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The Diatek Connector Assembly Replacement Kit is to be used for replacing the original connector assembly on a Diatek Cannon-Cath Dialysis Catheter if the connector assembly becomes damaged or dysfunctional. This prevents the patient from requiring additional surgery for catheter removal and replacement.

The Connector Assembly Replacement Kit is intended for use in any patient who has a previously implanted Diatek Cannon-Cath implanted.

The Diatek Connector Assembly Replacement Kit consists of a Cannon-Cath connector assembly and components needed to remove the previously implanted connector assembly and attach the new connector assembly to the previously implanted dialysis catheter.

The provided 510(k) summary for the Diatek Connector Assembly Replacement Kit (K020430) is not a study of device performance in the typical sense of measuring efficacy or safety in a clinical trial. Instead, it describes a component replacement kit for an existing, already cleared device (Diatek Cannon-Cath Dialysis Catheter).

The "study" cited here is not a clinical study but rather a statement of equivalence based on the components being identical to those already tested and found acceptable for the predicate device. Therefore, many of the requested categories related to clinical study design and performance metrics are not applicable in this context.

Here's an analysis based on the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a component replacement kit, the acceptance criteria are primarily focused on maintaining the safety and effectiveness profile of the original device. The "performance" is the fact that the components are the same as those already proven acceptable.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: This information is not provided in the summary. The summary refers to previous testing performed on the predicate device's components.
• Data Provenance: The original testing on the predicate device's components was conducted by "both internal and outside laboratories." The country of origin and whether it was retrospective or prospective data are not specified.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• Not Applicable. This type of information is pertinent to studies involving diagnostic accuracy or interpretation, often with imaging or clinical data. Since this is a hardware component replacement kit, "ground truth" established by experts in this manner is not relevant to the testing described. The "ground truth" would be the successful function and safety of the original components as determined by engineering and biocompatibility testing.

4. Adjudication Method for the Test Set

• Not Applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies where expert consensus is needed to resolve discrepancies in diagnosis or assessment. This is not reported for the engineering and material testing referenced.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No. An MRMC study is typically for evaluating diagnostic imaging systems or decision support tools where human readers are interpreting cases. This device is a mechanical component, so an MRMC study is not relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Not Applicable. This refers to the performance of an AI algorithm without human involvement. This device is not an AI algorithm. The performance of the components themselves (e.g., strength, biocompatibility, fluid dynamics) was likely evaluated in a standalone manner without human intervention during the specific tests, but this isn't in the context of an AI algorithm.

7. The Type of Ground Truth Used

• For the original predicate device components, the "ground truth" would have been established through bench testing results, material specifications, biocompatibility studies, and potentially animal or clinical performance data validating the functional integrity and safety of the components. The exact types are not specified beyond "a range of criteria."

8. The Sample Size for the Training Set

• Not Applicable. A "training set" refers to data used to train machine learning models. This device is a mechanical component, not an AI system.

9. How the Ground Truth for the Training Set Was Established

• Not Applicable. As above, there is no training set for a mechanical device.

Summary of the "Study" Proving Acceptance Criteria:

The "study" cited for the Diatek Connector Assembly Replacement Kit is a bridging argument based on identity to a predicate device's components, rather than new, independent testing or a clinical trial for the kit itself. The critical information provided is:

• The components in the replacement kit are identical to those in the predicate Diatek Cannon-Cath product.
• These identical components were previously tested (via 510(k) 010399) by internal and external laboratories against "a range of criteria" and found acceptable.

This approach is common for component-level changes or replacement kits that do not introduce new technology or alter the fundamental operating principles of an already cleared device. The focus is on demonstrating that the replacement kit maintains the same safety and effectiveness profile as the original, proven components.

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