FLEXOR RADIAL HYDROPHILIC INTRODUCER ACCESS SET

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with three parallel lines above them, resembling a stylized flag or banner. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 October 9, 2014 Cook, Inc. C/O David Lehr Regulatory Affairs Specialist 750 Daniels Way Bloomington, Indiana 47402 Re: K132592 > Trade/Device Name: Flexor® Radial Hydrophilic Introducer Access Set Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: September 3, 2014 Received: September 4, 2014 Dear Mr. Lehr, 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in {1}------------------------------------------------ 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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, Melissa A. Torres -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) K132592 Device Name Flexor® Radial Hydrophilic Introducer Access Set Indications for Use (Describe) The Flexor® Radial Hydrophilic Introducer Access Set is introduce diagnostic and interventional devices in radial arterv access procedures. Type of Use (Select one or both, as applicable) > Prescription Use (Part 21 CFR 801 Subpart D) _ Over-The-Counter Use (21 CFR 801 Subpart C) ### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. #### FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) 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}------------------------------------------------ # 510(k) Summary # Flexor® Radial Hydrophilic Introducer Access Set Traditional 510(k) 510(k) Summary 21 CFR §807.92 ## Submitter Information: | Applicant: | Cook Incorporated | |-----------------------|--------------------------------------------------| | Address: | 750 Daniels Way<br>Bloomington, IN 47404 | | Contact: | David Lehr, RAC | | Email: | david.lehr@cookmedical.com | | Contact Phone Number: | 812-335-3575 ext. 102309 | | Contact Fax Number: | 812-332-0281 | | Date Prepared: | 07 October 2014 | | Device Information: | | | Trade Name: | Flexor® Radial Hydrophilic Introducer Access Set | | Common Name: | Introducer Set | | Classification Name: | Catheter Introducer<br>DYB (21 CFR §870.1340) | # Predicate Devices: The Flexor® Radial Hydrophilic Introducer Access Set is substantially equivalent to the following devices: the Terumo Glidesheath Slender (K122980), the Pinnacle ROII Introducer Sheath (K082847), and the Greatbatch Medical RadialSource Transradial Access Kit (K110051). ## Comparison to Predicate: It has been demonstrated that the Flexor® Radial Hydrophilic Introducer Access Set is comparable to the predicate devices in terms of intended use, duration of use, principles of operation, technological characteristics, insertion method, and anatomical location. {4}------------------------------------------------ Cook Incorporated Flexor® Radial Hydrophilic Introducer Access Set Traditional 510(k) 07 October 2014 # Device Description: The Flexor Radial Hydrophilic Introducer Access Set is comprised of an introducer sheath, a dilator, a wire guide, and an access needle. ## Intended Use: The Flexor® Radial Hydrophilic Introducer Access Set is intended to introduce diagnostic and interventional devices in radial artery access procedures. # Test Data: The proposed Flexor Radial Hydrophilic Introducer Access Set was subjected to applicable testing to ensure reliable design and performance under the testing parameters. The following tests were conducted to ensure reliable design and performance: - . Dilator and introducer sheath tensile testing - Testing verified that, under proper clinical use of the dilator and introducer sheath, the peak load values shall be in accordance with the applicable values of BS EN ISO 11070:1999. The predetermined acceptance criteria were met. - . Connecting tube to check-flo tensile testing - Testing verified that, under proper clinical use of the device, the connection between the valve body and the connecting tube will meet the predetermined acceptance criteria. - Needle tensile testing - Testing verified that, under proper clinical use of the needle, the peak load values shall be in accordance with the applicable values of BS EN ISO 11070: 1999. The predetermined acceptance criteria were met. - . Needle tubing testing - Testing verified that, under proper clinical use of the needle, the tubing will resist breakage in accordance with EN ISO 9626: 1995. The predetermined acceptance criteria were met. - . Check-Flo valve dislodgement testing - Testing verified that the Check-Flo valve will not be dislodged during insertion and withdrawal when utilized according to the device's intended use. The predetermined acceptance criteria were 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. - Dimensional verification Testing verified that each component met the ● dimensions within tolerances of the predetermined acceptance criteria. - Fluoroscopic visibility evaluation Testing verified that each component was ● visible under fluoroscopy. The predetermined acceptance criteria were met. - Design validation Design was validated through simulated clinical use. The ● predetermined acceptance criteria were met. - . Insertion and extraction force evaluation – The insertion and extraction forces of the dilator through the check-flo valve were evaluated and characterized. The predetermined acceptance criteria were met, where appropriate. - Dilator and introducer sheath coating slough-off Testing verified that the ● hydrophilic coating met the requirements for durability. The predetermined acceptance criterion was met. {5}------------------------------------------------ Cook Incorporated Flexor® Radial Hydrophilic Introducer Access Set Traditional 510(k) 07 October 2014 - Particulate evaluation Particulate counts were recorded in continuous flow loop. ● - Introducer lubricity testing - Lubricity of the introducer shaft was evaluated. The predetermined acceptance criterion was met. - . Coating integrity testing - Surface of device, including the hydrophilic coating, was visually examined at multiple time points. - Wire guide testing Testing verified all predetermined acceptance criteria were . met for resistance to fracture, resistance to damage by flexing, tensile, tip deflection, torque response and torque strength as recommended in BS EN ISO 11070:1999 and in "Coronary and Cerebrovascular Guidewire Guidance," January 1995. - . Biocompatibility testing - Testing (i.e., cytotoxicity, sensitization, intracutaneous reactivity, systemic toxicity, pyrogen, hemocompatibility, complement activation, partial thromboplastin time, and thromboresistance) demonstrated the device as biocompatible. In conformance with the applicable sections of ISO 10993-1:2009, the predetermined acceptance criteria were met. In conclusion, the results of these tests provide reasonable assurance to support a determination of substantial equivalence to predicate devices.