(237 days)
The UV Radiation Treatment System models YK-6000A-T, YK-6000B, andYK-6000B-T, are intended for use under the direction of a physician, for the treatment of vitilizo, psoriasis, and eczema. The devices are intended for treatment of these conditions on Fitzpatrick Skin Types (I-VI).
The proposed device, UV Radiation Treatment System is a portable medical device that consists of tubes, irradiator, control circuit. It is a therapeutic product under the direction of a physician for individuals who require ultraviolet radiation for diagnosed skin disorders. It is for the partial treatment. It has four models: YK-6000A,YK-6000A-T,YK-6000B,YK-6000B-T,in which the model YK-6000A and YK-6000A-T emit UVA light and the model YK-6000B and YK-6000B-T emit UVB light.
This product has the features are as follows:
A. Use Philips special UV lamp as light source, with high stability and long service life:
B. Small bulk, lightweight, operation simply, patients can take with themselves;
C. There is glisten board inner radiation unit, which can raise radiant efficiency.
The UV Radiation Treatment System only can be used in Hospital, Clinic, Medical Center, Private Medical Practice, or Other Professional Medical Environments under direction of physician.
The provided document is a 510(k) summary for a UV Radiation Treatment System and specifies that no clinical study was performed to prove the device meets acceptance criteria. The submission relies solely on non-clinical (lab bench) testing and comparison to a predicate device. Therefore, many of the requested sections (2-5, 7-9) cannot be answered with information from this document because there was no study involving patient data, ground truth, or expert review.
Here's a breakdown of the available information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in the traditional sense of performance metrics against a defined standard (e.g., sensitivity, specificity for an AI device). Instead, it presents a comparison of the proposed device's characteristics against a predicate device, focusing on substantial equivalence. The "performance" is demonstrated through compliance with various safety and electrical standards via non-clinical bench testing.
| Characteristic / Acceptance Criterion (Implicitly "Substantially Equivalent") | Proposed Device Performance | Predicate Device (K181805) Performance |
|---|---|---|
| Product Code (FTC) | FTC | FTC |
| Regulation No. (21 CFR 878.4630) | 21 CFR 878.4630 | 21 CFR 878.4630 |
| Class (II) | II | II |
| Intended Use | Treatment of vitiligo, psoriasis, and eczema under direction of a physician, for Fitzpatrick Skin Types (I-VI). | Treatment of psoriasis, vitiligo, and atopic dermatitis (eczema) under direction of a physician, for all skin types (I-VI). Can be used in hospitals, clinics, and households. |
| Prescriptive (Yes) | Yes | Yes |
| Mode of operation | Portable | Handheld |
| Shell material (ABS) | ABS | ABS |
| Treatment Area | Partial treatment excluding eyes | Partial treatment excluding eyes |
| Treatment Time | 5~20 min | 0~30min |
| UV spectral output | UVA or UVB | UVA or UVB |
| Lamp configuration | 1 (9W UV tube) | 1 or 2 (9W UV tube) |
| Power Source | AC outlet | AC outlet or DC jack |
| Wavelength range (nm) | UVA: 320 | UVA: 350 |
| IPX – Rating / water resistance | IPX0 | IP22 |
| Application Environment | Hospital, Clinic, Medical Center, Private Medical Practice, or Other Professional Medical Environments under direction of physician | Hospital, Clinic, Medical Center, Private Medical Practice, or Other Professional Medical Environments, Household use under direction of physician. |
| Electrical Safety/Performance | Comply with IEC60601-1 and IEC 60601-2-57 | Comply with IEC60601-1 and IEC 60601-2-57 |
| Home Use | Not applied | Comply with IEC60601-1-11 |
| Sterile | N/A | N/A |
| Single Use | No | No |
| EMC | Comply with IEC60601-1-2 | Comply with IEC60601-1-2 |
| Biocompatibility | Cytotoxicity (ISO 10993-5:2009), Sensitization (ISO 10993-10:2010), Irritation (ISO 10993-10:2010), Pyrogen (ISO 10993-11:2017), Acute Systemic Toxicity (ISO 10993-11:2017) | Under the conditions of the study, Comply with the requirements |
| Label and Labeling | Conforms to FDA Regulatory Requirements | Conforms to FDA Regulatory Requirements |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- No test set was used. As explicitly stated in Section 8.0, "No clinical study is included in this submission." The evaluation for substantial equivalence was based on non-clinical bench testing and comparison to a predicate device.
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 study was performed, and therefore no ground truth needed to be established by experts for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No clinical study was performed.
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 UV radiation treatment system, not an AI diagnostic or assistance tool. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical UV treatment system, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not applicable. No clinical study involving patient data and ground truth was conducted. The "ground truth" for the non-clinical tests would be the established performance specifications and regulatory standards (e.g., measured electrical safety, biocompatibility results).
8. The sample size for the training set
- Not applicable. As a physical medical device, there is no "training set" in the context of an AI/ML algorithm.
9. How the ground truth for the training set was established
- Not applicable. There is no training set for this device.
§ 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.