLVE System in combination with Tone Applicator (manufactured by InMode Ltd.), is a computerized device intended to employ EMS (Electrical Muscle Stimulation) and TENS (Transcutaneous Electrical Nerve Stimulation) technologies for various medical applications.
The EVOLVE System with the Tone Applicator consists of an AC/DC power supply unit, controller and user interface including an LCD touch screen. The Tone Applicator is connected to the console via a cable, each of the subject device applicator units consist of a designated cable and of a connection port to be directly connected to one of the four connectors positioned on the rear side of the console. Up to four Tone Applicator units can be connected to the console simultaneously.
The delivery of the electrical energy is controlled by a Start/Stop button positioned on the LCD screen.
The System supports the following components:
- LCD display touch screen .
- Audio loudspeaker ●
- . 48V AC/DC power supply
- Controller
- . Fans
The System operates while connected to the Tone Applicator.
The provided document is a 510(k) summary for the InMode Ltd. EVOLVE System with the Tone Applicator. This type of submission to the FDA focuses on demonstrating substantial equivalence to a predicate device, rather than proving independent effectiveness through extensive clinical trials. Therefore, the information typically found in a study demonstrating acceptance criteria for the device's performance (especially related to clinical efficacy or AI model performance) is largely absent.
The "acceptance criteria" discussed in this document primarily refer to compliance with recognized consensus standards for safety and basic performance (bench testing) and demonstrating similar characteristics to a predicate device. There is no mention of an AI model within this submission, nor are there any clinical effectiveness studies, MRMC studies, or details on establishing ground truth for AI algorithms.
However, I can extract the information related to the device's performance based on the provided text, focusing on the available "acceptance criteria" (which are regulatory conformity and bench testing results) and the performance data for those criteria.
Based on the provided FDA 510(k) summary (K201285), here's an analysis of the "acceptance criteria" and the "study" proving the device meets them:
Crucial Caveat: This 510(k) summary does not describe an AI/ML model or its performance. The "acceptance criteria" and "study" described here pertain to the safety and basic functional performance of a medical device (an electro-muscle and transcutaneous nerve stimulator) demonstrating substantial equivalence to a legally marketed predicate device. Therefore, many of the requested points related to AI/ML model evaluation (e.g., sample sizes for training/test sets, expert adjudication of ground truth, MRMC studies) are not applicable and will not be found in this document.
1. Table of Acceptance Criteria and Reported Device Performance
The "acceptance criteria" here are framed as compliance with recognized consensus standards and meeting design requirements through bench testing. The "reported device performance" is the confirmation that these tests were passed and the design requirements were met. The table below summarizes the key performance specifications and their acceptance against the predicate device.
| Acceptance Criteria (What was measured) | Reported Device Performance (Subject Device) | Comparison/Comment (Relative to Predicate K192249) | Proving Study/Method |
|---|---|---|---|
| General Safety and Essential Performance | Compliance with ANSI AAMI ES 60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 | Complied. Similar to predicate. | Bench testing, Electrical and mechanical safety testing |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2 Edition 4.0 2014-02 | Complied. Similar to predicate. | EMC testing |
| Nerve and Muscle Stimulator Specific Safety | Compliance with IEC 60601-2-10 Edition 2.1 2016-04 | Complied. Similar to predicate. | Safety and essential performance testing |
| Usability | Compliance with IEC 60601-1-6 Edition 3.1 2013-10 | Complied. Similar to predicate. | Usability assessment/compliance |
| Biocompatibility of Patient-Contacting Materials | Compliance with ISO 10993-1 standard | Complied. Similar to predicate. | Biocompatibility testing |
