Extension Set

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three heads in profile, facing right. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 April 6, 2016 B. Braun Medical Inc. Ms. Kimberly Smith Regulatory Affairs Specialist 901 Marcon Blvd. Allentown, Pennsylvania 18109 Re: K153293 Trade/Device Name: Extension Set Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: March 8, 2016 Received: March 9, 2016 Dear Ms. Smith: 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 - for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ #### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration # Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page. 510(k) Number (if known) Not yet known K153293 Device Name Extension Sets #### Indications for Use (Describe) B. Braun Extension Sets may be used for direction, intermittent infusion, continuous infusion or aspiration of fluids. medications, blood and blood products. Select sets may be used with power injector procedures to a maximum pressure of 400 psi and a maximum flow rate of 15 mL per second. B. Braun's optional stabilization component on an extension set provides stability to an intravascular catheter by supporting the patient connector. B. Braum Extension Sets may patient population. 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) {3}------------------------------------------------ 510(k) SUMMARY | DATE: | March 8, 2016 | |-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | SUBMITTER: | B. Braun Medical Inc.<br>901 Marcon Boulevard<br>Allentown, PA 18109-9341<br>610-266-0500<br>Contact: Kimberly Smith, Regulatory Affairs Specialist<br>Phone: (610) 596-2326<br>Fax: (610) 266-4962<br>E-mail: kim.smith@bbraun.com | | DEVICE NAME: | Extension Sets | | COMMON OR USUAL NAME: | IV Administration Set | | CLASSIFICATION: | Class II, Product Code FPA, 21 CFR §880.5440,<br>Intravascular administration set | | PREDICATE DEVICES: | K083472 Medegen, Incorporated<br>K140831 CareFusion (formerly Medegen, Incorporated)<br>Class II, Product Code FPA, 21 CFR §880.5440 | ## DESCRIPTION: B. Braun Extension Sets are single use, disposable, add-on devices used for direct injection, intermittent infusion, continuous infusion or aspiration. In clinical practice, extension sets are connected to primary IV sets to add length and provide clamping capabilities or added to an intravascular catheter hub as a conduit for flow to and from the catheter. An extension set attached to a catheter hub allows the clinician to perform syringe aspirations and injections away from the patient's catheter site. Extension Sets are widely used in the clinical setting, are available in various lengths and dimensions, and may be comprised of various generic components that are broadly used throughout the industry. Various components such as stopcocks, clamps, injection sites, connectors, manifolds, filters and needleless connectors, previously cleared in 510(k)s, may be included on an Extension Set. B. Braun Extension Sets offer a range of lengths and a variety of tubing dimensions (ie: microbore, standard bore) that provide flexibility in a variety of clinical settings. B. Braun Extension Sets are configured to ensure the intended use of the device is met. {4}------------------------------------------------ B. Braun's optional stabilization component is a non-removable component that slides on the tubing and may be firmly positioned on the patient connector, secured at the discretion of the clinician at time of use. The optional stabilization component provides additional stabilization to intravascular catheters while firmly positioned on the patient connector of the Extension Set. The optional stabilization component supports the patient connector of the extension set, reducing its contact with the skin. The geometrical design of the stabilization component supports the patient connector maintaining the catheter insertion angle, minimizing the catheter movement in the vessel and the potential for catheter kinking at the insertion site. Select B. Braun Extension Sets that may be used with a power injector at a maximum pressure of 400 psi and a maximum flow rate of 15mL/second. B. Braun Extension Sets may be used for any patient population. Extension Sets comprised of a female luer adapter, extension tubing, slide clamp, stabilization component and a male luer adapter with cap are included in this premarket notification. The following Extension Set configurations are subject of this submission. - Smallbore Extension Set with stabilization component, Spin-Lock connector, ● removable slide clamp - Standard Bore Extension Set with stabilization component, Spin-Lock connector, ● slide clamp - Extension Set with stabilization component, Spin-Lock connector, slide clamp ● # INTENDED USE: B. Braun Extension Sets are intended for