CHROMOPHARE D500, D530, D650

{0}------------------------------------------------ MAY 27 1999 K991527 ### 8.0 510(k) SUMMARY As Required By 21 CFR 807.92 Submitter: Berchtold GmbH & Co Ludwigstaler Str. 25 D-78532 Tuttlingen Germany 0049 7461 181-0 Phone number: 0049 7461 181-100 Fax number: Wolfram K. Hill Contact person: Manager R & D Device Name: Trade Name: ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ 一 Classification name: Product code: Device class: CHROMOPHARE® D500 CHROMOPHARE® D530 CHROMOPHARE® D650 Light, Surgical, Ceiling Mounted FSY Class II Device Description: Devilos collection CHROMOPHARE® D Series lights are suitable for all types of surgical The light The Berchtold CHROMOPHARE® D Senes lights and "colder" light stypes that gold" of the light procedures and offers the physician a natural (whiter) and "colder" light procedures and oners the phycloids. In a continue. Quality is series lights provides a lights provides a light intensity from 85000lx up to 150000 lux. The light incorporates easy-to-operate switching on the second lamp The light of failure of the main leasy to exchange lamp cartidge. Frith le The light incorporates easy-to-perate switch easy to exchange lamp carridge. For the light in case of failler. For the available of failling of the main in case of failure of the main amp and an easy to exchange later available CHROMOPHARE® D650 and D530 is also an optional CCD-video camera available CHROMOPHARE® D650 and D530 is also an option. The light could be and a special version with "EndoLite" for endoscopical wonline of Control Control Control Control Control Control Control Control Control combined with other Berchtold lights and the Hermes Ort Some - Sense - See in the EC Motion, Inc. The light has been designed to and meets the requirements of the IEC . Motio 601 and UL 544 regulation for safety. #### Intended Use: The intent of the CHROMOPHARE® D650 is to illuminate locally the operating site on t of the Kesked on the a bigh intensiby, shadow free, "cold" light, Light functions could The intent of the CHROMOPHARE "Dost is to thinkling tour light functions could the patient's body with a high intensity, shadow free, "cod" light functions could the patient's body with a nigh mieristiy, stitacow libe, The HERMES . be controlled by touch panel mounted at the wall box. The HERMES . The controlled by accuracy in the ou be controlled by touch panel mounted at the wall being voice-activated control OR Control Center provide the surgeon with the option with the so allow for OR Control Center provide the surged with the Option of this is to allow for of the settings and adjustments of the CHROMOPHARE® D650. This is to allow for of the settings and adjustments of the Light settings by the physician, thereby simplified and more direct control of the Light settings between the su simplifed and more direct control of the Light security of the pryson the surgeon eliminating the necessity of relying upon verbal communications begined Light. eliminating the necessity of relying upon verbal ochinemation in the Surgical Light #### Substantial Equivalence: The CHROMOPHARE® D650 described in this submission is substantially equivalent to The CHROMOPHARE® D659 described in K965130. Any difference that exists has no the CHROMOPHARE" Doss described in though enhances the usefulness in the negative effect on safety of the medical supply units, as indicated above, has been chosen application. Safety of the medical supply units, as indicated above, has been t the chosen application. Salely of the medical ouppy." established by meeting the requirements of IEC 601 and UL 544. Image /page/0/Picture/22 description: The image shows the logo for Berchtold. The logo consists of the word "BERCHTOLD" in a sans-serif font, followed by two vertical lines and a solid black circle. The circle has a small "®" symbol to the right of it. 10 {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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three abstract shapes resembling birds in flight, arranged in a descending order of size. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 MAY 27 1999 Mr. Wolfram K. Hill Manager, Research and Development Berchtold GmbH & Co. Ludwigstaler Str. 25 Postfach 4052 D-78505 Tuttlingen Germany K991527 Re: Trade Name: Chromophare D500, D530, D530, D650 Regulatory Class: II Product Code: FSY Dated: April 28, 1999 Received: May 3, 1999 Dear Mr. Hill: We have reviewed your Section 510(k) notification of intent to market the device referenced We have reviewed your Section 510(x) notined.com tially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate comments as to de use stated in the enclosure) to devices manages in the Medical Devices that May 28, 1976, the enaculient date of the Meersal of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls Cosmetic Act (Act). You may, therefore, market the actively and the Act include requirements for provisions of the Act. The general cona of proufacturing practice, labeling, and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III If your device is classified (see above) into such additional controls. Existing major (Premarket Approval), It may be subject to satis atist stired Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Faris 600 to 697. A substaintain'y equirement, as set forth in the Quality System Current Good Manufacturing Practices: General regulation (21 CFR Part 820) and that, Regulation (QS) for Medical Devices: Sood and Drug Administration (FDA) will verify turough periodic (QS) inspections) in the GMP regulation may result in regulatory such assumptions. Fallure to comply with the SHF regulants concerning your device in the Federal Register. Please note: this response to your premarket notification submission does Federal Register. Trease note: this response to 70 through 542 of the Act for not affect any obligation you might have under society of the Food of the Federal laws or regulations. {2}------------------------------------------------ # Page 2 - Mr. Wolfram K. Hill This letter will allow you to begin marketing your device as described in your 510(k) . The substantial and me TDA finding of substantial equivalence of your device to This letter will allow you to begin marketing your device as usefice as user as a contracted to a premarket notification. The FDA finding of substitisation for your device a premarket notification. The Finding of substantial equivalence of your device and thus, permits Iegally marketed predicate device results in a classification for your device your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 Press and the contraction in adjustic devices), please contact the Office of If you desire specific advice for your device on our laboring regantset the Office of and additionally 809.10 for in vitro diagnostic devices), please constitution and and additionally 809.10 for in nitro diagnosic devices); productions on the promotion and Compliance at (301) 594-4595. please contact the Office of Compliance at (301) 594-4639. advertising of your device, please contact the Office of Compliance at (301) 594-4639 advertising of your device, please contact the Originating by reference to premarket. Also, please note the regulation entitled, "Misbranding by reference to premarket Also, please note the regulation entitled, "Misoration on your responsibilities under the notification" (21 CFR 807.97). Other general information on your responsibilities u notification" (21 CFR 807.97). Other general miorination on your roped. Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free s and be one Act may be obtained from the Division of Similar of Sincernet address number (800) 638-2041 or (301) 443-6597 or at its internet address 1977 (800) 638-2041 or (301) 443-6597 "http://www.fda.gov/cdrh/dsmamain.html". Sincerely yours, Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health V Enclosure {3}------------------------------------------------ Image /page/3/Picture/3 description: The image shows the word "BERCHTOLD" in a bold, sans-serif font. To the right of the word is a design consisting of two thick, parallel lines and a filled-in circle with a smaller circle to its right. The design appears to be a stylized logo or symbol associated with the name. ## 4.0 Indication for Use The Surgical lights CHROMOPHARE® D500, D630 and D650, are intended to illuminate locally the operating site on the patient's body with a high intensity, shadow free, "cold" light. Wolfram Her Nolfram Hill Manager K&D Berchtold GmbH & Co. May 19, 99 Date K 99152Y 510(k) Number **Prescription Use** (Per 21 CFR 801.109) (Division Sign-Off) Division of General Restorative Devices 510(k) Number S の