Multi-Sideport Catheter Infusion 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 and Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. April 25, 2019 Cook Incorporated Reuben Lidster Regulatory Affairs Specialist P.O. Box 489, 750 Daniels Way Bloomington, Indiana 47402 Re: K182071 Trade/Device Name: Multi-Sideport Catheter Infusion Set Regulation Number: 21 CFR 870.1210 Regulation Name: Continuous Flush Catheter Regulatory Class: Class II Product Code: KRA Dated: March 14, 2019 Received: March 15, 2019 Dear Mr. Lidster: 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. 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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 comprehensive regulatory information about mediation-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, Gregory 2019.04.25 10:03:51 -04'00' O'Connell 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) K182071 Device Name Multi-Sideport Catheter Infusion Set Indications for Use (Describe) The Multi-Sideport Catheter Infusion Set is intended to administer infusions of various therapeutic solutions and contrast media into the peripheral vasculature. | Type of Use (Select one or both, as applicable) | | |-----------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------| | <div> <span style="font-size: 10px;">☑</span> Prescription Use (Part 21 CFR 201 Subpart D) </div> | <div> <span style="font-size: 10px;">☐</span> Over-The-Counter Use (21 CFR 201 Subpart G) </div> | > Prescription Use (Part 21 CFR 801 Subpart D) | | Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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Below it, the word "MEDICAL" is written in a smaller, white, sans-serif font on a black background. 510(k) Summary COOK INCORPORATED 750 DANIELS WAY OOMINGTON, WW.COOKMEDICI K182071 # Multi-Sideport Catheter Infusion Set Traditional 510(k) Summary 21 CFR §807.92 ### Submitter Information | Applicant: | Cook Incorporated | |-----------------------|------------------------------------------| | Address: | 750 Daniels Way<br>Bloomington, IN 47404 | | Contact: | Reuben G. Lidster | | Email: | RegSubmissions@CookMedical.com | | Contact Phone Number: | 812-335-3575 ext. 104866 | | Contact Fax Number: | 812-332-0281 | | Date Prepared: | 31 July 2018 | ### Device Information | Trade Name: | Multi-Sideport Catheter Infusion Set | |----------------------|-------------------------------------------------------| | Common Name: | Continuous flush catheter | | Classification Name: | Catheter, Continuous, Flush<br>KRA (21 CFR §870.1210) | ### Predicate Device The predicate device is the Merit Medical Systems Inc. Fountain Infusion System cleared under 510(k) number K991619. The predicate device is manufactured in a diameter of 5.0 French and in lengths of 45 - 135 centimeters. The catheter is compatible with a 0.035 inch wire guide. The infusion segment lengths are 5 - 50 centimeters and come with 40 to 400 sideports. ### Reference Device The reference device is the AngioDynamics SpeedLyser™ (K170258), which is available in {4}------------------------------------------------ shorter lengths than the predicate. #### Comparison to Predicate Device The subject device, Multi-Sideport Catheter Infusion Set has a similar indication for use, duration of use, principles of operation, fundamental technological characteristics, and insertion method as the predicate device (K991619). Minor differences between the subject device and the predicate device include materials and dimensions. The differences between the subject device and the predicate device do not raise new questions of safety and effectiveness as demonstrated by the biocompatibility and performance testing. ### Device Description The Multi-Sideport Catheter Infusion Set is available in the 5.0 Fr size and is manufactured in lengths of 40, 65, 100 and 130 centimeters. The catheter is compatible with a 0.035 inch wire guide. The infusion segment lengths are 7, 15 or 20 centimeters and come with 14, 30 or 40 sideports. Each subject device set includes a catheter with a Luer lock adapter and a single lumen shaft, a tip occluder and Tuohy-Borst large bore clear plastic side adapter, and a dual check valve with a 1 ml syringe. ### Intended Use The Multi-Sideport Catheter Infusion Set is intended to administer infusions of various therapeutic solutions and contrast media into the peripheral vasculature. ### Test Data The Multi-Sideport Catheter Infusion Set, subject of this submission, was subjected to the applicable testing listed below to assure reliable design and performance under the testing parameters. Performance and biocompatibility testing were conducted in accordance with applicable standards and FDA guidance documents to confirm the reliable performance of critical device characteristics. - . Biocompatibility testing - Testing (i.e., cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, pyrogenicity, subchronic toxicity, genotoxicity, implantation, hemocompatibility, complement activation, partial thromboplastin time and in vivo thrombogenicity) demonstrated that the subject device is biocompatible for the intended use. In conformance with the applicable sections of ANSI AAMI ISO 10993- 1:2009(R)2013, the predetermined acceptance criteria were met. - Air Leakage Testing Testing verified that, under proper clinical use of the . K182071 {5}------------------------------------------------ subject device, there will be no air leakage when tested in accordance with the methods described in BS EN ISO 10555-1:2013, Annex D. The predetermined acceptance criterion was met. - Compatibility Testing Testing verified that the compatibility . requirements of the subject device are within a specified tolerance. The predetermined acceptance criteria were met. - Corrosion Testing Tested in accordance with Annex B of ISO 11070:2014. The . predetermined acceptance criteria were met. - . Dimensional Verification Testing - Testing was completed in accordance with an approved study protocol. The predetermined acceptance criteria were met. - . Liquid Leakage Testing - Testing verified that, under proper clinical use of the subject device, there will be no liquid leakage when tested in accordance with the methods described in BS EN ISO 10555-1:2013, Annex C. The predetermined acceptance criterion was met. - Tuohy Stress Cracking Testing verified the requirements of no signs of leakage . or stress cracking when tested in accordance with ISO 80369-7:2016. The predetermined acceptance criteria were met. - Tensile Testing of the Hub-to-Shaft Bond Testing verified that, under proper . clinical use of the subject device, the peak load value of the hub-to-shaft connection is in accordance with the methods of BS EN ISO 10555-1:2013, Annex B. The predetermined acceptance criterion was met. - Tensile Testing of the Marker Band to Shaft Bond Testing was completed in . accordance with an approved study protocol. The predetermined acceptance criterion was met. - Tensile Testing of the Sideported Area Testing verified that, under proper . clinical use of the subject device, the peak load value of the sideported area of the shaft is in accordance with the methods of BS EN ISO 10555-1:2013, Annex B. The predetermined acceptance criterion was met. - Radiopacity Testing The results verified, under the proper clinical use of the . subject device, the test articles were visible when imaged under fluoroscopy. The predetermined acceptance criterion was met. K182071 {6}------------------------------------------------ - K182071 - Simulated Use Testing The results verified, under simulated clinical use of the . subject device, the test articles can be loaded, advanced, flushed and withdrawn as intended, without kinks or material separation. The predetermined acceptance criteria were met. ### Conclusion The results of testing support a conclusion that the Multi-Sideport Catheter Infusion Set met the design input requirements based on the intended use and support the conclusion that the modifications do not raise new questions of safety or effectiveness. The results of these tests support a determination of substantial equivalence to the predicate device, the Merit Medical Fountain Infusion Catheter (K991619).