(325 days)
The Vygon 2 FR Epicutaneo PUR Catheter is intended for use in neonates who require form from therapy, drugs for pain management or intravenous fluids.
Not Found
The provided text is a 510(k) premarket notification document for a medical device, the Vygon 2 FR Epicutaneo PUR Catheter. This type of document is a submission to the FDA demonstrating that the device is substantially equivalent to a legally marketed predicate device, rather than a clinical study evaluating the device's performance against specific acceptance criteria.
Therefore, this document does not contain the information requested regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.
The document primarily states:
- Device Name: Vygon 2 FR Epicutaneo PUR Catheter
- Intended Use: For neonates who require long-term therapy, drugs for pain management, or intravenous fluids.
- Regulatory Class: Class II
- Product Code: LJS
- Date: May 26, 2000
- Outcome: The FDA determined the device to be substantially equivalent to a legally marketed predicate device, allowing it to proceed to market.
To summarize, the request cannot be fulfilled because the provided text is a regulatory submission for market clearance based on substantial equivalence, not a study evaluating device performance against pre-defined acceptance criteria.
§ 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.”