EMBOL-X INTRA-AORTIC FILTER: EXTRA-SMALL, SMALL, MEDIUM, LARGE, EXTRA-LARGE

{0}------------------------------------------------ ## NOV 0 3 2003 ## 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS 1000 The following 510(k) Summary of Safety and Effectiveness information is provided in accordance with the requirements of 21 CFR §807.92 and SMDA 1990. | 510(k) Number: | K031946 | |----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Date Prepared: | OCTOBER 20 2003 | | Applicant: | Edwards Lifesciences LLC | | Address: | Research Medical Division, 6864 South 300 West, Midvale, UTAH<br>84047 | | Phone Number: | 801 565 6231 | | Fax Number: | 801 565 6177 | | Contact Person: | Karen Jones | | Trade Name: | EMBOL•X® Intra-Aortic Filter | | Common Name: | Arterial Line Blood Filter | | Classification Name: | Filter, Blood, Cardiopulmonary Bypass, Arterial Line; 21 CFR<br>§870.4260; Class II | | Device Description: | The EMBOL•X Intra-aortic Filter device consists of three primary<br>components: (1) a distal heparin-coated mesh filter, mounted onto a<br>flexible frame to form a filter basket for particulate emboli capture and<br>retention; (2) a locking cartridge housing for attachment to the EMBOL•X<br>Aortic Cannula side port, permitting access to the aorta and to ensure<br>correct orientation of the filter during use; and (3) a proximal syringe-like<br>plunger mechanism to deploy and withdraw the distal basket into and<br>from the aorta, via the cannula, during surgery. The filter is introduced<br>surgically into the aorta via the previously placed cannula, and particulates<br>are captured and removed as blood passes through the filter basket. The<br>filter may remain in situ for up to 60 minutes. The EMBOL•X Intra-aortic<br>Filter utilizes conventional medical grade materials and processes, and is | provided packaged, labeled, and sterile, intended for single-use. CONFIDENTIAL {1}------------------------------------------------ - The EMBOL-X Intra-aortic Filter is indicated for use with the EMBOL-X Intended Use: Aortic Cannula in first time, non-emergent cardiac surgery procedures to capture and remove particulate emboli from the ascending aorta and heart during and following cross clamp removal in patients aged 18 years and older. Substantial equivalence is derived from a composite of characteristics Predicate from multiple predicate devices and detailed in K022071. The EMBOL-Devices: X Intra-aortic Filter is substantially equivalent in intended use, clinical application, principle of operation, design and materials, sterility and biocompatibility, and performance to the EMBOL-X Aortic Filter (K022071), the Medtronic Percusurge Guardwire plus temporary occlusion and aspiration system (K003992) and/or the Edwards Lifesciences AF-1025D/AF-1040D DURAFLO (heparin treated) arterial blood filter (K820044). - The EMBOL-X Intra-aortic Filter has similar intended use, design intent, Technological principle of operation, materials, sterility and biocompatibility, accessory Characteristics: requirements, and labeling as that of the predicate devices. Any noted differences between the devices (specific indications for use, method of device delivery, specific physical dimensions and geometry) do not raise new types of safety or effectiveness questions, do not introduce new technological issues, and therefore do not impact the substantial equivalence of the EMBOL-X Intra-aortic Filter. - The results of biocompatibility, in-vitro (bench), and pre-clinical Non-Clinical Test (animal) tests from K022071 demonstrate that the EMBOL-X Intra-Results: aortic filter is sterile, biocompatible, meets established internal performance specifications, and satisfies the requirements of relevant external standards and applicable FDA guidance. - Data to support the expanded indications for the EMBOL-X Intra-aortic Summary of Clinical Filter were obtained from the post market European ICEM Registry of Studies: 1645 patients. Seventeen (17) centers in Europe enrolled patients in this prospective, consecutive enrollment registry. The European Registry patient population was compared to the Filter Arm of the US IDE Study through analyses of the Composite Safety endpoint as defined in the US IDE Study (K022071). {2}------------------------------------------------ The patient population of the Registry included the following patients: those undergoing combination CABG and valve surgery (14.9%); those who have had prior CABG or valve surgery (4.7%); those undergoing emergent cardiac surgery (1.5%); other cardiac surgery (eg. Myxoma excision. 2.7%) and patients less than 60 years (20.7%). In addition, there were a significant number European Registry patients who met the criteria for the US IDE Clinical Study or patients undergoing first time, non-emergent coronary artery bypass grafting (CABG), aortic valve replacement or mitral valve repair or replacement only, aged 60 years and older (51.9%). A total of 98.2% of the EMBOL-X® Aortic Filters used in the Registry captured one or more particulates. The composite safety endpoint was comparable between the IDE Eligible Registry patients and the Filter arm of the US IDE Study. There were no increases in the composite safety endpoint between the IDE Eligible Registry patients and the Non-IDE Eligible Registry patients which were combination CABG/Valve or re-operations. Patients undergoing emergent cardiac surgery had higher event rates and patients < 60 yrs had lower event rates, both are expected given the preoperative risk factors. Further adjustments for preoperative risk factors when compared to a published, validated univariate analyses of morbidity indicated that the observed odds ratio was less than the expected. Similarly, analyses of mortality and preoperative patient risk factors indicate that the observed mortality was comparable to the expected mortality rate seen in the European Registry patients. ## Conclusions Drawn From European Registry The results from the post market European Registry demonstrate that there are no safety issues when the EMBOL-X Intra-aortic Filter is used in a broader patient population in cardiac surgery. The use of the EMBOL-X Intra-aortic Filter does not pose any additional risk to the treated patient population when compared to the US IDE Clinical Study in K022071 and the clinical data from the European Registry demonstrate that the EMBOL-X Intra-aortic Filter is compatible with cardiac surgery procedures. It was therefore concluded that the EMBOL-X Intra-aortic Filter is safe and effective when used as indicated in the instructions for use. - Review of the clinical performance of the device in a post market Summary: European Registry provides valid clinical evidence and reasonable assurance that the EMBOL-X Intra-aortic Filter is safe and effective for its intended use in a larger cardiac surgery patient population, namely first time, non-emergent cardiac surgery procedures in patients aged 18 years and older. {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines above them. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 NOV 0 3 2003 Edwards Lifesciences, LLC. c/o Ms. Jean C. Chang Consultant to Edwards Lifesciences Embol-X, Inc. 6864 South 300 West Midvale, UT 84047 Re: K031946 EMBOL-X Intra-Aortic Filter Regulation Number: 21 CFR 870.4260 Regulation Name: Cardiopulmonary Bypass Arterial Line Blood Filter Regulatory Class: Class II (two) Product Code: 74 DTM Dated: October 21, 2003 Received: October 22, 2003 Dear Ms. Chang: 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. {4}------------------------------------------------ Page 2 - Ms. Jean C. Chang 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International 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, 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 STATEMENT 510(k) Number (if known): K031946 Device Name: EMBOL-X Intra-aortic Filter The EMBOL-X Intra-aortic Filter is indicated for use Indications For Use: with the EMBOL-X Aortic Cannula in first time, nonemergent cardiac surgery procedures to capture and remove particulate emboli from the ascending aorta and heart during and following cross clamp removal in patients aged 18 years and older. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Qian Wella Fordiovascular Devices KO31946 510(k) Number Prescription Use X OR (Per 21 CFR §801.109) Over-The-Counter Use CONFIDENTIAL CONFIDENTIAL CONFIDENTIAL