GENICON TROCAR

{0}------------------------------------------------ K982472 ## Section II. 510(k) Summary GeniCon L.C. Contact: Gary Haberland 573 Waterscape Wav Orlando, FL 32828 Phone: (407) 273-7619 Fax: (407) 306-9356 Date Prepared: October 20, 1998 Trade Name: GeniCon Trocar/Cannula System Common Name: Trocar Classification Name: Trocar (per CFR 870.1390) The intended use of this device is for laparoscopic surgery by general, thoracic, gynecologic and urological surgeons. The legally marketed device to which we are claiming previous acceptance of predicate device is the Apple Medical Hunt/Reich Trocar and the Core Dynamics Entree II both in sizes 5, 7/8, 10 and 12mm systems. Engineering testing has demonstrated that the valve assembly performs better than that of the Apple and Core trocar valve assembly. This testing incorporated a simulated human abdominal cavity and the method of insertion of the device and use with various common laparoscopic instruments. In all areas of performance, this device performed equal to if not superior in pressure testing, ease of use and insertion. This device incorporates several design features which facilitate the surgeons use both during insertion and while instrumentation is being inserted and manipulated. Trocar Tip: - A modified pyramidal tip to provide easier insertion for the surgeon by enabling the tip to . minimally incise the tissue while providing a lower profile transition from the stainless tip to the cannula. Trocar Handle: - Enlarged to provide a more positive fit in the surgeon's palm during insertion, and provides a . groove to provide a more positive fit for the thumb during removal or re-insertion. ## Cannula: - Clear casing for visualization of instrument and tissue passage. . - Reverse trapezoidal fascia threads, they provide an easier insertion while a positive anchoring . during instrument use. - . Extended CO2 port with male luer cap provides a "finger grip" during device insertion while the male luer cap is easier to remove and replace than the Apple silicone cap. - . Double wall valve lock, assists in maintaining the valve position and to alleviate the premature release sometimes experienced by the Apple product. Valve: - . A tapered membrane assembly provides a more positive seal around the instrument, while the silicon membrane was designed to reduce friction during instrument use. - . A pull-tab was added to facilitate removal of the valve during specimen retrieval. Image /page/0/Picture/22 description: The image shows the logo for Genicon. The logo is in black and white and features the company name in a stylized font. Above the "o" in Genicon are two surgical instruments. Below the company name is the tagline "New Ideas for Modern Health Care". {1}------------------------------------------------ Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and features the department's name around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight. The symbol is composed of three curved lines that suggest movement and progress. Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 4 1999 EEB Mr. Gary Haberland Product Manager Genicon 573 Waterscape Way Orlando, Florida 32828 Re: K982472 > Trade Name: Genicon Trocar/Cannula System Regulatory Class: II Product Code: GEA Dated: January 19, 1999 Received: January 21, 1999 Dear Mr. Haberland: 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. {2}------------------------------------------------ Page 2 -- Mr. Gary Haberland 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. 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 vours. Styph Rhodes 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 {3}------------------------------------------------ Section I. Indications for Use 510 (k) Number: K982472 Device Name: Trocar Indications for Use: The GeniCon trocar is available in 5, 7/8, 10 and 12mm diameter with either a pyramidal or conical tip. This trocar has application in gynecologic, general, thoracic and urology endoscopic procedures to establish a port of entry for instrumentation. ## (PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED) Prescription Use_ X OR Over-The-Counter Use_ (Optional Format 1-2-96) Styt Durbe (Division Sign-Off) (Division of General Restorative Devices K9P2472 510(k) Number -