POLARIS 100/200

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K123776 ## 510(k) summary As required per CFR 21 807.92 ### General Company Information | Submitters Name and Address: | Dräger Medical GmbH | |------------------------------|--------------------------| | | Moislinger Allee 53-55, | | | D-23542 Luebeck, Germany | Manufacturer's Name and Address: Dräger Medical GmbH Moislinger Allee 53-55, D-23542 Luebeck, Germany Establishment Registration Number: 9611500 Contact Person: Mr. Ulrich Schroeder Moislinger Allee 53-55, D-23542 Luebeck, Germany Phone : 49 (451) 882-3648 Fax :49 (451) 882-3018 Email: Ulich.Schroeder@draeger.com Alternate Mrs. Beth Zis Draeger Medical Systems, Inc., 6 Tech Dr, Andover, MA 01810 Phone +1 (978) 3798255 Fax: +1 (978) 3798335 Email: beth.zis@draeger.com {1}------------------------------------------------ . Abbreviated 510(k) Polaris 100/200 Image /page/1/Picture/7 description: The image shows the word "Dräger" in a bold, sans-serif font. The "ä" in Dräger is represented by two dots above the letter "a". A horizontal line is present below the word, emphasizing the brand name. ## Device Name | Common Name: | Lamp, surgical | |--------------------------------------------|---------------------------| | Legally Marketed Device<br>Identification: | Polaris 100/200 | | Regulation Number | 878.4580 | | Regulation Description | Surgical Lamp | | Regulation Medical Specialty | General & Plastic Surgery | | Product Code | FTD | | Class | 2 | {2}------------------------------------------------ #### Device description: The Polaris 100/200 light is designed for use in as an operating light. For the Polaris 100/200 light, LED bulbs are used. The Polaris 100 light combines the illumination intensity of 48 white LED bulbs, the Polaris 200 light combines the illumination intensity of 66 white LED bulbs to form a homogeneous illumination volume of considerable illumination depth and low shadiness. A color temperature similar to natural light with good color rendering and dimmable illumination intensity ensure working conditions for surgical and treatment procedures. #### Indications / Intended Use: Polaris 100/200 lights are classified as operating lights in accordance with IEC 60601-2-41 and are intended to be used for the local illumination of the surgery and treatment area on the patient in operating and treatment rooms. Double light The combination of two operating lights as an operating light system enables the use in operating and treatment rooms. Versions - Polaris 100 light - Polaris 200 light #### Legally marketed devices: Drager is claiming substantial equivalence of its Polaris 100/200 surgical light to the Sola 700, Sola 500 from Dräger (K010724) and to the device iLED from Trumpf Medizin Systeme (K061317). - - #### Technological Characteristics: Performance testing was conducted to verify that the proposed Polaris 100/200 Surgical lamp meet the requirements for Medical Electrical Equipment as defined in IEC 60601-1 and IEC 60601-2-41 {3}------------------------------------------------ #### Substantial Equivalence: The proposed device Polaris 100/200 and all predicative devices have the similar intended use and they conform to the same particular standard: IEC 60601-2-41. In addition the iLED and the new Polaris 100/200 do use the same light source / technology: light emitting diodes (LED). There are differences in design and operation but these do not alter the safety or efficacy of the device. Dräger is claiming its Polaris 100/200 surgical light to be as safe, as effective, and performs as well as or better than the predicate devices. {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling an abstract caduceus or a series of flowing lines, representing health and human services. #### DEPARTMENT OF HEALTH & HUMAN SERVICES #### Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 March 8, 2013 Drager Medical GMBH % Draeger Medical Systems, Incorporated Ms. Beth Zis Director, Regulatory Affairs 6 Tech Drive Andover, Massachusetts 01810 Re: K123776 Trade/Device Name: Polaris 100/200 Regulation Number: 21 CFR 878.4580 Regulation Name: Surgical lamp Regulatory Class: II Product Code: FTD Dated: December 04, 2012 Received: December 10, 2012 Dear Ms. Zis: 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 {5}------------------------------------------------ Page 2 - Ms. Beth Zis CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. 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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, FOR # Peter D. Rumm -S Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {6}------------------------------------------------ # Indications for Use Statement Polaris 100/200 lights are classified as operating lights in accordance with IEC 60601-2-41 and are intended to be used for the local illumination of the surgery and treatment area on the patient in operating and treatment rooms. Double light The combination of two operating lights as an operating light system enables the use in operating and treatment rooms. Versions - Polaris 100 light - Polaris 200 light Prescription Use _ × (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) #### Concurrence of CDRH, Office of Device Evaluation (ODE) Neil R Ogden 2013.03.08 11:00:35 -05'00' (Division Sign-Off) for MXM Division of Surgical Devices 510(k) Number __ K123776