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 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.

AI/ML Overview

The Evolve System with the T3 Applicator is intended for temporary relief of minor muscle aches and pain, muscle spasm, and improved local blood circulation (RF mode), as well as relaxation of muscle spasms, prevention of disuse atrophy, increased local blood circulation, muscle re-education, maintaining/increasing range of motion, and immediate post-surgical stimulation of calf muscles to prevent venous thrombosis (EMS mode), and symptomatic relief of chronic, intractable, post-surgical, and post-trauma acute pain (TENS mode).

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

Characteristic	Acceptance Criteria (Subject Device, EVOLVE System with T3 Applicator)	Reported Device Performance (as per document)
RF Mode
Maximal Output Power	75 W	75 W
Frequency	1 MHz	1 MHz
Pulse Duration	2 sec	2 sec
EMS Mode
Waveform	Symmetrical Biphasic	Symmetrical Biphasic Waveform
Pulse Shape	Rectangular	Rectangular
Max Output Voltage	Up to 50 intensity level (=54 Vpeak)	Up to 50 intensity level (=54 Vpeak)
Pulse Width	20 to 400 µs	20 to 400 µs
Frequency	3 to 200 Hz	3 to 200 Hz
Net Charge @ 500Ω	0 µC/pulse @ 500Ω	0 µC/pulse @ 500Ω
Max Phase Charge	24 µC @ 500Ω	24 µC @ 500Ω
Max Current Density	0.74 mA/cm²	0.74 mA/cm² (Surface = 6.46cm²)
Max Power Density	22.2 mW/cm² @500Ω	22.2 mW/cm² @500Ω
Burst Mode	Yes: a. 3-200, b. 1, c. 1-60 sec, d. Time on / off	Yes: a. 3-200, b. 1, c. 1-60 sec, d. Time on / off
On Time	1 - 60 sec	1 - 60 sec
Off Time	1 - 60 sec	1 - 60 sec
Treatment Time	Up to 60 min.	Up to 60 min.
TENS Mode
Waveform	Symmetrical Biphasic	Symmetrical Biphasic Waveform
Pulse Shape	Rectangular	Rectangular
Max Output Voltage	Up to 15 intensity level (=19 Vpeak)	Up to 15 intensity level (=19 Vpeak)
Pulse Width	20 to 400 µs	20 to 400 µs
Frequency	3 to 200 Hz	3 to 200 Hz
Net Charge @ 500Ω	0 µC/pulse @ 500Ω	0 µC/pulse @ 500Ω
Max Phase Charge	15.2 µC @ 500Ω	15.2 µC @ 500Ω
Max Current Density	0.47 mA/cm²	0.47 mA/cm² (Surface = 6.46cm²)
Max Power Density	8.9 mW/cm² @500Ω	8.9 mW/cm² @500Ω
Burst Mode	Yes: a. 3-200, b. 1, c. 1-60 sec, d. Time on / off	Yes: a. 3-200, b. 1, c. 1-60 sec, d. Time on / off
On Time	1 - 60 sec	1 - 60 sec
Off Time	1 - 60 sec	1 - 60 sec
Treatment Time	Up to 60 min.	Up to 60 min.
General Safety/Design
Biocompatibility	Materials are biocompatible	Materials are biocompatible
Complies with standards	ANSI AAMI ES 60601-1, IEC 60601-1-2, IEC 60601-2-10, IEC 60601-1-6, IEC 60601-2-2	Yes, tested and complies with listed standards
Software Validation	Yes	Yes
Electrical/Mechanical Safety	Yes (IEC 60601-1)	Yes (IEC 60601-1)
Electromagnetic Compatibility	Yes (IEC 60601-1-2)	Yes (IEC 60601-1-2)
Nerve/Muscle Stimulator Safety	Yes (IEC 60601-2-10)	Yes (IEC 60601-2-10)
High-Frequency Surgical Equip. Safety	Yes (IES 60601-2-2)	Yes (IES 60601-2-2)

2. Sample Size Used for the Test Set and Data Provenance:

The document states that Non-Clinical (Bench) Performance Data was conducted to demonstrate the device performs as expected and meets design requirements. This included various bench tests (e.g., accuracy of RF output, electrode temperature sensors, thermal build-up, ex-vivo tissue thermal profile, safety and thermal profile testing, EMS/TENS output specifications).

