SelectSite C304-HIS Deflectable Catheter System

{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 15, 2019 Medtronic Inc. Linda O'Connor Senior Regulatory Affairs Specialist Parkmore Business Park West Galway, Ireland Re: K183493 Trade/Device Name: SELECTSITE C304-HIS Deflectable Catheter System Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II Product Code: DQY Dated: December 14, 2018 Received: December 17, 2018 Dear Linda O'Connor: 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). 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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) for {1}------------------------------------------------ devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) 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 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, Digitally signed by Hetal B. for Hetal B. Patel -S Date: 2019.03.15 Patel -S 07:16:01 -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) K183493 Device Name SELECTSITE C304-HIS Deflectable Catheter System Indications for Use (Describe) The device is indicated to provide a pathway through which diagnostic transvenous devices are introduced within the chambers and coronary vasculature of the heart and for introducing balloon catheters into the coronary sinus or leads into vessels of the left heart via the coronary sinus. Type of Use (Select one or both, as applicable) | <span></span> | <span></span> | |--------------------------------------------------------------------------------------|----------------------------------------------------------------------| | <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) | <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) | #### 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. 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." {3}------------------------------------------------ # K183493 – 510(k) Summary # 510(k) Summary per 21 CRF 807.92 # Date Prepared: 16 November 2018 # Applicant: Medtronic Ireland Parkmore Business Park West Galway Ireland # Official Correspondent: Linda O Connor Senior Regulatory Affairs Specialist Medtronic Ireland Parkmore Business Park West Galway Ireland Phone: (353) 91 708328 Fax: (353) 91 708672 Email: linda.oconnor(@medtronic.com # Common Name: SelectSite™ C304-HIS Delivery Catheter ## Device Classification: II ## Regulation Number: 21 CFR 870.1250 ## Classification Name: Percutaneous Catheter # Product Code: DQY {4}------------------------------------------------ #### Device Description: The C304-HIS device is a radio opaque, braid-reinforced catheter with a deflectable distal tip. The catheter shaft is constructed from Polyether Block Amid (PEBA), with a medical stainless-steel braid and an inner Polytetrafluoroethylene (PTFE) liner. The shaft construction is manufactured by an external vendor Teleflex. The shape of the distal catheter deflectable segment is controlled by a pull wire connected to the handle which can be adjusted to accommodate individual anatomies and to allow access to the target sites. The pull wire is anchored to a distal gold marker band. The device features a guide wire to access the vein, a valve to reduce blood loss during the implant procedure, a deflectable catheter to introduce a transvenous device, a catheter dilator to facilitate deflectable catheter passage, and a guide catheter slitter to remove the deflectable catheter. The deflectable catheter is designed for placement of transvenous devices in or near the bundle of His. It features a deflecting distal section, controlled by the deflectable catheter handle, and an out-of-plane curve on the distal tip. The body of the deflectable catheter is radiopaque for visibility on fluoroscopy. #### Indications For Use: The deflectable catheter system is indicated to provide a pathway though which diagnostic and therapeutic transvenous devices are introduced within the chambers and coronary vasculature of the heart, and for introducing balloon catheters into the coronary sinus or leads into vessels of the left heart via the coronary sinus. ## Substantially Equivalent Device: The C304-HIS device uses similar technology and has similar intended uses, function, materials and method of operation to the following predicate device: - SelectSite™ C304-S5901 and C304-L6901 Deflectable Catheter Systems ● (K033989, cleared January 22, 2004 and K061416, cleared October 26, 2006) The SelectSite™ C304HIS Catheter System is similar in shape to the following reference device: C315 Delivery Catheter (K101885, Cleared September 9, 2010) #### Summary of Technological Differences to the Predicate Device: The C304-HIS device will have a fixed curve shape design at the distal end, which is not present in the existing C304 catheter models. The C304-HIS device was designed to optimize placement of transvenous devices in or near the bundle of His. #### Summary of Non-Clinical Data: Device integrity testing was performed to support the equivalency of the C304-HIS device to the predicate devices. Testing included mechanical, functional, and biocompatibility testing. The C304-HIS device met all specified design and performance requirements. Biocompatibilitv Information: The biocompatibility evaluation completed for the C304-HIS device verifies that the C304-HIS device is biocompatible. The testing which supports the biocompatibility of the C304-HIS device is consistent with International Standard ISO 10993-1: "Biological Evaluation {5}------------------------------------------------ of Medical devices- Part 1: Evaluation and Testing." When classified according to this standard, the catheter and dilator included in the C304-HIS device are external communicating devices with limited exposure (<24 hours) to circulating blood. # Summary of Clinical Data: Clinical data was not generated. This section is not applicable. #### Sterilization Validation: The C304-HIS device will be sterilized using a validated Ethylene Oxide (EtO) sterilization process. #### Conclusion: Through the data and information presented, Medtronic considers the C304-HIS device to be substantially equivalent to legally marketed predicate devices.