Search Results

The Cordis Vanguard Steerable Guidewires are designed for use in angiographic procedures to introduce and position catheters and interventional devices within the peripheral vasculature.

The Cordis Vanguard Steerable Guidewires have a multi-tapered stainless steel corewire with a soft, flexible, highly radiopaque platinum alloy coil over the tip. A steering / torquing device may be attached to aid in steering/torquing the guidewire.

This document is a 510(k) premarket notification for the Cordis Vanguard Steerable Guidewire, submitted in 1997. It is a regulatory submission for a medical device and, as such, does not contain information about a study proving the device meets acceptance criteria in the way a clinical trial or performance study for a new AI/software device would.

The document discusses "substantial equivalence" to predicate devices, which is a regulatory pathway for class II devices. The "performance" mentioned refers to the device's functional characteristics compared to existing devices, not a study against predefined acceptance criteria for a novel technology.

Therefore, the requested information cannot be extracted from this document as it pertains to a different type of regulatory submission and device evaluation. Specifically, the following points cannot be answered from the provided text:

1. A table of acceptance criteria and the reported device performance: This document does not establish specific performance acceptance criteria or report performance data against them. It states the device is "similar in design, construction, indication for use and performance characteristics to other commercially available steerable guidewires."
2. Sample size used for the test set and the data provenance: Not applicable, as no such "test set" for performance evaluation (e.g., diagnostic accuracy) is mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable.
6. If a standalone performance (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

The document focuses on:

• Biocompatibility testing: "All appropriate Biocompatibility tests were successfully performed on the materials used for the Cordis Vanguard Steerable Guidewires per ISO 10993-1." (This is a type of acceptance criterion, but not performance in the sense of diagnostic accuracy or effect size.)
• Substantial Equivalence: The primary claim is that the device is substantially equivalent to existing predicate devices (TAD II Guide Wire System and Wholey Hi-Torque Guide Wire System K861765) in design, construction, indication for use, and performance characteristics.

In summary, this document is a regulatory submission demonstrating substantial equivalence of a physical medical device, not a performance study for a software/AI algorithm against specific acceptance criteria.

Ask a specific question about this device