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The Vial2Bag Advanced® 13mm Admixture Device is indicated to serve as a connection between a 50, 100 or 250mL V bag, vial with 13mm closure, and an external IV administration set. The integrated Vial Adapter makes it possible to reconstitute and/or admix drugs prior to administration to the patient. Indicated for adolescent and adult patients only.

The Vial2Bag Advanced® 13mm Admixture Device is a single use, fluid transfer device that allows for reconstitution and transfer of fluids from drug vials into the IV bag containing infusion solution, through the IV bag administration port. The device consists of the body, Protector, IV Port, and an integrated vial adapter. The device is provided as a sterile, nonpyrogenic product. The device is intended to be used with standard drug vials with a seal diameter of 13mm and an elastomeric stopper. The Vial2Bag Advanced® 13mm device is designed to work with a standard 50, 100, or 250mL IV bag and an external IV infusion set. Users should not attach a Vial2Bag Advanced device to another Vial2Bag Advanced Device. The device does not contain any medicinal substances and there are no additional accessories needed or provided with the Vial2Bag Advanced 13mm Device for the device to meet its intended purpose.

This document is a 510(k) Premarket Notification for a medical device (Vial2Bag Advanced® 13mm Admixture Device) and does not describe an AI/ML powered device. Therefore, many of the requested criteria, such as "number of experts used to establish ground truth," "adjudication method," "MRMC comparative effectiveness study," and "standalone (algorithm only) performance," are not applicable.

The document focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing, chemical tests, biocompatibility testing, sterilization validation, and a human factors study.

Here's the breakdown of the information provided in the document based on your request, with a clear indication of what is not applicable due to the nature of the device:

Device Reviewed: Vial2Bag Advanced® 13mm Admixture Device

Overall Conclusion: The device is deemed substantially equivalent to a predicate device (Vial2Bag Advanced 20mm Admixture Device, K201415), based on non-clinical performance data, chemical tests, biocompatibility tests, sterilization, and human factors study results. It is not an AI/ML device, thus direct AI-specific performance metrics are not available.

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't provide a direct "acceptance criteria" table with performance results in a single, concise format for each test. Instead, it lists the types of tests performed and states that the device "met the applicable design and performance requirements." For each test, the acceptance criteria are implicitly those defined by the referenced standards (e.g., ISO-8536-4, USP , EN ISO 8536-2, ISO 10993 series) or the in-house test methods mentioned. The performance is reported as meeting these requirements.

Here's a summary of the types of tests and the general reported performance:

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

• Sample Size for Test Set: The document explicitly mentions:
  • For Fragmentation and Coring tests: "sample size based on EN ISO 7864, Annex B. Section B.4." (Specific number not provided in this document, but directed to the standard).
  • For other performance tests, chemical tests, and biocompatibility, specific sample sizes are not detailed in this summary, but would be part of the underlying test reports.
  • For the Human Factors Validation Study: "recruited nurses, physicians, and pharmacists". The specific number of participants is not provided in this summary.
• Data Provenance: The studies are conducted by West Pharma. Services IL, Ltd. (Israel-based manufacturer). These are prospective tests performed on the manufactured device, not retrospective data analysis. The data is generated from laboratory testing and simulated use, not from clinical patient data from specific countries.

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

• Not Applicable (N/A) for AI/ML device ground truth. This device is a mechanical fluid transfer device. Ground truth is established through adherence to recognized international standards and in-house validated test methods, rather than expert annotation of data.
• For the Human Factors Validation Study, the "experts" are the intended users of the device (nurses, physicians, and pharmacists). Their "qualification" is their professional role and ability to use the device safely and effectively in a simulated environment. The number of such participants is not specified.

4. Adjudication Method for the Test Set

• N/A for AI/ML device adjudication. There is no "adjudication" in the context of human expert review of AI outputs for this type of device. The verification processes involve engineering testing and quality control.

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

• N/A. This is not an AI-powered diagnostic/assistance device, so no MRMC study or AI assistance evaluation was performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• N/A. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

• N/A in the AI/ML sense. For this device, "ground truth" equates to:
  • Validated engineering specifications and performance benchmarks: Established by international standards (e.g., ISO, USP, EN ISO) and the manufacturer's own design control processes.
  • Biocompatibility standards: ISO 10993 series.
  • Sterility standards: ISO 11135.
  • Human Factors validation: Demonstrated safe and effective use by intended users in a simulated setting.

8. The Sample Size for the Training Set

• N/A. There is no "training set" as this is not an AI/ML device.

9. How the Ground Truth for the Training Set was Established

• N/A. There is no "training set" and thus no ground truth establishment for such a set.

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