(104 days)
reVive Light Therapy® LED Cleansing System is an Over-the-Counter (OTC) LED device intended for use in treating 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 mild to moderate inflammatory acne. The device uses two types of LEDs: 630nm red and 415nm blue. The treatment time is controlled by the user. There are no user settings or adjustments required. The reVive Light Therapy® LED Cleansing System components include the unit 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). It is intended for users 13 years or older.
The provided FDA 510(k) summary for the reVive Light Therapy® LED Cleansing System (K180447) does not contain a typical acceptance criteria table with reported device performance metrics in the way a clinical study for diagnostic or prognostic devices would.
Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (Clear Bi-Light K153081) through comparison of technological characteristics and performance testing related to safety and functionality. The "acceptance criteria" can be inferred from the comparisons made to the predicate device and the pass/fail nature of the safety and usability tests.
Here's an analysis based on the information provided:
1. Table of Acceptance Criteria and Reported Device Performance
Since there isn't a direct table in the document, I will construct one based on the information provided, inferring acceptance criteria from the comparisons to the predicate and the documented test results.
| Acceptance Criterion (Inferred from Predicate Comparison/Safety Standards) | Reported Device Performance (reVive Light Therapy® LED Cleansing System) |
|---|---|
| Technological Characteristics | |
| Same intended use as predicate | Treatment of mild to moderate inflammatory acne |
| Similar output (mW/cm²) as predicate devices | "Similar output (mW/cm²) as predicate devices" (Specific value not provided for reVive Light Therapy® LED Cleansing System in this document, but deemed similar) |
| Same/similar treatment duration as predicate devices | 3 minutes per treatment |
| Similar recommended treatment regimen | "Similar recommended treatment regimen" |
| Wavelengths (comparison to predicate) | 415nm, 630nm |
| Irradiance source (comparison to predicate) | LED |
| Treatment Area (comparison to predicate) | 18.86 cm² |
| Safety and Functionality | |
| Conformance to IEC 60601-1 (Basic Safety & Essential Performance) | Conforms to standard |
| Conformance to IEC 60601-1-2 (EMC) | Conforms to standard |
| Conformance to ISO 10993-5 (Cytotoxicity) | Conforms to standard (Biocompatibility tests passed) |
| Conformance to ISO 10993-10 (Intracutaneous reactivity) | Conforms to standard (Biocompatibility tests passed) |
| Conformance to ISO 10993-10 (Skin Sensitization) | Conforms to standard (Biocompatibility tests passed) |
| Software validation per FDA guidance | Software tested and validated |
| Light sensitivity test demonstrated by users | 100% of participants able to demonstrate light sensitivity test |
| Successful device use by users | 100% of participants able to use the device successfully |
| Device temperature during continuous use (not exceeding 41C) | Does not exceed 41°C, even after 30 minutes continuous use |
2. Sample Size Used for the Test Set and Data Provenance
- Usability Study Test Set: 15 participants.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). This was a usability study, often conducted in a controlled environment, likely in the US where the submitter is located.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable to the studies presented for this device.
- For the usability study, "ground truth" was about successful execution of tasks and demonstrating light sensitivity, not clinical diagnosis. The performance was measured by participant action, not expert judgment.
- For the safety and functional performance testing, "ground truth" was established by adherence to international standards (e.g., IEC, ISO) and internal testing protocols, not by expert consensus on clinical outcomes.
4. Adjudication Method for the Test Set
Not applicable. The usability study involved observing participants' actions (e.g., "100% of the participants were able to demonstrate the light sensitivity test."). Safety and performance tests against standards have pass/fail criteria, not adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No. This type of study is for diagnostic devices where human readers interpret medical images or data. The reVive Light Therapy® LED Cleansing System is a direct treatment device, not a diagnostic tool requiring human interpretation with or without AI assistance.
6. If a Standalone (i.e. algorithm only, without human-in-the-loop performance) Was Done
Yes, in a sense. The "performance testing" described (functional performance testing, software validation, safety testing, thermal performance testing) essentially represents standalone performance of the device's physical and software aspects against defined specifications and standards, without real-time human intervention influencing its core operation during the test.
7. The Type of Ground Truth Used
- Usability Study: User performance metrics (ability to demonstrate a test, successful device use).
- Safety and Functional Testing: Adherence to established international consensus standards (IEC, ISO) and internal performance specifications (e.g., thermal limits, software functionality).
- Substantial Equivalence: Comparison to the technological characteristics, intended use, and treatment parameters of a legally marketed predicate device.
8. The Sample Size for the Training Set
Not applicable. This device is an LED therapy system, not an AI/machine learning algorithm that requires a training set in the typical sense. The software validation is likely for operational logic and safety features, not for learning from data.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for this device.
§ 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.