CARDICA C-PORT XA PLUS DISTAL ANASTOMOSIS SYSTEM, MODEL FG-000100

{0}------------------------------------------------ ## K101018 F. 510(k) Summary System Special 510{k) Premarket Notification Cardica C-Port® xA Hybrid PLUS Distal Anastomosis April 9, 2010 #### JUN 2 5 2010 #### F. 510(k) Summary | 510(k) Number | | | |-----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------| | Date Prepared | April 9, 2010 | | | Applicant<br>Information | Cardica, Inc.<br>900 Saginaw<br>Redwood City, California 94063<br>Main: 650-364-9975<br>Fax: 650-331-7195 | | | Contact Person | Matthew E. Chroust, Director of QA/RA<br>Office: 650-331-7152<br>Fax: 650-331-7195<br>e-mail: chroust@cardica.com | | | Establishment<br>Registration Number | 3004114958 | | | Device Information | Classification Name:<br>Regulation Number:<br>Trade Name:<br>Common Name: | Clip, Implantable<br>21 CFR §878.4300<br>Cardica® C-Port® xA PLUS Distal<br>Anastomosis System<br>Cardiovascular Surgical Instruments | | Legally Marketed<br>Predicate Device(s) | Cardica® C-Port® xA PLUS Distal Anastomosis System<br>(K090872) April 21, 2009 | | | Labeling and<br>Intended Use | The subject Cardica® C-Port® xA PLUS Distal Anastomosis<br>System is intended for the creation of anastomoses in blood<br>vessels and grafts, including use in coronary artery bypass<br>grafting procedures. This is the same intended use as<br>previously cleared for the predicate C-Port® xA PLUS Distal<br>Anastomosis System (K090872). | | | | Draft Instructions for Use can be found in Section E, Labeling,<br>of this submission. A redline showing the differences is also<br>provided for reference.<br>The Indications for Use statement can be found in Section H,<br>Indications for Use.<br>There is no change to the Product Label. | | | Device Description | The Cardica® C-Port® xA Plus Distal Anastomosis System<br>delivers a series of clips that create an anastomosis between a<br>small target vessel (e.g. coronary artery) and conduit (e.g.<br>saphenous vein graft). An array of metal clips creates a<br>complete, end-to-side anastomosis that is functionally<br>equivalent to a hand-sutured interrupted stitch anastomosis.<br>The system consists of one Anastomosis Device and one<br>Retractor Mount | | | Indications for Use | The C-Port® xA Hybrid Plus Anastomosis System is is intended<br>for use in the creation of anastomoses in blood vessels and<br>grafts, including use in coronary artery bypass grafting<br>procedures. The change in materials described above do not<br>impact the Indications for Use, therefore no changes will be<br>made to this labeling. | | ### C-Port xA Hybrid Distal Anastomosis System {1}------------------------------------------------ K101018 F. 510(k) Summary System Special 510(k) Premarket Notification Cardica C-Port® xA Hybrid PLUS Distal Anastomosis April 9, 2010 . . {2}------------------------------------------------ # KI01018 Cardica C-Port® xA Hybrid PLUS Distal Anastomosis April 9, 2010 | Comparison to<br>Predicate Device | The subject Cardica® C-Port® xA Plus Distal Anastomosis<br>System, is substantially equivalent to the predicate Cardica® C-<br>Port® xA PLUS Distal Anastomosis System, which was cleared<br>by FDA on April 21, 2009 (K090872) | |---------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 1. | Like its predicate device, the subject C-Port® xA Plus<br>Distal Anastomosis System, is a sterile, single-use<br>device for creation of a reliably patent end-to-side<br>anastomosis between a conduit (graft vessel) and target<br>vessel. | | 2. | Both products consist of sub-assemblies for stabilizing<br>and positioning the conduit for grafting and for creating<br>the anastomosis by deployment of an array of metal<br>clips. | | 3. | Once the graft vessel has been loaded onto the device<br>and the device positioned against the target vessel, the<br>anastomosis between the graft and target vessel is<br>completed by pushing the actuation button. | | | Modifications improving the reliability, manufacturability and<br>appearance of the predicate device included the following: | | 1. | Knife Component material changes from Stainless Steel<br>to Nitinol for durability; | | 2. | Heel Clip Component material changes from Stainless<br>Steel to Titanium To reduce the force required to clamp. | | 3. | Cartridge Housing Component material changes with<br>the addition of pink and blue colorant for aesthetics; | | 4. | A Cardica logo graphic is added to the Activation Knob<br>Component via pad printing for better market<br>recognition, and the material of the the Activation Knob<br>Component changes from glass-filled polycarbonate to<br>glass-filled nylon for durability. | | 5. | The Anvil Base Component material changes from<br>machined type 416 Stainless steel to metal-injection<br>molded (MIM) 17-4 Stainless steel to improve<br>manufacturability. Adding Dicronite, a dry lubricant to<br>the Anvil Base Component's cable channels reduces<br>friction in the cable system. | | 6. | Anvil Hinge Component material is changed, adding<br>carbon filling to the Victrex PEEK material for increased<br>dimensional stability. | | Device Testing<br>Results and<br>Conclusion | All the aforementioned modifications have been rigorously<br>verified and validated using Cardica's Design Control process<br>(Cardica procedures WD-0400 and 0401):<br><br>A Design Change Impact Analysis identified the system level<br>ramifications of changes to materials and provided guidance<br>and rationale for the selection of appropriate component and<br>system level qualifications. A battery of tests and evaluations<br>was performed to assess the impact of the component material<br>changes identified above to ensure that these modifications do<br>not alter the validity of <i>in vitro</i> and <i>in vivo</i> testing and other<br>design validation activities previously performed on the<br>predicate Cardica® C-Port® xA PLUS Distal Anastomosis<br>System and its packaging to ensure substantial equivalence to<br>the predicate device, and to ensure the safety and<br>effectiveness of the device.