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The Guarded Luer Connector is a fluid transfer device used in the pharmacy to provide the fluid path for transferring large source container ingredients into a smaller container.

The Guarded Luer Connector (GLC) is a polypropylene, sterile device, single use product intended to provide the fluid path for transferring large source container ingredients into smaller containers. The product is offered in two configurations; Female Luer lock (57-400) and Female-Male Luer Lock (57-401); both configurations meet the intended use. The Guarded Luer Connector is a connector for connecting two devices with fittings conforming to ISO 80369-7 for intravascular connectors and ISO 8536-10 for fluid line accessories.

The provided text describes a 510(k) summary for a medical device called the "Guarded Luer Connector." This document focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets specific performance criteria. Therefore, several of the requested categories of information, particularly those related to clinical studies, human readers, ground truth establishment, and training data, are not applicable or not present in this type of regulatory submission.

However, based on the context of a 510(k) for a connector, the acceptance criteria would primarily revolve around engineering and material performance standards to ensure safe and effective fluid transfer.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size for Test Set: Not explicitly stated in the document. For engineering bench testing, sample sizes are typically determined by statistical methods or regulatory guidelines for device testing (e.g., AQL – Acceptable Quality Limit).
• Data Provenance: The studies are described as "bench testing requirements" and "design verification," "engineering study," and "biocompatibility tests." This indicates the data was generated in a lab setting, likely by the manufacturer, and is prospective experimentation (though not a clinical trial).
• Countries of Origin: Not specified, but generally assumed to be from the manufacturer's testing facilities or contract labs.

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

This is not applicable as the device is a piece of hardware (a Luer connector), not an AI/imaging device requiring expert interpretation for ground truth. The "ground truth" for these tests are the objective measurements against established technical standards.

4. Adjudication Method for the Test Set:

Not applicable. This concept (adjudication) is typically used in clinical studies or expert review processes, which are not described here. The results of the bench tests are objective measurements.

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

No, an MRMC study was not done. This type of study is relevant for AI-powered diagnostic tools where human readers (e.g., radiologists) interpret cases with and without AI assistance. This device is a fluid transfer connector.

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

Not applicable. This device is a mechanical connector, not an algorithm.

7. The Type of Ground Truth Used:

The ground truth used for this device's evaluation is primarily objective measurements against established performance standards and material specifications. For instance:

• Fluid leak rates (implied by ISO 80369-7)
• Dimensional accuracy (implied by ISO 80369-7)
• Torque strength (Resistance to Override)
• Bacterial endotoxin levels (<2.0 EU/device)
• Sterility (SAL 10-6)
• Biocompatibility (based on specific test results like cytotoxicity, sensitization, etc.)

8. The Sample Size for the Training Set:

Not applicable. This device is not an AI/machine learning model, so there is no "training set."

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

Not applicable. There is no training set for this type of device.

Study Proving Acceptance Criteria:

The "study" proving the device meets the acceptance criteria is the collection of bench testing, design verification, and biocompatibility testing as summarized in the document. The document states:

• "Guarded Luer Connector meets the bench testing requirements per ISO 80369-7... and ISO 8536-10..."
• "Compliance with these international standards demonstrates that the proposed cap device is substantially equivalent to the predicate device."
• "All pre-determined acceptance criteria were met."
• "The device Guarded Luer Connector passed all biocompatibility tests."

The primary goal of this FDA 510(k) submission is to demonstrate substantial equivalence to an already legally marketed predicate device (TUBING SETS FOR BAXA EXACTA-MED PHARMACY PUMP, K900585), rather than proving novel efficacy. The testing (bench tests and biocompatibility) is used to show that despite minor design differences, the new device performs equivalently and safely according to recognized standards.

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