(130 days)
The GME ExSys 308 System is intended to be used for the treatment of psoriasis and vitiligo. It is to be used on intact skin only.
The ExSys 308 is an ultratraviolet light system designed to be used in Dermatological practice for the treatment of psoriasis and vitiligo. The ExSys 308 System consists of a base unit (touch screen, mains switch, key switch, Emergency Stop button, speaker), which controls an applicator unit. The applicator unit contains the UV light source. The model number is ExSys 308. The ExSys 308 System includes the following accessories: Power cord, optional foot switch, laser protective goggles, applicator holder, and set of treatment tips. The treatment tip (a distance spacer) is the only patient contacting part of the system. There are no single use parts in the ExSys 308 System.
This document is a 510(k) premarket notification for the GME ExSys 308 System, an ultraviolet light device for dermatological disorders. It aims to demonstrate substantial equivalence to a predicate device, the Quantel 308 Dermatological Excimer System. The information provided focuses on the device's technical specifications and safety testing, typical for a substantial equivalence claim under 510(k) for a Class II device. It does not contain a clinical study with acceptance criteria and device performance as typically understood for AI/ML device evaluations.
Therefore, the following points address what can be extracted from the provided text, and explicitly states where information is not available given the nature of this submission.
1. Table of Acceptance Criteria and Reported Device Performance
This 510(k) submission is for a physical medical device (UV lamp) and focuses on demonstrating substantial equivalence to a predicate device based on technical specifications and safety standards, rather than clinical performance metrics typically associated with AI/ML systems (e.g., sensitivity, specificity, accuracy).
| Characteristic | Acceptance Criteria (Predicate Device K090762 Specifications) | Reported Device Performance (GME ExSys 308) |
|---|---|---|
| Indications for Use | Treatment of psoriasis and vitiligo | Treatment of psoriasis and vitiligo |
| Wavelength | 308 nm +/- 4nm | 308 nm +/- 4nm |
| Light Source | XeCl excimer lamp produces monochromatic UVB light | XeCl excimer lamp produces monochromatic UVB light |
| Light Delivery | Light source in the Applicator handpiece | Light source in the Applicator handpiece |
| Cooling of Light Source | Integrated air cooling | Integrated air cooling |
| Maximum Beam Power | 800mW | 875mW (Greater than or equal to predicate) |
| Maximum Beam Power Density | 50 mW/cm² | 50 mW/cm² |
| Beam Class | III | III |
| Pulse Duration | 1-120 seconds | 1-40 seconds (Within predicate's range) |
| Applied Part Safety Class | Type B | Type B |
| Electrical Requirements | 100V - 240V | 100V - 240V |
| Power Calibration Method | Internal, automatic | Internal, automatic |
| Duty Cycle | 100% | 100% |
| Display | Touch Screen Control Panel | Touch Screen Control Panel |
| Illumination Homogeneity | Not explicitly stated for predicate in comparison table, but standards apply | Less than +/-20% deviation from illumination homogeneity (acceptance criterion from nonclinical testing) |
| Treatment Tip Transmission | Not explicitly stated for predicate in comparison table, but standards apply | No measurable unwanted transmission around the Treatment Tip (acceptance criterion from nonclinical testing) |
Note: For devices subject to 510(k), "acceptance criteria" are generally derived from demonstrating that the new device is as safe and effective as a legally marketed predicate device, often through comparison of technical specifications and adherence to recognized standards. Clinical performance metrics like sensitivity/specificity are not typically required for this type of device.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable. This submission does not involve a "test set" in the context of an AI/ML algorithm evaluation using patient data. It describes nonclinical safety and performance testing of a physical device.
- Data Provenance: Not applicable. The testing described is nonclinical (e.g., electrical safety, optical performance).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Number of Experts & Qualifications: Not applicable. Ground truth, in the context of clinical expert consensus, is not relevant to the nonclinical testing described for this device.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. No clinical test set or adjudication process is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is typically associated with evaluating AI interpretation or diagnostic assistance systems used by human readers, which is not the nature of this physical device.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Standalone Study: No, a standalone study (in the context of an algorithm's performance) was not done. The device is a direct treatment tool, not an AI/ML diagnostic or interpretive algorithm. The reported performance refers to the physical output and safety of the UV light system itself.
7. Type of Ground Truth Used
- Type of Ground Truth: For the nonclinical performance and safety testing, the "ground truth" refers to established engineering standards (e.g., IEC 60601-2-57, EN 60601-1, EN 60601-1-2) and the known specifications and performance of the predicate device. The illumination homogeneity and treatment tip transmission were evaluated against defined technical limits.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This device does not employ an AI/ML algorithm that requires a "training set."
9. How Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable, as there is no training set for an AI/ML algorithm.
§ 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.