(175 days)
Not Found
No
The device description and performance studies focus on mechanical and material properties, with no mention of AI or ML.
No
This device is a closed system drug transfer device (CSTD) that minimizes exposure to hazardous drugs by facilitating their transfer and administration, rather than directly treating a disease or condition in a patient.
No
Explanation: The device is described as a "closed system drug transfer device (CSTD)" intended for "reconstitution, transfer and administration of hazardous drugs." It is used to minimize exposure to drugs and prevent contamination, not to diagnose a medical condition.
No
The device description clearly states it is a physical, sterile, single-use closed system drug transfer device (CSTD) made of materials and with specific geometries, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the reconstitution, transfer, and administration of drugs (hazardous and non-hazardous). This is a therapeutic or drug delivery function, not a diagnostic one.
- Device Description: The description focuses on its function as a closed system drug transfer device (CSTD) to minimize exposure to drugs. This aligns with drug handling and administration, not diagnostic testing.
- No mention of in vitro testing: The document does not describe any process involving testing samples (like blood, urine, tissue) outside of the body to diagnose a condition or provide information about a patient's health status.
IVD devices are used to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is entirely related to the safe handling and delivery of medications.
N/A
Intended Use / Indications for Use
The BD Texium™ Closed Male Luer (CML) is a sterile, single-use closed system drug transfer device (CSTD) intended for the reconstitution, transfer and administration of hazardous drugs when paired with the SmartSite™ NFC.
The BD Texium™ Closed Male Luer (CML) is indicated for use by trained healthcare professionals within healthcare facilities who prepare and/or administer non-hazardous drugs for adults, pediatrics and neonates.
Product codes (comma separated list FDA assigned to the subject device)
ONB
Device Description
The BD Texium™ CML is an airtight, leak-free and drip-free closed system drug transfer device (CSTD). When paired with devices containing a SmartSite™ NFC, the BD Texium™ CML mechanically prohibits the transfer of environmental contaminants into the system and the escape of drug vapor concentrations outside the BD Texium™ CML/SmartSite™ NFC connection, thereby minimizing individual and environmental exposure to drugs, leaks and spills. The BD Texium™ CML is a sterile single-use CSTD intended for the reconstitution, transfer and administration of hazardous and non-hazardous drugs when paired with the SmartSite™ NFC.
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
adults, pediatrics and neonates.
Intended User / Care Setting
trained healthcare professionals within healthcare facilities
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 device. All test results met their acceptance criteria and support that the BD Texium™ CML is safe and effective and is substantially equivalent to the predicate Alaris® Safety Male Luer. The subject device and the predicate devices are sterilized via irradiation and are single patient use devices. Any differences in materials between the two products have been evaluated through ISO 10993 testing, which demonstrate material safety.
Both the subject and predicate devices have the same principle of operation. The primary technological differences between the subject device and the predicate are geometry and raw material changes to the male and female luers, as well as the actuator with seal. These differences are verified through testing of air leakage, vacuum leakage, fluid leakage and ISO 80369-7 testing. The BD Texium™ CML is claiming content sterile and the predicate claims fluid path sterile. Sterile barrier testing was performed to verify the claim. The BD Texium™ CML has changes to the primary packing in that an Instructions for Use is being provided with each shipper box.
Non-Clinical Tests included:
- Biocompatibility testing: ISO 10993-1, ISO 10993-3, ISO 10993-4, ISO 10993-5, ISO 10993-10, ISO 10993-11, ISO 10993-17, ISO 10993-18, ISO 10993-23.
- Particulate Testing: United States Pharmacopeia, National Formulary (USP), General Chapter , Particulate Matter in Injections.
- Sterilization testing: ISO 11137-1, ISO 11137-2, USP General Chapter , USP General Chapter , ANSI/AAMI ST72.
- Shelf-Life testing: ISO 11607-1, ISO 11607-2. Package testing included ASTM F88/F88M-21, ASTM F2251-13, internal testing for Seal Transfer Width, ASTM D6653/D6653M-13, ASTM F2096 and ASTM F2096-11, internal testing for Microbial Barrier, ASTM 3039-15.
