EmFace Device

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there 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, the words "U.S. FOOD & DRUG" are written in blue, with the word "ADMINISTRATION" written in a smaller font size below. October 29, 2019 InMode MD Ltd. % Amit Goren Regulatory Manager A. Stein - Regulatory Affairs Consulting Ltd. 20 Hata'as Str., Suite 102 Kfar Saba. Israel 4442520 Re: K191855 Trade/Device Name: EmFace Device Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: PBX Dated: July 4, 2019 Received: September 26, 2019 Dear Amit Goren: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. {1}------------------------------------------------ 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-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. 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 Enclosure {2}------------------------------------------------ DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration ## Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below. 510(k) Number (if known) K191855 Device Name EmFace Device Indications for Use (Describe) The EmFace Device with Cheek and Chin Applicators is indicated for the temporary relief of minor muscle aches and pain, temporary relief of muscle spasm, and temporary improvement of local blood circulation. | Type of Use (Select one or both, as applicable) | <table><tr><td><span style="font-size: 120%;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D)</td><td><span style="font-size: 120%;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C)</td></tr></table> | <span style="font-size: 120%;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-size: 120%;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) | |--------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------| | <span style="font-size: 120%;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-size: 120%;">☐</span> 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." {3}------------------------------------------------ # 510(K) SUMMARY # EMFACE DEVICE # 510(k) Number K191855 # Applicant Name: | Company Name: | InMode MD Ltd. | |-------------------------|------------------------------------------------------------| | Address: | Tabor Building, Shaar Yokneam<br>Yokneam 20692<br>Israel | | 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: | 20 Hata'as Str., Suite 102<br>Kfar Saba 4442520 Israel | | Tel: | + 972-9-7670002 | | Fax: | +972-9-7668534 | | E-mail: | amit@asteinrac.com | | Date Prepared: | Oct 24, 2019 | | Trade Name: | EmFace Device | | Classification Name: | CFR Classification section 878.4400; Product<br>codes: PBX | | Classification: | Class II Medical Device | | Predicate Device: | | The EmFace Device is substantially equivalent to the following predicate device: | Device Main Predicate | Manufacturer | 510(k) No. | |-----------------------|----------------|------------| | InMode PLUS System | InMode MD Ltd. | K153568 | {4}------------------------------------------------ # Device Description: The EmFace Device with the Cheek and Chin Applicators is a hands-free, easy to operate system, designed to deliver non-thermal RF energy to the skin and subdermal fat. The RF power levels used by the device can be adjusted from 10 to 50 Watts and the maximum skin temperature cutoff can be adjusted from 35℃ to a maximum of 43℃. The hands-free applicators multiple RF units are sequentially activated over the treatment area. This ensures homogenous and safe heating distribution over the entire treatment area. The EmFace Device consists of an AC/DC power supply unit, two RF generators, controller and user interface including an LCD touch screen. The System RF non-invasive Applicators are connected to the console via a cable. The delivery of the RF Energy is controlled by a Start/Stop button on the LCD screen. The System operates while connected to any of the following applicators: - . Chin Applicator (with three sequentially activated units) or; - . Cheek Applicator (with eight sequentially activated units) The applicator is connected to the main console via a designated cable and a connection port. The applicators' units are adjusted to the patient using an adjustable designated belt set. | Main Line Frequency (nominal): | 50-60 Hz | |--------------------------------|--------------------------------------------------------------------| | Input Voltage (nominal): | 100-240 VAC | | Dimension: | 40.7 cm W x 40.9 cm D x 102.5cm H<br>(16.1" W x 16.1" D x 40.3" H) | | System Weight: | 20 Kg (44 lbs) | | Chin Applicator Weight: | 0.5 Kg (1.1lb) | | Cheek Applicator Weight: | 0.9 Kg (2.0lb) | | Maximal RF Output Power: | 50 Watt | | RF Output Frequency: | 1[MHz] ± 