VENOUS DRAINAGE CANNULA WITH DURAFLO COATING

{0}------------------------------------------------ ﺔ، ﺗ K120072 | 510(k) Summary | | | | |----------------------|-------------------------------------------------------------------------|--------------|--| | Submitter: | Edwards Lifesciences LLC | MAY - 8 2012 | | | Contact Person: | Karen Jones, Senior Manager, Regulatory Affairs<br>12050 Lone Peak Pkwy | | | | | Draper, UT 84020 | | | | | (801) 565-6231 | | | | Date Prepared: | January 9, 2012 | | | | Trade Name: | Edwards Lifesciences® Venous Drainage Cannulae | | | | Classification Name: | Catheter, Cannula and Tubing, Vascular, Cardiopulmonary<br>Bypass | | | | | 21 CFR Part 870.4210, Product Code DWF, Class II | | | | Predicate Device: | K831769 - Venous Cannulae | | | | | K033464 - Pediatric Venous Cannulae | | | | | K092509 - Venous Cannulae | | | # Device Description: . Edwards Lifesciences venous return cannulae are soft cannulae with encapsulated steel wire reinforcement. Venous return cannulae are offered with various tip styles, hole patterns, French sizes, lengths, straight or angled tubing, and two sizes of connectors. Some styles are offered with obturators. The exterior and inner-luminal cannula surfaces of product codes containing a "D" or "DII" are coated with Duraflo heparin. When used on devices for cardiopulmonary surgery, the Duraflo coating improves the blood compatibility of non-biological surfaces in the extracorporeal circuit. Each Edwards Lifesciences device is packaged sterile and non-pyrogenic in a sealed, peel-type pouch. PROPRIETARY DATA: This document and the information contained herein may not be reproduced, used, or disclosed without written permission from Edwards Lifesciences, LLC. {1}------------------------------------------------ ### Indications for Use: ## Single Stage Venous Cannulae: Venous return cannulae are intended for cannula drainage from the right atrium or superior and inferior vena cava during extracorporeal circulation for a duration of ≤6 hours. Venous cannulae may be used in pediatric populations or adult populations based on flow rate requirements and patient anatomy. Please see labeling for maximum flow rate information. Extracorporeal circuit components with a Duraflo coating are intended for use in cardiopulmonary surgery when a heparin coated blood path is desired. ### Dual Stage Venous Cannulae: Dual drainage venous return cannulae are indicated for venous cannulation so that extracorporeal circulation of the venous blood to a heart-lung machine may be achieved, for a duration of ≤6 hours. Venous cannulae may be used in pediatric populations or adult populations based on flow rate requirements and patient anatomy. Please see labeling for maximum flow rate information. Extracorporeal circuit components with a Duraflo coating are intended for use in cardiopulmonary surgery when a heparin coated blood path is desired. # Comparative Analysis: The subject devices with revised Indications for Use statements have the same technological characteristics (i.e., design, material, chemical composition, energy source) as the predicate devices. It has been demonstrated that the subject Venous Drainage Cannulae are comparable to the predicate devices in fundamental scientific technology, material types, principles of operation, and functional performance evaluations. No new issues of safety or efficacy have been raised.Conclusion: The Venous Drainage Cannulae are substantially equivalent to the cited predicate devices. PROPRIETARY DATA: This document and the information contained herein may not be reproduced, used, or disclosed without written permission from Edwards Lifesciences, LLC. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three stripes forming its wings and tail. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA", which is arranged in a circular fashion around the left side of the logo. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 MAY - 8 2012 Edwards Lifesciences, LLC. c/o Ms. Karen Jones Sr. Principal Project Manager, Regulatory Affairs 12050 Lone Peak Parkway Draper, UT 84020 Re: K120072 Venous Drainage Cannulae Regulation Number: 21 CFR 870.4210 Regulation Name: Vascular Catheter, Cannula or Tubing . Regulatory Class: Class II Product Code: DWF Dated: March 26, 2012 Received: March 27, 2012 Dear Ms. Jones: We have reviewed your Section 510(k) premarket notification of intent to market the device we nave rowed your be your be device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreativent of the enactment date of the Medical Device Amendments, or to conimeres proc to they 20, 1976, 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 Costictle rice (110-) that the device, subject to the general controls provisions of the Act. The I ou may, merciolo, manel the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability adulteration. Trease noter 1920wever, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (boo acove) 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 lound in the Oode of reactal resgoncerning your device in the Federal Register. {3}------------------------------------------------ # Page 2 - Ms. Karen Jones Enclosure Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualled of a baceaanse of the ther requirements of the Act that FDA has made a decernmanon may Jour stered by other Federal agencies. You must or any Federal statutes and regulations admissions and limited to: registration and listing (21 comply with an the Act 3 requirements, and 801); medical device reporting (reporting of medical CFK Fall 807); abomig (21 OFR 803); good manufacturing practice requirements as set device-related adverse events) (21 OF R 805), good if applicable, the electronic forth in the quality systems (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 If you desire specific advice for your devices/CDRHOffices/ucm115809.htm for go to mip://www.lua.gov/AboundBArcellers/CDRH's) Office of Compliance. Also, please the Center for Devices and Radiological Health's (CDRH's) Office of Compliance (CDRH) Bet the Center for Devices and Radioneground ing by reference to premarket notification" (21CFR Part note the regulation entitied, "Misolunaning of televerse events under the MDR regulation (21 CFR Part 803), please go to CFK Part 803), prease go to illtp://www.rua.governman.government of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the You may obtain only general mormations one J ... 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 (800) 036-2041 01 (301) 770 710-510-510-510-510-11-2017 11:11:11 Sincerely yours, Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health {4}------------------------------------------------ # Statement of Indications for Use # 510(k) Number (if known): としこ○○7L Edwards Lifesciences® Single Stage Venous Cannulae Device Name: Edwards Lifesciences® Dual Stage Venous Cannulae #### Indications for Use: ### Single Stage Venous Cannulae: Venous return cannulae are intended for cannula drainage from the right atrium or superior and inferior vena cava during extracorporeal circulation for a duration of ≤6 hours. Venous cannulae may be used in pediatric populations or adult populations based on flow rate requirements and patient anatomy. Please see labeling for maximum flow rate information. Extracorporeal circuit components with a Duraflo coating are intended for use in cardiopulmonary surgery when a heparin coated blood path is desired. #### Dual Stage Venous Cannulae: Dual drainage venous return cannulae are indicated for venous cannulation so that extracorporeal circulation of the venous blood to a heart-lung machine may be achieved, for a duration of ≤6 hours. Venous cannulae may be used in pediatric populations or adult populations based on flow rate requirements and patient anatomy. Please see labeling for maximum flow rate information. Extracorporeal circuit components with a Duraflo coating are intended for use in cardiopulmonary surgery when a heparin coated blood path is desired. 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) | |--------------------------------------------------------| |--------------------------------------------------------| (Division Sign Off) PROPRIETARY DATA: This document and the information contained herein may not be reproduced, used, or disclosed to Edwards Lifesciences, LLC. | 510(k) Number | K120072 | |---------------|---------| |---------------|---------| Page 42