COOK CELECT AND GUNTHER TULIP VENA CAVA FILTER SETS

{0}------------------------------------------------ K121053 Special 510(k): Device Modification Günther Tulip® Vena Cava Filter Sets and Cook Celect® Vena Cava Filter Sets Cook Medical - William Cook Europe ApS #### 510(k) Summary Date Prepared: Submitted By: 3 April 2012 William Cook Europe ApS Sandet 6, DK-4632 Biaeverskov, Denmark 0045 5686 8769 Camilla Wamberg Munkesoe 0045 5686 8769 0045 5686 8568 Camilla.Munkesoe(@Cookmedical.com Günther Tulip® Vena Cava Filter Set For Femoral Approach Günther Tulip® Vena Cava Filter Set For Femoral and Jugular Approach Cook Celect® Vena Cava Filter Set For Femoral Approach Cook Celect® Vena Cava Filter Set For Femoral and Jugular Approach Inferior Vena Cava Filter Cardiovascular Intravascular Filter (21 CFR 870.3375, Product Code DTK) Class II Indications for Use: #### Günther Tulip Vena Cava Filter The Günther Tulip Vena Cava Filter implant is intended for the prevention of recurrent pulmonary embolism (PE) via placement in the vena cava in the following situations: - Pulmonary thromboembolism when anticoagulant therapy is contraindicated; . - Failure of anticoagulant therapy in thromboembolic diseases; . - Emergency treatment following massive PE where anticipated benefits of . conventional therapy are reduced; and Contact: Phone: Fax: Email: Device: Trade Name: Common Name: Classification Name: Classification: MAY - 4 2012 12 {1}------------------------------------------------ - Chronic, recurrent PE where anticoagulant therapy has failed or is . contraindicated. The Gunther Tulip Vena Cava Filter implant may be retrieved. Please refer to the Instructions for Use provided with the Günther Tulip Vena Cava Filter Retrieval Set (not included in the filter set). The product is intended for percutaneous placement via a femoral vein for filtration of inferior vena cava (IVC) blood to prevent PE. # Cook Celect Vena Cava Filter The Cook Celect Filter implant is intended for the prevention of recurrent pulmonary embolism (PE) via placement in the vena cava in the following situations: - Pulmonary thromboembolism when anticoagulant therapy is contraindicated; . - Failure of anticoagulant therapy in thromboembolic diseases; . - Emergency treatment following massive PE where anticipated benefits of . conventional therapy are reduced; and - Chronic, recurrent PE where anticoagulant therapy has failed or is contraindicated. . The Cook Celect Filter implant may be retrieved. Please refer to the Instructions for Use provided with the Günther Tulip Vena Cava Filter Retrieval Set (not included in the filter set). The product is intended for percutaneous placement via a femoral vein for filtration of inferior vena cava (IVC) blood to prevent pulmonary embolism. ## Predicate Devices: The Günther Tulip Vena Cava Filter Sets are substantially equivalent to the predicate Günther Tulip Vena Cava Filter Sets (K090140). The Cook Celect Vena Cava Filter Sets are substantially equivalent to the predicate Cook Celect Vena Cava Filter Sets (K090140). Compared to the predicate devices, the Günther Tulip Vena Cava Filter Sets and Cook Celect Vena Cava Filter Sets have identical indications for use, the same fundamental technological characteristics, and similar materials of construction. {2}------------------------------------------------ # Device Description: ### Günther Tulip Vena Cava Filter Set The Günther Tulip Vena Cava Filter is an inferior vena cava filter intended for use in prevention of pulmonary embolism. The filter is intended for percutaneous placement via either the jugular vein or femoral vein for filtration of inferior vena cava (IVC) blood. The Günther Tulip Vena Cava Filter Set For Femoral Approach consists of a preloaded filter, a coaxial introducer sheath system, a hydrophilically coated predilator, and a threeway stopcock. The filter is introduced and placed via a 7.0 French coaxial introducer sheath system with a Check-Flo® valve. The filter introducer has a flexible tip. The introducer dilator is a 7.5 French injectable dilator with 8 sideports. The Günther Tulip Vena Cava Filter Set is also available in a universal vein access version consisting of components necessary for both femoral and jugular vein approaches. The femoral introducer in the Günther Tulip Vena Cava Filter Set For Femoral and Jugular Approach also has a flexible tip. The Günther Tulip Vena Cava Filter is constructed from conichrome. The filter is 50 mm long along its main axis when compressed to a diameter of 30 mm. # Cook Celect Vena Cava Filter Set The Cook Celect Vena Cava Filter is an inferior vena cava filter intended for use in prevention of pulmonary embolism. The filter is intended for percutaneous placement via either the jugular vein or femoral vein for filtration of inferior vena cava (IVC) blood. The Cook Celect Vena Cava Filter Set For Femoral Approach consists of a preloaded filter, a coaxial introducer sheath system, a hydrophilically coated predilator, and a threeway stopcock. The filter is introduced and placed via a 7.0 French coaxial introducer sheath system with a Check-Flo valye. The filter introducer has a flexible tip. The introducer dilator is a 7.5 French injectable dilator with 8 sideports. The Cook Celect Vena Cava Filter Set is also available in a universal vein access version consisting of components for both femoral and jugular vein approaches. The femoral introducer in the proposed Cook Celect Vena Cava Filter Set For Femoral and Jugular Approach also has