(28 days)
The TrailBlazer™ angled support catheters are percutaneous, single lumen catheters designed for use in the peripheral vascular system. The TrailBlazer™ angled support catheters are intended to guide and support a guide wire during access of the vasculature, to allow for guide wire exchanges and provide a conduit for the delivery of saline solutions or diagnostic contrast agents.
The TrailBlazer™ angled support catheter is an over-the-wire (OTW) single lumen catheter with a tapered angled distal tip. The catheter system is compatible with 0.36 mm (0.014in.), 0.46 mm (0.018 in.), or 0.89 mm (0.035 in.) guidewires. The support catheter has working lengths of 65 cm. 90 cm. 135 cm. and 150 cm depending on the model. All models are compatible with a 4 Fr introducer sheath. The manifold provides proximal access to the lumen which transitions to the catheter shaft and terminates at the angled distal tip. The lumen is used to pass the catheter over a guidewire. The manifold is constructed from elastomer and molded to the catheter proximal shaft. The guidewire compatible diameter and length are marked on the strain relief that is clipped to the manifold post molding. The multi-layer elastomer catheter shaft is designed with a stainless steel braided mesh. Three radiopaque markers starting at the distal tip aid in positioning the catheter. The distal tip of the catheter is molded to a predetermined angle to optimize vessel subselection with a guidewire. The distal 40cm portion of the catheter is coated with a hydrophilic coating. Finished catheters are packaged in hoops, sealed in pouches and provided in 5-pack cartons with an IFU.
The provided text describes the 510(k) summary for the Medtronic TrailBlazer™ Angled Support Catheter (K162384). This document focuses on demonstrating substantial equivalence to predicate devices through bench testing and does not contain information about clinical studies involving human patients or ground truth established by medical experts for diagnostic performance.
Therefore, many of the requested elements related to clinical study design, sample sizes for test and training sets, expert involvement, and comparative effectiveness (MRMC) cannot be answered from the provided text.
Here's an overview of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The document lists various tests performed to demonstrate substantial equivalence. It does not explicitly state numerical acceptance criteria or specific quantitative performance values for each test in a table format. Instead, it generally states "All testing was performed in accordance with recognized standards. Results from this testing provide assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use."
However, the types of tests conducted can be considered the acceptance criteria categories:
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Dimensional Verification | Performed |
| Simulated Use | Performed |
| Catheter Bond Strength | Performed |
| Tip Pull Test | Performed |
| Flexibility and Kink Test | Performed |
| Torque Strength and Rotational Control | Performed |
| Radiopacity | Performed |
| Catheter Body Burst | Performed |
| Coating Integrity, and Particulate Evaluation | Performed |
| Contrast Media Flow rate | Performed |
| Packaging and Shelf Life | Performed |
| Biocompatibility (cytotoxicity, sensitization, irritation, systemic toxicity, pyrogen, hemolysis, thromboresistance, complement activation, partial thromboplastin time, platelet and leukocyte counts, mutagenicity, lymphoma and micronucleus) | Performed |
2. Sample size used for the test set and the data provenance
The document describes bench testing, not a clinical study with a test set of patient data. Therefore, this information is not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable as this was a bench study, not a study requiring expert ground truth for diagnostic performance assessment.
4. Adjudication method for the test set
Not applicable as this was a bench study.
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, and the studies were bench tests, not MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical medical device, not an algorithm. The "standalone" performance here refers to the physical and functional aspects of the catheter in isolation, which were assessed through the listed bench tests.
7. The type of ground truth used
For the bench tests, the "ground truth" was defined by recognized standards and specifications for medical devices. For example, a bond strength test would have a specified minimum acceptable force, and the outcome of the test (e.g., whether the bond held) would be compared against that standard.
8. The sample size for the training set
Not applicable. This device is a physical medical device where performance characteristics are often established through engineering design and testing against specifications, rather than machine learning training sets.
9. How the ground truth for the training set was established
Not applicable.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).