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The ZigiWire Guidewire Systems facilitate placement and exchange of catheters and other instruments in the peripheral vasculature. The ZigiWire Guidewire Systems are not intended for use in the coronary arteries or neurovasculature.

The Vadiswire ZigiWire Mode2 and ZigiWire Mode3 Guidewire Systems are sterile guidewire systems designed to facilitate the placement of diagnostic catheters and sheaths in the peripheral vasculature. The individual guidewires used in the ZigiWire Systems consist of exchange length peripheral guidewires cleared under AdvanceCath (TechDevice) Corporation's 510(k) K053251. TechDevice Corporation manufactures the guidewires used in the ZigiWire Systems for Vadiswire, which are individually the same as several of the guidewires previously cleared under K053251.

The ZigiWire Systems consist of two models: one (ZigiWire Mode3) incorporates three individual exchange length peripheral guidewires, and the second (ZigiWire Mode2) incorporating two individual exchange length peripheral guidewires. The individual guidewires used in the system range from 0.014 - 0.022 inches in diameter and are standard Teflon-coated, stainless steel guidewires with flexible radiopaque tips. Each ZigiWire System is provided with the individual guidewires in an all straight tip shape, or with all guidewires in the J-tip shape. The ZigiWire Systems are also provided with accessories which are intended to assist in inserting the guidewires into diagnostic catheters. These accessories consist of a wire introducer, which loosely holds the individual guidewires and helps to guide them into the hub of a catheter, a handle to separate the wires prior to use, and wire torquers for each wire. The handle incorporates a side port to enable flushing the introducer with the guidewires in place.

The provided text is a 510(k) summary for the ZigiWire Mode2 and Mode3 Guidewire Systems. A 510(k) submission is for demonstrating substantial equivalence to a predicate device, not for proving a device meets specific acceptance criteria in the context of a new, novel product with performance claims evaluated against a clinical study with ground truth. Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" are not applicable or cannot be extracted from this document, as it focuses on bench testing for equivalence rather than clinical performance or AI algorithm validation.

Here's a breakdown of what can and cannot be extracted:

1. A table of acceptance criteria and the reported device performance

Note: The document states that the results "demonstrate that the technological and performance characteristics of the subject ZigiWire Guidewire Systems are comparable to the predicate devices, support the safety and effectiveness of the devices that are the subject of this 510(k), and ensure the subject devices can perform in a manner equivalent to the predicate devices with the identical intended use." It does not provide specific numerical acceptance thresholds or detailed performance metrics for each test, as it's a summary tailored for substantial equivalence.

Regarding the other requested information (2-9), these are generally applicable to studies for novel performance claims, particularly for AI/CADe devices, and are largely not found in a 510(k) summary for a guidewire system:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable for this type of bench testing. The "test set" consisted of the guidewire systems themselves undergoing the listed physical tests. Data provenance in this context isn't about clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable. "Ground truth" in the AI/clinical study sense is not established by experts for physical performance of a guidewire system. The "truth" is determined by the physical properties and behavior of the device during the specified bench tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Adjudication methods are relevant for clinical studies where expert consensus might establish ground truth for image interpretation or disease diagnosis.
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 refers to AI-assisted diagnostic or interpretative devices, not a guidewire.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This refers to AI algorithms.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "truth" is based on the physical outcomes of the bench tests (e.g., bond strength, successful wire removal, steerability).
8. The sample size for the training set: Not applicable. There is no "training set" for physical guidewire testing.
9. How the ground truth for the training set was established: Not applicable.

In summary, this document describes a traditional 510(k) submission for a medical device (guidewire) based on established predicate devices and bench testing to demonstrate substantial equivalence, rather than a clinical study evaluating a novel diagnostic or therapeutic claim with specific performance acceptance criteria against "ground truth" as might be seen for an AI/CADe device.

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