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The CliniCath™ IR Peripherally Inserted Central Catheter is used when patient therapy requires repeated venous access for intravenous injection or infusion therapy and/or venous blood sampling.

The modified CliniCath™ IR Peripherally Inserted Central Catheters are similar in design and function to the current commercially available CliniCath™ Peripherally Inserted Venous Catheters.

The catheters are designed to permit repeated access to the venous system for the delivery of medications, fluids, and nutritional solutions, and for blood therapy and/or sampling.

The product consists of a single-lumen, radiopaque silicone catheter with preinserted catheter stiffening wire and attached flushing assembly. Catheters will be made available with and without the following accessories: introducer needle, guidewire, dilator/sheath assembly, syringe, tape measure, mini-scalpel and injection cap. Catheters will be provided in single- and multi-unit package configurations.

Device Acceptance Criteria and Study Details: CliniCath™ IR Peripherally Inserted Central Catheters (K970269)

1. Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance for Test Set

There was no specific "test set" in the context of a clinical study. The device's performance was evaluated through in-vitro functional testing and biocompatibility testing. Therefore, information regarding sample size, country of origin, or retrospective/prospective nature of a clinical test set is not applicable.

3. Number and Qualifications of Experts for Ground Truth

Not applicable. Ground truth for functional testing and biocompatibility testing does not typically rely on "experts" in the same way clinical imaging studies do. Functional tests are typically evaluated against established engineering specifications, and biocompatibility tests follow specific standardized protocols.

4. Adjudication Method for Test Set

Not applicable. As there was no clinical test set requiring ground truth establishment through expert review, no adjudication method was used.

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

No MRMC comparative effectiveness study was done. The submission explicitly states: "Clinical studies were not deemed necessary regarding the CliniCath™ IR Peripherally Inserted Central Catheter due to its similarity in materials; design and function to current commercially available CliniCath™ Peripherally Inserted Venous Catheters."

6. Standalone (Algorithm Only) Performance Study

Not applicable. This device is a physical medical device (catheter), not an AI algorithm. Therefore, a standalone algorithm performance study is not relevant.

7. Type of Ground Truth Used

The "ground truth" for the device's acceptable performance was based on:

• Engineering specifications for functional performance (evaluated through in-vitro testing).
• Standardized biocompatibility test results against established safety limits for medical device materials.

8. Sample Size for Training Set

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

9. How Ground Truth for Training Set Was Established

Not applicable. As there is no training set for an AI/machine learning model, no ground truth was established for it.

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