However, the document explicitly states "Clinical Performance Data: Non-Applicable." This implies that there was no clinical test set using human subjects or patient data. The evaluation for substantial equivalence relies on non-clinical bench testing and comparison to predicate devices, rather than a clinical study with a test set of patient data. Therefore, questions regarding sample size, data provenance (e.g., country of origin, retrospective/prospective) for a clinical test set are not applicable here.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Since no clinical test set was conducted, the concept of "ground truth" derived from expert consensus on patient data (e.g., from radiologists, pathologists) is not applicable to this submission. The "ground truth" for the non-clinical bench tests would be the established engineering and safety standards and design specifications against which the device's performance was measured.

4. Adjudication Method for the Test Set:

Not applicable, as no clinical test set was conducted.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, an MRMC comparative effectiveness study was not done. The submission explicitly states "Clinical Performance Data: Non-Applicable," making any evaluation of human reader improvement with or without AI assistance irrelevant in this context. The device is a physical therapeutic system, not an AI-assisted diagnostic tool.

6. Standalone (Algorithm Only) Performance Study:

Not applicable. This device is a physical therapeutic system, not an algorithm or AI. Its performance is tied directly to its hardware functionality and energy delivery.

7. Type of Ground Truth Used:

For the non-clinical performance data, the "ground truth" was based on:

Engineering and Design Requirements: The device was tested to verify that its performance meets its own design requirements.
Consensus Standards: The device's performance was evaluated against recognized consensus standards for medical electrical equipment, such as ANSI AAMI ES 60601-1, IEC 60601-1-2, IEC 60601-2-10, IEC 60601-1-6, and IEC 60601-2-2.
Predicate Device Specifications: The device's technical specifications and performance characteristics were compared directly to those of legally marketed predicate devices to establish substantial equivalence.

8. Sample Size for the Training Set:

Not applicable. This device is not an AI/ML algorithm that requires a training set. Its functionality is based on established physical principles of RF and EMS/TENS technology.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no training set for this device.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The FDA text logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION".

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.

{1}------------------------------------------------

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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

{2}------------------------------------------------

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

{3}------------------------------------------------

510(K) SUMMARY

THE EVOLVE SYSTEM WITH THE T3 APPLICATOR

510(k) Number K210877

Applicant Name:

Company Name:	InMode Ltd.
Address:	Tabor Building, Shaar YokneamYokneam 2069200Israel
Tel:	+972-4-9097470
Fax:	+972-4-9097471
E-mail:	amit@asteinrac.com
Contact Person:Official Correspondent:	Amit Goren
Company Name:	A. Stein - Regulatory Affairs Consulting Ltd
Address:	18 Hata'as St.Kfar Saba 4442518 Israel
Tel:	+ 972-9-7670002
Fax:	+972-9-7668534
E-mail:	amit@asteinrac.com
Date Prepared:	July 18, 2021
Trade Name:	EVOLVE System with the T3 Applicator
Classification Name:	CFR Classification section 890.5850;(Product codes: IPF)CFR Classification section 882.5890;(Product codes: GZJ)CFR Classification section 878.4400;(Product codes: ISA)CFR Classification section 878.4400;(Product codes: PBX)
Classification:	Class II Medical Device

{4}------------------------------------------------

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 ToneApplicator	InMode Ltd.	K201285
Secondary Predicate
The EVOLVE System	InMode Ltd.	K183450

Device Description:

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.

{5}------------------------------------------------

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 Applicator8.9cm 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

{6}------------------------------------------------

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

{7}------------------------------------------------

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.

