(368 days)
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.
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.
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.
§ 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.