The Transform 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 Transform 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 postsurgical stimulation of calf muscles to prevent venous thrombosis ●

The Transform Applicator in TENS mode is intended for:

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

Additionally the Transform Applicator in sequential RF/EMS mode is intended for:

. Non-invasive lipolysis (breakdown of fat) of the abdomen.
Reduction in circumference of the abdomen ●

Device Description

The Evolve System with the Transform 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 (K210877).

The Evolve System includes 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 Transform Applicator.

The purpose of this submission is to add non-invasive lipolysis (breakdown of fat) of the abdomen and reduction in circumference of the abdomen to the indications.

AI/ML Overview

The provided text describes the regulatory clearance of "The Evolve System with the Transform Applicator" and includes information about its performance data to demonstrate safety and efficacy. However, it does not present acceptance criteria in a formal table or describe a multi-reader multi-case (MRMC) comparative effectiveness study, nor does it explicitly define "acceptance criteria" for the clinical study results.

Based on the information provided, here's an attempt to answer your questions, interpreting some elements from the clinical study summary:

1. A table of acceptance criteria and the reported device performance

The document doesn't explicitly define "acceptance criteria" with numerical thresholds for performance. Instead, it states that "The success criteria for the percentage of subjects were met, with the correct identification rate exceeding 70%" for the photographic assessment. For the primary outcome (circumference measurement), it broadly states "Each of these measures independently demonstrated reduction in fat, and findings were consistent and strongly correlated with each other."

Without explicit pass/fail criteria from the submission, we can infer the "reported device performance" based on the study outcomes:

Acceptance Criteria (Inferred from Study Narrative)	Reported Device Performance
Demonstration of Safety	No serious adverse events were observed.
Demonstration of Efficacy - Fat Reduction (Primary Endpoint)	Circumference measurement by measurement tape, fat thickness caliper measurement, and fat layer ultrasound measurement all independently demonstrated reduction in fat, with consistent and strongly correlated findings.
Demonstration of Efficacy - Photographic Assessment	The success criteria for the percentage of subjects were met, with the correct identification rate exceeding 70% (by blinded evaluators).
Patient Comfort during Treatment	Average comfort scores were rated between comfortable and indifferent during treatment. Comfort scores statistically significantly improved when comparing initial and later treatments.
Patient Satisfaction	The majority of subjects were satisfied with the results.

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: 44 subjects.
Data Provenance: Prospective, multi-site, single-arm clinical study. The country of origin of the data is not specified in the provided text.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Number of Experts: Three blinded evaluators were used to assess the "before and after 3 months photographs."
Qualifications of Experts: The qualifications of these experts are not explicitly stated (e.g., radiologist with 10 years of experience). They are only referred to as "blinded evaluators."

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

The document states that "Three distinct measurements were used to evaluate fat reduction: circumference measurement by measurement tape (primary endpoint), fat thickness caliper measurement, and fat layer ultrasound measurement. Each of these measures independently demonstrated reduction in fat, and findings were consistent and strongly correlated with each other." It also mentions that "Before and after 3 months photographs were assessed by three blinded evaluators."

The method for reconciling differences between the three evaluators for the photographic assessment, or if simple majority or consensus was used, is not specified. Therefore, the adjudication method is unclear from the provided text.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

The provided text describes a single-arm clinical study evaluating the Evolve System with the Transform Applicator. It does not describe an MRMC comparative effectiveness study involving human readers or AI assistance. The study focuses solely on the device's performance in achieving non-invasive lipolysis and circumference reduction.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This device is not an AI algorithm but a physical device that delivers RF and EMS energy. Therefore, the concept of "standalone (algorithm only)" performance does not directly apply here in the way it would for a software-as-a-medical-device (SaMD) or AI-powered diagnostic tool. The study assesses the device's effect on patients.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth for the efficacy evaluation was based on clinical measurement and observation data:

Circumference measurement by measurement tape (primary endpoint)
Fat thickness caliper measurement
Fat layer ultrasound measurement
Assessment of before and after photographs by three blinded evaluators.
Patient-reported comfort and satisfaction.

8. The sample size for the training set

The provided text describes a clinical study validating the device's effectiveness. It does DNOT refer to a "training set" in the context of an AI/ML model. The 44 subjects are part of the performance data or test set for demonstrating the device's clinical efficacy.

9. How the ground truth for the training set was established

As there is no training set discussed in the context of an AI/ML model, this question is not applicable based on the provided document. The study is a clinical validation of a physical medical device.

