(246 days)
The 308nm Excimer System is intended to be used for the treatment of psoriasis and vitiligo. It is to be used on intact skin only.
The proposed device, 308nm Excimer System is a new type of ultraviolet light therapy instrument, which could emit high levels of UV light. It has the following features:
- High intensity UV light.
- The instrument is suitable for small area treatment with good targeting.
- 8 inches Super Large color touch LCD screen which make the operation display more convenient;
- Manual MED tests can also be performed according to the skin characteristics of the patient.
- One-click Control light source Output.
- Powerful user management capabilities.
- Can realize the export and view of user information;
- Multi-spec treatment handle light filter. The user can choose filter according to the size of the treatment area. Avoid excess radiation output.
- Fingerprint entry makes it easy for doctors to quickly access patient information (for KN-5000D):
- Accurate calibration system. Enhanced reliability of instrument dose output (KN-5000D applicable).
Here's a breakdown of the acceptance criteria and study information for the 308nm Excimer System, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" in a quantitative sense for performance as one might expect for an AI/diagnostic device. Instead, it relies on demonstrating substantial equivalence to predicate devices through technical comparisons and compliance with relevant safety and performance standards. The "performance" being evaluated is the device's adherence to these standards and its operational characteristics being comparable to legally marketed devices.
| Acceptance Criterion (Implicit) | Reported Device Performance (Proposed Device K200971) | Related Predicate Devices (K172273, K192642) |
|---|---|---|
| Product Code (FTC) | FTC | FTC |
| Regulation No. (21 CFR 878.4630) | 21 CFR 878.4630 | 21 CFR 878.4630 |
| Classification (Class II) | Class II | Class II |
| Intended Use (Treatment of psoriasis and vitiligo on intact skin) | The 308nm Excimer System is intended to be used for the treatment of psoriasis and vitiligo. It is to be used on intact skin only. | Same intended use (K172273, K192642 includes atopic dermatitis, and leukoderma for K192642) |
| Prescription Required (Yes) | Yes | Yes |
| Mode of Operation (Continuous operation) | Continuous operation | Continuous operation (for K172273) |
| Wavelength (308 nm ± 2nm) | 308 nm ± 2nm | 308 nm ± 3nm (K172273), 308 ± 2 nm (K192642) |
| Light Source (Xenon-Chlorine (XeCl) excimer lamp produces monochromatic UVB light) | Xenon-Chlorine (XeCl) excimer lamp produces monochromatic UVB light | Xenon-Chlorine (XeCl) excimer lamp produces monochromatic UVB light |
| Irradiation mode (Handheld irradiation) | Handheld irradiation | Handheld irradiation |
| Cooling of light source (Air cooling) | Air cooling | Air cooling (for K172273), Cooling fan (for K192642) |
| Max. UV Irradiation Intensity (50 mW/cm²) | 50 mW/cm² | 50 mW/cm² |
| Electrical Safety/Performance (Compliance with IEC 60601-1 and IEC 60601-2-57) | Comply with IEC60601-1 and IEC 60601-2-57 | Comply with IEC60601-1 and IEC 60601-2-57 |
| EMC (Compliance with IEC 60601-1-2) | Comply with IEC 60601-1-2 | Comply with IEC 60601-1-2 |
| Biocompatibility (Cytotoxicity, Irritation, Sensitization per ISO 10993) | Complies with requirements | Complies with requirements |
| Label and Labeling (Conforms to FDA Regulatory Requirements) | Conforms to FDA Regulatory Requirements | Conforms to FDA Regulatory Requirements |
Note on "Analysis 1, 2, 3, 4" from the document: These sections discuss slight differences in specifications like Max Power Output, Treatment Area, Treatment Time, Maximum Dose, Power Source, MED Dose Determination, and Operating/Storage Environment. The conclusion for each is that these differences fall within the range of predicate devices or comply with relevant standards, and therefore do not raise any safety or effectiveness issues, thus meeting the implicit acceptance criteria of being substantially equivalent.
2. Sample size used for the test set and the data provenance:
- No clinical test set was used for this submission. The document explicitly states: "No clinical study is included in this submission."
- The device's substantial equivalence was determined based on non-clinical (lab bench) testing and comparison to predicate devices' specifications and compliance with international standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. As no clinical studies were performed and the evaluation relied on non-clinical testing and comparison to predicate devices, there was no ground truth for a test set established by experts in the context of diagnostic performance.
4. Adjudication method for the test set:
- Not applicable. No clinical test set.
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 medical equipment (ultraviolet lamp) for treatment, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a medical device, not an algorithm. Its performance is evaluated based on its physical and operational specifications and compliance with safety standards, not an algorithm's output.
7. The type of ground truth used:
- For non-clinical tests: The "ground truth" implicitly refers to the specified values, ranges, and requirements outlined in the international standards (e.g., IEC 60601-1, IEC 60601-2-57, IEC 60601-1-2, IEC 62471, ISO 10993-5, ISO 10993-10) that the device was tested against. Compliance with these standards served as the "truth" for safety and basic performance characteristics.
- For substantial equivalence: The "ground truth" is the established safety and effectiveness of the legally marketed predicate devices, which the proposed device aims to demonstrate equivalence to based on technological characteristics and compliance with standards.
8. The sample size for the training set:
- Not applicable. This device is a physical medical equipment, not an AI model that requires 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.