(7 days)
The intended function of the UV-B ultraviolet lamp is therapy for Psoriasis and Vitiligo.
Philips PL-S 9W/12/2P UV-B
Watts - 9
Volts - 60
Base - G23
Length - max OAL - 167 mm
This document is a 510(k) Summary Statement for the Philips PL-S 9W/12/2P UV-B lamp, which is intended for therapy for Psoriasis and Vitiligo. It is a submission to the FDA for market clearance and confirms substantial equivalence to previously marketed predicate devices.
This document does not describe acceptance criteria for an AI/ML device, nor does it present the results of a study to prove a device meets such criteria.
The document states that the Philips PL-S 9W/12/2P UV-B lamp is substantially equivalent to existing predicate devices (TL20W/12/RS, TL40W/12/RS, TL100W/12 UV B) because, while dimensionally different, they have "substantially equivalent outputs." This implies that the acceptance criteria for this device are met by demonstrating that its UV-B output characteristics are comparable to those of already approved lamps for the indicated therapies.
Therefore, I cannot provide the detailed information requested in your prompt regarding acceptance criteria and a study to prove a device meets those criteria, as this information is not present in the provided text. The document is concerned with demonstrating substantial equivalence based on output, rather than performance against pre-defined acceptance criteria for a new type of device or AI/ML product.
{0}------------------------------------------------
Kǒ21514
Image /page/0/Picture/1 description: The image shows the Philips logo, which consists of the word "PHILIPS" in bold, uppercase letters above a shield-like emblem. The emblem features a stylized representation of stars and waves. The stars are four-pointed, and the waves are depicted as horizontal lines.
Image /page/0/Picture/2 description: The image shows the word "PHILIPS" in a bold, sans-serif font. The letters are all capitalized and evenly spaced. The word is black and the background is white.
MAY 1 6 2002
EXHIBIT 2
Philips Lighting Company
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 PL-S 9W/12/2P UV-B |
| Common Name: | UVB Lamps |
| Classification: | Light, Ultraviolet, Dermatological |
| Description: | Philips PL-S 9W/12/2P UV-BWatts - 9Volts - 60Base - G23Length - max OAL - 167 mm |
| Intended Use: | The intended function of the UV-B ultraviolet lamp is therapyfor Psoriasis and Vitiligo. |
| Equivalence: | Substantial equivalence previous devices. Lamps are differentdimensionally but have substantially equivalent outputs.TL20W/12/RSTL40W/12/RSTL100W/12 UV B |
Ref: FDA-510K Summary Statement File: 14.01.23
Image /page/0/Picture/9 description: The image shows the ISO 9001 KEMA CERT logo. The logo includes the text "ISO 9001" in bold, followed by "KEMA CERT" underneath. There are also two accreditation seals: one from the Dutch Council for Accreditation (RvA) and another from the Registrar Accreditation Board (RAB).
200 Franklin Square Drive
P.O. Box 6800 Somerset, NJ 08875-6800 Tel: (732) 563-3000
{1}------------------------------------------------
Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the department's name around the perimeter. Inside the circle is an abstract image of an eagle with three lines representing its wings. The seal is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 6 2002
Ms. Toni J. Hoffman Corporate Quality Analyst Philips Lighting Company 200 Franklin Square Drive Somerset, NJ 08875-6800
Re: K021514 Trade/Device Name: Philips PLS9W/12/2P UV-B Regulation Number: 878.4630 Regulation Name: Ultraviolet lamp for dermatologic disorders Regulatory Class: II Product Code: FTC Dated: May 7, 2002 Received: May 9, 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 J. Hoffman
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.
Muriam C. Provost
Por 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 globe-like design with wavy lines across the middle. The globe has cross-like shapes on the top and bottom.
Philips Lighting Company
EXHIBIT 3
INDICATION FOR USE STATEMENT
510(k) Number (if known):
): K021514
Device Name:
Philips PLS9W/12/2P UV-B
The intended function of the UV-B ultraviolet lamp is therapy for Psoriasis and Vitiligo.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of DCRH, Office of Device Evaluation (ODE)
Muriam C. Provost
f General. Restorative and Neurological Devices
Prescription Use
510(k) Number K021514
(Per 21 CRF 8001.109) OR Ov
Over-the-Counter Use
(Optional Format 1-2-96)
Image /page/3/Picture/17 description: The image shows the ISO 9001 KEMA CERT logo. The logo includes the text "ISO 9001" in bold letters above "KEMA CERT". Below that, it states "Accredited by the Dutch Council for Accreditation (RwA)" and "Accredited by the Registrar Accreditation Board (RAB)". The logo also contains a circular symbol with a triangle inside.
A division of Philips Electronics North America Corporation 200 Franklin Square Drive P.O. Box 6800 Somerset, NJ 08875-6800 Tel: (732) 563-3000
§ 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.