(69 days)
The Evis MD Platinum Blue Light Therapy device is intended to provide light to the body. Generally indicated to treat dermatological conditions and specifically indicated to treat mild to moderate inflammatory acne vulgaris.
The Evis MD Platinum Blue Light Therapy device that utilizes Light Emitting Diodes to provide LED light to the body. The hand hold device contains the power supplies and a built in timed sound signaling with auto shut off. The device delivers the light to the skin as it moves over the skin. The wavelength for Blue is 41.5 +/- 5 nm.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Evis MD Platinum Blue Light Therapy device:
1. Table of Acceptance Criteria and Reported Device Performance:
Based on the provided text, the submission focuses primarily on substantial equivalence to a predicate device rather than presenting specific performance metrics against defined acceptance criteria for clinical effectiveness.
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Safety | Electrical Safety | Complies with IEC/EN/UL 60601-1, CSA 601.1 |
| EMC (Electromagnetic Compatibility) | Complies with IEC/EN 60601-1-2, FCC 47CRF PT 18, ICES 005 | |
| Effectiveness | Equivalence to predicate device for treating mild to moderate inflammatory acne vulgaris | "virtually identical to the intended use and technological characteristics of the listed equivalent devices." "no significant differences exist between this system and the predicate systems quoted" |
2. Sample Size Used for the Test Set and Data Provenance:
The provided document does not describe a clinical study with a "test set" in the traditional sense of evaluating a device's clinical performance. The submission relies on a comparison to a predicate device and non-clinical engineering tests.
Therefore, there is no information on:
- Sample size used for the test set.
- Data provenance (e.g., country of origin of the data, retrospective or prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
As no clinical study with a "test set" is described, there is no mention of experts or the establishment of ground truth in this context within the provided document.
4. Adjudication Method for the Test Set:
Since there is no described clinical study involving a "test set" and human assessment of outcomes, there is no mention of an adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size:
No MRMC comparative effectiveness study is described in the provided 510(k) summary. The submission focuses on demonstrating substantial equivalence through technological comparison and non-clinical testing, not on quantifying improvement with AI assistance (as this is not an AI device).
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
This device is not an algorithm or AI system. It is a physical light therapy device. Therefore, the concept of "standalone (algorithm only)" performance does not apply.
7. The Type of Ground Truth Used:
For the clinical claim of effectiveness (treating mild to moderate inflammatory acne vulgaris), the "ground truth" implicitly relies on the established effectiveness of the predicate device (Tanda Skincare System Blue, K070185). The current device is deemed substantially equivalent in its intended use and technological characteristics.
For the non-clinical performance, the ground truth is established by validated engineering standards and regulations (IEC/EN/UL 60601-1, IEC/EN 60601-1-2, FCC 47CRF PT 18, ICES 005).
8. The Sample Size for the Training Set:
Not applicable. This device is not an AI/ML algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established:
Not applicable. This device is not an AI/ML algorithm that requires a "training set."
Summary of the Study:
The provided document, a 510(k) Summary, describes the submission for the Evis MD Platinum Blue Light Therapy device. The "study" presented here is primarily a non-clinical performance evaluation and a substantial equivalence argument based on comparison to a legally marketed predicate device.
- Non-Clinical Performance Data: The device underwent testing to ensure compliance with electrical safety (IEC/EN/UL 60601-1, CSA 601.1) and electromagnetic compatibility (IEC/EN 60601-1-2, FCC 47CRF PT 18, ICES 005) standards. These tests verify the device's technical specifications and safety aspects.
- Substantial Equivalence Argument: The core of the submission for effectiveness relies on demonstrating that the Evis MD Platinum Blue Light Therapy device is "virtually identical" to the predicate device (Tanda Skincare System Blue, K070185) in its intended use and technological characteristics. The submitter asserts that "Any differences...have no significant influence on safety or effectiveness." This approach means that the device's effectiveness for treating mild to moderate inflammatory acne vulgaris is inferred from the established effectiveness of the predicate.
In essence, the "study" for this 510(k) is a desktop comparison and engineering validation, rather than a prospective clinical trial with human subjects.
§ 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.