The BD Texium™ Needle-Free Syringe is a sterile, single-use closed system drug transfer device (CSTD) incorporating a bonded Texium™ Closed Male Luer and Syringe, intended for preparation and administration of hazardous and nonhazardous drugs when pared with the SmartSite™ Needle-free Connector (NFC). When paired with devices containing a SmartSite™ NFC the BD Texium™ Needle-Free Syringe mechanically prohibits the transfer of environmental contaminants into the system and the escape of drug vapor concentrations outside the BD Texium™ Needle-Free Syringe/ SmartSite™ NFC connection, thereby minimizing individual and environmental exposure to drugs, leaks, and spills. (e.g., airtight, leak-free and drip-free).

Device Description

The BD Texium™ Needle-Free Syringe is a single use piston syringe that consists of a syringe (3mL, 5mL, 10mL, 20mL, 30mL, or 50mL) permanently bonded to a closed male luer device (BD Texium™ Closed Male Luer, K223076). The Texium" Syringe is designed to promote safe handling of fluids and medications, particularly hazardous or cytotoxic drugs. Leakage of drug into the environment is effectively avoided during all phases of drug handling when the BD Texium™ Needle-Free Syringe is used in conjunction with the SmartSite™ Needle-Free Connector: the preparation of the drug, the administration of the drug to the patient, and waste handling. The BD Texium™ Needle-Free Syringe is a passive device – it requires no cap and automatically seals upon disconnection.

The BD Texium™ Needle-Free Syringe has a unique closed male luer connector that is intended to be used with the currently marketed BD SmartSite™ Needle-Free Connector. As with the predicate device, the male luer design of the BD Texium™ Needle-Free Syringe includes an internal mechanism that causes the luer to seal when disconnected from a female luer. In doing so, it prevents the dripping or accidental spillage of fluids that otherwise occur when using a standard, unsealed male luer. When used with the BD SmartSite" Needle-Free Connector, the BD Texium™ Needle-Free Syringe is intended to provide leak-free handling of potentially hazardous fluids, such as chemotherapy drugs. Furthermore, the BD Texium™ Needle-Free Syringe mechanically prohibits the transfer of environmental contaminants into the system and the escape of drug vapor concentrations outside of BD Texium™ Needle-Free Syringe/SmartSite™ NFC connection, thereby minimizing individual and environmental exposure to drugs, leaks, and spills (e.g., airtight, leak-free and drip-free).

AI/ML Overview

The provided text describes the BD Texium™ Needle-Free Syringe and its substantial equivalence to predicate devices, but it does not include specific acceptance criteria or reported device performance in a format that allows for a direct table comparison for all requested metrics.

However, based on the Discussion of Non-Clinical Tests and Performance Testing sections, I can infer some of the tests performed and their general outcomes. The document states "All test results met their acceptance criteria," but does not explicitly list those criteria numerically. No training set information is provided as this is a non-AI/ML device.

Here's an attempt to answer your questions based on the available information:

1. A table of acceptance criteria and the reported device performance

The document does not provide a table with specific numerical acceptance criteria and reported performance for all aspects. Instead, it indicates that all tests met their acceptance criteria. Here's a summary of the mentioned performance testing, acknowledging the lack of specific numerical criteria in the provided text:

