(379 days)
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.
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.
This is a 510(k) summary for IV Administration Sets by B. Braun Medical Inc. The document discusses the substantial equivalence of their proposed device (K202618) to two predicate devices (K170595 and K153293). It details the non-clinical performance testing conducted.
Here's an analysis of the provided text in response to your questions:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of "acceptance criteria" alongside specific quantitative performance metrics as typically seen in device efficacy studies (e.g., Sensitivity, Specificity, Accuracy for diagnostic devices). Instead, it lists various non-clinical tests performed to demonstrate substantial equivalence to predicate devices and conformity to established standards. The "performance" is reported as a conclusion that the tests were "successfully completed" or that "verification results confirm that the differences in the set components do not raise new or different questions of safety and effectiveness."
Here's a compilation of the tests and the implicit performance:
| Acceptance Criterion (Implied Standard/Test) | Reported Device Performance |
|---|---|
| IV Administration Sets (Proposed K202618 vs. Predicate K170595) | |
| Priming Test / Air Visualization | Verification results confirm no new safety/effectiveness concerns |
| Flow Rate and Occlusion | Verification results confirm no new safety/effectiveness concerns |
| Positive Pressure | Verification results confirm no new safety/effectiveness concerns |
| Negative Pressure (Additional test performed for proposed device) | Verification results confirm no new safety/effectiveness concerns |
| Dynamic Tensile | Verification results confirm no new safety/effectiveness concerns |
| Static Tensile | Verification results confirm no new safety/effectiveness concerns |
| Leakage (Additional test performed for proposed device) | Verification results confirm no new safety/effectiveness concerns |
| Clamp Pressure Resistance (Additional test performed for proposed device) | Verification results confirm no new safety/effectiveness concerns |
| Slide Clamp Pressure (Additional test performed for proposed device) | Verification results confirm no new safety/effectiveness concerns |
| Stability and Accuracy (Additional test performed for proposed device) | Verification results confirm no new safety/effectiveness concerns |
| Particulate Contamination (Additional test performed for proposed device) | Verification results confirm no new safety/effectiveness concerns |
| Microbial Ingress (Additional test performed for proposed device) | Verification results confirm no new safety/effectiveness concerns |
| Y-Connector Injection Site Assembly Pressure and Reseal (Additional test) | Verification results confirm no new safety/effectiveness concerns |
| Biocompatibility (Conformity to ISO 10993-1) | Conformed to ISO 10993-1 (Same as predicate) |
| Sterilization (Ethylene Oxide, SAL 10-6) | Ethylene Oxide, SAL 10-6 (Same as predicate) |
| For Components with Flow Regulators (Applicable to proposed device) | |
| Flow Rate Accuracy Test (ISO 8536-13:2016) | Successfully completed |
| Flow Rate Stability Test (ISO 8536-13:2016) | Successfully completed |
| Positive Pressure Test of Rate Control Device at Various Dial Settings (ISO 8536-13:2016) | Successfully completed |
| Negative Pressure Test of Rate Control Device at Various Dial Settings (ISO 8536-13:2016) | Successfully completed |
| For Clamps and Flow Regulators (Applicable to proposed device) | |
| Clamp Pressure Resistance (ISO 8536-14:2016) | Successfully completed |
| Slide Clamp Pressure (ISO 8536-14:2016) | Successfully completed |
| General Tests | |
| Particulate Matter in Injections (USP<788>) | Successfully completed |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not specify the sample sizes used for the non-clinical tests. Non-clinical studies for devices like IV administration sets typically involve testing a statistically significant number of units to ensure reliability, but the exact numbers are not disclosed in this summary.
The data provenance is from non-clinical performance testing conducted by B. Braun Medical Inc. The studies are by nature prospective as they are specifically conducted to support the 510(k) submission. There is no information regarding the country of origin of the data beyond the manufacturer being B. Braun Medical Inc. (located in Allentown, Pennsylvania, USA).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not applicable in the context of this 510(k) summary. The ground truth for the non-clinical performance tests is based on objective measurements against established engineering standards (e.g., ISO, USP) and internal B. Braun procedures, not on expert consensus or interpretation.
