InMode System with Tone Applicator

K192249 · InMode , Ltd. · IPF · Dec 17, 2019 · Physical Medicine

Device Facts

• Record ID: K192249
• Device Name: InMode System with Tone Applicator
• Applicant: InMode , Ltd.
• Product Code: IPF · Physical Medicine
• Decision Date: Dec 17, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5850
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The InMode System with Tone Applicator is used in EMS mode for: Prevention or retardation of disuse atrophy Maintaining or increasing range of motion Muscle re-education Relaxation of muscle spasms Increasing local blood circulation Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis And in TENS mode for: Symptomatic relief and management of chronic, intractable pain Post-surgical acute pain Post-traumatic acute pain

Device Story

InMode System with Tone Applicator; console-based electrical stimulator; provides EMS and TENS therapy. Inputs: user-selected parameters via LCD touch screen. Transformation: AC/DC power supply converts input to symmetrical biphasic rectangular electrical pulses; controlled by microprocessor. Outputs: electrical stimulation delivered via Tone Applicator electrodes to patient. Used in professional healthcare facilities; operated by clinicians. Output allows clinicians to manage pain or stimulate muscle tissue; benefits include atrophy prevention, pain relief, and improved circulation. Safety features include automatic overload/no-load trips, patient override, and automatic shut-off.

Clinical Evidence

Bench testing only. No clinical data. Bench testing validated output waveforms, unit characteristics, and design requirements. Biocompatibility assessment (cytotoxicity, acute systemic toxicity, sensitization) confirmed non-toxic and non-irritating.

Technological Characteristics

Console-based powered muscle stimulator; 100-240 VAC input; 48V DC output. Symmetrical biphasic rectangular waveforms; 3-200 Hz frequency; 20-400 μs pulse width. Housing: PC Makrolon 2458. Connectivity: Standalone console with wired applicator. Safety: Type BF, independent transformer isolation. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10, IEC 60601-1-6, ANSI/AAMI NS4.

Indications for Use

Indicated for patients requiring EMS for muscle atrophy prevention, range of motion maintenance, muscle re-education, spasm relaxation, local blood circulation, or post-surgical calf stimulation; and TENS for chronic, intractable, post-surgical, or post-traumatic pain management.

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

• Vectra Neo Clinical Therapy System (K132284)

Submission Summary (Full Text)

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December 17, 2019

InMode Ltd. % Amit Goren Regulatory Manager A. Stein - Regulatory Affairs Consulting Ltd. 20 Hata'as Str., Suite 102 Kfar Saba, 4442520 Israel

Re: K192249

Trade/Device Name: InMode System with Tone Applicator Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: IPF, GZJ Dated: September 16, 2019 Received: September 18, 2019

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.

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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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

For Vivek Pinto, Ph.D. 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) K192249

Device Name InMode System with Tone Applicator

Indications for Use (Describe)

The InMode System with Tone Applicator is used in EMS mode for:

Prevention or retardation of disuse atrophy

Maintaining or increasing range of motion

Muscle re-education

Relaxation of muscle spasms

Increasing local blood circulation

Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis

And in TENS mode for: Symptomatic relief and management of chronic, intractable pain Post-surgical acute pain Post-traumatic acute pain

Type of Use (Select one or both, as applicable)

X 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 INMODE SYSTEM WITH TONE APPLICATOR

# 510(k) Number K192249

# Applicant Name:

| Company Name: | InMode Ltd. |
|-------------------------|--------------------------------------------------------------------------------------------------------------------------------------|
| Address: | Tabor Building, Shaar Yokneam<br>Yokneam 20692<br>Israel<br>Tel: [phone]<br>Fax: [phone]<br>E-mail: [e-mail] |
| Contact Person: | |
| Official Correspondent: | Amit Goren |
| Company Name: | A. Stein - Regulatory Affairs Consulting Lt |
| Address: | 20 Hata'as Str., Suite 102<br>Kfar Saba 4442520 Israel<br>Tel: [phone]<br>Fax: [phone]<br>E-mail: [e-mail] |
| Date Prepared: | December 11, 2019 |
| Trade Name: | The InMode System with Tone Applicator |
| Classification Name: | Powered Muscle Stimulator |
| Common Name: | Powered Muscle Stimulator |
| Regulation Number: | 890.5850 & 882.5890 |
| Product Code: | IPF & GZJ |
| Classification: | Class II Medical Device |

