The Evolve System with the Transform Applicator

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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. 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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 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 {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 and<br>510(k) number | The Evolve System<br>with the Transform<br>Applicator | The SlimShape<br>System | 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/<br>Indications for Use | The Transform Applicator<br>in sequential RF/EMS<br>mode is intended for:<br>for non-invasive<br>lipolysis (breakdown<br>of fat) of the<br>abdomen. for reduction in<br>circumference of the<br>abdomen. | The SlimShape System<br>is indicated for non-<br>invasive lipolysis<br>(breakdown of fat) of<br>the abdomen. The<br>device is<br>indicated for reduction<br>in circumference of the<br>abdomen. | BTL-899ST is<br>indicated to be used<br>for:<br>Non-invasive lipolysis<br>(breakdown of fat) of<br>the abdomen. Reduction in<br>circumference of the<br>abdomen. Non-invasive lipolysis<br>(breakdown of fat) of<br>the thighs. Reduction in<br>circumference of the<br>thighs. | Same intended use.<br>Same indications as<br>SlimShape.<br>Same indications as a subset<br>of the indications of the BTL. | | User Population (Skin<br>Type) | No restrictions in skin<br>type | No restrictions in skin<br>type | BTL-899ST is intended<br>for use with Skin Type<br>I, II and III. | BTL is not indicated for use in<br>Skin Types darker than III.<br>This limitation of the predicate<br>is due to technological<br>factors, and any risks are<br>mitigated in the subject<br>device. | | Full name and<br>510(k) number | The Evolve System<br>with the Transform | The SlimShape<br>System | BTL-899ST | Comparison | | | Applicator | K163415 | K202199 | | | System Components | Energy generators,<br>Applicators,<br>Computer for<br>controlling the System console<br>(touch screen) | Energy generators,<br>Applicators,<br>Computer for<br>controlling the system's output<br>System console<br>(touch screen) | Energy<br>generators,<br>Applicators,<br>Computer for<br>controlling the system's output<br>System console<br>(touch screen) | Same | | Applicator Design | Hand-free applicators<br>fixed by a fixation belt | Hand-free applicators<br>fixed by a fixation belt | Hand-free applicators<br>fixed by a fixation belt | Same | | Selection of<br>Parameters (Intensity,<br>Time) by the User | Yes | Yes | Yes | Same | | Principles of Operation | User applies desired<br>variable amounts of<br>energy to the patient until<br>the tissue is heated,<br>while monitoring the<br>degree of heating and<br>any adverse reaction on<br>the patient's skin. | User applies desired<br>variable amounts of<br>energy to the patient<br>until the tissue is<br>heated, while<br>monitoring the degree<br>of heating and any<br>adverse reaction on the<br>patient's skin. | User applies desired<br>variable amounts of<br>energy to the patient<br>until the tissue is<br>heated, while<br>monitoring the degree<br>of heating and any<br>adverse reaction on<br>the patient's skin. | Same | | Skin Temperature<br>Monitoring | Yes | Yes | Yes | Same | | STOP Button for<br>Patient | Yes | Yes | Yes | Same | | Basic Technology | The system combines<br>bipolar radiofrequency<br>with electric muscle<br>stimulation | The system combines<br>bipolar radiofrequency<br>with mechanical<br>suction. | The system combines<br>bipolar radiofrequency<br>with electric muscle<br>stimulation | All systems are based on<br>bipolar RF energy<br>delivery.<br>The additional energy<br>applied is different in<br>SlimShape (vacuum; the<br>absence of this feature in<br>the subject device does<br>not raise any new risks).<br>The application of EMS<br>in the subject device is<br>similar to BTL. In<br>addition, safety is<br>supported by clinical<br>studies. | | 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}------------------------------------------------