BD INTIMA II CLOSED IV CATHETER

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are black and have a flowing, abstract design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 April 9, 2015 Becton Dickinson Infusion Therapy Systems Inc. Mr. John Roberts Manager, Regulatory Affairs 9450 South State Street Sandy, UT 84070 Re: K143610 Trade/Device Name: BD Intima IITM Closed IV Catheter System Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: II Product Code: FOZ Dated: March 12, 2015 Received: March 13, 2015 Dear Mr. Roberts: 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. {1}------------------------------------------------ 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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, Tina Kiang -S for Erin I. Keith, M.S. Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below. 510(k) Number (if known) K143610 K143610 Device Name BD Intima II Closed IV Catheter System ### Indications for Use (Describe) The BD Intima II Closed IV Catheter System is inserted into a patient's vascular system for short-term use to monitor blood pressure or administer fluids intravascularly. These devices may be used for any patient with consideration given to adequacy of vascular anatomy, procedure being performed, and duration of therapy. Type of Use (Select one or both, as applicable) 2 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}------------------------------------------------ Becton Dickinson Infusion Therapy Systems Inc. 9450 South State Street 0406 South State of Sandy, Utah 84070 USA tel: 801.565.2300 fax: 801.304.3963 www.bd.com Image /page/3/Picture/1 description: The image shows the logo for BD, a global medical technology company. The logo consists of two parts: a stylized graphic on the left and the letters "BD" on the right. Below the letters, there is a tagline that reads "Helping all people live healthy lives." # 510(k) Summary # 21 CFR §807.92 # BD Intima IITM Closed IV Catheter System | Submitter<br>Information | Submitter Name:<br>Submitter Address:<br><br>Contact Person:<br><br><br><br>Date of Preparation: | Becton Dickinson Infusion Therapy Systems Inc.<br>9450 South State Street<br>Sandy, UT 84070<br><br>John Roberts<br>Regulatory Affairs Manager<br>Phone: 801.565.2673<br>Fax: 801.304.3963<br>Email: john_w_roberts@bd.com<br><br>9 April 2015 | |--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Subject<br>Devices | Trade Name:<br>Common Name:<br>Classification Name:<br>CFR Reference:<br>Classification Panel: | BD Intima IITM Closed IV Catheter System<br>Peripheral Intravascular or IV Catheter<br>FOZ - Intravascular Catheter<br>21 CFR 880.5200 - Class II<br>General Hospital | | Predicate<br>Devices | Trade Name:<br>510(k) Reference:<br>Common Name:<br>Classification Name:<br>CFR Reference:<br>Classification Panel: | BD Intima IITM Closed IV Catheter System<br>K100775<br>Peripheral Intravascular or IV Catheter<br>FOZ - Intravascular Catheter<br>21 CFR 880.5200 - Class II<br>General Hospital | | Device<br>Description | The BD Intima IITM Closed IV Catheter System is a closed system IV Catheter.<br>The closed system is designed to keep blood contained within the device<br>throughout the insertion process. The system consists of a radiopaque VialonTM<br>material catheter, a notched needle for flashback visualization, a septum to<br>remove visible blood from the needle tubing, a clamp (slide clamp/pinch clamp),<br>extension tubing and Luer connector. It incorporates an integrated extension set<br>which is available in two configurations: Y Connection (dual port) and Straight<br>Connection (single port). The Luer connector is color-coded to indicate catheter<br>gauge. It is provided EO sterilized to achieve a Sterility Assurance Level (SAL) of<br>10-6. The package system is able to maintain the sterility during its specified shelf<br>life of 3 years. | | {4}------------------------------------------------ | Indications for<br>Use | The BD Intima II Closed IV Catheter System is inserted into a patient's vascular<br>system for short-term use to monitor blood pressure or administer fluids<br>intravascularly. These devices may be used for any patient population with<br>consideration given to adequacy of vascular anatomy, procedure being<br>performed, fluids being infused, and duration of therapy. | |------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| |------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| Technological Technological characteristics of the subject device are equivalent to the