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The Aquadex FlexFlowTM System is indicated for:
• Temporary (up to 8 hours) ultrafiltration treatment of patients with fluid overload who have failed diuretic therapy, and
• Extended (longer than 8 hours) ultrafiltration treatment of patients with fluid overload who have failed diuretic therapy and require hospitalization.
All treatments must be administered by a health care provider, under physician prescription, both of whom having received training in extracorporeal therapies.

The Aquadex FlexFlow System removes excess fluid from the patient in fluid overload by ultrafiltration of blood across a hollow-fiber hemofilter at the clinician selected rate. The system is comprised on a console mounted on a cart, proprietary software and accessories (venous access catheters, extensions and a blood pump circuit). Patient access is obtained via either peripheral or central venous veins.

This document describes regulatory information for the Aquadex FlexFlow System, specifically related to a software update (Rev. K). It is a 510(k) summary and an FDA clearance letter. It does not contain information about specific acceptance criteria, device performance, or a study proving that acceptance criteria were met.

The "Safety & Performance" section states:
"Regression testing was performed to verify and validate the software change and to generate data in support of the labeling change which incorporates a catheter compatibility chart using the principles of ISO 14971:2000 'Medical devices - Application of risk management to medical devices. Data generated demonstrated the Aquadex FlexFlow System continues to be safe and effective."

This statement indicates that testing was done to ensure the software update maintained safety and effectiveness, but it provides no further details regarding:

1. A table of acceptance criteria and the reported device performance: No specific criteria or performance metrics are listed.
2. Sample sized used for the test set and the data provenance: No sample size or data provenance is mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as there's no mention of a ground truth for a test set in this context.
4. Adjudication method for the test set: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable. This device is an ultrafiltration system, not an imaging device requiring human reader interpretation in an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device is a physical system with software, not a standalone algorithm in the typical sense for performance evaluation (e.g., image analysis). Regression testing of the software was done.
7. The type of ground truth used: Not explicitly stated, but for a physical device software update, "ground truth" would likely relate to system functionality, safety parameters, and output accuracy, confirmed through engineering tests and potentially clinical data if new features warranted it. The document mentions a "catheter compatibility chart" implying performance related to different catheters.
8. The sample size for the training set: Not applicable, as this is a software update for an existing physical device, not an AI model requiring a training set in the typical machine learning sense.
9. How the ground truth for the training set was established: Not applicable.

In summary, this document confirms the FDA clearance of a software update for an existing device based on regression testing, but it does not provide the detailed study information requested.

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