REPROCESSED DISPOSABLE TROCARS

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the text "Adven Medical, Inc." in a bold, italicized font. The text is underlined with a thick black line. The words are arranged horizontally, with "Adven" on the left, "Medical" in the center, and "Inc." on the right. The text appears to be a logo or heading. MAR 1 2002 KO13987 ## 510(k) SUMMARY Classification Name: 1001 Slaton Hwv. Lubbock, Texas 79404 Common/Usual Name: Trade/Proprietary: Trocar - KAB, KBG, KCI, FBQ, FBM, GCJ, DRC Trocar Reprocessed Disposable Trocars Mark W. Aldana Contact: Summary: AMI intends to market Surgical Trocars that have been reprocessed. "Reprocessed," means all operations performed to render a contaminated single-use device patient ready. AMI is a third party reprocessor. If all protocol parameters are met, AMI will reprocess each disposable trocar up to two times. Trocars are sold new by the original manufacture to the hospital uses the trocars, collects them and ships them to AMI for reprocessing. Trocars are reprocessed by AMI as described in our reprocessing protocol Control Document Number 40005 and returned to the hospital to be reused. Trocars that do not meet the AMI protocol are rejected. Rejection may occur during the first reprocessing (in which the trocar is not reprocessed at all) or second reprocessing. AMI believes that reprocessed trocars can be considered "reusable" as defined in the Food and Drug Administration Compliance Policy Guide #7124.16: they are able to withstand the necessary cleaning and sterilization process, the physical characteristics or quality of the device will not be adversely effected, and the device remains safe and effective for its intended use. AMI reprocesses only trocars that are currently sold on the market and which have met premarket requirements by the original manufacturer for single use. AMI Reprocessed Trocars addressed in this submission are the same devices that are currently sold on the market as "disposable" by the original manufacturer. The devices identified in this premarket notification are the predicate devices and therefore substantially equivalent to trocars currently on the market. The concept of marketing reprocessed trocars is similar to the concept of marketing resharpenable surgical saw blades which was found substantially equivalent by FDA in 510(K) 940501 (submitted by Adven Medical, Inc. and cleared on June 28, 1994). AMI has performed numerous tests to validate its reprocessing protocol. {1}------------------------------------------------ Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle with its wings spread. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 MAR 1 2002 Mr. Mark W. Aldana President Adven Medical, Inc. 1001 Slaton Highway Lubbock, Texas 79404 Re: K013987 Trade/Device Name: Reprocessed Disposable Trocars Regulation Number: 870.1390 Regulation Name: Trocar Regulatory Class: II Rogalatory - KBG, KCI, FBQ, FBM, GCJ, DCR Dated: December 3, 2001 Received: December 4, 2001 Dear Mr. Aldana: We have reviewed your Section 510(k) premarket notification of intent to market the device in diedic We have reviewed your Section 3 ro(x) premained is substantially equivalent (for the indications referenced above and have determined the device is substantially interests on felerenced above and nave acterimined by marketed predicate devices marketed in interscate for use stated in the encrosure) to regard) the enactment date of the Medical Device Amendments, or to commerce prior to May 26, 1976, the exactions of the Federal Food. Drug. devices that have been recalise in acceracited in assessor will of a premarket approval application (PMA). and Cosmetic Act (Act) that do not require approval of a premarket and Cosment Act (Act) that do not require approvise the general controls provisions of the Act. The Tou may, uncrerore, mance are act include requirements for annual registration. listing of general controls provisions of the riot 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 If your device is classified (500 above) als. Existing major regulations affecting your device can may be subject to such additional controls. Existing major regulations on may be subject to such additions, 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 I loase be advised that I Dr brisean that your device complies with other requirements of the Act that I DA has made a determinalations administered by other Federal agencies. You must or any I edelul statutes and regarments, including, but not limited to: registration and listing (21 Comply with an the Fet 8 requirements) CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFR Part 607); adoming (Dr CFR Part 820); and if applicable, the electronic forth in the quality of over of sions (Sections 531-542 of the Act); 21 CFR 1000-1050. {2}------------------------------------------------ Page 2 - Mr. Mark W. Aldana 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely yours, A. Mark N. Millerson Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ Page 1 of 1 510)k) Number: K013987 Reprocessed Disposable Trocars Device Name: Indications For Use: Reprocessed endoscopic trocars are designed to provide a pathway for entry of minimally invasive instruments to a body organ or cavity during general, abdominal, thoracic, gynecologic or other minimally invasive surgical procedures. Trocars are single patient used devices. ## (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) | | <p>for</p> <p>Mark N Milunson</p> | |-----------------------------------------------------------|-----------------------------------| | (Division Sign-Off) | | | Division of General, Restorative and Neurological Devices | | | 510(k) Number | K013987 | ﻪ Prescription Use (Per 21 CFR 801.109) OR Over-The-Counter Use (Optional Format 1-2-96)