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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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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. It may also be used for manual delivery of saline solution or diagnostic contrast agents.

The Venture Wire Control Catheter is a single use, over-the-wire support catheter with a radiopaque deflectable tip. A rotating knob at the handle controls the tip deflection angle. The tip can be deflected continuously up to about 90° from the catheter axis. The device is compatible with all 0.014" guidewires. It is torqueable and can be use to instantaneously shape, and control the curvature of the guidewire while in use as well as provide support to the guidewire when needed. A luer attachment is also provided to allow for the manual injection of dye through the guidewire lumen of the catheter

The provided text describes a 510(k) premarket notification for a medical device, the Venture Wire Control Catheter. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting extensive clinical studies with specified acceptance criteria and detailed performance metrics as one might find for novel device applications.

Therefore, the requested information elements related to detailed acceptance criteria, specific performance metrics, and studies proving these criteria are largely not present in the provided document. The submission primarily relies on demonstrating that the new device has "the same indication for use, principles of operation, and technological characteristics" as a previously cleared predicate device (Venture Wire Control Catheter K040922) and that any differences "do not raise new questions of safety or efficacy."

However, I can extract the available information and indicate where details are missing.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Sample Size for Test Set: Not specified. The document mentions "performance test data" and "test results" but does not detail the number of units tested.
• Data Provenance: Not specified. The performance tests are likely laboratory bench tests and material tests conducted by the manufacturer (Velocimed Inc.) in Minneapolis, MN, where the company is located. There is no indication of clinical studies, human subject data, or country of origin for such data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Number of Experts: Not applicable. The ground truth for the engineering and material tests would be established by the specifications of the referenced ISO and ASTM standards, not by clinical expert consensus.
• Qualifications of Experts: Not applicable.

4. Adjudication method for the test set

• Adjudication Method: Not applicable. The "test set" here refers to engineering and material tests, which are objective and do not require expert adjudication for ground truth.

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

• MRMC Study: No. This is a medical catheter and not an AI-powered diagnostic device, so an MRMC study is not relevant or described.
• Effect Size of AI: Not applicable.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

• Standalone Performance: Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used

• Type of Ground Truth: The ground truth for the performance data mentioned (biocompatibility, sterilization, packaging, catheter performance) is based on international and national standards (ISO 10555, ISO 10993-1, ASTM D-4169, ISO 11607, ISO 11135). The "truth" is whether the device meets the objective requirements and specifications outlined in these standards.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This submission is for a physical medical device, not a machine learning model, so there is no concept of a "training set."

9. How the ground truth for the training set was established

• How Ground Truth for Training Set was Established: Not applicable, as there is no training set mentioned or implied.

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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. It may also be used for manual delivery of saline solution or diagnostic contrast agents.

The Venture Wire Control Catheter is a single use, over-the-wire support catheter with a radiopaque tip that can be deflected continuously up to about 90° from the catheter axis. The device is compatible with all 0.014" guidewires. It is torqueable and can be use to guide the guidewire while in use as well as instantaneously shape, and control the curvature of the guidewire when needed. A luer attachment is also provided to allow for manual delivery of saline solution or diagnostic contrast agents through the guidewire lumen of the catheter.

This request is outside the scope of my current capabilities. I am a language model and cannot interpret images or process visual information from the provided text. I lack the ability to process the image/page/2/Picture/11 description to extract information.

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