ATTAIN 6227DEF DEFLECTABLE CATHETER DELIVERY SYSTEM

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the Medtronic logo. The logo consists of a circular graphic on the left and the word "Medtronic" in bold, sans-serif font on the right. The graphic appears to depict three figures in motion within the circle. Image /page/0/Picture/1 description: The image shows the text "K061480" in a handwritten style, with the date "AUG 21 2006" printed below it. The text is in black ink and appears to be scanned or photographed. The date is printed in a simple, sans-serif font, while the handwritten text has a more stylized appearance. # 510(k) SUMMARY OF SUBSTANTIAL EQUIVALENCE | Date Prepared: | May 26, 2006 | |---------------------------|-------------------------------------------------------------------------------------------------------------------------------| | Applicant: | Medtronic Ireland<br>Parkmore Business Park West<br>Galway<br>Ireland | | Submission Correspondent: | Michelle Nivala<br>Regulatory Affairs Specialist<br>Medtronic, Inc.<br>1015 Gramsie Road<br>Shoreview<br>MN 55126-3082<br>USA | | Telephone: | (763) 505 7863 | | Fax: | (763) 505 7877 | | E-Mail | michelle.d.nivala@medtronic.com | | Proprietary Name: | Attain® 6227DEF Deflectable Catheter<br>Delivery System | | Common Name: | Catheter, Percutaneous | | Device Classification: | Class II, 21 CFR 870.1250 | | Product Code: | DOY | #### Device Description The Attain® 6227DEF Deflectable Catheter Delivery System contains 1 deflectable catheter, 1 deflectable catheter dilator, 1 universal slitter, 1 valve, 1 guidewire, 1 needle and 1 syringe. The Attain® 6227DEF Deflectable Catheter Delivery System is designed to access the coronary sinus and the chambers of the heart using the percutaneous needle and syringe to access the venous insertion site, the guidewire to access the vein the introducer valve to reduce blood loss during the implant procedure, the deflectable catheter to introduce a transvenous device, the deflectable catheter dilator to facilitate {1}------------------------------------------------ Image /page/1/Picture/0 description: The image shows the Medtronic logo. The logo consists of a circular graphic on the left and the word "Medtronic" in bold, sans-serif font on the right. The graphic features three stylized human figures arranged in a circular pattern. deflectable catheter passage and the guide catheter slitter to remove the deflectable catheter. # Indications for Use The deflectable catheter delivery system is indicated to provide a pathway though which diagnostic and therapeutic transvenous devices are introduced within the chambers and coronary vasculature of the heart, and for introducing balloon catheters into the coronary sinus or leads into vessels of the left heart via the coronary sinus. ## Substantially Equivalent Devices: The Attain® 6227DEF Deflectable Catheter Delivery System uses similar technology and has similar intended uses, function, materials and method of operation to the following predicate device: - Medtronic Attain 6226DEF Deflectable Catheter Delivery System (510(k) . #032312, cleared November 3, 2003) ## Summary of Studies: Device integrity testing was performed to support the equivalency of the Attain® 6227DEF Deflectable Catheter Delivery System to the predicate devices. Testing included mechanical and functional testing. The Attain® 6227DEF Deflectable Catheter Delivery System met all specified design and performance requirements. ## Biocompatibility Information The biocompatibility evaluation which has been completed for the Attain® 6227DEF Deflectable Catheter Delivery System verifies that the Attain® 6227DEF Deflectable Catheter Delivery System is biocompatible. The testing which supports the biocompatibility of the Attain® 6227DEF Deflectable Catheter Delivery System is consistent with International Standard ISO 10993-1:, "Biological Evaluation of Medical devices- Part 1: Evaluation and Testing." When classified according to this standard, the catheter and dilator included in the Attain® 6227DEF Deflectable Catheter Delivery System are external communicating devices with limited exposure (<24 hours) to circulating blood. #### Sterilization Validation The Attain® 6227DEF Deflectable Catheter Delivery System will be sterilized using a validated Ethylene Oxide (EtO) sterilization process. #### Conclusion Through the data and information presented, Medtronic Ireland considers the Attain® 6227DEF Deflectable Catheter Delivery System to be substantially equivalent to legally marketed predicate devices. {2}------------------------------------------------ Image /page/2/Picture/11 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features a stylized eagle with three lines forming its body and wings. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA", which is arranged in a circular pattern around the eagle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 AUG 2 1 2006 Medtronic Ireland c/o Ms. Clare Higgins Regulatory Affairs Specialist 1015 Gramsie Road Shoreview, MN 55126 Re: K061480 Attain 6227DEF Deflectable Catheter Delivery System Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II (Two) Product Code: DQY Dated: August 11, 2006 Received: August 14, 2006 #### Dear Ms. Higgins: 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). 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 (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. {3}------------------------------------------------ Page 2 - Ms. Clare Higgins 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 or any Federal 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 vours. Mezayler Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ # INDICATIONS FOR USE 510(k) Number (if known): KO6 l 4 BO Device Name: Attain® 6227DEF Deflectable Catheter Delivery System Indications For Use: The deflectable catheter delivery system is indicated to provide a pathway though which diagnostic and therapeutic transvenous devices are introduced within the chambers and coronary vasculature of the heart, and for introducing balloon catheters into the coronary sinus or leads into vessels of the left heart via the coronary sinus. Prescription Use (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 IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Me May Division of Cardiovascular Devices 510(k) Number K061480