Who is the manufacturer of BD Texium Needle-Free Syringe?

Care Fusion filed the 510(k) submission for BD Texium Needle-Free Syringe (K231888).

What is the FDA product code for BD Texium Needle-Free Syringe?

FMF. It is classified under 21 CFR 880.5860 as a Class 2 device in the General Hospital panel.

What is the regulatory pathway for BD Texium Needle-Free Syringe?

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

What are the predicate devices for BD Texium Needle-Free Syringe?

Texium™ Syringe (K071108); BD Texium™ Closed Male Luer (K223076).

Who can help prepare an FDA 510(k) submission like BD Texium Needle-Free Syringe?

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

BD Texium Needle-Free Syringe

K231888 · Care Fusion · FMF · Sep 25, 2023 · General Hospital

Device Facts

Record ID	K231888
Device Name	BD Texium Needle-Free Syringe
Applicant	Care Fusion
Product Code	FMF · General Hospital
Decision Date	Sep 25, 2023
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 880.5860
Device Class	Class 2

Indications 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 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 Story

The BD Texium™ Needle-Free Syringe is a single-use piston syringe (3mL–50mL) permanently bonded to a closed male luer device. It functions as a closed system drug transfer device (CSTD) to facilitate safe handling of hazardous/cytotoxic drugs. The device features an internal spring-loaded actuator and membrane seals; when disconnected, the mechanism automatically seals to prevent leakage, spills, and vapor escape. When connected to a SmartSite™ Needle-Free Connector, the fluid path opens for bi-directional flow. Used in clinical settings by healthcare professionals, the device minimizes environmental and individual exposure to hazardous drugs. It provides a mechanical barrier against contaminants and drug vapors, ensuring airtight, leak-free, and drip-free drug preparation, administration, and waste handling.

Clinical Evidence

No clinical data included. Substantial equivalence is supported by non-clinical bench testing, including biocompatibility (ISO 10993), particulate matter (USP <788>), sterilization validation (ISO 11137), shelf-life/packaging integrity (ISO 11607, ASTM F1929, F1608, F2096, F88), and mechanical performance testing (torque, leakage, vacuum, ISO 7886-1).

Technological Characteristics

Materials: Polycarbonate (luer), Polypropylene (actuator, syringe barrel/plunger), TPE/Erucamide (actuator), Silicone (piston), Polyisoprene (stopper), Fluorosilicone/Polydimethyl Siloxane (lubricants), LDPE (cap). Principle: Spring-loaded actuator with triple membrane seal. Sterilization: Irradiation (SAL 10^-6). Connectivity: Mechanical interface with SmartSite™ NFC. Form factor: 3mL, 5mL, 10mL, 20mL, 30mL, 50mL piston syringes.

Indications for Use

Indicated for healthcare professionals for the preparation and administration of hazardous and non-hazardous drugs when used with the SmartSite™ Needle-free Connector.

Regulatory Classification

Identification

A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.

Predicate Devices

Texium™ Syringe (K071108)
BD Texium™ Closed Male Luer (K223076)

Related Devices

K071108 — TEXIUM SYRINGE · Cardinal Health, Alaris Products · May 24, 2007
K223076 — BD Texium Closed Male Luer · Care Fusion · Mar 24, 2023
K251722 — ProSeal Transfer Injector (421120, 421130, 421140) · Epic Medical Pte. , Ltd. · Dec 5, 2025
K140591 — BD PHASEAL CLOSED SYSTEM TRANSFER DEVICE - INJECTOR · Becton, Dickinson & CO · May 14, 2014
K172499 — NEOSHIELD · JMS North America Corporation · Jun 1, 2018

Submission Summary (Full Text)

