HeatLux Pro II is an over the counter hand held device intended to emit energy in the visible, near IR, and 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.

Device Description

The HeatLux Pro II Device is an over the counter, hand held device, utilizing low power light spectrum, array of 24 LEDs, at wavelength of 630±10nm and 850±50nm, RF output power (1MHz. maximal output power 24W) and electrical heating. The HeatLux Pro II Device consists of an applicator and an adaptor. The applicator is a hand held unit used for treatment, as the treatment surface at the applicator tip comes in direct contact with the skin. The device applicator comprises temperature stabilizer, which constantly maintains the applicator temperature to 41ºc.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:

Preamble: This document describes the acceptance criteria and studies for the HeatLux Pro II Device, an over-the-counter handheld device intended for temporary relief of minor muscular and joint pain and stiffness, minor arthritis pain or muscle spasm, temporary increase in local blood circulation, and temporary relaxation of muscles.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes the device's compliance with several performance standards and safety tests rather than explicit quantitative acceptance criteria with numerical targets. However, the overall acceptance criterion is Substantial Equivalence to legally marketed predicate devices, which is demonstrated by meeting various technical specifications, safety standards, and performance characteristics.

Acceptance Criterion Type	Specific Criteria / Standard	Reported Device Performance	Comments
Safety and Performance	IEC 60601-1 (2005/2006)	Complies	General requirements for basic safety and essential performance.
	IEC 60601-1-2 (2007)	Complies	Electromagnetic Compatibility.
	IEC 60601-2-57 (2011)	Complies	Basic safety and essential performance of non-laser light source equipment.
	IEC 60601-2-2 (2009)	Complies	Basic safety and essential performance of high frequency surgical equipment.
Biocompatibility	ISO 10993-1	Complies	Based on testing of the predicate HeatLux Pro I device, which uses identical patient contact materials.
Thermal Profile	Bench Tests	Met system requirements	Evaluated thermal profile and temperature stability.
RF Depth Penetration	Bench Tests	Met system requirements	Evaluated RF depth penetration.
Software Validation	Software Validation Testing	Met system requirements	Demonstrated that software modifications did not alter functionality or performance.
Usability/User Performance	User performance (usability) study	Successfully operated as intended with no safety issues	Evaluated user's ability to self-select, comprehend labeling, and operate safely/effectively.
Substantial Equivalence	Overall comparison to Velashape System (K122579) and HeatLux Pro I (K150175)	Substantially Equivalent	Demonstrated similar indications for use, technological characteristics, mechanism of action, and safety features. Differences did not raise new safety or effectiveness concerns.

Key Device Specifications (Relevant for comparison to predicates):

RF frequency: 1MHz
Maximal RF output power: 24W
Maximal heating plates output power: 12W
Maximal optical power density: 60mWatts/cm²
LED Wavelengths: 630±10nm and 850±50nm

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

Sample Size for Usability Study: Twenty eligible device users.
Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, the study was conducted to evaluate user performance for this specific device, implying it was a prospective study. The applicant is Home Skinovations Ltd., located in Israel, so it's possible the study was conducted there.

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

Usability Study: The document describes a "user performance (usability) study" with "device users." It does not mention the use of experts to establish a "ground truth" in the traditional sense of medical diagnosis. Instead, the study assessed the users' ability to operate the device and understand its labeling. The "ground truth" here would be the observed user interactions and safety outcomes. It tested if users could act safely and effectively, not if they could accurately diagnose a condition.

4. Adjudication Method for the Test Set

Usability Study: No explicit adjudication method (e.g., 2+1, 3+1) is mentioned. The study's focus was on direct observation of user performance and comprehension of instructions, rather than expert judgment on ambiguous cases. The "study results showed that potential device users had successfully operated the device as intended with no safety issues reported," suggesting a clear outcome was observed for each participant.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done.

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

This device is not an AI/algorithm-based diagnostic or assistive device. It is a physical medical device that emits energy. Therefore, the concept of "standalone (algorithm only without human-in-the-loop performance)" is not applicable. The performance studies focus on the physical device's specifications, safety, and human interaction/usability.