predicate. Characteristics The BD Intima IITM Closed IV Cather System achieves its intended use based on the same technology and principles of operation. The subject device has been modified from the predicate as listed below. The results of design verification demonstrate that these changes are substantially equivalent to the predicate device. All other aspects of the subject device are identical to those of the predicate device. · Change to various adhesives and lubricants utilized during assembly - Qualification of new pinch clamp as alternate to the current slide clamp; | Attribute | SUBJECT DEVICE | PREDICATE DEVICE | | |------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------| | Indications<br>for Use | BD Intima II TM Closed IV Catheter<br>System is inserted into a patient's<br>vascular system for short-term use to<br>monitor blood pressure or administer<br>fluids intravascularly. | BD Intima II TM Closed IV Catheter<br>System is inserted into a patient's<br>vascular system for short-term use to<br>monitor blood pressure or administer<br>fluids intravascularly. | | | Design | A single-winged, polyurethane IV<br>Catheter with an integrated extension<br>set incorporating either a single port<br>or Y (dual)-port injection site.<br>Incorporates BD Instaflash technology<br>to assist with flashback visualization | A single-winged, polyurethane IV<br>Catheter with an integrated extension<br>set incorporating either a single port or<br>Y (dual)-port injection site. Incorporates<br>BD Instaflash technology to assist with<br>flashback visualization | | | Materials | Component | Subject Device | Predicate Device | | | Catheter Tubing | BD Vialon | BD Vialon | | | Catheter Tipping<br>Lubricant | Silicone | Silicone | | | Catheter Lubricant | Silicone | Silicone | | | Metal Wedge | Stainless Steel | Stainless Steel | | | Y-Adapter | Propionate | Propionate | | | Septum/Sleeve<br>Stopper | Polyisoprene | Polyisoprene | | | Needle | Stainless Steel | Stainless Steel | | | Needle Cover | Polyethylene | Polyethylene | | | Extension Tubing | Polyvinyl Chloride | Polyvinyl Chloride | | | Pinch Clamp | Polyoxymethylene | Not applicable | | | Slide Clamp | Polystyrene | Polystyrene | | | Luer Connection Site | Polypropylene | Polypropylene | | PRN Body | Polycarbonate | Polycarbonate | | {5}------------------------------------------------ | | PRN Injection Port | Polyisoprene | Polyisoprene | | |--------------------------------------------|------------------------------|------------------------------------|------------------------------------|--| | | PRN Shrink Wrap<br>Band | Polyvinyl Chloride | Polyvinyl Chloride | | | | Cap | Acrylonitrile Butadiene<br>Styrene | Acrylonitrile Butadiene<br>Styrene | | | | Extension Tubing<br>Adhesive | UV-Cured Epoxy | UV-Cured Epoxy | | | | Needle Adhesive | UV-Cured Epoxy | 2-Part Epoxy | | | | Septum Adhesive | UV-Cured Epoxy | UV-Cured Epoxy | | | | Paddle Hub | Polystyrene | Polystyrene | | | | SUBJECT DEVICE | | PREDICATE DEVICE | | | Physical /<br>Mechanical<br>Specifications | Catheter Diameters: | | Catheter Diameters: | | | | 18G, 20G, 22G, 24G | | 18G, 20G, 22G, 24G | | | | Catheter Lengths: | | Catheter Lengths: | | | | | 0.75", 1.00", 1.16" | 0.75", 1.00", 1.16" | | #### Summary of Pursuant to 21 CFR 820.30, Design Controls, design verification tests were Performance performed based on the risk analysis, and the results of these tests demonstrate that the BD Intima II ™ Closed IV Catheter System is substantially equivalent Tests manner to the predicate device. Design Verification testing included the following: | Characteristic / Test<br>Performed | Test Method | Results | |-------------------------------------------------|-------------------------------|---------| | Biocompatibility | Per ISO 10993 | Pass | | Needle/Paddle Hub Pull Force | Same Methodology as Predicate | Pass | | Catheter/Catheter Adaptor<br>Pull Force | Same Methodology as Predicate | Pass | | Extension Tubing/Catheter<br>Adapter Pull Force | Same Methodology as Predicate | Pass | | Septum Burst Test | Same Methodology as Predicate | Pass | | Catheter Burst Test | Same Methodology as Predicate | Pass | #### Summary of Based on the indications for use, technological characteristics, and safety and performance testing, the subject BD Intima II™ Closed IV Catheter meets all Substantial Equivalence predetermined requirements in accordance with 21 CFR 820.30, Design Controls, and demonstrates that the subject device is substantially equivalent to the predicate devices.