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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 port or standard open female luers.

The Texium™ Syringe is a single use piston syringe that consists of a syringe (3mL, 5mL, 10mL, 20mL or 60mL) permanently bonded to a closed male luer device (Texium™ Closed Male Luer, K053049). The Texium™ Syringe is designed to promote safe handling of fluids and medications, particularly hazardous or cytotoxic drugs. Leakage of drug into the environments is effectively avoided during all phases of drug handling when the Texium™ Syringe is used in conjunction with the SmartSite® Needle Free Valve port: the preparation of the drug, the administration of the drug to the patient, and waste handling. The Texium™ Syringe is a passive device - it requires no cap and automatically seals upon disconnection.

The provided text is a 510(k) summary for the Texium™ Syringe, a medical device for handling hazardous fluids. This document is a regulatory submission before the device is marketed, and as such, it focuses on demonstrating substantial equivalence to existing predicate devices rather than proving performance against specific acceptance criteria through detailed studies as one might find for a novel AI/software device.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set details, and how ground truth was established for a novel device performance study cannot be found in this document.

The document states: "The performance data indicate that the Texium™ Syringe meets specified requirements and is substantially equivalent to the predicate devices." However, it does not explicitly list those "specified requirements" as acceptance criteria in a table, nor does it detail the comprehensive studies with the level of information requested for AI/software.

This submission is about a physical device (a syringe) and its safety and effectiveness are established primarily through:

• Comparison to predicate devices: The bulk of the argument is that the Texium™ Syringe is "of comparable type and is substantially equivalent" to existing devices (Texium™ Closed Male Luer and Becton Dickinson Syringe) in terms of intended use and technological characteristics.
• Demonstration of basic performance: While not detailed, the "performance data" mentioned would likely refer to standard engineering and usability tests typical for a syringe, such as:
  • Leak-free operation (as it's a key intended use).
  • Material compatibility.
  • Sterility.
  • Flow rates/pressure limits.
  • Durability.
  • Compatibility with the SmartSite® Needle Free Valve port.

In summary, the document does not contain the information required to populate the requested table and answer the specific questions about acceptance criteria and detailed study methodology in the context of an AI/software device. This is because it is a filing type common for traditional medical devices showing substantial equivalence, not a detailed performance study for a novel algorithm.

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