The EmBodyPLUS hand piece 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 EmBodyFX Hand piece is intended for the treatment of the following medical conditions using RF combined with massage:

· Relief of minor muscle aches and pain, relief of muscle spasm, temporary improvement of local blood circulation.

· Temporary reduction in the appearance of cellulite.

Device Description

The EmBody System with the EmBodyFX and EmBodyPlus Applicators is a free hand, easy to operate system, designed to deliver non-thermal RF energy to the skin and subdermal fat. The EmBodyFX Applicator also incorporates a mechanical vacuum skin massaging mechanism.

The EmBody System is employing RF technology for various aesthetic applications.

The device provides individual adjustment of non-thermal RF power and vacuum pulse duration to achieve maximum efficiency and safety for each patient. The design of the device applicators allows efficient treatment of large tissue surfaces.

The EmBody System consists of an AC/DC power supply unit, two RF generators, controller and user interface including an LCD touch screen. The System RF noninvasive applicators are connected to the console via a cable. The delivery of the RF Energy is controlled by a Start/Stop button located on the LCD screen.

The EmBody System operates while connected to any of the following Applicators:

. EmBodyFX (Up to Six units connected simultaneously) or;
. EmBodyPlus (Up to Eight units connected simultaneously)

Each applicator unit is connected to the main console via a designated cable and a connection port. The applicator units are adjusted to the patient body using a designated belt set.

AI/ML Overview

The provided text describes the EmBody System, which is intended for temporary relief of minor muscle aches and pain, muscle spasms, local blood circulation improvement, and temporary reduction in the appearance of cellulite. The device uses non-thermal RF energy and, in the case of the EmBodyFX applicator, a mechanical vacuum skin massaging mechanism.

Here's a breakdown of the requested information based on the provided text:

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

The provided text does not explicitly state "acceptance criteria" in a quantitative, measurable format for device performance. Instead, it focuses on demonstrating substantial equivalence to predicate devices and proving safety and effectiveness through various tests.

However, based on the non-clinical and clinical studies, the implied performance outcomes and safety parameters could be considered acceptance criteria and reported performance:

Acceptance Criteria (Implied)	Reported Device Performance
Safety: No tissue necrosis	Ex-vivo animal study: No signs of tissue necrosis in all animal tissues treated with device applicators at all power levels.
Safety: Achieves a desirable and safe thermal profile	Ex-vivo animal study: Measured temperature on tissue surface was around 43°C and lower in deeper tissue layers. Human clinical study: Skin thermal profile showed a desirable temperature level of around 43°C.
Safety: No adverse events reported	Human clinical study: No adverse events were reported.
Effectiveness (similar to predicate): Equivalent thermal effect and mechanism of operation as predicate devices for intended use.	Bench test: Showed similar thermal effect for both the subject and predicate devices, indicating an equivalent mechanism of operation. Human clinical study: Treatment methodology of both EmBody device applicators contributes to the same thermal outcomes obtained by using the respective predicate devices for the same intended use.
Tolerance/Discomfort: Manageable by subjects	Human clinical study: Most subjects endured maximal treatment parameters with mild to moderate discomfort levels.

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

Sample Size for Test Set:
- Bench Test (Thermal Effect Comparison): The text mentions "human volunteers" but does not specify the sample size for this comparative bench test.
- Ex-vivo Animal Study: Not specified, but involved "porcine tissue."
- Human Clinical Study: Thirty (30) eligible human subject participants.
Data Provenance:
- Bench Test (Thermal Effect Comparison): Conducted in-house by the manufacturer (InMode MD Ltd.) comparing their own devices. Specific country of origin not explicitly stated, but the manufacturer is based in Israel.
- Ex-vivo Animal Study: Conducted in-house by the manufacturer. Specific country of origin not explicitly stated, but the manufacturer is based in Israel.
- Human Clinical Study: Conducted in-house by the manufacturer. Specific country of origin not explicitly stated, but the manufacturer is based in Israel. This was a prospective study.

