Evolve System with the T3 Applicator

K210877 · InMode , Ltd. · PBX · Jul 19, 2021 · General, Plastic Surgery

Device Facts

• Record ID: K210877
• Device Name: Evolve System with the T3 Applicator
• Applicant: InMode , Ltd.
• Product Code: PBX · General, Plastic Surgery
• Decision Date: Jul 19, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Evolve System with the T3 Applicator employs RF technology or EMS-TENS technology for the treatment of selected medical conditions. The T3 Applicator in RF mode is intended for the temporary relief of minor muscle aches and pain, temporary relief of muscle spasm, and temporary improvement of local blood circulation. The T3 Applicator in EMS mode is intended 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. The T3 Applicator in TENS mode is intended for: Symptomatic relief and management of chronic, intractable pain; Post-surgical acute pain; Post-trauma acute pain. The RF treatment mode and EMS/TENS mode should not be used in combination or sequentially.

Device Story

Evolve System with T3 Applicator delivers non-thermal RF energy, electro-muscle stimulation (EMS), and transcutaneous electrical nerve stimulation (TENS) for therapeutic use in hospital or clinic settings. System comprises console with LCD touch screen, power supply, controller, and RF generators; T3 applicator connects to console via cables. User selects treatment mode (RF, EMS, or TENS) via interface; system software regulates energy delivery. RF mode targets muscle aches, spasms, and circulation; EMS mode targets atrophy, muscle re-education, range of motion, and venous thrombosis prevention; TENS mode targets pain management. Device provides non-invasive treatment; healthcare provider operates system to deliver therapy; output affects clinical decision-making by providing symptomatic relief and physical rehabilitation. Benefits include temporary pain relief, improved circulation, and muscle function maintenance.

Clinical Evidence

No clinical data. Bench testing only, including RF output accuracy, electrode temperature sensor accuracy, temperature build-up profiles, ex-vivo tissue thermal profiles, and EMS/TENS output specification verification.

Technological Characteristics

Class II device; RF (1 MHz) and EMS/TENS (symmetrical biphasic, rectangular waveform) energy sources. Console dimensions 46x46x100cm; T3 applicator 8.9x4cm. Biocompatible materials. Software-controlled energy delivery. Complies with ANSI AAMI ES 60601-1, IEC 60601-1-2, IEC 60601-2-10, IEC 60601-1-6, and IEC 60601-2-2.

Indications for Use

Indicated for adult patients requiring treatment for minor muscle aches/pain, muscle spasms, disuse atrophy, local blood circulation improvement, muscle re-education, range of motion maintenance/increase, post-surgical calf muscle stimulation to prevent venous thrombosis, and management of chronic, intractable, post-surgical, or post-trauma acute pain.

Regulatory Classification

Identification

An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.

Predicate Devices

• Evolve System with the Tone Applicator (K201285)
• The EVOLVE System (K183450)

Submission Summary (Full Text)

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July 19, 2021

InMode Ltd. % Amit Goren Regulatory Consultant A. Stein - Regulatory Affairs Consulting Ltd. 18 Hata'as Str., Suite 21 Kfar Saba, 4442518 Israel

Re: K210877 Trade/Device Name: Evolve System with the T3 Applicator Regulation Numbers: 21 CFR 878.4400 21 CFR 882.5890 21 CFR 890.5850 Regulation Name: Electrosurgical cutting and coagulation device and accessories, Transcutaneous electrical nerve stimulator for pain relief, Powered muscle stimulator Regulatory Class: Class II Product Code: PBX, GZJ, IPF Dated: June 22, 2021 Received: June 24, 2021

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/ofdocs/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.

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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 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 medical devices and radiation-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/cdrl-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,

Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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### Indications for Use

510(k) Number (if known)

#### K210877

Device Name

Evolve System with the T3 Applicator

Indications for Use (Describe)

The Evolve System with the T3 Applicator employs RF technology or EMS-TENS technology for the treatment of selected medical conditions.

The T3 Applicator in RF mode is intended for the temporary relief of minor muscle aches and pain, temporary relief of muscle spasm, and temporary improvement of local blood circulation.

The T3 Applicator in EMS mode is intended 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

The T3 Applicator in TENS mode is intended for:

- · Symptomatic relief and management of chronic, intractable pain
- · Post-surgical acute pain
- · Post-trauma acute pain

The RF treatment mode and EMS/TENS mode should not be used in combination or sequentially.