<br><br>Risk Management File review and Clinical Risk Benefit<br>Analysis were conducted to ensure the continued safety and<br>efficacy of the device. A detailed description of these changes<br>is available in Section D, Summary of Design Controls. | | Technological | See Device Description above | | Characteristics | | | Substantial<br>Equivalence<br>Summary | Both the subject Cardica® C-Port® xA PLUS Distal<br>Anastomosis System and its predicate have the same<br>Indications for Use and the same technological characteristics<br>as the predicate device C-Port xA PLUS (K090872). This<br>premarket notification has described the characteristics of the<br>modified device in sufficient detail to assure substantial<br>equivalence. | | | The subject C-Port® xA PLUS Distal Anastomosis System has<br>the following similarities to those previously described and<br>cleared for the predicate device:<br><br>1. same indicated use,<br>2. same operating principle,<br>3. same basic device design and size,<br>4. same materials (with the exception of those changes<br>identified above),<br>5. same manufacturing processes,<br>6. same packaging and sterilization materials,<br>7. Instructions for Use are essentially identical, with the only<br>changes being the model name and the clarification in the<br>System Description of the Clip array construction being<br>Stainless Steel and Nitinol in the Subject C-Port xA PLUS,<br>where they had been Stainless Steel in the predicate. | | Conclusions | In summary, the subject C-Port® xA PLUS Distal Anastomosis<br>System described in this submission is substantially equivalent<br>to the predicate device. This Special 510(k) for Device<br>Modification submission has demonstrated Substantial<br>Equivalence as defined and understood in the Federal Food<br>Drug and Cosmetic Act and various guidance documents. | CARDICA, INC. CONFIDENTIAL & PROPRIETARY . Pg. 3 of 6 {3}------------------------------------------------ · . F. 510(k) Summary System Special 510(k) Premarket Notification · Cardica C-Port® xA Hybrid PLUS Distal Anastomosis April 9, 2010 CARDICA, INC. CONFIDENTIAL & PROPRIETARY Pg. 4 of 6 {4}------------------------------------------------ Cardica C-Port® xA Hybrid PLUS Distal Anastomosis April 9, 2010 CARDICA, INC. CONFIDENTIAL & PROPRIETARY . . {5}------------------------------------------------ : 100000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000 : . Cardica C-Port® xA Hybrid PLUS Distal Anastomosis . : April 9, 2010 . : and the same of the same . : , | issued by the Center for Devices and Radiological Health. | |-----------------------------------------------------------| |-----------------------------------------------------------| and the control control control controlled in the consideration : . : : . CARDICA, INC. CONFIDENTIAL & PROPRIETARY . : . {6}------------------------------------------------ Image /page/6/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 body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -W066-G609 Silver Spring, MD 20993-0002 JUN 2 5 2010 Cardica, Inc. c/o Mr. Matthew E. Chroust Director, Quality & Regulatory Affairs 900 Saginaw Drive Redwood City, CA 94063 Re: K101018 Trade/Device Name: Cardica® xA™ PLUS Distal Anastomosis System Regulation Number: 21 CFR 878.4300 Regulation Name: Clip, Implantable and Delivery System Regulatory Class: Class II Product Code: FZP Dated: May 27, 2010 Received: May 28, 2010 Dear Mr. Chroust: 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, 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 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. {7}------------------------------------------------ Page 2 - Mr. Matthew E. Chroust Please be advised that FDA's issuance of a substantial equivalence determination does not mean I Toase of action that I Drimination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must corply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical Of ice rated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (2) CFR Part 820); and if applicable, the electronic forth in the quarted 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 n you attp://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/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 note the 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 I ou may 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, Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {8}------------------------------------------------ Cardica C-Port® xA PLUS Distal Anastomosis System April 9, 2010 ## Indications for Use Statement | 510(k) Number:<br>(if known) | | |------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Name: | Cardica® C-Port® xA Plus Distal Anastomosis System | | Indications for Use: | The Cardica® C-Port® xA Plus Distal Anastomosis System is intended for the creation of anastomoses in blood vessels and grafts, including use in coronary artery bypass grafting procedures. | Prescription Use × (Part 21 CFR§801.109) . Over-The-Counter Use OR (Optional Format 1-2-96) . (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) . · Concurrence of CDRH, Office of Device Evaluation (ODE) | (Division/Sign-Off) | |---------------------| |---------------------| CARDICA, INC. CONFIDENTIAL & PROPRIETDivision of Cardiovascular Devices | 510(k) Number | K161018 Pg. 1 of 1 | |---------------|--------------------| |---------------|--------------------|