| Output Waveform | Symmetrical Biphasic, Rectangular shape (Both EMS & TENS modes) | Identical to predicate. | Bench testing (validation of output waveform) |
| Maximum Output Voltage (EMS) | 56V @ 500Ω, 2 kΩ, 10 kΩ (± 10%) | Identical to predicate. | Bench testing (validation of output specifications) |
| Maximum Output Current (EMS) | 92.86 mA @ 500 Ω, 26.7 mA @ 2 kΩ, 5.4 mA @ 10 kΩ (± 10%) | Subject device current slightly lower at 500Ω (92.86mA vs 98.46mA) and 2kΩ (26.7mA vs 27.3mA) than predicate, identical at 10kΩ. Considered "minor differences." | Bench testing (validation of output specifications) |
| Pulse Width (EMS & TENS) | 20 to 400 μs | Identical to predicate. | Bench testing (validation of output specifications) |
| Frequency (EMS & TENS) | 3 to 200 Hz | Identical to predicate. | Bench testing (validation of output specifications) |
| Maximum Phase Charge (EMS) | 43.2 μC @ 500Ω | Identical to predicate. | Bench testing (validation of output specifications) |
| Maximum Current Density (EMS) | 0.72 mA/cm² (Surface = 12cm²) | Identical to predicate. | Bench testing (validation of output specifications) |
| Maximum Power Density (EMS) | 55 mW/cm² @ 500Ω | Identical to predicate. | Bench testing (validation of output specifications) |
| Maximum Output Voltage (TENS) | 36V @ 500Ω, 2 kΩ, 10 kΩ (± 10%) | Identical to predicate. | Bench testing (validation of output specifications) |
| Maximum Output Current (TENS) | 67.8 mA @ 500 Ω, 17.7 mA @ 2 kΩ, 3.6 mA @ 10 kΩ (± 10%) | Subject device current slightly lower at 500Ω (67.8mA vs 72mA) and 2kΩ (17.7mA vs 18mA) than predicate, identical at 10kΩ. Considered "minor differences." | Bench testing (validation of output specifications) |
| Maximum Phase Charge (TENS) | 28.8 μC @ 500Ω | Identical to predicate. | Bench testing (validation of output specifications) |
| Maximum Current Density (TENS) | 0.48 mA/cm² (Surface = 12cm²) | Lower than predicate (0.48 mA/cm² vs 0.65 mA/cm²). Considered "minor differences." | Bench testing (validation of output specifications) |
| Maximum Power Density (TENS) | 17.3 mW/cm² @ 500Ω | Lower than predicate (17.3 mW/cm² vs 22.7 mW/cm²). Considered "minor differences." | Bench testing (validation of output specifications) |
| Software/Firmware/Microprocessor Control | Yes | Identical to predicate. | Software validation testing (mentioned under performance tests) |
| Automatic Overload/No-Load Trip, Automatic Shut Off | Yes | Identical to predicate. | Bench testing, adherence to safety standards |
| Patient Override Control | Yes | Identical to predicate. | Device functionality review |
| Timer Range | 0-60 minutes | Identical to predicate. | Device functionality review |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: This is a medical device safety and performance submission, not an AI/ML model evaluation. Therefore, there are no "test set" sample sizes in the sense of patient data for clinical performance evaluation. The "tests" performed are bench tests and compliance with recognized standards.
- Data Provenance: The "data" comes from mandated bench testing and compliance documentation. There is no mention of patient data, clinical studies, or data provenance (e.g., country of origin, retrospective/prospective) in the context of efficacy testing. The document explicitly states "Clinical Performance Data: Non-Applicable."
3. Number of Experts Used to Establish Ground Truth and Qualifications:
- Not Applicable. This submission does not involve an AI/ML model where "ground truth" adjudicated by experts is typically needed. The "ground truth" for this device's performance is established by direct physical measurements during bench testing and adherence to engineering and safety standards.
4. Adjudication Method for the Test Set:
- Not Applicable. As there is no clinical or image-based "test set" requiring expert interpretation or labeling, no adjudication method (e.g., 2+1, 3+1) was used.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- Not Applicable. No MRMC study was done, as this is not an AI-assisted diagnostic device, nor is it reporting on human reader performance. The document states "Clinical Performance Data: Non-Applicable."
6. Standalone (Algorithm Only) Performance:
- Not Applicable. There is no AI algorithm being evaluated. The device functions as a physical muscle/nerve stimulator.
