The BD Texium™ Closed Male Luer (CML) is a sterile, single-use closed system drug transfer device (CSTD) intended for the reconstitution, transfer and administration of hazardous drugs when paired with the SmartSite™ NFC.

The BD Texium™ Closed Male Luer (CML) is indicated for use by trained healthcare professionals within healthcare facilities who prepare and/or administer non-hazardous drugs for adults, pediatrics and neonates.

Device Description

The BD Texium™ CML is an airtight, leak-free and drip-free closed system drug transfer device (CSTD). When paired with devices containing a SmartSite™ NFC, the BD Texium™ CML mechanically prohibits the transfer of environmental contaminants into the system and the escape of drug vapor concentrations outside the BD Texium™ CML/SmartSite™ NFC connection, thereby minimizing individual and environmental exposure to drugs, leaks and spills. The BD Texium™ CML is a sterile single-use CSTD intended for the reconstitution, transfer and administration of hazardous and non-hazardous drugs when paired with the SmartSite™ NFC.

AI/ML Overview

This document describes the premarket notification (510(k)) for the BD Texium™ Closed Male Luer (CML). It is a sterile, single-use closed system drug transfer device (CSTD) intended for the reconstitution, transfer, and administration of hazardous and non-hazardous drugs when paired with the SmartSite™ Needle-Free Connector (NFC).

Here's an analysis of the acceptance criteria and study data:

Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria alongside performance data in a dedicated section. However, the "Technological Characteristics and Substantial Equivalence" table outlines differences and similarities between the subject device (BD Texium™ CML) and the predicate device (Alaris® Safety Male Luer, K053049) and indicates where testing was conducted to verify new claims or differences. The "Substantial Equivalence Discussion" and "Discussion of Non-Clinical Tests" sections detail the types of tests performed and state that "All test results met their acceptance criteria".

Below is a reconstructed table based on the provided text, indicating acceptance criteria implicitly by reference to the predicate or standards, and the reported performance as meeting those criteria.

Feature / Test Category	Acceptance Criteria (Implicit from Predicate/Standards)	Reported Device Performance
FDA Regulation Number	21 CFR 880.5440 (Intravascular Administration Set)	Same as Predicate
FDA Regulation Name	Intravascular Administration Set	Same as Predicate
FDA Class	Class II	Same as Predicate
Principle of Operation	Airtight, leak-free, drip-free, mechanically prohibits transfer of environmental contaminants and escape of drug vapor (similar to predicate)	Equivalent; air leakage, vacuum leakage, fluid leakage, and residual fluid testing verified new claims.
Device Compatibility	Use with SmartSite™ Needle-Free Connector (similar to predicate's SmartSite™ Needle Free Valve port)	Equivalent; device to be used with SmartSite™ Needle-Free Connector.
Method of Administration	Closed system drug transfer device (CSTD)	Same as Predicate
Non-DEHP	Yes	Same as Predicate
Device Components/Materials	Biocompatible and functionally equivalent materials (predicate materials: Polycarbonate, Polypropylene, TPE, Silicone, Fluorosilicone Fluid, Acetal, PTFE). Verification through biocompatibility testing, ISO 80369-7, air/vacuum/fluid leakage.	Different materials, but biocompatibility testing conducted to assess new materials; female luer body design changes verified through ISO 80369-7; actuator and male luer body changes verified through air/vacuum/fluid leakage.
Packaging	Maintain sterility and integrity (similar to predicate packaging). Verification through packaging validation.	Different packaging, but packaging validation verifies new webs.
No natural rubber latex	Yes	Same as Predicate
Sterilization Method	Irradiation	Same as Predicate
Sterilization Claim	Content Sterile (predicate claims Fluid Path Sterile). Verification through package integrity testing.	Different claim, but package integrity testing (seal strength, corner thickness, seal width, air volume, microbial barrier, dye test, bubble leak testing) verified sterile barrier claim.
Biocompatibility	Biocompatible for intended use per ISO 10993-1 and related sub-standards (similar to predicate).	Same as Predicate; specific testing per ISO 10993-1, -3, -4, -5, -10, -11, -17, -18, -23.
Non-Pyrogenic	Yes	Same as Predicate
Duration of Use	7 days	Same as Predicate
Disinfect with 70% IPA	Disinfect with 70% Isopropyl Alcohol	Same as Predicate
Priming Volume	≤ 0.2 ml maximum (predicate specification)	0.17 ml (within predicate specification)
Flow Rate	≥ 4756 ml/hr (predicate specification)	>4280 ml/hr, when activated with min 3.2 mm insertion depth (flow rate conducted to verify rate). Implicitly meets internal specification, though slightly lower than predicate.
Shelf Life	3 Years	Same as Predicate; data supports 3 years.
Particulate Testing	Meets requirements of USP, General Chapter <788>, Particulate Matter in Injections.	Device meets particulate requirements.
Microbial Ingress	Performance demonstrated according to FDA guidance.	Additional testing conducted for harsh infusates.

