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The Vaxcel™ Plus Chronic Dialysis Catheter is designed for chronic hemodialysis and apheresis. Catheter lengths of 37 cm and 50 cm are indicated for femoral vein insertion.

The major components of the Vaxcel™ Plus Dialysis Catheter are the dual lumen catheter, dead end cap, introducer sheath/dilator, tunneler and CSR wrap.

The provided document is a 510(k) summary for the Vaxcel™ Plus Chronic Dialysis Catheter, dated May 18, 2004. This type of document is a pre-market notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device.

The document does not contain the kind of detailed information requested about acceptance criteria, specific device performance against those criteria, detailed study designs (sample sizes for test and training sets, data provenance, expert qualifications, etc.), or specific statistical analyses (like MRMC studies or standalone performance metrics). This information is typically found in the full 510(k) submission, not in the publicly available summary.

Based on the provided text, here's what can be extracted and what cannot:

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

• Acceptance Criteria/Performance: The document states that "All data gathered demonstrate this device as substantially equivalent." This is the overarching acceptance criterion for a 510(k) submission. However, it does not specify what performance metrics (e.g., flow rates, complication rates, material properties) were used to demonstrate this equivalence, nor does it present a direct comparison of those metrics against specific numerical acceptance thresholds. It only mentions the device "has been tested and compared to the predicate device."

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

• Not provided. The document does not specify any sample sizes for tests conducted, nor does it mention the country of origin of the data or whether the data was retrospective or prospective.

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

• Not applicable/Not provided. This type of information is relevant for studies involving human interpretation (e.g., imaging devices). For a physical medical device like a catheter, "ground truth" is typically established through engineering tests, clinical performance, and comparisons to predicate device characteristics, not through expert human review in the same way an AI diagnostic tool would be evaluated. The document does not refer to any experts establishing ground truth.

4. Adjudication method for the test set

• Not applicable/Not provided. As with point 3, adjudication methods like 2+1 or 3+1 are used for human-reviewed data, not typically for evaluating a physical device's performance through engineering or clinical tests in this context.

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

• No. This is not relevant to a chronic dialysis catheter. This type of study applies to diagnostic imaging or AI-assisted interpretation, which is not the device's function.

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

• No. This is also not relevant to a chronic dialysis catheter. This applies to AI algorithms.

7. The type of ground truth used

• Implicitly, "substantial equivalence" to predicate devices. For this type of device, "ground truth" isn't a single definitive external reference like pathology for an image. Instead, it's defined by meeting the performance characteristics (e.g., material properties, flow rates, thrombogenicity, biocompatibility, infection rates, ease of insertion, durability) demonstrated by legally marketed predicate devices, which are considered safe and effective for their intended use. This often involves a combination of bench testing, pre-clinical (animal) studies, and, sometimes, limited clinical data comparing performance parameters. The document states, "The Vaxcel™ Plus Chronic Dialysis Catheter and tunneler have been tested and compared to the predicate device."

8. The sample size for the training set

• Not applicable/Not provided. The concept of a "training set" applies to machine learning algorithms. This document describes a physical medical device, not an AI model.

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

• Not applicable/Not provided. As explained in point 8, "training set" and "ground truth for training" are not relevant here.

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The Vaxcel™ Plus Chronic Dialysis Catheter Tunneler is indicated to assist in tunneling and insertion of Vaxcel™ Plus Chronic Dialysis Catheters of corresponding size (19, 23, 28 cm).

The Vaxcel Plus Chronic Dialysis Catheter Tunneler is a slender, cylindrical device made of biocompatible stainless steel or delrin. The tunneler is designed to assist in tunneling the Vaxcel Plus Chronic Dialysis Catheters through subcutaneous tissue during catheter implantation. It has a tapered end, which is used to tunnel through subcutaneous tissue, and a barbed end for attachment of the dialysis catheter tip prior to tunneling.

The provided text describes a 510(k) submission for the Vaxcel™ Plus Chronic Dialysis Catheter Tunneler. This type of submission is for medical devices and focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific performance criteria through a detailed study like those for AI/ML-driven devices.

Therefore, the document does not contain the information required to populate the fields in your request regarding acceptance criteria, study details, expert involvement, or specific performance metrics. It primarily states that the device is substantially equivalent to a predicate device.