7. Type of Ground Truth Used:
- Technical Specifications and Compliance with Standards. The "ground truth" for this device's acceptance is its adherence to a specified design and its ability to pass established engineering, electrical safety, EMC, and specific performance standards for muscle/nerve stimulators (e.g., IEC 60601 series). This is verified through direct measurement and documentation from bench testing.
8. Sample Size for the Training Set:
- Not Applicable. There is no AI/ML model for which a "training set" would be used.
9. How the Ground Truth for the Training Set Was Established:
- Not Applicable. As there is no AI/ML model, there is no training set or associated ground truth establishment process.
In summary: The provided document is a regulatory submission demonstrating substantial equivalence for a physical medical device. It focuses on engineering specifications, safety compliance, and bench testing, not on the performance of a software algorithm or clinical efficacy requiring a test set, ground truth experts, or training data for AI.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 5, 2021
InMode Ltd. % Amit Goren Regulatory Manager A. Stein - Regulatory Affairs Consulting Ltd. 20 Hata'as Str., Suite 102 Kfar Saba, 4442520 Israel
Re: K201285
Trade/Device Name: Evolve System with the Tone Applicator Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: IPF, GZJ Dated: May 10, 2020 Received: May 13, 2020
Dear Amit Goren:
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
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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,
Jitendra Virani Acting 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
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Indications for Use
510(k) Number (if known) K201285
Device Name
EVOLVE System with the Tone Applicator
Indications for Use (Describe)
The EVOLVE System with the Tone Applicator is an electro-muscle and transcutaneous nerve stimulation device for the treatment of different body areas.
The EVOLVE System with Tone Applicator is designed to operate in two modes - EMS and TENS.
In EMS mode it is used for:
- Relaxation of muscle spasms
- · Prevention or retardation of disuse atrophy
- Increasing local blood circulation
- · Muscle re-education
- · Maintaining or increasing range of motion
- · Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
And in TENS mode is intended for
- · Symptomatic relief and management of chronic, intractable pain
- · Post-surgical acute pain
- Post-trauma acute pain
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ---------------------------------------------- | --------------------------------------------- |
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510(K) SUMMARY
THE EVOLVE SYSTEM WITH THE TONE APPLICATOR
510(k) Number K201285
Applicant Name: Company Name: InMode Ltd. Tabor Building, Shaar Yokneam Address: Yokneam 20692 Israel Tel: +972-4-9097470 Fax: +972-4-9097471 E-mail: amit(@asteinrac.com Contact Person: Official Correspondent: Amit Goren A. Stein - Regulatory Affairs Consulting Ltd. Company Name: Address: 20 Hata'as Str., Suite 102 Kfar Saba 4442520 Israel Tel: + 972-9-7670002 Fax: +972-9-7668534 E-mail: amit(@asteinrac.com Date Prepared: February 11, 2021 Trade Name: EVOLVE System with the Tone Applicator Powered muscle stimulator, Transcutaneous electrical Classification Name: nerve stimulator for pain relief Regulation No .: 890.5850, 882.5890 Product Codes: IPF, GZJ Classification: Class II Medical Device
Predicate Device:
The EVOLVE System with the Tone Applicator is substantially equivalent to the following main and reference predicate devices.
| Manufacturer | Device | 510(k) No. |
|---|---|---|
| Main Predicate | ||
| InMode System with the Tone Applicator | InMode Ltd. | K192249 |
| Reference Predicate | ||
| The EVOLVE System | InMode Ltd. | K183450 |
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Device Description:
The EVOLVE System in combination with Tone Applicator (manufactured by InMode Ltd.), is a computerized device intended to employ EMS (Electrical Muscle Stimulation) and TENS (Transcutaneous Electrical Nerve Stimulation) technologies for various medical applications.
