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The VIKING Fixed Curve Diagnostic Catheter is indicated for use to diagnose cardiac arrhythmias.

The Viking Fixed Curve Diagnostic Catheters (also referred to as Viking Catheters) are intended for use in electrophysiology procedures to record, stimulate and pace in the diagnosis of cardiac arrhythmias.

The Viking Catheters receive electrical signals from the cardiac tissue, which are transmitted via the electrode wiring through the connector and cable to an amplifier, where the signals are displayed on an EP recording system for the physician to view and interpret in diagnosing cardiac arrhythmias. The physician inserts the diagnostic catheter into the vasculature percutaneously. To reach the right side of the heart, either the internal jugular vein, the subclavian veins, or the femoral veins can be accessed. To reach the left ventricle, the retrograde approach via the femoral artery can be used. In some cases, the radial artery may be used to access the targeted cardiac chamber. Using fluoroscopic guidance, the physician then navigates the diagnostic catheter to the target site using the catheter steering mechanism, as confirmed by the intracardiac electrograms and/or pacing threshold, confirming electrode to endocardium interface.

Viking Catheters are radiopaque, flexible, insulated catheters. The catheters have a polymer shaft that houses the electrical wiring that connects the electrodes to a connector at the proximal end of the catheter; each electrode wire is soldered into this connector. When the catheter is used, the connector is attached to a sterile cable that connects to the hospital recording and pacing equipment.

The Viking Catheters are offered pre-packaged sterile and are a single use product not to be reused, reprocessed, or resterilized. The method of sterilization is ethylene oxide (EO).

The provided FDA 510(k) clearance letter and summary for the VIKING™ Fixed Curve Diagnostic Catheter do not contain any information regarding acceptance criteria and studies demonstrating device performance in the context of an AI/algorithm-based diagnostic device.

The document describes a medical device, specifically a diagnostic catheter, and the FDA's determination of substantial equivalence to a predicate device. The performance data discussed relates to:

• Bioburden Testing: To confirm bioburden levels were not adversely affected.
• Design Verification Testing: To demonstrate adherence to product specifications at baseline and after accelerated aging (25 months/761 days).
• Packaging Verification Testing: To ensure packaging meets design input and maintains sterility.

These tests are standard for physical medical devices to ensure safety, sterility, functionality, and shelf-life, not for evaluating the diagnostic accuracy or effectiveness of an AI algorithm.

Therefore, I cannot provide the requested information for acceptance criteria and studies related to an AI diagnostic device because the provided text is for a physical diagnostic catheter and does not involve AI or algorithmic performance evaluation.

To directly answer your numbered points based only on the provided text, without making assumptions:

1. A table of acceptance criteria and the reported device performance: Not applicable for AI performance from this document. The document presents performance data for physical device characteristics (bioburden, design verification, packaging verification) to support substantial equivalence, but no specific acceptance criteria or reported values are detailed in the summary itself.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable for AI performance from this document. The document refers to "Design Verification Testing" and "Packaging Design Verification testing" but does not specify sample sizes or data provenance in the context of diagnostic accuracy.
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 for AI performance from this document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for AI performance from this document.
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, as this is a physical diagnostic 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, as this is a physical diagnostic catheter, not an AI algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable for AI performance from this document. The "ground truth" for the catheter's physical performance would be its adherence to engineering specifications and international standards.
8. The sample size for the training set: Not applicable, as this is a physical diagnostic catheter, not an AI algorithm.
9. How the ground truth for the training set was established: Not applicable, as this is a physical diagnostic catheter, not an AI algorithm.

In summary, the provided FDA document pertains to the clearance of a physical medical device (a catheter) and does not involve the evaluation of an AI algorithm or its diagnostic performance.

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