BD Texium™ Needle-Free Syringe
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
Submission Summary (Full Text)
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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)
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)
| <span style="font-size: 10pt;"> <span style="font-family: Symbol;">ü</span> Prescription Use (Part 21 CFR 801 Subpart D)</span> |
|---------------------------------------------------------------------------------------------------------------------------------|
| <span style="font-size: 10pt;"> <span style="font-family: Symbol;">□</span> Over-The-Counter Use (21 CFR 801 Subpart C)</span> |
| 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.<br>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<br>System |
| Regulation Number: | 21 CFR 880.5440 |
| Regulation Name: | Intravascular Administration Set |
| Regulatory Class: | Class II |
510(k) Summary
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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.,
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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<br>Number | 21 CFR 880.5860 | 21 CFR 880.5860 | Different -<br>additional<br>product code,<br>ONB, based on<br>Indications for<br>Use |
| FDA Regulation<br>Name | Piston Syringe | Piston Syringe | Same |
| FDA Class | Class II | Class II | Same |
| FDA Product Code | FMF,<br>ONB | FMF | Different -<br>additional<br>product code<br>based on<br>Indications for<br>Use |
| Indication for Use | The BD Texium™ Needle-<br>Free Syringe is a sterile,<br>single-use closed system<br>drug transfer device<br>(CSTD) incorporating a<br>bonded Texium™ Closed<br>Male Luer and Syringe,<br>intended for preparation<br>and administration of<br>hazardous and non-<br>hazardous drugs when<br>paired with the SmartSite™<br>Needle-free Connector<br>(NFC). When paired with<br>devices containing a<br>SmartSite™ NFC the BD<br>Texium™ Needle-Free<br>Syringe mechanically<br>prohibits the transfer of | The Texium™ Syringe is<br>indicated for use by<br>healthcare professionals for<br>fluid aspiration/injection,<br>reconstituting,<br>dispensing/transferring,<br>administering, and disposal<br>of potentially hazardous<br>fluids, such as chemotherapy,<br>radioactive isotopes, and<br>blood products, as well as<br>non-hazardous fluids. The<br>Texium™ Syringe is<br>intended for use with the<br>SmartSite® Needle Free<br>Valve or standard open<br>female luers. | Different -<br>(updates to<br>align with ONB<br>product code) -<br>air leakage,<br>vacuum<br>leakage, and<br>fluid leakage<br>testing was<br>conducted to<br>verify new<br>claims. This<br>difference does<br>not raise new<br>questions of<br>safety or<br>effectiveness,<br>and the subject<br>device is still<br>substantially |
| | SUBJECT | PREDICATE (Primary) | Substantial |
| | BD Texium™ Needle-Free | Texium™ Syringe | Equivalence |
| | Syringe | (K071108) | |
| | contaminants into the<br>system and the escape of<br>drug vapor concentrations<br>outside the BD Texium™<br>Needle-Free<br>Syringe/SmartSite™ NFC<br>connection, thereby<br>minimizing individual and<br>environmental exposure to<br>drugs, leaks, and spills.<br>(e.g., airtight, leak-free and<br>drip-free). | | equivalent to<br>the predicate<br>device. |
| Principle of<br>operation/mechanism<br>of operation | The BD Texium™ Needle-<br>Free Syringe has a unique<br>male luer connector (BD<br>Texium™ Closed Male Luer<br>previously cleared under<br>K223076) that is intended to<br>be used with the currently<br>marketed BD SmartSite™<br>Needle-Free Connector port<br>and standard open female<br>luers. When the BD<br>Texium™ Needle-Free<br>Syringe is disengaged from<br>female luer, the membranes<br>within the male luer<br>connector act as tight seals<br>that prevent leakage. When<br>the male end of the BD<br>Texium™ Needle-Free<br>Syringe is connected to the<br>BD SmartSite™ Needle-Free<br>Connector