(41 days)
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 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 510(k) submission for the Echelon™ Micro Catheter, which is a medical device. This document focuses on demonstrating substantial equivalence to a predicate device through in-vitro performance testing and biocompatibility testing.
Medical device submissions like this typically involve engineering performance testing rather than studies involving AI algorithms, human readers, or complex ground truth establishment as would be seen in software as a medical device (SaMD) or AI/ML-based diagnostic tools. Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC studies, standalone performance of an algorithm, training set details) are not applicable to this type of device and submission.
Here's the information that can be extracted or deduced from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The general acceptance criteria for medical devices like this typically involve meeting pre-defined mechanical, chemical, and biological performance specifications that ensure safety and effectiveness. The reported performance confirms that the device met these criteria for various in-vitro tests and biocompatibility. Specific numerical acceptance criteria and their corresponding reported performance values are not provided in this summary document, but the fact that the device was deemed "substantially equivalent" implies these criteria were met.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| In-vitro Performance Testing | Included dimensional inspection, tensile strength tests, burst pressure tests, flow rate tests, torque tests, and performance under simulated conditions. (Specific numeric criteria and results are not detailed in this summary, but the device passed these tests to achieve substantial equivalence). |
| Biocompatibility Testing | Verified in accordance with ISO 10993-1, Biological Evaluation of Medical Devices. Test results confirmed biocompatibility of the catheter was tested 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).