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

The provided text does not mention using experts to establish ground truth for the test set. The evaluation was based on:

Thermal measurements.
Skin observation.
Tissue vitality evaluation (in the animal study).
Adverse event reporting.
Subject discomfort levels.

Therefore, no information on the number or qualifications of experts for ground truth establishment is available.

4. Adjudication method for the test set

The provided text does not mention any adjudication method for the test set. The safety and performance assessments were directly observed (e.g., thermal measurements, skin observation, adverse event reporting) rather than requiring independent review or consensus.

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

There is no indication that a multi-reader multi-case (MRMC) comparative effectiveness study was done. This device is an electrosurgical device for aesthetic and therapeutic applications, not an AI-powered diagnostic imaging tool that would typically involve human readers or AI assistance in interpretation.

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

This refers to a physical medical device, not an algorithm or AI. Performance was assessed through direct physical interaction with tissue (bench, animal, and human studies), not through an algorithm operating independently. Therefore, this question is not applicable.

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

The ground truth for evaluating the device's safety and performance was primarily based on:

Physiological measurements: Thermal measurements (temperature around 43°C).
Direct observation: Skin observation for transient responses, absence of tissue necrosis, and absence of adverse events.
Subjective reporting: Discomfort levels reported by human subjects.
Comparison to predicate devices: Demonstration of "similar thermal effect" and "same thermal outcomes" as the legally marketed predicate devices.

8. The sample size for the training set

The provided context describes performance testing for device clearance, not the development or training of an AI model. Therefore, there is no "training set" in the context of this document.

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

As there is no training set for an AI model, this question is not applicable.

Summary

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June 20, 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: K183450

Trade/Device Name: EmBody System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: PBX, ISA Dated: May 20, 2019 Received: May 23, 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.

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

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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 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/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

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Indications for Use

510(k) Number (if known) K183450

Device Name EmBody System

Indications for Use (Describe)

The InMode EmBody System with its designated hand pieces is intended for the treatment of the following medical conditions;

The EmBodyPLUS hand piece 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 EmBodyFX Hand piece is intended for the treatment of the following medical conditions using RF combined with massage:

· Relief of minor muscle aches and pain, relief of muscle spasm, temporary improvement of local blood circulation.

· Temporary reduction in the appearance of cellulite.

	And And And And States of Street States of Street Station Station Comparent of Children	------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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510(K) SUMMARY EMBODY SYSTEM DEVICE

510(k) Number K183450

Applicant Name:

Company Name:Address:	InMode MD Ltd.Tabor Building, Shaar YokneamYokneam 20692IsraelTel: +972-4-9097470Fax: +972-4-9097471E-mail: amit@asteinrac.com
Contact Person:
Official Correspondent:Company Name:Address:	Amit GorenA. Stein - Regulatory Affairs Consulting Ltd.20 Hata'as Str., Suite 102Kfar Saba 4442520 IsraelTel: + 972-9-7670002Fax: +972-9-7668534E-mail: amit@asteinrac.com
Date Prepared:	June 18, 2019
Trade Name:	EmBody System
Classification Name:	CFR Classification section 878.4400;(Product codes: ISA &PBX)
Classification:	Class II Medical Device
Predicate Device:

The EmBody System is substantially equivalent to the following predicate devices.

Device Main Predicate	Manufacturer	510(k) No.
InMode WMbody	InMode MD Ltd.	K131362
InMode PLUS System	InMode MD Ltd.	K172302

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Device Description:

The EmBody System is employing RF technology for various aesthetic applications.

The EmBody System operates while connected to any of the following Applicators:

. EmBodyFX (Up to Six units connected simultaneously) or;
. EmBodyPlus (Up to Eight units connected simultaneously)

Each applicator unit is connected to the main console via a designated cable and a connection port. The applicator units are adjusted to the patient body using a designated belt set.