a flexible tip. The Cook Celect Vena Cava Filter is constructed from conichrome. The filter is 48 mm long along its main axis when compressed to a diameter of 30 mm. {3}------------------------------------------------ # Technological Characteristics: The Günther Tulip and Cook Celect Vena Cava Filter Sets For Femoral Approach have the same intended use, the same fundamental technological characteristics, and similar materials of construction as the predicate filter sets. The Günther Tulip Vena Cava Filter implant and the Cook Celect Vena Cava Filter implant are physically identical to the predicate devices. The jugular introducer of the filter sets is physically identical to the predicate devices. The tip of the femoral introducer of the filter sets has been modified to enhance trackability through the venous anatomy. # Non-clincial Performance Data: The Gunther Tulip and Cook Celect Vena Cava Filter Sets were subjected to the following tests to assure reliable design and performance under the specified testing parameters. - Deployment Testing . - Trackability Testing ● - Tensile Testing . . - Biocompatibility Testing . The results of these tests provide reasonable assurance that the devices have been designed and tested to assure conformance to the requirements for their intended use. {4}------------------------------------------------ # DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized eagle emblem, depicted with bold, black lines. The eagle's head is facing to the right, and its wings are suggested by curved lines. #### Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 William Cook Europe ApS C/O Ms. Jennifer Brown MED Institute Inc. 1 Geddes Way West Lafayette, IN 47906 MAY - 4 2012 Re: K121057 Trade/Device Name: Günther Tulip® and Cook Celect® Vena Cava Filter Sets Regulation Number: 21 CFR 870.3375 Regulation Name: Cardiovascular Intravascular Filter Regulatory Class: Class II Product Code: DTK Dated: April 4, 2012 Received: April 6, 2012 Dear Ms. Brown: 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 ideications 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, Drio, 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, include of devices, good manufacturing practice, labeling, and prohibitions against misbanding and adulteration. Please note: CDRH does not evaluate information related to contractly and warranties. We remind you, however, that device labeling must be truthful and not micher you If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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. 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 {5}------------------------------------------------ ## Page 2 - Ms. Jennifer Brown CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHQffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. 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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Sincerely yours, M. G. Hillebert / Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {6}------------------------------------------------ # Indications for Use 510(k) Number (if known): K121057 Device Name: Günther Tulip® Vena Cava Filter Set For Femoral Approach Günther Tulip® Vena Cava Filter Set For Femoral and Jugular Approach Cook Celect® Vena Cava Filter Set For Femoral Approach Cook Celect® Vena Cava Filter Set For Femoral and Jugular Approach ## The following Indications for Use statements are identical to the predicate devices. Indications for Use for the Günther Tulip® Vena Cava Filter: The Günther Tulip Vena Cava Filter implant is intended for the prevention of recurrent pulmonary embolism (PE) via placement in the vena cava in the following situations: - Pulmonary thromboembolism when anticoagulant therapy is contraindicated; ● - Failure of anticoagulant therapy in thromboembolic diseases; . - Emergency treatment following massive PE where anticipated benefits of conventional therapy are reduced; and - Chronic, recurrent PE where anticoagulant therapy has failed or is contraindicated. ● The Günther Tulip Vena Cava Filter implant may be retrieved. Please refer to the Instructions for Use provided with the Günther Tulip Vena Cava Filter Retrieval Set (not included in the filter set). The product is intended for percutaneous placement via a femoral vein for filtration of inferior vena cava (IVC) blood to prevent PE. Indications for Use for the Cook Celect® Vena Cava Filter: The Cook Celect Filter implant is intended for the prevention of recurrent pulmonary embolism (PE) via placement in the vena cava in the following situations: - Pulmonary thromboembolism when anticoagulant therapy is contraindicated; . - Failure of anticoagulant therapy in thromboembolic diseases; . - Emergency treatment following massive PE where anticipated benefits of . conventional therapy are reduced; and - Chronic, recurrent PE where anticoagulant therapy has failed or is contraindicated. . 9 {7}------------------------------------------------ The Cook Celect Filter implant may be retrieved. Please refer to the Instructions for Use provided with the Günther Tulip Vena Cava Filter Retrieval Set (not included in the filter set). The product is intended for percutaneous placement via a femoral vein for filtration of inferior vena cava (IVC) blood to prevent pulmonary embolism. XX Prescription Use (Part 21 CFR 801 Subpart D) OR Over-the-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) M.A. Killehen (Division Sign-Off) Division of Cardiovascular Devices 510(k) Number_K 11-1057