Search Results

Niagara Dual Lumen Catheters are indicated for use in attaining short-term (less than 30 days) vascular access for hemodialysis, hemoperfusion and apheresis therapy via the jugular, subclavian or femoral vein.

Flexxicon II Dual Lumen Catheters are "Indicated for use in attaining temporary vascular access for hemodialysis, hemoperfusion and apheresis treatments. They are intended to be inserted in the subclavian, jugular or femoral vein, as required."

Short-Term Dialysis Catheters as currently distributed by BAS are dual lumen catheters, available in straight and precurved configurations with multiple insertion lengths. Catheters are made from soft polyurethane containing barium sulfate to provide radiopacity. Colored luer connectors identify the arterial (red) and venous (blue) lumens. Each extension has an atraumatic occlusion clamp, which closes the access to the catheter. A fixed, rotatable suture wing is located at the bifurcation.

The provided document is a 510(k) summary for a change in luer connectors for short-term dialysis catheters. It describes non-clinical performance data and does not contain information about studies involving human subjects, AI, or expert adjudication. Therefore, many of the requested details cannot be extracted from this document.

Here's a breakdown of the available information:

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria are based on compliance with several recognized standards and FDA guidances. The document states that "All test results confirm the modified devices to be substantially equivalent to the predicate devices."

• Dimensions
• Tensile strength of catheter body to hub attachment (extension leg to hub attachment)
• Leakage at hub
• Catheter burst pressure (positive internal pressure) | "The test results met the requirements."
  "The Short-Term Dialysis Catheters with new luer connectors met all the performance criteria of the tests performed." |
  | General Catheter Requirements | ISO 10555-1:1997 (Sterile, single-use intravascular catheters, Part 1: General requirements) | Addressed implicitly by the overall claim of meeting performance criteria, though specific results for this standard are not detailed beyond the luer connection. |
  | Central Venous Catheter Requirements | ISO 10555-3:1997 (Sterile, single-use intravascular catheters, Part 3: Central venous catheters) | Addressed implicitly by the overall claim of meeting performance criteria, though specific results for this standard are not detailed beyond the luer connection. |
  | Biocompatibility | AAMI/ANSI/ISO-10993-1:1997 (Biological evaluation of medical devices – Part 1: Evaluation and testing)
  FDA Modified ISO 10993 Test Profile for externally communicating blood contacting long-term devices (worst-case for these short-term devices) | "Biocompatibility testing results met the requirements of ISO-10993, 'Biological Evaluation of Medical Devices Part-1: Evaluation and Testing' and the FDA Modified ISO 10993 Test Profile..." |
  | Sterilization | AAMI/ANSI/ISO 11135:1994 (Medical devices Validation and routine control of ethylene oxide sterilization) | The device uses ethylene oxide sterilization, implying compliance, as the document refers to this standard when discussing conformance to recognized standards. |

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

• Sample Size: Not specified in the document. The testing was "bench testing" of the luer connectors.
• Data Provenance: The studies were non-clinical, bench tests, not involving human subjects or patient data. Therefore, country of origin or retrospective/prospective does not apply.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable. The ground truth was established through adherence to recognized international standards and FDA guidances for non-clinical device performance. No experts were described as establishing a "ground truth" in the context of interpretation or diagnosis as would be relevant for software or imaging studies.

4. Adjudication Method

This information is not applicable as there was no human interpretation or decision-making process described that would require adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done. This study is a non-clinical device engineering evaluation, not a clinical study involving human readers or AI assistance.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)

No, a standalone algorithm performance study was not done. This study is related to the physical performance of a medical device component.

7. Type of Ground Truth Used

The "ground truth" for the device's performance was established by recognized international standards and FDA guidances for medical device safety and performance (e.g., ISO 594-1, ISO 594-2, ISO 10555 series, ISO 10993, AAMI/ANSI/ISO 11135, and FDA's specific guidance for intravascular catheters). This is a technical ground truth based on engineering and biocompatibility criteria.

8. Sample Size for the Training Set

Not applicable. There was no "training set" as this was a physical device modification, not an AI/machine learning study.

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

Not applicable, as there was no training set.

Ask a specific question about this device