Study Details

The document describes non-clinical testing to demonstrate substantial equivalence to a predicate device.

Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- The document does not specify the exact sample sizes for each non-clinical test (e.g., number of devices tested for leakage, biocompatibility, flow rate).
- The data provenance is not explicitly stated regarding country of origin or whether it was retrospective or prospective. Given it's a premarket submission for a new device design and material changes, the testing is prospective and conducted by the manufacturer, CareFusion/BD.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
- This is a non-clinical device test for physical and chemical properties, not a clinical study involving diagnosis or interpretation by human experts. Therefore, the concept of "experts establishing ground truth" as it applies to AI/clinical diagnostic studies is not relevant here. Ground truth is established by standardized test methods and measurement equipment.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable as this is not a study involving human interpretation or clinical adjudication. Test results are objective measurements against predefined criteria from standards.
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:
- No MRMC study was done. This is a non-clinical device submission, not an AI/software as a medical device (SaMD) product.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device, not an algorithm or AI.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the non-clinical tests is established by recognized international and national standards (e.g., ISO, USP, ASTM, ANSI/AAMI) and the performance of a legally marketed predicate device. For example:
  - Biocompatibility: Conformance to ISO 10993 series of standards.
  - Sterilization: Conformance to ISO 11137 series and USP chapters.
  - Packaging: Conformance to ISO 11607 series and ASTM standards.
  - Performance (Leakage, Flow Rate, etc.): Conformance to ISO 80369 series and ISO 8536-4, as well as showing performance equivalent to or better than the predicate device.
  - Particulate: Conformance to USP <788>.
The sample size for the training set:
- Not applicable. This is a physical device, not an AI/ML model that requires a training set. The device design and materials are developed and then validated through testing.
How the ground truth for the training set was established:
- Not applicable, as there is no training set for a physical device.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".

March 24, 2023

CareFusion Elgin Oktay Staff Regulatory Affairs Specialist 10020 Pacific Mesa Blvd San Diego, California 92121

Re: K223076

Trade/Device Name: BD Texium™ Closed Male Luer Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: ONB Dated: February 24, 2023 Received: February 24, 2023

Dear Elgin Oktay:

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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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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 (QS) 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,

David Walloschek

David Wolloscheck, Ph.D. Acting 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) K223076

Device Name BD Texium™ Closed Male Luer

Indications for Use (Describe)

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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K223076-10(k)Summary

Submitter Information

Company Name: Company Address:

Name of contact Person: Company Phone: Email: Date Prepared:

CareFusion 10020 Pacific Mesa Blvd. San Diego, CA 92121, USA Elgin Oktay, Staff Regulatory Affairs Specialist 801-304-3908 Elgin.Oktay@bd.com March 24, 2023

Subject Device Identification

BD Texium™ Closed Male Luer Trade/Proprietary Name: Common Name: Closed System Drug Transfer Device (CSTD) Classification Name: Closed Antineoplastic and Drug Reconstitution and Transfer System Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: ONB Classification Panel: General Hospital

Predicate Device Identification

Trade/Proprietary Name:
Common Name:
Classification Name:
Regulation Number:
Regulation Name:
Regulatory Class:
Product Code:
Classification Panel:
Premarket Notification:

Alaris® Safety Male Luer Intravascular Administration Set Intravascular Administration Set 21 CFR 880.5440 Intravascular Administration Set Class II FPA General Hospital K053049

Reason for the Submission

The reason for this submission is to incorporate the following changes:

New sterilization claim to "content sterile"
Indications use updated to align with ONB product code
Design modifications and material changes

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Packaging material changes ●

Device Description

Indication for Use

The BD Texium™ Closed Male Luer (CML) is indicated for use by trained healthcare professionals within healthcare facilities who prepare and or administer non-hazardous drugs for adults, pediatrics and neonates.

