Who is the manufacturer of IV Administration Sets?

B.Braun Medical, Inc. filed the 510(k) submission for IV Administration Sets (K202618).

What is the FDA product code for IV Administration Sets?

FPA. It is classified under 21 CFR 880.5440 as a Class 2 device in the General Hospital panel.

What is the regulatory pathway for IV Administration Sets?

510(k) clearance (submission type: Traditional).

What are the predicate devices for IV Administration Sets?

IV Administration Sets (K170595); Extension Set (K153293).

Who can help prepare an FDA 510(k) submission like IV Administration Sets?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

IV Administration Sets

K202618 · B.Braun Medical, Inc. · FPA · Sep 24, 2021 · General Hospital

Device Facts

Record ID	K202618
Device Name	IV Administration Sets
Applicant	B.Braun Medical, Inc.
Product Code	FPA · General Hospital
Decision Date	Sep 24, 2021
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 880.5440
Device Class	Class 2
Attributes	Therapeutic

Intended Use

Delivery of fluids from a container into a patient's vascular system.

Device Story

IV Administration Sets are gravity-fed, single-use, disposable devices used to deliver fluids from a container into a patient's vascular system. Extension sets provide additional length, clamping, or access for direct injection, intermittent/continuous infusion, or aspiration. Components include insertion spikes, drip chambers, tubing, clamps, luer access devices, check valves, y-connectors, and flow regulators. Operated by healthcare professionals in clinical settings. The device functions as a conduit for fluid delivery; flow is managed via manual clamps or integrated flow regulators. Output is the controlled delivery of fluids to the patient. Benefits include reliable fluid administration and vascular access. The device does not support power injection or blood/blood product delivery.

Clinical Evidence

No clinical data. Bench testing only. Performance verified via ISO 8536-4, ISO 8536-13, ISO 8536-14, USP 788, and ISO 10993-1 standards, covering flow rate accuracy, pressure resistance, tensile strength, particulate contamination, and biocompatibility.

Technological Characteristics

Materials: ABS, Silicone, MABS, PC, LDPE, HDPE, Polyisoprene, Cyrolite, Synthetic Polyisoprene, Acrylic, Nylon, PVC, Polyamide, Stainless steel, Polypropylene, Acetal. Sterilization: Ethylene Oxide (SAL 10^-6). Connectivity: None (gravity-fed). Components: Insertion spike, drip chamber, tubing, luer connections, needleless access device, clamps, check valve, flow regulator, y-connector. Standards: ISO 8536-4, ISO 8536-13, ISO 8536-14, ISO 10993-1, USP 788, ISO 11135.

Indications for Use

Indicated for delivery of fluids from a container into a patient's vascular system. Extension sets are indicated for direct injection, intermittent infusion, continuous infusion, or aspiration of fluids and medications. Devices may be used for any patient population with consideration given to adequacy of vascular anatomy, appropriateness for the solution being infused, and duration of therapy.

Regulatory Classification

Identification

An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.

Special Controls

*Classification.* Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.

Predicate Devices

IV Administration Sets (K170595)
Extension Set (K153293)

Related Devices

K170595 — IV Administration Sets · B.Braun Medical, Inc. · Nov 7, 2017
K223645 — I.V. Administration Set, I.V. Extension Set · Bq Plus Medical Co., Ltd. · May 18, 2023
K991932 — INTRAVASCULAR ADMINISTRATION SET · The Kipp Group · Aug 20, 1999
K213588 — Q2 IV Administration Sets · Quest Medical, Inc. · Jun 2, 2022
K050906 — VITALCARE I.V. ADMINISTRATION SET · Vitalcare Group, Inc. · Aug 23, 2005