- Performance testing: ISO 8536-4:2020, ISO 80369-1:2018, ISO 80369-7:2021, ISO 80369-20:2015. Specific tests conducted included Leakage by pressure decay, Sub-Atmospheric Air Pressure Leakage, Stress Cracking, Resistance to Separation from Axial Load, Resistance to Separation from Unscrewing, Resistance to Overriding, Air leakage, Vacuum leakage, Fluid leakage, Residual fluid, Flow rate.
- Microbial Ingress Testing: Based on FDA guidance "Intravascular Administration Sets Premarket Notification Submissions [510(k)], July 11, 2008".
- Additional testing: Harsh Infusates testing.
No clinical data was included in the 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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
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March 24, 2023
CareFusion Elgin Oktay Staff Regulatory Affairs Specialist 10020 Pacific Mesa Blvd San Diego, California 92121
Re: K223076
Trade/Device Name: BD Texium™ Closed Male Luer Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: ONB Dated: February 24, 2023 Received: February 24, 2023
Dear Elgin Oktay:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
David Walloschek
David Wolloscheck, Ph.D. Acting Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices. and Human Factors OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K223076
Device Name BD Texium™ Closed Male Luer
Indications for Use (Describe)
The BD Texium™ Closed Male Luer (CML) is a sterile, single-use closed system drug transfer device (CSTD) intended for the reconstitution, transfer and administration of hazardous drugs when paired with the SmartSite™ NFC.
The BD Texium™ Closed Male Luer (CML) is indicated for use by trained healthcare professionals within healthcare facilities who prepare and/or administer non-hazardous drugs for adults, pediatrics and neonates.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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K223076-10(k)Summary
Submitter Information
Company Name: Company Address:
Name of contact Person: Company Phone: Email: Date Prepared:
CareFusion 10020 Pacific Mesa Blvd. San Diego, CA 92121, USA Elgin Oktay, Staff Regulatory Affairs Specialist 801-304-3908 Elgin.Oktay@bd.com March 24, 2023
Subject Device Identification
BD Texium™ Closed Male Luer Trade/Proprietary Name: Common Name: Closed System Drug Transfer Device (CSTD) Classification Name: Closed Antineoplastic and Drug Reconstitution and Transfer System Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: ONB Classification Panel: General Hospital
Predicate Device Identification
| Trade/Proprietary Name: | |
|---|---|
| Common Name: | |
| Classification Name: | |
| Regulation Number: | |
| Regulation Name: | |
| Regulatory Class: | |
| Product Code: | |
| Classification Panel: | |
| Premarket Notification: |
Alaris® Safety Male Luer Intravascular Administration Set Intravascular Administration Set 21 CFR 880.5440 Intravascular Administration Set Class II FPA General Hospital K053049
Reason for the Submission
The reason for this submission is to incorporate the following changes:
- New sterilization claim to "content sterile"
- Indications use updated to align with ONB product code
- Design modifications and material changes
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- Packaging material changes ●
Device Description
The BD Texium™ CML is an airtight, leak-free and drip-free closed system drug transfer device (CSTD). When paired with devices containing a SmartSite™ NFC, the BD Texium™ CML mechanically prohibits the transfer of environmental contaminants into the system and the escape of drug vapor concentrations outside the BD Texium™ CML/SmartSite™ NFC connection, thereby minimizing individual and environmental exposure to drugs, leaks and spills. The BD Texium™ CML is a sterile single-use CSTD intended for the reconstitution, transfer and administration of hazardous and non-hazardous drugs when paired with the SmartSite™ NFC.
Indication for Use
The BD Texium™ Closed Male Luer (CML) is a sterile, single-use closed system drug transfer device (CSTD) intended for the reconstitution, transfer and administration of hazardous and non-hazardous drugs when paired with the SmartSite™ Needle-Free Connector (NFC).
The BD Texium™ Closed Male Luer (CML) is indicated for use by trained healthcare professionals within healthcare facilities who prepare and or administer non-hazardous drugs for adults, pediatrics and neonates.
