(57 days)
The Quantel 308 Excimer System is intended to be used for the treatment of psoriasis and vitiligo.
The 308 is indicated for dermatological procedures for the treatment of psoriasis and vitiligo. The lamp is a xenon-chloride excimer lamp with a wavelength of 308 nanometers. Its output power is 800 mW ±10% for 2.48 ' ? (16 cm2). It is computer controlled, and displays the treatment parameters.
The provided 510(k) summary for the Quantel Medical 308 Dermatological Excimer System (K073066) explicitly states that clinical tests were not performed or deemed necessary for this device. The manufacturer's conclusion is based on the premise that the 308 system uses the "same technology as the predicate device" (PhotoMedex VTRAC XL, K051428) and is therefore "equivalent in safety and efficacy."
As such, acceptance criteria related to clinical performance are not provided, nor is a study that proves the device meets such criteria. The "performance data" section only includes non-clinical tests regarding the lamp itself and software validation.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Clinical Efficacy/Safety: Not applicable based on substantial equivalence claim. | Not applicable; no clinical data provided. |
| Non-clinical (Lamp Output): | Output power: 800 mW ±10% |
| Non-clinical (Software): | Software has been validated. |
| Non-clinical (Electrical Safety): | Tested to ISO 60601-1 |
| Non-clinical (Electromagnetic Compatibility): | Tested to ISO 60601-1-2 |
| Technology Equivalence: Uses the same technology as the predicate device (PhotoMedex VTRAC XL, K051428). | Confirmed. |
| Intended Use Equivalence: Treatment of psoriasis and vitiligo. | Confirmed. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable. No clinical test set was used for performance validation.
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. No clinical test set was used.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No clinical test set was used.
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 device is a phototherapy system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a hardware device for phototherapy, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not applicable. No clinical ground truth was established as no clinical studies were conducted for this 510(k). The "ground truth" for the submission's approval was substantial equivalence to a predicate device.
8. The sample size for the training set
- Not applicable. No clinical training set was used.
9. How the ground truth for the training set was established
- Not applicable. No clinical training set was used.
Summary of Device Approval Approach:
The Quantel Medical 308 Dermatological Excimer System (K073066) received 510(k) clearance based on its substantial equivalence to a predicate device (PhotoMedex VTRAC XL, K051428). The core argument for safety and efficacy was that the device uses the "same technology" and has the same intended use. Therefore, clinical studies were explicitly deemed "not necessary" by the manufacturer and accepted by the FDA for this particular submission. The performance assessment was based solely on non-clinical testing for lamp output, stability, software validation, and electrical safety standards (ISO 60601-1 and ISO 60601-1-2).
§ 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.