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A properly placed ViaValve® Safety I.V. Catheter provides access to a vein or artery to sample blood, monitor blood pressure, or administer fluids. The needle guard locks over the needle as the catheter is threaded into the vessel to help reduce the risk of accidental needlesticks. These catheters may be used for any patient population with consideration given to patient size, appropriateness for the solution being infused, and duration of therapy. 18 to 24 gauge catheters may be used with power injectors up to 300 PSI.

The ViaValve® Safety I.V. Catheter provides access to a vein or artery. The ViaValve® Safety I.V. Catheter incorporates a valve inside the catheter hub which is designed to reduce blood exposure during initial catheter placement. The valve will open and allow flow once the Luer connector is attached and will remain open after initial activation. The needle assembly incorporates a needle guard which locks over the needle as the ViaValve® Safety I.V. Catheter is threaded into the vessel to help reduce the risk of accidental needlesticks.

The provided documentation describes the ViaValve® Safety I.V. Catheter (K160235), which is a peripheral intravenous catheter. This submission is a 510(k) premarket notification, meaning it seeks to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving novel safety and effectiveness. Therefore, the "acceptance criteria" and "study" described herein are primarily focused on demonstrating this substantial equivalence through a comparison of technological characteristics and non-clinical performance data.

Here's a breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" in a quantitative performance metric format for the device itself (e.g., specific sensitivity/specificity thresholds, or mean values with standard deviations). Instead, the acceptance criteria are implicitly met by demonstrating compliance with various ISO standards and showing that the subject device's performance is equivalent to the predicate device in relevant non-clinical tests. The "reported device performance" is largely framed as "passes" or "complies" with the specified standards.

Implicit Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document relates to a medical device (catheter) and the "study" is a set of non-clinical, bench and biological tests, not a clinical trial with patient data. Therefore, the concepts of "test set sample size" and "data provenance" (country/retrospective/prospective) in the context of clinical data do not directly apply.

• Sample Size for Testing: The specific sample sizes for each bench or biological test (e.g., number of catheters tested for flow rate, or number of units for biocompatibility) are not detailed in this summary. The summary only lists the standards to which the tests were conducted.
• Data Provenance: The data provenance is from non-clinical laboratory testing performed to comply with international (ISO) standards. The location of the testing laboratories or country of origin of the data is not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This question is not applicable. The device is hardware, and the 'ground truth' for its performance is established through compliance with engineering and biological standards, not through expert consensus on interpretation of medical images or patient outcomes. The testing involves standardized procedures and measurements (e.g., flow rate, material strength, biocompatibility), not expert judgment on diagnostics.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This question is not applicable. Adjudication methods like 2+1 or 3+1 refer to arbitration processes used when multiple human readers (e.g., radiologists) provide conflicting interpretations of diagnostic data. Since these are non-clinical, objective bench and biological tests, there is no "adjudication method" in this context.

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

This question is not applicable. The device is a physical medical instrument (an IV catheter), not an AI algorithm or a diagnostic tool that assists human readers. Therefore, an MRMC study comparing human reader performance with and without AI assistance is irrelevant to this device.

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

This question is not applicable. The device is a physical medical instrument, not a software algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

The "ground truth" for the performance of this device is established by:

• Compliance with recognized international standards (ISO): These standards define acceptable performance limits and test methodologies for various aspects of the device (e.g., material safety, physical integrity, functional performance).
• Comparison to a predicate device: The core of a 510(k) submission is to demonstrate that the new device is "substantially equivalent" to an existing, legally marketed device. Thus, the performance of the predicate device, as established by its clearance and adherence to standards, serves as a de facto ground truth for the subject device.

8. The sample size for the training set

This question is not applicable. The device is a physical medical instrument and does not involve AI or machine learning models that require a "training set."

9. How the ground truth for the training set was established

This question is not applicable, as there is no training set for this device.

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