Technological Characteristics and Substantial Equivalence

The following table presents an overview of comparisons between the subject device and the predicate device.

	SUBJECTBD Texium™ CML(Subject Device)	PREDICATEAlaris® Safety Male Luer(K053049)	SubstantialEquivalence
FDA RegulationNumber	21 CFR 880.5440	21 CFR 880.5440	Same
FDA RegulationName	Intravascular AdministrationSet	Intravascular AdministrationSet	Same
FDA Class	Class II	Class II	Same
FDA Product Code	ONB	FPA	Different –product code“ONB” was notavailable at thetime ofpredicatesubmission

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Traditional 510(k) Premarket Notification
BD Texium™ Closed Male Luer

	SUBJECTBD Texium™ CML(Subject Device)	PREDICATEAlaris® Safety Male Luer(K053049)	SubstantialEquivalence
Principle ofoperation/mechanismof operation	The BD Texium™ Closed Male Luer (CML) is a sterile, single-use closed system drug transfer device (CSTD) intended for the reconstitution, transfer and administration of non-hazardous and hazardous drugs when paired with the SmartSite™ Needle-Free Connector (NFC). When paired with devices containing a SmartSite™ NFC the BD Texium™ CML mechanically prohibits the transfer of environmental contaminants into the system and the escape of drug vapor concentrations outside the BD Texium™ CML/SmartSite™ NFC connection, thereby minimizing individual and environmental exposure to drugs, leaks, and spills. (e.g., airtight, leak-free and drip-free).	The Safety Male Luer is indicated for use when reconstituting, dispensing/transferring, administering, and disposal of potential hazardous fluids, such as chemotherapy, radioactive isotopes, and blood products, as well as non-hazardous fluids. The Safety Male Luer is intended for use with the SmartSite Needle Free Valve port or standard open female luers.	Equivalent (updates to align with ONB product code) – air leakage, vacuum leakage, fluid leakage and residual fluid testing was conducted to verify new claims
Indication for Use	The BD Texium™ Closed Male Luer is a sterile, single-use closed system drug transfer device (CSTD) intended for the reconstitution, transfer and administration of hazardous and non-hazardous drugs when paired with the SmartSite™ NFC.The BD Texium™ Closed Male Luer is indicated for use by trained healthcare professionals within	The Safety Male Luer is indicated for use when reconstituting, dispensing/transferring, administering, and disposal of potential hazardous fluids, such as chemotherapy, radioactive isotopes, and blood products, as well as non-hazardous fluids. The Safety Male Luer is intended for use with the SmartSite Needle Free Valve port or standard open female luers.	Different – clarified the medical setting and user
	SUBJECTBD Texium™ CML(Subject Device)	PREDICATEAlaris® Safety Male Luer(K053049)	SubstantialEquivalence
DeviceCompatibility	prepare and/or administernon-hazardous andhazardous drugs for adults,pediatrics and neonates.SmartSite™ Needle-FreeConnector	SmartSite™ Needle FreeValve port or standard openfemale luers.	Equivalent –device to beused withSmartSite™Needle-FreeConnector
Method ofAdministration	Closed system drug transferdevice (CSTD)	Closed system drug transferdevice (CSTD)	Same
NON-DEHP	Yes	Yes	Same
Device Components/ Materials	CMLMale & Female Luer:Polycarbonate (MakrolonRX1805)Actuator: Polyvel Erucamide(RE 20)Piston: SiliconeSeal Lubricant:Fluorosilicone FluidCapPolypropylene	SMLMale & Female Luer:PolycarbonateActuator: Polypropylene,TPEPiston: SiliconeSeal Lubricant:Fluorosilicone FluidPriming CapSeal: PolypropyleneActuator: AcetalMembrane/Filter: PTFE	Different –biocompatibilitytesting wasconducted toassess newmaterials;female luerbody designchanges wereverified throughISO 80369-7testing; actuatorand male luerbody designchanges wereverified throughair leakage,vacuumedleakage andfluid leakage
Packaging	Individual device in peelablepouch. 50 pouches placed indispenser box. 2 dispenserboxes in each shipper withone (1) Directions for Use.New black ink and websincluded with primarypackaging.	Individual device in peelablepouch with instructions. 50pouches placed in dispenserbox. 2 dispenser boxes ineach shipper.	Different –packagingvalidationverifies newwebs
No natural rubberlatex	Yes	Yes	Same
Sterilization Method	Irradiation	Irradiation	Same

