InMode System with vTone Applicator

K200293 · InMode , Ltd. · KPI · May 5, 2020 · Gastroenterology, Urology

Device Facts

• Record ID: K200293
• Device Name: InMode System with vTone Applicator
• Applicant: InMode , Ltd.
• Product Code: KPI · Gastroenterology, Urology
• Decision Date: May 5, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5320
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The InMode System with the vTone Applicator is intended to provide electrical stimulation and neuromuscular reeducation for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of stress, urge, and mixed urinary incontinence in women.

Device Story

The InMode System is a console-based neuromuscular electrical stimulation device used in hospital or clinic settings by healthcare professionals. It consists of an AC/DC power supply, controller, and LCD touch screen interface. The system connects to a single-use vTone applicator, which features chrome-coated plastic electrodes. The device generates rectangular, biphasic electrical pulses to stimulate pelvic floor muscles, facilitating neuromuscular reeducation. Users select stimulation intensity (1-50 levels), pulse width (50-450µsec), and frequency (3-100Hz) via the touch screen. The system operates in bursts of 1-60 seconds followed by relaxation periods of 1-60 seconds. By inducing muscle contractions, the device aims to rehabilitate weak pelvic floor muscles, potentially improving symptoms of urinary incontinence. The healthcare provider monitors the session via the console display and controls delivery using a Start/Stop button.

Clinical Evidence

No clinical data. Bench testing only. Performance verified through output waveform validation, electrical/mechanical safety testing (IEC 60601-1), EMC testing (IEC 60601-1-2), and nerve/muscle stimulator performance testing (IEC 60601-2-10). Biocompatibility of vTone applicator materials (chrome-coated plastic) confirmed via cytotoxicity, acute systemic toxicity, sensitization, and vaginal irritation studies in accordance with ISO 10993-1.

Technological Characteristics

Console-based neuromuscular stimulator; AC/DC power supply (100-240 VAC to 48Vdc). Output: Biphasic, rectangular waveform; 5-54V peak; 50-450µsec pulse width; 3-100Hz frequency. Applicator: Chrome-coated plastic electrodes (9.58cm²). Connectivity: Wired connection between console and applicator. Software: Microprocessor-controlled with LCD touch interface. Safety: Type BF applied part, independent transformer isolation, automatic no-load trip. Sterilization: Not specified (single-use applicator). Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10, IEC 60601-1-6.

Indications for Use

Indicated for women requiring rehabilitation of weak pelvic floor muscles for the treatment of stress, urge, and mixed urinary incontinence.

Regulatory Classification

Identification

A nonimplanted electrical continence device is a device that consists of a pair of electrodes on a plug or a pessary that are connected by an electrical cable to a battery-powered pulse source. The plug or pessary is inserted into the rectum or into the vagina and used to stimulate the muscles of the pelvic floor to maintain urinary or fecal continence. When necessary, the plug or pessary may be removed by the user. This device excludes an AC-powered nonimplanted electrical continence device and the powered vaginal muscle stimulator for therapeutic use (§ 884.5940).

Predicate Devices

• Kegel8 device (K081480)

Submission Summary (Full Text)

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May 5, 2020

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

Re: K200293

> Trade/Device Name: InMode System with vTone Applicator Regulation Number: 21 CFR§ 876.5320 Regulation Name: Nonimplanted electrical continence device Regulatory Class: II Product Code: KPI Dated: January 30, 2020 Received: February 5, 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.