port or any open<br>female luer, the fluid path is<br>open via direct contact with a<br>spring-loaded actuator housed<br>within the BD Texium™<br>Needle-Free Syringe. This<br>provides bi-directional fluid<br>flow through the BD<br>Texium™ Needle-Free<br>Syringe. | The Texium™ Syringe has a<br>unique male luer connector<br>(Texium™ Closed Male Luer<br>previously cleared under<br>K053049) that is intended to<br>be used with the currently<br>marketed SmartSite® Needle<br>Free port and standard open<br>female luers. When the<br>Texium™ Syringe is<br>disengaged from female luer,<br>the membranes within the<br>male luer connector<br>(K053049) act as tight seals<br>that prevent leakage. When<br>the male end of the<br>Texium™ Syringe is<br>connected to the SmartSite®<br>valve port or any open<br>female luer, the fluid path is<br>open via direct contact with a<br>spring-loaded actuator<br>housed within the Texium™<br>Syringe. This provides bi-<br>directional fluid flow through<br>the Texium™ Syringe.<br><br>When disconnected, the<br>actuator of the Texium™<br>Syringe is in a normally<br>closed position that tightly<br>seals the male luer internal<br>diameter (ID) in two places.<br>A secondary seal is provided | Equivalent<br>(updates to<br>align with ONB<br>product code) –<br>air leakage,<br>vacuum<br>leakage, and<br>fluid leakage<br>testing was<br>conducted to<br>verify new<br>claims |
| | SUBJECT<br>BD Texium™ Needle-Free<br>Syringe | PREDICATE (Primary)<br>Texium™ Syringe<br>(K071108) | Substantial<br>Equivalence |
| | Needle-Free Syringe is in a<br>normally closed position that<br>tightly seals the male luer<br>internal diameter (ID) in two<br>places. A secondary seal is<br>provided between the closed<br>male luer and the syringe via<br>a split-septum membrane<br>design feature of the BD<br>Texium™ Closed Male Luer. | between the closed make luer<br>and the syringe via a split-<br>septum membrane design<br>feature of the Texium™<br>closed male luer. | |
| Device<br>Compatibility | SmartSite™ Needle-Free<br>Connector | SmartSite™ Needle-Free<br>Valve port or standard open<br>female luers. | Equivalent |
| Method of<br>Administration | Closed system drug transfer<br>device (CSTD) | Closed system drug transfer<br>device (CSTD) | Same |
| NON-DEHP | Yes | Yes | Same |
| Device Components | BD Syringe BD Texium™<br>Closed Male Luer<br>(K223076) Cap Adhesive | BD Syringe Alaris Safety Male<br>Luer (K053049) Cap Adhesive | Different - BD<br>Texium™<br>Closed Male<br>Luer was<br>cleared under<br>K223076. This<br>difference does<br>not raise new<br>questions of<br>safety or<br>effectiveness,<br>and the subject<br>device is still<br>substantially<br>equivalent to<br>the predicate<br>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<br>difference does<br>not raise new<br>questions of<br>safety or<br>effectiveness,<br>and the subject<br>device is still<br>substantially<br>equivalent to<br>the predicate<br>device. |
| | SUBJECT<br>BD Texium™ Needle-Free<br>Syringe | PREDICATE (Primary)<br>Texium™ Syringe<br>(K071108) | Substantial<br>Equivalence |
| No natural rubber<br>latex | Yes | Yes | Same |
| Sterilization Method | Irradiation | Irradiation | Same |
| Sterility Assurance<br>Level | $10^-6$ | $10^-6$ | Same |
| Sterilization Claim | Content Sterile | Fluid Path Sterile | Different –<br>package<br>integrity testing<br>including seal<br>strength, corner<br>thickness, seal<br>width, air<br>volume,<br>microbial<br>barrier, dye test,<br>and bubble leak<br>testing was<br>conducted to<br>verify sterile<br>barrier claim.<br>This difference<br>does not raise<br>new questions<br>of safety or<br>effectiveness,<br>and the subject<br>device is still<br>substantially<br>equivalent to<br>the predicate<br>device. |
| Biocompatibility | Biocompatible for the<br>intended use per<br>ISO 10993-1 | Biocompatible for the<br>intended use per<br>ISO 10993-1 | Same |
| Non-Pyrogenic | Yes | Yes | Same |
| Shelf Life | 3 Years…
