(189 days)
The UV Phototherapy is intended for use, by or under the direction of a physician for the treatment of psoriasis, vitiligo, and atopic dermatitis (eczema). It is intended for use on all skin types (I-VI). It can be used in hospitals, clinics and households.
The proposed device is a hand held ultraviolet phototherapy device, intended for partial treatment excluding eyes. Irradiation time can be adjusted from 0~30min and the treatment status can be controlled by the button on the device. The light comb equipped on the device is intended for easier treatment of target skin covered by hair, such as the scalp. The device is available in sixteen specifications. The device model KN-4003AL2S, KN-4003BL2S, KN-4003AL2DS, KN-4003BL2DS, KN-4006AL1S, KN-4006BL1S, KN-4006AL1DS and KN-4006BL1DS are designed with SD card. The recommended treatment can be written into the SD card by a physician. The device can be used in hospitals, clinics and households.
This document is a 510(k) Summary for a UV Phototherapy device (K181805) and describes non-clinical testing for substantial equivalence, not a clinical study to prove the device meets acceptance criteria. Therefore, most of the requested information regarding acceptance criteria and clinical study details cannot be extracted.
However, I can provide the following based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present acceptance criteria in a table format with corresponding device performance results in the typical sense of a clinical trial. Instead, it states that "Non clinical tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device complies with the following standards". These standards implicitly act as the acceptance criteria for non-clinical aspects.
| Acceptance Criteria (Standard Compliance) | Reported Device Performance |
|---|---|
| ISO 10993-5:2009 Biological evaluation of medical devices- Part 5: Test for in vitro cytotoxicity | "No cytotoxicity" |
| ISO 10993-10:2010 Biological evaluation of medical devices- Part 10: Test for irritation and delayed-type hypersensitivity | "No irritation", "No sensitization" |
| ISO 10993-11:2017 Biological evaluation of medical devices- Part 11: Test for systemic toxicity | "No evidence of acute toxicity" |
| IEC60601-1:2005+CORR.1:2006+CORR.2:2007+AM1:2012 Medical electrical equipment Part 1: General requirements for basic safety and essential performance | "Comply with IEC60601-1" (for Electrical safety) |
| IEC 60601-2-57: 2011 Medical electrical equipment Part2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/ aesthetic use | (Implicitly complied, as it is listed among standards for which testing was conducted to verify design specifications) |
| IEC 60601-1-2:2014 Medical electrical equipment-Part 1-2: General requirements for basic safety and essential performance-Collateral standard: Electromagnetic compatibility-Requirements and tests | "Comply with IEC 60601-1-2" (for EMC) |
| IEC 60601-1-11 Medical electrical equipment-Part 1-11: General requirements for basic safety and essential performance-Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment. | (Implicitly complied, as it is listed among standards for which testing was conducted to verify design specifications) |
| IEC 62133:2012 Secondary Cells And Batteries Containing Alkaline Or Other Non-Acid Electrolytes - Safety Requirements For Portable Sealed Secondary Cells, And For Batteries Made From Them, For Use In Portable Applications [Including: Corrigendum 1 (2013)] | (Implicitly complied, as it is listed among standards for which testing was conducted to verify design specifications) |
| Absence of pyrogen (Biocompatibility) | "No pyrogen" |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document explicitly states: "No clinical study is included in this submission." Therefore, there is no clinical test set, sample size, or data provenance to report in this context. The document focuses on non-clinical testing for compliance with international standards.
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, as no clinical study with a test set requiring expert ground truth was conducted or submitted.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical study with a test set requiring adjudication was conducted or submitted.
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 is a phototherapy device, not an AI diagnostic tool, and no clinical comparative effectiveness study was conducted or submitted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a phototherapy device, not an algorithm, and no clinical performance study was conducted or submitted.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical tests conducted, the "ground truth" is compliance with the specified international standards and established test methods for biocompatibility and electrical safety. For example, for cytotoxicity, the "ground truth" is the determination of whether cytotoxicity is present according to ISO 10993-5.
8. The sample size for the training set
Not applicable, as no clinical study was conducted. There is no mention of a training set as this is not an AI/algorithmic device requiring training data.
9. How the ground truth for the training set was established
Not applicable, as 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.