#### Predicate Device:

The InMode System with Tone Applicator is substantially equivalent to the following predicate device.

| Predicate | Manufacturer | 510(k) No. |
|------------------------------------|--------------|------------|
| Vectra Neo Clinical Therapy System | DJO, LLC | K132284 |

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## Device Description:

The InMode System in combination with Tone Applicator (manufactured by InMode Ltd.), is a versatile device intended to employ EMS (Electrical Muscle Stimulation) and TENS (Transcutaneous Electrical Nerve Stimulation) technologies for various medical applications. The InMode System with Tone Applicator consists of an AC/DC power supply unit, controller and user interface including an LCD touch screen. The delivery of the electrical energy is controlled by a Start/Stop button positioned on the front panel.

The System support 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 InMode System with Tone Applicator specifications:

| Main Line Frequency (nominal): | 50-60 Hz |
|--------------------------------|------------------------------------------|
| Input Voltage (nominal): | 100-240 VAC |
| Input Current (rms) | 2A |
| Dimension: | |
| Console | 35cm W x 35cm D x 100cm H |
| [W x H x D] | [18.2" W x 18.2" D x 40" H] |
| Applicator | Tone Applicator |
| [L x D] | 12cm L x 10cm D [4.7" L x 4" D] |
| Weight Console: | 20 Kg (44 lbs) |
| Tone Applicator Weight: | 0.22 Kg [0.5 lbs.] |
| Platform modules | Converts AC input voltage (90-264Vac) to |
| AC/DC power supply | 48Vdc, 300W |
| Waveform | Symmetrical Biphasic |
| Shape | Rectangular |
| Intensity (output Voltage) | Up to 50 intensity level (=54 Vpeak) |
| Pulse Width | |
| Tone Applicator | 20 to 400 $ \mu $ S |
| Frequency | |
| Tone Applicator | 3 to 200 Hz |

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## Intended Use/Indication for Use:

The InMode System with Tone Applicator is used in EMS mode for:

- 트 Prevention or retardation of disuse atrophy
- Maintaining or increasing range of motion ■
- Muscle re-education ■
- Relaxation of muscle spasms
- Increasing local blood circulation
- Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis

And in TENS mode for:

- Symptomatic relief and management of chronic, intractable pain 트
- 트 Post-surgical acute pain
- Post-traumatic acute pain

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#### Performance Standards:

The InMode System with Tone Applicator has been tested and complies with the following FDA recognized consensus standards:

- · IEC 60601-1: Medical Electrical Equipment Part 1: General Requirements For Basic Safety And Essential Performance ES60601-1:2005/(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 (IEC 60601-1:2005 Edition 3rd, MOD)
- · Appendix 6-Clause 3.2.2.1 and Clause 3.2.2.2 from ANSI/AAMI NS4:2013/(R)2017
- · IEC 60601-1-2: Medical electrical equipment; Part 1-2: Collateral Standard: Electromagnetic compatibility - Requirements and tests, Edition 4.0 (2014). Environment of intended uses: Professional Healthcare Facility Environment
- · IEC 60601-2-10 Medical electrical equipment Part 2: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators (IEC 60601-2-10 Edition 2.1 2016-04) IEC 60601-2-10: 2012, AMD1:2016 for use in conjunction with IEC 60601-1:2005/AMD1:2016
- · IEC 60601-1-6 Medical Electrical Equipment Part 1-6: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Usability (60601-1-6 Edition 3.1 2013-10, AMD1:2013)

## Non-Clinical (Bench) Performance Data:

Bench testing was conducted to demonstrate that the InMode System with 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

The biocompatibility of the Tone Applicator outer components (handle and electrodes)