The EVOLVE System with the Tone Applicator consists of an AC/DC power supply unit, controller and user interface including an LCD touch screen. The Tone Applicator is connected to the console via a cable, each of the subject device applicator units consist of a designated cable and of a connection port to be directly connected to one of the four connectors positioned on the rear side of the console. Up to four Tone Applicator units can be connected to the console simultaneously.
The delivery of the electrical energy is controlled by a Start/Stop button positioned on the LCD screen.
The System supports the following components:
- LCD display touch screen .
- Audio loudspeaker ●
- . 48V AC/DC power supply
- Controller
- . Fans
The System operates while connected to the Tone Applicator.
Following are The EVOLVE System with the Tone Applicator specifications:
| Main Line Frequency (nominal): | 50-60 Hz |
|---|---|
| Input Voltage (nominal): | 100-240 VAC |
| Input Current (rms) | 4A |
| Dimension: | |
| Console | 46cm W x 46cm D x 100cm H [18.2" W x18.2" D x 44" H] |
| [W x H x D] | |
| Applicator | Tone Applicator |
| [L x D] | 12cm L x 10cm D [4.7'' L x 4'' D] |
| Weight Console: | 33 Kg (73 lbs.) |
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| Tone Applicator Weight: | 0.22 Kg [0.5 lbs.] |
|---|---|
| Platform modulesAC/DC power supply | Converts AC input voltage (100-240Vac) to6Vdc |
| Waveform | Symmetrical Biphasic |
| Shape | Rectangular |
| Intensity (output Voltage) | Up to 50 intensity level (=54 Vpeak) |
| Pulse WidthTone Applicator | 20 to 400 $ μ$ S |
| FrequencyTone Applicator | 3 to 200 Hz |
Intended Use/Indication for Use:
The EVOLVE System with the Tone Applicator is an electro-muscle and transcutaneous nerve stimulation device for the treatment of different body areas.
The EVOLVE System with Tone Applicator is designed to operate in two modes – EMS and TENS.
In EMS mode it is used for:
- . Relaxation of muscle spasms
- . Prevention or retardation of disuse atrophy
- . Increasing local blood circulation
- . Muscle re-education
- . Maintaining or increasing range of motion
- Immediate postsurgical stimulation of calf muscles to prevent venous . thrombosis
And in TENS mode is intended for:
- Symptomatic relief and management of chronic, intractable pain
- Post-surgical acute pain
- Post-trauma acute pain
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Performance Standards:
The EVOLVE System with the Tone Applicator has been tested and complies with the following FDA recognized consensus standards:
[Rec. Number 19-4] ANSI AAMI ES 60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
[Rec. Number 19-8] IEC 60601-1-2 Edition 4.0 2014-02 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance -Collateral Standard: Electromagnetic disturbances - Requirements and tests
[Rec. Number 17-16] IEC 60601-2-10 Edition 2.1 2016-04 Medical Electrical Equipment - Part 2-10: Particular Requirements for The Basic Safety and Essential Performance of Nerve and Muscle Stimulators
[Rec. Number 5-89] IEC 60601-1-6 Edition 3.1 2013-10 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance -Collateral standard: Usability
Sterilization/Disinfection/Cleaning:
The cleaning and reprocessing instructions set forth in the device user manual for all of the reprocessed device Applicator components. The handle should be thoroughly cleaned by the user by using 70% alcohol absorbed pad for at least 30 sec. The user should carefully examine the applicator components prior to their assembly and usage for complete drying and for any visible damage.
The device user manual and device labels, provide users with the proper symbolling and instructions/warnings for safe and effective device use and for a safe discard of the single use components upon their usage.
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All device materials in contact with the patient are biocompatible.
Non-Clinical (Bench) Performance Data:
Bench testing was conducted to demonstrate that the EVOLVE System with the Tone Applicator performs as expected under anticipated conditions of use and to verify that the device performance meets the device design requirements. The device was tested for validation of output waveform, basic unit characteristics, and output specifications.
The bench testing results demonstrated that the device performs as expected under anticipated conditions of use.
Pre-Clinical (Animal) Performance Data:
Non-Applicable.
Clinical Performance Data:
Non-Applicable.
