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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.

Study Details

The document describes non-clinical testing to demonstrate substantial equivalence to a predicate device.

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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 <788>.

7. 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.

8. How the ground truth for the training set was established:

   • Not applicable, as there is no training set for a physical device.

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