Search Results

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.

Ask a specific question about this device

The NexSite HD, Hemodialysis Catheter for long term use is indicated for use in attaining long term vascular access for hemodialysis and apheresis. It may be inserted percutaneously and is primarily inserted in the internal jugular vein of an adult patient. Alternate insertion sites include the subclavian vein.

The NexSite HD, Hemodialysis Catheter for long term use is a long term catheter intended for use in attaining long term vascular access for hemodialysis and apheresis. The polyurethane NexSite HD, Hemodialysis Catheter for long term use is available in two lengths, 24cm and 28cm, and has a Dacron cuff distal to the bifurcation hub. A Polyurethane/Dacron Dermal Ingrowth Support Collar (DISC) supplied with the Catheter is implanted subcutaneously, and is intended to minimize Catheter movement. The Catheter and DISC are packaged with accessories (stainless steel Tunneler and Sleeve, 0.038" Guidewire, 16Fr Introducer/Dilator, Coring Scalpel and Luer Caps) that are used to facilitate catheter placement. The NexSite HD, Hemodialysis Catheter for long term use is provided as a sterile, single-use device, and is sterilized using a validated ethylene oxide process. The NexSite HD, Hemodialysis Catheter for long term use is a blood contact device with greater than 30 days of exposure.

The provided text describes a medical device, the NexSite™ HD Hemodialysis Catheter, and its 510(k) submission for regulatory clearance. It details the device's intended use, comparison to predicate devices, and the testing performed. However, it does not contain the kind of information typically associated with acceptance criteria and study results for an AI/device performance study as described in your request.

The document pertains to a physical medical device (catheter) and focuses on demonstrating substantial equivalence to already marketed devices through in vitro and in vivo (animal, not human clinical) testing, rather than a study evaluating the performance of an AI algorithm or digital medical device.

Therefore, many of the requested fields cannot be filled. I will fill in what information is available based on the provided text, and explicitly state when information is not present.

Acceptance Criteria and Study for NexSite™ HD Hemodialysis Catheter

The document describes the testing performed for the NexSite™ HD Hemodialysis Catheter to demonstrate its safety and effectiveness for substantial equivalence, rather than setting distinct acceptance criteria for an AI algorithm's performance. The "acceptance criteria" here are implied by meeting the requirements of applicable standards and demonstrating substantial equivalence to predicate devices through various tests.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance:

• Test Set Sample Size: Not explicitly stated as numerical sample sizes for each test in the provided text. The document refers to "finished NexSite™ HD devices" and "commercial predicate devices" being tested.
• Data Provenance: The "in vivo implantation studies" suggest animal studies, not human data. The in vitro testing was performed on the device itself. Specific country of origin for the data is not mentioned beyond the manufacturing location (Ireland) and the regulatory submission to the FDA (USA). The studies were conducted specifically for the purpose of this 510(k) submission (prospective, in the context of device development and regulatory clearance).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable/Not mentioned. This device does not involve expert-established ground truth in the context of diagnostic AI. The "ground truth" for its performance is determined by physical and biological testing against established standards and predicate device performance.

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

• Not applicable/Not mentioned. This concept is not relevant to the type of device testing described.

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 or imaging device that would involve human readers.

6. 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. The testing described is "standalone" in the sense that it evaluates the physical performance of the device without human interaction in the performance metrics, but it is not an algorithm.

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

• The "ground truth" for this device is based on engineering standards (ISO 10555-1:2004) for in vitro tests, and biological/physiological performance in animal models for in vivo tests, demonstrating the device performs "as intended" and is substantially equivalent to predicate devices.

8. The sample size for the training set:

• Not applicable. This is not an AI/machine learning device; therefore, there is no "training set."

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

• Not applicable. No training set for an AI model.

Ask a specific question about this device

The NovoFlo™ Catheter LT Dual Lumen Long Term Hemodialysis Catheters are indicated for use in attaining long term vascular access for hemodialysis and apheresis. It may be inserted percutaneously and is primarily placed in the internal jugular vein of an adult patient. Alternate insertion sites include the subclavian vein as required. Catheters greater than 40cm in length are intended for femoral vein insertion.

The NovoFlo™ Catheter LT Dual Lumen Long Term Hemodialysis Catheter is manufactured from soft radiopaque polyurethane material which provides increased patient comfort while providing excellent biocompatibility. The Hemodialysis Catheter can be connected to an extracorporeal tubing system via a connecting tube equipped with a Luer-Lock connector. The proximal lumen (red clamp) provides "arterial" blood outflow from the patient, the distal lumen (blue clamp) provides "venous" blood return to the patient. Important information such as priming volume and catheter length is printed on both sides of the clamp. The catheter comes in a variety of sizes and lengths with straight or curved extensions.

The provided text describes a medical device called the "NovoFlo Catheter LT Dual Lumen Long Term Hemodialysis Catheter" and its substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria, device performance metrics, or a study that uses statistical analysis with human readers or standalone algorithm performance.

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing extensive clinical study data as might be found in a PMA (Premarket Approval) submission or detailed clinical trial reports.

Therefore, many of the requested fields cannot be filled from the provided text.

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

1. Table of acceptance criteria and the reported device performance:

• Acceptance Criteria: Not explicitly stated in terms of quantitative performance thresholds (e.g., sensitivity, specificity, accuracy). The acceptance criteria were based on demonstrating substantial equivalence to the predicate device in terms of design, materials, performance, biocompatibility, safety, and product effectiveness.
• Reported Device Performance: No specific quantitative performance metrics (e.g., flow rates, complication rates, longevity) are reported for the NovoFlo™ Catheter itself. The document states there are "no major differences in design, materials, performance, biocompatibility, safety and product effectiveness" compared to the predicate device.

2. Sample size used for the test set and the data provenance:

• Not applicable. This device is not an AI/diagnostic device that uses a "test set" of patient data in the computational sense. The "tests" mentioned are engineering studies and biocompatibility tests. No human patient data test set is described.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. No "ground truth" establishment by experts on a test set is described.

4. Adjudication method for the test set:

• Not applicable. No test set adjudication is described.

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 device, and no MRMC study is mentioned.

6. 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.

7. The type of ground truth used:

• Not applicable in the context of diagnostic/AI performance studies. The "ground truth" for the device's substantial equivalence likely refers to established industry standards (ISO, FDA guidances) and the performance characteristics of the predicate device.

8. The sample size for the training set:

• Not applicable. This is not an AI device.

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

• Not applicable.

Summary based on provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance:

• Not applicable. The provided document details a 510(k) submission for a physical medical device, not a diagnostic algorithm. The "tests" were engineering studies and biocompatibility evaluations, not clinical studies with patient data test sets.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. No "ground truth" involving expert consensus on patient data is mentioned.

4. Adjudication method for the test set:

• Not applicable.

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 device, and no MRMC study was performed.

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

• Not applicable. This is a physical medical device.

7. The type of ground truth used:

• For the purpose of the 510(k) submission, the "ground truth" was the established characteristics and performance of the legally marketed predicate device (Medcomp Hemo-Flow Catheter), as well as adherence to recognized industry standards (ISO 10555, ISO 10993) and FDA guidance documents.

8. The sample size for the training set:

• Not applicable. This is not an AI device.

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

• Not applicable.

Ask a specific question about this device