MODIFICATION TO GUARDDOG OCCLUSION SYSTEM

{0}------------------------------------------------ K062220 ## Section 3 – 510k Summary Information AUG 1 1 2006 | Applicant: | Possis Medical, Inc.<br>9055 Evergreen Boulevard N.W.<br>Minneapolis, MN 55433-8003<br>Tel: (612) 780-4555<br>Fax: (612) 780-2227 ERN: 2183460 | Applicant: | Possis Medical, Inc.<br>9055 Evergreen Boulevard N.W.<br>Minneapolis, MN 55433-8003<br>Tel: (612) 780-4555<br>Fax: (612) 780-2227<br>Establishment Registration Number: 2183460 | |-------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person: | Mark D. Stenoien<br>Director of Worldwide Regulatory Affairs<br>P. 763.717.1092<br>Email: mark.stenoien@possis.com | Contact Person: | Mark D. Stenoien<br>Director of World Wide Regulatory Affairs<br>P. 763.717.1092<br>Email: mark.stenoien@possis.com | | Date Prepared: | 31 July 2006 | Date Prepared: | 31 July 2006 | | Trade Name: | GuardDOG® Occlusion System | Contract Manufacture: | Synovis Interventional Solutions Inc.<br>475 Apollo Dr.<br>Lino Lakes, MN 55104<br>ERN #3004594493 | | Common Name of<br>Device/ Classification<br>and Code: | Vascular Clamp Product Code: MJN<br>Class II/21 CFR 870.4450 Cardiovascular | Sterilizer Contractor: | Guide Wire:<br>STERIS Isomedix Services<br>380 90th Ave. NW, Coon Rapids, MN 55433<br>ERN#2183744<br>Inflation Device:<br>STERIS Isomedix Services<br>7828 Nagle Avenue Morton Grove, IL 60053<br>ERN#1450253 | | Predicate Device: | The GuardDOG Occlusion System - K031357<br>Possis Medical, Inc.<br>9055 Evergreen Boulevard N.W.<br>Minneapolis, MN 55433-8003 | Trade Name: | GuardDOG™ Occlusion System | | Device Description: | The GuardDOG System consists of two components: an Occlusion<br>Guide Wire and a carbon dioxide (CO2) Inflation Device. The<br>GuardDOG Inflation Device is used to inflate the occlusion balloon<br>and seal the guide Wire once it is in position. | Common Name of<br>Device/Product<br>Classification and<br>Code: | Vascular Clamp<br>Product Code: MJN<br>Class II/21 CFR 870.4450<br>Cardiovascular | | Intended Use: | The GuardDOG™ Occlusion System is indicated for use in the<br>peripheral vasculature to facilitate the localized infusion of therapeutic<br>or diagnostic fluids, with or without vessel occlusion. | Predicate Device: | The GuardDOG Occlusion System - K031357<br>Possis Medical, Inc.<br>9055 Evergreen Boulevard N.W.<br>Minneapolis, MN 55433-8003 | | | The safety and effectiveness of this device have not been established<br>in the coronary, cerebral, or carotid vasculature. | Device Description: | The GuardDOG System consists of two components: an Occlusion<br>Guide wire and a carbon dioxide (CO2) Inflation Device. The<br>GuardDOG Guide wire is 0.035" in size; 300cm in length (260cm<br>working length); is compatible with a 0.038, or larger, guide catheter;<br>has a shapeable tip; a radiopaque marker proximal and distal to the<br>inflatable balloon; and a crimp zone that can be sealed to maintain<br>balloon inflation on the proximal end.<br><br>The GuardDOG Inflation device is used to inflate the occlusion<br>balloon and seal the guide wire once it is in position. The GuardDOG<br>Inflation device is a disposable CO2 delivery device with two | | Summary of<br>Technological<br>Characteristics: | Representative samples of the device underwent testing including but<br>not limited to mechanical testing, biocompatibility, sterility, and<br>animal testing. | | | | Conclusion: | Possis Medical, Inc. considers the GuardDOG Occlusion System to be<br>substantially equivalent to the predicate device listed above and<br>demonstrate appropriate safety and efficacy of the GuardDOG<br>Occlusion System for use in the peripheral vasculature to facilitate the<br>localized infusion of therapeutic or diagnostic fluids, with or without<br>vessel occlusion. | | | --- {1}------------------------------------------------ ## Section 4 -- General Information : : . {2}------------------------------------------------ | | integrated syringes and a gauge. One syringe contains 20cc of CO2<br>and the second syringe is used to evacuate air from the Occlusion<br>Guide Wire. The gauge is used to measure pressure of CO2 delivered.<br>The GuardDOG Inflation device is packaged in Tyvek pouch for<br>sterilization and then into a sealable can to maintain the CO2<br>environment. | |-------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use: | The GuardDOG™ Occlusion System is indicated for use in the<br>peripheral vasculature to facilitate the localized infusion of therapeutic<br>or diagnostic fluids, with or without vessel occlusion.<br><br>The safety and effectiveness of this device have not been established<br>in the coronary, cerebral, or carotid vasculature. | | Summary of<br>Technological<br>Characteristics: | Representative samples of the device underwent bench testing,<br>including but not limited to mechanical testing, biocompatibility,<br>sterility to demonstrate safety and effectiveness and appropriate<br>functional and performance characteristics. Animal testing was<br>conducted to demonstrate performance characteristics only. | | Conclusion: | Possis Medical, Inc. considers the GuardDOG Occlusion System to be<br>substantially equivalent to the predicate device listed above and<br>demonstrate appropriate safety and efficacy of the GuardDOG—<br>Occlusion System for use in the peripheral vasculature to facilitate the<br>localized infusion of therapeutic or diagnostic fluids, with or without<br>vessel occlusion.<br><br>This conclusion is based upon the devices' similarities in functional<br>design, materials, indications for use, and principles of operation. | : and the comments of the country of : {3}------------------------------------------------ Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HUMAN SERVICES - USA" around the perimeter. The text is in all capital letters and is evenly spaced around the circle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 AUG 1 1 2006 Possis Medical, Inc. c/o Mr. Mark Stenoien Director of Worldwide Regulatory Affairs 9055 Evergreen Boulevard NW Minneapolis, MN 55433-8003 Re: K062220 GuardDog Occlusion System Regulation Number: 21 CFR 870.4450 Regulation Name: Vascular Clamp Regulatory Class: II (Two) Product Code: MJN Dated: July 31, 2006 Received: August 2, 2006 Dear Mr. Stenoien: 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). and ooometherefore, 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. {4}------------------------------------------------ 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 that i Drederal 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 CFR Part 807); labeling (21 CFR Part 801); 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. 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), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, Duna R. Lochner ( Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ ## Section 2 - Indications For Use Statement 510(k) Number (if known): K O6 2220 Device Name: The GuardDOG® Occlusion System ## Indications for Use: The GuardDOG Occlusion System is indicated for use in the peripheral vasculature to facilitate the localized infusion of therapeutic or diagnostic fluids, with or without vessel occlusion. The safety and effectiveness of this device have not been established in the coronary, cerebral, or carotid vasculature. Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Duna R. Vicker cm ision Sian-Off Division of Cardiovascular Devices 510(k) Number 40622 0 Possis Special 510k for the GuardDOG Occlusion System Page 6