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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 devicerelated 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/guidanceregulatory-information/postmarketing-safety-reporting-combination-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-devices/medical-devicesafety/medical-device-reporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-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/medicaldevices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-andconsumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Purva Pandya Acting Assistant Director DHT3B: Division of Reproductive, Gynecology and Urology Devices OHT3: Office of Gastrorenal, ObGyn, General Hospital and Urology 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) K200293

Device Name InMode System with vTone Applicator

Indications for Use (Describe)

The InMode System with the vTone Applicator is intended to provide electrical stimulation and neuromuscular reeducation for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of stress, urge, and mixed urinary incontinence in women.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> <span style="font-size: 16px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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#### 510(K) SUMMARY

## THE INMODE SYSTEM WITH THE VTONE APPLICATOR

#### 510(k) Number K200293

#### Applicant Name:

| Company Name: | InMode MD Ltd. |
|------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|
| Address: | Tabor Building, Shaar Yokneam<br>Yokneam 20692<br>Israel<br>Tel: [phone]<br>Fax: [phone]<br>E-mail: [e-mail] |
| Contact Person: | Amit Goren |
| Official Correspondent:<br>Company Name: | A. Stein - Regulatory Affairs Consulting Ltd. |
| 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: | April 21, 2020 |
| Trade Name: | The InMode System with vTone Applicator |
| Classification Name: | CFR Classification section 876.5320;<br>(Product code: KPI)<br>Nonimplanted Electrical Continence Device |
| Classification: | Class II Medical Device |

#### Predicate Device:

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

| Predicate | Manufacturer | 510(k) No. |
|---------------|-------------------------------|------------|
| Kegel8 device | Mantra International (HK) Ltd | K081480 |

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### Device Description:

The InMode System is a computerized device intended to provide electrical stimulation and neuromuscular reeducation for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of stress, urge, and mixed urinary incontinence in women. . The System consists of an AC/DC power supply unit, controller and user interface including an LCD touch screen. The single use vTone Applicator is connected to the console via pulse generator adaptor.

The delivery of the electrical energy is controlled by a Start/Stop button positioned on the LCD screen.

The System emits an electrical signal of rectangular bi-phasic wave, and allows selecting intensity level of stimulation pulses from 1 to 50 intensity levels (equivalent to 5-54V). The system pulse width ranges from 50 to 450usec.

The system pulse frequency ranges from 3 to 100Hz. In addition, the device emits the pulses in bursts of 1-60 sec, with a succeeding relaxation time of 1-60 sec, depending on the intensity level chosen by the user.

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 following applicator:

- · vTone Applicator
Following are The InMode System with vTone Applicator specifications:

| Main Line Frequency (nominal): | 50-60 Hz |
|--------------------------------|-----------------------------|
| Input Voltage (nominal): | 100-240 VAC |
| Input Current (rms): | 2A |
| Dimensions: | |
| Console | 35cm W x 35cm D x 100cm H |
| [W x H x D] | [18.2" W x 18.2" D x 40" H] |
| vTone Applicator | 8.8cm L x 2.8cm D |
| | |

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| [L x D] | [3.5'' L x 1.1'' D] |
|----------------------------|-------------------------------------------|
| Console Weight: | 20 Kg (44 lbs) |
| vTone Applicator Weight: | 0.11 Kg [0.25 lbs.] |
| vTone electrode material | Chrome coated plastic |
| vTone electrode size | 9.58cm2 |
| Platform modules | Converts AC input voltage (100-240VAC) to |
| AC/DC power supply | 48Vdc, 300W |
| Waveform | Biphasic |
| Shape | Rectangular |
| Intensity (output Voltage) | Up to 50 intensity level (=54 Vpeak) |
| Pulse Width | 50 to 450 usec |
| Frequency | 3 to 100 Hz |

### Intended Use/Indication for Use:

The InMode System with the vTone Applicator is intended to provide electrical stimulation and neuromuscular re-education for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of stress, urge, and mixed urinary incontinence in women.

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#### Performance Standards:

The InMode System with vTone 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)
- · 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 vTone 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 vTone Applicator outer components (handle and electrodes) was verified in a set of Biocompatibility Tests in accordance with the Biocompatibility classification set forth in ISO 10993-1:2018 and in compliance with the FDA Guidance Document on Medical Device Biocompatibility; "Use of International Standard ISO

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10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" Issued June 16, 2016.

