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The r4 Duraspan™ and the Duraspan™ Ultra long-term dialysis catheter is indicated for attaining short and long term (>30 days) vascular access for hemodialysis, hemoperfusion or apheresis therapy. Access is attained via the internal jugular vein, external jugular vein, subclavian vein or femoral vein. Catheters 40 cm and longer are for femoral vein insertion. The ability of the Biomimetic Coating to reduce platelet adhesion and thrombus accumulation is supported exclusively by in-vitro and animal testing.

The Duraspan™ Dialysis Catheter is designed for patients with End Stage Renal Disease needing chronic hemodialysis. The catheter is inserted percutaneously through the Subclavian or Jugular veins and placed in the venous system of the patient. Once in place, the catheters two proximal luer connectors are connected to a hemodialysis machine's blood lines. The machine's pump draws blood through the proximal lumen, indicated with the red connector, removing blood from the patient. The blood is processed in the hemodialysis filter or apheresis centrifuge. The blood is then returned through the lumen, marked by a blue connector, exiting out the most distal tip. The tip of the catheter is staggered to reduce recirculation of the blood.

The catheters include female luer locking adapters and a tissue ingrowth cuff for fixing the catheters in a subcutaneous tunnel. The Duraspan™ kit includes a catheter and introduction components. The catheter is supplied sterile.

The Duraspan 114 product line has catheters in a 15.5 Fr dual lumen. The catheters come in a variety of lengths (24-55cm) for patient specificity and access preference.

The Duraspan 104 is similar to the Duraspan ™ Ultra with a reduced tip stagger to address the variability of the dimensions of the vena cava in patients allowing for appropriate positioning of the arterial and venous lumens within the vena cava and right atrium.

The provided text does not describe a study that uses AI or machine learning technology. It is a 510(k) summary for a medical device called the Duraspan™ Long-Term Hemodialysis Catheter. The document focuses on the substantial equivalence of this catheter to a predicate device, based on design, materials, sterilization, principles of operation, and performance testing against existing standards and test methods.

Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, sample sizes for test/training sets, expert ground truth, adjudication methods, or MRMC studies, as these concepts are specifically relevant to AI/ML device evaluations and are not present in this document.

The document states:

• "The Duraspan ™ was thoroughly tested with tests based on existing standards and test methods and demonstrates that the Duraspan ™ is substantially equivalent to the listed predicates."
• "Based on indications for use, technological characteristics and performance testing the Duraspan™ catheters met the requirements for its intended use and the Duraspan™ is substantially equivalent in design, materials, sterilization, principles of operation and indications for use to current commercially available catheters/cited predicates."

These statements indicate that the device met pre-defined requirements or standards, usually involving bench testing and potentially animal studies for physical and biological characteristics, to demonstrate substantial equivalence to a predicate device. However, specific acceptance criteria and performance metrics for an AI/ML system are not applicable here.

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The r4 Duraspan"10 long-term dialysis catheter is indicated for attaining short and long term (>30 days) vascular access for hemodialysis, hemoperfusion or apheresis therapy. Access is attained via the internal jugular vein, external jugular vein, subclavian vein or femoral vein. Catheters 40 cm and longer are for femoral vein insertion. The ability of the Biomimetic Coating to reduce platelet adhesion and thrombus accumulation is supported exclusively by in-vitro and animal testing.

The Duraspan™ Dialysis Catheter is designed for patients with End Stage Renal Disease needing chronic hemodialysis. The catheter is inserted percutaneously through the Subclavian or Jugular veins and placed in the venous system of the patient. Once in place, the catheters two proximal luer connectors are connected to a hemodialysis machine's blood lines. The machine's pump draws blood through the proximal lumen, indicated with the red connector, removing blood from the patient. The blood is processed in the hemodialysis filter or apheresis centrifuge. The blood is then returned through the lumen, marked by a blue connector, exiting out the most distal tip. The tip of the catheter is staggered to reduce recirculation of the blood.

The catheters include female luer locking adapters and a tissue ingrowth cuff for fixing the catheters in a subcutaneous tunnel. The Duraspan" kit includes a catheter and introduction components. The catheter is supplied sterile.

The Duraspan 114 product line has catheters in a 15.5 Fr dual lumen. The catheters come in a variety of lengths (24-55cm) for patient specificity and access preference.

The Duraspan 10 is similar to the Bard HemoGlide Star Series and the tip stagger is similar to the Arrow Step-Tip with the addition of a Biomimetic Coating that is identical to the coating on the Zeus Catheter.

The provided text describes a 510(k) premarket notification for a medical device, the Duraspan™ Long-Term Hemodialysis Catheter. However, it does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria in the way a diagnostic AI device typically would.

Instead, the document focuses on demonstrating substantial equivalence to predicate devices for regulatory approval. This is a different type of evaluation.

Therefore, I cannot fulfill the request for information regarding acceptance criteria, reported device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, or standalone performance because this information is not present in the provided text. The document's purpose is to show the device is similar enough to already approved devices, not to establish novel performance metrics against a defined ground truth.

Here's an explanation of what the document does describe in relation to the prompt:

• Acceptance Criteria and Reported Device Performance: This information is not explicitly stated in terms of quantitative metrics or a table of performance. The "acceptance criteria" for a 510(k) submission are that the device is "substantially equivalent" to predicate devices and raises "no new questions regarding safety or efficacy." The reported "performance" is that it "met the requirements for its intended use" through testing based on existing standards and test methods, demonstrating substantial equivalence.

• Sample Size Used for the Test Set and Data Provenance: Not applicable. The document refers to "testing" and "performance testing" but does not detail a specific "test set" of patient data in the way an AI diagnostic study would. The testing would likely involve bench testing, biocompatibility, and perhaps animal studies, but not a human subject "test set" for a diagnostic algorithm.

• Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts: Not applicable. There is no concept of "ground truth" establishment by experts in this context, as it's not an AI diagnostic device being evaluated for its accuracy.

• Adjudication Method for the Test Set: Not applicable.

• If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done: No. This type of study is for evaluating human performance with and without AI assistance for interpretation tasks, which is not relevant to a hemodialysis catheter.

• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No. This is not an algorithm-based device.

• The Type of Ground Truth Used: Not applicable. For this catheter, the "ground truth" would be successful function and safety in a physiological environment, assessed through various engineering tests, biocompatibility tests, and potentially animal studies.

• The Sample Size for the Training Set: Not applicable. This is not an AI device that uses a "training set."

• How the Ground Truth for the Training Set was Established: Not applicable.

Summary based on the provided text:

The document outlines the regulatory basis for the Duraspan™ Long-Term Hemodialysis Catheter. It claims that the device:

• Met the requirements for its intended use.
• Is substantially equivalent in design, materials, sterilization, principles of operation, and indications for use to current commercially available catheters/cited predicates.
• Was thoroughly tested with tests based on existing standards and test methods.
• Raises no new questions regarding safety or efficacy.

The "study" or evaluation performed was a series of engineering and biocompatibility tests designed to demonstrate substantial equivalence to legally marketed predicate devices (HemoGlide Star Series, Zeus CT PICC, Arrow Step-Tip). The basis of approval is this demonstrated equivalence, not a direct measurement of diagnostic accuracy against a "ground truth" in human patients as would be expected for an AI diagnostic device.

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