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Duet™ Catheter System: The Duet™ Long-Term Hemodialysis Catheter System is recommended for use in attaining short-term and long-term vascular access for hemodialysis, hemoperfusion or apheresis therapy. The Duet™ Long-Term Hemodialysis Catheter System is indicated for use in attaining short-term or long-term vascular access for hemodialysis, hemoperfusion or apheresis therapy. The catheters may be inserted percutaneously into the internal jugular vein, subclavian or external jugular vein.

Duet™ Long-Term Hemodialysis Catheter System Catheter Repair Kit: Duet™ Long-Term Hemodialysis Catheter System Catheter Repair Kit is intended to replace extension leg assemblies on the Duet™ Long-Term Hemodialysis Catheter System. To replace Extension Leg Assembly where there is a minimum of 6.0 cm of viable catheter on the Duet™ Long-Term Hemodialysis Catheter System.

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The provided text is a 510(k) Summary for the Duet™ Long-Term Hemodialysis Catheter System and its Repair Kit. This document focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a dedicated study proving device performance against those criteria in a traditional sense (like a clinical trial with specific performance endpoints).

Here's a breakdown of the requested information based on the provided text, and where the information is absent or not applicable in this context:

1. Table of Acceptance Criteria and Reported Device Performance

This type of table is not explicitly present in the provided 510(k) summary. The summary states: "Performance standards have not been established by FDA under section 514 of the Federal Food, Drug and Cosmetic Act."

Instead of explicit acceptance criteria and performance data, the submission relies on demonstrating substantial equivalence. The "Summary of Substantial Equivalence" section states: "Based on the indications for use, technological characteristics, and safety and performance testing, the subject Duet™ Catheter System and Duet™ Long-Term Hemodialysis Catheter System Catheter Repair Kit met the minimum requirements that are considered adequate for its intended use and is substantially equivalent in design, materials, sterilization, principles of operation and indications for use to current commercially available catheters/cited predicates."

This implies that the "acceptance criteria" are implicitly met by demonstrating similar technological characteristics, safety, and performance to the predicate devices. The document does not report specific quantitative performance metrics for the Duet™ system such as flow rates, durability, or infection rates, and therefore, an explicit table comparing these to acceptance criteria cannot be formed from the provided text.

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

This information is not provided in the given text. A 510(k) summary focuses on equivalence, and while performance testing is mentioned, details about the test set (sample size, data provenance, e.g., country of origin, retrospective/prospective) are not included.

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

This information is not applicable and not provided. This type of information is usually relevant for studies involving subjective assessments, like image interpretation for AI algorithms. For a medical device like a catheter system, "ground truth" would typically refer to objective measurements of physical properties, biocompatibility, and functional performance, not expert consensus on interpretations.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. Similar to point 3, adjudication methods (like 2+1 or 3+1 for consensus building) are typically used for subjective assessments or when there's ambiguity in establishing ground truth, which is not the primary focus of demonstrating substantial equivalence for a physical medical device like this.

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

This information is not applicable and not provided. An MRMC study is relevant for evaluating the impact of AI on human reader performance, typically in diagnostic imaging. This 510(k) is for a physical medical device (catheter system), not an AI-assisted diagnostic tool.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This information is not applicable and not provided. This question is relevant for AI algorithms. The device in question is a physical catheter system for hemodialysis.

7. The Type of Ground Truth Used

For a physical device like the Duet™ catheter system, "ground truth" would generally refer to objective measurements of its physical and functional properties deemed essential for its intended use and equivalent to predicate devices. While not explicitly detailed, safety and performance testing would involve:

• Material properties: Biocompatibility, tensile strength, kink resistance.
• Functional characteristics: Flow rates, ability to withstand intended pressures, durability.
• Sterilization efficacy.
• Design conformity to established engineering and medical device standards.

These "ground truths" would be established through laboratory testing and engineering verification, rather than clinical outcomes data or pathology reports in the context of this specific 510(k) submission. There is no mention of pathology or outcomes data being used as "ground truth" within this document.

8. The Sample Size for the Training Set

This information is not provided and is not applicable for this type of device submission. Training sets are relevant for machine learning algorithms.

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

This information is not provided and is not applicable for this type of device submission.

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