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 Study<br>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 |
| ISO Vaginal Irritation sensitization<br>in rabbit | The test article extract was<br>considered a nonirritant to<br>vaginal tissue of the rabbit | No irritation |

#### 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 InMode System with vTone Applicator and the proposed predicate devices; The InMode System with the vTone Applicator is substantially equivalent to the previously FDA cleared Kegel 8 device (manufactured by Mantra International (HK) Ltd.), subject of 510(k) files no. K081480

| Characteristic | Subject Device | Predicate |
|--------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) file No. | K200293 | K081480 |
| Device Name | InMode System with<br>vTone Applicator | Kegel8 |
| Equivalence | Platform vTone Applicator | NA Applicator |
| Manufacturer | InMode Ltd. | Mantra International (HK) Ltd |
| Prescription/O<br>TC | Prescription | Prescription |
| Class, Product<br>Code. | Class II<br>KPI | Class II<br>KPI |
| Indications for<br>Use | The InMode System with<br>the vTone Applicator is<br>intended to provide<br>electrical stimulation and<br>neuromuscular re-<br>education for the purpose<br>of rehabilitation of weak<br>pelvic floor muscles for<br>the treatment of stress,<br>urge, and mixed urinary<br>incontinence in women | The 'Kegel8' Pelvic Muscle<br>Trainer is intended to provide<br>electrical stimulation and<br>neuromuscular re-education for<br>the purpose of rehabilitation of<br>weak pelvic floor muscles for<br>the treatment of stress urge and<br>mixed urinary incontinence in<br>women |
| Target<br>Population | Adult Population which<br>require treatment as<br>specified in the indication<br>for use | Idem |
| Anatomical<br>Sites | Body parts requiring<br>treatment as specified in<br>the indication for use | Idem |
| Environment<br>Used | Hospital or Clinic setting | Idem |
| Characteristic | Subject Device | Predicate |
| 510(k) file No. | K200293 | K081480 |
| Device Name | InMode System with<br>vTone Applicator | Kegel8 |
| Equivalence | • Platform<br>• vTone Applicator | • NA<br>• Applicator |
| Manufacturer | InMode Ltd. | Mantra International (HK) Ltd |
| Design: | The InMode System with<br>vTone Applicator consists<br>of an AC/DC power<br>supply unit, controller and<br>user interface including<br>an 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><br>The System support the<br>following components:<br><br>• LCD display touch<br>screen<br>• Audio loudspeaker<br>• 48V AC/DC power<br>supply<br>• Controller<br><br>The System operates<br>while connected to the<br>following applicator:<br><br>• vTone Applicator | The Kegel8 Pelvic Muscle<br>Trainer is a small lightweight<br>battery powered dual<br>channel neuromuscular<br>stimulation device supplied with<br>a vaginal two electrode<br>stimulation probe.<br><br>The probe connects to the<br>control unit by cable and plug. |
| Mechanism of<br>Action | Muscle contraction by<br>electrical pulsing | Idem |
| Characteristic | Subject Device | Predicate |
| 510(k) file No. | K200293 | K081480 |
| Device Name | InMode System with<br>vTone Applicator | Kegel8 |
| Equivalence | • Platform<br>• vTone Applicator | • NA<br>• Applicator |
| Manufacturer | InMode Ltd. | Mantra International (HK) Ltd |
| - 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>• vTone Applicator<br>connected to the<br>console via a cable. | The Kegel 8 treatment unit<br>consists of the following<br>components:<br>• 9V PP3 Battery, user<br>interface and LCD display<br>• Probe and lead |
