(28 days)
Indicated for short-or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to the administration of fluids, medications, and nutrients; the sampling of blood; central venous pressure monitoring; and power injection of contrast media. Rated for maximum power injection flow rate of 5.0ml/s
The HydroPICC 4F Single Lumen Catheter is comprised of a radiopaque hydrophilic catheter material with a suture wing, Luer lock hub, and extension tubing made from materials commonly used in the manufacture of catheters are provided packaged in kit configurations with the appropriate accessories for placement in the respective clinical environments. The maximum power injection flow rate for the lumen is indicated on the clamp. HydroPCC has been shown to be effective in reducing thrombus accumulation and thrombotic occlusions f thrombus accumulation and thrombotic occusions were evaluated using in vitro and in vivo models. Pre-clinical in vivo evaluations do not necessarily predict clinical performance with respect to thrombus formation.
The provided text is a 510(k) summary for the HydroPICC 4Fr Single Lumen Marked catheter, where the purpose of the submission is to modify the power injection ratings in the indications for use. As such, it focuses on demonstrating substantial equivalence to a predicate device rather than providing details of a study against specific acceptance criteria for a new device's performance.
Therefore, the document does not contain the information requested regarding acceptance criteria, a specific study proving device meets acceptance criteria, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details.
The document discusses "comprehensive data demonstrating the safety and efficacy" and "rigorous testing protocols" including "in vitro" data to support the modified power injection rating, and states that "the form, fit, and function of these devices have not changed from their previous clearances." However, it does not provide specific details of these tests or their results in a measurable, quantifiable way that would allow for the completion of the requested table and study breakdown.
§ 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.”