(67 days)
The Medcomp@ 6F Triple Pro-Line® CT Power Injectable CVC is indicated for short or long term access to the central venous system. It is designed for administering I.V. fluids, blood products, drugs, and parenteral nutrition solutions. as well as blood withdrawal, allows for central venous pressure monitoring and power injection of contrast media. The maximum recommended infusion rate is 5cc/sec.
The Pro-Line of Power Injectable CVC triple lumen is an open-ended triple lumen catheter designed for power injection through one designated lumen. The power injectable central venous catheter is comprised of a soft radiopaque polyurethane material. The lumen has a reverse taper design and is connected to the extensions via a soft pliable hub with suture wing for secure placement. Clamps are provided on the extension tubes to prevent air/fluid communication. Female luer connectors provide the connection for intravenous administration. The designated 17ga. power injectable extension line and clamp material are purple in color to differentiate it from the clear 19ga. non-power injectable extensions. The purple lumen identifies it as a power injectable catheter. The center extension is also printed with the words power injectable. The I.D. Ring within the clamp on the power extension contains information regarding checking for blood return and flushing along with rate of infusion for power injection.
The catheter has a usable length of 60 cm with numerical markings every 5 cm and depth markings in 1 cm increments. Stylet and adaptor sideport are provided to assist in catheter insertion.
The catheter is packaged sterile with the necessary accessories to facilitate catheter insertion.
The provided text describes a medical device, the Medcomp® Pro-Line CT Power Injectable CVC, and its submission for 510(k) clearance. It does not describe an AI/ML-driven device or diagnostic software. Therefore, the requested information regarding acceptance criteria for device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details is not applicable to the provided document.
The document discusses the substantial equivalence of the Medcomp® Pro-Line CT Power Injectable CVC to predicate devices based on:
- Intended Use: Short or long-term central venous access for IV fluids, blood products, drugs, parenteral nutrition, blood withdrawal, CVP monitoring, and power injection of contrast media (max 5cc/sec).
- Technological Characteristics: Basic design, materials, performance, labeling, manufacturing process, and sterilization.
- Bench/Performance Data: Conducted in accordance with applicable international standards and internal engineering protocols, to demonstrate substantial equivalence.
- Biocompatibility: Materials meet ISO 10993 requirements, with testing previously submitted for other Medcomp devices.
"Clinical studies were not deemed necessary since in-vitro testing was sufficient to demonstrate safety and effectiveness by way of comparison to the legally marketed predicate device." This statement directly indicates that performance criteria based on clinical outcomes, or metrics that would necessitate human expert review or an MRMC study, were not part of the clearance process for this specific medical device.
Therefore, I cannot provide the requested table and study details as they pertain to AI/ML device evaluation within this document.
The document is a 510(k) premarket notification for a traditional medical device (catheter), not an AI/ML diagnostic or treatment planning system.
§ 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.”