CXI TriForce Peripheral Crossing Set

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION". November 13, 2017 Cook Incorporated Ms. Sarah Reeves Regulatory Affairs Manager 750 Daniels Wav, P.O. Box 489 Bloomington, Indiana 47402 Re: K170931 Trade/Device Name: CXI TriForce Peripheral Crossing Set Regulation Number: 21 CFR 870.1210 Regulation Name: Continuous Flush Catheter Regulatory Class: Class II Product Code: KRA Dated: October 24, 2017 Received: October 25, 2017 Dear Ms. Reeves: 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); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {1}------------------------------------------------ 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, Kenneth J. Cavanaugh -S for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K170931 Device Name CXI TriForce Peripheral Crossing Set Indications for Use (Describe) The CXI TriForce is intended to be percutaneously introduced into blood vessels and support a wire guide while performing percutaneous peripheral intervention. The product is also intended for injection of radiopaque contrast media for the purpose of angiography. Type of Use (Select one or both, as applicable) | <div> <span> <span style="text-decoration: overline;">X</span> Prescription Use (Part 21 CER 801 Subpart D) </span> </div> | |--------------------------------------------------------------------------------------------------------------------------------------------| | <div> <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. 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Box 489 Bloomington, IN 47402 Phone: (812) 335-3575 x175024 Fax: (812) 332-0281 Date Prepared: 31 October 2017 ### Device: Trade Name: Common Name: Classification: Product Code (Regulation): CXI™ TriForce Peripheral Crossing Set Continuous flush catheter Class II DYB (21 CFR §870.1340) ## Indications for Use: The CXI™ TriForce is intended to be percutaneously introduced into blood vessels and support a wire guide while performing percutaneous peripheral intervention. The product is also intended for injection of radiopaque contrast media for the purpose of angiography. ### Predicate Device: The device, subject of this submission, is substantially equivalent to the predicate device of identical name, the CXI™ TriForce Peripheral Crossing Set, cleared under 510(k) number K111263. Additionally, the Flexor Radial Hydrophilic Introducer Access Set (K152044) and the Flexor Check-Flo Introducer, Ansel Modification, Flexor Check-Flo Introducer, Balkin Up and Over Contralateral Design, Flexor Check-Flo Introducer, Raabe Modification and Flexor Check-Flo Performer Introducer (K142829) are considered reference devices for this submission. COOK INCORPORATED 750 DANIELS WAY, P.O. BOX . LOOMINGTON, IN 47402-0489 812.339.2235 TOLLEREE: 800.45 WWW.COOKMEDICAL.CC K170931 Page 1 of 3 {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the Cook Medical logo. The word "COOK" is in white, sans-serif font on a red background. Below the word "COOK" is the word "MEDICAL" in white, sans-serif font on a red background. The red background is shaped like a rectangle with a notch cut out of the lower left corner. SO DANIELS WAY DO F ### Comparison to Predicate Device: It has been demonstrated that the CXI™ TriForce Peripheral Crossing Set is comparable to the predicate device. The CXI™ TriForce Peripheral Crossing Set is identical in terms of intended use, principles of operation, basic technological characteristics, and materials of construction, with the exception of the modification to labeling and check-flo valve, to the predicate device. The check-flo valve material and design has been modified to provide more consistent hemostasis. The labeling has been updated to provide the user more accurate information for clinical use. The testing performed supports a determination of substantial equivalence to the predicate device. ## Device Description: The CXI™ TriForce Peripheral Crossing Set is an introducer set, supplied with a 5.0 French Flexor introducer sheath, a 4.0 French CXI Support Catheter and a peel-away sheath. The sets are compatible with the supplied 0.035" wire guide. The sets are supplied sterile and intended for one-time use. ## Test Data: The following tests were performed to demonstrate that the CXI™ TriForce Peripheral Crossing Set met applicable design and performance requirements and support a determination of substantial equivalence. - . Acute Performance - Testing performed verified that performance parameters were acceptable for clinical use. The predetermined acceptance criterion was met. - . Check-Flo valve liquid leakage testing -- Testing verified that the Check-Flo valve will not experience excessive leakage when utilized according to the device's intended use. The predetermined acceptance criteria were met. - . Flow Rate Testing - Flow rates through the device were measured at designated injection pressures using saline and contrast. {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for Cook Medical. The logo is set against a red background. The word "COOK" is in large, white, sans-serif font, and the word "MEDICAL" is in a smaller, white, sans-serif font below the word "COOK". The following tests were leveraged to support a determination of substantial equivalence. - . Biocompatibility testing – cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, material mediated pyrogenicity and hemocompatibility, including partial thromboplastin time, SC5b-9 and C3a complement activation assay, testing have been completed. The predetermined acceptance criteria were met. In conclusion, the results of these tests support a determination of substantial equivalence to the predicate device.