Acceptance Criteria (Inferred from tests performed)	Reported Device Performance (General Statement in document)
Biocompatibility: Meeting ISO 10993-1, 2, 4, 5, 10, 11, 12, 23 standards for intended use.	Biocompatible for the intended use per ISO 10993-1 and related standards.
Particulate Matter: Meeting USP <788> requirements.	Product meets particulate requirements of USP <788>.
Sterilization: Meeting ISO 11137-1/2, USP <85>, <161>, ANSI/AAMI ST72, AAMI TIR 35 standards for sterility assurance level of $10^{-6}$.	Sterilization data supports a shelf-life claim of 3 years and meets all relevant standards.
Shelf-Life (Packaging): Meeting ISO 11607-1/2 and specific ASTM standards (F1929, F1608, F2096, F88, F2251) for package integrity, microbial barrier, and seal strength.	Data supports a shelf-life claim of 3 years and meets all relevant packaging and integrity standards.
Torque Withstand (Bond): Meeting specifications (e.g., ≥ 70 in-oz).	All test results met their acceptance criteria. (Specifically mentioned ≥ 70 in-oz in comparison table).
Air Leakage: Meeting specifications (e.g., ≥ 300kPa for 3mL, 5mL, 10mL; ≥ 200kPa for 20 mL and 50 mL).	All test results met their acceptance criteria. (Specifically mentioned ≥ 300kPa / ≥ 200kPa in comparison table).
Vacuum Leakage: Meeting specifications (e.g., < 40.00 µL).	All test results met their acceptance criteria. (Specifically mentioned < 40.00 µL in comparison table).
Leakage actuated	All test results met their acceptance criteria.
Vacuum Leakage - actuated	All test results met their acceptance criteria.
Syringe Performance: Meeting ISO 7886-1: 2017 standards.	All test results met their acceptance criteria.
Microbial Ingress	Microbial ingress was performed and met acceptance criteria.
Harsh Infusates testing	Performed and showed no negative impact on mechanical functions or performance.

2. Sample sized 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 sample sizes used for any of the non-clinical tests.
The provenance of the data (country of origin, retrospective or prospective) is not mentioned. These are non-clinical (laboratory/bench) tests rather than clinical studies.

3. 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 not applicable as the document details non-clinical (bench/laboratory) testing for device performance and safety, not an AI/ML study requiring expert ground truth for interpretation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable for the same reason as point 3.

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

No MRMC study was mentioned or performed. This document describes non-clinical testing of a physical medical device (syringe), not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable as there is no algorithm or AI component in this device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the non-clinical tests described would be the established scientific and engineering standards and specifications (e.g., ISO standards, ASTM standards, USP chapters, internal specifications) against which the device's performance was measured. For example, for sterility, the ground truth is a Sterility Assurance Level (SAL) of $10^{-6}$.

8. The sample size for the training set

This is not applicable as there is no AI/ML component or a "training set" for this physical device.

9. How the ground truth for the training set was established

This is not applicable as there is no AI/ML component or a "training set" for this 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, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Carefusion Breanna Casados Staff Regulatory Affairs Specialist 10020 Pacific Mesa Blvd San Diego, California 92121

Re: K231888

Trade/Device Name: BD Texium™ Needle-Free Syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Syringe, Piston Regulatory Class: Class II Product Code: FMF, ONB Dated: June 26, 2023 Received: June 27, 2023

Dear Breanna Casados:

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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

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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.

Image /page/1/Picture/5 description: The image shows the name "Courtney Evans -S" in large, bold font. To the right of the name, there is the word "Digitally" followed by "Courtney" and then "Date: 20". The time "19:13:0" is below the date. The text is clear and easy to read.

Digitally signed by Courtney Evans -S Date: 2023.09.25 19:13:06 -04'00'

For CAPT Alan Stevens 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) K231888

Device Name BD Texium™ Needle-Free Syringe

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

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

| X | Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

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K231888 – 510(k) Summary

Submitter Information

Company Name:	CareFusion
Company Address:	10020 Pacific Mesa Blvd.San Diego, CA 92121, USA
Name of contact Person:	Breanna Casados, Staff Regulatory Affairs Specialist
Company Phone:	(801) 857-7561
Email:	Breanna.Casados@bd.com
Date Prepared:	September 25, 2023

Subject Device Identification

Trade/Proprietary Name:	BD Texium™ Needle-Free Syringe
Common Name:	Piston Syringe
Classification Name:	Syringe, Piston
Regulation Number:	21 CFR 880.5860
Regulation Name:	Piston Syringe
Regulatory Class:	Class II
Product Code:	FMF, ONB
Classification Panel:	General Hospital

