(30 days)
The 2.6F Vascu-PICC® catheters are indicated for short or long term access to the central venous system for peripheral infusion of fluids, blood products, medication, and nutritional therapy.
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The provided document is a 510(k) clearance letter from the FDA for a medical device called "2.6F Vascu-PICC". This document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment relevant to AI/ML device evaluations.
The letter states that the device is substantially equivalent to legally marketed predicate devices, which is a regulatory pathway for certain medical devices. It primarily focuses on the regulatory classification, applicable regulations, and administrative information regarding the device's marketability.
Therefore, I cannot fulfill your request for information regarding acceptance criteria and study details based on the provided text. The document is not an AI/ML device submission or a performance study report.
§ 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.”