2% | Following are the EmFace Device specifications: #### Intended Use/Indication for Use: The EmFace Device with the Cheek and Chin Applicators is indicated for the temporary relief of minor muscle aches and pain, temporary relief of muscle spasm, and temporary improvement of local blood circulation. {5}------------------------------------------------ # Performance Standards: The EmFace Device has been tested and complies with the following FDA recognized consensus standards: - · AAMI ANSI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD). - · IEC 60601-1-2 Medical electrical equipment Part 1-2: Collateral Standard: Electromagnetic compatibility -Requirements and tests (2014, 4th Ed.). - · IEC 60601-2-2 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 (2017, 6th Ed.). # Sterilization/Disinfection/Cleaning/Shelf Life/Use life: The EmFace Device Cheek and Chin Applicators are intended for multiple use and therefore must be cleaned according to the instructions provided in the device Instructions for Use. The device belt set is intended for single use and should be discarded upon a single use completion. There are no sterilized parts or accessories involved with this device. The shelf life of the EmFace Device console is 5 years and the shelf life of the EmFace Applicator components is 2 years. The use life of the EmFace Device Applicator components is 2 years. #### Biocompatibility: The EmFace Device components that come in direct contact with the human body are the device applicator unit's plastic housing and RF electrodes and the applicator adjustable belt set. All of the materials used for the manufacturing of these device components are biocompatible. # Non-Clinical (Bench) Performance Data: In order to evaluate the similarities of the subject and predicate applicator electrodes in terms of heat transfer/heat loss and temperature stability, the company had performed temperature build up test. {6}------------------------------------------------ The results of these tests, measured at two different RF outputs levels (30W and 50W), showed similar temperature build up. This is mainly due to the fact that both the subject and predicate devices deliver the same RF output power and that their electrodes geometry is identical. #### Pre-Clinical (Animal) Performance Data: The EmFace Device with the Cheek and Chin Applicators was evaluated for its thermal effect in an ex-vivo animal study model. The device safety assessment included tissue vitality evaluation and tissue temperature profiling following a single treatment with either the Cheek or Chin Applicators on porcine tissue. The device applicators were operated in different power outputs for the recommended treatment time. The study results revealed no signs of tissue necrosis in all of the animal tissues treated with the device applicators in all power levels. The measured temperature on tissue surface was around 43ºC and lower in deeper tissue layers following the treatment with the device applicators in all power levels. # Clinical Performance Data: The EmFace Device with the Cheek and Chin Applicators was further evaluated for its safe performance on thirty eligible human subject participants with different age, gender, and Fitzpatrick skin types. The study consisted of a single treatment followed by immediate photography and thermal measurements of the treatment area per each applicator treatment. Skin observation was done immediately and 24h post treatment and was extended up to 48h following treatment to assess possible skin transient response. Subjects were treated on their Cheek facial area with the Cheek Applicator and on their Chin facial area with the Chin Applicator. Treatment included a maximal number of applicator units according to area size, utilizing maximal RF power setting (50W), at the highest cut-off temperature value (43ºC). The study results clearly show the safe use of the EmFace Device with the Cheek and the Chin Applicators for its intended use while utilized in accordance with the device operator manual treatment instructions. The temperature measurements along with the skin observation for adverse events show that the treatment methodology of both EmFace Device Applicators contribute for the same thermal outcomes obtained by using the respective predicate device for the same intended use. The safe use of the EmFace Device Applicators was shown on all potential end-users with different age, gender and skin type. No adverse events were reported in this study and the skin thermal profile showed a desirable temperature level of around 43ºC. Most of the subjects endured the maximal {7}------------------------------------------------ EmFace Device 510(k) file