{8}------------------------------------------------

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 DeviceEVOLVE Systemwith the T3Applicator	Primary PredicateDeviceEVOLVE Systemwith the ToneApplicatorK201285	SecondaryPredicate DeviceEVOLVE Systemwith the TiteApplicatorK183450
Manufacturer	InMode Ltd.	InMode Ltd.	InMode Ltd.
Prescription/OTC	Prescription	idem	idem
ClassProduct Code	Class IIIPF GZJISA PBX	Class IIIPF GZJ	Class IIISA PBX
Indications forUse	The EVOLVE Systemwith T3 Applicatorwhen used in RFmode is intended forthe temporary reliefof minor muscleaches and pain,temporary relief ofmuscle spasm, andtemporaryimprovement of localblood circulation.The EVOLVE Systemwith T3 Applicatorwhen used in EMS-TENS mode isintended forEMS mode:Relaxation ofmuscle spasms	The EVOLVE Systemwith Tone Applicatoris used in EMS modefor:Relaxation ofmuscle spasms Prevention orretardation ofdisuse atrophy Increasing localblood circulation Muscle re-education Maintaining orincreasing rangeof motion Immediatepostsurgicalstimulation ofcalf muscles toprevent venousthrombosis	The InMode EmBodySystem with itsdesignated handpieces is intended forthe treatment of thefollowing medicalconditions;TheEmBodyPLUSS hand pieceis intendedfor thetemporaryrelief ofminor muscleaches andpain,temporaryrelief ofmusclespasm, andtemporaryimprovement
Characteristic	Subject DeviceEVOLVE Systemwith the T3Applicator	Primary PredicateDeviceEVOLVE Systemwith the ToneApplicatorK201285	SecondaryPredicate DeviceEVOLVE Systemwith the TiteApplicatorK183450
	Prevention orretardation ofdisuse atrophy Increasing localbloodcirculation Muscle re-education Maintaining orincreasingrange of motion Immediatepostsurgicalstimulation ofcalf muscles toprevent venousthrombosis TENS mode: Symptomaticrelief andmanagement ofchronic,intractable pain Post-surgicaland post-trauma acutepain The RF treatmentmode andEMS/TENS mode	In TENS mode it isused for: Symptomaticrelief andmanagement ofchronic,intractable pain Post-surgical andpost-traumaacute pain	of local bloodcirculation.
	should not be usedin combination orsequentially.
TargetPopulation	Adult Populationwhich requirestreatment asspecified in theindication for use	Idem	Idem
AnatomicalSites	Body parts requiringtreatment asspecified in theindication for use	Idem	Idem
EnvironmentUsed	Hospital or Clinicsetting	Idem	Idem
Characteristic	Subject DeviceEVOLVE Systemwith the T3Applicator	Primary PredicateDeviceEVOLVE Systemwith the ToneApplicatorK201285	SecondaryPredicate DeviceEVOLVE Systemwith the TiteApplicatorK183450
Applied energyDesign:	RF/EMS-TENSThe EVOLVESystem with T3Applicator consistsof an AC/DC powersupply unit,controller, 2 RFgenerators and userinterface includingan LCD touchscreen. The deliveryof the RF/electricalenergy is controlledby a Start/Stopbutton positioned onthe front panel.The System supportsthe followingcomponents:LCD displaytouch screenAudioloudspeaker48V AC/DCpower supplyController2 RF GeneratorsThe System operateswhile connected tothe T3 Applicator inRF mode or inEMS/TENs mode.	EMS-TENSThe EVOLVE Systemwith Tone Applicatorconsists of an AC/DCpower supply unit,controller, 2 RFGenerators (disabled)and user interfaceincluding an LCDtouch screen. Thedelivery of theelectrical energy iscontrolled by aStart/Stop buttonpositioned on thefront panel.The System supportsthe followingcomponents:LCD displaytouch screenAudioloudspeaker48V AC/DCpower supplyController2 RF Generators(disabled)The System operateswhile connected tothe Tone Applicator.	RFThe EVOLVE Systemwith Tite Applicatorconsists of an AC/DCpower supply unit,controller, 2 RFgenerators and userinterface including anLCD touch screen.The delivery of the RFenergy is controlledby a Start/Stopbutton positioned onthe front panel.The System supportsthe followingcomponents:LCD displaytouch screenAudioloudspeaker48V AC/DCpower supplyController2 RF GeneratorsThe System operateswhile connected tothe Tite Applicator.
