Search Results

An intravascular administration set with needle access to be used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vessel.

IV Extension/Administration Sets with Needle

The provided text pertains to a 510(k) premarket notification for an "IV Extension/Administration Sets with Needle" device (K980994) received by the FDA in 1998. The document is an FDA clearance letter confirming substantial equivalence to a predicate device.

This document does not contain any information regarding acceptance criteria, device performance, study details (sample sizes, data provenance, expert-established ground truth, adjudication methods, MRMC studies, standalone performance), or training set information for an AI/algorithm-based device.

The document is a regulatory clearance letter for a physical medical device (IV administration sets), not a software or AI medical device. Therefore, the questions posed in the prompt about AI/algorithm performance and study methodologies are not applicable to the content provided.

Ask a specific question about this device

An extension set to be used as an extension to the Intravascular administration set to be assul in the IV extension set will connect the administration set to a catheter or needle inserted into a vessel. The IV IV administration bet to a calleless access devices to protect the users from needle stick injuries.

Not Found

This document is a marketing clearance letter from the FDA for a medical device, specifically "Starluck® IV Extension Sets with Needleless Access Devices." It states that the device is substantially equivalent to legally marketed predicate devices and outlines general controls and regulations.

Unfortunately, this document does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria. It is an administrative document related to market approval, focusing on regulatory classification and substantial equivalence, not performance testing details.

Therefore, I cannot provide the requested information based on the provided text.

Ask a specific question about this device