ProtekDuo Mini Veno-Venous Cannula Set

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May 25, 2018 CardiacAssist Inc Greg Johnson VP, Regulatory Affairs and Quality Assurance 240 Alpha Drive Pittsburg, Pennsylvania 15238 Re: K181150 Trade/Device Name: ProtekDuo Mini Veno-Venous Cannula Set Regulation Number: 21 CFR 870.4210 Regulation Name: Cardiopulmonary Bypass Vascular Catheter, Cannula, Or Tubing Regulatory Class: Class II Product Code: DWF Dated: April 30, 2018 Received: May 1, 2018 Dear Greg Johnson: 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. 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); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); {1}------------------------------------------------ and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, ### Nicole G. Ibrahim -S for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ | DEPARTMENT OF HEALTH AND HUMAN SERVICES<br>Food and Drug Administration | | |-------------------------------------------------------------------------|----------------------------------| | | Form Approved: OMB No. 0910-0120 | | | Expiration Date: 06/30/2020 | | | See PRA Statement below. | **Indications for Use** | 510(k) Number (if known) | K181150 | |--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Name | ProtekDuo Mini Veno-Venous Cannula Set | | Indications for Use (Describe) | The ProtekDuo Mini Veno-Venous Cannula Set is intended for use as a single cannula for both venous drainage and reinfusion of blood via an internal jugular vein during extracorporeal life support procedures. | | Type of Use (Select one or both, as applicable) | <div><label><input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label></div> <div><label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label></div> | |-------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| |-------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| CONTINUE ON A SEPARATE PAGE IF NEEDED. 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Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." | FORM FDA 3881 (7/17) | Page 1 of 1 | |----------------------|-------------------------------------------| | | PSC Publishing Services (301) 443-6740 EF | Company of the country of the country of the country of the {3}------------------------------------------------ ### TANDEM LIFE Section 5 510(k) Summary 510(k) Special Date: 30 April 2018 #### Applicant CardiacAssist, Inc. dba TandemLife 240 Alpha Drive Pittsburgh, PA 15238 Telephone: 412-963-7770 Fax: 412-963-0800 #### Contact person Greg Johnson, PhD Title: VP, Regulatory Affairs and Quality Assurance Phone: 412-963-7770 x266 e-mail: gjohnson@tandemlife.com #### Device | Trade/Proprietary Name: | ProtekDuo Mini Veno-Venous Cannula Set | |-------------------------|-------------------------------------------------------------------------------------------------| | Common Name: | Veno-Venous Cannula Set | | Classification Name: | Cardiopulmonary bypass vascular catheter, cannula, or tubing (21 CFR 870.4210 Product Code DWF) | #### Predicate Device TandemHeart 31 Fr. (31 Fr. ProtekDuo) Veno-Venous Cannula Set (K160257) (marketed under Trade Name: 31 Fr. ProtekDuo) #### Device Description The ProtekDuo Mini Veno-Venous Cannula Set consists of two components: a 31 Fr. Dual Lumen Veno-Venous Cannula and a 15.5 Fr. Introducer is designed to accept a standard 0.038 inch guidewire. The ProtekDuo Mini Veno-Venous Cannula Set is intended as a single patient, single use, sterile device. Image /page/3/Figure/13 description: The image shows a technical drawing of a medical device. The device has barbed connectors on one end and insertion depth markers labeled 36, 34, and 32. There are also tantalum markers and a wire-reinforced area labeled with numbers 18, 16, and 14. Figure 5-1. ProtekDuo Mini Veno-Venous Cannula {4}------------------------------------------------ ## TANDEM LIFE Section 5 510(k) Summary 510(k) Special The ProtekDuo Mini Veno-Venous Cannula (Figure 5-1) consists of two distinct lumens with a wire-reinforced cannula body. The inner lumen is located entirely within the outer lumen forming two concentric channels. The distal section (inner lumen/cannula) of the cannula body has six side holes near the distal tip opening. The proximal sections of each lumen are clear and not wire-reinforced to allow visualization of blood and to enable clamping to prevent blood flow during setup and removal of the cannula from the extracorporeal circulatory support equipment (see