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510(k) Data Aggregation
(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 (<24 hrs) device. Test results confirmed biocompatibility. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes for each in-vitro test. The data provenance is in-vitro testing conducted by Micro Therapeutics, Inc. The location or timeline of these tests (retrospective/prospective) is not explicitly stated, but in-vitro tests are typically prospective for a device submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This is an in-vitro performance and biocompatibility study, not a clinical study involving expert interpretation of data for ground truth. The "ground truth" for these tests would be the established engineering specifications and ISO standards for biocompatibility.
4. Adjudication Method for the Test Set
Not applicable. There was no clinical data requiring adjudication.
5. 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
Not applicable. This is a medical catheter, not an AI-powered diagnostic or assistive device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical catheter, not an algorithm.
7. The Type of Ground Truth Used
For the in-vitro performance tests, the "ground truth" would be the established engineering specifications, design requirements, and applicable industry standards for medical catheters. For biocompatibility, the ground truth was based on the requirements of ISO 10993-1.
8. The Sample Size for the Training Set
Not applicable. This is not a machine learning or AI device.
9. How the Ground Truth for the Training Set was Established
Not applicable.
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