PHILIPS TL 20W/01RS UV-B, PHILIPS PL-S 9W/01/2P UV, AND PHILIPS PL-L 36W/01/4P UV-B

• K Number: K021092
• Device Name: PHILIPS TL 20W/01RS UV-B, PHILIPS PL-S 9W/01/2P UV, AND PHILIPS PL-L 36W/01/4P UV-B
• Manufacturer: PHILIPS LIGHTING CO.
• Date Cleared: 2002-05-16 ( 42 days)
• Product Code: FTC
• Regulation Number: 878.4630
• Type: Traditional
• Panel: SU
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

The intended function of the UV-B ultraviolet lamp is therapy for Psoriasis and Vitiligo.

Device Description

Philips TL20W/01/RS UV-B
Watts - 20
Volts - 57
Base - G13
Bulb - T12
Length - max 604mm pin end to pin end
Philips PL-S 9W/01/2P UV-B
Watts - 9
Volts - 60
Base - G23
Length - max OAL - 167 mm
Philips PL-L 36W/01/4P UV-B
Watts - 36
Volts - 105
Base - 2G11
Length - max OAL - 417 mm

AI/ML Overview

This Philips 510(k) submission (K021092) is for UVB lamps (Philips TL20W/01/RS UV-B, Philips PL-S 9W/01/2P UV-B, and Philips PL-L 36W/01/4P UV-B) intended for therapy for Psoriasis and Vitiligo. The submission states that the lamps are "Substantially equivalent to previous devices. Lamps are different dimensionally but have substantially equivalent outputs to Philips TL100W/01 UV-B."

Therefore, the study proving the device meets acceptance criteria is based on a comparative equivalency analysis to a predicate device (Philips TL100W/01 UV-B), rather than a standalone clinical study with defined acceptance criteria for efficacy or safety metrics typically seen in AI/software device submissions.

Here's a breakdown of the requested information based on the provided document:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Implied)	Reported Device Performance
Substantial equivalence to predicate device (Philips TL100W/01 UV-B) in terms of UV-B output for therapeutic use.	The submitted devices have "substantially equivalent outputs to Philips TL100W/01 UV-B".

Note: The document explicitly states "Lamps are different dimensionally but have substantially equivalent outputs". This is the core of their performance claim for equivalence. There are no detailed quantitative acceptance criteria (e.g., minimum UV-B irradiance or specific wavelength ranges) provided in this summary. The FDA's acceptance of the 510(k) implies agreement with this claim of substantial equivalence.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: Not applicable in the context of a clinical test set. The "samples" here are the three new lamp models being compared to the predicate lamp.
• Data Provenance: Not applicable for a clinical test set. The data would pertain to the comparative output characteristics of the lamps themselves, likely from internal testing measurements by Philips.

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)

• Number of Experts: Not applicable. Ground truth in this context would be the measured physical output characteristics of the lamps, not expert interpretation.
• Qualifications of Experts: Not applicable.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Adjudication Method: Not applicable. The "test set" is the physical lamps and their measured output, not subjective interpretation.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI/software devices where human readers interact with AI assistance. This submission is for physical UV-B lamps.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Standalone Performance Study: No, a standalone performance study in the context of an algorithm's performance was not done. This submission is for physical UV-B lamps. The "standalone" performance here refers to the output characteristics of the new lamps.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Type of Ground Truth: The "ground truth" used is the measured UV-B output characteristics of the predicate device (Philips TL100W/01 UV-B). The new devices' outputs were then compared to this established "ground truth" to determine substantial equivalence. This would likely involve quantifiable physical measurements of spectral irradiance.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This is not an AI/ML device requiring a training set.

9. How the ground truth for the training set was established

• Ground Truth for Training Set Establishment: Not applicable. This is not an AI/ML device requiring a training set.

Regulation Number and Section

§ 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.