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 EVOLVE SYSTEM WITH THE T3 APPLICATOR

## 510(k) Number K210877

## Applicant Name:

| Company Name: | InMode Ltd. |
|--------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | Tabor Building, Shaar Yokneam<br>Yokneam 2069200<br>Israel |
| Tel: | [phone] |
| Fax: | [phone] |
| E-mail: | [e-mail] |
| Contact Person:<br>Official Correspondent: | Amit Goren |
| Company Name: | A. Stein - Regulatory Affairs Consulting Ltd |
| Address: | 18 Hata'as St.<br>Kfar Saba 4442518 Israel |
| Tel: | + 972-9-7670002 |
| Fax: | [phone] |
| E-mail: | [e-mail] |
| Date Prepared: | July 18, 2021 |
| Trade Name: | EVOLVE System with the T3 Applicator |
| Classification Name: | CFR Classification section 890.5850;<br>(Product codes: IPF)<br>CFR Classification section 882.5890;<br>(Product codes: GZJ)<br>CFR Classification section 878.4400;<br>(Product codes: ISA)<br>CFR Classification section 878.4400;<br>(Product codes: PBX) |
| Classification: | Class II Medical Device |

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### Predicate Devices:

The EVOLVE System with the T3 Applicator is substantially equivalent to the following primary and secondary predicate devices.

| Manufacturer | Device | 510(k) No. |
|-------------------------------------------|-------------|------------|
| Primary Predicate | | |
| Evolve System with the Tone<br>Applicator | InMode Ltd. | K201285 |
| Secondary Predicate | | |
| The EVOLVE System | InMode Ltd. | K183450 |

#### Device Description:

The Evolve System with the T3 Applicator is designed to deliver non-thermal RF energy and electro-muscle and transcutaneous nerve stimulation for the treatment of different body areas for various medical applications. The Evolve System software controls and regulate the different applied energies in accordance with the user system preprograming and treatment settings. The subject device platform system is identical to the FDA-Cleared Evolve System platform (a.k.a EmBody System and the subject of K183450). The same platform system was recently FDA-Cleared for the use with the Tone Applicator (subject of K201285).

The Evolve System supports the placement of the following components:

- LCD display touch screen,
- Audio loudspeaker, ●
- 48V AC/DC power supply,
- Real time controller, distributor card and 2 RF generators,
- Fans

The System operates while connected to the T3 Applicator.

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| Main Line Frequency (nominal): | 50-60 Hz |
|--------------------------------|-------------------------------------------------------|
| Input Voltage (nominal): | 100-240 VAC |
| Input Current (rms) | 4A |
| Dimension: | |
| Console [W x H x D] | 46cm W x 46cm D x 100cm H [18.2" W x 18.2" D x 44" H] |
| Applicator [L x D] | T3 Applicator<br>8.9cm L x 4cm D [3.6" L x 1.6" D] |
| Weight Console: | 33 Kg (73 lbs.) |
| Tone Applicator Weight: | 0.16 Kg [0.4 lbs.] |
| EMS/TENS | |
| Platform modules | Converts AC input voltage (100-240Vac) to |
| AC/DC power supply | 6Vdc |
| Waveform | Symmetrical Biphasic |
| Shape | Rectangular |
| Intensity (output Voltage) | Up to 50 intensity level (=54 Vpeak) |
| Pulse Width | 20 to 400 $\mu$ Sec |
| T3 Applicator Frequency | 3 to 200 Hz |
| RF | |
| Maximal Output power | 75W |
| Frequency | 1 MHz |
| Pulse duration | 2 sec |

Following are the EVOLVE System with the T3 Applicator specifications:

## Intended Use/Indication for Use:

The Evolve System with the T3 Applicator employs RF technology or EMS-TENS technology for the treatment of selected medical conditions.

The T3 Applicator in RF mode is intended for the temporary relief of minor muscle aches and pain, temporary relief of muscle spasm, and temporary improvement of local blood circulation.

The T3 Applicator in EMS mode is intended for:

- Relaxation of muscle spasms
- . Prevention or retardation of disuse atrophy
- o Increasing local blood circulation
- . Muscle re-education

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- Maintaining or increasing range of motion ●
- Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis

The T3 Applicator in TENS mode is intended for:

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

The RF treatment mode and EMS/TENS mode should not be used in combination or sequentially.

## Performance Standards:

The EVOLVE System with the T3 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
- [Rec. Number 6-389] IEC 60601-2-2 Edition 6.0 2017-03 Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential per

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# 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.

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 T:3 Applicator performs as expected under anticipated conditions of use and to verify that the device performance meets the device design requirements.

The following tests were conducted:

- Accuracy testing of the RF output parameters .
- . Accuracy of electrode temperature sensors measurements
- Temperature build-up profile measurements .
- Ex-vivo Tissue thermal profile ●
- Safety and thermal profile testing
- Testing of EMS/TENs output specifications ●

The bench testing results demonstrated that the device performs as expected under anticipated conditions of use.

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# Pre-Clinical (Animal) Performance Data:

Non-Applicable.

### Clinical Performance Data:

Non-Applicable.

