(113 days)
This ultraviolet lamp is intended for use in sunlamp products for tanning of human skin.
The component ultraviolet lamp model family or part numbers are for use in sunlamp products to tan human skin. They fall into a generic class of UV lamps that have the same basic technological features, characteristics, except for power rating, diameter and length, with the exact same intended use. The UV sunlamp model family are for tanning human skin use. They vary in brand ID and unique lamp ratings accordingly. These sunlamps fit into a wavelength range of 200-710nm and operate from the end product ballast supply.
There are individual component sunlamps listed in the exhibit page. They are classified as low pressure, mercury rare gas discharge devices and generally have the same construction and technical principals of operation as that of a common fluorescent lamp. The UV lamps have a tubular glass envelope with internal surface coated with fluorescent phosphor. The sealed lamps include the composition and electrical means to activate the UV light within the wavelength specification. The construction is controlled by production procedures and test methods defined in the QMS. The UV radiation is controlled by these methods to assure safe use.
This document is a 510(k) summary for UV Lamps for Sunlamp Products (K180581). It describes the device, its intended use, predicate devices, and the performance data and design control activities. However, it does not contain the information required to answer your specific questions relating to acceptance criteria and a study that proves the device meets the acceptance criteria in the context of clinical performance or algorithm evaluation.
This document is a regulatory submission for a physical device (UV lamps), not an AI/ML software device. As such, concepts like "acceptance criteria and reported device performance" as you've framed them (often related to diagnostic accuracy, sensitivity, specificity), "sample size for test set," "data provenance," "ground truth experts," "adjudication method," "MRMC comparative effectiveness study," "standalone performance," and "training set details" are not applicable to this type of device and submission.
The document primarily focuses on demonstrating substantial equivalence to predicate devices through technical specifications, compliance with international consensus standards, and a quality management system.
Here's a breakdown of what is available in the document and why other requested information is not present:
Information Present in the Document (and its interpretation for this context):
-
A table of acceptance criteria and the reported device performance:
- Acceptance Criteria (as regulatory compliance): The device (UV Lamps) must comply with:
- IEC/EN 61195:2014 - Double Capped Fluorescent Lamps Safety Specifications
- IEC/EN 60355-2-27:2013 - Particular Appliances Safety Requirements for Skin Exposure to UV and IR Radiation
- EN60081:1998 - Double Capped Fluorescent Lamps - Performance Specifications
- EN61228:2008 - Fluorescent Ultraviolet Lamps Used for Tanning. Measurement and Specification Method
- EN62471:2008- Photobiological Safety of Lamps and Lamp Systems
- EN50581: 2012 - Technical Documentation for the Assessment of Electrical and Electronic with Respect to the Restriction of Hazardous Substances
- 21 CFR 1040.20 - Performance standard for sunlamp products and ultraviolet lamps intended for the use in sunlamp products (FDA mandatory standard).
- ISO9001 Quality Management System.
- Reported Device Performance (as compliance with the above): The document states:
- "The Feilo Sylvania UV lamps are intended for use in sunlamp products for tanning of human skin comply with the consensus standards and specifications listed below and are therefore validated as safe for the intended use."
- "Specific performance testing (spectral analysis) data is submitted to CDRH for the component UV lamps with measurement of irradiance to verify compliance with radiation limits defined in 21CFR1040.20."
- "The control activity shows that there are no new questions of safety and effectiveness for the described UV Sunlamps."
- "Inspection verification procedures assure performance concerns are compliant to QMS specifications."
- The comparison table (page 5) lists "Radiation 21CFR1040.20" for the Feilo Sylvania device and "CDRH compliant" for predicate devices, implying adherence.
- Acceptance Criteria (as regulatory compliance): The device (UV Lamps) must comply with:
-
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not applicable/Not mentioned in the document. This is not a study involving human subjects or data sets in the typical sense of software or diagnostic device evaluations. Performance testing would be on the physical lamps themselves, but sample sizes for this are not specified.
-
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. This is a physical device, not an AI/ML or diagnostic tool where expert ground truth is typically established.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable.
-
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 not an AI-assisted device.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable in the typical sense. The "ground truth" here is compliance with established engineering and safety standards (e.g., spectral characteristics, irradiance limits as defined in 21CFR1040.20, safety specifications for lamps).
-
The sample size for the training set:
- Not applicable. This is a physical device, not an AI/ML algorithm requiring a training set.
-
How the ground truth for the training set was established:
- Not applicable.
In summary, this 510(k) pertains to a hardware device (UV lamps) and therefore the questions are largely incongruent with the information and type of study presented. The "study" here is essentially the demonstration of compliance with established engineering and regulatory performance standards through internal testing and external certifications, rather than a clinical trial or algorithm validation study.
§ 878.4635 Sunlamp products and ultraviolet lamps intended for use in sunlamp products.
(a)
Identification. A sunlamp product is any device designed to incorporate one or more ultraviolet (UV) lamps intended for irradiation of any part of the living human body, by UV radiation with wavelengths in air between 200 and 400 nanometers, to induce skin tanning. This definition includes tanning beds and tanning booths. A UV lamp intended for use in sunlamp products is any lamp that produces UV radiation in the wavelength interval of 200 to 400 nanometers in air.(b)
Classification. Class II (special controls). The special controls for sunlamp products and UV lamps intended for use in sunlamp products are:(1) Conduct performance testing that demonstrates the following:
(i) Device meets appropriate output performance specifications such as wavelengths, energy density, and lamp life; and
(ii) Device's safety features, such as timers to limit UV exposure and alarms, function properly.
(2) Demonstrate that device is mechanically safe to prevent user injury.
(3) Demonstrate software verification, validation, and hazard analysis.
(4) Demonstrate that device is biocompatible.
(5) Demonstrate that device is electrically safe and electromagnetically compatible in its intended use environment.
(6)
Labeling —(i)Sunlamp products. (A) The warning statement below must appear on all sunlamp products and must be placed in a black box. This statement must be permanently affixed or inscribed on the product when fully assembled for use so as to be legible and readily accessible to view by the person who will be exposed to UV radiation immediately before the use of the product. It shall be of sufficient durability to remain legible throughout the expected lifetime of the product. It shall appear on a part or panel displayed prominently under normal conditions of use so that it is readily accessible to view whether the tanning bed canopy (or tanning booth door) is open or closed when the person who will be exposed approaches the equipment and the text shall be at least 10 millimeters (height). Labeling on the device must include the following statement: Attention: This sunlamp product should not be used on persons under the age of 18 years. (B) Manufacturers shall provide validated instructions on cleaning and disinfection of sunlamp products between uses in the user instructions.
(ii)
Sunlamp products and UV lamps intended for use in sunlamp products. Manufacturers of sunlamp products and UV lamps intended for use in sunlamp products shall provide or cause to be provided in the user instructions, as well as all consumer-directed catalogs, specification sheets, descriptive brochures, and Web pages in which sunlamp products or UV lamps intended for use in sunlamp products are offered for sale, the following contraindication and warning statements:(A) “Contraindication: This product is contraindicated for use on persons under the age of 18 years.”
(B) “Contraindication: This product must not be used if skin lesions or open wounds are present.”
(C) “Warning: This product should not be used on individuals who have had skin cancer or have a family history of skin cancer.”
(D) “Warning: Persons repeatedly exposed to UV radiation should be regularly evaluated for skin cancer.”
(c)
Performance standard. Sunlamp products and UV lamps intended for use in sunlamp products are subject to the electronic product performance standard at § 1040.20 of this chapter.