IV Sets not made with PVC

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. March 19, 2020 B. Braun Medical Inc. Angela Caravella Sr. Regulatory Affairs Specialist 901 Marcon Boulevard Allentown, Pennsylvania 18109 Re: K191658 Trade/Device Name: IV Sets not made with PVC Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: FPA Dated: February 14, 2020 Received: February 18, 2020 Dear Angela Caravella: 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 {1}------------------------------------------------ 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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Tina Kiang, Ph.D. Director DHT3C: Division of Drug Delivery and General Hospital Devices. and Human Factors OHT3: Office of Gastrorenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K191658 Device Name IV Sets not made with PVC Indications for Use (Describe) The IV Administration Sets not made with PVC are intravenous administration sets intended for delivery of fluids from a container into a patient's vascular system. The IV Extension Sets not made with PVC may be used for direct injection, intermittent infusion, continuous infusion or aspiration of fluids, medications, blood and blood products. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------| | <label><input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> | <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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Braun Medical Inc. 510(k) Premarket Notification IV Sets not made with PVC ### 5. 510(k) SUMMARY | 510(k) Number: | K191658 | |--------------------|---------------------------------------------------------------------------------------------------------| | Date: | March 17, 2020 | | SUBMITTER: | B. Braun Medical Inc.<br>901 Marcon Boulevard<br>Allentown, PA 18109-9341<br>610-266-0500 | | | Contact: Angela J. Caravella<br>Sr. Regulatory Affairs Specialist | | | Phone: (610) 596-2966 | | | Fax: (610) 266-4962 | | | E-mail: angela.caravella@bbraunusa.com | | DEVICE NAME: | IV Sets not made with PVC | | COMMON NAME: | Intravascular Administration Set | | CLASSIFICATION: | Set, Administration, Intravascular, 21 CFR 880.5440, Class II,<br>Product Code FPA | | PREDICATE DEVICES: | K170595, IV Administration Sets, B. Braun Medical Inc.<br>K153293, Extension Set, B. Braun Medical Inc. | ## DEVICE DESCRIPTION: The IV Sets not made with PVC are gravity, single use, disposable, IV administration sets and extension sets. IV administration sets are used to deliver fluids from a container into a patient's vascular system. The IV extension sets are used for direct injection, intermittent infusion, continuous infusion or aspiration. These sets may be comprised of various components, which are broadly used throughout industry including insertion spikes, drip chambers, clamps, needleless luer access devices, check valves, tubing, filters, stopcocks and luer connections (connector, adaptor). The proposed sets have not been made with polyvinylchloride (PVC). The tubing in these sets is made of polyurethane (PUR). {4}------------------------------------------------ ### INDICATIONS FOR USE The IV Administration Sets not made with PVC are intravenous administration sets intended for delivery of fluids from a container into a patient's vascular system. The IV Extension Sets not made with PVC may be used for direct injection, intermittent infusion, continuous infusion or aspiration of fluids, medications, blood and blood products. #### SUBSTANTIAL EQUIVALENCE: The IV Sets not made with PVC are substantially equivalent to the B. Braun Medical Inc. IV Administration Sets (K170595) and the B. Braun Medical Inc. Extension Sets (K153293) predicate devices. The predicate devices used for comparison to the IV Sets not made with PVC were utilized to demonstrate the substantial equivalence in indications for use, intended use, and design between the proposed device and the predicate devices. The proposed IV Sets not made with PVC include IV Administration Sets and IV Extension Sets. The indications for use for the proposed IV Sets includes the indications for use from the predicate devices; IV Administration Sets and Extension Sets. The only exception is the predicate Extension Set indication for power injection compatibility. The proposed IV Sets not made with PVC are not indicated for power injection. This reduction in indications for use does not introduce a new intended use. The intended use of the proposed IV Administration Sets not made with PVC is identical to the predicate IV Administration Sets: Delivery of fluids from a container into a patient's vascular system. The intended use of the proposed