Here's why the information you're asking for isn't present in this type of document:

• Acceptance Criteria and Reported Device Performance: 510(k)s for non-AI devices typically don't present acceptance criteria in the format you described (e.g., Sensitivity, Specificity, AUC). Instead, they demonstrate that the new device meets the same safety and performance characteristics as a predicate device through various means (e.g., material testing, mechanical testing, functional testing if applicable, and comparison of design, manufacturing, and sterilization processes). The document states: "All performance characteristics are substantially equivalent to currently marketed devices."
• Sample Size, Ground Truth, Experts, Adjudication, MRMC studies, Standalone studies, Training Set: These concepts are relevant for studies evaluating the performance of AI/ML algorithms, especially in diagnostic imaging or similar fields. The Vaxcel™ Plus Chronic Dialysis Catheter Tunneler is a physical medical device (a catheter tunneler), not an AI algorithm. Therefore, these types of studies and methodologies are not applicable to its regulatory submission.

Summary based on the provided text:

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

   • Acceptance Criteria: Not explicitly stated as quantitative performance metrics. The underlying acceptance criterion for a 510(k) submission is "substantial equivalence" to a predicate device in terms of safety and effectiveness. This implies that the device must perform similarly to the predicate device in its intended use.
   • Reported Device Performance: "All performance characteristics are substantially equivalent to currently marketed devices." No specific quantitative metrics (e.g., sensitivity, specificity, accuracy) are provided, as this is a physical device, not a diagnostic algorithm.

2. Sample size used for the test set and the data provenance: Not applicable. This document pertains to a physical medical device, not an AI/ML algorithm requiring a test set of data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

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.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable.

8. The sample size for the training set: Not applicable.

9. How the ground truth for the training set was established: Not applicable.

Explanation of the "Study" mentioned in the document:

The "study" or assessment performed for this device, as implied by the 510(k) submission, involved demonstrating that its "design characteristics, manufacturing, and sterilization processes are identical to the predicate devices" and that "all performance characteristics are substantially equivalent to currently marketed devices." This typically involves:

• Design comparison: Reviewing specifications, materials, dimensions, and functionality against the predicate device.
• Material biocompatibility: Ensuring materials are safe for human contact.
• Mechanical/Functional testing: If applicable, demonstrating the device can withstand expected forces or perform its mechanical function (e.g., strength of the tunneler, secure attachment of the catheter).
• Sterilization validation: Ensuring the sterilization process is effective.

These are not "studies" in the context of clinical trials or performance assessments for AI algorithms, but rather engineering and regulatory compliance evaluations.

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

The Vaxcel™ Plus Chronic Dialysis Catheter is designed for chronic hemodialysis and apheresis. The major components of the Vaxcel™ Plus Dialysis Catheter are the dual lumen catheter, injection cap, introducer sheath/dilator and tunneler.

Despite the comprehensive nature of your request, the provided text does not contain information about acceptance criteria or a study proving the device meets said criteria.

The document is a 510(k) summary for the Vaxcel™ Plus Chronic Dialysis Catheter, indicating its submission to the FDA for market clearance. It focuses on demonstrating substantial equivalence to a previously marketed predicate device.

Here's why the information you're looking for is absent:

• Substantial Equivalence: The primary goal of a 510(k) submission is to show that a new device is "substantially equivalent" to a legally marketed predicate device. This typically involves comparing design, materials, intended use, and performance characteristics to the predicate. It does not usually require new, extensive clinical trials or performance studies with specific statistical acceptance criteria as would be needed for a de novo submission or a PMA (Premarket Approval).
• Lack of Performance Data: The summary explicitly states: "All data gathered demonstrate this device as substantially equivalent. No new issues of safety or efficacy have been raised." This implies that the comparison to the predicate device, rather than a standalone performance study with specific acceptance criteria, was the basis for approval. There's no mention of performance metrics (like sensitivity, specificity, accuracy), sample sizes for testing, ground truth establishment, or expert involvement.
• Performance Standards: The document notes: "Performance Standards have not been established by FDA under Section 514 of the Food, Drug and Cosmetic Act." This further supports the idea that the device was not evaluated against predefined, quantitative performance benchmarks.
• "Study" Implication: While the text mentions "data gathered" and "tested and compared" to the predicate, it doesn't describe a formal study in the sense of a clinical trial or a statistically powered performance assessment with defined acceptance criteria. It refers to activities conducted to support the claim of substantial equivalence.

Therefore, I cannot provide the requested table or detailed study information because it is not present in the provided FDA document.

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