(113 days)
The Marksman™ Catheter is intended 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.
The provided text is a 510(k) summary for the Marksman™ Catheter, detailing its design, indications for use, and a declaration of substantial equivalence to predicate devices. This document does not describe or include an acceptance criteria table, device performance data, or a description of a study proving device performance against acceptance criteria.
Instead, the document states:
- Substantial Equivalence Determination: The safety and effectiveness of the Marksman™ Catheter are based on its substantial equivalence to predicate endovascular catheters. The conclusion of substantial equivalence is drawn from comparisons in design, function, manufacturing, materials, indications, packaging, sterilization, and labeling.
- Clinical Evaluation: A clinical evaluation was conducted to show that "no new risks were identified and that the safety and effectiveness profile is similar to well-established predicate devices cleared for the market." This evaluation was performed in the neurovascular anatomy, considered the "worst case representation of the cardiac and peripheral vascular anatomies."
Since the document does not present specific quantitative acceptance criteria or detailed study results, I cannot fill in the requested table or provide information for most of the points about a specific performance study.
Here's what can be inferred or explicitly stated based on the provided text, acknowledging the limitations due to the lack of a detailed performance study section:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not provided in the document. The device's safety and effectiveness are established through substantial equivalence to predicate devices, rather than meeting specific quantifiable performance criteria presented here. | Clinical Evaluation: "No new risks were identified and that the safety and effectiveness profile is similar to well-established predicate devices cleared for the market." |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified. The document mentions a "clinical evaluation," but provides no details on participant numbers.
- Data Provenance: Not specified, but likely prospective as it refers to a "clinical evaluation" conducted to confirm safety and effectiveness for the specific device being submitted.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The document does not describe a study involving expert-established ground truth for a test set. The clinical evaluation focuses on comparing the device's safety and effectiveness profile to existing predicate devices.
4. Adjudication method for the test set:
- Not applicable. No details about an adjudication method are provided.
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 device is a catheter, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a catheter, not an algorithm.
7. The type of ground truth used:
- Not explicitly stated as "ground truth" in the context of an accuracy study. The "clinical evaluation" aimed to demonstrate that the device's "safety and effectiveness profile is similar to well-established predicate devices." This implies that the 'truth' or benchmark was the known safety and effectiveness of existing, legally marketed catheters.
8. The sample size for the training set:
- Not applicable. There is no mention of a "training set" in the context of an algorithmic or AI model.
9. How the ground truth for the training set was established:
- Not applicable. There is no mention of a "training set" or its ground truth.
§ 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).