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Substantial Equivalence:
The below table summarizes the main comparison aspects between the EVOLVE System with the Tone Applicator and the proposed predicate device.
| Characteristic | Subject Device | Predicate |
|---|---|---|
| 510(k) file No. | K201285 | K192249 |
| Device Name | EVOLVE System withthe Tone Applicator | InMode System with theTone Applicator |
| Manufacturer | InMode MD Ltd. | InMode MD Ltd. |
| Class, Product Code. | Class IIIPF GZJ | Class IIIPF, GZJ |
| Design: | The EVOLVE System withTone Applicator consists ofan AC/DC power supplyunit, controller and userinterface including an LCDtouch screen. The deliveryof the electrical energy iscontrolled by a Start/Stopbutton positioned on thefront panel.The System supports thefollowing components:● LCD display touchscreen● Audio loudspeaker● 48V AC/DC powersupply● Controller● The System operateswhile connected to theTone Applicator. | The InMode System withTone Applicator consists ofan AC/DC power supplyunit, controller and userinterface including an LCDtouch screen. The delivery ofthe electrical energy iscontrolled by a Start/Stopbutton positioned on the frontpanel.The System supports thefollowing components:● LCD display touchscreen● Audio loudspeaker● 48V AC/DC powersupply● Controller● The System operates whileconnected to the ToneApplicator. |
| Mechanism of Action | Muscle contraction byelectrical pulsing. | Muscle contraction byelectrical pulsing. |
| ComponentsConsole | The EVOLVE Systemconsists of the followingcomponents:● Console, including apower supply unit,controller and userinterface including anLCD touch screen. | The InMode System consistsof the following components:● Console, including apower supply unit,controller and userinterface including anLCD touch screen. |
| Characteristic | Subject Device | Predicate |
| 510(k) file No. | K201285 | K192249 |
| Device Name | EVOLVE System withthe Tone Applicator | InMode System with theTone Applicator |
| Manufacturer | InMode MD Ltd. | InMode MD Ltd. |
| • Tone applicator with upto 4 units connected tothe console via 4designated cables and 4designated connectionports. | • Tone applicator with up to2 units connected to theconsole via a cable withsplitter and a singleconnection port. | |
| DimensionConsole[W x H x D] | 46cm W x 46cm D x100cm H [18.2" W x18.2" D x 44" H] | 35cm W x 35cm D x 100cmH [18.2" W x 18.2" D x40" H] |
| Applicator[L x D] | Tone Applicator12cm L x 10cm D[4.7" L x 4" D] | Tone Applicator12cm L x 10cm D[4.7" L x 4" D] |
| Weight Console | 33.0 Kg [73 lbs.] | 20.0 Kg [44 lbs.] |
| Weight applicator | Tone: 0.22 Kg [0.5 lbs.] | Tone: 0.22 Kg [0.5 lbs.] |
| PerformanceSpecifications:ComponentsConsole | Main Line Frequency(nominal)50-60HzInput Voltage (nominal)100-240VACInput Current (rms)4A | Main Line Frequency(nominal)50-60HzInput Voltage (nominal)100-240VACInput Current (rms)2A |
| Method of Line CurrentIsolation | Independent transformerisolated | Independent transformerisolated |
| Electrical Type | Type BF | Type BF |
| Patient Leakage Current- Normal Condition (μΑ) | <100uA patient leakage | <100uA patient leakage |
| Patient Leakage Current- Single Fault Condition(μΑ) | <300uA line leakage | <300uA line leakage |
| Number of Output Modes | 2 | 2 |
| Number of OutputChannels | 2 | 2 |
| Synchronous orAlternating | See Output SpecificationsBelow | See Output SpecificationsBelow |
| Method of ChannelIsolation | Through transformers andisolators | Through transformers andisolators |
