EDWARDS LIFESCIENCES RESEARCH MEDICAL PEDIATRIC VENOUS RETURN CANNULAE

{0}------------------------------------------------ JUN 2 2 2004 # 510(k) Summary | Submitter: | Edwards Lifesciences LLC<br>One Edwards Way<br>Irvine, California 92614 USA | |-------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact: | Jason Smith, Senior Regulatory Affairs Specialist<br>Phone: 949-250-2662<br>Fax: 949-250-3579<br>E-mail: jason_smith@edwards.com | | Date Prepared: | October 29, 2003 | | Trade Name: | Edwards Lifesciences Research Medical Inc. Pediatric<br>Venous Return Cannulae (abbreviated to ERMI Pediatric<br>Venous Return Cannulae) | | Common Name: | Cardiopulmonary Bypass Vascular Catheter, Cannula, or<br>Tubing (21 CFR 870.4210) | | Predicate<br>Devices: | Research Industries' Various Cardiovascular Devices | | | Research Medical, Inc. Fem-Flex Femoral Access<br>Cannulation Kit | | | Terumo L-Series 1968 Type Pediatric Venous Catheters | | Device<br>Description: | The ERMI Pediatric Venous Return Cannulae are used to<br>access the vena cavae or femoral vein during<br>cardiopulmonary bypass. | | Indications for<br>Use: | The Research Medical Dual Drainage Venous Return<br>Cannulae are indicated for venous cannulation so that<br>extracorporeal circulation of venous blood to a heart-lung<br>machine may be achieved for a duration ≤ 6 hours.<br>Venous Cannulae in sizes 6 Fr. to 18 Fr. can be used in<br>pediatric patient populations. | | | The Research Medical Duraflo Heparin Treated Dual<br>Drainage Venous Return Cannulae are indicated for<br>venous cannulation so that extracorporeal circulation of<br>venous blood to a heart-lung machine may be achieved for<br>a duration ≤ 6 hours. Venous Cannulae in sizes 6 Fr. to<br>18 Fr. can be used in pediatric patient populations.<br>Extracorporeal circuit components with a Duraflo<br>Treatment are indicated for use in cardiopulmonary | {1}------------------------------------------------ surgery when a heparin-treated blood path is desired. The Research Medical Venous Return Cannulae are intended for cannula drainage superior and inferior vena nnendod ing extracorporeal circulation for a duration for a duration for a duration for a hours. Venous Cannulae in sizes 6 Fr. to 18 Fr. can be used in pediatric patient populations. NOTE: The Research Medical 40 Fr. and 46 Fr. Venous Return Cannulae are also intended for use in single cannula return of the right atrium. The Research Medical Duraflo Heparin Treated Venous Return Cannulae are intended for cannula drainage superior and inferior vena cave during extracorporeal circulation for a duration ≤ 6 hours. Venous Cannulae in sizes 6 Fr. to 18 Fr. can be used in pediatric patient populations. NOTE: The Research Medical 40 Fr. and 46 Fr. Venous Return Cannulae are also intended for use in single cannula return of the right atrium. Extracorporeal circuit components with a Duraflo Treatment are indicated for use in cardiopulmonary surgery when a heparin-treated blood path is desired. The Research Medical FEM-FLEX Femoral Access Cannulae are intended for use in situations which require rapid femoral venous and arterial access for short term cardiopulmonary bypass. Venous and arterial access is left to the discretion of the physician for a duration ≤ 6 hours. Femoral Cannulae in sizes 6 Fr. to 14 Fr. can be used in pediatric patient populations. The Research Medical Duraflo Heparin Treated FEM-FLEX Femoral Access Cannulae are intended for use in situations which require rapid femoral venous and arterial access for short term cardiopulmonary bypass. Venous and arterial access is left to the discretion of the physician for a duration ≤ 6 hours. Femoral Cannulae in sizes 6 Fr. to 14 Fr. can be used in pediatric patient populations. Extracorporeal circuit components with a Duraflo Treatment are indicated for use in cardiopulmonary surgery when a heparin-treated blood path is desired. {2}------------------------------------------------ # KO33464 PG 3043 . | Comparative<br>Analysis: | The only difference between the subject catheters and the<br>predicate Research Medical catheters is the subject<br>catheters are smaller in diameter and length. Aside from<br>the smaller sizes, there is no difference between the ERMI<br>Pediatric Venous Return Cannulae and the predicate<br>devices. | |-------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Functional/Safety<br>Testing: | The ERMI Pediatric Venous Return Cannulae have<br>successfully undergone functional and biocompatibility<br>testing. | | Conclusion: | The ERMI Pediatric Venous Return Cannulae are<br>substantially equivalent to the predicate devices. | {3}------------------------------------------------ Public Health Service Image /page/3/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the seal is a stylized eagle with three lines representing its wings. JUN 2 2 2004 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Edwards Lifesciences LLC c/o Mr. Jason Smith Senior Regulatory Affairs Specialist One Edwards Way