(70 days)
UVB Phototherapy for psoriasis, vitiligo, atopic dermatitis, and leukoderma
The XTRAC Ultra Excimer Laser System, Model AL10000 is a complete self-contained compact UVB laser light source, which utilizes a XeCl gas mixture to generate an operator selected dose and target-specific ultraviolet light at monochromatic wavelength of 308 nm. The laser system consists of a touch-screen display, an advanced fiberoptic cable attached to a handpiece, and a foot-switch to initiate exposure. The laser is enclosed in a protective interlocked housing. The unit is designed to operate on standard AC power available from wall outlets and can accommodate US, European and other nominal supply voltages and operating frequencies.
This document describes the PhotoMedex XTRAC Ultra2 Excimer Laser System, Model AL10000. However, the provided text does not contain information about acceptance criteria or a study proving the device meets them in the way a typical diagnostic or AI device submission would.
Instead, this is a 510(k) premarket notification for a medical device that appears to be seeking substantial equivalence to previously cleared predicate devices. This means the manufacturer is asserting their new device is as safe and effective as existing legally marketed devices, rather than conducting new clinical trials to demonstrate efficacy from scratch.
Here's an analysis based on the provided text, highlighting what is and is not present:
Acceptance Criteria and Study for PhotoMedex XTRAC Ultra2 Excimer Laser System, Model AL10000
The provided 510(k) summary for the PhotoMedex XTRAC Ultra2 Excimer Laser System, Model AL10000, does not detail explicit acceptance criteria for clinical performance or a rigorous clinical study designed to prove the device meets such criteria. Instead, the submission relies heavily on substantial equivalence to predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly defined for clinical efficacy in this submission. The submission states the device "will perform in an identical manner as the identified predicates" for its intended uses. | The device provides "targeted UVB phototherapy for treatment of the skin conditions including psoriasis, vitiligo, atopic dermatitis, and leukoderma." The primary difference from predicates is "a moderate increase in the maximum laser repetition rate," which the submitter believes "will not affect the device's safety or intended use." |
Explanation: In a substantial equivalence submission for a laser device, the "acceptance criteria" revolve around demonstrating that the new device's technological characteristics (e.g., wavelength, energy output, repetition rate, safety features) are either identical to or do not raise new safety or efficacy concerns compared to the predicates. The clinical performance itself is accepted based on the established performance of the predicate devices.
2. Sample Size for Test Set and Data Provenance
- Sample Size (Test Set): Not applicable. No new clinical "test set" was used for performance evaluation in the context of this 510(k) submission.
- Data Provenance: Not applicable. The submission refers to previously cleared indications and performance of predicate devices, rather than new data generated for this specific model's effectiveness.
3. Number of Experts and Their Qualifications (for Ground Truth)
- Not applicable. No new ground truth establishment by experts for a test set is described in this submission. The efficacy of UVB phototherapy for the stated conditions is presumably well-established from the predicate devices' clearances.
4. Adjudication Method (for Test Set)
- Not applicable. No new clinical test set or adjudication process is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Not applicable. This device is a laser system for dermatological treatment, not a diagnostic imaging or AI-assisted interpretation device. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant to this submission.
6. Standalone Performance Study (Algorithm Only)
- Not applicable. This device is a physical laser system, not an algorithm.
7. Type of Ground Truth Used
- Implicit Ground Truth: The ground truth for the efficacy of targeted UVB phototherapy for psoriasis, vitiligo, atopic dermatitis, and leukoderma is implicitly derived from the clinical evidence and regulatory clearances of the predicate devices. The submission argues that since the new device operates similarly and introduces no new safety/efficacy issues, the prior established "ground truth" (i.e., that these treatments are effective for these conditions) applies.
8. Sample Size for the Training Set
- Not applicable. This is not an AI/machine learning device that requires a training set.
9. How Ground Truth for the Training Set Was Established
- Not applicable.
Summary of Approach:
The PhotoMedex XTRAC Ultra2 Excimer Laser System, Model AL10000, gained market clearance through the 510(k) substantial equivalence pathway. The core argument is stated in Section 6 and 7:
- Identical Intended Use: The intended use (targeted UVB phototherapy for psoriasis, vitiligo, atopic dermatitis, and leukoderma) is identical to previously cleared predicate devices (K992914, K003705, K011382, K020847, K031451, K041943).
- Similar Technology: The difference is "limited to a moderate increase in the maximum laser repetition rate."
- No New Safety/Efficacy Issues: The manufacturer believes this increase "will not affect the device's safety or intended use as compared to the identified predicates."
- No Duplicative Clinical Data Required: Because the device "does not introduce any new indications for use, and will perform in an identical manner as the identified predicates," PhotoMedex states that "duplicative clinical data is not required."
Instead of clinical performance testing, the submission highlights Product Performance Testing (Section 8), which includes:
- Conformance to IEC 60601 standards.
- Conformance to 21 CFR Part 1040.10 & 1040.11 (Performance Standards for Light-Emitting Products).
- Certification to UL 60601-1 Medical Electrical Equipment classification standard.
- Risk management utilizing ISO 14971.
These product performance tests ensure the device meets safety and operational standards but do not constitute clinical efficacy trials as would be expected for a novel diagnostic or therapeutic approach.
§ 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.