Section 05 - 510(k) Summary treatment parameters with mild to moderate discomfort levels. The device safety was shown using the device applicators with the maximal performance specifications applied. Additionally, lower performance specifications that were applied on subjects with low tolerance to maximal performance parameters showed of similar safety outcomes. {8}------------------------------------------------ # Substantial Equivalence: The below table summarizes the main comparison aspects between the EmFace Device and its proposed predicate device; the InMode PLUS (FDA cleared in K153568). | Characteristic | Subject Device | Main Predicate | |--------------------------------------------------------------|-----------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------| | 510(k) file No. | K191855 | K153568 | | Device Name | EmFace Device | InMode PLUS System | | Manufacturer | InMode MD Ltd. | InMode MD Ltd. | | Product Code, Class | PBX<br>Class II | ISA PBX<br>Class II | | Energy Used / Delivered | RF energy, | RF energy | | Physical specifications:<br>Dimensions | Dimensions: W*D*H<br>16.1x16.1x 40.3 in/<br>40.7x40.9 x102.5 cm | Dimensions: W*D*H<br>18.2 x18.2 x40 in /<br>46 x 46 x 100cm | | Weight Console | Weight: 20 Kg / 44 lbs | Weight: 30 Kg / 66 lbs. | | Weight Hand pieces | Chin Applicator 0.5kg [1.1lb]<br>Cheek Applicator 0.90kg [2.00lb] | 0.110 Kg [0.243 lbs] | | Performance Specifications:<br>Main Line Frequency (nominal) | 50-60Hz | 50-60 Hz | | Input Voltage (nominal) | 100-240VAC | 100-240VAC | | Input Current (rms) | 4.0A | 2.0A | | RF Frequency: | 1 MHz | 1 MHz | | RF electrical power: | Up to 50 watts | Up to 50 watts | | Pulse duration: | Chin and Cheek Applicators:<br>units are sequentially<br>activated - 2 seconds per unit | Pulse duration mode:<br>Continuous (during<br>movement within target area)<br>or Pulsed (maximal pulse<br>duration: 30sec) | | Cut off Temperature: | 35-43°C | 35-43°C | | Standards Met | AAMI ANSI ES 60601-1<br>IEC 60601-1-2<br>IEC60601-2-2 | IEC 60601-1<br>IEC 60601-1-2<br>IEC 60601-2-2 | {9}------------------------------------------------ The device classification and indications for use of the EmFace Device are substantially equivalent to the device classification and indications for use of the predicate device. The technological characteristics of the subject device is based on that of the predicate device. The EmFace Device comprises similar platform components; AC/DC power supply unit, RF generators, controller and user interface including an LCD touch screen. The EmFace Device design mainly differentiate from its predicate device with the option to perform a hands-free treatment using multiple applicator units, operated sequentially. The device is provided with three units of the Chin applicator and eight units of the Cheek (4 on each cheek side) applicator. With this design change, the applicators' performance specifications, mainly the RF frequency and electrical power, pulse duration, were left unchanged, but the treatment technique has been modified to provide the same performance outcomes to the target area; warm heating of the skin and subdermal layers by non-thermal RF energy. In order to support this design change, a few platform modifications were made including an additional RF generator and an increased input current of 4A to support the multi applicator unit's functionality and an upgrade in system software and hardware components to support the aforementioned change. The EmFace Device is backed up with the safety features as applied in the predicate device systems. The EmFace Device was tested and complies with the safety and EMC standards as requested for RF technology-based devices. The EmFace Device with the Cheek and Chin Applicators was further evaluated for its safe performance in bench temperature build up tests, ex-vivo Animal study and in a human clinical study. The results of these studies demonstrated that the EmFace Device is safe for use as intended and that the minor design differences between the subject and predicate device, mainly in the treatment methodology, do not raise any new safety or effectiveness concerns. Consequently, it can be concluded that the EmFace Device is substantially equivalent to the InMode PLUS System predicate device, FDA cleared under 510(k) file no. K153568. #### Conclusions: Based on the comparison to the predicate device and on the bench, non-clinical and clinical performance testing results demonstrating that the EmFace Device is as safe and effective as the predicate device, it can be concluded that the EmFace Device is substantially equivalent to the predicate device and therefore, may be legally marketed in the USA.