Main Line Frequency (nominal):	50-60 Hz
Input Voltage (nominal):	100-240 VAC
Dimension:	46cm W x 46cm D x 100cm H
	(18.2" W x 18.2" D x 44" H)
System Weight:	20 Kg (44 lbs)
EMBodyPlus Applicator Weight:	0.17 Kg (0.375lb)
EMBodyFX Applicator Weight:	0.9 Kg (2.0lb)
Maximal RF Output Power:	50 Watt
RF Output Frequency:	1 [MHz] ± 2%
Vacuum (available in EMBodyFX	200-500 mbar (Automatically controlled)
Applicator only):

Following are the EmBody System specifications:

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Intended Use/Indication for Use:

The EmBody System with its designated applicators is intended for the treatment of the following medical conditions;

The EmBodyPlus Applicator 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 EmBodyFX Applicator is intended for the treatment of the following medical conditions using RF combined with massage:

. Relief of minor muscle aches and pain, relief of muscle spasm, temporary improvement of local blood circulation.
. Temporary reduction in the appearance of cellulite.

Performance Standards:

The EmBody System has been tested and complies with the following FDA recognized consensus standards:

· IEC 60601-1 Medical Electrical Equipment Part 1: General requirements for basic safety and essential performance (2005 +Am.1 2012, 3rd Ed.).
· IEC 60601-1-2 Medical electrical equipment Part 1-2: Collateral Standard: Electromagnetic compatibility -Requirements and tests (2014, 4th Ed.).
· IEC 60601-1-6 Medical Electrical Equipment Part 1-6: General requirements for safety – Collateral Standard: Usability (2010 + A1:2013, Ed. 3.1).
· 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.).
· IEC 62304 Medical device software: Software life-cycle processes (2006, 1st Ed. + A1:2015).

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Sterilization/Disinfection/Cleaning/Shelf Life:

The device EmBodyFX and EmBodyPlus 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 use completion.

There are no sterilized parts or accessories involved with this device.

The shelf life of the EmBody System console is 5 years and the shelf life of the EmBody Applicator components is 2 years.

Non-Clinical (Bench) Performance Data:

A comparative bench test was performed utilizing the EMBody System with the EMBodyFX and EMBodyPlus Applicators and the respective predicate devices; the InMode WMBody and InMode Plus to evaluate the thermal effect on human volunteers. Both the subject device and predicate devices were operated using the same performance specifications according to the devices' operation recommendations. The study results showed of similar thermal effect for both the subject and predicate devices indicating on equivalent mechanism of operation.

Pre-Clinical (Animal) Performance Data:

The EmBody System with the EmBodyFX and EmBodyPlus 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 EmBodyPlus or EmBodyFX 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 EmBody System with the EmBodyPlus 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

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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 abdomen, back, arms and thighs with either the EmBodyPlus or EmBodyFX 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 (430C).

The study results clearly show the safe use of the EmBody System with the EmBodyPlus and the EmBodyFX 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 EmBody device Applicators contribute for the same thermal outcomes obtained by using the respective predicate devices for the same intended use. The safe use of the EmBody device applicators was shown on all potential end-users with different age, gender and skin type and on all potential treatment body areas. No adverse events were reported in this study and the skin thermal profile showed a desirable temperature level of around 43%C. Most of the subjects endured the maximal 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.

Substantial Equivalence:

The below table summarizes the main comparison aspects between the EMBody System and its proposed predicate devices; the InMode PLUS (FDA cleared in K172302) and InMode WMBody (FDA cleared in K131362).