Irvine, CA 92614 Re: K033464 R055404 Duraflo® coated and uncoated Venous Return, Dual Drainage Venous Return, and FEM-FLEX Femoral Access Cannulae Regulation Number: 21 CFR 870.4210 Regulation Name: Cardiopulmonary Bypass Vascular Catheter, Cannula, and Tubing Regulatory Class: Class II (two) Product Code: DWF Dated: May 25, 2004 Received: May 26, 2004 Dear Mr. Smith: 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 for the barrant 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 r ou may, arontrols 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}------------------------------------------------ Page 2 - Mr. Jason Smith Please be advised that FDA's issuance of a substantial equivalence determination does not mean Frease oc advised that I Dri 3 issuants or our device complies with other requirements of the Act that IDA has made a dolorimiansis as as as as a ministered by other Federal agencies. You must or any it cach statutes and registments, including, but not limited to: registration and listing (21 Comply with an the 110 110 - 5 requirements (01); good manufacturing practice requirements as set CFR I at 607); and img (21 CFR Part 820); and if applicable, the electronic form in the quarty by overns (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provider as arketing your device as described in your Section 510(k) I his icher will anow you to ough finding of substantial equivalence of your device to a legally premarket notification: "The PDF intelling of easification 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 If you desire specific acrioliance at (301) 594-4646. Also, please note the regulation entitled, eonalor the Office of Centre to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely yours, Dina R. Vichner ( Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ ### Indications for Use ## 510(k) Number (if known): _K033464 # Device Name: Research Medical Venous Return, Dual Drainage Venous Return, Duraflo Heparin Treated Venous Return and FEM-FLEX Femoral Access Cannulae ### Indications For Use: - : For Use: The Research Medical Dual Drainage Venous Return Cannulae is indicated for venous of for a duretion l . I he Research Medical Dual Dramage Venous Retarn Balline may be achieved or a duration ≤ that extracorporeal circulation of venous blood to a heart-lung machine may that extraction of vehicles of vehous blood to a near thegative patient populations. - The Research Medical Duraflo Heparin Treated Dual Drainage Venous Return Cannulae is indicated for 2. I he Research Medical Durano Heparti Treated Bud of venous blood to a heart-lung may be and in adjatrio venous cannulation ≤6 hours. Venous Cannulac in sizes 6 Fr. to 18 Fr. can be used in pediatric achieved for a duration ≤ 0 nous. Venous Califation in views Treatment are indicated for use in parent populations. Bitharbirn a heparin-treated blood path is desired. - The Research Medical Venous Return Cannulac are intended for cannula drainage superior and inferior 3. I he Research Medical Venous Recurn Camination ≤ 6 hours. Venous Cannulae in sizes 6 Fr. to 18 Fr. can be used in pediatric patient populations. NOTE: The Research Medical 40 Fr. and 46 Fr. Venous Return Cannulae are also intended for use in single cannula return of the right atrium. - The Research Medical Duraflo Heparin Treated Venous Return Cannulae are intended for Cannula 4. I he Research Medical Duratio repair. Trucios extracorporeal circulation for a duration ≤ 6 hours. dramage superior and interior rena 8 Fr. can be used in pediatric patient populations. NOTE: The Research Medical 40 Fr. and 46 Fr. Venous Return Cannulae are also intended for use in NOTE: The Research Medical 4011: and 40 11: Volvou receit components with a Duraflo Treatment are single cannulu rount of the or monary surgery when a heparin-treated blood path is desired. - The Research Medical FEM-FLEX Femoral Access Cannulae are intended for use in situations which รา I he Research Medical I EM-I LEA I entrolate resease bart term cardiopulmonary bypass. Venous and require rapid remoral vonoda and antentation ≤ 6 hours. Femoral Cannulae in aires 6 Fr. to 14 Fr. can be used in pediatric patient populations. - The Research Medical Duraflo Heparin Treated FEM-FLEX Femoral Access Cannulae are intended for 6. The Research Medical i2arano reparts 1761 venous and arterial access for short term cardiopulmonary use in studions which require rapie seef to the discretion of the physician for a duration ≤ 6 hours. bygass. Venous and arterial access is lett to 14 Fr. can be used in pediatric patient populations. Extracorporeal Femoral Califialat in Sizes of F. I Freatment are indicated for use in cardiopulmonary surgery when a heparin-treated blood path is desired. Prescription Use X_____________________________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) AND/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) Page 1 of 1 - Dana D. Vachner (Division Sian-C Division of Cardiovascular Devices 510(k) Number K033464