(28 days)
The Marathon™ Flow Directed Micro Catheter is intended to access the 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 Marathon™ Flow Directed Micro Catheters are single-lumen, endhole 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 catheter has 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 catheter incorporates a standard luer adapter to facilitate the attachment of accessories. The catheter has a radiopaque marker at the distal end to facilitate fluoroscopic visualization. The outer surfaces of the catheter are coated to increase lubricity. Microcatheter may be used with stylet, guidewire or introducer sheath to increase the rigidity of the distal section during introduction into the guiding catheter.
The provided text describes a 510(k) premarket notification for a medical device, the Marathon™ Flow Directed Micro Catheter. The document focuses on demonstrating substantial equivalence to a predicate device through technical comparisons and bench testing.
However, the provided text DOES NOT contain information regarding:
- AI/Algorithm performance: This document is for a physical medical device, not an AI or algorithmic diagnostic tool.
- Acceptance criteria for an AI model: The acceptance criteria listed are for physical characteristics and performance of a catheter.
- Sample size for a test set or training set for an AI model: No AI model is being evaluated.
- Data provenance, expert ground truth, adjudication methods, MRMC studies, or standalone performance: These are all concepts relevant to the evaluation of AI/ML-based medical devices or diagnostic algorithms, which are not the subject of this document.
- Effect size of human reader improvement with AI assistance: Not applicable.
- Type of ground truth used (pathology, outcomes data, etc.): Not applicable in this context.
Therefore, I cannot provide a table of acceptance criteria and reported device performance in the context of an AI/ML model, nor can I answer the specific questions about AI model testing that were asked.
The document instead focuses on demonstrating the substantial equivalence of the Marathon™ Flow Directed Micro Catheter to a predicate device (K093750) through bench testing and biocompatibility assessments.
Here's the relevant information about the device's acceptance criteria and proven performance based on the provided text, re-framed to address the questions where applicable, but noting when the question is not relevant to this document.
1. A table of acceptance criteria and the reported device performance (for the physical device, not AI):
| Bench Testing Category | Acceptance Criteria (Test Method Summary) | Reported Device Performance (Summary of Results) |
|---|---|---|
| Biocompatibility | ||
| Cytotoxicity | Test article extract should show no evidence of causing cell lysis or toxicity; should be non-cytotoxic. | The test article met the requirements of the test since the test article was non-cytotoxic. |
| Hemocompatibility | Test article should show no evidence of color and be free of particulates; should be non-hemolytic. | The test article met the test requirements and was non-hemolytic. |
| Performance Data - Bench | ||
| Dimension - Usable Length | Marathon™ Flow Directed Micro Catheter should measure 165 ± 2.5cm. | The Marathon™ Flow Directed Micro Catheter met the acceptance criteria for usable length. |
| Dynamic Burst | Evaluated per ISO 10555-1 2014/A1:2017 Annex G. | The Marathon™ Flow Directed Micro Catheter met the acceptance criteria for dynamic burst. |
| Static Burst | Evaluated per ISO 10555-1 2014/A1:2017 Annex F. | The Marathon™ Flow Directed Micro Catheter met the acceptance criteria for static burst. |
| Static Burst Post Plug & Push | Evaluated per ISO 10555-1 2014/A1:2017 Annex F. | The Marathon™ Flow Directed Micro Catheter met the acceptance criteria for static burst, post plug and push. |
| Hub Tensile | Evaluated per ISO 10555-1 2013/A1:2017 Annex B. | The Marathon™ Flow Directed Micro Catheter met the acceptance criteria for hub tensile. |
| Hub Tensile Post Plug & Push | Evaluated per ISO 10555-1 2014/A1:2017 Annex F. | The Marathon™ Flow Directed Micro Catheter met the acceptance criteria for hub tensile post plug and push. |
| Deadspace | Marathon™ Flow Directed Micro Catheter deadspace should be ≤ 0.27 ml and ≥ 0.23 ml, without Syringe adapter. | The Marathon™ Flow Directed Micro Catheter met the acceptance criteria for deadspace. |
| Visual Inspection | Marathon™ Flow Directed Micro Catheter Hub should be clear and free from defects and crazing. | The Marathon™ Flow Directed Micro Catheter met the acceptance criteria for visual inspection. |
| Standard Luer Hub Requirements | Evaluated per ISO 80369-7:2016 and ISO 80369-20:2015. | The Marathon™ Flow Directed Micro Catheter met the acceptance criteria for standard luer hub requirements. |
| Hub Air Leak | Evaluated per ISO 10555-1 2014/A1:2017 Annex D. | The Marathon™ Flow Directed Micro Catheter met the acceptance criteria for hub air leak. |
2. Sample size used for the test set and the data provenance:
- This document is for a physical medical device and discusses bench testing, not an AI model's test set.
- Sample Size for Bench Testing:
- Specific sample sizes for each bench test are not explicitly stated in this summary table, only the results. However, typical regulatory submissions for physical devices involve testing a statistically representative number of units.
- Data Provenance: Not applicable in the terms used for AI. The data originates from internal laboratory bench testing conducted by the manufacturer (Micro Therapeutics, Inc. d/b/a ev3 Neurovascular).
- Retrospective/Prospective: Not applicable in this context. These are lab tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This device is evaluated through engineering bench tests and biocompatibility testing, not through expert-labeled diagnostic data for an AI model.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This is for a physical device, not an AI test set requiring human 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 document is about a physical medical device (catheter), not an AI system that assists human readers. No MRMC study was conducted or is relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the biocompatibility tests, the "ground truth" is established by standard biological assays and the observation of cellular and blood responses against established safety thresholds.
- For the bench performance tests, the "ground truth" is the physical properties and performance characteristics of the catheter as measured against predefined engineering specifications and international standards (e.g., ISO 10555-1, ISO 80369). These are objective measurements.
8. The sample size for the training set:
- Not applicable. There is no AI model requiring a training set described here.
9. How the ground truth for the training set was established:
- Not applicable. There is no AI model or training set described here.
§ 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).