DORNIER LASERTRODE FIBER

{0}------------------------------------------------ 9 1999 JUN K991183 ![]()DornierMedTech # 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Dornier Surgical Products, Inc.'s Lasertrode Fiber In response to the Safe Medical Devices Act of 1990, the following is a summary of the safety and effectiveness information upon which the substantial equivalence determination is based. The safety and effectiveness of the Dornier Lasertrode is based upon a determination of the substantial equivalence as well as the safety and effectiveness of its predicate devices which includes the following: ### Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared | Dornier Surgical Products, Inc. | Phone: | 770-426-1315 | |---------------------------------|-------------------------------|--------------| | 10027 South 51st Street | Facsimile: | 770-514-6288 | | Phoenix, AZ 85044 | | | | Contact Person: Carol Wernecke | Date Prepared: March 31, 1999 | | ### Name of Device and Name/Address of Sponsor Dornier Lasertrode Fiber Dornier Surgical Products, Inc. 10027 South 51st Street Phoenix. AZ 85044 ### Classification Name Laser Surgical Instrument Accessories. ## Predicate Devices Dornier Light Guide with Bare Fiber Tip (K982629) ## Intended Use The Dornier Lasertrode fiber is intended to be used for vaporization, cutting, ablation and coaqulation of soft tissue in conjunction with or without endoscopic equipment including laparoscopes, hysteroscopes, bronchoscopes, cystoscopes, gastroscopes, colonoscopes, or for open surgery for contact or non-contact surgery with or without handpiece for use in coagulation, incision/excision, ablation and vaporization of soft tissue. {1}------------------------------------------------ The Dornier Lasetrode is indicated for use in medicine and surgery in the following specialties: Urology, Plastic Surgery, Radiology, Dermatology, Pulmonology, Gastroenterology, Gynecology, ENT and General Surgery. # Technological Characteristics and Substantial Equivalence From a clinical perspective and comparing design specifications, the Dornier Lasertrode Fiber and the predicate device are substantially equivalent and have the same intended use. Dornier Surgical Products, Inc. believes the minor differences of the Dornier Lasertrode fiber and its predicate laser accessories should not raise any concerns regarding the overall safety or effectiveness. - Advisory: This information was prepared for the sole purpose of compliance with the Safe Medical Devices Act of 1990. It does not imply that the procedures described herein can be performed with the equipment described without substantial risk of personal injury or death to patients due to operator error or in procedures requiring a high degree of skill. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure in profile, with three overlapping faces suggesting a sense of community and support. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 9 1999 JUN Ms. Carol Wernecke Director, Regulatory and Clinical Affairs Dornier Medical Systems, Inc. 1155 Roberts Boulevard Kennesaw, Georgia 30144 Re: K991183 Trade Name: Dornier Lasertrode Fiber Regulatory Class: II Product Code: GEX Dated: April 5, 1999 Received: April 8, 1999 Dear Ms. Wernecke: We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations. This letter will allow you to begin marketing your device as described in your 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. {3}------------------------------------------------ Page 2 - Ms. Carol Wernecke If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "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 Enclosure {4}------------------------------------------------ K981183 # Dornier Surgical Products, Inc.'s Lasertrode # INDICATIONS FOR USE The Domier Lasertrode fiber is intended to be used for vaporization, cutting, ablation and coagulation of soft tissue in conjunction with or without endoscopic equipment including laparoscopes, hysteroscopes, bronchoscopes, cystoscopes, gastroscopes, colonoscopes, or for open surgery for contact or non-contact surgery with or without handpiece for use in coagulation, incision/excision, ablation and vaporization of soft tissue. The Dornier Lasetrode is indicated for use in medicine and surgery in the following specialties: Urology, Plastic Surgery, Radiology, Dermatology, Pulmonology, Gastroenterology, Gynecology, ENT and General Surgery. Prescription Use (Per 21 CFR 801.109) Acotefa