(86 days)
The 7 Series Phototherapy Devices are indicated for use to treat diagnosed skin disorders such, as but not limited to, psoriasis, vitiligo, and atopic dermatitis (eczema) under the direction of a physician. The population may range from pediatric to geriatric.
The 7 Series Phototherapy Equipment is a partial-body, ultraviolet light source emitting phototherapy panel. The physician will determine the light spectrum (ultraviolet to visible), the energy or duration of the treatment, as well as the treatment environment. Its nominal size ranges from a 4 lamp no door; 74.5 In X 20 In X 24 In, 75 lbs (189.2 cm X 50.8 cm X 61 cm, 34 kg) to a 12 lamp with doors open; 74.5 In X 39.5 In X 24 In, 129 Lbs. (189.2 cm X 100.3 cm X 61 cm, 58.5 Kg) that is controlled by either an integrated digital timer with an LCD segmented display and four membrane buttons as the interface (the Flex Controller) or a microprocessor controller with an LCD touch screen display (the ClearLink Controller). When the operator sets the treatment time or the desired dose using the operator interface located on the control panel, the treatment begins by illuminating the lamps which emit the prescribed light. The treatment area consists of 4, 6, 8, 10, or 12 100-watt lamps and reflective surfaces configured in a panel. The patient stands in front of the panel during treatment.
This document describes the 7 Series Phototherapy Device, which is a medical device and not an AI or software device. Therefore, the questions related to AI/software performance criteria (such as sample size, ground truth, experts, MRMC studies, or standalone performance) are not applicable.
The performance of the 7 Series Phototherapy Device is established through comparison to a legally marketed predicate device, the ClearLink Phototherapy Equipment (K182215). The submission states that the new device's performance data is "the same as or very similar" to the predicate.
Here's the information available regarding acceptance criteria and performance:
1. Table of Acceptance Criteria and Reported Device Performance:
| Feature | Acceptance Criteria (Implicit by Equivalence to Predicate) | Reported Device Performance (7 Series Phototherapy Device) |
|---|---|---|
| Energy Source | Identical to predicate | Identical to predicate |
| Materials | Identical or similar composition to predicate | Identical or similar composition to predicate |
| Spectral Output | Same or similar to predicate | Same or similar to predicate |
| Mode of Operation | Same or similar to predicate | Same or similar to predicate |
| Labeling | Same or similar to predicate | Same or similar to predicate |
| Treatment Area | Same or similar to predicate | Same or similar to predicate |
| Treatment Modality | Same or similar to predicate | Same or similar to predicate |
| Patient Safety | Same or similar to predicate | Same or similar to predicate |
| General Operating Principles | Same or similar to predicate | Same or similar to predicate |
2. Sample size used for the test set and data provenance:
This information is not applicable as the device's performance is demonstrated through substantial equivalence to a predicate device, rather than a clinical trial with a distinct test set. The submission states that the 7 Series Phototherapy Equipment is constructed with "identical energy sources and materials of identical or similar composition" and that the "lamps and construction used in the production of the predicate devices and the 7 Series phototherapy equipment are the same."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. No ground truth establishment by experts is described for this type of device submission, as it relies on substantial equivalence to an existing device.
4. Adjudication method for the test set:
Not applicable. No test set requiring adjudication is described.
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:
Not applicable. This is not an AI-assisted device.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done:
Not applicable. This is not an AI algorithm.
7. The type of ground truth used:
Not applicable. Performance is established by demonstrating substantial equivalence to a predicate device, not by comparing to a "ground truth" in the context of diagnostic accuracy.
8. The sample size for the training set:
Not applicable. This is not an AI/machine learning device.
9. How the ground truth for the training set was established:
Not applicable. This is not an AI/machine learning device.
Study Summarized:
The study that proves the device meets the acceptance criteria is a substantial equivalence comparison study to a predicate device (ClearLink Phototherapy Equipment, K182215). The core of the evidence is that the 7 Series Phototherapy Equipment shares fundamental technological characteristics and performance features with the legally marketed predicate.
The 510(k) summary explicitly states that the 7 Series phototherapy equipment is constructed "in the same design configuration as the predicate device, utilizing identical energy sources and materials of identical or similar composition." It further asserts that the "spectral output, mode of operation, labeling, treatment area, treatment modality, patient safety, and general operating principals of the 7 Series phototherapy equipment is the same or similar to those of the predicate device."
This type of study does not involve prospective clinical trials with specific acceptance criteria in the typical sense of measuring efficacy against a clinical outcome. Instead, it demonstrates that the new device performs as safely and effectively as a device already on the market through direct comparison of its technical specifications and principles of operation.
§ 878.4630 Ultraviolet lamp for dermatologic disorders.
(a)
Identification. An ultraviolet lamp for dermatologic disorders is a device (including a fixture) intended to provide ultraviolet radiation of the body to photoactivate a drug in the treatment of a dermatologic disorder if the labeling of the drug intended for use with the device bears adequate directions for the device's use with that drug.(b)
Classification. Class II.