| Dimensions<br>Console<br>[W x H x D] | 35cm W x 35cm D x<br>100cm H<br>[18.2" W x 18.2" D x<br>40" H] | 6.2cm W x 2.3cm D x 10.8cm H<br>[2.4" W x 0.9" D x 4.25" H] |
| Applicator<br>[L x D] | 8.8cm L x 2.8cm D<br>[3.5" L x 1.1" D] | 8.7 cm L x 2.6 cm D<br>[3.41" L x 1.01" D] |
| Weight Console | 20.0 Kg [44 lbs.] | 0.07 Kg without battery, 0.1KG<br>with battery |
| Weight<br>applicator | 0.11 Kg [0.25 lbs.] | Not publicly available |
| Performance Specifications: System | | |
| Power<br>Source(s) | Main Line Frequency<br>(nominal)<br>50-60Hz<br>Input Voltage (nominal)<br>100-240VAC<br>Input Current (rms)<br>2A | 9V PP3 |
| Method of Line<br>Current<br>Isolation | Independent transformer<br>isolated | NA - Battery powered |
| Characteristic | Subject Device | Predicate |
| 510(k) file No. | K200293 | K081480 |
| Device Name | InMode System with<br>vTone Applicator | Kegel8 |
| Equivalence | • Platform<br>• vTone Applicator | • NA<br>• Applicator |
| Manufacturer | InMode Ltd. | Mantra International (HK) Ltd |
| Electrical Type | Type BF | Type BF |
| Patient Leakage<br>Current -<br>Normal<br>Condition (μΑ) | <100 μΑ | NA – Battery powered |
| Patient Leakage<br>Current - Single<br>Fault Condition<br>(μΑ) | <500 μΑ | NA – Battery powered |
| Number of<br>Output Modes | 1 | 1 |
| Number of<br>Output<br>Channels | 1 | 2 |
| Synchro<br>–<br>nous or<br>Alternati<br>ng | NA – 1 Channel | Synchronous/ Alternating |
| Method<br>–<br>of<br>Channel<br>Isolation | NA – 1 Channel | Individually isolated circuits |
| Regulated<br>Current or<br>Regulated<br>Voltage (output<br>signals only) | Regulated Voltage with<br>current limit | Regulated Current |
| Software/Firmw<br>are/Microproces<br>sor Control | Yes | Yes |
| Automatic<br>Overload Trip | No | Not publicly available |
| Automatic No-<br>Load Trip | Yes | Not publicly available |
| Characteristic | Subject Device | Predicate |
| 510(k) file No. | K200293 | K081480 |
| Device Name | InMode System with<br>vTone Applicator | Kegel8 |
| Equivalence | • Platform<br>• vTone Applicator | • NA<br>• Applicator |
| Manufacturer | InMode Ltd. | Mantra International (HK) Ltd |
| Automatic Shut Off | Yes, On/off switch | Yes |
| Patient Override Control | No | Not publicly available |
| Indicator Display:<br>- On/Off Status<br>- Battery | Yes<br>No<br>Yes | Yes<br>Yes<br>Yes |
| Voltage/Current level | | |
| Timer Range (Minutes) | Up to 60 | Up to 90 |
| Performance Specifications: Applicator | | |
| Applicator Name | vTone Applicator | Kegel8 Applicator |
| Output Specifications: Waveform | Biphasic | Biphasic |
| Pulse Shape | Rectangular | Rectangular |
| Maximum Output Voltage (± 10%) | 45V @500Ω<br>54V @2 kΩ<br>54V @10kΩ | 45V @ 500 Ω<br>100V @ 2 kΩ<br>190V @ 10 kΩ |
| Maximum Output Current (± 10%) | 90 mA @ 500 Ω current limit<br>28 mA @ 2 kΩ<br>5.6 mA @ 10 kΩ | 90mA @ 500 Ω<br>50mA @ 2 kΩ<br>19mA @ 10 kΩ<br>And thus, shuts off |
| Pulse Width (μsec.) - The output active positive pulse width | 50 to 450 [μsec] | 50 to 450 [μsec]<br>Program dependent |
| Characteristic | Subject Device | Predicate |
| 510(k) file No. | K200293 | K081480 |
| Device Name | InMode System with<br>vTone Applicator | Kegel8 |
| Equivalence | • Platform<br>• vTone Applicator | • NA<br>• Applicator |
| Manufacturer | InMode Ltd. | Mantra International (HK) Ltd |
| Pulse<br>Frequency (Hz) | 3 to 100 $[Hz]$…