(2 days)
The Rebar Micro Catheter is intended for the controlled selective infusion of physician-specified therapeutic agents or contrast media into the vasculature of the peripheral and neuro anatomy.
The UltraFlow HPC Flow Directed Micro Catheter is intended for the controlled selective infusion of physician-specified pharmacologic agents or contrast media into the distal vasculature of the peripheral and neuro anatomy. It is not intended for use in the coronary vasculature.
The Nautica Micro Catheter is intended to access peripheral and neurovasculature for the controlled selective infusion of physician-specified therapeutic agents such as embolization materials and of diagnostic materials such as contrast media. Not intended for use in the coronary vasculature.
The Marathon Micro Catheter is intended to access peripheral and neuro vasculature for the controlled selective infusion of physician-specified therapeutic agents such as embolization materials and of diagnostic materials such as contrast media.
The Echelon™ Micro Catheter is intended to access peripheral and neuro vasculature for the controlled selective infusion of physician-specified therapeutic agents such as embolization materials and of diagnostic materials such as contrast media.
The MTI/ev3 micro catheters are single-lumen, end-hole catheters designed for the sub selective infusion of physician-specified therapeutic agents such as embolization materials and diagnostic materials such as contrast media in tortuous, distal vessels. The catheters have a semi-rigid proximal shaft and a highly flexible distal shaft to facilitate the advancement of the catheter in the anatomy. The proximal end of the catheters incorporates a standard luer adapter to facilitate the attachment of accessories. The catheters have single or dual radiopaque markers at the distal end to facilitate fluoroscopic visualization. The outer surfaces of the catheters are coated to increase lubricity.
The provided document, K093750, is a Special 510(k) submission for ev3 Micro Catheters. It explicitly states:
"The micro catheter devices have not changed; there is no performance data included in this submission. The Instructions for Use have been revised to remove the pediatric and neonatal contraindication."
"The devices have not changed and no new risks have been identified. The indications for use demonstrate the MTI/ev3 Micro Catheters are substantially equivalent to the predicate devices."
Therefore, based on the provided text, the following information cannot be extracted:
- Table of acceptance criteria and the reported device performance: No performance data is included as the device has not changed.
- Sample size used for the test set and the data provenance: No test set data is provided.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no test data is provided.
- Adjudication method for the test set: Not applicable as no test data is provided.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: This document describes a micro catheter, not an AI or imaging device, so MRMC studies involving human readers and AI are not relevant.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as this is a physical medical device, not an algorithm.
- The type of ground truth used: Not applicable as no performance data is provided.
- The sample size for the training set: Not applicable as no performance data or machine learning components are described.
- How the ground truth for the training set was established: Not applicable as no performance data or machine learning components are described.
The submission focuses on demonstrating substantial equivalence to predicate devices because the micro catheter devices themselves have not changed. The only change mentioned is a revision to the Instructions for Use to remove pediatric and neonatal contraindications.
§ 870.1210 Continuous flush catheter.
(a)
Identification. A continuous flush catheter is an attachment to a catheter-transducer system that permits continuous intravascular flushing at a slow infusion rate for the purpose of eliminating clotting, back-leakage, and waveform damping.(b)
Classification. Class II (performance standards).