7. The Type of Ground Truth Used

Bench Tests (Thermal Profile, RF Depth, Temperature Stability): The ground truth was based on objective measurements against pre-defined system requirements and engineering specifications.
Safety Standards (IEC series): The ground truth was compliance with the requirements set forth in the international voluntary standards.
Biocompatibility (ISO 10993-1): The ground truth was compliance with the international standard for biological evaluation of medical devices, leveraging prior testing of the predicate device.
Usability Study: The "ground truth" was the observed actual performance of users in operating the device and understanding its labeling, confirming safe and effective use.

8. The Sample Size for the Training Set

This is not an AI/machine learning device; therefore, the concept of a "training set" in that context is not applicable.
However, regarding device development and testing: The device's design and software modifications were likely guided by previous versions (like HeatLux Pro I) and engineering principles. The "training" or development data would be internal engineering data, prototypes, and iterative testing, which is not detailed in the summary.

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

As this is not an AI/machine learning device, the concept of "ground truth for a training set" as typically understood in AI development is not applicable.
For the development and optimization of the physical device, ground truth would have been established through engineering principles, physical laws, established safety standards, and iterative bench testing during the design and manufacturing process, to ensure the device met its intended specifications and safety profile.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, resembling a bird-like shape.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 29, 2016

Home Skinovations Ltd. % Ms. Ahava Stein A.Stein-Regulatory Affairs Consulting Ltd. 20 Hata'as Str., Suite 102 Kfar Saba, 4442520 Israel

Re: K152087

Trade/Device Name: Heatlux Pro II Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared Lamp Regulatory Class: Class II Product Code: ILY, GEI Dated: July 10, 2016 Received: July 13, 2016

Dear Ms. Stein:

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. 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Christopher J. Ronk -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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Indications for Use

510(k) Number (if known) K152087

Device Name HeatLux Pro II Device

Indications for Use (Describe)

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

| | Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(K) SUMMARY HEATLUX PRO II DEVICE

510(k) Number K152087

Applicant Name:

Company Name:	Home Skinovations Ltd.
Address:	Tavor Building, POB 533
	Yokneam Iillit 2069206 Israel
	Tel: +972(4)9097440
	Fax: +972(4)9097471
	E-mail: amit@asteinrac.com; ahava@asteinrac.com

Contact Person:

Official Correspondent:	Ahava Stein
Company Name:	A. Stein – Regulatory Affairs Consulting Ltd.
Address:	20 Hata'as Str., Suite 102Kfar Saba 4442520 IsraelTel: +972-9-7670002Fax: +972-9-7668534E-mail: amit@asteinrac.com; ahava@asteinrac.com
Date Prepared:	July 29, 2016
Trade Name:	HeatLux Pro II Device
Classification Name:	CFR Classification section 890.5500;(Product code ILY & GEI)
Classification:	Class II Medical Device

Predicate Device:

The HeatLux Pro II Device is substantially equivalent to the following predicate devices:

Device	Vamitactirer	1/1/1
FATERS LATER	PRESSENT SERVER PLANE PL	FART THE FALLTT 1 OA CHA
アイスティアアミックスタム『の日本のアイアンティッP P S 2 2 2 7 7 4 1 7 7 7 7 7 7 7 7 7 7 7 7 7 7 7 7 7 7 7 7 7 7 7 7 7 7 7 7 7 7 7 7 7 7 7 7 7 7 7 7 7 7 7 7 7 7 7 7 7 7 7 7 7 7 7 7 7 7 7 7 7 7 7 7 7 7 7 7 7 7 7 7 7 7 7 7 7	A T T S . T . Tアッショップトン 2000 アクセット 5 シリーズアクセスタット 1 1 1 2 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1	PP 9 9 9 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 -PVIPALP T T TAVAT THE P

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Device Description:

Device Specifications:

RF frequency: 1MHz Maximal RF output power: 24W Maximal heating plates output power: 12W Maximal optical power density: 60mWatts/cm2 Package dimensions: 22cm x 22cm x 14cm Weight: 250gr Main Line Frequency (nominal): 50-60 Hz Input Voltage (nominal): 100-240 VAC

Intended Use/Indication for Use:

Performance Standards:

The HeatLux Pro II Device has been tested and complies with the following voluntary recognized standards:

