InMode Evolve System with the Tone Applicator

K201285 · InMode , Ltd. · IPF · Mar 5, 2021 · Physical Medicine

Device Facts

• Record ID: K201285
• Device Name: InMode Evolve System with the Tone Applicator
• Applicant: InMode , Ltd.
• Product Code: IPF · Physical Medicine
• Decision Date: Mar 5, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5850
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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 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.

Device Story

Computerized electro-muscle and transcutaneous nerve stimulation device; console with LCD touch screen, power supply, and controller; connects to up to four Tone Applicators via cables. Operates in EMS or TENS modes; delivers symmetrical biphasic rectangular electrical pulses to body areas. Used in clinical settings by healthcare providers. Output intensity, pulse width, and frequency are adjustable via the user interface. Benefits include muscle re-education, pain relief, and prevention of venous thrombosis post-surgery. Safety features include automatic overload/no-load trips, patient override control, and automatic shut-off.

Clinical Evidence

Bench testing only. No clinical data provided. Testing validated output waveforms, basic unit characteristics, and compliance with IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-10 standards. Biocompatibility confirmed per ISO 10993-1.

Technological Characteristics

Powered muscle/nerve stimulator; 100-240 VAC input; 48V AC/DC power supply. Symmetrical biphasic rectangular waveform; 3-200 Hz frequency; 20-400 μs pulse width; up to 54 Vpeak intensity. Housing: PC Makrolon 2458. Connectivity: Wired applicators. Standards: ANSI AAMI ES 60601-1, IEC 60601-1-2, IEC 60601-2-10, IEC 60601-1-6.

Indications for Use

Indicated for patients requiring muscle stimulation (spasm relaxation, atrophy prevention, circulation, re-education, range of motion, post-surgical calf stimulation) or pain management (chronic intractable, post-surgical, or post-trauma acute pain).

Regulatory Classification

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.

Predicate Devices

• InMode System with the Tone Applicator (K192249)