### Substantial Equivalence:

The below table summarizes the main comparison aspects between the EVOLVE System with the T3 Applicator and the proposed predicate devices.

| Characteristic | Subject Device<br>EVOLVE System<br>with the T3<br>Applicator | Primary Predicate<br>Device<br>EVOLVE System<br>with the Tone<br>Applicator<br>K201285 | Secondary<br>Predicate Device<br>EVOLVE System<br>with the Tite<br>Applicator<br>K183450 |
|---------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | InMode Ltd. | InMode Ltd. | InMode Ltd. |
| Prescription/<br>OTC | Prescription | idem | idem |
| Class<br>Product Code | Class II<br>IPF GZJ<br>ISA PBX | Class II<br>IPF GZJ | Class II<br>ISA PBX |
| Indications for<br>Use | The EVOLVE System<br>with T3 Applicator<br>when used in RF<br>mode is intended for<br>the temporary relief<br>of minor muscle<br>aches and pain,<br>temporary relief of<br>muscle spasm, and<br>temporary<br>improvement of local<br>blood circulation.<br><br>The EVOLVE System<br>with T3 Applicator<br>when used in EMS-<br>TENS mode is<br>intended for<br><br>EMS mode:<br><br>Relaxation of<br>muscle spasms | The EVOLVE System<br>with Tone Applicator<br>is used in EMS mode<br>for:<br>Relaxation of<br>muscle spasms Prevention or<br>retardation of<br>disuse atrophy Increasing local<br>blood circulation Muscle re-<br>education Maintaining or<br>increasing range<br>of motion Immediate<br>postsurgical<br>stimulation of<br>calf muscles to<br>prevent venous<br>thrombosis | The InMode EmBody<br>System with its<br>designated hand<br>pieces is intended for<br>the treatment of the<br>following medical<br>conditions;<br>The<br>EmBodyPLUS<br>S hand piece<br>is intended<br>for the<br>temporary<br>relief of<br>minor muscle<br>aches and<br>pain,<br>temporary<br>relief of<br>muscle<br>spasm, and<br>temporary<br>improvement |
| Characteristic | Subject Device<br>EVOLVE System<br>with the T3<br>Applicator | Primary Predicate<br>Device<br>EVOLVE System<br>with the Tone<br>Applicator<br>K201285 | Secondary<br>Predicate Device<br>EVOLVE System<br>with the Tite<br>Applicator<br>K183450 |
| | Prevention or<br>retardation of<br>disuse atrophy Increasing local<br>blood<br>circulation Muscle re-<br>education Maintaining or<br>increasing<br>range of motion Immediate<br>postsurgical<br>stimulation of<br>calf muscles to<br>prevent venous<br>thrombosis TENS mode: Symptomatic<br>relief and<br>management of<br>chronic,<br>intractable pain Post-surgical<br>and post-<br>trauma acute<br>pain The RF treatment<br>mode and<br>EMS/TENS mode | In TENS mode it is<br>used for: Symptomatic<br>relief and<br>management of<br>chronic,<br>intractable pain Post-surgical and<br>post-trauma<br>acute pain | of local blood<br>circulation. |
| | should not be used<br>in combination or<br>sequentially. | | |
| Target<br>Population | Adult Population<br>which requires<br>treatment as<br>specified in the<br>indication for use | Idem | Idem |
| Anatomical<br>Sites | Body parts requiring<br>treatment as<br>specified in the<br>indication for use | Idem | Idem |
| Environment<br>Used | Hospital or Clinic<br>setting | Idem | Idem |
| Characteristic | Subject Device<br>EVOLVE System<br>with the T3<br>Applicator | Primary Predicate<br>Device<br>EVOLVE System<br>with the Tone<br>Applicator<br>K201285 | Secondary<br>Predicate Device<br>EVOLVE System<br>with the Tite<br>Applicator<br>K183450 |
| Applied energy<br>Design: | RF/EMS-TENS<br>The EVOLVE<br>System with T3<br>Applicator consists<br>of an AC/DC power<br>supply unit,<br>controller, 2 RF<br>generators and user<br>interface including<br>an LCD touch<br>screen. The delivery<br>of the RF/electrical<br>energy is controlled<br>by a Start/Stop<br>button positioned on<br>the front panel.<br>The System supports<br>the following<br>components:<br>LCD display<br>touch screenAudio<br>loudspeaker48V AC/DC<br>power supplyController2 RF Generators<br>The System operates<br>while connected to<br>the T3 Applicator in<br>RF mode or in<br>EMS/TENs mode. | EMS-TENS<br>The EVOLVE System<br>with Tone Applicator<br>consists of an AC/DC<br>power supply unit,<br>controller, 2 RF<br>Generators (disabled)<br>and user interface<br>including an LCD<br>touch screen. The<br>delivery of the<br>electrical energy is<br>controlled by a<br>Start/Stop button<br>positioned on the<br>front panel.