direct injection, intermittent infusion, continuous infusion or aspiration. # INDICATIONS FOR USE: B. Braun Extension Sets may be used for direct injection, intermittent infusion, continuous infusion or aspiration of fluids, medications, blood and blood products. Select sets may be used with power injector procedures to a maximum pressure of 400 psi and a maximum flow rate of 15 mL per second. B. Braun's optional stabilization component on an extension set provides stability to an intravascular catheter by supporting the patient connector. B. Braun Extension Sets may be used for any patient population. {5}------------------------------------------------ #### Proposed Device: Predicate Device: Predicate Device: Item Extension Sets CareFusion (formerly CareFusion (formerly Medegen Incorporated) Medegen K083472, Publically Incorporated) Available Information K140831, Publically Available Information 510(k) Number K153293 K083472 K140831 FDA Regulation 21 CFR 880.5440 21 CFR 880.5440 21 CFR 880.5440 Intravascular Administration Number, Intravascular Intravascular Administration Set Administration Set Set Regulation Name, Class, Class II Class II Class II and Product FPA FPA FPA Code Intended Use Intended for direct Intended for direct Intended for direct injection, injection, intermittent injection, intermittent intermittent infusion, infusion, continuous infusion, continuous continuous infusion or infusion or aspiration. infusion or aspiration. aspiration. Indications B. Braun Extension Sets The Medegen Pressure Pressure Rated: The may be used for direct Rated Extension Sets are MaxZero multi fuse iniection, intermittent intended for use in today's extension set with needleless infusion, continuous growing professional connector is for single use infusion or aspiration of healthcare environment, only. The extension set may fluids, medications, including healthcare be used for direct injection. blood and blood facilities, home care and intermittent infusion, products. Select sets medical transport that continuous infusion or may be used with power utilize infusion systems for aspiration. This set may be injector procedures to a the delivery of fluids. used with power injector procedures to a maximum maximum pressure of medications, blood and pressure of 325 psi at a flow 400 psi at a maximum blood products. The flow rate of 15 mL per Medegen Pressure Rated rate of 10mL per second. second. B. Braun's Extension Sets allow the Non Pressure Rated: The optional stabilization user to add medication into MaxZero multi fuse extension set with needleless component on an the primary line without extension set is intended the use of a needle. The connector is for single use to provide stability to Medegen Pressure only. The extension set may Extension Sets may also be the patient connector, be used for direct injection, which is attached to an used with low-pressure intermittent infusion, intravascular catheter. power injectors rated up to continuous infusion or B. Braun Extension Sets 325 psi. aspiration. may be used for any patient population. Description B. Braun Extension Sets Extension Sets are intended Extension Sets are intended are single use. for single patient use, for for single patient use, disposable, add-on infusion systems for the including pediatrics and devices used for direct delivery of fluids. immuno-compromised injection, intermittent medications, blood and patients, for direct injection, infusion, continuous blood products. The intermittent infusion infusion or aspiration of Medegen Pressure Rated continuous infusion or fluids, medications, Extension Sets allow the aspiration of drugs, blood blood and blood user to add medication into and fluids. Pressure rated sets products. Select B. the primary line without the may be used with power Braun Extension Sets use of a needle. injector procedures to a may be used with power The Medegen Pressure maximum pressure of 325 psi # SUBSTANTIAL EQUIVALENCE: {6}------------------------------------------------ | | injector procedures to a<br>maximum pressure of<br>400 psi and at a<br>maximum flow rate of<br>15mL per second. B.