Search Results

The 5.2F dELC catheter is a peripheral venous access catheter, inserted preferably in the basilic vein (arm) and antecubital region respectively and specifically for use with the Aquadex™ System 100 when the blood flow rate is set at ≤20ml/minute.

The catheter is not intended for the infusion of medications or fluids, for laboratory sampling, or other venous access needs.

The Aquadex System 100 is indicated for temporary (up to 8 hours) ultrafiltration treatment of patients with fluid overload.

The 5.2F dELC is a 16 gauge, polyurethane, dual lumen extended-length catheter. It is intended to provide short-term peripheral venous access to facilitate blood removal and return for the purposes of ultrafiltration. The catheter has a low profile, flexible hub with suture wings for securement to the skin. The dual lumen tubing in the proximal portion of the catheter shaft is a double-D configuration and is fused to a single lumen tube for the distal portion. The catheter shaft construction includes a 304 stainless steel coil to minimize kinking from bending. The blood is drawn up through the single lumen tubing, and infused back into the vessel through the short proximal dual lumen section of the catheter shaft. The catheter will connect directly to the UF circuit of the Aquadex System 100 to conduct blood to and from the patient for the purposes of ultrafiltration. The 5.2F dELC is compatible with the Aquadex System 100 which utilizes software allowing blood flow rate adjustment as this catheters' optimal blood flow rate is at ≤20ml/minute.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance for Test Set

The provided document does not specify a separate "test set" in the context of clinical trials or data for performance evaluation beyond bench testing. The assessment relies on "bench tests" to demonstrate compatibility and similar characteristics to predicate devices. Therefore, details regarding sample size, country of origin, or retrospective/prospective nature of a distinct test set are not available.

3. Number of Experts and Qualifications for Ground Truth (Test Set)

Not applicable, as the evaluation was based on bench testing of physical properties and compatibility, not a clinical study requiring expert consensus on a test set.

4. Adjudication Method (Test Set)

Not applicable for the reasons stated above.

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

No. This document describes the premarket notification for a medical device (a catheter), not an AI algorithm or a diagnostic tool that would typically undergo an MRMC study. The evaluation focuses on the safety and effectiveness of the physical device through comparison with predicate devices and bench testing, not on human reader performance with or without AI assistance.

6. Standalone (Algorithm Only) Performance Study

No. This document is for a physical medical device (catheter), not an algorithm or software. Therefore, standalone algorithm performance is not relevant.

7. Type of Ground Truth Used

The "ground truth" for this device's evaluation is based on bench testing results and comparison to the established characteristics and performance of predicate devices. This includes verifying material similarity, packaging, sterilization, sterility, nonpyrogenicity, and functional compatibility with the Aquadex System 100 at specified flow rates.

8. Sample Size for the Training Set

Not applicable. This device is not an AI or machine learning model, so there is no concept of a "training set" in this context.

9. How Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this device.

Ask a specific question about this device