(70 days)
The Psoria-Light Model PS1000 is indicated for use in targeted PUVA photochemistry and UVB phototherapy for the treatment of skin conditions including psoriasis, vitiligo, atopic dermatitis (eczema), and seborrheic dermatitis. In addition, the system UVB channel is indicated for the treatment of leukoderma.
Psoria-Light™ Model PS1000 delivers targeted ultraviolet (UV) light to small regions of affected skin (2.88 cm), sparring healthy skin. The system is capable of delivering either UVB light (300 to 320nm) or UVA light (350 to 395nm). Psoria-Light™ Model PS1000 generates both UVA and UVB light via LED technology, avoiding environmental concerns associated with disposal and exchange of mercury gas lamps, Xenon, and Chlorine gases commonly associated with targeted UV phototherapy devices. Psoria-Light's™ UVB LEDs emit light between 300 and 320 nm, avoiding light emissions below 300nm. Psoria-Light™ Model PS1000 incorporates a unique safety feature, a non-contact sensor located about the aperture of the handpiece that detects human skin. The trigger mechanism for UV dosage administration (located on the handpiece) is disabled until a suitable surface is detected by this sensor.
The Psoria-Light Model PS1000 is a targeted UVA/UVB phototherapy system for dermatologic disorders. The provided document is a 510(k) summary for the device, focusing on its substantial equivalence to previously cleared predicate devices rather than new clinical effectiveness studies.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Clinical Performance: | |
| New Indications for Use | No new indications for use introduced by Psoria-Light Model PS1000. All indications (psoriasis, vitiligo, atopic dermatitis (eczema), seborrheic dermatitis, and leukoderma for UVB) have been previously cleared for predicate devices. |
| Product Performance (Non-Clinical): | |
| Conformance to IEC 60601 series of standards | The Psoria-Light Model PS1000 shall have completed all testing to these standards prior to sale. |
| Conformance to 21 CFR Part 1040.10 (Performance Standard for Light-Emitting Products) | The Psoria-Light Model PS1000 shall have completed all testing to these standards prior to sale. |
| Certification to UL 60601-1 Medical Electrical Equipment classification standard | The Psoria-Light Model PS1000 shall have completed all testing to these standards prior to sale. |
| Compliance with EMC requirements (FCC rules part 15, IEC 60601-1-2, EN55011) | The Psoria-Light Model PS1000 shall have completed all testing to these standards prior to sale. |
| Application of risk management per ISO 14971 | The Psoria-Light Model PS1000 has been reviewed for risk management utilizing ISO 14971, ensuring all aspects are reviewed for potential hazards. |
| Manufacturing in an FDA-registered facility | Products shall be produced and distributed by a facility that has been registered with the FDA to manufacture medical devices. |
| Substantial Equivalence: | |
| Equivalent design, composition, and function to predicate devices | The characteristics of the Psoria-Shield Psoria-Light Model PS1000 are substantially equivalent to those of the predicate devices (TheraLight Inc. DuaLight UV120-2, PhotoMedex, Inc. XTRAC Ultra2 Excimer Laser System). |
| Equivalent output wavelengths, power, and light sources to predicate devices | Operation of the predicate devices, including output wavelengths, power, and light sources, received 510(k) clearance previously. The Psoria-Light Model PS1000 performs in a substantially equivalent manner. |
2. Sample Size Used for the Test Set and Data Provenance
No clinical performance test set (i.e., patient data) was used for this 510(k) submission. The submission explicitly states that "duplicative clinical data is not required as a condition of granting market clearance" because the device does not introduce new indications for use and performs in a substantially equivalent manner to predicate devices. The "study" for acceptance criteria was based on demonstrating substantial equivalence to these previously cleared devices through non-clinical performance testing and comparison of device specifications.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. No clinical test set requiring expert ground truth was employed for this 510(k) submission. The device's safety and effectiveness were argued based on substantial equivalence to predicate devices, which had presumably undergone such evaluations during their own clearance processes.
4. Adjudication Method for the Test Set
Not applicable. No clinical test set requiring adjudication was employed.
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 or interpretive tool. Therefore, an MRMC study related to human reader performance with or without AI assistance is not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a hardware phototherapy system, not an algorithm. Its performance is evaluated based on its physical characteristics, light output, and compliance with safety and electrical standards.
7. The Type of Ground Truth Used
For the non-clinical product performance testing, the "ground truth" would be established by the specifications and requirements of the referenced international and national standards (e.g., IEC 60601, 21 CFR Part 1040.10, UL 60601-1, ISO 14971, FCC rules). The device's performance is measured against these established engineering and safety benchmarks. For the clinical indications, the "ground truth" was established by the previous 510(k) clearances of the predicate devices, which had demonstrated clinical effectiveness for the stated indications.
8. The Sample Size for the Training Set
Not applicable. This device is a hardware phototherapy system and does not involve AI or machine learning that would require a 'training set.'
9. How the Ground Truth for the Training Set Was Established
Not applicable. No training set was used.
§ 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.