The RF-Relief is an over the counter hand held device intended to emit energy in RF spectrum to provide topical heating for the purpose of elevating tissue temporary relief of minor muscular and joint pain and stiffness, minor arthritis pain or muscle spasm, the temporary increase in local blood circulation, and temporary relaxation of muscles.

Device Description

The RF-Relief is an OTC, home use device, designed to deliver RF energy and mechanical skin massaging. RF energy does not cause thermal damage to the treated skin and the subdermal adipose layer. The level of the RF power, to achieve maximum comfort is user selectable. The ergonomic hand held device allows efficient treatment of the indicated body areas. It is a non-invasive, non-ablative device and it is supplied as non-sterile.

The RF-Relief device consists of power supply, RF power generator, Programmable Logic Controller (PLC, microcontroller) embedded in PCBA and user interface. The device also includes four Bi-polar (2 pairs) electrodes, two redundant temperature sensors and a vibration motor. The PLC (on the PCBA) is especially configured software combined with hardware circuits that provides the operational and safety function of the system.

The RF-Relief device is operated while continuously moving it over the treatment area. This ensures a uniform distribution of the RF energy together with mechanical massage over the entire treatment area.

AI/ML Overview

The RF-Relief device is an over-the-counter handheld device intended to emit radio frequency (RF) energy for topical heating to temporarily relieve minor muscular and joint pain and stiffness, minor arthritis pain or muscle spasms, temporarily increase local blood circulation, and temporarily relax muscles.

Here's an analysis of the acceptance criteria and supporting studies, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Safety - Overheating Protection	The two redundant temperature sensors embedded in the device constantly measure skin temperature and deactivate RF delivery when temperature exceeds 41ºC/ 105.8ºF. This temperature was determined to be acceptable based on published information that human skin begins to feel pain at 44°C and may start to develop burns at 48°C.
Power Accuracy	The device was validated for different power levels (6±1, 8±1 and 10±1 Watt) on a 150 Ω load (appropriate reference for average user load) and other impedance values in relevant environmental conditions. The measured total power was within the predefined error margin.
Parameter Validation	The device was tested for varied parameters including radio frequency (1±0.05 MHz), pulse cycle, waveform, and pulse duration. All results were within the acceptance criteria.
Electrical Safety and EMC Compliance	Complies with IEC 60601-1:2012/EN 60601-1:2013 (General safety), IEC 60601-1-2:2014 (EMC), IEC 60601-2-2:2009 (High-frequency surgical equipment), and IEC 60601-1-11:2015 (Home healthcare environment).
Software Verification and Validation	Documentation provided as recommended by FDA guidance for "moderate" level of concern software.
Temperature during Treatment (Effectiveness)	Temperature measurement of the skin during treatment showed that when operated according to instructions for use and in all treatment modes, a safe and effective temperature around 41°C is reached and maintained over 10-20 minutes on all skin types.
Labeling Comprehension/Self-Selection	Demonstrated that intended OTC users can understand the package labeling and correctly choose this device for themselves for the indicated aesthetic use.
Usability/User Interface	Evaluated usability performance for intended use.
Biocompatibility	Body contact materials are biocompatible per ISO 10993-5:2009 (cytotoxicity) and ISO 10993-10:2010 (irritation and skin sensitization) for "Surface device, Skin Contact for limited contact duration" (<24 hours). This was based on the predicate device's compliance, as materials are identical.

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

The document describes various bench tests, verification and validation (V&V) activities, and other performance studies. However, specific numerical sample sizes for each of these test sets are generally not provided.

Bench Tests (Overheating safety, Power accuracy, Parameter validation): These tests typically involve multiple measurements and iterations but the exact number of units or repetitions is not specified.
Electrical Safety and EMC testing: Performed according to recognized standards (IEC 60601 family), which specify testing methodologies but not necessarily sample sizes in this summary.
Software Verification and Validation: Verification and validation testing was conducted, but the sample size (e.g., number of test cases or iterations) for this is not explicitly stated.
Performance testing - temperature during treatment: The study measured "temperature measurement of the skin during treatment," but the number of subjects or test runs is not specified. It states "all skin types," implying a range of conditions were tested.
Labeling comprehension/Self-Selection study: A study "Demonstrated that intended OTC users can understand the package labeling." No sample size for users is given.
Usability/User Interface study: "Evaluated usability performance for intended use." No sample size for users is given.
Biocompatibility: The biocompatibility evaluation was conducted based on the identical materials of the predicate device. It's not a study with a sample size for the RF-Relief itself, but rather a compliance assessment based on the predicate.

