(57 days)
The Peripherally Inserted Central Vein Access catheters are designed for short or long term peripheral access to the central venous system for intravenous therapy and blood sampling. For central venous pressure monitoring (CVP), it is recommended that catheter lumen of 20 gauge or larger be used.
The Midline catheters are indicated for short or long term peripheral access to the peripheral venous system for selected intravenous therapies and blood sampling. (See Contraindications). For blood therapy it is recommended that a 4French or larger catheter be used.
Not Found
The document provided is a 510(k) clearance letter from the FDA for a medical device (Vascu-PICC® and Midline Catheters). It does not contain information about acceptance criteria, study design, or performance metrics of a device being tested.
Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment. This type of information would typically be found in a separate submission document, such as a 510(k) summary or an IDE report, which would detail the clinical or non-clinical studies conducted to support the device's safety and effectiveness.
The letter only confirms that the FDA has determined the device is substantially equivalent to a legally marketed predicate device for the stated indications for use.
§ 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.”