- ComponentsConsole	The EVOLVESystem consists ofthe followingcomponents:Console,including a powersupply unit,controller anduser interfaceincluding an LCDtouch screen.	The EVOLVE Systemconsists of thefollowingcomponents:Console, includinga power supplyunit, controllerand user interfaceincluding an LCDtouch screen.	The EVOLVE Systemconsists of thefollowingcomponents:Console, includinga power supplyunit, controllerand user interfaceincluding an LCDtouch screen.
Characteristic	Subject DeviceEVOLVE Systemwith the T3Applicator	Primary PredicateDeviceEVOLVE Systemwith the ToneApplicatorK201285	SecondaryPredicate DeviceEVOLVE Systemwith the TiteApplicatorK183450
	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.
DimensionConsole[W x H x D]	46cm W x 46cm D x100cm H [18.2" W x18.2" D x 44" H]	46cm W x 46cm D x100cm H [18.2" W x18.2" D x 44" H]	46cm W x 46cm D x100cm H [18.2" W x18.2" D x 44" H]
Applicator unit[L x D]	T3 Applicator unit:67.3mm L x 54.3mmD [2.7" L x2.2" D]	Tone Applicator unit:120mm L x 100mm D[4.8" L x4.0" D]	Tite Applicator unit:40.9mm L x 36.1mmD [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 unittreatment area(EMS/TENS)	T3: 6.46 cm²(3 small electrodes$1.05x2.05x3=6.46$ )	Tone: 12 cm²
Applicator unittreatment area(RF)	T3: 33.7 cm²		Tite: 14.8 cm²
Performance Specifications:
System
Power Source(s)	Main LineFrequency(nominal)50-60HzInput Voltage(nominal)100-240VACInput Current (rms)4A	Main Line Frequency(nominal)50-60HzInput Voltage(nominal)100-240VACInput Current (rms)4A	Main Line Frequency(nominal)50-60HzInput Voltage(nominal)100-240VACInput Current (rms)4A
RF Frequency	1 MHz	Disabled	1 MHz
Maximal RFoutput power	75 W	Disabled	50 W
Method of LineCurrent Isolation	Independenttransformer isolated	Independenttransformer isolated	N/A
Characteristic	Subject DeviceEVOLVE Systemwith the T3Applicator	Primary PredicateDeviceEVOLVE Systemwith the ToneApplicatorK201285	SecondaryPredicate DeviceEVOLVE Systemwith the TiteApplicatorK183450
Electrical Type	Type BF	Type BF	N/A
Patient LeakageCurrent - NormalCondition ( $µ$ A)	<100uA patientleakage	<100uA patientleakage	N/A
Patient LeakageCurrent - SingleFault Condition( $μ$ Α)	<300uA line leakage	<300uA line leakage	N/A
Number of OutputChannels	6	4	8
Synchronous orAlternating	See OutputSpecifications Below	See OutputSpecifications Below	N/A
Method ofChannel Isolation	Throughtransformers andisolators	Through transformersand isolators	N/A
Regulated Currentor RegulatedVoltage (outputsignals only)	Regulated voltage onall channelsWith current limit	Regulated voltage onall channelsWith current limit	N/A
Software/Firmware/MicroprocessorControl	Yes	Yes	N/A
AutomaticOverload Trip	Yes	Yes	N/A
Automatic No-Load Trip	Yes	Yes	N/A
Automatic ShutOff	Yes, On/off switch	Yes, On/off switch	N/A
Patient OverrideControl	Yes	Yes	N/A
Indicator Display;
On/Off Status	Yes	Yes	N/A
Battery	No battery	No battery	N/A
Voltage/Currentlevel	Yes, voltage levels	Yes, voltage levels	N/A
Characteristic	Subject DeviceEVOLVE Systemwith the T3Applicator	Primary PredicateDeviceEVOLVE Systemwith the ToneApplicatorK201285	SecondaryPredicate DeviceEVOLVE Systemwith the TiteApplicatorK183450