| Characteristic | Subject Device | Predicate |
| 510(k) file No. | K201285 | K192249 |
| Device Name | EVOLVE System withthe Tone Applicator | InMode System with theTone Applicator |
| Manufacturer | InMode MD Ltd. | InMode MD Ltd. |
| Regulated Current orRegulated Voltage(output signals only) | Regulated voltage on allchannelsWith current limit | Regulated voltage on allchannelsWith current limit |
| Software/Firmware/Microprocessor Control | Yes | Yes |
| Automatic Overload Trip | Yes | Yes |
| Automatic No-Load Trip | Yes | Yes |
| Automatic Shut Off | Yes, On/off switch | Yes, On/off switch |
| Patient Override Control | Yes | Yes |
| Indicator Display | Yes | Yes |
| On/Off Status | Yes | Yes |
| Battery | No battery | No battery |
| Voltage/Current level | Yes, voltage levels | Yes, voltage levels |
| Timer Range (Minutes) | 0-60 [minutes] | 0-60 [minutes] |
| Compliance with 21 CFR890.5850 (IPF) | Yes | Yes |
| Compliance with 21 CFR882.5890 (GZJ) | Yes | Yes |
| Applicator Name | Tone Applicator | Tone Applicator |
| EMS Output Mode | ||
| Output Specifications:Waveform | Symmetrical BiphasicWaveform | Symmetrical BiphasicWaveform |
| Pulse Shape | Rectangular | Rectangular |
| Maximum Output Voltage(± 10%) | 56V @500Ω | 56V @500Ω |
| 56V @2 kΩ | 56V @2 kΩ | |
| 56V @10kΩ | 56V @10kΩ | |
| Maximum Output Current(± 10%) | 92.86 mA @ 500 Ω | 98.46 mA @ 500 Ω |
| 26.7 mA @ 2 kΩ | 27.3 mA @ 2 kΩ | |
| 5.4 mA @ 10 kΩ | 5.4 mA @ 10 kΩ | |
| Pulse Width (μsec.) - Theoutput active positive pulsewidth | 20 to 400 [μs] | 20 to 400 [μs] |
| Frequency (Hz) | 3 to 200 [Hz] | 3 to 200 [Hz] |
| Net Charge @ 500 ohms[μC/pulse] | 0 [μC] @ 500Ω | 0 [μC] @ 500Ω |
| Characteristic | Subject Device | Predicate |
| 510(k) file No. | K201285 | K192249 |
| Device Name | EVOLVE System withthe Tone Applicator | InMode System with theTone Applicator |
| Manufacturer | InMode MD Ltd. | InMode MD Ltd. |
| Maximum Phase Charge[μC] | 43.2 [μC] @ 500Ω | 43.2 [μC] @ 500Ω |
| Maximum Current Density[mA/cm²] | 0.72 [mA/cm²]Surface = 12cm² | 0.72 [mA/cm²]Surface = 12cm² |
| Maximum Power Density[mW/cm²] | 55[mW/cm²] @500Ω | 55[mW/cm²] @500Ω |
| Burst Mode (i.e., pulsetrains) | Yes: | Yes: |
| a. Pulses per burst | 3 - 200 | 3 - 200 |
| b. Bursts per second | 1 | 1 |
| c. Burst duration (seconds) | 1-60 sec | 1-60 sec |
| d. Duty Cycle [Line (b) xLine (c)] | Time on / off | Time on / off |
| On Time (sec.) | 1 - 60 [sec] | 1 - 60 [sec] |
| Off Time (sec.) | 1 - 60 [sec] | 1 - 60 [sec] |
| Treatment Time (min) - thetime limit that will put thesystem in STOP state | Up to 60 min. | Up to 60 min. |
| Level - The output intensitylevel | 1 to 50 (5-54v) | 1 to 50 (5-54v) |
| TENS Output Mode | ||
| Output Specifications:Waveform | Symmetrical BiphasicWaveform | Symmetrical BiphasicWaveform |
| Pulse Shape | Rectangular | Rectangular |
| Maximum Output Voltage(± 10%) | 36V @500Ω | 36V @500Ω |
| 36V @2 kΩ | 36V @2 kΩ | |
| 36V @10kΩ | 36V @10kΩ | |
| Maximum Output Current(± 10%) | 67.8 mA @ 500 Ω | 72 mA @ 500 Ω |
| 17.7 mA @ 2 kΩ | 18 mA @ 2 kΩ | |
| 3.6 mA @ 10 kΩ | 3.6 mA @ 10 kΩ | |
| Pulse Width (μsec.) - Theoutput active positive pulsewidth | 20 to 400 [μs] | 20 to 400 [μs] |
| Frequency (Hz) | 3 to 200 [Hz] | 3 to 200 [Hz] |
| Net Charge @ 500 ohms[μC/pulse] | 0 [μC] @ 500Ω | 0 [μC] @ 500Ω |
| Characteristic | Subject Device | Predicate |
| 510(k) file No. | K201285 | K192249 |
| Device Name | EVOLVE System with the Tone Applicator | InMode System with the Tone Applicator |