Primary Predicate Device Identification

Trade/Proprietary Name:	Texium™ Syringe
Common Name:	Piston Syringe
Classification Name:	Syringe, Piston
Regulation Number:	21 CFR 880.5860
Regulation Name:	Piston Syringe
Regulatory Class:	Class II
Product Code:	FMF
Classification Panel:	General Hospital
Premarket Notification:	K071108

Secondary Predicate Device Identification

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

510(k) Summary

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Product Code:	ONB
Classification Panel:	General Hospital
Premarket Notification:	K223076

Reason for the Submission

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

. Including the recently cleared BD Texium™ Closed Male Luer (K223076)
Updating Indications for Use to align with ONB product code ●
Fluid path sterile claim to content sterile

Device Description

Indication for Use

The BD Texium™ Needle-Free Syringe is a sterile, single-use closed system drug transfer device (CSTD) incorporating a bonded Texium™ Closed Male Luer and Syringe, intended for preparation and administration of hazardous and non-hazardous drugs when paired with the SmartSite™ Needle-free Connector (NFC). When paired with devices containing a SmartSite™ NFC the BD Texium™ Needle-Free Syringe mechanically prohibits the transfer of environmental contaminants into the system and the escape of drug vapor concentrations outside the BD Texium™ Needle-Free Syringe/SmartSite™ NFC connection, thereby minimizing individual and environmental exposure to drugs, leaks, and spills. (e.g.,

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airtight, leak-free and drip-free).

Technological Characteristics and Substantial Equivalence

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

Table 1: Comparison between Subject BD Texium™Needle-Free Syringe and Primary Predicate Texium™ Syringe (K071108)