Reference Devices

• The EVOLVE System (K183450)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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: [phone] Fax: [phone] 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: [phone] 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 x<br>18.2" 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 modules<br>AC/DC power supply | Converts AC input voltage (100-240Vac) to<br>6Vdc |
| Waveform | Symmetrical Biphasic |
| Shape | Rectangular |
| Intensity (output Voltage) | Up to 50 intensity level (=54 Vpeak) |
| Pulse Width<br>Tone Applicator | 20 to 400 $ μ$ S |
| Frequency<br>Tone 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 with<br>the Tone Applicator | InMode System with the<br>Tone Applicator |
| Manufacturer | InMode MD Ltd. | InMode MD Ltd. |
| Class, Product Code. | Class II<br>IPF GZJ | Class II<br>IPF, GZJ |
| Design: | The EVOLVE System with<br>Tone Applicator consists of<br>an AC/DC power supply<br>unit, controller and user<br>interface including an LCD<br>touch screen. The delivery<br>of the electrical energy is<br>controlled by a Start/Stop<br>button positioned on the<br>front panel.<br><br>The System supports the<br>following components:<br>● LCD display touch<br>screen<br>● Audio loudspeaker<br>● 48V AC/DC power<br>supply<br>● Controller<br>● The System operates<br>while connected to the<br>Tone Applicator. | The InMode System with<br>Tone Applicator consists of<br>an AC/DC power supply<br>unit, controller and user<br>interface including an LCD<br>touch screen. The delivery of<br>the electrical energy is<br>controlled by a Start/Stop<br>button positioned on the front<br>panel.<br><br>The System supports the<br>following components:<br>● LCD display touch<br>screen<br>● Audio loudspeaker<br>● 48V AC/DC power<br>supply<br>● Controller<br>● The System operates while<br>connected to the Tone<br>Applicator. |
| Mechanism of Action | Muscle contraction by<br>electrical pulsing. | Muscle contraction by<br>electrical pulsing. |
| Components<br>Console | The EVOLVE System<br>consists of the following<br>components:<br>● Console, including a<br>power supply unit,<br>controller and user<br>interface including an<br>LCD touch screen. | The InMode System consists<br>of the following components:<br>● Console, including a<br>power supply unit,<br>controller and user<br>interface including an<br>LCD touch screen. |
| Characteristic | Subject Device | Predicate |
| 510(k) file No. | K201285 | K192249 |
| Device Name | EVOLVE System with<br>the Tone Applicator | InMode System with the<br>Tone Applicator |
| Manufacturer | InMode MD Ltd. | InMode MD Ltd. |
| | • Tone applicator with up<br>to 4 units connected to<br>the console via 4<br>designated cables and 4<br>designated connection<br>ports. | • Tone applicator with up to<br>2 units connected to the<br>console via a cable with<br>splitter and a single<br>connection port. |
| Dimension<br>Console<br>[W x H x D] | 46cm W x 46cm D x<br>100cm H [18.2" W x<br>18.2" D x 44" H] | 35cm W x 35cm D x 100cm<br>H [18.2" W x 18.2" D x<br>40" H] |
| Applicator<br>[L x D] | Tone Applicator<br>12cm L x 10cm D<br>[4.7" L x 4" D] | Tone Applicator<br>12cm L x 10cm D<br>[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.] |
| Performance<br>Specifications:<br>Components<br>Console | Main Line Frequency<br>(nominal)<br>50-60Hz<br>Input Voltage (nominal)<br>100-240VAC<br>Input Current (rms)<br>4A | Main Line Frequency<br>(nominal)<br>50-60Hz<br>Input Voltage (nominal)<br>100-240VAC<br>Input Current (rms)<br>2A |
| Method of Line Current<br>Isolation | Independent transformer<br>isolated | Independent transformer<br>isolated |
| Electrical Type | Type BF | Type BF |
| Patient Leakage Current<br>- Normal Condition (μΑ) | <100uA patient leakage | <100uA patient leakage |
| Patient Leakage Current<br>- Single Fault Condition<br>(μΑ) | <300uA line leakage | <300uA line leakage |
| Number of Output Modes | 2 | 2 |
| Number of Output<br>Channels | 2 | 2 |
| Synchronous or<br>Alternating | See Output Specifications<br>Below | See Output Specifications<br>Below |
| Method of Channel<br>Isolation | Through transformers and<br>isolators | Through transformers and<br>isolators |
| Characteristic | Subject Device | Predicate |
| 510(k) file No. | K201285 | K192249 |
| Device Name | EVOLVE System with<br>the Tone Applicator | InMode System with the<br>Tone Applicator |
| Manufacturer | InMode MD Ltd. | InMode MD Ltd. |
| Regulated Current or<br>Regulated Voltage<br>(output signals only) | Regulated voltage on all<br>channels<br>With current limit | Regulated voltage on all<br>channels<br>With current limit |
| Software/Firmware/Micr<br>oprocessor 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 CFR<br>890.5850 (IPF) | Yes | Yes |
| Compliance with 21 CFR<br>882.5890 (GZJ) | Yes | Yes |
| Applicator Name | Tone Applicator | Tone Applicator |
| EMS Output Mode | | |
| Output Specifications:<br>Waveform | Symmetrical Biphasic<br>Waveform | Symmetrical Biphasic<br>Waveform |
| Pulse Shape | Rectangular | Rectangular |
| Maximum Output Voltage<br>(± 10%) | 56V @500Ω | 56V @500Ω |
| | 56V @2 kΩ | 56V @2 kΩ |
| | 56V @10kΩ | 56V @10kΩ |
| Maximum Output Current<br>(± 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.) - The<br>output active positive pulse<br>width | 20 to 400 [μs] | 20 to 400 [μs] |
| Frequency (Hz) | 3 to 200 [Hz] | 3 to 200 [Hz] |
| Net Charge @ 500 ohms<br>[μC/pulse] | 0 [μC] @ 500Ω | 0 [μC] @ 500Ω |
| Characteristic | Subject Device | Predicate |
| 510(k) file No. | K201285 | K192249 |
| Device Name | EVOLVE System with<br>the Tone Applicator…