(154 days)
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
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Function according to specification (based on in-vitro testing) | The results of the testing indicated that the CliniCath™ IR Peripherally Inserted Central Catheter functions according to specification. |
| Materials are biocompatible | The materials used in the device are biocompatible. |
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.
§ 880.5970 Percutaneous, implanted, long-term intravascular catheter.
(a)
Identification. A percutaneous, implanted, long-term intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings, such as luer hubs, and accessories that facilitate the placement of the device. The device allows for repeated access to the vascular system for long-term use of 30 days or more, and it is intended for administration of fluids, medications, and nutrients; the sampling of blood; and monitoring blood pressure and temperature. The device may be constructed of metal, rubber, plastic, composite materials, or any combination of these materials and may be of single or multiple lumen design.(b)
Classification. Class II (special controls) Guidance Document: “Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters.”