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The Dual Lumen Extended Length Catheter (dELC) is indicated for use up to 72 hours in attaining vascular venous access for use with the Aquadex FlexFlow® and Aquadex SmartFlow® systems for ultrafiltration therapy. It is not for pediatric use. The catheter is not intended for the infusion of medications or fluids, for laboratory sampling, or other venous access needs.

The Dual Lumen Extended Length Catheter (dELC) is a 6F reverse-tapered dual lumen venous access device with stainless steel coil reinforcement. It is inserted into peripheral venous circulation by way of a peel away introducer. The catheter is intended for use with the Aquadex FlexFlow® and Aquadex SmartFlow® Systems in attaining vascular venous access for ultrafiltration treatment of patients with fluid overload. It has two models, 320101 and 320102, with identical hub designs but different shaft lengths, 12 cm and 16 cm, to adapt to the patient's body size.

The catheter has a radiopaque polyurethane shaft with two equal-sized inner lumens designed in a "double D" configuration. The shaft has a reverse-tapered design to minimize resistance to flow. Its outside diameter starts at 6F on the distal end and tapers back to 7F on the proximal end. The shaft with the coil reinforcement, designed based on the FDA cleared 5.2F dELC via K041791, provides kinking resistance and ensures consistent flow. Depth markings are provided in 0.5cm increments along the insertable length of the catheter shaft. The proximal end of the catheter shaft and clear polyurethane extension tubes are over-molded into a polyurethane hub, which has suture wings for securement to the skin.

Additionally, the catheter has female ISO 80369-compliant luer connectors to connect with the Aquadex blood tubing set for withdrawal and infusion. When the catheter is not in use, two yellow male locking caps can be placed on the female luer connectors for reducing the risk of infection. Each extension tube has a clamp: blue on the blood withdrawal tube (marked by the withdrawal ID ring) and white on the blood infusion tube (marked by the infusion ID ring). The blood is drawn up through the withdrawal lumen, which is proximal to the infusion lumen. The skived offset tip is designed to minimize blood recirculation.

An attached MRI tag indicates the device is MR unsafe.

The provided FDA 510(k) clearance letter (K252226) describes a medical device, the Dual Lumen Extended Length Catheter (dELC), and details the rationale for its substantial equivalence to a predicate device. This submission focuses on a material change to an existing cleared device, rather than a de novo submission for a novel AI/software device. Therefore, the information typically requested regarding acceptance criteria and study proving performance for an AI/software device (e.g., accuracy, sensitivity, specificity, MRMC studies, ground truth establishment) is not applicable in this context.

The acceptance criteria here pertain to the safety and effectiveness equivalency of the modified medical device (specifically, the change in material for the Female Luer Lock Connector) compared to its predicate. The study conducted is non-clinical performance testing rather than a clinical trial or AI model validation.

Here's a breakdown of the available information relevant to "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of this specific 510(k) submission:

Acceptance Criteria and Reported Device Performance (for a Material Change)

The core acceptance criterion for this 510(k) submission is to demonstrate that the change in material for the Female Luer Lock Connector does not raise new questions of safety and effectiveness and that the modified device remains substantially equivalent to the predicate device.

Information NOT APPLICABLE to this 510(k) (as it's a material change, not an AI/software device):

The following points are standard for AI/software device clearances but are not relevant to this specific 510(k) for a material change in a physical medical device.

2. Sample sizes used for the test set and data provenance: Not applicable. The "test set" here refers to physical samples of the device undergoing non-clinical bench testing, not a dataset for an algorithm. Data provenance (country, retrospective/prospective) is typically for patient data used in AI validation.
3. Number of experts used to establish ground truth for the test set and qualifications: Not applicable. There is no "ground truth" to establish in the context of an algorithmic output. The performance tests are specific to the mechanical and chemical properties of the device.
4. Adjudication method for the test set: Not applicable. No human interpretation or adjudication of an algorithm's output.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable. MRMC studies are used to assess the impact of AI on human reader performance, which doesn't apply to this physical device change.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
7. The type of ground truth used: Not applicable. Ground truth typically refers to a verified diagnosis or measurement used to evaluate an AI model's accuracy. For this device, "ground truth" would be established through calibrated instruments measuring physical properties.
8. The sample size for the training set: Not applicable. There is no AI model or training set involved.
9. How the ground truth for the training set was established: Not applicable.

In summary, this 510(k) demonstrates substantial equivalence through non-clinical bench testing to affirm that a material change to a connector on a physical medical device does not compromise its safety or effectiveness when compared to the previously cleared predicate device. It specifically avoids the need for clinical studies by establishing this equivalence.

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The Dual Lumen Extended Length Catheter (dELC) is indicated for use up to 72 hours in attaining vascular venous access for use with the Aquadex FlexFlow® and Aquadex SmartFlow® systems for ultrafiltration therapy. It is not for pediatric use. The catheter is not intended for the infusion of medications or fluids, for laboratory sampling, or other venous access needs.

The Dual Lumen Extended Length Catheter (dELC) is a 6F reverse-tapered dual lumen venous access device with stainless steel coil reinforcement. It is inserted into peripheral venous circulation by way of a peel away introducer. The catheter is intended for short-term use with the Aquadex FlexFlow® and Aquadex SmartFlow® Systems in attaining vascular venous access for ultrafiltration treatment of patients with fluid overload. It has two models, 320101 and 320102, with identical hub designs but different effective (insertable) shaft lengths, 12 cm and 16 cm, to adapt to the patient's body size. The catheter has a radiopaque polyurethane shaft with two equal-sized inner lumens designed in a "double D" configuration. The shaft has a reverse-tapered design to minimize resistance to flow. Its outside diameter starts at 6F on the distal end and tapers back to 7F on the proximal end. The shaft with reinforcement provides kinking resistance and ensures consistent flow. the Catheter has female ISO 80369-compliance Luer connectors to connect with the Aquadex blood tubing set for withdrawal and infusion. Each extension tube has a clamp: blue on the blood withdrawal tube and white on the blood infusion tube. The blood is drawn up through the withdrawal lumen, which is proximal to the infusion lumen. The skived offset tip is designed to minimize blood recirculation.

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, comparison to predicate devices, and performance data submitted to support substantial equivalence.

However, the provided text DOES NOT contain information about an AI device or a software component that would require an acceptance criteria table, a study proving the device meets that criteria with details about sample sizes, expert ground truth establishment, MRMC studies, or standalone algorithm performance.

The "Performance Data" section (Section VII) lists various bench tests (e.g., Dimensional Analysis, Shaft Stiffness, Flow Rate, Kink Resistance) and biocompatibility tests performed on the physical catheter. These are standard tests for a physical medical device and are not related to an AI/software component.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study proving an AI device meets the acceptance criteria, as this information is not present in the provided document. The document pertains to a physical catheter, not an AI or software-based medical device.

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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.

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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.

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