(370 days)
An intravascular catheter, inserted peripherally for long-term administration of solutions for parenteral nutrition and/or administration of drugs
Not Found
The provided text is a 510(k) premarket notification letter from the FDA to Vygon US LLC regarding their Nutriline and Nutriline Twinflow Catheters. This document does not contain any information about acceptance criteria or a study proving the device meets those criteria.
The letter primarily:
- Confirms the review of the 510(k) submission (K052475).
- States that the device is substantially equivalent to legally marketed predicate devices.
- Informs the manufacturer about general controls and other applicable regulations.
- Encloses the "Indications for Use" for the device.
Therefore, I cannot provide the requested information from the given text. A 510(k) summary or a more detailed submission document would typically contain such study information if it were required for the substantial equivalence demonstration.
§ 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.”