Characteristic	Subject Device	Main Predicate	Main Predicate
510(k) file No.	–	K131362	K172302
Device Name	EmBody System	InMode WMBody	InMode PLUS System
Manufacturer	InMode MD Ltd.	InMode MD Ltd.	InMode MD Ltd.
Product Code,Class	ISA PBXClass II	ISA NUVClass II	ISA PBXClass II
Energy Used /Delivered	RF energy,	RF energy	RF energy
Physicalspecifications:Dimensions	Dimensions:WDH18.2 x 18.2 x 40 in /46 x 46 x 100 cm	Dimensions:WDH14.2 x 14.2 x 40 in /36 x 36 x 100 cm	Dimensions:WDH18.2 x18.2 x40 in /46 x 46 x 100cm

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EmBody System 510(k) file Section 05 - 510(k) Summary

Characteristic	Subject Device	Main Predicate	Main Predicate
510(k) file No.	-	K131362	K172302
Device Name	EmBody System	InMode WMBody	InMode PLUSSystem
Manufacturer	InMode MD Ltd.	InMode MD Ltd.	InMode MD Ltd.
Weight Console	Weight: 20 Kg / 44lbs	Weight: 30 Kg / 66lbs	Weight: 30 Kg / 66lbs.
Weight Hand pieces	EmBodyPLUS Handpiece0.17kg [0.375lb]EmBodyFX Handpiece0.90kg [2.00lb]	WMBody HP:0.90 Kg [2.00 lbs.]	PLUS Applicator0.170 Kg [0.352 lbs]
PerformanceSpecifications:
Main LineFrequency (nominal)	50-60Hz	50-60 Hz	50-60 Hz
Input Voltage(nominal)	100-240VAC	100-240VAC	100-240V
Input Current (rms)	4A	2A	2A
RF Frequency:	1 MHz	1 MHz	1 MHz
Vacuum:	200-500 mbar	200-500 mbar
RF electrical power:	Up to 50 watts	Up to 50 watts	Up to 50 watts
Pulse duration:	EMBodyPlusApplicator: 2-7secondsEMBodyFXApplicator: 2seconds	2-7 seconds	Pulse duration mode:Continuous (duringmovement withintarget area) or Pulsed(maximal pulseduration: 30sec)
Cut off Temperature:	35-43°C	35-43°C	35-43°C
Standards Met	IEC 60601-1IEC 60601-1-2IEC60601-2-2	IEC 60601-1IEC 60601-1-2IEC 60601-2-2	IEC 60601-1IEC 60601-1-2IEC 60601-2-2

The device classification and indications for use of the EmBody System are substantially equivalent to the device classification and indications for use of the predicate devices.

The technological characteristics of the subject device is based and that of the predicate devices. The EMBody System comprise similar platform components; AC/DC power supply unit, RF generators, controller and user interface including an LCD touch screen and similar applicators; EMBodyFX equivalent to the InMode WMBody applicator and EMBodyPlus equivalent to the InMode PLUS applicator. The EMBody System design mainly differentiate from its predicate devices with the option to perform a free hand

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treatment using multiple applicator units, operated sequentially. The device is provided with up to six units of EMBodyFX and up to eight units of EMBodyPlus applicators. With this design change, the applicators' performance specifications, mainly the RF frequency and electrical power, pulse duration and vacuum pressure, 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 to support the multi applicators functionality and an upgrade in system software and hardware components to support the aforementioned change. The EMBody System is backed up with the safety features as applied in the predicate device systems. The EMBody System was tested and complies with the safety and EMC standards as requested for RF technologybased devices. The EMBody System with the EMBodyFX and EMBodyPlus Applicators was further evaluated for its safe performance in ex-vivo animal study and in a human clinical study. The results of these studies showed that the EmBody System is safe for us 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 EmBody System is substantially equivalent to the InMode WMbody and to the InMode PLUS System predicate devices, FDA cleared under 510(k) file no. K131362 and K172302, respectively.

Conclusions:

Based on the comparison to the predicate devices and on the non-clinical and clinical performance testing results demonstrating that the EmBody System is as safe and effective as the predicate devices, it can be concluded that the EmBody System is substantially equivalent to the predicate devices 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.