(46 days)
The Marathon™ Flow Directed 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 Marathon™ Micro Catheters are single-lumen, endhole catheters designed for the subselective infusion of physician specified therapeutic agents or 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. The stylet accompanying the catheter is used to increase the rigidity of the distal section during introduction into the guiding catheter.
This document is a 510(k) summary for the Marathon™ Flow Directed Micro Catheter. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study to prove device performance against specific metrics. Therefore, several requested elements cannot be extracted directly from the provided text.
Here is the information that can be gleaned and a clear indication of what is not present:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not Explicitly Stated as Numerical Acceptance Criteria | |
| Biocompatibility | "MTI performed in vitro and in vivo tests to verify and validate product design...Biocompatibility" (Implied as met, but no specific benchmark or result provided.) |
| Angiographic visualization | "MTI performed in vitro and in vivo tests to verify and validate product design...Angiographic visualization" (Implied as met, but no specific benchmark or result provided.) |
| Dimensional verification | "MTI performed in vitro and in vivo tests to verify and validate product design...Dimensional verification" (Implied as met, but no specific benchmark or result provided.) |
| Functional performance | "MTI performed in vitro and in vivo tests to verify and validate product design...Functional performance" (Implied as met, but no specific benchmark or result provided.) |
| Device and Embolic Material Compatibility (including DMSO and Onyx®) | "substantially equivalent device and embolic material compatibility to predicate devices" (Implied as met, but no specific benchmark or result provided.) |
| Flow Directability and Accessibility | "substantially equivalent flow directability and accessibility to the predicate UltraFlow HPC Flow Directed Micro Catheter device" (Implied as met, but no specific benchmark or result provided.) |
| Materials and Construction | "substantially equivalent materials and construction to the predicate devices" (Implied as met, but no specific benchmark or result provided.) |
| Intended Use | "an identical intended use to the predicate device (Echelon)" (Implied as met, as it's identical.) |
Explanation: The document describes "in vitro and in vivo tests" that were performed, but it does not specify quantitative acceptance criteria (e.g., "Visualization must be X to Y" or "Biocompatibility must pass ISO 10993 XYZ levels"). Instead, it states that the device is "substantially equivalent" to predicate devices for various characteristics. This indicates that the performance was assessed against the predicates, but the exact acceptance thresholds are not provided.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified.
- Data Provenance: The document states "MTI performed in vitro and in vivo tests." This implies the testing was conducted by or for Micro Therapeutics, Inc. However, it does not specify the country of origin of any patient data (if applicable to "in vivo tests," which could also refer to animal studies) or whether the data was retrospective or prospective. Given the nature of a 510(k) for a micro catheter, "in vivo" could refer to animal models rather than human patient data for demonstrating substantial equivalence for engineering characteristics.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This information is not provided. The 510(k) summary does not mention expert review or ground truth establishment in the context of device performance testing.
4. Adjudication Method for the Test Set
- This information is not provided. There is no mention of an adjudication process for any test results.
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
- No, an MRMC comparative effectiveness study was not done. This document pertains to a medical device (a micro catheter), not an AI algorithm.
- Therefore, there is no effect size related to human readers improving with AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No, this is not applicable. The device is a physical micro catheter, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- This information is not explicitly stated in relation to the "in vitro and in vivo tests." The "ground truth" for a physical device like a catheter would typically be its measured physical properties (e.g., dimensions, force, flow rates) and biological compatibility, verified against established standards or predicate device performance.
8. The sample size for the training set
- Not applicable. This document describes a physical medical device, not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established
- Not applicable. As above, there is no "training set" for a physical medical device.
§ 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).