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The ToxiSeal™ Vial Adaptor with External Balloon mechanically prohibits environmental contaminants from entering the system and the escape of drug or vapor concentrations from the system, thereby minimizing individual and environmental exposure to drug vapor, aerosols, and spills. The device also prevents the introduction of microbial contaminations into the drug or fluid path for up to 168 hours (or 7 days) when used as intended.

The ToxiSeal™ Vial Adaptor with External Balloon devices are single-use, sterile, nonpyrogenic CSTD drug vial adaptors that are fitted to the drug vials and seal against the closures of the vials. They are used as sterile docking interfaces between the drug vials and the ProSeal™ Injectors for injection of diluents into the drug vials and/or aspiration of liquid drug from the vials.

In addition, the ToxiSeal™ Vial Adaptor with External Balloon devices equalize the pressure difference which occurs when fluid or air is added to or removed from the drug vial. This neutral pressure is maintained utilizing an external balloon/ expansion chamber.

The ToxiSeal™ Vial Adaptor with External Balloon devices, designed to be used with the cleared ProSeal™ Injector within the ProSeal™ CSTD system (K192075), are additions of CSTD vial adaptor component device offerings to the ProSeal™ CSTD system. The additions enhance the completeness of the portfolio of ProSeal™ CSTD devices system.

The provided text is a 510(k) summary for the Epic Medical ToxiSeal™ Vial Adaptor with External Balloon. It addresses the substantial equivalence of the device to a predicate device but does not contain information about a study that uses a test set, ground truth established by experts, or acceptance criteria in the context of device performance metrics like accuracy, sensitivity, or specificity for a diagnostic or AI-driven device.

The "acceptance criteria" discussed in the document refer to:

• Compliance with recognized standards: The device was tested to conform with various ISO standards (ISO 22413:2010, ISO 8871-5:2016, ISO 8536-2:2010, ISO 8536-4:2019) and a draft NIOSH CSTD Test Protocol for functional performance.
• Biocompatibility: Testing was conducted according to ISO 10993-1:2018 for cytotoxicity, skin sensitization, intracutaneous reactivity, acute systemic toxicity, pyrogenicity, subacute/subchronic systemic toxicity, hemocompatibility, chemical characterization, and toxicological risk management. Particulate matter testing met USP acceptance criteria.
• Sterility, Shipping, and Shelf-Life: Compliance with ISO 11135:2014 for sterilization, package integrity (ASTM F88), and shelf-life validation (ASTM 1980-16).

Since the device described is an "Intravascular administration set" (specifically a vial adapter) and not a diagnostic or AI-driven device, the detailed information typically requested for AI/diagnostic devices (such as sample sizes for test/training sets, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, or standalone performance) is not applicable and therefore not present in this document.

The document focuses on demonstrating substantial equivalence through comparison of technological characteristics and performance testing against established safety and performance standards for medical devices, rather than a clinical study evaluating diagnostic accuracy against a ground truth.

Therefore, I cannot provide the requested table and information as it pertains to AI/diagnostic device performance because the provided document does not describe such a study or device.

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