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The Peregrine System™ Infusion Catheter is intended for the infusion of diagnostic and therapeutic agents into the perivascular area of the peripheral vasculature.

The Peregrine System Infusion Catheter is a continuous flush catheter designed to deliver diagnostic and therapeutic agents through a vessel wall and into the perivascular space. The catheter contains three distal needles which are deployed using the control handle. Fluids are administered through the proximal injection lumen in the handle, which delivers the fluid through the needles at the distal end of the device. The micro-needles and the guide tubes are radiopaque for fluoroscopic visibility. The device is intended for vessels 3-7 mm in diameter and is compatible with guide catheters of at least 7F.

This document is a 510(k) summary from the FDA for the Peregrine System™ Infusion Catheter. It does not describe a study involving AI or a multi-reader multi-case (MRMC) comparative effectiveness study, nor does it detail acceptance criteria related to algorithmic performance.

Instead, this document details the substantial equivalence of a medical device (a catheter) to a previously cleared predicate device. The acceptance criteria and performance data discussed are related to the physical and functional properties of the catheter, not the performance of an AI algorithm in diagnosing or detecting conditions.

Therefore, I cannot extract the information required by your prompt, as the provided text pertains to a traditional medical device clearance, not an AI-based system. The prompt's questions (e.g., sample size for test set, data provenance, number of experts for ground truth, MRMC study, standalone performance, training set details) are relevant to the evaluation of AI/ML-driven medical devices, which is not the subject of this FDA clearance letter.

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