{0}------------------------------------------------ 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 {1}------------------------------------------------ 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 {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K231888 Device Name BD Texium™ Needle-Free Syringe #### Indications for Use (Describe) 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). 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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the CareFusion logo. The logo consists of an orange circle with a white shield inside, followed by the text "CareFusion" in gray. Below the text, in smaller font, it says "has joined BD". # 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 Transfer System | | Regulation Number: | 21 CFR 880.5440 | | Regulation Name: | Intravascular Administration Set | | Regulatory Class: | Class II | 510(k) Summary {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the CareFusion logo. The logo consists of an orange circle with a white shield inside, followed by the text "CareFusion" in a dark gray sans-serif font. Below the text, in a smaller, lighter gray font, it says "has joined BD". | 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 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). #### 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., {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for CareFusion. The logo consists of an orange circle with a white shield inside, and the text "CareFusion" in gray. Below the text, in a smaller font, it says "has joined BD". 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 Regulation Number | 21 CFR 880.5860 | 21 CFR 880.5860 | Different - additional product code, ONB, based on Indications for Use | | FDA Regulation Name | Piston Syringe | Piston Syringe | Same | | FDA Class | Class II | Class II | Same | | FDA Product Code | FMF, ONB | FMF | Different - additional product code based on Indications for Use | | 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 | The Texium™ Syringe is indicated for use by healthcare professionals for fluid aspiration/injection, reconstituting, dispensing/transferring, administering, and disposal of potentially hazardous fluids, such as chemotherapy, radioactive isotopes, and blood products, as well as non-hazardous fluids. The Texium™ Syringe is intended for use with the SmartSite® Needle Free Valve or standard open female luers. | Different - (updates to align with ONB product code) - air leakage, vacuum leakage, and fluid leakage testing was conducted to verify new claims. This difference does not raise new questions of safety or effectiveness, and the subject device is still substantially | | | SUBJECT | PREDICATE (Primary) | Substantial | | | BD Texium™ Needle-Free | Texium™ Syringe | Equivalence | | | Syringe | (K071108) | | | | 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). | | equivalent to the predicate device. | | Principle of operation/mechanism of operation | The BD Texium™ Needle- Free Syringe has a unique male luer connector (BD Texium™ Closed Male Luer previously cleared under K223076) that is intended to be used with the currently marketed BD SmartSite™ Needle-Free Connector port and standard open female luers. When the BD Texium™ Needle-Free Syringe is disengaged from female luer, the membranes within the male luer connector act as tight seals that prevent leakage. When the male end of the BD Texium™ Needle-Free Syringe is connected to the BD SmartSite™ Needle-Free Connector port or any open female luer, the fluid path is open via direct contact with a spring-loaded actuator housed within the BD Texium™ Needle-Free Syringe. This provides bi-directional fluid flow through the BD Texium™ Needle-Free Syringe. | The Texium™ Syringe has a unique male luer connector (Texium™ Closed Male Luer previously cleared under K053049) that is intended to be used with the currently marketed SmartSite® Needle Free port and standard open female luers. When the Texium™ Syringe is disengaged from female luer, the membranes within the male luer connector (K053049) act as tight seals that prevent leakage. When the male end of the Texium™ Syringe is connected to the SmartSite® valve port or any open female luer, the fluid path is open via direct contact with a spring-loaded actuator housed within the Texium™ Syringe. This provides bi- directional fluid flow through the Texium™ Syringe. When disconnected, the actuator of the Texium™ Syringe is in a normally closed position that tightly seals the male luer internal diameter (ID) in two places. A secondary seal is provided | Equivalent (updates to align with ONB product code) – air leakage, vacuum leakage, and fluid leakage testing was conducted to verify new claims | | | SUBJECT BD Texium™ Needle-Free Syringe | PREDICATE (Primary) Texium™ Syringe (K071108) | Substantial Equivalence | | | Needle-Free Syringe is in a normally closed position that tightly seals the male luer internal diameter (ID) in two places. A secondary seal is provided between the closed male luer and the syringe via a split-septum membrane design feature of the BD Texium™ Closed Male Luer. | between the closed make luer and the syringe via a split- septum membrane design feature of the Texium™ closed male luer. | | | Device Compatibility | SmartSite™ Needle-Free Connector | SmartSite™ Needle-Free Valve port or standard open female luers. | Equivalent | | Method of Administration | Closed system drug transfer device (CSTD) | Closed system drug transfer device (CSTD) | Same | | NON-DEHP | Yes | Yes | Same | | Device Components | BD Syringe BD Texium™ Closed Male Luer (K223076) Cap Adhesive | BD Syringe Alaris Safety Male Luer (K053049) Cap Adhesive | Different - BD Texium™ Closed Male Luer was cleared under K223076. This difference does not raise new questions of safety or effectiveness, and the subject device is still substantially equivalent to the predicate device. | | 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 - This difference does not raise new questions of safety or effectiveness, and the subject device is still substantially equivalent to the predicate device. | | | SUBJECT BD Texium™ Needle-Free Syringe | PREDICATE (Primary) Texium™ Syringe (K071108) | Substantial Equivalence | | No natural rubber latex | Yes | Yes | Same | | Sterilization Method | Irradiation | Irradiation | Same | | Sterility Assurance Level | $10^-6$ | $10^-6$ | Same | | Sterilization Claim | Content Sterile | Fluid Path Sterile | Different – package integrity testing including seal strength, corner thickness, seal width, air volume, microbial barrier, dye test, and bubble leak testing was conducted to verify sterile barrier claim. This difference does not raise new questions of safety or effectiveness, and the subject device is still substantially equivalent to the predicate device. | | Biocompatibility | Biocompatible for the intended use per ISO 10993-1 | Biocompatible for the intended use per ISO 10993-1 | Same | | Non-Pyrogenic | Yes | Yes | Same | | Shelf Life | 3 Years…

BD Texium Needle-Free Syringe

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Related Devices

Submission Summary (Full Text)

Panel 1

Section Matches

Product Code Matches

Special Control Matches

My Alerts

BD Texium Needle-Free Syringe

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Related Devices

Submission Summary (Full Text)

Panel 1

Section Matches

Product Code Matches

Special Control Matches

My Alerts

Create Alert

Search Filters

Agent Token

Welcome

Check your email

Welcome!

BD Texium Needle-Free Syringe