4. Adjudication Method for the Test Set
This is not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies or studies involving human readers/interpreters to resolve discrepancies in diagnoses or assessments. The tests described here are physical and mechanical performance tests with objective pass/fail criteria based on standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
There was no MRMC comparative effectiveness study done. This device is an IV administration set, a physical medical device, not an AI-powered diagnostic or assistive tool for human readers. Therefore, the concept of human readers improving with or without AI assistance is irrelevant here.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
There was no standalone (algorithm only) performance study done. As mentioned, this is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the non-clinical performance tests is derived from established industry standards (ISO, USP) and internal B. Braun procedures, which outline specific test methodologies, parameters, and pass/fail criteria. For instance, for flow rate, the ground truth would be the expected flow rate range defined by the standard under specific conditions. For tensile strength, it would be the minimum force the material must withstand.
8. The Sample Size for the Training Set
This is not applicable. This is a physical medical device, and the evaluation involves non-clinical performance testing, not machine learning or AI that requires a "training set" of data.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the same reasons as point 8.
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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
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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,
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
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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)
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| 510(k) SUMMARY K202618 | |
|---|---|
| DATE: | September 23, 2021 |
| SUBMITTER: | B. Braun Medical Inc.901 Marcon BoulevardAllentown, PA 18109-9341Contact: Kimberly SmithPhone: (610) 596-2326Fax: (610) 266-4962E-mail: kim.smith@bbraunusa.com |
| TRADE OR PROPRIETARYDEVICE NAME: | IV Administration Sets |
| COMMON NAME:CLASSIFICATION: | Intravascular Administration SetIntravascular administration setClass 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 §880.5440K153293, 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 andExtension 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.
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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 Differencesand Similarities | |
| Manufacturer | B. Braun Medical Inc. | B. Braun Medical Inc. | Same |
| Intended Use | Delivery of fluids from acontainer into a patient'svascular system. | Delivery of fluids from acontainer into a patient'svascular 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 Differencesand Similarities | |
| Indications forUse | IV Sets are intravenousadministration sets intendedfor delivery of fluids from acontainer into a patient'svascular system.These devices may be usedfor any patient populationwith consideration given toadequacy of vascularanatomy and appropriatenessfor the solution being infusedand duration of therapy. | The IV Administration Setsare intravenousadministration sets intendedfor delivery of fluids from acontainer into a patient'svascular system.These devices may be usedfor any patient populationwith consideration given toadequacy of vascularanatomy and appropriatenessfor the solution being infusedand duration of therapy. | Same |
| Mode of FluidDelivery | Gravity Administration | Gravity Administration | Same |
| Set Components | Sets configured with variousindustry standardcomponents including:insertion spikedrip chamberPVC tubingluer connections (connector/adaptor)needleless luer access deviceclampscheck valveflow regulatory-connector | Sets configured with variousindustry standardcomponents including:insertion spikedrip chamberPVC tubingluer connections (connector/adaptor)needleless luer access deviceclampscheck valvemanifoldstopcocks | Different components.The proposed devices containa flow regulator and y-connector component.Both the predicate andsubject devicesconfigurations achieve thesame intended use. |
| Summary ofnonclinical testsfor determinationof substantialequivalence | • Priming Test / AirVisualization• 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 SiteAssembly pressure andreseal | • Priming Test / AirVisualization• Flow Rate and Occlusion• Positive Pressure• Dynamic Tensile• Static Tensile• Luer Compliance | Additional verificationtesting was performed on theproposed device whencompared to the predicate.Verification results confirmthat the differences in the setcomponents do not raise newor different questions ofsafety 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 Differencesand Similarities | |
| Materials | ABS, Silicone, MABS, PC,LDPE, HDPE,Polyisoprene, Cyrolite,Synthetic Polyisoprene,Acrylic, Nylon, PVC,Polyamide, Stainless steel,Polypropylene, Acetal,Cyclohexanone, MethylEthyl Ketone (MFK),Methylene Chloride (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) | Materials were evaluated inaccordance with ISO 10993-1for both the predicate andsubject devices. The differentmaterials do not raise differentquestions of safety andeffectiveness. |
