(90 days)
Not Found
No
The device description focuses on mechanical features for safe fluid handling and does not mention any computational or data-driven capabilities. The "Mentions AI, DNN, or ML" section also indicates "Not Found".
No
The device is described as a closed system drug transfer device (CSTD) designed for the preparation and administration of drugs, focusing on preventing exposure to hazardous substances and environmental contaminants. It does not exert any therapeutic effect on the patient.
No
The device is described as a "closed system drug transfer device (CSTD)" and a "single use piston syringe" intended for "preparation and administration of hazardous and nonhazardous drugs," "safe handling of fluids and medications," and preventing "leakage of drug into the environment." Its function is to transfer substances, not to diagnose conditions or diseases.
No
The device description clearly outlines a physical syringe with a bonded luer connector, focusing on mechanical properties and fluid handling. There is no mention of software as a component or the primary function of the device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the "preparation and administration of hazardous and nonhazardous drugs." This is a therapeutic or drug delivery function, not a diagnostic one.
- Device Description: The description focuses on the mechanical aspects of a syringe and luer connector designed for safe handling and delivery of fluids and medications. There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific substances in samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
The device is described as a closed system drug transfer device (CSTD) for minimizing exposure to drugs during preparation and administration. This falls under the category of medical devices used for drug delivery and patient safety, not in vitro diagnostics.
N/A
Intended Use / 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 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., airtight, leak-free and drip-free).
Product codes (comma separated list FDA assigned to the subject device)
FMF, ONB
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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare professionals
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Design verification testing was performed to demonstrate that the subject device is equivalent to the predicate 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.
Non-Clinical Tests:
The BD Texium™ Needle-Free Syringe was evaluated for biocompatibility appropriate to the contact characterization (surface device: skin (, Particulate Matter in Injections (Current Standard).
Sterilization and Shelf Life:
The device is radiation sterilized and data supports a shelf-life claim of 3 years. Testing was in accordance with relevant ISO and USP standards (ISO 11137-1, ISO 11137-2, USP , USP , ANSI/AAMI ST72, AAMI TIR 35, ISO 11607-1, ISO 11607-2).
Package testing included: Package Integrity Test (dye leak test) (ASTM F1929-15), Ink Legibility Test (Internal Testing), Visual Label Adhesion (Internal Testing), Microbial Barrier (ASTM F1608-16 and internal testing), Bubble Leak Integrity Test (ASTM F2096 and ASTM F2096-11), Seal Strength (ASTM F88/F88M-21), Seal Transfer Width (Internal testing), Standard Test Method for Thickness Measurement of Flexible Packaging Material (ASTM F2251-13).
Performance Testing:
Performance testing was executed with samples conditioned with an infusate representative of the worst-case hazardous drug. Results showed this infusate did not negatively impact mechanical functions or performance. Testing included:
- Torque Withstand
- Leakage actuated
- Vacuum Leakage - actuated
Performance testing also included: ISO 7886-1: 2017 "Sterile Hypodermic Syringes for Single Use Part 1: Syringes for manual use".
Microbial Ingress Testing:
Performed based on 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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)
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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 Transfer |
| System | |
| 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
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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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 | 3 Years | Same |
| Materials of
Construction | CML
Male and Female Luer:
Polycarbonate
Actuator: Polypropylene,
TPE, and Erucamide
Piston: Silicone
Seal Lubricant:
Fluorosilicone Fluid
Cap: Low-density | CML
Male and Female Luer:
Polycarbonate
Actuator: Polypropylene,
TPE, and Erucamide
Piston: Silicone
Seal Lubricant:
Fluorosilicone Fluid
Cap: Low-density | Same |
| | SUBJECT
BD TexiumTM Needle-Free
Syringe | PREDICATE (Primary)
TexiumTM Syringe
(K071108) | Substantial
Equivalence |
| | Syringe:
Barrel and Plunger:
Polypropylene
Stopper: Polyisoprene
Lubricant: Polydimethyl
Siloxane | Syringe:
Barrel and Plunger:
Polypropylene
Stopper: Polyisoprene
Lubricant: Polydimethyl
Siloxane | |
| Torque Withstand
(Bond)
Specifications | ≥ 70 in-oz | ≥ 70 in-oz | Same |
| Air Leakage
Specifications | ≥ 300kPa (For 3mL, 5mL and
10mL sizes)
≥ 200kPa (For 20 mL and 50
mL) | ≥ 300kPa (For 3mL, 5mL
and 10mL sizes)
≥ 200kPa (For 20 mL, 50 mL
and 50 mL) | Same |
| Vacuum Leakage
Specifications | , 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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Image /page/14/Picture/0 description: The image shows the logo for CareFusion. The logo consists of an orange circle with a white shield inside on the left, and the word "CareFusion" in gray text on the right. Below the word "CareFusion" are the words "has joined BD" in a smaller, lighter gray font.
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 , Bacterial ● Endotoxins Test
- United States Pharmacopeia, National Formulary (USP), General Chapter , 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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Image /page/15/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 font, it says "has joined BD".
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.