Summary

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

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

October 13, 2023

InMode Ltd. % Janice Hogan Partner Hogan Lovells US LLP 1735 Market Street, Suite 2300 Philadelphia, Pennsylvania 19103

Re: K231495

Trade/Device Name: The Evolve System with the Transform Applicator Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: GEI Dated: September 12, 2023 Received: September 12, 2023

Dear Janice Hogan:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Mark
Digitally signed by
Mark Trumbore -S
Trumbore -S Date: 2023.10.13
15:16:56-04'00'

Mark Trumbore, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices

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

Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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

510(k) Number (if known)

Device Name

The Evolve System with the Transform Applicator

Indications for Use (Describe)

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

The Transform 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 Transform 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 postsurgical stimulation of calf muscles to prevent venous thrombosis ●

The Transform Applicator in TENS mode is intended for:

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

Additionally the Transform Applicator in sequential RF/EMS mode is intended for:

. Non-invasive lipolysis (breakdown of fat) of the abdomen.
Reduction in circumference of the abdomen ●

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

区 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."

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

510(k) SUMMARY

InMode's Evolve System with the Transform Applicator

Submitter

InMode Ltd. Address: Tabor Building, Shaar Yokneam Yokneam 2069200 lsrael Tel: +972-4-9097470 Fax: +972-4-9097471 Contact Person: Suhair Francis-Najjar Date Prepared: May 14, 2023

Name of Device: The Evolve System with the Transform Applicator

Common or Usual Name: Electrosurgical, Cutting & Coagulation Device & Accessories

Classification Name: 21 CFR 878.4400 Electrosurgical, Cutting & Coagulation Device & Accessories

Regulatory Class: Class II

Product Code: GEI

Predicate Devices

K202199 BTL-899ST K163415 Syneron Medical's SlimShape System

Reference Devices

K210877 Inmode's Evolve System with T3 Applicator

Device Description

The Evolve System includes the following components:

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

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

The System operates while connected to the Transform Applicator.

The purpose of this submission is to add non-invasive lipolysis (breakdown of fat) of the abdomen and reduction in circumference of the abdomen to the indications.

Intended Use / Indications for Use

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

The Transform 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 Transform 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 postsurgical stimulation of calf muscles to prevent venous thrombosis

The Transform Applicator in TENS mode is intended for:

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

Additionally the Transform Applicator in sequential RF/EMS mode is intended for:

. Non-invasive lipolysis (breakdown of fat) of the abdomen.
Reduction in circumference of the abdomen

Summary of Technological Characteristics

The subject of this 510(k) submission is the expansion of indications for use for the Evolve System with the Transform Applicator to include non-invasive lipolysis (breakdown of fat) of the abdomen. There are no physical changes to the device since its clearance in K210877 which includes both bipolar radiofrequency (RF) / Electrical Muscle Stimulation (EMS) treatment modes. There have been minor software changes to allow the delivery of a sequential RF/EMS for non-invasive lipolysis treatment. Importantly, the parameters of the

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

delivered RF or EMS pulse are unchanged, the only change is that the treatments are automatically delivered sequentially.

With respect to the proposed additional indication (non-invasive lipolysis of the abdomen; reduction in circumference of the abdomen), the Evolve System with the Transform Applicator is substantially equivalent to the primary predicate device BTL-899ST (K202199) by BTL and the additional predicate device, SlimShape System (K163415) by Syneron Medical. BTL-899ST is selected as primary predicate, as it similarly supplies RF/EMS to achieve noninvasive lipolysis. SlimShape (K163415) is selected as an additional predicate as its RF treatment parameters closely resemble those used by the subject device. The system is also physically identical to the reference device, Evolve System with T3 Applicator cleared in K210877 (aside from minor software changes). A substantial equivalence chart comparing the similarities and differences between the Transform System and its predicate devices is provided below. None of the minor differences in technological features from the predicates raise any new safety or effectiveness questions, and clinical data confirms that these differences do not adversely impact safety or effectiveness.

Performance Data

Updated software documentation was supplied to support the minimal changes to software.

A prospective, multi-site, single arm clinical study of 44 subjects was completed to demonstrate safety and efficacy of the Evolve System with Transform Applicators in circumference reduction. - Treatments of sequential bi-polar RF energy and EMS were performed in 3 sessions, two weeks apart from each other. Patients were evaluated at baseline (pre-treatment) and at follow-up visits at 1 and 3 months post-treatment.

Three distinct measurements were used to evaluate fat reduction: circumference measurement by measurement tape (primary endpoint), fat thickness caliper measurement, and fat layer ultrasound measurement. Each of these measures independently demonstrated reduction in fat, and findings were consistent and strongly correlated with each other.