Technological Characteristics and Substantial Equivalence
The following table presents an overview of comparisons between the subject device and the predicate device.
| | SUBJECT
BD Texium™ CML
(Subject Device) | PREDICATE
Alaris® Safety Male Luer
(K053049) | Substantial
Equivalence |
|--------------------------|-----------------------------------------------|----------------------------------------------------|--------------------------------------------------------------------------------------------------------|
| FDA Regulation
Number | 21 CFR 880.5440 | 21 CFR 880.5440 | Same |
| FDA Regulation
Name | Intravascular Administration
Set | Intravascular Administration
Set | Same |
| FDA Class | Class II | Class II | Same |
| FDA Product Code | ONB | FPA | Different –
product code
“ONB” was not
available at the
time of
predicate
submission |
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| Traditional 510(k) Premarket Notification |
|---|
| BD Texium™ Closed Male Luer |
| | SUBJECT
BD Texium™ CML
(Subject Device) | PREDICATE
Alaris® Safety Male Luer
(K053049) | Substantial
Equivalence |
|-----------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Principle of
operation/mechanism
of operation | The BD Texium™ Closed Male Luer (CML) is a sterile, single-use closed system drug transfer device (CSTD) intended for the reconstitution, transfer and administration of non-hazardous and hazardous drugs when paired with the SmartSite™ Needle-Free Connector (NFC). When paired with devices containing a SmartSite™ NFC the BD Texium™ CML mechanically prohibits the transfer of environmental contaminants into the system and the escape of drug vapor concentrations outside the BD Texium™ CML/SmartSite™ NFC connection, thereby minimizing individual and environmental exposure to drugs, leaks, and spills. (e.g., airtight, leak-free and drip-free). | The Safety Male Luer is indicated for use when reconstituting, dispensing/transferring, administering, and disposal of potential hazardous fluids, such as chemotherapy, radioactive isotopes, and blood products, as well as non-hazardous fluids. The Safety Male Luer is intended for use with the SmartSite Needle Free Valve port or standard open female luers. | Equivalent (updates to align with ONB product code) – air leakage, vacuum leakage, fluid leakage and residual fluid testing was conducted to verify new claims |
| Indication for Use | The BD Texium™ Closed Male Luer is a sterile, single-use closed system drug transfer device (CSTD) intended for the reconstitution, transfer and administration of hazardous and non-hazardous drugs when paired with the SmartSite™ NFC.
The BD Texium™ Closed Male Luer is indicated for use by trained healthcare professionals within | The Safety Male Luer is indicated for use when reconstituting, dispensing/transferring, administering, and disposal of potential hazardous fluids, such as chemotherapy, radioactive isotopes, and blood products, as well as non-hazardous fluids. The Safety Male Luer is intended for use with the SmartSite Needle Free Valve port or standard open female luers. | Different – clarified the medical setting and user |
| | SUBJECT
BD Texium™ CML
(Subject Device) | PREDICATE
Alaris® Safety Male Luer
(K053049) | Substantial
Equivalence |
| Device
Compatibility | prepare and/or administer
non-hazardous and
hazardous drugs for adults,
pediatrics and neonates.
SmartSite™ Needle-Free
Connector | SmartSite™ Needle Free
Valve port or standard open
female luers. | Equivalent –
device to be
used with
SmartSite™
Needle-Free
Connector |
| Method of
Administration | Closed system drug transfer
device (CSTD) | Closed system drug transfer
device (CSTD) | Same |
| NON-DEHP | Yes | Yes | Same |
| Device Components
/ Materials | CML
Male & Female Luer:
Polycarbonate (Makrolon
RX1805)
Actuator: Polyvel Erucamide
(RE 20)
Piston: Silicone
Seal Lubricant:
Fluorosilicone Fluid
Cap
Polypropylene | SML
Male & Female Luer:
Polycarbonate
Actuator: Polypropylene,
TPE
Piston: Silicone
Seal Lubricant:
Fluorosilicone Fluid
Priming Cap
Seal: Polypropylene
Actuator: Acetal
Membrane/Filter: PTFE | Different –
biocompatibility
testing was
conducted to
assess new
materials;
female luer
body design
changes were
verified through
ISO 80369-7
testing; actuator
and male luer
body design
changes were
verified through
air leakage,
vacuumed
leakage and
fluid leakage |
| Packaging | Individual device in peelable
pouch. 50 pouches placed in
dispenser box. 2 dispenser
boxes in each shipper with
one (1) Directions for Use.
