Search Results

The large-bore two-lumen catheter is indicated for temporary or short-term hemodialysis and apheresis. It may be inserted in the subclavian or femoral veins.

The device is a dual-lumen, polyurethane catheter, 14 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. The catheter is available in a length of 16cm and is identical in appearance and function to the other manufactured catheter products aforementioned in section 3b. Moreover, the ARROW 14 Fr Hemodialysis Catheter is also identical to the ARROW predicate catheter with the exception of French size.

An ARROW 14 Fr Hemodialysis Two-Lumen 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 guides, 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 tray and wrapped with in an absorbent cloth. The wrapped kit is then packaged into another tray and sealed with Tyvek lidstock. The complete trays are placed in shipping containers, labeled and sterilized.

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the ARROW 14 Fr Hemodialysis Two-Lumen Catheterization Kit:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly list numerical acceptance criteria for each test. Instead, it states that "The results of the laboratory tests demonstrated that the device is safe, and as effective as the legally marketed predicate device." This implies a comparison to a predicate device and meeting equivalent performance.

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

The document does not provide the specific sample sizes used for each of the performance tests. It only lists the types of tests conducted.

The data provenance is not explicitly stated as 'country of origin' or 'retrospective/prospective'. However, since these are laboratory performance tests for a medical device seeking FDA clearance, they would typically be conducted in a controlled, prospective manner by the manufacturer (ARROW International, Inc., based in the USA).

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

This information is not applicable and not provided in the document. The "ground truth" for a medical device's physical and functional performance tests (like tensile strength, flow rate) is established through standardized engineering and laboratory testing protocols, not through expert human review of data in the same way, for example, a diagnostic imaging device might require expert radiologist review. The document focuses on objective physical and functional characteristics.

4. Adjudication Method for the Test Set

This is not applicable to the type of performance testing described. Adjudication methods (like 2+1, 3+1) are typically used for studies involving human interpretation or subjective assessments, such as clinical trials or diagnostic imagery reviews, where multiple readers might have differing opinions. For physical device performance tests, the results are typically quantitative and objectively measured.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This information is not applicable. The device described is a hemodialysis catheter, which is a physical medical device, not an AI-powered diagnostic tool requiring human interpretation. Therefore, an MRMC comparative effectiveness study involving AI assistance for human readers would not be relevant to this product.

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

This is not applicable for the reasons stated in point 5. The device itself is not an algorithm. The performance tests are for the physical integrity and function of the catheter.

7. The Type of Ground Truth Used

The "ground truth" for the performance tests listed (tensile, flow rate, prime volume, flex fatigue, recirculation, kink, shelf-life, mechanical hemolysis) would be objective laboratory measurements based on established engineering and materials science principles, and comparison to the performance of the legally marketed predicate device.

8. The Sample Size for the Training Set

There is no "training set" in the context of this device's performance testing. The listed tests are for verification and validation of the device's physical and functional properties, not for training a machine learning model.

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

As there is no training set for an AI/algorithm in this context, this point is not applicable.

Ask a specific question about this device