(71 days)
The reVive Light Therapy LED Cleansing System is intended for treatment of wrinkles and mild to moderate inflammatory acne.
The reVive Light Therapy® LED Cleansing System is an over-the counter light emitting diode (LED) device, that emits energy for use in dermatology for the treatment of wrinkles and mild to moderate inflammatory acne, as defined in 21 CFR § 878.4810. In addition to the LED light therapy treatment function, reVive Light Therapy® LED Cleansing System has a separate function for cleansing. The system includes two cleansing brush-heads, constructed of TPE material. The reVive Light Therapy® LED Cleansing System components include the device containing the LED module, USB power cord, and power adapter. The unit is applied directly to the skin to ensure consistent administration of light during each treatment. The device does not contain any user serviceable components. The device is sold as Over the Counter (OTC).
This document describes a 510(k) premarket notification for the reVive Light Therapy® LED Cleansing System (K221430). It establishes substantial equivalence by comparing the new device to two predicate devices (K180445 and K180447).
Here's an analysis of the provided information regarding acceptance criteria and the study:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state numerical acceptance criteria for clinical performance (e.g., specific reduction percentages for wrinkles or acne severity scores). Instead, it relies on demonstrating that the modified device performs "as well as the legally marketed devices" and meets "product system requirements, which is based on the predicate devices."
The table below summarizes the comparison of technological characteristics between the new device and its predicates, which forms the basis of the performance claim.
| Feature | Predicate Device K180445 (Wrinkle Treatment) | Predicate Device K180447 (Acne Treatment) | New Device K221430 (Wrinkle & Acne Treatment) | Implied Acceptance Criteria | Reported Device Performance (K221430) |
|---|---|---|---|---|---|
| Wavelengths | 605nm, 630nm, 660nm, 880nm | 415nm, 630nm | Wrinkle Treatment: 605nm, 630nm, 660nm, 880nm | ||
| Acne Treatment: 415nm, 630nm | Wavelengths should match or encompass those of relevant predicates for respective indications. | Wrinkle Treatment: Matches K180445. | |||
| Acne Treatment: Matches K180447. (All stated to be identical.) | |||||
| Irradiance Source | LED | LED | LED | LED technology should be used. | LED (Identical to predicates). |
| Treatment Area | 18.86 cm² | 18.86 cm² | 18.86 cm² | Treatment area should be 18.86 cm². | 18.86 cm² (Identical to predicates). |
| Treatment Method | Place device directly on the skin | Place device directly on the skin | Place device directly on the skin | Device should be applied directly to the skin. | Place device directly on the skin (Identical to predicates). |
| Treatment Time | 3 minutes | 3 minutes | 3 minutes | Treatment duration should be 3 minutes. | 3 minutes (Identical to predicates). |
| Material | ABS | ABS | ABS | Material should be ABS. | ABS (Identical to predicates). |
| Power Source | 3.7 V Lithium Battery | 3.7 V Lithium Battery | 3.7 V Lithium Battery | Power source should be 3.7 V Lithium Battery. | 3.7 V Lithium Battery (Identical to predicates). |
| Type/Class | OTC | OTC | OTC | Device should be Over-The-Counter (OTC). | OTC (Identical to predicates). |
| IFU | Treatment of wrinkles | Treatment of mild to moderate inflammatory acne | Treatment of wrinkles and mild to moderate inflammatory acne | Should cover wrinkles (like K180445) and acne (like K180447). | Covers both wrinkles and mild to moderate inflammatory acne (combines IFUs of both predicates). |
Study Proving Acceptance Criteria:
The document describes a study that aimed to confirm that the modifications made to the device were "correctly implemented and that the device performs as well as the legally marketed devices." The study focused on software testing and validation:
- Study Name/Description: The specific name of the study is not given, but it is described as "Testing" in Section 6.
- Methodology: The "reVive Light Therapy® LED Cleansing system software was tested and validated in accordance with FDA's "Guidance for the content of Premarket Submissions for Software Contained in Medical Devices."
- Conclusion: The testing "confirmed that modifications made to the device were correctly implemented and that the device performs as well as the legally marketed devices."
Important Note: This submission is a 510(k) for a modified device, leveraging existing predicates. Clinical studies demonstrating efficacy for wrinkles and acne are implied to have been conducted for the original predicate devices, not extensively for this specific modification, which primarily involves updated software and associated hardware while maintaining the fundamental scientific technology and parameters.
Here's the breakdown for the additional information requested, based on the provided text:
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified. The document states "The reVive Light Therapy® LED Cleansing system software was tested and validated..." but does not provide details on the number of test cases, subjects, or data points used during this software testing and validation.
- Data Provenance: Not specified. There is no mention of the origin (e.g., country) of any data used for testing, nor whether it was retrospective or prospective. Given it's a software validation for a hardware modification, it's likely internal testing without external patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable/Not specified. The document describes software testing and validation for a device modification, not a clinical study requiring expert ground truth for diagnostic or therapeutic outcomes on patients. The "ground truth" here would likely be defined by engineering and software requirements.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not specified. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies for interpretation of images or symptoms by multiple experts. This documentation focuses on software and hardware verification against established design specifications and predicate performance.
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
- No. A multi-reader, multi-case comparative effectiveness study (MRMC) was not conducted or reported in this document. This device is an LED therapy system for direct use, not an AI-assisted diagnostic tool that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This is not an AI algorithm in the context of diagnostic or interpretive tools; it's an LED therapy device with software controls. The "standalone" performance here refers to the device's functional integrity as a light therapy system. The document states that "Testing confirmed that modifications made to the device were correctly implemented and that the device performs as well as the legally marketed devices." This implies testing of the device's operational parameters (light output, timing, power, etc.) in a standalone capacity.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the software testing and validation mentioned, the "ground truth" would be the design specifications and functional requirements of the device's software and hardware, as well as the established performance of the predicate devices. It is not clinical ground truth like pathology or patient outcomes for this specific submission, but rather adherence to engineering and safety standards.
8. The sample size for the training set
- Not applicable. This is not a machine learning or AI algorithm in the context of a "training set." The device is a physical light therapy product.
9. How the ground truth for the training set was established
- Not applicable, as there is no "training set" in the context of an AI/ML algorithm for this submission.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.