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows 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. September 24, 2021 B. Braun Medical Inc. Kimberly Smith Sr. Regulatory Affairs Specialist 901 Marcon Blvd. Allentown, Pennsylvania 18109-9341 Re: K202618 Trade/Device Name: IV Administration Sets Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular administration set Regulatory Class: Class II Product Code: FPA Dated: August 25, 2021 Received: August 26, 2021 Dear Kimberly 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. 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, For Payal Patel Assistant 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) K202618 Device Name IV Administration Sets Indications for Use (Describe) IV Sets are intravenous administration sets intended for delivery of fluids from a container into a patient's vascular system. These devices may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness for the solution being infused and duration of therapy. Extension Sets may be used for direction, intermittent infusion, continuous infusion or aspiration of fluids and medications. These devices may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness for the solution being infused and duration of therapy. X Prescription Use (Part 21 CFR 801 Subpart D) 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}------------------------------------------------ | 510(k) SUMMARY K202618 | | |--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | DATE: | September 23, 2021 | | SUBMITTER: | B. Braun Medical Inc. 901 Marcon Boulevard Allentown, PA 18109-9341 Contact: Kimberly Smith Phone: (610) 596-2326 Fax: (610) 266-4962 E-mail: kim.smith@bbraunusa.com | | TRADE OR PROPRIETARY DEVICE NAME: | IV Administration Sets | | COMMON NAME: CLASSIFICATION: | Intravascular Administration Set Intravascular administration set Class II, Product Code FPA, 21 CFR §880.5440 | | PREDICATE DEVICE: | K170595, IV Administration Sets, B. Braun Medical Inc. Class II, Product Code FPA, 21 CFR §880.5440 K153293, Extension Set, B. Braun Medical Inc. Class II, Product Code FPA, 21 CFR §880.5440 | | REASON FOR 510(K): | The following changes are addressed in this submission. • Indications for Use that include both IV Sets and Extension Sets • Addition of a flow regulator component · Addition of a 10 drop drip chamber component • Addition of a y-connector component | ### Description IV Administration Sets are gravity, single use, disposable, IV sets and extension sets. IV Administration Sets are used to deliver fluids from a container into a patient's vascular system. Extension sets are connected to primary IV administration 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 and are used for direct injection, intermittent infusion, continuous infusion or aspiration of fluids and medications. These sets may be comprised of various components which are broadly used throughout industry including insertion spike, drip chamber, clamp, luer access device, check valve, tubing, luer connections (connector/adaptor), y-connector, and flow regulator. {4}------------------------------------------------ ### Indications for Use IV Sets are intravenous administration sets intended for delivery of fluids from a container into a patient's vascular system. These devices may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness for the solution being infused and duration of therapy. Extension Sets may be used for direct injection, intermittent infusion, continuous infusion or aspiration of fluids and medications. These devices may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness for the solution being infused and duration of therapy. ### Intended Use Delivery of fluids from a container into a patient's vascular system. ### Substantial Equivalence The IV Administration Sets 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 IV Administration Sets presented in this submission have the same intended use, the same principle of operation, the same fundamental scientific technology, and similar Indications for Use as the predicate devices. They are comprised of similar component types and meet the same relevant performance specifications as the predicate devices. The differences between the predicate devices and the subject devices are the addition of a flow regulator component, a 10 drop drip chamber component, and a y-connector component. Additionally, the extension sets are not indicated for use with blood or blood products or for use with power injectors. The following Tables 1 and 2 summarize the comparison between the subject devices and the predicate devices. | Table 1-Comparison of Proposed and Predicate Devices IV Administration Sets | | | | |---------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Proposed Device (K202618) IV Administration Sets | Predicate Device (K170595) IV Administration Sets | Comparison of Differences and Similarities | | Manufacturer | B. Braun Medical Inc. | B. Braun Medical Inc. | Same | | Intended Use | Delivery of fluids from a container into a patient's vascular system. | Delivery of fluids from a container into a patient's vascular system. | Same | | Table 1-Comparison of Proposed and Predicate Devices IV Administration Sets | | | | | | Proposed Device (K202618) IV Administration Sets | Predicate Device (K170595) IV Administration Sets | Comparison of Differences and Similarities | | Indications for Use | IV Sets are intravenous administration sets intended for delivery of fluids from a container into a patient's vascular system. These devices may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness for the solution being infused and duration of therapy. | The IV Administration Sets are intravenous administration sets intended for delivery of fluids from a container into a patient's vascular system. These devices may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness for the solution being infused and duration of therapy. | Same | | Mode of Fluid Delivery | Gravity Administration | Gravity Administration | Same | | Set Components | Sets configured with various industry standard components including: insertion spike drip chamber PVC tubing luer connections (connector/ adaptor) needleless luer access device clamps check valve flow regulator y-connector | Sets configured with various industry standard components including: insertion spike drip chamber PVC tubing luer connections (connector/ adaptor) needleless luer access device clamps check valve manifold stopcocks | Different components. The proposed devices contain a flow regulator and y- connector component. Both the predicate and subject devices configurations achieve the same intended use. | | Summary of nonclinical tests for determination of substantial equivalence | • Priming Test / Air Visualization • Flow Rate and Occlusion • Positive Pressure • Negative Pressure • Dynamic Tensile • Static Tensile • Leakage • Clamp Pressure Resistance • Slide Clamp Pressure • Stability and Accuracy • Particulate Contamination • Microbial Ingress • Y-Connector Injection Site Assembly pressure and reseal | • Priming Test / Air Visualization • Flow Rate and Occlusion • Positive Pressure • Dynamic Tensile • Static Tensile • Luer Compliance | Additional verification testing was performed on the proposed device when compared to the predicate. Verification results confirm that the differences in the set components do not raise new or different questions of safety and effectiveness. | | Table 1-Comparison of Proposed and Predicate Devices IV Administration Sets | | | | | | Proposed Device (K202618) IV Administration Sets | Predicate Device (K170595) IV Administration Sets | Comparison of Differences and Similarities | | Materials | ABS, Silicone, MABS, PC, LDPE, HDPE, Polyisoprene, Cyrolite, Synthetic Polyisoprene, Acrylic, Nylon, PVC, Polyamide, Stainless steel, Polypropylene, Acetal, Cyclohexanone, Methyl Ethyl Ketone (MFK), Methylene Chloride (MC), Tetrahydrofuran (THF) | PVC, LDPE, HDPE, PC, PP, ABS, Stainless steel, MABS, Acetal, Acrylic, Nylon, High impact polystyrene, Polyamide, Santoprene, Synthetic Polyisoprene, Cyrolite, Parylene-N, Silicone rubber, Liquid silicone rubber, Polydimethylsiloxane, Cyclohexanone, Methylene Chloride(MC), Tetrahydrofuran(THF) | Materials were evaluated in accordance with ISO 10993-1 for both the predicate and subject devices. The different materials do not raise different questions of safety and effectiveness. | | Patient Contact category/duration | Externally Communicating, Blood Path Indirect prolonged exposure | Externally Communicating, Blood Path Indirect prolonged exposure | Same | | Biocompatibility | Conforms to ISO 10993-1 | Conforms to ISO 10993-1 | Same | | Sterilization | Ethylene Oxide, SAL 10-6 | Ethylene Oxide, SAL 10-6 | Same | {5}------------------------------------------------ {6}------------------------------------------------ {7}------------------------------------------------ | Table 2: Comparison of Proposed and Predicate Devices IV Administration Extension Sets | | | | |----------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Proposed Device (K202618) IV Administration Extension Sets | Predicate Device (K153293) Extension Sets | Comparison of Differences and Similarities | | Manufacturer | B. Braun Medical Inc. | B. Braun Medical Inc. | Same | | Intended Use | Delivery of fluids from a container into a patient's vascular system. | Delivery of fluids from a container into a patient's vascular system. | Same | | Indications for Use | Extension Sets may be used for direct injection, intermittent infusion, continuous infusion or aspiration of fluids and medications. These devices may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness for the solution being infused and duration of therapy. | 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 or 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. | Equivalent -Both the predicate and subject devices may be used for direct injection, intermittent infusion, continuous infusion or aspiration of fluids and medications and both may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness for the solution being infused and duration of therapy. The proposed devices are not indicated for use with blood or blood products and are not intended to be used for power injection. The proposed devices do not contain a stabilization component. The differences in the indications for use does not result in a new intended use. | | Mode of Fluid Delivery | Gravity Administration | Gravity or Power Injection | The proposed devices are not intended for power injection. | | Set