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The BD Intima II PLUS Closed IV Catheter System is inserted into a patient's vascular system for short-term use to monitor blood pressure or administer fluids intravascularly. These devices may be used for any patient with consideration given to adequacy of vascular anatomy, procedure being performed, fluids being infused, and duration of therapy.

The BD Intima II PLUS™ Closed IV Catheter System is a closed system IV catheter designed to keep blood contained within the device throughout the insertion process. The system consists of a radiopaque Vialon™ material catheter, a notched needle for flashback visualization, a septum to remove visible blood from the needle tubing, a pinch clamp, extension tubing and Luer connector. The system incorporates an integrated extension set which is available in three configurations: 1) Y Connection (dual port) with PRN adapter and end cap; 2) Y Connection (dual port) with two PRN adapters; and 3) Straight Connection (single port) with PRN adapter. The Luer connector is color-coded to indicate catheter gauge size. The system is provided EO sterilized to achieve a Sterility Assurance Level (SAL) of 10-6. The package system is able to maintain product sterility during its specified shelf life of 3 years.

The provided document is a 510(k) summary for the BD Intima II PLUS Closed IV Catheter System, seeking substantial equivalence to the predicate device, BD Intima II Closed IV Catheter System (K143610). The submission focuses on modifications to materials, the removal of a clamp option, and the addition of new configurations.

Here's an analysis of the acceptance criteria and study information, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the specific sample sizes for each performance test. It mentions that "Performance tests completed on the subject device were limited to those tests required to support a determination of substantial equivalence to the predicate devices." It also states: "When technological characteristics between the subject and predicate devices were found to be identical, results of performance testing conducted on the predicate devices were applied to the subject device." This suggests that some testing may have been done on the new configurations and materials, while for other aspects, reliance was placed on the predicate's testing.

The data provenance is not specified in terms of country of origin or whether it was retrospective or prospective. Given the nature of a 510(k) submission for mechanical and material changes, the data would typically be generated in a laboratory setting by the manufacturer, rather than clinical trials with patient data.

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

Not applicable. This is a medical device submission focused on physical and mechanical performance, and biocompatibility, not a diagnostic or AI-based device requiring expert interpretation for ground truth establishment. The "ground truth" here is objective measurement against specified engineering and biological standards.

4. Adjudication Method for the Test Set

Not applicable. As noted above, this is not a study involving human interpretation or subjective assessments that would require an adjudication method. The testing involves objective measurements against predefined acceptance criteria.

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

Not applicable. This device is an IV catheter system, not a diagnostic device or an AI-assisted system. Therefore, an MRMC study is irrelevant.

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

Not applicable. This device does not involve an algorithm or AI.

7. The Type of Ground Truth Used

The "ground truth" for the performance tests conducted on the BD Intima II PLUS Closed IV Catheter System relies on:

• Engineering Specifications: Predetermined requirements for physical and mechanical properties (e.g., pull force, leakage pressure, clamp seal pressure).
• Standardized Biocompatibility Protocols: Adherence to international standards like ISO 10993-1:2009 for biological evaluation, where acceptance criteria are defined for various biological responses (cytotoxicity, sensitization, etc.).
• Manufacturing Quality Standards: Requirements for package integrity and particulate analysis.

Essentially, the ground truth is established by objective, measurable standards and tests designed to ensure the device performs safely and effectively according to its intended use.

8. The Sample Size for the Training Set

Not applicable. There is no AI or machine learning component to this device; therefore, no "training set" exists.

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

Not applicable, as there is no training set.

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