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The dual-lumen hemodialysis catheter permits venous access to the central circulation system for rapid fluid administration, temporary or acute hemodialysis and apheresis . It oyoton for rapid have actual an, or femoral veins of children, adolescents and small adults.

The device is a dual-lumen, polyurethane catheter, 8 French in size, with two independent non-communicating lumens, extension lines, Luer hubs and extension line clamps. Each lumen exits at the distal end of the catheter through individual ports spaced at a given distance apart. A soft tip that is more pliable than the catheter body is grafted onto the distal tip of the catheter. At the proximal end of the juncture hub the lumens are connected to clear separate extension lines. Each extension line contains either a red or blue clamp. The colored clamps indicate arterial flow (outflow) or venous flow (inflow). Also, centimeter markings are placed along the length of the indwelling catheter body to facilitate proper positioning. This catheter is identical in appearance and function to the Quinton® manufactured catheter aforementioned in section 3c. Moreover, the ARROW Pediatric Two-Lumen Hemodialysis Catheter is also identical to the ARROW predicate catheter with the exception of French size and length.

An ARROW Pediatric Two-Lumen Hemodialysis Catheterization Kit consists of a dual-lumen catheter packaged with various accessory components that are required during catheterization. These components include combinations of the following: spring wire quides. dilators, introducer needles, catheter over needle assemblies, syringes, pressure transduction probes, scalpels, disposal cups and medication. Moreover, the kit also includes labeling information including instructions for use, contents sheet and various unit package labels. The contents of the kit are contained in the tray and wrapped with a CSR wrap. The wrapped kit is then packaged into another tray and sealed with Tyvek lidstock. The complete trays are placed in corrugated shipping cartons and labeled.

The provided text describes a Special 510(k) submission for a device modification, not a study proving acceptance criteria for a novel device. Therefore, much of the requested information (like expert ground truth, MRMC studies, standalone performance, training set details) is not applicable to this type of submission.

This submission aims to demonstrate substantial equivalence to a predicate device, meaning the modified device is as safe and effective as a device already legally marketed. The primary "study" here is a series of performance tests to show the modified device maintains its safety and effectiveness.

Here's the breakdown of the information that can be extracted or inferred from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Important Note: The document states, "The results of the laboratory tests demonstrated that the device is safe, and as effective as the legally marketed predicate device." However, it does not explicitly list the quantitative acceptance criteria or the specific numerical results for each test. These would typically be detailed in the full submission, not necessarily in the 510(k) summary.

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

• Sample Size: Not explicitly stated. The tests are described as "laboratory tests," suggesting in-vitro testing. The number of units tested for each specific performance test (tensile, flow rate, etc.) is not provided.
• Data Provenance: Not explicitly stated, but it's generated by the manufacturer (ARROW International, Inc.) through internal "laboratory tests." This would be prospective testing on the modified device.

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

• Not Applicable. This is a performance testing submission for a physical medical device, not an AI/diagnostic software. Ground truth in this context refers to engineering and performance specifications, not clinical diagnoses by experts.

4. Adjudication Method for the Test Set

• Not Applicable. As above, this applies to clinical or diagnostic studies, not engineering performance tests.

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. This is not an AI-assisted diagnostic device. It is a physical medical device (catheterization kit).

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

• Not Applicable. This is not an algorithm or AI device.

7. The Type of Ground Truth Used

• For the performance tests, the ground truth would be defined by pre-established engineering specifications and performance requirements derived from regulatory standards, internal product design specifications, and comparison data from the predicate device. For example, "tensile strength must exceed X Newtons" or "flow rate must be Y ml/min at Z pressure."

8. The Sample Size for the Training Set

• Not Applicable. This device does not use machine learning or AI, so there is no "training set."

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

• Not Applicable. As above, there is no training set.

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