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was justified using a biocompatibility assessment performed on a family of related products and by scientific evidence. The following biocompatibility tests were performed as part of the biocompatibility assessment:

| Test | Test Summary | Conclusions |
|----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|---------------------------------|
| Cytotoxicity Study Using the ISO<br>Elution Method | The test article extract<br>showed no evidence of<br>causing cell lysis or<br>toxicity | Non-toxic |
| ISO Acute Systemic Toxicity<br>Study in Mice | The test article extracts<br>showed no evidence of<br>causing delayed dermal<br>contact sensitization in the<br>guinea<br>pig. | Non-toxic |
| ISO Guinea Pig Maximization<br>Sensitization Test | There was no mortality or<br>evidence of systemic<br>toxicity from the extracts<br>injected into mice | No irritation/<br>sensitization |

# Pre-Clinical (Animal) Performance Data:

Non-Applicable.

#### Clinical Performance Data:

Non-Applicable.

# Substantial Equivalence:

The below table summarizes the main comparison aspects between the InMode System with Tone Applicators and the proposed predicate device.

| Characteristic | Subject Device | Predicate |
|------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) file No. | K192249 | K132284 |
| Device Name | InMode System with<br>Tone Applicator | Vectra Neo<br>Clinical Therapy<br>System |
| Manufacturer | InMode Ltd. | DJO, LLC |
| Class, Product Code. | Class II<br>IPF GZJ | Class II<br>IPF, GZJ<br>IMG, HCC, GZI |
| Characteristic | Subject Device | Predicate |
| 510(k) file No. | K192249 | K132284 |
| Device Name | InMode System with<br>Tone Applicator | Vectra Neo<br>Clinical Therapy<br>System |
| Manufacturer | InMode Ltd. | DJO, LLC<br>LIH, ILY |
| Design: | The InMode System with<br>Tone Applicator consists<br>of an AC/DC power<br>supply unit, controller and<br>user interface including an<br>LCD touch screen. The<br>delivery of the electrical<br>energy is controlled by a<br>Start/Stop button<br>positioned on the front<br>panel.<br>The System support the<br>following components:<br>• LCD display touch<br>screen<br>• Audio loudspeaker<br>• 48V AC/DC power<br>supply<br>• Controller<br>• Fans<br>The System operates<br>while connected to the<br>Tone Applicator. | The Vectra Neo<br>Vlinical Therapy<br>System consists of<br>an AC/DC power<br>supply unit,<br>controller and user<br>interface including<br>color display. The<br>delivery of the<br>electrical energy is<br>controlled by a<br>Start/Stop button<br>positioned on the<br>front panel. |
| Mechanism of Action | Muscle contraction by<br>electrical pulsing. | Idem |
| Components<br>Console | The InMode 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.<br>• Tone Applicator<br>connected to the<br>console via a cable. | Vectra Neo Clinical<br>Therapy System<br>consists of the<br>following<br>components:<br>• Console,<br>including a power<br>supply unit,<br>controller and<br>user interface<br>including an LCD<br>touch screen.<br>• Several types of<br>applicators for<br>different |
| Characteristic | Subject Device | Predicate |
| 510(k) file No. | K192249 | K132284 |
| Device Name | InMode System with<br>Tone Applicator | Vectra Neo<br>Clinical Therapy<br>System |
| Manufacturer | InMode Ltd. | DJO, LLC |
| | | indications (EMS,<br>Ultrasound, EMG<br>& Laser)<br>connected to the<br>console via a<br>cable. |
| Dimension<br>Console<br>[W x H x D] | 35cm W x 35cm D<br>x 100cm H<br>[18.2" W x 18.2" D x<br>40" H] | not publicly<br>available |
| Applicator<br>[L x D] | Tone Applicator<br>12cm L x 10cm D<br>[4.7" L x 4" D] | |