Timer Range(Minutes)	0-60 [minutes]	0-60 [minutes]	N/A
Compliance with21 CFR 890.5850(IPF)	Yes	Yes	N/A
Compliance with21 CFR 882.5890?(GZJ)	Yes	Yes	N/A
PerformanceSpecifications:Applicator	T3 Applicator	Tone Applicator	Tite Applicator
RF Output Mode
Maximal RFoutput power	75 W	Deactivated	50 W
Pulse Duration	2 sec	Deactivated	2 sec
EMS Output Mode
OutputSpecifications:Waveform	SymmetricalBiphasic Waveform	Symmetrical BiphasicWaveform	N/A
Pulse Shape	Rectangular	Rectangular	N/A
Maximum Output	30V @500Ω	56V @500Ω	N/A
Voltage (± 10%)	54V @2 kΩ	56V @2 kΩ	N/A
	54V @10kΩ	56V @10kΩ	N/A
Maximum Output	60 mA @ 500 Ω	92.86 mA @ 500 Ω	N/A
Current (± 10%)	27 mA @ 2 kΩ	26.7 mA @ 2 kΩ	N/A
	5.4 mA @ 10 kΩ	5.4 mA @ 10 kΩ	N/A
Intensity level(output volteage)	Up to 50 intensitylevel (=54 Vpeak)	Up to 50 intensitylevel (=54 Vpeak)	N/A
Pulse Width(usec.) - Theoutput activepositive pulsewidth	20 to 400 [µs]	20 to 400 [µs]	N/A
Frequency (Hz)	3 to 200 [Hz]	3 to 200 [Hz]	N/A
Net Charge @ 500ohms [µC/pulse]	0 [µC] @ 500Ω	0 [µC] @ 500Ω	N/A
Maximum PhaseCharge [µC]	24 [µC] @ 500Ω	43.2 [µC] @ 500Ω	N/A
MaximumCurrent (RMS)Density [mA/cm2]	0.74 [mA/cm²]Surface = 6.46cm2	0.72 [mA/cm²]Surface = 12cm2	N/A
Characteristic	Subject DeviceEVOLVE Systemwith the T3Applicator	Primary PredicateDeviceEVOLVE Systemwith the ToneApplicatorK201285	SecondaryPredicate DeviceEVOLVE Systemwith the TiteApplicatorK183450
Maximum PowerDensity[mW/cm²]	22.2 [mW/cm²]@500Ω	55[mW/cm²] @500Ω	N/A
Burst Mode (i.e.,pulse trains)	Yes:	Yes:	N/A
a. Pulses per burst		a. 3 - 200
b. Bursts persecond		b. 1
c. Burst duration(seconds)		c. 1-60 sec
d. Duty Cycle[Line (b) x Line(c)]	d. Time on /off	d. Time on / off
On Time (sec.)	1 - 60 [sec]	1 - 60 [sec]	N/A
Off Time (sec.)	1 - 60 [sec]	1 - 60 [sec]	N/A
Treatment Time(min) - the timelimit that will putthe system inSTOP stateLevel	Up to 60 min.	Up to 60 min.	N/A
TENS Output Mode
OutputSpecifications:Waveform	SymmetricalBiphasic Waveform	Symmetrical BiphasicWaveform	N/A
Pulse Shape	Rectangular	Rectangular	N/A
Maximum OutputVoltage (± 10%)	19V @500Ω19V @2 kΩ19V @10kΩ	36V @500Ω36V @2 kΩ36V @10kΩ	N/A
Maximum OutputCurrent (± 10%)	38 mA @ 500 Ω9.5 mA @ 2 kΩ1.9 mA @ 10 kΩ	67.8 mA @ 500 Ω17.7 mA @ 2 kΩ3.6 mA @ 10 kΩ	N/A
Intensity level(output volteage)	Up to 15 intensitylevel (=19 Vpeak)	Up to 50 intensitylevel (=54 Vpeak)	N/A
Pulse Width(μsec.) - Theoutput activepositive pulsewidth	20 to 400 [μs]	20 to 400 [μs]	N/A
Frequency (Hz)	3 to 200 [Hz]	3 to 200 [Hz]	N/A
Characteristic	Subject DeviceEVOLVE Systemwith the T3Applicator	Primary PredicateDeviceEVOLVE Systemwith the ToneApplicatorK201285	SecondaryPredicate DeviceEVOLVE Systemwith the TiteApplicatorK183450
Net Charge @ 500ohms [μC/pulse]	0 [μC] @ 500Ω	0 [μC] @ 500Ω	N/A
Maximum PhaseCharge [μC]	15.2 [μC] @ 500Ω	28.8 [μC] @ 500Ω	N/A
MaximumCurrent Density[mA/cm²]	0.47 [mA/cm²]Surface = 6.46cm²	0.48 [mA/cm²]Surface = 12cm²	N/A
Maximum PowerDensity[mW/cm²]	8.9 [mW/cm²]@500Ω	17.3 [mW/cm²]@500Ω	N/A
Burst Mode (i.e.,pulse trains)	Yes:a. 3 - 200b. 1c. 1 - 60 secd. Time on / off	Yes:a. 3 - 200b. 1c. 1 - 60 secd. Time on / off	N/A
On Time (sec.)	1 - 60 [sec]	1 - 60 [sec]	N/A
Off Time (sec.)	1 - 60 [sec]	1 - 60 [sec]	N/A
Treatment Time(min) - the timelimit that will putthe system inSTOP stateLevel	Up to 60 min.	Up to 60 min.	N/A
Biocompatibility	Materials arebiocompatible	Materials arebiocompatible	Materials arebiocompatible
Sterility	N/A	N/A	N/A