<br>Braun Extension Sets<br>may be comprised of<br>various generic<br>components that are<br>broadly used in clinical<br>practice such as<br>stopcocks, clamps,<br>injection sites,<br>connectors, manifolds,<br>filters and needleless<br>connectors. B. Braun<br>Extension Sets also<br>contain an optional<br>stabilization device. | Extension Sets may also be<br>used with low-pressure<br>power injectors rated up to<br>325 psi. Configurations are<br>available with needleless<br>connectors, split septum<br>ports, filters, stopcocks,<br>manifolds and/or T-<br>connectors. | at a flow rate of 10mL per<br>second. Configurations are<br>available with needleless<br>connectors, split septum<br>ports, filters, stopcocks,<br>manifolds and/or T-<br>connectors. | |----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device<br>Components | Tubing, Luer, Slide<br>Clamp, Stabilization<br>Component, Spin-Lock<br>Connector (also known<br>as patient connector,<br>male luer adapter) | Tubing, Luer, Check<br>Valve, Slide Clamp,<br>Needleless Connector,<br>Male Spin lock connector | Tubing, Luer, Check Valve,<br>Slide Clamp, Needleless<br>Connector, Male Spin lock<br>connector | # Technological Characteristics The B. Braun Extension sets have the following similarities to the predicate devices: - · Same Intended Use - · Indications for Use - · Extension Set design - · Principle of operation - · May be used with power injection procedures The following differences exist between the subject and predicate devices: - · the subject device includes a stabilization component - · the subject device may be used may be used with power injector procedures to a maximum pressure of 400 psi and a maximum flow rate of 15 mL per second - · the subject device may be used with a needleless connector whereas the predicate device has a needleless connector incorporated on the set These differences in the indications for use statement for the subject device and predicate devices do not alter the intended use of the subject device. Both the subject and predicate devices have the same intended use for direct injection, intermittent infusion, continuous infusion or aspiration. {7}------------------------------------------------ ## Non-Clinical Data - Performance Testing B. Braun performed design verification performance testing to verify, demonstrate and support the claim of substantial equivalence to the predicate devices. All test results met their acceptance criteria and support that B. Braun Extension sets are appropriately designed for their intended use. The following performance standards were utilized in evaluating the functionality of the Extension Sets: ISO 594-1:1986, "Conical fittings with a 6% (luer) taper for syringes, needles and certain other medical equipment - Part 1: General requirements" ISO 594-2:1998, "Conical fittings with a 6% (luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock fittings" ISO 1135-4:2012: "Transfusion equipment for medical use - Part 4: Transfusion sets for single use" ISO 8536-4:2010, "Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed" ISO 8536-8:2015, "Infusion equipment for medical use - Part 8: Infusion equipment for use with pressure infusion apparatus" ISO 11135-1:2007, "Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices" Successful functional performance testing was completed with the proposed Extension Sets with a stabilization component to demonstrate that the sets perform as intended. The following performance data were provided in support of the substantial equivalence determination: - Stabilization Component Angular/Axial Stabilization/Performance ● - Visual ● - Catheter Angle ● - Flow Rate No Catheter ● - Flow Rate - With Catheter - Tape Removal - Occlusion - Negative Pressure - Positive Pressure ● - Clamp and Positive Pressure - Tensile Strength ● - Power Injection ● - Mechanical Hemolysis Aspiration and Injection ● - Luer Connection {8}------------------------------------------------ - Gauging ● - Liquid and Air Leakage ● - Separation Force - Stress Cracking ● - Collar Retention ● - Joint Qualification - Particulate Contamination ● # Biocompatibility The materials of construction of the subject device were evaluated according to the provisions of ISO 10993-1:2009, "Biological evaluation of medical devices - part 1: Evaluation and testing within a risk management process". B. Braun applied component material testing as well as finished product testing to demonstrate the biocompatibility of the final device. B. Braun performed testing according to the following parts of the ISO 10993 standard. ISO 10993-4:2002, "Biological evaluation of medical devices - part 4: Selection of tests for interactions with blood" ISO 10993-5:2009, "Biological evaluation of medical devices - part 5: Tests for in vitro cytotoxicity" ISO 10993-10:2010, "Biological evaluation of medical devices - Part 10: Test for irritation and delayed-type hypersensitivity" ISO 10993-11:2006. "Biological evaluation of medical devices - Part 11: Test for systemic toxicity" ISO 10993-17:2002, "Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances" ISO 10993-18:2005,"Biological evaluation of medical devices - Part 18: Chemical characterization of materials" # CONCLUSION: Results of functional performance and biocompatibility testing conducted with the proposed device along with the same intended use, similarities in indications for use and technological characteristics demonstrate that the B. Braun Extension Sets are substantially equivalent to the predicate device.