| Manufacturer | InMode MD Ltd. | InMode MD Ltd. |
| Maximum Phase Charge [µC] | 28.8 [µC] @ 500Ω | 28.8 [µC] @ 500Ω |
| Maximum Current Density [mA/cm2] | 0.48 [mA/cm2]Surface = 12cm² | 0.65 [mA/cm2]Surface = 12cm² |
| Maximum Power Density [mW/cm2] | 17.3 [mW/cm2] @500Ω | 22.7 [mW/cm2] @500Ω |
| Burst Mode (i.e., pulse trains) | Yes:a. 3 - 200b. 1c. 1 - 60 secd. Time on / off | Yes:a. 3 - 200b. 1c. 1 - 60 secd. Time on / off |
| On Time (sec.) | 1 - 60 [sec] | 1 - 60 [sec] |
| Off Time (sec.) | 1 - 60 [sec] | 1 - 60 [sec] |
| Treatment Time (min) - the time limit that will put the system in STOP state | Up to 60 min. | Up to 60 min. |
| Level - The output intensity level | 1 to 50 (5-54v) | 1 to 50 (5-54v) |
| Electrode area | 12 cm² | 12 cm² |
| Housing Material | PC Makrolon 2458 | PC Makrolon 2458 |
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The EVOLVE System with the Tone Applicator is a versatile machine, offering potential users with EMS and TENS technology-based treatment methods for several medical indications. The subject device and predicate devices utilize the same technology, for the same indication for use, and with almost identical design specifications. The device emits electrical signals with identical power and current densities, pulse characteristics, and bear almost identical system components to its predicate devices such as; user interface, and hardware components. All of the subject device performance specifications are equal to those of its predicate device. The minor differences in technical specifications should not alter the device safety and effectiveness.
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Furthermore, the subject device had underwent the required performance testing and validation testing and demonstrates its conformance with device design requirements and with applicable standards.
The safety features and compliance with safety standards of the subject device are similar to the safety features and compliance with safety standards of the predicate device. All user-contacting materials were tested for biocompatibility and found to comply with the ISO 10993-1 standard. Furthermore, the design and development phases of the subject device were validated throughout a set of performance tests, including software validation testing, electrical and mechanical safety testing according to IEC 60601-1 standard, electromagnetic compatibility testing according to IEC 60601-1-2 standard, safety and essential performance of nerve and muscle stimulators testing according to IEC 60601-2-10 standard, and bench performance tests. All in all, these performance tests demonstrated that the device specifications meet the system requirements and do not raise new safety or effectiveness concerns.
Consequently, it can be concluded that the EVOLVE System with the Tone Applicator is substantially equivalent to its predicate device and can be sold in the US market.
Conclusions:
Based on the comparison to the predicate devices and on the non-clinical performance testing results demonstrating that the EVOLVE System with the Tone Applicator is as safe and effective as the predicate device, it can be concluded that The EVOLVE System with the Tone Applicator is substantially equivalent to the predicate device; InMode System with the Tone Applicator cleared under 510(k) K192249, and therefore may be legally marketed in the USA.
§ 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).