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Fresenius Model 2008T Hemodialysis Machine is indicated for acute and chronic dialysis therapy.

The Venofer® Pump Module is an optional accessory for use on Fresenius 2008T Hemodialysis Machines and is intended to administer Venofer®, an iron sucrose, to treat iron deficiency anemia in patients with chronic kidney disease undergoing hemodialysis, where Venofer®, in conjunction with hemodialysis, is prescribed by a physician.

The Venofer Pump Module is an optional module for use on Fresenius 2008T Hemodialysis Machines. The module is designed to administer Venofer, an iron sucrose supplement, during dialysis treatments. The Venofer Pump Module is to be used in accordance with the approved Venofer Indications for Use and the physician's prescription.

The Venofer Pump Module is intended to provide ease and consistent delivery of Venofer, an iron sucrose supplement, indicated for the treatment of iron deficiency anemia for Hemodialysis dependent-chronic kidney disease patients. Anemia commonly occurs in patients with chronic kidney disease undergoing Hemodialysis and effective anemia management is recognized as an important factor in improving the outcomes of these patients. Iron deficiency is a frequent contributing factor which complicates the treatment of anemia in chronic kidney disease patients. Iron sucrose is commonly delivered to improve iron status in patients who have chronic kidney disease. Venofer is an injectable iron preparation drug approved for treatment of iron deficiency and is the most commonly used drug to treat iron deficiency anemia in dialysis patients. Renal Solutions has developed the Venofer Pump Module that provides the means to deliver Venofer when undergoing Hemodialysis on a Fresenius 2008T Dialysis System.

The Venofer Pump Module fits into the module compartment of existing Fresenius 2008T Machines and consists of a control panel, vial holder, fluid detector, and a peristaltic pump.

The provided text describes a 510(k) premarket notification for the "Fresenius Model 2008T Hemodialysis Machine with Venofer Pump Module." This document focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a detailed study with acceptance criteria and performance data for a novel device. Therefore, much of the requested information regarding acceptance criteria, sample sizes, expert ground truth, adjudication methods, and comparative effectiveness studies is not available in the provided text.

Based on the information given, here's what can be extracted:

1. A table of acceptance criteria and the reported device performance:

This information is not provided in the document. The submission is for a medical device accessory and states that non-clinical testing was performed, but it doesn't detail specific acceptance criteria or quantitative performance results in a table format. It generally claims the device is "as safe, as effective, and performs at least as safely and effectively as the legally marketed devices identified as predicate devices."

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

This information is not provided in the document. The text mentions "non-clinical testing" but does not specify sample sizes or data provenance.

3. 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):

This information is not provided in the document. The nature of the device (a pump for administering medication during hemodialysis) suggests that ground truth would likely be established through engineering and medical performance standards, rather than expert-derived ground truth in the way a diagnostic imaging AI might.

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

This information is not provided in the document.

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:

This information is not applicable and not provided in the document. The Venofer Pump Module is an accessory for a hemodialysis machine, administering medication. It is not an AI-assisted diagnostic tool that would typically involve human "readers" or an MRMC study.

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

This information is not applicable in the context of an AI algorithm. The device is a physical pump module. The document states, "Like the Heparin Pump, the Venofer Pump Module is not a stand alone device. The Venofer Pump Module cannot operate unless it is connected to the 2008T Hemodialysis Machine." This refers to its operational dependency on the larger hemodialysis machine, not a standalone AI performance evaluation.

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

This information is not explicitly stated in the document. Given the device's function, ground truth for its performance would likely be established through engineering specifications, flow rate accuracy, absence of adverse events, and efficacy of drug delivery as measured by standard medical parameters (e.g., successful iron administration without pump-related complications), rather than categorical labels like pathology or expert consensus on image interpretation. The submission relies on "verification, safety, performance and software testing."

8. The sample size for the training set:

This information is not provided in the document. The device is a physical pump, not an AI algorithm that undergoes a "training set" in the machine learning sense.

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

This information is not provided in the document, as it's not an AI device with a training set.

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