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K Number
K132643
Device Name
UV PHOTOTHERAPY
Manufacturer
XUZHOU KERNEL MEDICAL EQUIPMENT CO., LTD.
Date Cleared
2014-01-30

(157 days)

Product Code
FTC
Regulation Number
878.4630
Type
Traditional
Panel
SU
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The UV phototherapy, model KN-4001/KN-4002/KN-4003/KN-4004/KN-4005/KN-4006, delivers ultraviolet (UV) light to targeted affected skin. It is intended for use, by or under the direction of a physician, for the treatment of psoriasis, vitiligo, and atopic dermatitis (eczema) on all skin types (I - VI).

Device Description

The UV Radiation Treatment System model KN-4001/KN-4002/KN-4003/KN-4004/KN-4005/KN-4006 delivers ultraviolet (UV) light to targeted affected skin, via Fluorescent UV lamps. It is a Stationary base unit with hand held therapy wand or hand held device.

AI/ML Overview

The provided text does not contain information regarding an acceptance criteria table, device performance, and the study details requested. The document is a 510(k) summary for a UV phototherapy device (K132643) that focuses on establishing substantial equivalence to a predicate device based on intended use, technological characteristics, and safety standards (IEC 60601-1 and IEC 60601-1-2) and biocompatibility.

Specifically, the following information is not available in the provided text:

  1. A table of acceptance criteria and the reported device performance.
  2. Sample size used for the test set and the data provenance.
  3. Number of experts used to establish the ground truth for the test set and their qualifications.
  4. Adjudication method for the test set.
  5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of how much human readers improve with AI vs without AI assistance.
  6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done.
  7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
  8. The sample size for the training set.
  9. How the ground truth for the training set was established.

The document discusses:

  • The device being a UV phototherapy system (model KN-4001/KN-4002/KN-4003/KN-4004/KN-4005/KN-4006) intended for the treatment of psoriasis, vitiligo, and atopic dermatitis.
  • Comparison to a predicate device (DermaPal) based on product code, regulation number, intended use, material, sterility, single use, energy source, safety standards, biocompatibility, mode of operation, and features.
  • Confirmation from the FDA of substantial equivalence based on the provided information.

To fulfill the request, further documentation describing the device's validation and clinical studies would be required.

§ 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.