	SUBJECT	PREDICATE (Primary)	Substantial
	BD Texium™ Needle-Free	Texium™ Syringe	Equivalence
	Syringe	(K071108)
FDA RegulationNumber	21 CFR 880.5860	21 CFR 880.5860	Different -additionalproduct code,ONB, based onIndications forUse
FDA RegulationName	Piston Syringe	Piston Syringe	Same
FDA Class	Class II	Class II	Same
FDA Product Code	FMF,ONB	FMF	Different -additionalproduct codebased onIndications forUse
Indication for Use	The BD Texium™ Needle-Free Syringe is a sterile,single-use closed systemdrug transfer device(CSTD) incorporating abonded Texium™ ClosedMale Luer and Syringe,intended for preparationand administration ofhazardous and non-hazardous drugs whenpaired with the SmartSite™Needle-free Connector(NFC). When paired withdevices containing aSmartSite™ NFC the BDTexium™ Needle-FreeSyringe mechanicallyprohibits the transfer of	The Texium™ Syringe isindicated for use byhealthcare professionals forfluid aspiration/injection,reconstituting,dispensing/transferring,administering, and disposalof potentially hazardousfluids, such as chemotherapy,radioactive isotopes, andblood products, as well asnon-hazardous fluids. TheTexium™ Syringe isintended for use with theSmartSite® Needle FreeValve or standard openfemale luers.	Different -(updates toalign with ONBproduct code) -air leakage,vacuumleakage, andfluid leakagetesting wasconducted toverify newclaims. Thisdifference doesnot raise newquestions ofsafety oreffectiveness,and the subjectdevice is stillsubstantially
	SUBJECT	PREDICATE (Primary)	Substantial
	BD Texium™ Needle-Free	Texium™ Syringe	Equivalence
	Syringe	(K071108)
	contaminants into thesystem and the escape ofdrug vapor concentrationsoutside the BD Texium™Needle-FreeSyringe/SmartSite™ NFCconnection, therebyminimizing individual andenvironmental exposure todrugs, leaks, and spills.(e.g., airtight, leak-free anddrip-free).		equivalent tothe predicatedevice.
Principle ofoperation/mechanismof operation	The BD Texium™ Needle-Free Syringe has a uniquemale luer connector (BDTexium™ Closed Male Luerpreviously cleared underK223076) that is intended tobe used with the currentlymarketed BD SmartSite™Needle-Free Connector portand standard open femaleluers. When the BDTexium™ Needle-FreeSyringe is disengaged fromfemale luer, the membraneswithin the male luerconnector act as tight sealsthat prevent leakage. Whenthe male end of the BDTexium™ Needle-FreeSyringe is connected to theBD SmartSite™ Needle-FreeConnector port or any openfemale luer, the fluid path isopen via direct contact with aspring-loaded actuator housedwithin the BD Texium™Needle-Free Syringe. Thisprovides bi-directional fluidflow through the BDTexium™ Needle-FreeSyringe.	The Texium™ Syringe has aunique male luer connector(Texium™ Closed Male Luerpreviously cleared underK053049) that is intended tobe used with the currentlymarketed SmartSite® NeedleFree port and standard openfemale luers. When theTexium™ Syringe isdisengaged from female luer,the membranes within themale luer connector(K053049) act as tight sealsthat prevent leakage. Whenthe male end of theTexium™ Syringe isconnected to the SmartSite®valve port or any openfemale luer, the fluid path isopen via direct contact with aspring-loaded actuatorhoused within the Texium™Syringe. This provides bi-directional fluid flow throughthe Texium™ Syringe.When disconnected, theactuator of the Texium™Syringe is in a normallyclosed position that tightlyseals the male luer internaldiameter (ID) in two places.A secondary seal is provided	Equivalent(updates toalign with ONBproduct code) –air leakage,vacuumleakage, andfluid leakagetesting wasconducted toverify newclaims
