(42 days)
The intended function of the UV-B ultraviolet lamp is therapy for Psoriasis and Vitiligo.
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
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.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows a logo for Philips. The logo is a shield shape with the word "PHILIPS" at the top. Inside the shield is a globe with horizontal and vertical lines, and a wavy line across the middle. There is also a star at the bottom of the globe.
Image /page/0/Picture/2 description: The image shows the word "PHILIPS" in a bold, sans-serif font. The letters are large and black, contrasting with the white background. The text appears to be a logo or brand name. The image is clear and easy to read.
Philips Lighting Company
MAY 1 6 2002
510K SUMMARY STATEMENT
| Company Name: | Philips Lighting Company200 Franklin Square DriveSomerset, NJ 08875-6800 |
|---|---|
| Contact: | Toni J. HoffmannCorporate Quality Analyst |
| Telephone: | 732-563-3081 |
| Trade Names: | Philips TL20W/01/RS UV-BPhilips PL-S 9W/01/2P UV-BPhilips PL-L 36W/01/4P UV-B |
| Common Name: | UVB Lamps |
| Classification: | Light, Ultraviolet, Dermatological |
| Description: | Philips TL20W/01/RS UV-BWatts - 20Volts - 57Base - G13Bulb - T12Length - max 604mm pin end to pin endPhilips PL-S 9W/01/2P UV-BWatts - 9Volts - 60Base - G23Length - max OAL - 167 mmPhilips PL-L 36W/01/4P UV-BWatts - 36Volts - 105Base - 2G11Length - max OAL - 417 mm |
| Intended Use: | The intended function of the UV-B ultraviolet lamp is therapy forPsoriasis and Vitiligo. |
| Equivalence: | Substantial equivalence previous devices. Lamps are differentdimensionally but have substantially equivalent outputs to PhilipsTL100W/01 UV-B |
Ref: FDA-510K Summary Statement File: 14.01.23
Image /page/0/Picture/8 description: The image shows the ISO 9001 KEMA CERT logo. The logo includes the text "ISO 9001" in bold letters above the text "KEMA CERT". Below this, there are two accreditation statements, though the text is too small to read clearly. The logo is black and white and appears to be part of a larger document.
200 Franklin Square Drive P.O. Box 6800
Somerset, NJ 08875-6800
Tel: (732) 563-3000
{1}------------------------------------------------
Image /page/1/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three overlapping wing shapes, symbolizing the department's mission to protect and promote the health and well-being of all Americans. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle, emphasizing the department's name and national scope.
MAY 1 6 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Toni Hoffmann Corporate Quality Analyst Philips Lighting Company 200 Franklin Square Drive Somerset. NJ 08875-6800
Re: K021092
Trade/Device Name: Philips TL20W/01/RS UV-B Philips PL-S 9W/01/2P UV-B Philips PL-L 36W/01/4P UV-B
Regulation Number: 878.4630 Regulation Name: Ultraviolet lamp for dermatologic disorders Regulatory Class: II Product Code: FTC Dated: March 7, 2002 Received: April 4, 2002
Dear Ms. Hoffman:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
{2}------------------------------------------------
Page 2 - Ms. Toni Hoffmann
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
Miriam C. Provost
For Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{3}------------------------------------------------
Image /page/3/Picture/0 description: The image shows the Philips logo, which is a shield shape with the word "PHILIPS" at the top. Inside the shield, there is a circular design that appears to represent a globe or a stylized depiction of the earth. The design includes lines that could be interpreted as landmasses, water, or other geographical features. The logo is in black and white.
Image /page/3/Picture/1 description: The image shows the word "PHILIPS" in large, bold, black letters. The font is sans-serif and the letters are closely spaced. The word appears to be a logo or brand name, and the image is likely a close-up of the wordmark.
Philips Lighting Company
INDICATION FOR USE STATEMENT
510(k) Number (if known): K021092
Philips TL20W/01/RS UV-B Device Names: Philips PL-S 9W/01/2P UV-B Philips PL-L 36W/01/4P UV-B
The intended function of the UV-B ultraviolet lamp is therapy for Psoriasis and Vittiligo.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of DCRH, Office of Device Evaluation (ODE)
Miriam C. Provost
- Restorative
OR
021092
Prescription Use (Per 21 CRF 8001.109)
Image /page/3/Picture/12 description: The image shows a logo for ISO 9001 certification. The logo includes the text "ISO 9001" in bold, black letters. Below the text, it says "KEMA CERT" in smaller letters. There is also some text below that, but it is too blurry to read.
A division of Philips Electronics North America Corporation
510(k) Number
200 Franklin Bq P.O. Box 6800 Somerser, NJ 08875-680 Tel: (732) 563-3000
(Optional Format 1-2-96)
Over-the-Counter Use
Ref: FDA Indication Use Statement
§ 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.