New black ink and webs
included with primary
packaging. | Individual device in peelable
pouch with instructions. 50
pouches placed in dispenser
box. 2 dispenser boxes in
each shipper. | Different –
packaging
validation
verifies new
webs |
| No natural rubber
latex | Yes | Yes | Same |
| Sterilization Method | Irradiation | Irradiation | Same |
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Traditional 510(k) Premarket Notification
Traditional 510(k) Premarket Notification
The BD Texium™ Closed Male Luer
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| Traditional 510(k) Premarket Notification | |
|---|---|
| BD Texium™ Closed Male Luer |
| | SUBJECT
BD Texium™ CML
(Subject Device) | PREDICATE
Alaris® Safety Male Luer
(K053049) | Substantial
Equivalence |
|-----------------------------------------|----------------------------------------------------------------------------------|-----------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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. |
| Biocompatibility | Biocompatible for the
intended use per ISO
10993-1 | Biocompatible for the
intended use per ISO 10993-
l | Same |
| Non-Pyrogenic | Yes | Yes | Same |
| Duration of Use | 7 days | 7 days | Same |
| Disinfect with 70%
Isopropyl Alcohol | Disinfect with 70%
Isopropyl Alcohol | Disinfect with 70% Isopropyl
Alcohol | Same |
| Priming Volume | 0.17 ml | 0.2 ml maximum | Equivalent -
specification is
within predicate
specification |
| Flow Rate | >4280 ml/hr, when activated
with a minimum 3.2 mm
(0.125") insertion depth | >4756 ml/hr | Different - flow
rate was
conducted to
verify rate |
| Shelf Life | 3 Years | 3 Years | Same |
Substantial Equivalence Discussion:
Design verification testing was performed to demonstrate that the subject device is equivalent to the predicate device. All test results met their acceptance criteria and support that the BD Texium™ CML is safe and effective and is substantially equivalent to the predicate Alaris® Safety Male Luer. The subject device and the predicate devices are sterilized via irradiation and are single patient use devices. Any differences in materials between the two products have been evaluated through ISO 10993 testing, which demonstrate material safety.
Both the subject and predicate devices have the same principle of operation. The primary technological differences between the subject device and the predicate are geometry and raw material changes to the male
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and female luers, as well as the actuator with seal. These differences are verified through testing of air leakage, vacuum leakage, fluid leakage and ISO 80369-7 testing. The BD Texium™ CML is claiming content sterile and the predicate claims fluid path sterile. Sterile barrier testing was performed to verify the claim. The BD Texium™ CML has changes to the primary packing in that an Instructions for Use is being provided with each shipper box.
Discussion of Non-Clinical Tests:
The BD Texium™ CML, like the predicate device, was evaluated for biocompatibility appropriate to the contact characterization (tissue contacting (indirect) prolonged (> 24 hours to 30 days)). Testing is performed in accordance with the requirements of ISO 10993-1 Biological evaluation of medical devices -Part 1: Evaluation and testing within a risk management process, and the FDA Guidance for Industry - Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". Specific testing included:
- ISO 10993-3:2014 "Biological evaluation of medical device Part 3: Tests for genotoxicity, . carcinogenicity, and reproductive toxicity"
- ISO 10993-4:2017 "Biological evaluation of medical device Part 4: Selection of tests for ● interactions with blood"
- . ISO 10993-5:2009 "Biological evaluation of medical device – Part 5: Tests for in vitro cytotoxicity"
- ISO 10993-10:2021 "Biological evaluation of medical device Part 10: Tests for skin sensitization" ●
- ISO 10993-11:2017 "Biological evaluation of medical device - Part 11: Tests for systemic toxicity"
- ISO 10993-17:2002 "Biological evaluation of medical device Part 17: Establishment of allowable ● limits for leachable substances"
- ISO 10993-18:2020 "Biological evaluation of medical device - Part 18: Chemical characterization of materials"
- ISO 10993-23:2021 "Biological evaluation of medical device Part 23: Test for irritation" .
