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Arisure® is a Closed System Drug Transfer Device (CSTD) that mechanically prohibits the release of drugs in vapor, aerosol or liquid form during preparation and administration, and prevents the introduction of microbial and airborne contaminants into the drug or fluid path, allowing the system to minimize exposure of individuals, healthcare personnel, and the environment to hazardous drugs.

Arisure® Closed System Drug Transfer Device (CSTD) uses three primary components to prevent the escape of drug and ingress of microbes: Closed Vial Adapter, Closed Male Luer, and Dry Spike. The Closed Vial Adapter attaches to the drug vial allowing access to the vial contents while preventing vial pressurization by capturing displaced vapor and allowing filtered air into the vial. The Dry Spike attaches to an IV container allowing drug to be injected into the container while a separate port accepts the spike of an administration set. The Closed Male Luer syringe adapter provides a means of closed fluid transfer from the drug vial to the IV container. The Closed Male Luer was designed specifically to access the needle-free valve (neutral valve) on the Closed Vial Adapter and Dry Spike. The fluid path of the Closed Vial Adapter, Dry Spike, and Closed Male Luer is normally closed, opening only when the Closed Male Luer is connected to the neutral valve.

The Yukon Medical, LLC Arisure Closed System Drug Transfer Device (CSTD) (K201422) demonstrates substantial equivalence to its predicate device (TEVADAPTOR® Closed Drug Reconstitution and Transfer System, K141448) based on a comprehensive set of non-clinical performance data.

1. Acceptance Criteria and Reported Device Performance:

The document provides a table of various tests conducted to support the substantial equivalence of the Arisure CSTD. The reported device performance is indicated by its compliance with the specified standards or by direct statements of outcome (e.g., "Non-pyrogenic," "Single use"). Where acceptance criteria are implicitly stated through comparison with standards, the device is reported to have met these. Explicit performance metrics are provided for certain aspects.

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

The document does not explicitly state the specific sample sizes used for each of the non-clinical performance tests. The provenance of the data is not detailed, but given the nature of the tests (biocompatibility, mechanical performance, packaging, etc.) and the regulatory context (510(k) submission), these would typically be internal laboratory tests conducted by the manufacturer or contracted to specialized testing facilities. The tests are non-clinical, meaning they do not involve human or animal subjects for clinical outcome assessment.

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

This information is not applicable. The listed tests are objective, quantifiable, non-clinical engineering and biological performance evaluations. They do not rely on expert interpretation for "ground truth" in the way clinical diagnostic studies might. Compliance is determined by meeting pre-defined standards or objective measurements.

4. Adjudication Method for the Test Set:

This information is not applicable. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies where multiple experts assess the same cases and discrepancies need a resolution. The tests performed here are objective performance measurements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

No, an MRMC comparative effectiveness study was not done. The document describes non-clinical performance testing of a medical device, not a diagnostic algorithm that requires human interpretation.

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 medical device (Closed System Drug Transfer Device), not an algorithm or AI software. Therefore, the concept of "standalone performance" in the context of an algorithm does not apply.

7. The Type of Ground Truth Used:

The ground truth for these non-clinical tests is established by:

• International Standards: Many tests refer to ISO, AAMI, ASTM, and USP standards (e.g., ISO 10993 for biocompatibility, ISO 594-2 for luer access). Compliance with these validated standards serves as the "ground truth" for acceptable performance.
• Pre-defined Engineering Specifications: For custom tests (e.g., Valve Removal Torque, Attachment Force, Misuse Leakage, Coring), the "ground truth" is defined by the specific, objective performance criteria set by the manufacturer to ensure the device meets its intended function and safety requirements (e.g., ">4.5 in-lbs", "<40 lbf", "no leakage").
• Functional Verification: For tests like "Gloved Hands" and "Dry Disconnection," the ground truth is simply the successful demonstration of the intended function.

8. The Sample Size for the Training Set:

This information is not applicable. This is a physical medical device, not a machine learning model or algorithm, so there is no "training set" in the computational sense. The device's design and manufacturing processes are validated, not "trained."

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

This information is not applicable for the same reason as above.

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