<br>The System supports<br>the following<br>components:<br>LCD display<br>touch screenAudio<br>loudspeaker48V AC/DC<br>power supplyController2 RF Generators<br>(disabled)<br>The System operates<br>while connected to<br>the Tone Applicator. | RF<br>The EVOLVE System<br>with Tite Applicator<br>consists of an AC/DC<br>power supply unit,<br>controller, 2 RF<br>generators and user<br>interface including an<br>LCD touch screen.<br>The delivery of the RF<br>energy is controlled<br>by a Start/Stop<br>button positioned on<br>the front panel.<br>The System supports<br>the following<br>components:<br>LCD display<br>touch screenAudio<br>loudspeaker48V AC/DC<br>power supplyController2 RF Generators<br>The System operates<br>while connected to<br>the Tite Applicator. |
| - Components<br>Console | The EVOLVE<br>System consists of<br>the 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. | The EVOLVE System<br>consists of the<br>following<br>components:<br>Console, including<br>a power supply<br>unit, controller<br>and user interface<br>including an LCD<br>touch screen. | The EVOLVE System<br>consists of the<br>following<br>components:<br>Console, including<br>a power supply<br>unit, controller<br>and user interface<br>including an LCD<br>touch screen. |
| Characteristic | Subject Device<br>EVOLVE System<br>with the T3<br>Applicator | Primary Predicate<br>Device<br>EVOLVE System<br>with the Tone<br>Applicator<br>K201285 | Secondary<br>Predicate Device<br>EVOLVE System<br>with the Tite<br>Applicator<br>K183450 |
| | 2 RF Generators T3 Applicator with up to 6 units connected to the console via 6 designated cables and 6 designated connection ports. | 2 RF Generators (disabled) Tone applicator with up to 4 units connected to the console via 4 designated cables and 4 designated connection ports. | Tite applicator with up to 8 units connected to the console via 8 designated cables and 8 designated connection ports. |
| 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] | 46cm W x 46cm D x<br>100cm H [18.2" W x<br>18.2" D x 44" H] | 46cm W x 46cm D x<br>100cm H [18.2" W x<br>18.2" D x 44" H] |
| Applicator unit<br>[L x D] | T3 Applicator unit:<br>67.3mm L x 54.3mm<br>D [2.7" L x2.2" D] | Tone Applicator unit:<br>120mm L x 100mm D<br>[4.8" L x4.0" D] | Tite Applicator unit:<br>40.9mm L x 36.1mm<br>D [1.6" L x1.4" D] |
| Cable length | 280 cm [110``L] | 280 cm [110``L] | 280 cm [110``L] |
| Weight Console | 33.0 Kg [73 lbs.] | 33.0 Kg [73 lbs.] | 33.0 Kg [73 lbs.] |
| Weight applicator | T3: 0.16 Kg [0.4 lbs.] | Tone: 0.22 Kg [0.5 lbs.] | Tite: 0.17 Kg [0.4 lbs.] |
| Applicator unit<br>treatment area<br>(EMS/TENS) | T3: 6.46 cm²<br>(3 small electrodes<br>$1.05x2.05x3=6.46$ ) | Tone: 12 cm² | |
| Applicator unit<br>treatment area<br>(RF) | T3: 33.7 cm² | | Tite: 14.8 cm² |
| Performance Specifications: | | | |
| System | | | |
| Power Source(s) | Main Line<br>Frequency<br>(nominal)<br>50-60Hz<br>Input Voltage<br>(nominal)<br>100-240VAC<br>Input Current (rms)<br>4A | Main Line Frequency<br>(nominal)<br>50-60Hz<br>Input Voltage<br>(nominal)<br>100-240VAC<br>Input Current (rms)<br>4A | Main Line Frequency<br>(nominal)<br>50-60Hz<br>Input Voltage<br>(nominal)<br>100-240VAC<br>Input Current (rms)<br>4A |
| RF Frequency | 1 MHz | Disabled | 1 MHz |
| Maximal RF<br>output power | 75 W | Disabled | 50 W |
| Method of Line<br>Current Isolation | Independent<br>transformer isolated | Independent<br>transformer isolated | N/A |
| Characteristic | Subject Device<br>EVOLVE System<br>with the T3<br>Applicator | Primary Predicate<br>Device<br>EVOLVE System<br>with the Tone<br>Applicator<br>K201285 | Secondary<br>Predicate Device<br>EVOLVE System<br>with the Tite<br>Applicator<br>K183450 |
| Electrical Type | Type BF | Type BF | N/A |
| Patient Leakage<br>Current - Normal<br>Condition ( $µ$ A) | <100uA patient<br>leakage | <100uA patient<br>leakage | N/A |
| Patient Leakage<br>Current - Single<br>Fault Condition<br>( $μ$ Α) | <300uA line leakage | <300uA line leakage | N/A…