	SUBJECTBD Texium™ Needle-FreeSyringe	PREDICATE (Primary)Texium™ Syringe(K071108)	SubstantialEquivalence
	Needle-Free Syringe is in anormally closed position thattightly seals the male luerinternal diameter (ID) in twoplaces. A secondary seal isprovided between the closedmale luer and the syringe viaa split-septum membranedesign feature of the BDTexium™ Closed Male Luer.	between the closed make luerand the syringe via a split-septum membrane designfeature of the Texium™closed male luer.
DeviceCompatibility	SmartSite™ Needle-FreeConnector	SmartSite™ Needle-FreeValve port or standard openfemale luers.	Equivalent
Method ofAdministration	Closed system drug transferdevice (CSTD)	Closed system drug transferdevice (CSTD)	Same
NON-DEHP	Yes	Yes	Same
Device Components	BD Syringe BD Texium™Closed Male Luer(K223076) Cap Adhesive	BD Syringe Alaris Safety MaleLuer (K053049) Cap Adhesive	Different - BDTexium™Closed MaleLuer wascleared underK223076. Thisdifference doesnot raise newquestions ofsafety oreffectiveness,and the subjectdevice is stillsubstantiallyequivalent tothe predicatedevice.
Volume sizes	3 mL 5 mL 10 mL 20 mL 30 mL 50 mL	3 mL 5 mL 10 mL 20 mL 60 mL	Different - Thisdifference doesnot raise newquestions ofsafety oreffectiveness,and the subjectdevice is stillsubstantiallyequivalent tothe predicatedevice.
	SUBJECTBD Texium™ Needle-FreeSyringe	PREDICATE (Primary)Texium™ Syringe(K071108)	SubstantialEquivalence
No natural rubberlatex	Yes	Yes	Same
Sterilization Method	Irradiation	Irradiation	Same
Sterility AssuranceLevel	$10^-6$	$10^-6$	Same
Sterilization Claim	Content Sterile	Fluid Path Sterile	Different –packageintegrity testingincluding sealstrength, cornerthickness, sealwidth, airvolume,microbialbarrier, dye test,and bubble leaktesting wasconducted toverify sterilebarrier claim.This differencedoes not raisenew questionsof safety oreffectiveness,and the subjectdevice is stillsubstantiallyequivalent tothe predicatedevice.
Biocompatibility	Biocompatible for theintended use perISO 10993-1	Biocompatible for theintended use perISO 10993-1	Same
Non-Pyrogenic	Yes	Yes	Same
Shelf Life	3 Years	3 Years	Same
Materials ofConstruction	CMLMale and Female Luer:PolycarbonateActuator: Polypropylene,TPE, and ErucamidePiston: SiliconeSeal Lubricant:Fluorosilicone FluidCap: Low-density	CMLMale and Female Luer:PolycarbonateActuator: Polypropylene,TPE, and ErucamidePiston: SiliconeSeal Lubricant:Fluorosilicone FluidCap: Low-density	Same
	SUBJECTBD TexiumTM Needle-FreeSyringe	PREDICATE (Primary)TexiumTM Syringe(K071108)	SubstantialEquivalence
	Syringe:Barrel and Plunger:PolypropyleneStopper: PolyisopreneLubricant: PolydimethylSiloxane	Syringe:Barrel and Plunger:PolypropyleneStopper: PolyisopreneLubricant: PolydimethylSiloxane
Torque Withstand(Bond)Specifications	≥ 70 in-oz	≥ 70 in-oz	Same
Air LeakageSpecifications	≥ 300kPa (For 3mL, 5mL and10mL sizes)≥ 200kPa (For 20 mL and 50mL)	≥ 300kPa (For 3mL, 5mLand 10mL sizes)≥ 200kPa (For 20 mL, 50 mLand 50 mL)	Same
Vacuum LeakageSpecifications	< 40.00 µL	< 40.00 µL	Same