Data Provenance: The studies are primarily described as non-clinical (bench) performance data conducted by EL Global Trade Ltd., presumably in Israel (where the company is based). The Labeling comprehension/Self-Selection study and Usability/User interface study would have involved human subjects, but their geographical origin is not specified, though likely related to the company's location or target market. All data are prospective tests performed to support the 510(k) submission.

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

No information is provided regarding the number of experts or their qualifications for establishing ground truth for any of the described test sets.
For bench and V&V tests, ground truth is typically established by engineering specifications and recognized international standards.
For the labeling comprehension and usability studies, "ground truth" would be determined by the study design (e.g., whether users correctly understood labels or successfully operated the device), not by expert consensus in the traditional sense.

4. Adjudication Method

No specific adjudication method (e.g., 2+1, 3+1) is mentioned for any of the described studies.
For quantitative bench tests, acceptance is usually based on pre-defined numerical thresholds.
For qualitative studies like usability or labeling comprehension, acceptance would be based on predefined success rates or other qualitative metrics, not typically requiring expert adjudication.

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

No MRMC comparative effectiveness study was done. The submission explicitly states: "No clinical data is included in this submission."
Therefore, there is no information on human reader improvement with or without AI assistance as this device is not an AI/imaging diagnostic tool, and no clinical studies were performed.

6. Standalone Performance Study

Standalone performance studies were conducted in the form of bench testing and verification/validation (V&V) activities. These studies assess the device's inherent performance characteristics (e.g., power accuracy, temperature control, parameter validation, electrical safety) independently of human operation nuances, though a "human-in-the-loop" aspect exists for the usability and labeling comprehension studies.
The "Performance testing - temperature during treatment" also evaluated the device's standalone ability to reach and maintain a safe and effective temperature on skin, indicating its core functional performance.

7. Type of Ground Truth Used

Bench Tests (Overheating safety, Power accuracy, Parameter validation, Electrical Safety and EMC): The ground truth relies on engineering specifications, international standards (e.g., IEC 60601 family), and established scientific principles (e.g., human skin pain/burn thresholds from NIST).
Software Verification and Validation: Ground truth is against the software requirements specification and design documents.
Performance testing - temperature during treatment: Ground truth for "safe and effective temperature" is based on published medical/scientific information (e.g., National Institute for Standard and Technology reference) and the device's intended use.
Labeling Comprehension/Self-Selection and Usability/User Interface: Ground truth for these studies would be based on the correctness of user responses/actions against predefined criteria for understanding and usability.
Biocompatibility: Ground truth is compliance with international standards (ISO 10993) and the previously cleared predicate device.

8. Sample Size for the Training Set

The document does not describe the use of any AI/ML components that would require a "training set." All described tests are for a hardware device with embedded software.
Therefore, the concept of a training set for an algorithm is not applicable here.

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

As no training set is mentioned or applicable to this device submission, this information is not provided.

Summary

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July 24, 2018

EL Global Trade Ltd Martin Gurovich CEO Tzoran 8th St, P.O. Box 8242 Netanya, 4250608 Israel

Re: K181095

Trade/Device Name: RF-Relief Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: PBX, GEI Dated: April 15, 2018 Received: April 26, 2018

Dear Martin Gurovich:

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/cdrl/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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

David Krause -S

for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure

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Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

See PRA Statement below.

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K181095

Device Name RF-Relief

Indications for Use (Describe)

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)	Prescription Use (Part 21 CFR 801 Subpart D)	☑ Over-The-Counter Use (21 CFR 801 Subpart C)
Prescription Use (Part 21 CFR 801 Subpart D)
☑ Over-The-Counter Use (21 CFR 801 Subpart C)

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EL Global Trade Ltd

Tzoran 8th St, P.O.Box 8242, Netanya 4250608, Israel Tel: +972-9-7889069 Fax: +972-9-7734831

RF-Relief – 510K Submission

RD-12073 A0

510(K) SUMMARY

DATE PREPARED: JULY 24, 2018

1. 510(K) OWNER NAME

EL Global Trade Ltd.

Tzoran 8th st, P.O.Box 8242, Netanya 425068, Israel.

Phone: +972-9-7889069, Fax: +972-9-7734831.

Contact person name: Dr. Yael Liebes-Peer, RA/ QA Manager (E mail: ra qa@homewellt.com) and Martin Gurovich, CEO (E mail: Martin@elglobalt.com).

Phone: +972-9-7889069, Fax: +972-9-7734831.

