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

The Dual Lumen ELC catheters are peripheral venous access catheters, inserted preferably in the basilic vein (arm) and antecubital region respectively, and specifically for use with the System 100. The catheter is not intended for the infusion of medications or fluids, for laboratory sampling, or other venous access needs. The System 100 is indicated for temporary (up to 8 hours) ultrafiltration treatment of patients with fluid overload.

The dELC is a 6 French, 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 bonded to a single lumen tube for the distal portion. The blood is drawn up through the single lumen tubing, and infused back into the vessel through the short proximal section of the catheter shaft. The catheter will connect directly to the UF circuit of the System 100 to conduct blood to and from the patient for the purposes of ultrafiltration.

The provided text is a 510(k) summary for a medical device called the "Dual-Lumen Extended Length Catheter (dELC)". It describes the device, its intended use, and states that bench tests demonstrate its compatibility with the System 100. However, it does not include information about specific acceptance criteria or a detailed study proving the device meets those criteria, as typically found in clinical trials or performance studies. The document primarily focuses on demonstrating substantial equivalence to predicate devices based on design, materials, packaging, sterilization, and limited bench testing.

Therefore, many of the requested details about acceptance criteria, study design, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness studies are not present in this 510(k) summary.

Here's a breakdown of what can be extracted and what cannot:

Acceptance Criteria and Reported Device Performance

Study Details (Based on available information)

1. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

   • Not provided. The document only mentions "bench tests," which are typically laboratory-based and do not involve human patient data in the context of this 510(k) summary. No details on the number of samples or data provenance are given.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

   • Not applicable/Not provided. Since "bench tests" are mentioned for compatibility, there's no indication of a test set requiring expert-established ground truth in the traditional sense of diagnostic or clinical performance studies.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • Not applicable/Not provided. As stated above, this type of adjudication is typically for clinical or diagnostic performance studies, which are not described here.

4. 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:

   • No. This device is a physical medical catheter, not an AI-powered diagnostic tool. Therefore, an MRMC study related to AI assistance for human readers is not relevant and was not conducted.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

   • Not applicable. This is a physical medical device, not an algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • Not applicable/Not provided. For the "bench tests" mentioned, the "ground truth" would likely be the physical properties and functional performance of the catheter according to engineering specifications and compatibility with the System 100. This is not explicitly detailed.

7. The sample size for the training set:

   • Not applicable/Not provided. There is no mention of a "training set" as this is not an AI/machine learning device.

8. How the ground truth for the training set was established:

   • Not applicable/Not provided. There is no training set for this type of device.

Summary of Device and Evidence Presented in 510(k):

The 510(k) submission for the Dual-Lumen Extended Length Cathether (dELC) demonstrates its substantial equivalence to predicate devices (B. Braun Accuguide®, CHF Solutions System 100, and medComp® VASCU-PICC™ and Duo-Flow™) by:

• Being similar in materials of construction.
• Being identical for packaging and sterilization.
• Being provided sterile and nonpyrogenic.
• Having "bench tests" that demonstrate compatibility with the System 100.

The document uses these points to conclude that the device is "safe and effective for its intended use" for temporary peripheral venous access for ultrafiltration treatments for patients with fluid overload, and is therefore "substantially equivalent" to legally marketed predicate devices. The evidence presented focuses on design, materials, manufacturing processes, and general functional compatibility rather than detailed quantitative performance metrics from a formal "study" with set acceptance criteria in the clinical sense.

Ask a specific question about this device

For use with the System 100. The System 100 is indicated for temporary (up to eight hours) ultrafiltration treatment of patients with fluid overload.

The UF500 blood circuit with needleless access port allows for aspiration, injection, or gravity flow of fluids using a male luer fitting.

The modified/alternate UF500 circuit incorporates an in-line needleless valve on the circuit withdrawal, infusion or both tubing lines. The in-line needless valve is independently commercially available medical device cleared for commercial distribution since May 15, 1996 (K955585) known as the ULTRASITE® valve. This is a luer activated valve manufactured and distributed by B. Braun Medical. CHF Solutions, Inc. is placing this valve at the end of a short piece of tubing (extension arm) that is permanently joined to the A1500 circuit of the System 100 (K013733) with a tee connector. A sliding clamp is also included on the extension arm and is blue on the withdrawal side and white on the infusion side. The in-line needleless access port allows the health care provided access to the circuit/vasculature without disconnecting the catheter connections or catheter extension (when used) for aspiration, injection, or gravity flow of fluids.

The provided text describes a 510(k) summary for a medical device called "System 100 Modified/Alternate UF500 With In-line Needleless Access Port." However, the document does not contain specific acceptance criteria or a study that rigorously proves the device meets such criteria in a quantitative sense as typically seen in AI/software medical device submissions.

This submission is for a modification of an existing device (UF500 circuit) by adding a commercially available, already cleared, in-line needleless access port. The "study" here is primarily a demonstration of substantial equivalence through bench testing, rather than a clinical trial or performance study with defined statistically-derived acceptance criteria.

Therefore, many of the requested fields cannot be directly extracted from the provided text because they are not applicable to the type of submission described.

Here's an analysis of what information is available:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria: The document implies that the acceptance criteria are met if the modified device remains compatible with the System 100, is sterile, nonpyrogenic, and satisfies the intended use without introducing new safety concerns compared to the predicate devices. The phrase "Bench tests demonstrate the modified/alternative UF500 is remains compatible with the System 100" serves as the primary "acceptance."

Reported Device Performance:

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

• Sample Size: Not specified. The study involved "bench tests," which are typically laboratory tests of the device itself rather than tests on human subjects or clinical data. The quantity of devices tested is not mentioned.
• Data Provenance: The "bench tests" are presumably conducted by the manufacturer, CHF Solutions, Inc., in the United States. They are retrospective in the sense that they were conducted on the modified device before submission.

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

• Not applicable. This is a hardware modification submission, not an AI/software device requiring expert interpretation for ground truth.

4. Adjudication Method for the Test Set

• Not applicable. This type of submission does not involve adjudication of clinical data or expert opinions. The evaluation is based on engineering and performance specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

• No. This is not an AI or software device, and no MRMC study was performed.

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

• Not applicable. This is a physical medical device (circuit with a port), not an algorithm.

7. The Type of Ground Truth Used

• Not applicable in the typical sense for AI/software devices. The "ground truth" here is adherence to engineering specifications for compatibility, sterility, non-pyrogenicity, and mechanical integrity, as demonstrated through bench testing and comparison to predicate device characteristics.

8. The Sample Size for the Training Set

• Not applicable. No training set is mentioned or relevant for this type of device modification.

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

• Not applicable. No training set is mentioned or relevant for this type of device modification.

Summary of the Study (as described in the document):

The study was a series of bench tests conducted by CHF Solutions, Inc. to demonstrate the safety and effectiveness of the modified UF500 circuit. The core of the study aimed to show that integrating an existing, cleared needleless access port into the UF500 circuit did not negatively impact the performance, safety, and compatibility with the System 100. Key aspects verified were:

• Materials, Packaging, and Sterilization: These were confirmed to be identical to the predicate System 100 circuit, leveraging the existing clearance for these aspects.
• Sterility and Nonpyrogenicity: The final modified product was confirmed to be sterile and nonpyrogenic.
• Compatibility: Bench tests specifically demonstrated that the modified/alternative UF500 circuit remains compatible with the System 100, which is crucial as the needleless port is an add-on.

The overall conclusion was that, based on these bench tests and the technological characteristics, the modified device is "safe and effective for its intended use" and "substantially equivalent" to the predicate devices.

Ask a specific question about this device