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.

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).

AI/ML Overview

I am sorry, but based on the provided text, I cannot describe the acceptance criteria and the study that proves the device meets them in the format you requested because the document is a 510(k) premarket notification for "IV Sets not made with PVC", which demonstrates substantial equivalence to predicate devices, rather than presenting a study with specific acceptance criteria and performance data for a novel device.

Here's why I cannot fulfill your request:

No Acceptance Criteria for "Novel" Performance: The document aims to establish "substantial equivalence" of the new device ("IV Sets not made with PVC") to already cleared predicate devices. It doesn't set new performance acceptance criteria in the way a novel device might. Instead, it compares the proposed device's characteristics and performance testing results to those of the predicate devices and relevant industry standards (ISO, ASTM) to show they are "substantially equivalent."
Performance is Compared, Not a Single Device's Performance Against Criteria: The "device performance" reported is a comparison of the proposed device's attributes and test results to those of the predicate devices, rather than a standalone performance metric against a set acceptance threshold.
No Standalone Performance Study: The document explicitly states: "No clinical testing was performed as this device does not require clinical studies to demonstrate substantial equivalence with the predicate device." Non-clinical tests were conducted to show the proposed device performs as intended and that differences (like tubing material) do not raise new safety/effectiveness issues, but this is distinct from a standalone performance study with specific acceptance thresholds for a novel claim.
No MRMC Study: A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is entirely irrelevant to this type of device (IV administration sets) and this type of regulatory submission (510(k) for substantial equivalence based on non-clinical testing). MRMC studies are typically for image-based diagnostic devices.
No Explicit Test Set/Training Set: The tests listed are non-clinical, functional, and performance tests on the device itself, not a statistical study on a "test set" of patient data or "training set" of data.
Ground Truth Irrelevance: "Ground truth" (expert consensus, pathology, outcomes data) is a concept typically applied to diagnostic or prognostic devices where a "true" condition needs to be established for comparison. For an IV set, the "ground truth" equates to whether the device meets its functional and biocompatibility requirements.

The document focuses on:

Intended Use and Indications for Use: Showing they are substantially equivalent to the predicate devices (with slight reduction in indication for power injection).
Technological Characteristics: Highlighting the main differences (PUR tubing and an in-line AirStop filter) and explaining why these do not raise new safety/effectiveness issues.
Non-Clinical Performance Testing: Demonstrating the device meets relevant recognized standards (ISO, ASTM) and functional requirements (e.g., flow rate, particulate contamination, microbial ingress, biocompatibility, sterilization). These tests are designed to show the device is safe and performs as intended, similar to the predicate devices.

Therefore, I cannot provide the requested table or information because the nature of this 510(k) submission does not include the elements of acceptance criteria, standalone performance against those criteria, or a study design (test set, ground truth, experts, MRMC) as typically seen for devices making novel diagnostic or therapeutic claims. The "acceptance criteria" here are implicitly that the device performs equivalently to the predicate devices and meets relevant industry standards for safety and function.

Summary

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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

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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

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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)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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B. 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.901 Marcon BoulevardAllentown, PA 18109-9341610-266-0500
	Contact: Angela J. CaravellaSr. 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,Product Code FPA
PREDICATE DEVICES:	K170595, IV Administration Sets, B. Braun Medical Inc.K153293, Extension Set, B. Braun Medical Inc.

DEVICE DESCRIPTION:

The proposed sets have not been made with polyvinylchloride (PVC). The tubing in these sets is made of polyurethane (PUR).

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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