2. DEVICE NAME

Common/Usual Name: OTC topical heating device for pain relief

Proprietary/Trade name: RF-Relief

Classification: EL Global Trade Ltd.'s RF-Relief device has been classified as Class II device under the following classification names:

Device Category	ProductCode	RegulationNumber	Panel
Massager, Vacuum, RadioFrequency Induced Heat	PBX	878.4400	General and PlasticSurgery
Electrosurgical, Cutting &Coagulation & Accessories	GEI	878.4400	General and PlasticSurgery

3. PREDICATE DEVICES

EL Global Trade Ltd.'s sensiFirm device is substantially equivalent to the following Predicate Devices:

3.1 SensiFirm by EL Global Trade Ltd., cleared under Premarket Notification K170637, dated July 14, 2017.
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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EL Global Trade Ltd	Tzoran 8th St, P.O.Box 8242, Netanya 4250608, IsraelTel: +972-9-7889069Fax: +972-9-7734831
RF-Relief – 510K Submission	RD-12073 A0

3.2 InMode System MiniFX Handpiece by InMode MD Ltd., cleared under Premarket Notification K160329, dated August 19, 2016.
3.3 InMode Plus System by InMode MD Ltd., cleared under Premarket Notification K153568, dated July 12, 2016.

4. DEVICE DESCRIPTION

Device specifications:

Maximal power output: 10±1 Watt. .
Skin level power: 6±1, 8±1 and 10±1 Watt (energy levels 1-3, respectively). .
Frequency: 1±0.05 MHz. ●
Maximal temperature allowed: 41℃/ 105.80F. ●

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EL Global Trade Ltd	Tzoran 8th St, P.O.Box 8242, Netanya 4250608, IsraelTel: +972-9-7889069		Fax: +972-9-7734831
RF-Relief — 510K Submission		RD-12073 A0

5. INTENDED USE/ INDICATIONS FOR USE

The RF-Relief device is an over the counter hand held device intended to emit energy in the RF spectrum to provide topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscular and joint pain and stiffness, minor arthritis pain or muscle spasm, the temporary increase in local blood circulation, and temporary relaxation of muscles.

NON-CLINICAL (BENCH) PERFORMANCE DATA 6.

The following performance data (bench tests) were provided in support of the performance, safety and efficacy of the RF-Relief device as well as the substantial equivalence determination.

Safety Bench Tests and Verification & Validation (V&V) Summary

Bench testing was conducted according to IEC 60601 family of standards to demonstrate that the RF-Relief device performs as expected under anticipated conditions of use. This testing included safety performance verification (electrical and mechanical) according to IEC 60601-1, essential requirements according to IEC 60601-1-2 and particular requirements for home use medical device per IEC60601-1-11.

In addition, the following bench testing was conducted (among others) to demonstrate the device performance characteristics as part of the V&V (Verification and Validation):

Over-heating safety. The two redundant temperature sensors embedded in . the device constantly measure the skin temperature and deactivate RF delivery when temperature exceeds 41ºC/ 105.8ºF. This temperature was determined to be acceptable, based on published information from the National Institute for Standard and Technology

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EL Global Trade Ltd	Tzoran 8th St, P.O.Box 8242, Netanya 4250608, IsraelTel: +972-9-7889069 Fax: +972-9-7734831
RF-Relief – 510K Submission	RD-12073 A0

(http://www.nist.gov/fire/fire_behavior.cfm), which states that human skin begins to feel pain at 44°C and may start to develop skin burns at 48°C.

Power accuracy. The device was validated for the different power levels on . a 150 Ω load, which is appropriate as the reference of the average load of the user, as well as on other impedance values and in overall relevant environmental conditions. The measured total power was within the predefined error margin, indicating that the device met the acceptance criteria.
Parameter validation. The device was tested for its varied parameters, . including radio frequency, pulse cycle, wave form and pulse duration. All results were within the acceptance criteria.

Electrical safety and electromagnetic compatibility (EMC)

The RF-Relief device complies with the following recognized standards for Electrical Safety and EMC testing:

IEC 60601-1:2012/EN 60601-1:2013, General safety standard: safety . requirements for medical electrical systems.
IEC 60601-1-2:2014, Medical electrical equipment Part 1-2 General . requirements for basic safety and essential performance - Collateral Standard: Electromagnetic Compatibility – Requirements and Tests.
IEC 60601-2-2: 2009, 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.
IEC 60601-1-11:2015, Medical electrical equipment Part 1-11 -. Requirements for the medical electrical equipment and medical electrical systems used in the home healthcare environment.

