(23 days)
The MTI Echelon™ 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 MTI Echelon™ Micro Catheter is an end-hole, single-lumen catheter designed to be introduced over a steerable guidewire into the vasculature. The catheter has a semi-rigid proximal shaft which transitions into the flexible distal shaft to facilitate the advancement of the catheter in the anatomy. Dual radiopaque markers at the distal end facilitate fluoroscopic visualization. The outer surface of the catheter is coated to increase lubricity.
The provided text describes a Special 510(k) submission for the Echelon™ Micro Catheter, which is a modification to the previously cleared Rebar® Micro Catheter (K993672). As such, the submission focuses on demonstrating substantial equivalence to the predicate device through performance testing rather than establishing de novo clinical efficacy for a novel device. Therefore, many of the requested categories related to clinical studies, AI performance, and expert ground truth are not applicable to this type of submission.
Here's a summary of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The submission describes in-vitro performance testing and biocompatibility testing. The "acceptance criteria" themselves are not explicitly detailed as quantitative thresholds in the provided text, but rather implied by successful completion of these tests to demonstrate substantial equivalence to the predicate device.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Dimensional specifications met | Dimensional inspection performed (results not detailed, but implied met for clearance) |
| Tensile strength within acceptable limits | Tensile strength tests performed (results not detailed, but implied met for clearance) |
| Burst pressure within acceptable limits | Burst pressure tests performed (results not detailed, but implied met for clearance) |
| Flow rate within acceptable limits | Flow rate tests performed (results not detailed, but implied met for clearance) |
| Torque characteristics within acceptable limits | Torque tests performed (results not detailed, but implied met for clearance) |
| Performance under simulated conditions equivalent to predicate | Performance under simulated conditions tested (results not detailed, but implied met for clearance) |
| Biocompatibility in accordance with ISO 10993-1 | Biocompatibility verified as an external communicating, blood contact, limited exposure ( |
§ 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).