Extension Sets not made with PVC is identical to the predicate Extension Sets: Direct injection, intermittent infusion, continuous infusion or aspiration. #### Comparison of Technological Characteristics with the Predicate Devices The IV Sets not made with PVC possess similar technological characteristics to the predicate devices B. Braun Medical Inc. IV Administration Sets cleared under K170595 and B. Braun Medical Inc. Extension Sets cleared under K153293. The two main differences between the proposed and predicate devices is in componentry: the proposed device tubing material utilizes polyurethane (PUR) within its formulation instead of polyvinylchloride (PVC) and some of the proposed devices contain an additional in-line AirStop filter. These technological differences between the proposed and predicate devices do not raise new issues of safety and effectiveness. Non-clinical testing was performed to demonstrate the differences {5}------------------------------------------------ did not raise new questions. A table summarizing the comparison between the IV Sets not made with PVC to the predicate devices is provided below: | Substantial Equivalence - Comparison of Proposed Device with Predicate Devices | | | | |--------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Proposed Device<br>IV Sets not made with<br>PVC | Predicate Device<br>(K170595) IV<br>Administration Sets | Predicate Device<br>(K153293) Extension Sets | | Intended Use | The IV Administration Sets<br>not made with PVC are<br>intravenous administration<br>sets intended for delivery<br>of fluids from a container<br>into a patient's vascular<br>system.<br>The IV Extension Sets not<br>made with PVC are<br>intended for direct<br>injection, intermittent<br>infusion, continuous<br>infusion or aspiration. | Delivery of fluids<br>from a container into a<br>patient's vascular<br>system. | Intended for direct<br>injection, intermittent<br>infusion, continuous<br>infusion or aspiration. | | Indications for<br>Use | The IV Administration Sets<br>not made with PVC are<br>intravenous administration<br>sets intended for delivery<br>of fluids from a container<br>into a patient's vascular<br>system.<br>The IV Extension Sets not<br>made with PVC may be<br>used for direct injection,<br>intermittent infusion,<br>continuous infusion or<br>aspiration of fluids,<br>medications, blood and<br>blood products. | The IV<br>Administration Sets<br>are intravenous<br>administration sets<br>intended for delivery<br>of fluids from a<br>container into a<br>patient's vascular<br>system.<br>These devices<br>may be used for any<br>patient population<br>with consideration<br>given to adequacy of<br>vascular anatomy and<br>appropriateness for<br>the solution being<br>infused and duration | B. Braun Extension Sets<br>may be used for direct<br>injection, intermittent<br>infusion, continuous<br>infusion or aspiration of<br>fluids, medications, blood<br>and blood products. Select<br>sets may be used with<br>power injector procedures<br>to a maximum pressure of<br>400 psi and a maximum<br>flow rate of 15 mL per<br>second. B. Braun's<br>optional stabilization<br>component on an<br>extension set provides<br>stability to an<br>intravascular catheter by<br>supporting the patient<br>connector. | | Substantial Equivalence - Comparison of Proposed Device with Predicate Devices | | | | | | Proposed Device<br>IV Sets not made with<br>PVC | Predicate Device<br>(K170595) IV<br>Administration Sets | Predicate Device<br>(K153293) Extension Sets | | | | therapy. | B. Braun Extension Sets<br>may be used for any<br>patient population. | | Mode of Fluid<br>Delivery | Gravity | Gravity | Gravity or Power<br>Injection | | Set Components | Sets configured with<br>various industry<br>standard components<br>including:<br>insertion spike<br>drip chamber<br>PUR tubing<br>luer connections<br>(connector/adaptor)<br>needleless luer access<br>device<br>stopcocks<br>clamps<br>check valve<br>in line filters | Sets configured with<br>various industry<br>standard components<br>including:<br>insertion spike<br>drip chamber<br>PVC tubing<br>luer connections<br>(connector/adaptor)<br>manifold<br>needleless luer access<br>device<br>stopcocks<br>clamps<br>check valve | PVC tubing<br>Luer<br>Slide clamp<br>Stabilization Component<br>Spin-lock connector<br>(patient connector/male<br>luer adapter) | | Materials | PUR, LDPE, HDPE, PC, PP,<br>PS, PE, MABS, SBC/SBS,<br>PTFE, Acrylic, Nylon,<br>Borosilicate glass fiber paper,<br>High impact polystyrene,<br>Polyamide,<br>Polyethersulphone,<br>Polyarylsulphone,<br>Polyvinylpyrrolidone,<br>Synthetic Polyisoprene,<br>Cyrolite, Parylene-N, Silicone<br>rubber, Liquid Silicone<br>rubber, Polydimethylsiloxane,<br>Cyclohexanone, Methyl Ethyl<br>Ketone (MEK), Methylene<br>Chloride (MC),<br>Tetrahydrofuran (THF) | PVC, LDPE, HDPE,<br>PC, PP, ABS, Stainless<br>steel, MABS, Acetal,<br>Acrylic, Nylon, High<br>impact polystyrene,<br>Polyamide, Santoprene,<br>Synthetic Polyisoprene,<br>Cyrolite, Parylene-N.