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EL Global Trade Ltd	Tzoran 8th St, P.O.Box 8242, Netanya 4250608, IsraelTel: +972-9-7889069 Fax: +972-9-7734831
RF-Relief – 510K Submission	RD-12073 A0

Software Verification and Validation Testing

Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level of concern since inadvertent software errors could result in skin burns to the user.

Performance testing- temperature during treatment

The temperature measurement of the skin during treatment showed that when the device is operated according to instructions for use and in all treatment modes, a safe and effective temperature for its intended use, around 41°C, is reached and maintained over 10-20 minutes on all skin types.

Labeling comprehension/ Self-Selection study

Demonstrated that intended OTC users can understand the package labeling and correctly choose this device for themselves for the indicated aesthetic use.

Usability/ User interface study

Evaluated usability performance for intended use.

7. PERFORMANCE TESTING - ANIMAL

No animal testing was performed with the subject device

8. CLEANING, STERILIZATION, SHELF LIFE AND BIOCOMPATIBILITY

The RF-Relief is a non-sterile, reusable device, intended for a single user. The device cleaning instructions are based on the cleaning instructions of the predicate devices due to the fact that both devices are made from the same materials and are used similarly.

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EL Global Trade Ltd	Tzoran 8th St, P.O.Box 8242, Netanya 4250608, IsraelTel: +972-9-7889069Fax: +972-9-7734831
RF-Relief – 510K Submission	RD-12073 A0

The shelf-life expectancy of the device is 5 years, similarly to the predicate device.

The biocompatibility evaluation for the RF-Relief device was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing,"" May 1, 1995, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA.

EL Global has categorized its RF-Relief device as: "Surface device, Skin Contact for limited contact duration", with contact duration of less than 24h ("A", up to 24 hours). Therefore, the battery of testing included the following tests: cytotoxicity, sensitization and irritation tests. The body contact materials are biocompatible per:

. ISO 10993-5:2009, Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity.
. ISO 10993-10:2010, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization.

9. CLINICAL PERFORMANCE DATA

No clinical data is included in this submission.

10. SUBSTANTIAL EQUIVALENCE

The indications for use and technological characteristics of the RF-Relief device are substantially equivalent to the indications for use and technological characteristics of the predicate devices.

The design, components, specifications and performance specifications of the RF-Relief device are identical to the ones of the sensiFirm predicate device and are of high similarity to the InMode System MiniFX Handpiece and InMode Plus System predicate devices. All devices are based on RF energy (Bi-polar source delivering

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EL Global Trade Ltd	Tzoran 8th St, P.O.Box 8242, Netanya 4250608, IsraelTel: +972-9-7889069 Fax: +972-9-7734831
RF-Relief – 510K Submission	RD-12073 A0

1 MHz frequency and similar intensity and power) with the same mechanism of action. The technological component (i.e. the vibration massage) incorporated in the RF-Relief device, is the same as in the sensiFirm predicate device. This feature does not alter the functionality and performances of the RF-Relief device compared to predicate devices since it does not affect the RF performances and the predetermined temperature. All these features and characteristics supports the suitability of the RF-Relief to its intended use.

The safety features and compliance with safety standards of both the RF-Relief device and its predicate devices are identical.

All patient contact materials are identical to the materials found in the sensiFirm predicate device, which was tested and found to be in compliance with the ISO 10993-1 standard.

The minor differences in the technological characteristics do not raise new safety or effectiveness concerns and are demonstrated to be substantially equivalent through bench testing. Furthermore, RF-Relief device has qualified with varied performance tests, including software validation testing, electrical and mechanical safety testing according to IEC 60601-1, electromagnetic compatibility testing according to IEC 60601-1-2, compatibility as medical electrical equipment for home healthcare environment according to 60601-1-11, and high frequency of surgical equipment according to IEC 60601-2-2. 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 RF-Relief device is substantially equivalent to the predicate devices selected: the sensiFirm device, cleared under K170637, the InMode System MiniFX Handpiece cleared under K160329 and the InMode Plus System, cleared under K153568.

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EL Global Trade Ltd	Tzoran 8th St, P.O.Box 8242, Netanya 4250608, IsraelTel: +972-9-7889069 Fax: +972-9-7734831
RF-Relief - 510K Submission	RD-12073 A0

11. CONCLUSIONS

Based on the performance testing and comparison to predicate devices, the RF-Relief device is substantially equivalent to the previously cleared predicate devices.

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.