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The TEVADAPTOR™, Drug Reconstitution and Transfer System is a contained system to be used by pharmacists or other healthcare professionals to prepare drugs, including cytotoxic drugs, for intravenous infusion or injection.

The device comprises of the following components:

• Vial Adaptor System with 13 mm Vial converter
• Syringe Adaptor System
• Infusion Bag Adaptor
• -I Connector

The Vial Adaptor System is intended to fit over vials with 20mm caps. A converter accessory enables the use of the Vial Adaptor System with a 13 mm cap vial. A special venting mechanism ensures automatic. sterile, pressure equalization within the vial, preventing drug particle escape into the environment. An elastomeric, non-latex septum is designed for connection of the Syringe Adaptor System for introduction or withdrawal of liquid.

The Syringe Adaptor System is intended for connection to a standard luer lock svringe. A special non-latex elastomer protector covers the liquid dispensing needle tip. A clamp mechanism reversibly connects the Syringe Adaptor System to the other components.

The Infusion Bag Adaptor is intended for connection to the spike port of an infusion bag. A non- latex septum enables connection to the Syringe Adaptor System for withdrawal of diluents or introduction of drug. A capped short tubing enables connection of the drug containing bag to a delivery set in the hospital ward.

An injection accessory enables the connection of the Syringe Adaptor System to an intravenous infusion line for direct drug injection.

I apologize, but the provided text from the 510(k) submission for the TEVADAPTOR™ Drug Reconstitution and Transfer System does not contain the detailed information necessary to fully answer your request regarding acceptance criteria and the specifics of a study proving the device meets those criteria.

The document primarily focuses on establishing substantial equivalence to a predicate device (PhaSeal®) and describes the device's components and indications for use. It lacks:

• A specific table of acceptance criteria.
• Reported device performance metrics against defined criteria.
• Details about a study's methodology (sample size, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance, training set specifics).

Therefore, I cannot generate the table or provide the detailed study information you requested based on the given text.

The closest information related to performance is the statement: "The TEVADAPTORTM, Drug Reconstitution and Transfer System... has equivalent performance characteristics" to the predicate device. However, it does not elaborate on what these performance characteristics are, how they were measured, or what specific acceptance criteria were used.

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