Search Results

The Vaxcel™ Dialysis Catheter is designed for chronic hemodialysis and apheresis.

The major components of the Vaxcel™ Dialysis Catheter are the dual lumen catheter, hub, injection cap, introducer sheath/dilator and metal tunneler with protective sheath.

This a Vaxcel™ Dialysis Catheter, which is a Class III medical device. There is no information in the provided text to calculate the performance of the device or the acceptance criteria. The document is simply a 510(k) summary and the FDA's clearance letter, stating that the device is substantially equivalent to a predicate device.

Here's why the requested information cannot be extracted:

• No Acceptance Criteria or Performance Data: The provided text does not include any acceptance criteria, performance metrics, or study results for the Vaxcel™ Dialysis Catheter itself. The "Summary of Substantial Equivalence" section only states: "The Vaxcel Dialysis catheters have been tested and compared to the predicate device. All data gathered demonstrate this device as substantially equivalent. No new issues of safety or efficacy have been raised." This is a high-level statement and does not detail the specific tests, their results, or the acceptance thresholds.
• Focus on Substantial Equivalence, Not Performance Study: The entire submission and the FDA's response revolve around the concept of "Substantial Equivalence" to a legally marketed predicate device (also named Vaxcel™ Dialysis Catheter) under 510(k) regulations. This means the manufacturer argued the new device is as safe and effective as the existing one, not necessarily that it met specific, newly defined performance criteria in a clinical study.
• No Clinical Study Details: There is no mention of a human clinical study, an AI component, or any details about sample sizes, expert involvement, ground truth, or adjudication methods for either a test or training set.
• Not an AI/Diagnostic Device: The Vaxcel™ Dialysis Catheter is a physical medical device (a catheter) for hemodialysis and apheresis, not a diagnostic algorithm or an AI-powered system that requires performance metrics like sensitivity, specificity, or reader studies.

Therefore, since the device is a physical catheter and the submission focuses on substantial equivalence rather than a detailed performance study against specific criteria, none of the requested information (table of acceptance criteria, sample sizes, expert qualifications, adjudication, MRMC study, standalone performance, ground truth type, or training set details) can be provided from the given document.

Ask a specific question about this device

The Vaxcel™ Dialysis Catheter is designed for chronic hemodialysis and apheresis.

The major components of the Vaxcel™ Dialysis Catheter are the dual lumen catheter, hub, injection cap, introducer sheath/dilator and metal tunneler.

This document is a 510(k) summary for the Vaxcel™ Dialysis Catheter, submitted by Boston Scientific. It does not contain information about acceptance criteria or a study proving device performance in the context of typical AI/ML device evaluations.

The document focuses on demonstrating substantial equivalence to a predicate device, which is a different regulatory pathway than showing performance against specific acceptance criteria for a novel device, especially in the context of AI/ML.

Therefore, most of the requested information (points 1-9) cannot be extracted from the provided text, as it pertains to a different type of device evaluation.

Here's a breakdown based on the provided text:

• Acceptance Criteria and Reported Device Performance: Not applicable/not provided. The submission focuses on substantial equivalence, not performance against predefined metrics.
• Sample size for the test set and data provenance: Not applicable/not provided. No specific "test set" for performance evaluation is mentioned. The submission refers to "All data gathered" demonstrating substantial equivalence, but details are absent.
• Number of experts and their qualifications: Not applicable/not provided. Expert ground truth establishment is not mentioned in this type of submission.
• Adjudication method: Not applicable/not provided.
• Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable/not provided. This type of study is typical for AI-assisted diagnostic tools, not for a physical medical catheter demonstrating substantial equivalence.
• Standalone (algorithm only) performance: Not applicable/not provided. This is a physical medical device, not an algorithm.
• Type of ground truth used: Not applicable/not provided.
• Sample size for the training set: Not applicable/not provided. A "training set" is not relevant for this type of device submission.
• How ground truth for the training set was established: Not applicable/not provided.

Summary of Safety and Effectiveness from the provided text:

The submission states that "The Vaxcel Dialysis catheters have been tested and compared to the predicate device. All data gathered demonstrate this device as substantially equivalent. No new issues of safety or efficacy have been raised." This indicates that the device's performance was deemed equivalent to an existing, legally marketed device, but no specific performance metrics or acceptance criteria are detailed in the provided summary.

Ask a specific question about this device