<br>Silicone rubber, Liquid<br>silicone rubber,<br>Polydimethylsiloxane,<br>Cyclohexanone,<br>Methylene Chloride<br>(MC), Tetrahydrofuran<br>(THF) | PVC, LDPE, HDPE, PC,<br>PP, ABS, Methylene<br>Chloride (MC),<br>Tetrahydrofuran (THF) | | Summary of<br>non-clinical | ● Visual Inspection<br>● IV Spike function | ● Luer Compliance<br>● Priming Test / Air | ● Stabilization<br>● Component | | Substantial Equivalence - Comparison of Proposed Device with Predicate Devices | | | | | | Proposed Device<br>IV Sets not made with<br>PVC | Predicate Device<br>(K170595) IV<br>Administration Sets | Predicate Device<br>(K153293) Extension Sets | | tests for<br>determination<br>of substantial<br>equivalence | • Closure-piercing device<br>dimensions<br>• Priming/Air<br>Visualization<br>• Air-inlet device<br>function<br>• Flow Rate<br>• Filter performance<br>• Clamp (roller and slide)<br>function<br>• Drip Chamber Drop<br>former function<br>• Joint/leakage<br>(occlusion, positive<br>pressure, negative<br>pressure, static tensile,<br>dynamic tensile)<br>• Particulate<br>Contamination (USP<br>788 and ISO 8536-4)<br>• Microbial Ingress<br>(leveraged from<br>K140311) | • Visualization<br>• Flow rate and<br>occlusion<br>• Positive pressure<br>test<br>• Dynamic Tensile<br>test<br>• Static Tensile test | • Performance<br>• Visual<br>• Catheter Angle<br>• Flow Rate- No<br>Catheter<br>• Flow Rate - With<br>Catheter<br>• Tape Removal<br>• Occlusion<br>• Negative Pressure<br>• Positive Pressure<br>• Clamp and Positive<br>Pressure<br>• Tensile Strength<br>• Power Injection<br>• Mechanical<br>• Hemolysis -<br>Aspiration and<br>Injection<br>• Luer Connection<br>• Gauging<br>• Liquid and Air<br>Leakage<br>• Separation Force<br>• Stress Cracking<br>• Collar Retention<br>• Joint Qualification<br>• Particulate<br>Contamination | | Patient Contact<br>category /<br>duration | Externally Communicating,<br>Blood Path Indirect<br>prolonged exposure | Externally<br>Communicating,<br>Blood Path Indirect<br>prolonged exposure | Externally<br>Communicating, Blood<br>Path Indirect prolonged<br>exposure | | Biocompatibility | Conforms to ISO 10993-1 | Conforms to ISO<br>10993-1 | Conforms to ISO 10993-1 | | Sterilization | Ethylene Oxide, SAL 10-6 | Ethylene Oxide, SAL<br>10-6 | Ethylene Oxide, SAL 10-6 | {6}------------------------------------------------ {7}------------------------------------------------ {8}------------------------------------------------ ### Non Clinical Performance Testing Non-clinical performance testing was completed with the proposed IV Sets not made with PVC to demonstrate that the sets perform as intended. The test results demonstrated that the proposed device considered the following standards: ISO 8536-4: "Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed" ISO 8536-14: "Infusion Equipment For Medical Use – Part 14: Clamps and flow regulator for transfusion and infusion equipment without fluid contact" ISO 10993-1: "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" - Cytotoxicity Sensitization Irritation Systemic Toxicity Hemocompatibility Genotoxicity Material Mediated Pyrogenicity SubChronic Toxicity ISO 11135, "Sterilization of health care products – Ethylene oxide – Requirements for development, validation and routine control of a sterilization process for medical devices" ISO 80369-7, "Small-bore connectors for liquids and gases in healthcare applications- Part 7: Connectors for intravascular or hypodermic applications" ASTM F2096, "Standard Test Method for Detecting Gross Leaks in Medical Packaging by Internal Pressurization (Bubble Test)" In addition, the following functional and performance tests were successfully completed to demonstrate that the IV Administration Sets perform as intended. - · Particulate Contamination (USP 788 and ISO 8536-4) - · Microbial Ingress (leveraged from K140311) - Bacterial Endotoxin Testing . {9}------------------------------------------------ Results of the testing demonstrate that the proposed device can be used according to its intended use. No clinical testing was performed as this device does not require clinical studies to demonstrate substantial equivalence with the predicate device. ### CONCLUSION: Results of testing and content within this traditional 510(k) submission demonstrates that the proposed IV Sets not made with PVC are substantially equivalent to the predicate devices.