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The Contrast Media Transfer Sets are intended to be used for the transfer of contrast media from a primary source container to a secondary unit. These sets are intended to allow for multiple unit doses from the same Contrast Media primary container.

The Contrast Media Transfer Sets are intended to be used for the transfer of contrast media from a primary supply container to a secondary unit. These sets will allow for multiple unit doses from the same contrast media primary container. The three sets include the CT Transfer Set, the Cath Lab Transfer Set and the Cath Lab Extension Set.

The CT Transfer Set consists of a vented dual-flow spike at the primary source connection end and tubing that runs from the spike to an Ultrasite® luer lock needle-free access valve.

The Cath Lab Transfer Set consists of a vented dual-flow spike at the primary source connection end, a burette chamber which is designed with a stopcock and air inlet filter that allows for priming of the burette, and a second tubing segment that leads from the burette chamber to an Ultrasite® valve. The burette is designed with an auto-shutoff disk which inhibits air from entering the set when the primary contrast media container is depleted.

A Cath Lab Extension Set, which is available as a single patient use extension device, is attached to the Cath Lab Transfer Set at the Ultrasite The Cath Lab Extension Set is equipped with two backcheck valve. In a clinical setting, following connection to the Cath Lab valves. Transfer Set, the extension set is connected to a manifold which allows for the dispensing of multiple doses of contrast media to the patient during the cath lab procedure. Attachment of a new Cath Lab Extension Set to the Cath Lab Transfer Set for each patient allows for dispensing from the same bottle of contrast media to multiple patients.

Here's a breakdown of the requested information based on the provided text. It's important to note that this document is a 510(k) summary, which often provides high-level information. Therefore, detailed specifics about the study design, acceptance criteria, and performance results might be limited.

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary for K052252 does not explicitly list specific acceptance criteria in a table format with corresponding performance results for the Contrast Media Transfer Sets. The submission focuses on demonstrating "substantial equivalence" to predicate devices. The "Performance Test Data" is listed as an attachment (Attachment V), but the details are not included in the summary itself.

However, based on the description and the nature of the device, implied performance aspects would include:

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

The provided 510(k) summary does not specify the sample size used for any test set or the data provenance (e.g., country of origin, retrospective or prospective) for the performance testing. It only mentions "Performance Test Data" as an attachment without detailing the studies themselves.

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

This information is not available in the provided 510(k) summary. For devices like the Contrast Media Transfer Sets, the "ground truth" often relates to objective physical and chemical testing (e.g., sterility, flow rates, material integrity) rather than expert interpretation of diagnostic images. Therefore, the concept of "experts establishing ground truth" in the diagnostic imaging sense might not apply directly here.

4. Adjudication Method (for the test set)

The 510(k) summary does not mention any adjudication method. This is generally relevant for studies involving human interpretation or subjective assessments, which are not explicitly detailed in this summary.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or reported in this 510(k) summary. MRMC studies are typically performed for diagnostic imaging devices to assess the impact of AI on human reader performance. This device is a medical accessory for fluid transfer, not an imaging diagnostic tool.

6. Standalone (Algorithm Only) Performance Study

A standalone performance study for an algorithm was not conducted in this context. The device is a physical medical accessory, not an AI algorithm. Therefore, "algorithm only performance" is not applicable.

7. Type of Ground Truth Used

Based on the device type and typical testing for such accessories, the ground truth would likely be established through:

• Objective physical testing: Measurable parameters like flow rates, leak integrity, connection strength, and air elimination.
• Chemical testing: Compatibility with contrast media, extractables.
• Sterility testing: Confirmation of the sterile barrier.
• Biocompatibility testing: As listed in Attachment III.

This information is derived from the common requirements for fluid transfer sets and is implied, as the specific methodologies are not detailed in the summary.

8. Sample Size for the Training Set

This information is not applicable as the Contrast Media Transfer Sets are physical medical devices, not AI-powered systems that require a "training set."

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

This information is not applicable as the device does not involve a training set.

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