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Traditional 510(k) Premarket Notification

Traditional 510(k) Premarket Notification
The BD Texium™ Closed Male Luer

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Traditional 510(k) Premarket Notification
	BD Texium™ Closed Male Luer

	SUBJECTBD Texium™ CML(Subject Device)	PREDICATEAlaris® Safety Male Luer(K053049)	SubstantialEquivalence
Sterilization Claim	Content Sterile	Fluid Path Sterile	Different -packageintegrity testingincluding sealstrength, cornerthickness, sealwidth, airvolume.microbialbarrier, dye test,and bubble leaktesting wasconducted toverify sterilebarrier claim.
Biocompatibility	Biocompatible for theintended use per ISO10993-1	Biocompatible for theintended use per ISO 10993-l	Same
Non-Pyrogenic	Yes	Yes	Same
Duration of Use	7 days	7 days	Same
Disinfect with 70%Isopropyl Alcohol	Disinfect with 70%Isopropyl Alcohol	Disinfect with 70% IsopropylAlcohol	Same
Priming Volume	0.17 ml	0.2 ml maximum	Equivalent -specification iswithin predicatespecification
Flow Rate	>4280 ml/hr, when activatedwith a minimum 3.2 mm(0.125") insertion depth	>4756 ml/hr	Different - flowrate wasconducted toverify rate
Shelf Life	3 Years	3 Years	Same

Substantial Equivalence Discussion:

Design verification testing was performed to demonstrate that the subject device is equivalent to the predicate device. All test results met their acceptance criteria and support that the BD Texium™ CML is safe and effective and is substantially equivalent to the predicate Alaris® Safety Male Luer. The subject device and the predicate devices are sterilized via irradiation and are single patient use devices. Any differences in materials between the two products have been evaluated through ISO 10993 testing, which demonstrate material safety.

Both the subject and predicate devices have the same principle of operation. The primary technological differences between the subject device and the predicate are geometry and raw material changes to the male

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and female luers, as well as the actuator with seal. These differences are verified through testing of air leakage, vacuum leakage, fluid leakage and ISO 80369-7 testing. The BD Texium™ CML is claiming content sterile and the predicate claims fluid path sterile. Sterile barrier testing was performed to verify the claim. The BD Texium™ CML has changes to the primary packing in that an Instructions for Use is being provided with each shipper box.

Discussion of Non-Clinical Tests:

The BD Texium™ CML, like the predicate device, was evaluated for biocompatibility appropriate to the contact characterization (tissue contacting (indirect) prolonged (> 24 hours to 30 days)). Testing is performed in accordance with the requirements of ISO 10993-1 Biological evaluation of medical devices -Part 1: Evaluation and testing within a risk management process, and the FDA Guidance for Industry - Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". Specific testing included:

ISO 10993-3:2014 "Biological evaluation of medical device Part 3: Tests for genotoxicity, . carcinogenicity, and reproductive toxicity"
ISO 10993-4:2017 "Biological evaluation of medical device Part 4: Selection of tests for ● interactions with blood"
. ISO 10993-5:2009 "Biological evaluation of medical device – Part 5: Tests for in vitro cytotoxicity"
ISO 10993-10:2021 "Biological evaluation of medical device Part 10: Tests for skin sensitization" ●
ISO 10993-11:2017 "Biological evaluation of medical device - Part 11: Tests for systemic toxicity"
ISO 10993-17:2002 "Biological evaluation of medical device Part 17: Establishment of allowable ● limits for leachable substances"
ISO 10993-18:2020 "Biological evaluation of medical device - Part 18: Chemical characterization of materials"
ISO 10993-23:2021 "Biological evaluation of medical device Part 23: Test for irritation" .