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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 DeviceIV Sets not made withPVC	Predicate Device(K170595) IVAdministration Sets	Predicate Device(K153293) Extension Sets
Intended Use	The IV Administration Setsnot made with PVC areintravenous administrationsets intended for deliveryof fluids from a containerinto a patient's vascularsystem.The IV Extension Sets notmade with PVC areintended for directinjection, intermittentinfusion, continuousinfusion or aspiration.	Delivery of fluidsfrom a container into apatient's vascularsystem.	Intended for directinjection, intermittentinfusion, continuousinfusion or aspiration.
Indications forUse	The IV Administration Setsnot made with PVC areintravenous administrationsets intended for deliveryof fluids from a containerinto a patient's vascularsystem.The IV Extension Sets notmade with PVC may beused for direct injection,intermittent infusion,continuous infusion oraspiration of fluids,medications, blood andblood products.	The IVAdministration Setsare intravenousadministration setsintended for deliveryof fluids from acontainer into apatient's vascularsystem.These devicesmay be used for anypatient populationwith considerationgiven to adequacy ofvascular anatomy andappropriateness forthe solution beinginfused and duration	B. Braun Extension Setsmay be used for directinjection, intermittentinfusion, continuousinfusion or aspiration offluids, medications, bloodand blood products. Selectsets may be used withpower injector proceduresto a maximum pressure of400 psi and a maximumflow rate of 15 mL persecond. B. Braun'soptional stabilizationcomponent on anextension set providesstability to anintravascular catheter bysupporting the patientconnector.
Substantial Equivalence - Comparison of Proposed Device with Predicate Devices
	Proposed DeviceIV Sets not made withPVC	Predicate Device(K170595) IVAdministration Sets	Predicate Device(K153293) Extension Sets
		therapy.	B. Braun Extension Setsmay be used for anypatient population.
Mode of FluidDelivery	Gravity	Gravity	Gravity or PowerInjection
Set Components	Sets configured withvarious industrystandard componentsincluding:insertion spikedrip chamberPUR tubingluer connections(connector/adaptor)needleless luer accessdevicestopcocksclampscheck valvein line filters	Sets configured withvarious industrystandard componentsincluding:insertion spikedrip chamberPVC tubingluer connections(connector/adaptor)manifoldneedleless luer accessdevicestopcocksclampscheck valve	PVC tubingLuerSlide clampStabilization ComponentSpin-lock connector(patient connector/maleluer adapter)
Materials	PUR, LDPE, HDPE, PC, PP,PS, PE, MABS, SBC/SBS,PTFE, Acrylic, Nylon,Borosilicate glass fiber paper,High impact polystyrene,Polyamide,Polyethersulphone,Polyarylsulphone,Polyvinylpyrrolidone,Synthetic Polyisoprene,Cyrolite, Parylene-N, Siliconerubber, Liquid Siliconerubber, Polydimethylsiloxane,Cyclohexanone, Methyl EthylKetone (MEK), MethyleneChloride (MC),Tetrahydrofuran (THF)	PVC, LDPE, HDPE,PC, PP, ABS, Stainlesssteel, MABS, Acetal,Acrylic, Nylon, Highimpact polystyrene,Polyamide, Santoprene,Synthetic Polyisoprene,Cyrolite, Parylene-N.Silicone rubber, Liquidsilicone rubber,Polydimethylsiloxane,Cyclohexanone,Methylene Chloride(MC), Tetrahydrofuran(THF)	PVC, LDPE, HDPE, PC,PP, ABS, MethyleneChloride (MC),Tetrahydrofuran (THF)
Summary ofnon-clinical	● Visual Inspection● IV Spike function	● Luer Compliance● Priming Test / Air	● Stabilization● Component
Substantial Equivalence - Comparison of Proposed Device with Predicate Devices
	Proposed DeviceIV Sets not made withPVC	Predicate Device(K170595) IVAdministration Sets	Predicate Device(K153293) Extension Sets
tests fordeterminationof substantialequivalence	• Closure-piercing devicedimensions• Priming/AirVisualization• Air-inlet devicefunction• Flow Rate• Filter performance• Clamp (roller and slide)function• Drip Chamber Dropformer function• Joint/leakage(occlusion, positivepressure, negativepressure, static tensile,dynamic tensile)• ParticulateContamination (USP788 and ISO 8536-4)• Microbial Ingress(leveraged fromK140311)	• Visualization• Flow rate andocclusion• Positive pressuretest• Dynamic Tensiletest• Static Tensile test	• Performance• Visual• Catheter Angle• Flow Rate- NoCatheter• Flow Rate - WithCatheter• Tape Removal• Occlusion• Negative Pressure• Positive Pressure• Clamp and PositivePressure• Tensile Strength• Power Injection• Mechanical• Hemolysis -Aspiration andInjection• Luer Connection• Gauging• Liquid and AirLeakage• Separation Force• Stress Cracking• Collar Retention• Joint Qualification• ParticulateContamination
Patient Contactcategory /duration	Externally Communicating,Blood Path Indirectprolonged exposure	ExternallyCommunicating,Blood Path Indirectprolonged exposure	ExternallyCommunicating, BloodPath Indirect prolongedexposure
Biocompatibility	Conforms to ISO 10993-1	Conforms to ISO10993-1	Conforms to ISO 10993-1
Sterilization	Ethylene Oxide, SAL 10-6	Ethylene Oxide, SAL10-6	Ethylene Oxide, SAL 10-6

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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 .

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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.

Regulation Number and Section

§ 880.5440 Intravascular administration set.

(a)
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.(b)
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.