Components | Sets configured with various industry standard components including: | Sets configured with various industry standard components including: | Different components. The proposed devices contain a flow regulator and y- connector. The differences | | | PVC tubing luer connections (connector/ adaptor) Spin-lock connector needleless luer access device flow regulator y-connector clamps check valve | PVC tubing Luer Slide Clamp Stabilization Component Spin-lock connector (patient connector/male luer adapter) | between the subject and predicate configurations do not raise different questions of safety and effectiveness. Both the predicate and subject devices configurations achieve the same intended use. | | ' Table 2: Comparison of Proposed and Predicate Devices IV Administration Extension Sets | | |------------------------------------------------------------------------------------------|--| |------------------------------------------------------------------------------------------|--| {8}------------------------------------------------ | | Proposed Device (K202618) IV Administration Extension Sets | Predicate Device (K153293) Extension Sets | Comparison of Differences and Similarities | |---------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Summary of nonclinical tests for determination of substantial equivalence | Priming Test / Air Visualization Flow Rate and Occlusion Leakage Positive Pressure Negative Pressure Dynamic Tensile Static Tensile Clamp Pressure Resistance Slide Clamp Pressure Stability and Accuracy Particulate Contamination Y-Connector Injection Site Assembly pressure and reseal Microbial Ingress | Stabilization Component Performance Visual Catheter Angle Flow Rate-No Catheter Tape Removal Occlusion Negative Pressure Positive Pressure Clamp and Positive Pressure Tensile Strength Power Injection Mechanical Hemolysis - Aspiration and Injection Luer Connection Gauging Liquid and Air Leakage Separation Force Stress Cracking Collar Retention Joint Qualification Particulate Contamination | Verification testing was performed on the proposed device. Verification results confirm that the differences in the set components do not raise new questions of safety and effectiveness. | | Materials | ABS, Silicone, MABS, PC, LDPE, HDPE, Polyisoprene, Cyrolite, Synthetic Polyisoprene, Acrylic, Nylon, PVC, Polyamide, Stainless steel, Polypropylene, Acetal, Cyclohexanone, Methyl Ethyl Ketone (MFK), Methylene Chloride (MC), Tetrahydrofuran (THF) | PVC, LDPE, HDPE, PC, PP, ABS, Methylene Chloride (MC), Tetrahydrofuran (THF) | Materials were evaluated in accordance with ISO 10993-1 for both the predicate and subject devices. The different materials do not raise different questions of safety and effectiveness. | | Patient Contact category/duration | Externally Communicating, Blood Path Indirect prolonged exposure | Externally Communicating, Blood Path Indirect prolonged exposure | Same | | Biocompatibility | Conforms to ISO 10993-1 | Conforms to ISO 10993-1 | Same | ### 12 ﺎ ﻓﻲ ﺍﻟﺘﻲ d Prodicato Davices IV Adminiatration - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - Toblo 2. C. E # Non Clinical Performance Testing The non clinical performance tests successfully completed are listed under the applicable standard. Standard {9}------------------------------------------------ ISO 8536-4:2019, "Infusion equipment for medical use - Part 4: Infusion sets for single use, gravitv feed" Tests - Positive Pressure Test of IV Set, Negative Pressure Test of IV Set, Static Tensile Test, Visual Test, Particulate Contamination Test ## Standard ISO 8536-13:2016, "Infusion equipment for medical use - Part 13: Graduation flow regulators for single use with fluid contact" Tests - Flow Rate Accuracy Test, Flow Rate Stability Test, Positive Pressure Test of Rate Control Device at Various Dial Settings, Negative Pressure Test of Rate Control Device at Various Dial Settings ### Standard ISO 8536-14:2016, "Infusion equipment for medical use - Part 14: Clamps and flow regulators for transfusion and infusion equipment without fluid contact" Tests - Clamp Pressure Resistance, Slide Clamp Pressure Standard USP<788> Test - Particulate Matter in Injections ## Standard ISO 10993-1:2018, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" Tests - Cytotoxicity, Sensitization, Intracutaneous Reactivity, Systemic Toxicity, Sub-Chronic Toxicity, Hemocompatibility, Material Mediated Rabbit Pyrogen Standard ISO 11135, "Sterilization of health care products - Ethylene oxide - Requirements for development, validation and routine control of a sterilization process for medical devices" ### Additional tests performed per internal B. Braun procedure - · Priming and Flow Rate - · Y-Connector Injection Site Assembly pressure and reseal - Microbial Ingress Results of the testing demonstrate that the proposed devices can be used according to their intended use. Clinical Tests Not applicable ### CONCLUSION The differences between the predicate and the subject device do not raise any new or different questions of safety or effectiveness. The results of testing and content within this traditional {10}------------------------------------------------ 510(k) submission demonstrates that the proposed IV Administration Sets are substantially equivalent to the predicate devices.