(29 days)
The DermaPal® is a hand held ultraviolet light emitting fluorescent lamp. It is intended for use, by or under the direction of a physician, for the treatment of psoriasis, vitiligo, and atopic dermatitis (eczema) on all skin types (I - VI).
The DermaPal® a hand held ultraviolet light-emitting medical device.
The DermaPal® integrated operator interface consists of three main components: a LCD, a Membrane with 4 buttons, and a lamp wand. When the operator sets the treatment time and begins the treatment the famp illuminates, emitting ultraviolet light through the wand. The operator holds the wand over the effected area(s) of the body. When the time set on the DermaPal® timer has elapsed, the lamps turn off. The DermaPal® is also equipped with an integrated comb, which is removable. The comb allows for easier treatment of effected areas of skin covered by hair, such as the scalp.
The provided 510(k) summary for the DermaPal® device (K073587) indicates that the device's performance data is "the same as or very similar to that of the claimed predicate device" (DermaPal® K022104). The submission concludes that the new DermaPal® with Digital Timer is substantially equivalent to the predicate device due to identical energy sources, similar materials, and the same intended use, indications for use, spectral output, mode of operation, labeling, treatment area, and general operating principles.
This submission does NOT include a "study that proves the device meets the acceptance criteria" in the way one might expect for a digital health or AI/ML device. Instead, it relies on substantial equivalence to a predicate device. Therefore, many of the requested elements for a study (like sample size, ground truth, experts, etc.) are not applicable in this context.
Here's a breakdown based on the provided text, acknowledging the nature of the submission:
1. Table of Acceptance Criteria and Reported Device Performance:
Since this is a substantial equivalence claim based on an existing device, there are no explicit "acceptance criteria" presented as quantitative performance metrics for a new study. The acceptance criterion is essentially that the new device performs "the same as or very similar to" the predicate device.
| Acceptance Criteria (Implied for Substantial Equivalence) | Reported Device Performance (as stated in 510(k) Summary) |
|---|---|
| Utilization of identical energy sources (UV lamps) | Yes, "utilizing identical energy sources (UV lamps)" |
| Materials of identical composition | Yes, "materials of identical composition" |
| Same intended use | Yes, "The intended use... are the same or similar" |
| Same general and specific indications for use | Yes, "The... indications for use... are the same or similar" |
| Same spectral output | Yes, "The... spectral output... are the same or similar" |
| Same mode of operation | Yes, "The... mode of operation... are the same or similar" |
| Same labeling | Yes, "The... labeling... are the same or similar" |
| Same treatment area | Yes, "The... treatment area... are the same or similar" |
| Same general operating principles | Yes, "The... general operating principals... are the same or similar" |
| Performance data same as or very similar to predicate | Yes, "The DermaPal's® with Digital Timer's performance data is the same as or very similar to that of the claimed predicate device." |
| Updated control system hardware and software (as a difference, not a criterion) | Yes, "the control system hardware and software has been updated to utilize current technology." |
Regarding the specific questions about a study:
Given this is a 510(k) for a physical medical device (an ultraviolet phototherapy unit) and not a digital health or AI/ML device, the concept of a "test set," "ground truth," "experts for ground truth," "adjudication method," "MRMC comparative effectiveness study," or "standalone performance" for an algorithm is not applicable to this submission.
The "study" cited is the comparison to the predicate device. The performance data is stated to be "the same as or very similar" because the core components (UV lamps and construction) are identical to the predicate device.
Let's address the questions with this context in mind:
2. Sample Size Used for the Test Set and the Data Provenance:
- Not Applicable. There is no explicit "test set" in terms of patient data or new device performance data generated for this substantial equivalence claim. The claim is based on the known performance and design of the predicate device.
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 mentioned, as there isn't a new clinical or diagnostic performance study for this device.
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set:
- Not Applicable. No adjudication method is mentioned.
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 a physical phototherapy device, not an AI-assisted diagnostic or interpretation tool. MRMC studies are irrelevant here.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This device does not involve an "algorithm only" component in the sense of AI/ML. Its core function is emitting UV light.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable. No ground truth of this nature is established or used for the purpose of this 510(k) where "performance data" refers to the physical characteristics and output of the device compared to its predecessor.
8. The Sample Size for the Training Set:
- Not Applicable. This is not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
- Not Applicable. No training set is involved.
§ 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.