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Table 2: Comparison between Subject BD Texium™ Needle-Free Syringe and Secondary Predicate Texium™ Closed Male Luer (K223076)

	SUBJECTBD Texium™ Needle-Free Syringe	PREDICATE(Secondary)Texium™ Closed MaleLuer (CML) (K223076)	SubstantialEquivalence
FDA RegulationNumber	21 CFR 880.5440	21 CFR 880.5440	Different – subjectdevice incorporates asyringe
FDA RegulationName	IntravascularAdministration Set	IntravascularAdministration Set	Different – subjectdevice incorporates asyringe
FDA Class	Class II	Class II	Same
FDA Product Code	FMF,ONB	ONB	Different - subjectdevice incorporates asyringe
Indication for Use	The BD Texium™Needle-Free Syringe is asterile, single-use closedsystem drug transferdevice (CSTD)incorporating a bondedTexium™ Closed MaleLuer and Syringe,	The BD Texium™Closed Male Luer (CML)is a sterile, single-useclosed system drugtransferdevice (CSTD) intendedfor the reconstitution,transfer and	Different – TheSecondary Predicatedoes not include abonded syringe. Thisdifference does notraise new questionsof safety oreffectiveness, and the
	SUBJECTBD Texium™ Needle-Free Syringe	PREDICATE(Secondary)Texium™ Closed MaleLuer (CML) (K223076)	SubstantialEquivalence
	intended for preparationand administration ofhazardous and non-hazardous drugs whenpaired with theSmartSite™ Needle-freeConnector (NFC). Whenpaired with devicescontaining a SmartSite™NFC the BD Texium™Needle-Free Syringemechanically prohibitsthe transfer ofenvironmentalcontaminants into thesystem and the escape ofdrug vapor concentrationsoutside the BD Texium™Needle-FreeSyringe/SmartSite™NFC connection, therebyminimizing individualand environmentalexposure to drugs, leaks,and spills. (e.g., airtight,leak-free and drip-free).	administration ofhazardous andnon-hazardous drugswhen paired with theSmartSite™ Needle-FreeConnector (NFC). Whenpaired with devicescontaining a SmartSite™NFC the BD Texium™CML mechanicallyprohibits the transfer ofenvironmentalcontaminants into thesystem and the escape ofdrug vapor concentrationsoutside the BD Texium™CML/SmartSite™ NFCconnection,thereby minimizingindividual andenvironmental exposureto drugs, leaks, and spills.(e.g.,airtight, leak-free anddrip-free).	subject device is stillsubstantiallyequivalent to thepredicate device.
Principle ofoperation/mechanismof operation	The BD Texium™ Needle-Free Syringe has a uniquemale luer connector (BDTexium™ Closed MaleLuer previously clearedunder K223076) that isintended to be used withthe currently marketed BDSmartSite™ Needle-FreeConnector port andstandard open female luers.When the BD Texium™Needle-Free Syringe isdisengaged from femaleluer, the membranes withinthe male luer connector actas tight seals that preventleakage. When the maleend of the BD Texium™	The BD Texium™ CMLare fluid-transferring andutilize a patented triplemembrane technique. TheBD Texium™ CML issealed off with anelastomeric seal in its tip,a sliding O-ring sealwithin the tip, and a slitmembrane at the femaleend of the valve. Themembranes are joinedtogether, and transfer ismade via an actuator.When the BD Texium™CML is disengaged, theseseals passively close toprevent leakage.	Different - TheSecondary Predicatedoes not include abonded syringe.
SUBJECTBD Texium™ Needle-Free Syringe	PREDICATE(Secondary)Texium™ Closed MaleLuer (CML) (K223076)	SubstantialEquivalence
Needle-Free Syringe isconnected to the BDSmartSite™ Needle-FreeConnector port or any openfemale luer, the fluid pathis open via direct contactwith a spring-loadedactuator housed within theBD Texium™ Needle-FreeSyringe. This provides bi-directional fluid flowthrough the BD Texium™Needle-Free Syringe.When disconnected, theactuator of the BDTexium™ Needle-FreeSyringe is in a normallyclosed position that tightlyseals the male luer internaldiameter (ID) in twoplaces. A secondary seal isprovided between theclosed male luer and thesyringe via a split-septummembrane design feature ofthe BD Texium™ ClosedMale Luer.	When the male end of theBD Texium™ CML isconnected to aSmartSite™ NFC valveport or standard openfemale Luer, the fluid pathis open via direct contactwith a spring-loadedactuator housed within theBD Texium™ CML. Thisprovides bi-directionalfluid flow through the BDTexium™ CML. Whendisconnected, the actuatorof the BD Texium™ CMLis in a normally closedposition that tightly sealsthe male Luer internaldiameter (ID) in twoplaces. A secondary seal isprovided at the female endof the BD Texium™ CMLvia a split-septummembrane design featureof the piston.The optional priming capis attached to the BDTexium™ CML at the endof the administration set toallow priming. When theactuator on the primingcap is depressed, air isvented through ahydrophobic membrane toopen the Luer. Thehydrophobic filter alsoprevents fluid fromflowing past the cap whenpriming is complete
DeviceCompatibility	SmartSite™ Needle-FreeConnector	SmartSite™ Needle-FreeConnector	Same
Method ofAdministration	Closed system drug transferdevice (CSTD)	Closed system drugtransfer device (CSTD)	Same
	SUBJECTBD Texium™ Needle-Free Syringe	PREDICATE(Secondary)Texium™ Closed Male	SubstantialEquivalence
		Luer (CML) (K223076)
NON-DEHP	Yes	Yes	Same
Device Components/ Materials	CMLMale and Female Luer:PolycarbonateActuator: Polypropylene,TPE, and ErucamidePiston: SiliconeSeal Lubricant:Fluorosilicone FluidCap: Low-densitypolyethyleneSyringe:Barrel and Plunger:PolypropyleneStopper: PolyisopreneLubricant: PolydimethylSiloxane	CMLMale & Female Luer:PolycarbonateActuator: Polypropylene,TPE, and ErucamidePiston: SiliconeSeal Lubricant:Fluorosilicone FluidCap: Low-densityPolyethylene	Same with respect tothe CML and Cap.The SecondaryPredicate does nothave a Syringe.
Packaging	Individual device inpeelable pouch. 50 pouchesplaced in shipper box for30 mL and 50mL syringes.100 pouches placed inshipper box for 3mL, 5 mL,10 mL, 20 mL syringes.One (1) Directions for Usewill be included in eachshipper box. Black ink andwebs included with primarypackaging.	Individual device inpeelable pouch. 50pouches placed indispenser box. Two (2)dispenser boxes in eachshipper with one (1)Directions for Use in eachshipper box. Black inkand webs included withprimary packaging.	Different – Subjectdevice does not havedispenser boxes andthe units per box willvary depending onsyringe sizes.
No natural rubberlatex	Yes	Yes	Same
Sterilization Method	Irradiation	Irradiation	Same
Sterilization Claim	Content Sterile	Content Sterile	Same
Biocompatibility	Biocompatible for theintended use perISO 10993-1	Biocompatible for theintended use perISO 10993-1	Same
Non-Pyrogenic	Yes	Yes	Same

