Search Results

The TEVADAPTOR™, Closed Drug Reconstitution and Transfer System is a closed 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
• Connecting Set
• Spike Port Adaptor
• Luer Lock Adaptor
  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 and aerosol escape into the environment. The Vial Adaptor is also effective when used with Radionuclide drugs. A special charcoal layer within the venting system prevents also drug vapor from escaping, ensuring the system is closed to all toxic species. The air entering the vial is sterile due to this combination of filters. An elastomeric, nonlatex septum is designed for connection of the Syringe Adaptor System for introduction or withdrawal of liquid. The interface for connecting with the Syringe Adaptor is designed so that it can be easily cleaned and disinfected when required.
  The Syringe Adaptor System is intended for connection to a standard luer lock syringe. 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 design incorporates a Passive-Needle protection that eliminates chances of needle-stick injuries.
  The Spike Port 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. Capped short tubing enables connection of the drug containing bag to a delivery set in the hospital ward.
  The Connecting set is similar to the Spike Port Adaptor, except for a female luer lock connection at the distal end.
  The Luer Lock Adaptor enables the connection of the Syringe Adaptor System to an intravenous infusion line for direct drug injection.

The provided text is a 510(k) summary for the TEVADAPTOR™, Closed Drug Reconstitution and Transfer System. It details the device's description, intended use, and its substantial equivalence to a predicate device. However, it does not include specific information regarding acceptance criteria, study methodologies, or performance metrics in the format requested (e.g., a table of acceptance criteria and reported device performance, sample sizes, expert qualifications, or details on comparative effectiveness studies).

Such detailed information is typically found in the full submission documents, often referred to as validation or verification reports, which are not included in this publicly available 510(k) summary. The summary focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing the granular data of performance studies.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance: This information is not present in the provided document.
2. Sample sizes used for the test set and the data provenance: Not explicitly stated for performance testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Ground truth establishment for performance data is not detailed.
4. Adjudication method: Not described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: Not applicable to this type of device (a drug reconstitution and transfer system) and not mentioned in the summary.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical medical device, not an AI algorithm.
7. The type of ground truth used: Not specified for performance testing.
8. The sample size for the training set: Not applicable and not mentioned.
9. How the ground truth for the training set was established: Not applicable and not mentioned.

The document primarily states that the device "has equivalent performance characteristics" to its predicate device, the PhaSeal® closed system (K980381), and concludes that "The evaluation... does not raise any additional concerns regarding safety and effectiveness and may therefore be considered substantially equivalent to the predicate devices." This implies that the performance characteristics were deemed acceptable, likely based on similarity to the predicate and internal testing, but the specifics of how these were tested and what the acceptance criteria were are not detailed here.

Ask a specific question about this device

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.

Ask a specific question about this device

The Infusion Adapter serves as a the connecting part between the IV bag and an external IV line (e.g. IV regulators). The Infusion Adapter has a built in Connector which makes it possible to admix drugs into the infusion solution using the sealed PhaSeal double membrane technique.

PhaSeal is a closed system for handling of parenteral drugs where the component devices are dedicated to each other to create the system. These single use devices are designed to promote safe handling of medications, particularly cytotoxic drugs. Leakage of drug into the environment is effectively avoided during all three phases of drug handling when the PhaSeal system is used: the preparation of the drug, the administration of the patient, and waste handling. All drug transferring utilizes a patented double membrane technique. Each component device is sealed off with an elastomeric membranes are joined together and transfer is made via a specially cut injection cannula. When the component devices of the system are separated after transfer, the membranes act as tight seals that prevent leakage.

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves the device meets specific acceptance criteria.

The document is a 510(k) premarket notification summary for a medical device (PhaSeal Infusion Adapter). It describes the device, its intended use, and states its substantial equivalence to previously accepted PhaSeal devices. The letter from the FDA confirms the substantial equivalence determination and permits the device to proceed to market, subject to general controls and regulations.

The text does not include:

• A table of acceptance criteria or reported device performance.
• Details about a sample size, test set, data provenance, or ground truth establishment.
• Information regarding expert involvement, adjudication methods, or MRMC studies.
• Any standalone algorithm performance data.
• Details about a training set or its ground truth.

Therefore, I cannot fulfill your request for this specific information using the provided document.

Ask a specific question about this device