PROXENON 350, MODEL 902XX

{0}------------------------------------------------ ## Welch Allyn Traditional 510(k) Premarket Notification ProXenon 350 Premarket Notification [510(k)] Summary 5. Submitted By: Welch Allyn, Inc. 4341 State Street Road P.O. Box 220 Skaneateles Falls, NY 13153-0220 JUN 1 4 2007 Phone: (315) 685-4571 Fax: (315) 685- 2532 Contact: John E. Sawyer, Vice-President, Quality Assurance & Regulatory Affairs light, surgical, fiberoptic Common Name: Trade Name: ProXenon 350 Classification: Class II; 21 CFR § 878.4580, General & Plastic Surgery Predicate Device: The Isolux Fiber Optic Surgical Headlight System with 510(k) number K991572 Description: The Welch Allyn ProXenon 350 Fiber Optic Surgical Illuminator is designed for use with fiber optic headlight systems. The ProXenon 350 Fiber Optic Surgical Illuminator uses a Welch Allyn high-intensity, narrow-beam, rugged xenon short arc lamp with a fixed internal reflector to produce a uniform profile beams. The Four Port Turret accepts Wolf, Storz, Olympus, and ACMI fiber optic cables. Each port is readily identified on the turret perimeter. The ProXenon 350 system consists of 3 major components; a 300W Xenon light source, a fiber optic bundle, a headlight consisting of a luminaire (contains optics to focus and direct the illumination) and a headband. The surgeon uses the headlight to provide auxiliary illumination when performing surgical procedures. The headlight is especially useful for illumination of deep body cavities since it provides shadow free illumination. Intended Use: The ProXenon 350 Light Source is designed for use with fiber optic headlight systems. It will accept fiber optic light guides for Wolf, Storz, Olympus and ACMI instrumentation. Accessory Headlight is a passive luminaire that is illuminated by fiber optic light and utilized to provide supplemental light for surgical and medical procedures. Section 5 - Page 1 of 1 This document contains information considered to be CONFIDENTIAL to Welch Allyn, Inc. ppl {1}------------------------------------------------ Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular pattern around the symbol. The caduceus is a common symbol associated with healthcare and medicine. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Welch Allyn, Inc. % Mr. Chris Horacek Vice President Chief Compliance Officer 4341 State Street Road P.O. Box 220 Skaneateles Falls, New York 13153-0220 JUN 1 4 2007 Re: K071218 Trade/Device Name: ProXenon 350 Regulation Number: 21 CFR 878.4580 Regulation Name: Surgical lamp Regulatory Class: II Product Code: FST Dated: June 7, 2007 Received: June 12, 2007 Dear Mr. Horacek: 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 {2}------------------------------------------------ Page 2 - Mr. Chris Horacek 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. 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, For Mark N. Melkerson Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ ## WelchAllyn ## Traditional 510(k) Premarket Notification ProXenon 350 4. Statement of Indications For Use 510(k) Number (if known): Device Name: ProXenon 350 Indications For Use: The ProXenon 350 Light Source is designed for use with fiber optic, headlight systems. It will accept fiber optic light guides for Wolf, Storz, Olympus and ACMI instrumentation. Accessory Headlight is a passive luminaire that is illuminated by fiber optic light and utilized to provide supplemental light for surgical and medical procedures. (Division Sign-Off) Division of General, Restorative, and Neurological Devices **510(k) Number** L01128 Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (Part 21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) MPD FCD-0024, Rev. 3 Section 4 - Page 1 of 1 This document contains information considered to be CONFIDENTIAL to Welch Allyn, Inc.