Figure 5-1). A non-vented barbed connector is affixed to both proximal ends (inner/distal and outer/proximal lumens) of the cannula and allow for connection of standard 3/8 inch blood circuit tubing for subsequent connection to extracorporeal circulatory support equipment. The introducer (Figure 5-2) consists of a tube with a luer hub. The introducer fits inside the inner lumen of the cannula during insertion of the cannula/introducer assembly. The introducer is used to advance the cannula over a guidewire and facilitate cannula placement within the target vessel. The introducer has a luer hub at its proximal end to manage introducer insertion and removal from the cannula. The luer hub can also enable contrast injection, if necessary, to facilitate placement and final positioning of the cannula within the target vessel. The hemostasis cap minimizes blood loss when the cannula/introducer assembly is inserted into the target vessel. The introducer body is constructed from radiopaque material for visualization under fluoroscopy. Image /page/4/Figure/5 description: The image shows a medical device, specifically an introducer needle, with labels pointing to its components. The "Introducer Hub" is labeled at the left end of the needle, which is the part that connects to other medical equipment. The "Hemostasis Cap" is labeled near the hub, indicating a component that helps control bleeding during insertion. Figure 5-2: 15.5 Fr. Introducer #### Indications for Use The ProtekDuo Mini Veno-Venous Cannula Set is intended for use as a single cannula for both venous drainage and reinfusion of blood via an internal jugular vein during extracorporeal life support procedures. #### Comparison of Technological Characteristics ProtekDuo Mini Veno-Venous Cannula Set is an extension to the ProtekDuo Veno-Venous Cannula Family. It is identical to the TandemHeart 31 Fr. (31 Fr. ProtekDuo) Veno-Venous Cannula Set, except the distal lumen is approximately 14.2 cm shorter in length. The introducer is also approximately 14.2 cm shorter. It is designed for the same {5}------------------------------------------------ # TANDEM LIFE Section 5 510(k) Summary 510(k) Special intended use as the TandemHeart 31 Fr. (31 Fr. ProtekDuo) Veno-Venous Cannula Set. All materials and methods of manufacture are identical. ### Summary of Non-clinical Testing Testing of the ProtekDuo Mini Veno-Venous Cannula Set included comparative hemolysis, pressure-flow testing, tensile strength, pathway integrity, kink radius, and stiffness. | Test | Method | Conclusion | |--------------------------|------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Comparative<br>Hemolysis | Side-by-side comparison with<br>predicate of bench top<br>hemolysis levels over 6 hours. | No difference in hemolysis levels<br>between test articles and predicate<br>controls. | | Pressure-Flow | Measure pressure losses across<br>cannula at different flow rates. | Measured flow rates exceed the<br>longer predicate at all levels of<br>pressure difference across the<br>cannula. Design specifications<br>were met. | | Tensile Strength | Pull testing of both cannula and<br>introducer | Acceptance criteria were identical<br>to those of the predicate and were<br>met in all tests. | | Pathway Integrity | Pressure testing | Acceptance criterion was identical<br>to that of the predicate and was met<br>in all tests. | | Kink Radius | Flow rate reduction caused by<br>specified minimum bend radius<br>was measured | Acceptance criterion was identical<br>to that of the predicate and was met<br>in all tests. | | Stiffness | Deflection testing to measure<br>force required to bend cannula<br>a specified distance | The cannula, the introducer, and the<br>cannula/introducer assembly met<br>acceptance criteria established to<br>ensure the cannula is stiff enough to<br>insert while remaining flexible<br>enough to avoid vessel injury. | #### Conclusion The ProtekDuo Mini Veno-Venous Cannula Set is made from the same materials, using the same manufacturing processes and sterilization techniques as the predicate device. Testing demonstrated that hemolysis, tensile strength, pathway integrity, and kink radius are identical to the predicate. Stiffness and pressure-flow properties differed as expected for the shorter length cannula and met established acceptance criteria. The ProtekDuo Mini Veno-Venous Cannula Set is determined to be substantially equivalent to the predicate TandemHeart 31 Fr. (31 Fr. ProtekDuo) Veno-Venous Cannula Set. {End of Section}