(175 days)
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.
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.
This document describes the premarket notification (510(k)) for the BD Texium™ Closed Male Luer (CML). It 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).
Here's an analysis of the acceptance criteria and study data:
Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria alongside performance data in a dedicated section. However, the "Technological Characteristics and Substantial Equivalence" table outlines differences and similarities between the subject device (BD Texium™ CML) and the predicate device (Alaris® Safety Male Luer, K053049) and indicates where testing was conducted to verify new claims or differences. The "Substantial Equivalence Discussion" and "Discussion of Non-Clinical Tests" sections detail the types of tests performed and state that "All test results met their acceptance criteria".
Below is a reconstructed table based on the provided text, indicating acceptance criteria implicitly by reference to the predicate or standards, and the reported performance as meeting those criteria.
| Feature / Test Category | Acceptance Criteria (Implicit from Predicate/Standards) | Reported Device Performance |
|---|---|---|
| FDA Regulation Number | 21 CFR 880.5440 (Intravascular Administration Set) | Same as Predicate |
| FDA Regulation Name | Intravascular Administration Set | Same as Predicate |
| FDA Class | Class II | Same as Predicate |
| Principle of Operation | Airtight, leak-free, drip-free, mechanically prohibits transfer of environmental contaminants and escape of drug vapor (similar to predicate) | Equivalent; air leakage, vacuum leakage, fluid leakage, and residual fluid testing verified new claims. |
| Device Compatibility | Use with SmartSite™ Needle-Free Connector (similar to predicate's SmartSite™ Needle Free Valve port) | Equivalent; device to be used with SmartSite™ Needle-Free Connector. |
| Method of Administration | Closed system drug transfer device (CSTD) | Same as Predicate |
| Non-DEHP | Yes | Same as Predicate |
| Device Components/Materials | Biocompatible and functionally equivalent materials (predicate materials: Polycarbonate, Polypropylene, TPE, Silicone, Fluorosilicone Fluid, Acetal, PTFE). Verification through biocompatibility testing, ISO 80369-7, air/vacuum/fluid leakage. | Different materials, but biocompatibility testing conducted to assess new materials; female luer body design changes verified through ISO 80369-7; actuator and male luer body changes verified through air/vacuum/fluid leakage. |
| Packaging | Maintain sterility and integrity (similar to predicate packaging). Verification through packaging validation. | Different packaging, but packaging validation verifies new webs. |
| No natural rubber latex | Yes | Same as Predicate |
| Sterilization Method | Irradiation | Same as Predicate |
| Sterilization Claim | Content Sterile (predicate claims Fluid Path Sterile). Verification through package integrity testing. | Different claim, but package integrity testing (seal strength, corner thickness, seal width, air volume, microbial barrier, dye test, bubble leak testing) verified sterile barrier claim. |
| Biocompatibility | Biocompatible for intended use per ISO 10993-1 and related sub-standards (similar to predicate). | Same as Predicate; specific testing per ISO 10993-1, -3, -4, -5, -10, -11, -17, -18, -23. |
| Non-Pyrogenic | Yes | Same as Predicate |
| Duration of Use | 7 days | Same as Predicate |
| Disinfect with 70% IPA | Disinfect with 70% Isopropyl Alcohol | Same as Predicate |
| Priming Volume | ≤ 0.2 ml maximum (predicate specification) | 0.17 ml (within predicate specification) |
| Flow Rate | ≥ 4756 ml/hr (predicate specification) | >4280 ml/hr, when activated with min 3.2 mm insertion depth (flow rate conducted to verify rate). Implicitly meets internal specification, though slightly lower than predicate. |
| Shelf Life | 3 Years | Same as Predicate; data supports 3 years. |
| Particulate Testing | Meets requirements of USP, General Chapter , Particulate Matter in Injections. | Device meets particulate requirements. |
| Microbial Ingress | Performance demonstrated according to FDA guidance. | Additional testing conducted for harsh infusates. |
Study Details
The document describes non-clinical testing to demonstrate substantial equivalence to a predicate device.
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Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- The document does not specify the exact sample sizes for each non-clinical test (e.g., number of devices tested for leakage, biocompatibility, flow rate).
- The data provenance is not explicitly stated regarding country of origin or whether it was retrospective or prospective. Given it's a premarket submission for a new device design and material changes, the testing is prospective and conducted by the manufacturer, CareFusion/BD.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
- This is a non-clinical device test for physical and chemical properties, not a clinical study involving diagnosis or interpretation by human experts. Therefore, the concept of "experts establishing ground truth" as it applies to AI/clinical diagnostic studies is not relevant here. Ground truth is established by standardized test methods and measurement equipment.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable as this is not a study involving human interpretation or clinical adjudication. Test results are objective measurements against predefined criteria from standards.
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If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No MRMC study was done. This is a non-clinical device submission, not an AI/software as a medical device (SaMD) product.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device, not an algorithm or AI.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the non-clinical tests is established by recognized international and national standards (e.g., ISO, USP, ASTM, ANSI/AAMI) and the performance of a legally marketed predicate device. For example:
- Biocompatibility: Conformance to ISO 10993 series of standards.
- Sterilization: Conformance to ISO 11137 series and USP chapters.
- Packaging: Conformance to ISO 11607 series and ASTM standards.
- Performance (Leakage, Flow Rate, etc.): Conformance to ISO 80369 series and ISO 8536-4, as well as showing performance equivalent to or better than the predicate device.
- Particulate: Conformance to USP .
- The "ground truth" for the non-clinical tests is established by recognized international and national standards (e.g., ISO, USP, ASTM, ANSI/AAMI) and the performance of a legally marketed predicate device. For example:
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The sample size for the training set:
- Not applicable. This is a physical device, not an AI/ML model that requires a training set. The device design and materials are developed and then validated through testing.
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How the ground truth for the training set was established:
- Not applicable, as there is no training set for a physical device.
§ 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.