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Baxter solution administration sets with capped luer activated valves are intended for use with a vascular access device for the administration of drugs and solutions. The capped luer activated valve will replace the Y-injection site on the set. The valve can be connected to standard male luer adapters (e.g., syringes or sets), for continuous or intermittent fluid administration or the withdrawal of fluids.

The subject of this submission is a capped luer activated valve which Baxter intends to incorporate into currently marketed solution sets. The capped luer activated valve will replace the Y-injection site on the set for continuous or intermittent fluid administration or the withdrawal of fluids. The normally closed valve is opened by removing the cap and inserting a standard male luer adapter such as on syringes or sets to the female end of the valve automatically closes when the male luer is disconnected. The valve is intended to be capped when not in use.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Solution Administration Sets with Capped Luer Activated Valve:

Acceptance Criteria and Study Analysis

The provided 510(k) summary for the "Solution Administration Sets with Capped Luer Activated Valve" describes a device intended to replace a Y-injection site on existing solution administration sets. The submission focuses on demonstrating substantial equivalence to a predicate device, the Abbott I.V. Sets with Capped Reflux Valve Port.

It's important to note: The provided document is a 510(k) summary, not a full study report. As such, detailed information regarding specific acceptance criteria, test methodologies, and data breakdowns is very limited. The document states that "A description of the functional testing along with test results has been provided," implying these details were part of the complete 510(k) submission to the FDA, but they are not present in this public summary.

Therefore, many of the requested fields below cannot be fully populated from the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The document broadly states that the device was evaluated for "functional performance" and met "all functional requirements." However, it does not specify what those functional requirements were (e.g., specific flow rates, pressure resistance, leakage limits, number of activations without failure, material compatibility, sterilization effectiveness, etc.).

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

• Sample Size (Test Set): Not specified in the provided text.
• Data Provenance: Not specified in the provided text. The testing would have been conducted by Baxter Healthcare Corporation, likely at their facilities, but no geographic origin or retrospective/prospective nature is mentioned.

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

• Number of Experts: Not applicable. This device is a mechanical medical device (solution administration set). The "ground truth" for its performance is established through engineering and functional testing, not typically through human expert adjudication as would be the case for diagnostic AI.
• Qualifications of Experts: N/A

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. For a mechanical device, testing results are objectively measured against predefined engineering specifications. There is no subjective adjudication process mentioned or typically used for this type of device.

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

• MRMC Study Done? No. This type of study is relevant for diagnostic devices that humans interpret (e.g., radiology AI). This submission is for a mechanical solution administration set, which does not involve human interpretation in its primary function, nor does it involve "AI."
• Effect Size of AI Assistance: Not applicable.

6. Standalone Performance (Algorithm Only)

• Standalone Performance Done? N/A. This device does not have an "algorithm" in the sense of AI or software interpreting data. Its performance is entirely "standalone" in that it functions as a mechanical component.

7. Type of Ground Truth Used

• Type of Ground Truth: Engineering specifications and performance metrics. For example, leakage tests, flow rate measurements, pressure resistance, ability to connect and disconnect luer adapters, durability/number of cycles, material biocompatibility, and sterilization validation would all contribute to the "ground truth" of the device's functional performance. The document only broadly refers to "functional requirements."

8. Sample Size for the Training Set

• Sample Size (Training Set): Not applicable. This submission is for a mechanical medical device, not an AI/ML model that requires a training set. The development of such devices involves design, prototyping, and iterative functional testing, but not a "training set" in the computational sense.

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

• Ground Truth Establishment (Training Set): Not applicable.

Summary of Limitations from the Document:

The provided 510(k) summary is a high-level overview. It confirms that functional testing was performed and that the device met its requirements for substantial equivalence. However, it lacks the detailed technical specifications and study breakdowns that would be present in the full original 510(k) submission to the FDA. Specifically, it does not provide:

• Exact numerical acceptance criteria for any functional test.
• Quantified test results (e.g., "passed 1000 cycles" vs. "meets requirements").
• The number of units tested (sample size).
• Specific test methodologies.
• Any information related to clinical trials or human factors testing, beyond "intended for use with a vascular access device."

The document's primary purpose is to declare substantial equivalence to a predicate device (Abbott I.V. Sets with Capped Reflux Valve Port) based on similar technological characteristics and demonstrated functional performance, allowing the device to be marketed.

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