IEC 60601-1, (Third Edition, 2005 / 2006), Medical Electrical Equipment Part . 1: General requirements for basic safety and essential performance
IEC 60601-1-2, (Third Edition, 2007), Medical Electrical Equipment Part 1-2: ● General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility -- Requirements and Tests
IEC 60601-2-57, (First Edition, 2011), IEC 60601-2-57 (2011), Medical ● Electrical Equipment - Part 2-57: Particular Requirements for The Basic Safety And Essential Performance Of Non-Laser Light Source Equipment Intended For Therapeutic, Diagnostic, Monitoring And Cosmetic/Aesthetic Use.
IEC 60601-2-2 Edition 5.0 2009-02. 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.

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Non-Clinical (Bench) Performance Data:

A set of bench tests were performed to evaluate the thermal profile, RF depth penetration and temperature stability of the HeatLux Pro II Device.

The tests' results along with the comparison to the predicate devices demonstrated that the HeatLux Pro II Device has met the system requirements. The subject device presented similar technological specifications to the presented predicate devices and therefore, is substantially equivalent to the predicate devices.

Pre-Clinical (Animal Study) Performance Data:

Not Applicable

Clinical Performance Data:

User performance (usability) study was conducted on twenty eligible device users. The study evaluated the users' ability to self-select the device, comprehend the device labeling and operate the device as intended in a safe and effective means.

The study results showed that potential device users had successfully operated the device as intended with no safety issues reported.

Substantial Equivalence:

The indications for use and technological characteristics of the HeatLux Pro II device are substantially equivalent to the indications for use and technological characteristics of the Velashape System and of the HeatLux Pro I device.

The design and components in the HeatLux Pro II device, including the wall adaptor and the applicator are similar to the design and components found in the predicate HeatLux Pro I device. Both devices utilize optical and electrical energies with the same mechanism of action. The additional technological components (i.e. the RF generator and the IR LEDs) that were disabled by the software in the HeatLux Pro I device were activated in the HeatLux Pro II device using software modifications. The activation of these technological features does not alter the functionality and performance of the subject device whereas the treatment temperature profile has unchanged as shown in the performance tests provided in section 12.

Furthermore, the HeatLux Pro II device possesses similar technological modalities as in the Velashape System predicate device. Both devices utilize Bi-polar RF energy and IR optical LEDs, for the same mechanism of action and for the same indications for use.

The safety features and compliance with safety standards in the HeatLux Pro II device are similar to the safety features and compliance with safety standards found in the HeatLux Pro I device. All patient contact materials are identical to the materials found at the HaetLux Pro I device. The HaetLux Pro I device was tested for biocompatibility

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and comply with the ISO 10993-1 standard (see biocompatibility testing in section 12). The differences in the technological characteristics do not raise new safety or effectiveness concerns. Furthermore, the modified HeatLux Pro II device underwent performance testing, including software validation testing (provided in Section 12), electrical and mechanical safety testing according to IEC 60601-1, electromagnetic compatibility testing according to IEC 60601-1-2, non-laser light source equipment testing according to IEC 60601-2-57 and high frequency surgical equipment and high frequency surgical accessories testing according to IEC 60601-2-2 (provided in Section 12) and bench tests (provided in Section 12). These performance tests demonstrated that the differences in the device specifications meet the system requirements and do not raise new safety or effectiveness concerns.

Consequently, it can be concluded that the HeatLux Pro II device is substantially equivalent to the main predicate the Velashape System, cleared under 510(k) K122579 and to the reference predicate the HeatLux Pro I device, cleared under 510(k) K150175; and therefore, may be legally marketed in the USA.

Conclusions:

Based on the performance testing and comparison to predicate device, the HeatLux Pro II device is substantially equivalent to the aforementioned predicate devices for the mentioned intended use.

Regulation Number and Section

§ 890.5500 Infrared lamp.

(a)
Identification. An infrared lamp is a device intended for medical purposes that emits energy at infrared frequencies (approximately 700 nanometers to 50,000 nanometers) to provide topical heating.(b)
Classification. Class II (special controls). The device, when it is an infrared therapeutic heating lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.