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The Venture™ Wire Control Catheter is indicated for directing, steering, controlling, and supporting a guide wire to access discreet regions of the coronary and peripheral vasculature.

The rapid exchange (RX) version of the Venture™ Wire Control Catheter is a single use support catheter consisting of a radiopaque deflectable tip, 30cm long guide wire lumen, and a proximal shaft (hypotube). A rotating knob at the handle controls the tip deflection angle. The tip can be deflected up to 90° from the catheter axis. The device is compatible with all 0.014" guide wires and 6 Fr or larger guide catheters. It is torqueable and can be used to instantaneously shape and control the curvature of the guide wire during use as well as provide support to the guide wire when needed.

The provided text is a 510(k) summary for the St. Jude Medical Venture™ Wire Control Catheter (Rapid Exchange version). It describes design modifications and demonstrates substantial equivalence to a previously cleared predicate device. This document focuses on the regulatory submission process and does not contain information about acceptance criteria for device performance in the context of a study that uses a "test set" or "ground truth" to evaluate an algorithm or AI.

The "Test Summary" section explicitly states: "The Rapid Exchange Venture Wire Control Catheter passed all verification specification criteria for dimensional, strength, functional, packaging, sterilization, biocompatibility, and shelf life tests. Test results confirm the device performs as intended without raising additional questions of safety and efficacy. Given the scope of the modifications incorporated to create the rapid exchange version of the Venture™ catheter no additional animal or clinical data was deemed necessary."

Therefore, the following information cannot be extracted from the provided document:

1. A table of acceptance criteria and the reported device performance: The document mentions "verification specification criteria" but does not detail them or present specific performance data in a tabular format as would be expected for a clinical or AI-based study.
2. Sample size used for the test set and the data provenance: No test set in the context of AI evaluation is mentioned. The testing performed was engineering verification and validation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth in the context of expert consensus or diagnostic accuracy is mentioned.
4. Adjudication method for the test set: Not applicable as there is no "test set" in the AI or diagnostic sense.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: The document states "no additional animal or clinical data was deemed necessary," indicating no MRMC study was performed.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable as it's a physical medical device, not an algorithm.
7. The type of ground truth used: Not applicable as no ground truth in the diagnostic sense was established. The "ground truth" for this device's performance would be the engineering specifications and whether the device met them.
8. The sample size for the training set: Not applicable as it's a physical medical device, not an AI model.
9. How the ground truth for the training set was established: Not applicable.

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