(108 days)
The Marksman™ Catheter is indicated for the introduction of interventional devices and infusion of diagnostic or therapeutic agents into the neuro, peripheral and coronary vasculature.
The Marksman™ Catheter is a variable stiffness, single lumen catheter designed to access small, tortuous vascular areas. The outer surface of the catheter's distal segment is coated with a hydrophilic material to provide lubricity during use. The catheter also incorporates a PTFE liner to facilitate movement of introduction devices passed through its lumen. The Marksman™ Catheter has a radiopaque marker at the distal tip to facilitate fluoroscopic visualization. The distal tip of the catheter is shapeable. The Marksman™ Catheter is provided with various working lengths. The Marksman™ Catheter is for single use only.
This is not an AI/ML device. This is a medical device, a catheter, for which the manufacturer is seeking approval for a modified version with a different coating. Therefore, the questions related to AI/ML device performance metrics, such as accuracy, AUC, F1 score, expert consensus for ground truth, training/test set sizes, and MRMC studies, are not applicable here.
The submission is a Special 510(k) for the Marksman™ Catheter, focusing on demonstrating substantial equivalence to a predicate device after a change in the hydrophilic coating. The safety and performance verification is based on engineering and biocompatibility testing, not on AI/ML performance evaluation.
Here's how the provided information relates to the general concept of acceptance criteria and proving device meets them, adapted for a non-AI/ML medical device:
- A table of acceptance criteria and the reported device performance
- Acceptance Criteria/Performance Metrics: The primary "acceptance criteria" here is substantial equivalence to the predicate device, specifically demonstrating that the new Biocoat™ coating does not introduce new risks and that the device maintains its existing safety and performance characteristics.
- Reported Device Performance: The submission states:
- Biocompatibility: "The Marksman™ Catheter with Biocoat™ coating meets the requirements for biocompatibility." and "All test results obtained were acceptable for the device's intended use."
- Safety and Performance Verification Tests: "These tests yielded acceptable results substantially equivalent to the predicate device."
- Table: While not presented in a formal table in the provided text as numerical values for specific performance metrics (which are typical for AI/ML devices), the key areas of evaluation and their "performance" are summarized as "SAME" or "acceptable results".
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Design, Function, Indications, Packaging, Sterilization, Shelf life, Labeling | SAME as predicate device (substantially equivalent). |
| Manufacturing | SAME as predicate device, except for hydrophilic coating. |
| Materials | SAME as predicate device, except for hydrophilic coating. |
| Biocompatibility | Meets requirements, acceptable for intended use. |
| Risk Evaluation | No new risks identified, safety and effectiveness profile similar to predicate. |
| Safety & Performance Verification Tests (dimensional, material, access/tractability, coating durability, particulate) | Acceptable results, substantially equivalent to predicate device. |
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Sample size used for the test set and the data provenance
- This question is not applicable in the context of an AI/ML system evaluating data. For a physical medical device, testing typically involves a sufficient number of device units or components to ensure statistical confidence in the results for the specific tests performed (e.g., biocompatibility on samples, mechanical stress tests on multiple catheters). The document doesn't specify the exact number of units tested for each physical or biological test, but it indicates the tests were performed.
- Provenance: The biocompatibility testing was performed by Toxikon (Bedford, MA), a certified laboratory. The nature of testing is likely prospective in that the new coating was specifically manufactured and then tested according to predetermined protocols.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This is not applicable to this type of device submission. There is no concept of "ground truth" established by experts in the context of evaluating the performance of a physical catheter with a new coating; rather, it relies on standardized physical, chemical, and biological testing methods.
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Adjudication method
- This is not applicable.
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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
- This is not applicable.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This is not applicable.
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The type of ground truth used
- This is not applicable. For this device, "ground truth" is analogous to established scientific and engineering principles, material standards, and biological responses as measured by validated laboratory tests and existing clinical knowledge of similar devices and materials.
- Specifically, biocompatibility relies on standardized in vitro and in vivo biological tests (e.g., per EN ISO 10993-1: 2009 for biocompatibility). Physical performance validation uses engineering and material testing methods.
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The sample size for the training set
- This is not applicable. There is no "training set" for this type of medical device.
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How the ground truth for the training set was established
- This is not applicable.
§ 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).