Other standards followed included:

ISO 8536-4:2019 "Infusion equipment for medical use Part 4: Infusion Sets for Single Use . Gravity Feed, Section 8 Chemical Requirements and Biological Requirements"

Particulate Testing:

The BD Texium™ CML was tested to demonstrate the product meets particulate requirements of United States Pharmacopeia, National Formulary (USP), General Chapter <788>, Particulate Matter in Injections (Current Standard).

Sterilization and Shelf Life

The subject device is radiation sterilized and data supports a shelf-life claim of 3 years. Sterilization and shelf-life testing were completed in accordance with the following FDA recognized guidelines:

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Sterilization:

. ISO 11137-1:2006/AMD 1:2013 "Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices - Amendment 1"
ISO 11137-2:2013 "Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose"
United States Pharmacopeia, National Formulary (USP), General Chapter <85>, Bacterial . Endotoxins Test
. United States Pharmacopeia, National Formulary (USP), General Chapter <161>, Medical Devices - Bacterial Endotoxin and Pyrogen Tests (2015)
ANSI/AAMI ST72:2011 R:2016 Bacterial endotoxins Test methods, routine monitoring and ● alternatives to batch testing.

Shelf-Life:

ISO 11607-1 First Edition 2006-04-15 Packaging for Terminally Sterilized Medical Devices Part . 1: Requirements for Materials, Sterile Barrier Systems And Packaging Systems [Including: Amendment 1 (2014)]
. ISO 11607-2 First Edition 2006-04-15 Packaging for Terminally Sterilized Medical Devices – Part 2: Validation Requirements for Forming, Sealing and Assembly Processes [Including: Amendment 1 (2014)].
Package testing included: ●
- O Standard Test Method for Seal Strength of Flexible Barrier Materials: ASTM F88/F88M-21
- O Standard Test Method for Thickness Measurement of Flexible Packaging Material: ASTM F2251-13
- Seal Transfer Width: internal testing O
- Standard Test Methods for Determining the Effects of High Altitude on Packaging Systems O by Vacuum Method: ASTM D6653/D6653M-13
- Bubble Leak Detection Test: ASTM F2096 and ASTM F2096-11 O
- Microbial Barrier: internal testing o
- Toluidine Blue Leak Detection Test: ASTM 3039-15 O

Performance Testing:

The BD Texium™ CML was tested to verify compliance with the relevant sections of the following standards:

ISO 8536-4:2020 "Infusion equipment for medical use Part 4: Infusion sets for single use, . gravity feed"
ISO 80369-1:2018 "Small-bore connections for liquids and gases in healthcare applications ● - Part 1: General requirements"

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ISO 80369-7:2021 "Small-bore connections for liquids and gases in healthcare applications ● - Part 7: Connectors for intravascular or hypodermic applications"
ISO 80369-20:2015 "Small-bore connections for liquids and gases in healthcare applications ● - Part 20: Common test methods"

Performance testing was conducted per below:

Leakage by pressure decay
Sub-Atmospheric Air Pressure Leakage ●
Stress Cracking
Resistance to Separation from Axial Load ●
Resistance to Separation from Unscrewing
Resistance to Overriding
Air leakage
Vacuum leakage ●
Fluid leakage ●
Residual fluid
Flow rate

Microbial Ingress Testing:

Microbial ingress was performed based on the following FDA guidance document:

. Guidance for Industry and FDA staff; Intravascular Administration Sets Premarket Notification Submissions [510(k)], July 11, 2008
Additional testing was conducted to demonstrate:
. Harsh Infusates testing: Device tests for multiple days with worst case infusates

Clinical Data:

There are no clinical data included in this submission.

Conclusion:

The information in this submission supports the safety and efficacy of the subject device for its intended use and demonstrates substantial equivalence with the predicate device. The BD Texium™ CML differences in geometry, materials and sterilization claim do not raise new questions about safety and effectiveness.

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.