{9}------------------------------------------------

{10}------------------------------------------------

{11}------------------------------------------------

{12}------------------------------------------------

{13}------------------------------------------------

{14}------------------------------------------------

{15}------------------------------------------------

The EVOLVE System with the T3 Applicator is a versatile machine, offering potential users with RF, EMS and TENS technology-based treatment methods for several medical indications. The subject device and predicate devices utilize the same technology, for the same indication for use, and with almost identical design specifications. The device emits RF energy or EMS-TENS electrical signals with identical power and current densities, pulse characteristics, and bear almost identical system components to its predicate devices such as; user

{16}------------------------------------------------

interface, and hardware components. All of the subject device performance specifications are equal to those of its predicate devices. The minor differences in technical specifications should not alter the device safety and effectiveness. Furthermore, the subject device had underwent the required performance testing and validation testing and demonstrates its conformance with device design requirements and with applicable standards .

The safety features and compliance with safety standards of the subject device are similar to the safety features and compliance with safety standards of the predicate devices. All user-contacting materials were tested for biocompatibility and found to comply with the ISO 10993-1 standard. Furthermore, the design and development phases of the subject device were validated throughout a set of performance tests, including software validation testing, electrical and mechanical safety testing according to IEC 60601-1 standard, electromagnetic compatibility testing according to IEC 60601-1-2 standard, safety and essential performance of nerve and muscle stimulators testing according to IEC 60601-2-10 standard, Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories (IES 60601-2-2), bench, exvivo tissue study and thermal profile study on human volunteers performance tests. All in all, these performance tests demonstrated that the device specifications meet the system requirements and do not raise new safety or effectiveness concerns.

Consequently, it can be concluded that the EVOLVE System with the T3 Applicator is substantially equivalent to its predicate device and can be sold in the US market.

Conclusions:

Based on the comparison to the predicate devices and on the non-clinical performance testing results demonstrating that the EVOLVE System with the T3 Applicator is as safe and effective as the predicate device, it can be concluded

{17}------------------------------------------------

that The EVOLVE System with the T3 Applicator is substantially equivalent to the primary and secondary predicate devices; The Evolve System with the Tone Applicator FDA cleared under 510(k) K201285, and the Evolve System with Tite Applicator FDA cleared under 510(k) K183450 and therefore may be legally marketed in the USA.

Regulation Number and Section

§ 878.4400 Electrosurgical cutting and coagulation device and accessories.

(a)
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.(b)
Classification. Class II.

Indications for Use

K210877

CONTINUE ON A SEPARATE PAGE IF NEEDED.

*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW *

510(K) SUMMARY

THE EVOLVE SYSTEM WITH THE T3 APPLICATOR

510(k) Number K210877

Applicant Name:

Predicate Devices:

Device Description:

Intended Use/Indication for Use:

Performance Standards:

Sterilization/Disinfection/Cleaning:

Non-Clinical (Bench) Performance Data:

Pre-Clinical (Animal) Performance Data:

Clinical Performance Data:

Substantial Equivalence:

Conclusions:

§ 878.4400 Electrosurgical cutting and coagulation device and accessories.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW