Polyethylene Catheter

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out as "U.S. Food & Drug Administration". March 22, 2019 Cook, Inc. Reuben Lidster Regulatory Affairs Specialist P.O. Box 489, 750 Daniels Way Bloomington, IN 47402 Re: K181722 Trade/Device Name: Polyethylene Catheter Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II Product Code: DQO Dated: February 21, 2019 Received: February 22, 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 {1}------------------------------------------------ 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 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, | For | Gregory O'Connell | |-----|--------------------------------------------| | | 2019.03.22 | | | 11:48:35 -04'00' | | | 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) K181722 Device Name Polyethylene Catheter | Indications for Use (Describe) | The Polyethylene Catheter is intended for use in angiographic procedures. | |--------------------------------|---------------------------------------------------------------------------| |--------------------------------|---------------------------------------------------------------------------| | Type of Use (Select one or both, as applicable) | |-------------------------------------------------| |-------------------------------------------------| |X 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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COOK INCORPORATED 750 Daniels Way BLOOMINGTON, IN 47404 USA 39.2235 TOLL FREE: 800.457.4500 www.cookmedical.com # Polyethylene Catheter Traditional 510(k) Summary 21 CFR §807.92 ### Submitter Information | Applicant: | Cook Incorporated | |-----------------------|--------------------------------| | Address: | 750 Daniels Way | | | 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: | 28 June 2018 | #### Device Information | Trade Name: | Polyethylene Catheter | |----------------------|---------------------------------------------------------------| | Common Name: | Diagnostic intravascular catheter | | Classification Name: | Catheter, Intravascular, Diagnostic<br>DQO (21 CFR §870.1200) | #### Predicate Device The predicate device is the Cook Incorporated Slip-Cath® Beacon® Tip Catheter cleared under 510(k) number K122937 (part number prefix SCBR). The predicate device is manufactured in diameters of 4.0 to 6.5 French and in lengths of 60 to 150 centimeters. The catheter is compatible with a 0.035 or 0.038 inch wire guide. These catheters are manufactured in a variety of distal tip configurations. {4}------------------------------------------------ Cook Incorporated Polyethylene Catheter Traditional 510(k) 28 June 2018 #### Reference Device Cook has utilized the Angiodynamics AngiOptic® Catheter (K964033) as a reference device, which is available in the 3.0 Fr diameter only, to support the 3.0 Fr diameter size of the subject device, the Polyethylene Catheter. Cook has utilized the Angiodynamics Soft-Vu® Angiographic Catheter (K161596) as a reference device, which is available in lengths of 25 to 140 centimeters, to support the shorter length (35 centimeters) of the subject device, the Polyethylene Catheter. #### Comparison to Predicate Device The subject device, Polyethylene Catheter has similar indications for use, duration of use, principles of operation, fundamental technological characteristics, and insertion method as the predicate device. Minor differences between the subject device and the predicate device include wording of intended use, material, and dimension. The differences between the subject device and the predicate device do not raise new questions of safety and effectiveness as demonstrated by performance and biocompatibility testing. #### Device Description The Polyethylene Catheter, the subject of this submission, is a sterile, single use device designed for use in angiographic procedures. The Polyethylene Catheter is available in the 3.0 Fr size and is manufactured in lengths of 35, 40, 50, 55 and 65 centimeters. Each configuration includes a Luer lock adapter and a single lumen shaft. #### Intended Use The Polyethylene Catheter is intended for use in angiographic procedures. #### Test Data The Polyethylene Catheter 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 FDA guidance documents to confirm the reliable performance of critical device characteristics. Simulated use preconditioning was performed. Packaging integrity and sterility data were leveraged from similar devices manufactured by Cook based on a technical analysis. {5}------------------------------------------------ Cook Incorporated Polyethylene Catheter Traditional 510(k) 28 June 2018 - Biocompatibility testing Testing (i.e., cytotoxicity, sensitization, intracutaneous . reactivity, systemic toxicity, pyrogenicity, hemocompatibility, complement activation, in vivo thrombogenicity, and partial thromboplastin time) demonstrated that the 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 . catheter, 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. - Dimensional Verification Testing Testing verified that the dimensional . requirements of the subject device are within a specified tolerance. The predetermined acceptance criteria were met. - Liquid Leakage Testing Testing verified that, under proper clinical use of the . catheter, 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. - . Tensile Testing of the Catheter Shaft - Testing verified that, under proper clinical used of the catheter, the catheter meets the requirements of the methods described in BS EN ISO 10555-1. Annex B. The predetermined acceptance criterion was met. - Tensile Testing of the Hub-to-Shaft Bond Testing verified that, under proper . clinical use of the catheter, 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 Sideported Area Testing verified that, under proper . clinical use of the catheter, 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. {6}------------------------------------------------ Cook Incorporated Polyethylene Catheter Traditional 510(k) 28 June 2018 ### Conclusions The results of testing provide reasonable assurance that the Polyethylene Catheter has been designed so that it conforms to the requirements of its intended use. The evidence demonstrates that the subject device is substantially equivalent to the predicate device, the Cook Incorporated Slip-Cath® Beacon® Tip Catheter (K122937), and does not raise new questions of safety or effectiveness.