(166 days)
The MTI 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 Echelon Micro Catheter is an endhole, single-lumen catheter designed to be introduced over a steerable guidewire into the vasculature. The proximal end of the catheter incorporates a standard luer adapter to facilitate the attachment of accessories. 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 document is a 510(k) summary for a medical device (MTI Echelon Micro Catheter) and does not describe acceptance criteria or a study proving the device meets those criteria in the way typically required for AI/software-as-a-medical-device (SaMD).
Instead, this document focuses on demonstrating substantial equivalence to predicate devices through in-vitro performance testing and biocompatibility testing for a physical catheter. The "acceptance criteria" here are implied by the successful completion and comparison of these physical tests to the predicate device, not statistical performance metrics of an algorithm.
Therefore, many of the requested categories for AI/SaMD studies are not applicable to this 510(k) submission. I will address only the relevant information from the provided text.
Relevant Information from the 510(k) Summary for the MTI Echelon™ Micro Catheter Family (K051990):
1. Table of acceptance criteria and the reported device performance:
The document lists the types of in-vitro performance tests conducted rather than explicit acceptance criteria with numerical performance data. The implicit acceptance criterion is that the new device performs comparably to the predicate devices in these tests.
| Test Category | Reported Device Performance |
|---|---|
| Dimensional Inspection | Performed (details not provided, but implies measurements were within specifications or comparable to predicate). |
| Visual Analysis | Performed (details not provided, but implies visual characteristics were acceptable or comparable to predicate). |
| Tensile Strength Tests | Performed (details not provided, but implies tensile strength was within specifications or comparable to predicate). |
| Tip Tensile Strength | Performed (details not provided, but implies tip tensile strength was within specifications or comparable to predicate). |
| Burst Pressure Tests | Performed (details not provided, but implies burst pressure was within specifications or comparable to predicate). |
| Flow Rate Tests | Performed (details not provided, but implies flow rates were within specifications or comparable to predicate). |
| Torque Tests | Performed (details not provided, but implies torque characteristics were within specifications or comparable to predicate). |
| Tip Reshape-ability/Retention | Performed (details not provided, but implies tip could be reshaped and retained shape as expected or comparable to predicate). |
| Tip Offset Distances Measurement | Performed (details not provided, but implies offset distances were within specifications or comparable to predicate). |
| Tip Length Measurement Specification | Performed (details not provided, but implies tip length met specifications or was comparable to predicate). |
| Guidewire Friction | Performed (details not provided, but implies guidewire friction was acceptable or comparable to predicate). |
| Coil Friction | Performed (details not provided, but implies coil friction was acceptable or comparable to predicate). |
| Performance under Simulated Conditions | Performed (details not provided, but implies the device performed acceptably in simulated use conditions or comparably to predicate). |
| Biocompatibility | Verified in accordance with ISO 10993-1, Biological Evaluation of Medical Devices. Test results confirmed biocompatibility 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).