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Image /page/11/Picture/1 description: The image shows the CareFusion logo. The logo consists of an orange circle with a white shield inside on the left. To the right of the logo is the text "CareFusion" in a dark gray sans-serif font. Below the text is the phrase "has joined BD" in a smaller, lighter gray font.

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Substantial Equivalence Discussion:

Design verification testing was performed to demonstrate that the subject device is equivalent to the predicate

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devices. All test results met their acceptance criteria and support that the BD Texium™ Needle-Free Syringe is safe and effective and is substantially equivalent to the predicate devices. The subject device and the predicate devices are sterilized via irradiation and are single use devices.

Both the subject and predicate devices have the same principle of operation. The primary technological differences between the subject device and the predicates are the addition of the newly cleared BD Texium™ Closed Male Luer (K223076) which substantiates the product code ONB. These differences were verified under K223076. BD Texium™ Needle-Free Syringe is claiming content sterile and the primary predicate claims fluid path sterile. Sterile barrier testing was performed to verify the claim.

Discussion of Non-Clinical Tests:

The BD Texium™ Needle-Free Syringe, like the predicate device, was evaluated for biocompatibility appropriate to the contact characterization [surface device: skin (<24 hours)]. 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 10993-2:2006 "Biological evaluation of medical device Part 2: Animal welfare requirements" ●
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 10993-23:2021 "Biological evaluation of medical device Part 23: Test for irritation" ●
ISO 10993-12:2021 "Biological evaluation of medical device Part 12: Sample preparation and ● reference materials"

Particulate Testing:

The BD Texium™ Needle-Free Syringe 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:

Sterilization:

. ISO 11137-1:2006/AMD 1:2013 "Sterilization of health care products - Radiation - Part 1:

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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.
. AAMI TIR 35:2016 Sterilization of health care products – Radiation sterilization – Product adoption and alternative sampling plans for verification dose experiments and sterilization dose audits.

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: ●
- Package Integrity Test (dye leak test): ASTM F1929-15 റ
- Ink Legibility Test: Internal Testing O
- Visual Label Adhesion: Internal Testing O
- Microbial Barrier: ASTM F1608-16 and internal testing O
- Bubble Leak Integrity Test: ASTM F2096 and ASTM F2096-11 O
- Seal Strength: ASTM F88/F88M-21 o
- Seal Transfer Width: Internal testing O
- o Standard Test Method for Thickness Measurement of Flexible Packaging Material: ASTM F2251-13

Performance Testing:

Performance testing for the BD Texium™ Needle-Free Syringe was executed with samples that were conditioned with an infusate representative of the worst-case hazardous drug that would be used with the subject device. Results of the testing showed that this worst-case infusate did not negatively impact the device's mechanical functions or performance characteristics. Testing for the conditioned BD Texium™ Needle-Free Syringe includes the following:

Torque Withstand
Leakage actuated ●
Vacuum Leakage - actuated

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Performance testing also included:

ISO 7886-1: 2017 "Sterile Hypodermic Syringes for Single Use Part 1: Syringes for manual use" .

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

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 devices. The BD Texium™ Needle-Free Syringe differences compared to the predicate devices 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.