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The PhaSeal system is an airtight and leakproof closed system drug transfer device (CSTD) that mechanically prohibits the transfer of environmental contaminants into the system and the escape of drug or vapor concentrations outside the system, thereby minimizing individual and environmental exposure to drug vapor, aerosols and spills. The PhaSeal system also prevents microbial ingress.

The PhaSeal® System is a sterile single-use closed system drug transfer device. The closed transfer of liquid takes place through a double membrane utilizing self-sealing elastomeric membranes, tightly fitted together through a bayonet fitting on all PhaSeal components. A single lumen cannula perforates the double membranes for the transfer of liguid. When the cannula is retracted the membranes seal off the transfer of environmental contaminants into the system and/or escape of drug or vapor concentrations outside the system, thereby minimizing the individual and environmental exposure to drug vapor, aerosols and spills and also minimizing the risk of microbial contamination.

The PhaSeal Injector is one component of the PhaSeal system. It is a luer device adaptor that may be fitted to a syringe or IV tubing. It is used to gain dry and leak-proof access to a drug container or administration device which has been sealed with a PhaSeal Protector or Connector. Liquid transfer takes place through tightly fitting elastomeric double membranes to minimize exposure to potentially hazardous drug aerosols and spills occurring during reconstitution, administration and disposal processes.

This document describes the performance and acceptance criteria for the BD PhaSeal Closed System Transfer Device - Injector, as summarized from the provided text.

1. Table of Acceptance Criteria and Reported Device Performance:

The document outlines design verification tests to demonstrate substantial equivalence to the predicate device. The acceptance criteria are implicit in the "Equivalent to Predicate" or "Per ISO 10993" results for each characteristic.

2. Sample Size Used for the Test Set and Data Provenance:

The document does not explicitly state the sample sizes used for the "Dye Leak Test" or "Fragmentation Test." It mentions "Design Verification tests were performed based on the risk analysis performed," suggesting a controlled testing environment, but no specific sample numbers are given. The data provenance is internal to BD Medical - Medical Surgical Systems, likely conducted in a laboratory setting for device validation. It is a prospective study in the sense that the tests were performed specifically to verify the modified device's performance.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

This information is not provided in the given text. The tests appear to be objective performance tests (dye leak, fragmentation) rather than expert-dependent assessments requiring ground truth establishment by human experts. Biocompatibility (ISO 10993) is likely assessed by trained laboratory personnel in accordance with the standard, not necessarily clinical "experts" in the sense of radiologists or similar.

4. Adjudication Method for the Test Set:

This information is not applicable as the tests performed (Biocompatibility, Membrane Leakage, Membrane Fragmentation) are objective measurements or adherence to standards, not subjective assessments requiring adjudication by multiple readers.

5. 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:

This information is not applicable. The device is a Closed System Transfer Device (CSTD), a physical medical device, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study with human readers and AI assistance is irrelevant to its purpose and performance evaluation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

This information is not applicable. The device is a physical product and does not involve an algorithm or AI.

7. The Type of Ground Truth Used:

For the performance tests:

• Biocompatibility: The "ground truth" would be adherence to the established scientific and regulatory standards outlined in ISO 10993 for biological evaluation of medical devices.
• Membrane Leakage & Fragmentation: The "ground truth" or reference for performance is the predicate device (BD PhaSeal® Connector, Injector, Protector - K123213). The goal was to prove "equivalence," meaning the modified device should perform as well as the predicate device in these specific functional tests.

8. The Sample Size for the Training Set:

This information is not applicable. The described study is a design verification for a physical medical device, not a machine learning model that requires a training set.

9. How the Ground Truth for the Training Set Was Established:

This information is not applicable for the same reason as above (no training set).

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