Before and after 3 months photographs were assessed by three blinded evaluators. The success criteria for the percentage of subjects were met, with the correct identification rate exceeding 70%. Subjects rated comfort during treatment using the Therapy Comfort Questionnaire immediately after each of their three treatments. The average comfort scores for each timepoint were rated as between comfortable and indifferent during treatment. Comfort scores statistically significantly improved when comparing the initial and later treatments, suggesting that subjects either acclimated to the treatment over time or that subsequent treatments are less uncomfortable. The majority of subjects were satisfied with the results.

No serious adverse events were observed.

Overall, the findings of this study provide strong evidence for the safety and effectiveness of the system.

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

Conclusions

The Evolve System with the Transform Applicator is as safe and effective as the predicate devices. The Evolve System with the Transform Applicator has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate devices. The minor technological differences between the Evolve System with the Transform Applicator and its predicate devices raise no new issues of safety or effectiveness. Clinical data demonstrate that the Evolve System with the Transform Applicator is as safe and effective as the predicates. Thus, the Evolve System with the Transform Applicator is substantially equivalent.

Full name and510(k) number	The Evolve Systemwith the TransformApplicator	The SlimShapeSystem	BTL-899ST	Comparison
		K163415	K202199
Device Class	II	II	II	Same
Regulation Number	21 CFR 878.4400	21 CFR 878.4400	21 CFR 878.4400	Same
Product Code	GEI	GEI	GEI	Same
Intended Use/Indications for Use	The Transform Applicatorin sequential RF/EMSmode is intended for:for non-invasivelipolysis (breakdownof fat) of theabdomen. for reduction incircumference of theabdomen.	The SlimShape Systemis indicated for non-invasive lipolysis(breakdown of fat) ofthe abdomen. Thedevice isindicated for reductionin circumference of theabdomen.	BTL-899ST isindicated to be usedfor:Non-invasive lipolysis(breakdown of fat) ofthe abdomen. Reduction incircumference of theabdomen. Non-invasive lipolysis(breakdown of fat) ofthe thighs. Reduction incircumference of thethighs.	Same intended use.Same indications asSlimShape.Same indications as a subsetof the indications of the BTL.
User Population (SkinType)	No restrictions in skintype	No restrictions in skintype	BTL-899ST is intendedfor use with Skin TypeI, II and III.	BTL is not indicated for use inSkin Types darker than III.This limitation of the predicateis due to technologicalfactors, and any risks aremitigated in the subjectdevice.
Full name and510(k) number	The Evolve Systemwith the Transform	The SlimShapeSystem	BTL-899ST	Comparison
	Applicator	K163415	K202199
System Components	Energy generators,Applicators,Computer forcontrolling the System console(touch screen)	Energy generators,Applicators,Computer forcontrolling the system's outputSystem console(touch screen)	Energygenerators,Applicators,Computer forcontrolling the system's outputSystem console(touch screen)	Same
Applicator Design	Hand-free applicatorsfixed by a fixation belt	Hand-free applicatorsfixed by a fixation belt	Hand-free applicatorsfixed by a fixation belt	Same
Selection ofParameters (Intensity,Time) by the User	Yes	Yes	Yes	Same
Principles of Operation	User applies desiredvariable amounts ofenergy to the patient untilthe tissue is heated,while monitoring thedegree of heating andany adverse reaction onthe patient's skin.	User applies desiredvariable amounts ofenergy to the patientuntil the tissue isheated, whilemonitoring the degreeof heating and anyadverse reaction on thepatient's skin.	User applies desiredvariable amounts ofenergy to the patientuntil the tissue isheated, whilemonitoring the degreeof heating and anyadverse reaction onthe patient's skin.	Same
Skin TemperatureMonitoring	Yes	Yes	Yes	Same
STOP Button forPatient	Yes	Yes	Yes	Same
Basic Technology	The system combinesbipolar radiofrequencywith electric musclestimulation	The system combinesbipolar radiofrequencywith mechanicalsuction.	The system combinesbipolar radiofrequencywith electric musclestimulation	All systems are based onbipolar RF energydelivery.The additional energyapplied is different inSlimShape (vacuum; theabsence of this feature inthe subject device doesnot raise any new risks).The application of EMSin the subject device issimilar to BTL. Inaddition, safety issupported by clinicalstudies.
Sterility	Not Sterile	Not Sterile	Not Sterile	Similar
Single/Multiple Use	Multiple use	Multiple use	Multiple use	Similar

InMode's Transform System Substantial Equivalence Chart

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

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.