| Patient Contactcategory/duration | Externally Communicating,Blood Path Indirectprolonged exposure | Externally Communicating,Blood Path Indirectprolonged 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 |
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| Table 2: Comparison of Proposed and Predicate Devices IV Administration Extension Sets | |||
|---|---|---|---|
| Proposed Device(K202618)IV AdministrationExtension Sets | Predicate Device(K153293)Extension Sets | Comparison of Differencesand Similarities | |
| Manufacturer | B. Braun Medical Inc. | B. Braun Medical Inc. | Same |
| Intended Use | Delivery of fluids from acontainer into a patient'svascular system. | Delivery of fluids from acontainer into a patient'svascular system. | Same |
| Indications forUse | Extension Sets may be usedfor direct injection,intermittent infusion,continuous infusion oraspiration of fluids andmedications.These devices may be usedfor any patient populationwith consideration given toadequacy of vascularanatomy andappropriateness for thesolution being infused andduration of therapy. | B. Braun Extension Sets maybe used for direct injection,intermittent infusion,continuous infusion oraspiration of fluids,medications, blood and bloodproducts. Select sets may beused with power injectorprocedures or a maximumpressure of 400 psi and amaximum flow rate of 15 mLper second. B. Braun'soptional stabilizationcomponent on an extensionset provides stability to anintravascular catheter bysupporting the patientconnector. B. BraunExtension sets may be usedfor any patient population. | Equivalent -Both thepredicate and subject devicesmay be used for directinjection, intermittentinfusion, continuous infusionor aspiration of fluids andmedications and both may beused for any patientpopulation with considerationgiven to adequacy of vascularanatomy and appropriatenessfor the solution being infusedand duration of therapy. Theproposed devices are notindicated for use with bloodor blood products and are notintended to be used for powerinjection. The proposeddevices do not contain astabilization component. Thedifferences in the indicationsfor use does not result in anew intended use. |
| Mode of FluidDelivery | Gravity Administration | Gravity or Power Injection | The proposed devices are notintended for power injection. |
| Set Components | Sets configured withvarious industry standardcomponents including: | Sets configured with variousindustry standardcomponents including: | Different components.The proposed devices containa flow regulator and y-connector. The differences |
| PVC tubingluer connections (connector/adaptor)Spin-lock connectorneedleless luer access deviceflow regulatory-connectorclampscheck valve | PVC tubingLuerSlide ClampStabilization ComponentSpin-lock connector(patient connector/male lueradapter) | between the subject andpredicate configurations donot raise different questionsof safety and effectiveness.Both the predicate andsubject devicesconfigurations achieve thesame intended use. |
| ' Table 2: Comparison of Proposed and Predicate Devices IV Administration Extension Sets | |
|---|---|
| ------------------------------------------------------------------------------------------ | -- |
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| Proposed Device(K202618)IV AdministrationExtension Sets | Predicate Device(K153293)Extension Sets | Comparison of Differencesand Similarities | |
|---|---|---|---|
| Summary ofnonclinical testsfor determinationof substantialequivalence | Priming Test / AirVisualization Flow Rate and Occlusion Leakage Positive Pressure Negative Pressure Dynamic Tensile Static Tensile Clamp PressureResistance Slide Clamp Pressure Stability and Accuracy Particulate Contamination Y-Connector InjectionSite Assembly pressureand reseal Microbial Ingress | Stabilization ComponentPerformance Visual Catheter Angle Flow Rate-No Catheter Tape Removal Occlusion Negative Pressure Positive Pressure Clamp and PositivePressure 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 wasperformed on the proposeddevice. Verification resultsconfirm that the differencesin the set components do notraise new questions of safetyand effectiveness. |
| Materials | ABS, Silicone, MABS, PC,LDPE, HDPE,Polyisoprene, Cyrolite,Synthetic Polyisoprene,Acrylic, Nylon, PVC,Polyamide, Stainless steel,Polypropylene, Acetal,Cyclohexanone, MethylEthyl Ketone (MFK),Methylene Chloride (MC),Tetrahydrofuran (THF) | PVC, LDPE, HDPE, PC,PP, ABS, MethyleneChloride (MC),Tetrahydrofuran (THF) | Materials were evaluated inaccordance with ISO 10993-1for both the predicate andsubject devices. The differentmaterials do not raisedifferent questions of safetyand effectiveness. |
| Patient Contactcategory/duration | Externally Communicating,Blood Path Indirectprolonged exposure | Externally Communicating,Blood Path Indirectprolonged 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
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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
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510(k) submission demonstrates that the proposed IV Administration Sets are substantially equivalent to the predicate devices.
§ 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.