(65 days)
INTENDED USE: This ultraviolet lamp is intended for use in sunlamp products for the exclusive purpose of cosmetic tanning of the human skin.
This 510(k) applies to more than one hundred and sixty individual devices that fall into a generic class of ultraviolet lamps that have the same basic technological features and exactly the same intended use. The ultraviolet sunlamps of this 510(k) are classified scientifically as low pressure, mercuryrare gas discharge devices. The general lamp construction and technological principle of operation of all of the devices of this 510(k) is the same as that of a common fluorescent lamp. The main differentiators for the various sunlamps of this 510(k) include: lamp length, lamp diameter, lamp wattage, spectral characteristics and private labeling thereof.
The ultraviolet lamps named herein comprise a tubular glass envelope, the internal surface of which is coated with a fluorescent phosphor. To each end of the tube, a glass mount is sealed. The main purpose of the mount is to provide 1) for a means of hermetically sealing the internal atmosphere of the tube. 2) a means of supporting an electrode and a means of 3) electrically accessing the internal atmosphere of the device via electrically conducting lead-wires. Once assembled as described, the envelope is evacuated of air, the air is replaced by an inert gas at a pressure significantly lower than that of the normal atmosphere, and a drop of mercury is injected into the enclosed envelope. Finally, the envelope is sealed.
In operation, the device, now called a "lamp", is connected to an electrical source typically in series with a ballast that provides for 1) ignition of a discharge through the inert-gas-mercury vapor mixture and 2) its subsequent stabilization and sustainment of the electrical behavior of the lamp. Once connected to the applied electric field, free electrons are accelerated through the mercury vapor wherein collisions take place with the mercury atoms. These collisions cause excitation of the electrons in the mercury (Hg) atom and the production of photons at various wavelengths. Certain of these photons travel to the bulb wall and excite the phosphor powder. The phosphor, in turn, emits radiation that is transmitted through the transparent glass envelope. The radiation that is emitted from a standard fluorescent general lighting lamp is primarily in the visible region of the spectrum (380nm-760nm). The radiation that is emitted from an ultraviolet sunlamp is primarily in the UV range of the electromagnetic spectrum (300nm-400nm). Modern day, low pressure ultraviolet sunlamps typically emit most of their energy in the wavelength range that is closest to the visible; that is, in the UVA range (320nm-400nm) range. The emission spectrum of sunlamps usually contains a relatively small proportion of UVB radiation. (260nm-320nm)
This submission concerns Cosmedico Light Inc.'s Ultraviolet lamps, specifically for tanning purposes. The document states that the device's performance is not being proven by a study, but rather by demonstrating substantial equivalence to predicate devices that were legally marketed prior to September 2, 2014. The claim is that the contemporary ultraviolet lamps are identical to these predicate devices in terms of intended use, technological design characteristics, and conformity to special controls required by reclassification. Therefore, the "acceptance criteria" and "device performance" in the table refer to meeting the characteristics of these predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Performance Requirements of Predicate Devices) | Reported Device Performance |
|---|---|
| Functionality / Light up | Yes |
| Electrical Characteristics | Yes |
| Burn-in Behavior | Yes |
| Dimensional Characteristics | Yes |
| Mechanical Safety | Yes |
| Electrical Safety | Yes |
| Physical Design (e.g., reflector angle) | Yes |
| UV Performance | Yes |
| UVA Irradiance | Yes |
| Erythemal Effective Irradiance | Yes |
| UVC/UVB Ratio (per 21 CFR 1040.20) | Yes |
2. Sample Size Used for the Test Set and Data Provenance:
The document explicitly states: "As noted, the subject lamps of this 510(k) are identical to the predicate devices. Therefore, the subject lamps and the predicate devices have the same performance requirements."
This indicates that a separate "test set" in the traditional sense, involving a distinct validation study with a specified sample size of the new device, was not conducted because the claim is that the devices are fundamentally the same as already-marketed devices. Therefore, there is no specific sample size for a test set or data provenance mentioned for a new study. The performance is assessed against the established characteristics of the predicate devices.
The document mentions that all lamps are "100% tested for functionality at the end of the manufacturing process" and that a "Quality Sampling Plan" is used for in-process and post-production testing. However, this is described as routine quality control, not a specific "test set" for a device performance study as typically understood in regulatory submissions for new or modified devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
No experts were used to establish ground truth for a test set related to this submission because the device's performance is asserted to be identical to predicate devices. The "ground truth" here is essentially the established performance and safety characteristics of the legally marketed predicate devices, which are assumed to be known and accepted.
4. Adjudication Method for the Test Set:
Not applicable, as no separate test set requiring adjudication was conducted.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done:
No, an MRMC comparative effectiveness study was not done. This submission focuses on demonstrating substantial equivalence based on identical technological characteristics and intended use, not on comparing performance with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done:
Not applicable. This device is an ultraviolet lamp, not an algorithm or AI system.
7. The Type of Ground Truth Used:
The "ground truth" implicitly used is the established performance and safety profiles of the legally marketed predicate ultraviolet sunlamps. The submission argues that the new devices are essentially the same as these predicate devices.
8. The Sample Size for the Training Set:
Not applicable. This device is an ultraviolet lamp, not an AI/ML algorithm that requires a training set. The submission does not refer to any training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for this device.
§ 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.