| Weight Console | 20.0 Kg [44 lbs.] | not publicly<br>available |
| Weight applicator | 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>2A | not publicly<br>available |
| Method of Line Current Isolation | Independent transformer<br>isolated | not publicly<br>available |
| Electrical Type | Type BF | not publicly<br>available |
| Patient Leakage Current - Normal<br>Condition (μΑ) | <100uA patient leakage | not publicly<br>available |
| Patient Leakage Current - Single<br>Fault Condition (μΑ) | <300uA line leakage | not publicly<br>available |
| Number of Output Modes | 2 | not publicly<br>available |
| Number of Output Channels | 2 | not publicly<br>available |
| Characteristic | Subject Device | Predicate |
| 510(k) file No.<br>Device Name | K192249<br>InMode System with<br>Tone Applicator | K132284<br>Vectra Neo<br>Clinical Therapy<br>System |
| Manufacturer | InMode Ltd. | DJO, LLC |
| Synchronous or Alternating | See Output Specifications<br>Below | not publicly<br>available |
| Method of Channel Isolation | Through transformers and<br>isolators | not publicly<br>available |
| Regulated Current or Regulated<br>Voltage (output signals only) | Regulated voltage on all<br>channels<br>With current limit | not publicly<br>available |
| Software/Firmware/Microprocessor<br>Control | Yes | not publicly<br>available |
| Automatic Overload Trip | Yes | not publicly<br>available |
| Automatic No-Load Trip | Yes | not publicly<br>available |
| Automatic Shut Off | Yes, On/off switch | not publicly<br>available |
| Patient Override Control | Yes | not publicly<br>available |
| Indicator Display | Yes | not publicly<br>available |
| On/Off Status | Yes | not publicly<br>available |
| Battery | No battery | not publicly<br>available |
| Voltage/Current level | Yes, voltage levels | not publicly<br>available |
| Timer Range (Minutes) | 0-60 [minutes] | not publicly<br>available |
| Compliance with 21 CFR 890.5850<br>(IPF) | Yes | not publicly<br>available |
| Compliance with 21 CFR 882.5890<br>(GZJ) | Yes | not publicly<br>available |
| Applicator Name | Tone Applicator | Vectra Neo Clinical<br>Therapy System<br>Applicator |
| Characteristic | Subject Device | Predicate |
| 510(k) file No. | K192249 | K132284 |
| Device Name | InMode System with<br>Tone Applicator | Vectra Neo<br>Clinical Therapy<br>System |
| Manufacturer | InMode Ltd. | DJO, LLC |
| EMS Output Mode | | |
| Output Specifications:<br>Waveform | Symmetrical Biphasic<br>Waveform | not publicly<br>available |
| Pulse Shape | Rectangular | not publicly<br>available |
| Maximum Output Voltage (± 10%) | 56V @500Ω | not publicly<br>available |
| | 56V @2 kΩ | not publicly<br>available |
| | 56V @10kΩ | not publicly<br>available |
| Maximum Output Current (± 10%) | 112 mA @ 500 Ω | not publicly<br>available |
| | 28 mA @ 2 kΩ | not publicly<br>available |
| | 5.6 mA @ 10 kΩ | not publicly<br>available |
| Pulse Width (μsec.) - The output<br>active positive pulse width | 20 to 400 [µs] | not publicly<br>available |
| Frequency (Hz) | 3 to 200 [Hz] | not publicly<br>available |
| Net Charge @ 500 ohms<br>[µC/pulse] | 0 [μC] @ 500Ω | not publicly<br>available |
| Maximum Phase Charge [µC] | 44.8 [µC] @ 500Ω | not publicly<br>available |
| Maximum Current Density<br>[mA/cm2] | 1 [mA/cm2]<br>Surface = 12cm² | not publicly<br>available |
| Maximum Power Density<br>[mW/cm2] | 55[mW/cm2] @500Ω | not publicly<br>available |
| Burst Mode (i.e., pulse trains) | Yes: | not publicly<br>available |
| a. Pulses per burst | a. 3 - 200 | |
| b. Bursts per second | b. 1 | |
| c. Burst duration (seconds) | c. 1-60 sec | |
| d. Duty Cycle [Line (b) x Line (c)] | d. Time on / off | |
| On Time (sec.) | 1 - 60 [sec] | not publicly<br>available…