Other standards followed included:
- ISO 8536-4:2019 "Infusion equipment for medical use Part 4: Infusion Sets for Single Use . Gravity Feed, Section 8 Chemical Requirements and Biological Requirements"
Particulate Testing:
The BD Texium™ CML was tested to demonstrate the product meets particulate requirements of United States Pharmacopeia, National Formulary (USP), General Chapter , Particulate Matter in Injections (Current Standard).
Sterilization and Shelf Life
The subject device is radiation sterilized and data supports a shelf-life claim of 3 years. Sterilization and shelf-life testing were completed in accordance with the following FDA recognized guidelines:
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Sterilization:
- . ISO 11137-1:2006/AMD 1:2013 "Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices - Amendment 1"
- ISO 11137-2:2013 "Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose"
- United States Pharmacopeia, National Formulary (USP), General Chapter , 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.
Shelf-Life:
- ISO 11607-1 First Edition 2006-04-15 Packaging for Terminally Sterilized Medical Devices Part . 1: Requirements for Materials, Sterile Barrier Systems And Packaging Systems [Including: Amendment 1 (2014)]
- . ISO 11607-2 First Edition 2006-04-15 Packaging for Terminally Sterilized Medical Devices – Part 2: Validation Requirements for Forming, Sealing and Assembly Processes [Including: Amendment 1 (2014)].
- Package testing included: ●
- O Standard Test Method for Seal Strength of Flexible Barrier Materials: ASTM F88/F88M-21
- O Standard Test Method for Thickness Measurement of Flexible Packaging Material: ASTM F2251-13
- Seal Transfer Width: internal testing O
- Standard Test Methods for Determining the Effects of High Altitude on Packaging Systems O by Vacuum Method: ASTM D6653/D6653M-13
- Bubble Leak Detection Test: ASTM F2096 and ASTM F2096-11 O
- Microbial Barrier: internal testing o
- Toluidine Blue Leak Detection Test: ASTM 3039-15 O
Performance Testing:
The BD Texium™ CML was tested to verify compliance with the relevant sections of the following standards:
- ISO 8536-4:2020 "Infusion equipment for medical use Part 4: Infusion sets for single use, . gravity feed"
- ISO 80369-1:2018 "Small-bore connections for liquids and gases in healthcare applications ● - Part 1: General requirements"
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- ISO 80369-7:2021 "Small-bore connections for liquids and gases in healthcare applications ● - Part 7: Connectors for intravascular or hypodermic applications"
- ISO 80369-20:2015 "Small-bore connections for liquids and gases in healthcare applications ● - Part 20: Common test methods"
Performance testing was conducted per below:
- Leakage by pressure decay
- Sub-Atmospheric Air Pressure Leakage ●
- Stress Cracking
- Resistance to Separation from Axial Load ●
- Resistance to Separation from Unscrewing
- Resistance to Overriding
- Air leakage
- Vacuum leakage ●
- Fluid leakage ●
- Residual fluid
- Flow rate
Microbial Ingress Testing:
Microbial ingress was performed based on the following FDA guidance document:
-
. Guidance for Industry and FDA staff; Intravascular Administration Sets Premarket Notification Submissions [510(k)], July 11, 2008
Additional testing was conducted to demonstrate: -
. Harsh Infusates testing: Device tests for multiple days with worst case infusates
Clinical Data:
There are no clinical data included in this submission.
Conclusion:
The information in this submission supports the safety and efficacy of the subject device for its intended use and demonstrates substantial equivalence with the predicate device. The BD Texium™ CML differences in geometry, materials and sterilization claim do not raise new questions about safety and effectiveness.