EDWARDS LIFESCIENCES INTRACLUDE INTRA-AORTIC CATHETER

{0}------------------------------------------------ K132175 | 510(k) Summary | | | |----------------------|-------------------------------------------------------------------------------------------------------------|--------------| | Submitter: | Edwards Lifesciences LLC | | | Contact Person: | Luke Meidell, Regulatory Affairs Associate II<br>12050 Lone Peak Pkwy<br>Draper, UT 84020<br>(801) 565-6212 | SEP 1 3 2013 | | Date Prepared: | September 12, 2013 | | | Trade Name: | Edwards Lifesciences® IntraClude™ Intra-Aortic Occlusion<br>Device | | | Classification Name: | Vascular Clamp<br>21 CFR Part 870.4450, Product Code DXC, Class II | | | Predicate Device: | K113182: IntraClude™ Intra-Aortic Occlusion Device | | ### Device Description: The IntraClude Intra-Aortic Occlusion Device is a 10.5 Fr (3.5 mm), triple-lumen, 100cm-long catheter with an elastomeric balloon near its distal tip designed to occlude the ascending aorta in order to partition the aortic root from arterial circulation during cardiopulmonary bypass (CPB). The balloon expands to occlude a range of aorta sizes from 20 to 40 mm. This device is designed to be used in the femoral approach with the Edwards arterial cannula/introducer sheath. The shaft is provided with an extended strain relief, which tapers from 10.5 Fr to the remaining 9 Fr catheter, and is designed to prevent kinking and to avoid compressing the shaft when the hemostasis valve of an arterial cannula/introducer sheath is firmly closed around the catheter body. The large central lumen of the IntraClude catheter serves three functions: accommodating the guidewire, delivering cardioplegia solution to the aortic root, and venting fluid and air from the aortic root. The two remaining lumens serve as conduits for balloon inflation/deflation and aortic root pressure monitoring. The hub has two flexible extension tubes with an integrated luer connection to provide access for accessories. The shaft is provided with markers to indicate the insertion depth. A blue Clamp-Lock device, provided on the extended strain relief portion, allows the IntraClude catheter to be locked in position to prevent balloon migration during aortic occlusion. For situations {1}------------------------------------------------ Edwards Lifesciences LLC Traditional 510(k) Premarket Notification IntraClude Intra-Aortic Occlusion Device where the 9 Fr section of the device is outside of the arterial cannula or introducer sheath, a white suture loop/box clamp is provided for locking the catheter in position. The IntraClude catheter is packaged sterile and non-pyrogenic and is for single use only. ### Indications For Use: The IntraClude Intra-Aortic Occlusion Catheter is indicated for use in patients undergoing cardiopulmonary bypass. The IntraClude Intra-Aortic Occlusion Catheter occludes and vents the ascending aorta when the balloon is inflated. The device's central lumen allows delivery of cardioplegia to arrest the heart. The pressure lumen allows monitoring of the aortic root pressure. ### Comparative Analysis: The subject device has the same intended use and technological characteristics (i.e., design, material, chemical composition) as the predicate device. It has been demonstrated that the subject IntraClude device is comparable to the predicate device in fundamental scientific technology, material types, principles of operation, and functional performance evaluations. No new issues of safety or efficacy have been raised as a result of the design modifications. ### Functional/Safety Testing: The following functional and accelerated aging bench testing was performed. All data met acceptance criteria. - Biocompatibility cytotoxicity and pyrogenicity Per ISO 10993-1 for External . communicating device, direct circulating blood path, duration ≤ 24 hours. - Tensile testing device hub to shaft Confirmation of the bond strength of the . catheter, lumens, and connected accessories. - Kink testing axial kink force, kink test under tension, hub kink test -. Confirmation of kink resistance of the catheter, lumens, and connected accessories. - Dimensional testing -- Analysis of shaft outer diameter, distal curve, and marking . distance. - · Clamp lock testing Confirmation that the clamp lock functions with the catheter shaft. - Design Validation Design was validated through bench top in-vitro studies. . {2}------------------------------------------------ # Conclusion: The IntraClude Intra-Aortic Occlusion Device is substantially equivalent to the cited predicate device. Additionally, the IntraClude device met all acceptance criteria to confirm safety and efficacy. {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle with three tails, positioned to the right of a circular emblem. The circular emblem contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter of the circle. ### DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 September 13, 2013 Edwards Lifesciences, LLC Mr. Luke Meidell Regulatory Affairs Associate II 12050 Lone Peak Pkwy Draper, UT 84020 Re: K132175 Trade/Device Name: Edwards Lifesciences ® IntraClude™ Intra-Aortic Occlusion Catheter Regulation Number: 21 CFR 870.4450 Regulation Name: Vascular Clamp Regulatory Class: Class II Product Code: DXC Dated: July 12, 2013 Received: July 15, 2013 Dear Mr. Meidell: We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed four beether wind the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for asc stated in the enorosals) to regardent date of the Medical Device Amendments, or to continered provide that 20, 1978 the 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 The general controls provisions ac the labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability additeration. Picase note: CDNT abos hat orains labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA). If your device is classified (see above) major regulations affecting your device can be If may be subject to additional controls. 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 mall DA has made a decembiations administered by other Federal agencies. You must of any I ederal statutes and regariments. including, but not limited to: registration and listing (21 CFR Part 807); labeling (2) CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803): good manufacturing practice requirements as set {4}------------------------------------------------ Page 2 - Mr. Meidell 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resources/or You/Industry/default.htm. 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/ReportalProblem/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.ida.goy/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours. M.A. Lilleheimer for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ # Statement of Indications for Use ## Indications for Use 510(k) Number (if known): K 132175 Edwards Lifesciences IntraClude Intra-Aortic Occlusion Catheter Device Name: The IntraClude Intra-Aortic Occlusion Catheter is Indicated for use in patients undergoing cardiopulmonary bypass. The IntraClude Intra-Aortic Occlusion Catheter occludes and vents the ascending aorta when the balloon is inflated. The device's central lumen allows delivery of cardioplegia to arrest the heart. The pressure lumen allows monitoring of the aortic root pressure. Prescription Use × (Per 21 CFR 801.109) OR Over-The-Counter Use_ (PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office Of Device Evaluation (ODE) ______________________________________________________________________________________________________________________________________________________________________________ M.A. Willemsen Page B-2