(64 days)
The Aquadex FlexFlow™ 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.
The provided document is a 510(k) summary for the Aquadex FlexFlow™ System, specifically addressing the addition of a new blood circuit (UF250). This document is primarily focused on demonstrating substantial equivalence to a predicate device for regulatory approval, rather than outlining a clinical study with detailed acceptance criteria and performance metrics typically found for AI/ML-based medical devices or devices undergoing extensive efficacy trials.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and the Reported Device Performance:
The document does not explicitly state acceptance criteria in terms of performance metrics (e.g., sensitivity, specificity, accuracy) that would be relevant for an AI/ML device or a device requiring new clinical efficacy data. Instead, the acceptance is based on demonstrating safety and effectiveness through regression testing and bench tests for the software change and the new blood circuit.
| Acceptance Criteria Focus | Reported Device Performance |
|---|---|
| Software Validation | Regression testing verified and validated the software change. |
| New Component Validation (UF 250 Blood Circuit) | Bench tests were performed to validate the incorporation of the UF 250 Blood Circuit. |
| Overall Safety & Effectiveness | Data demonstrated the Aquadex FlexFlow System continues to be safe and effective. |
| Substantial Equivalence | The alternate UF 250 blood circuit (PN A1600) was shown to be safe and effective, substantially equivalent to the predicate, and acceptable for the intended use. |
2. Sample Size Used for the Test Set and the Data Provenance:
The document does not mention "test sets" in the context of clinical data or AI/ML model evaluation. The "data" referred to is from regression testing and bench tests. Therefore, no information on sample size (e.g., number of patients or cases) or data provenance (country of origin, retrospective/prospective) is provided, as these types of studies were not conducted for this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
This information is not applicable to the provided document. The evaluation was based on engineering testing (regression and bench tests) of a medical device's components and software changes, not on expert-adjudicated ground truth from medical images or clinical outcomes.
4. Adjudication Method for the Test Set:
Not applicable, as there was no test set requiring expert adjudication.
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 device is an ultrafiltration system, not an AI/ML diagnostic or assistive tool. No MRMC study was conducted.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an AI/ML algorithm. The "standalone" performance here refers to the device's functional operation in a controlled bench test environment.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" here is the expected functional performance and safety parameters of the device and its components, established through engineering specifications, regulatory standards, and comparison to the predicate device. This is determined through regression testing for software and bench testing for hardware (the UF 250 Blood Circuit). It is not based on expert consensus, pathology, or outcomes data in the traditional clinical trial sense for this submission.
8. The sample size for the training set:
Not applicable. This is not an AI/ML device with a training set.
9. How the ground truth for the training set was established:
Not applicable.
§ 876.5860 High permeability hemodialysis system.
(a)
Identification. A high permeability hemodialysis system is a device intended for use as an artificial kidney system for the treatment of patients with renal failure, fluid overload, or toxemic conditions by performing such therapies as hemodialysis, hemofiltration, hemoconcentration, and hemodiafiltration. Using a hemodialyzer with a semipermeable membrane that is more permeable to water than the semipermeable membrane of the conventional hemodialysis system (§ 876.5820), the high permeability hemodialysis system removes toxins or excess fluid from the patient's blood using the principles of convection (via a high ultrafiltration rate) and/or diffusion (via a concentration gradient in dialysate). During treatment, blood is circulated from the patient through the hemodialyzer's blood compartment, while the dialysate solution flows countercurrent through the dialysate compartment. In this process, toxins and/or fluid are transferred across the membrane from the blood to the dialysate compartment. The hemodialysis delivery machine controls and monitors the parameters related to this processing, including the rate at which blood and dialysate are pumped through the system, and the rate at which fluid is removed from the patient. The high permeability hemodialysis system consists of the following devices:(1) The hemodialyzer consists of a semipermeable membrane with an in vitro ultrafiltration coefficient (K
uf ) greater than 8 milliliters per hour per conventional millimeter of mercury, as measured with bovine or expired human blood, and is used with either an automated ultrafiltration controller or anther method of ultrafiltration control to prevent fluid imbalance.(2) The hemodialysis delivery machine is similar to the extracorporeal blood system and dialysate delivery system of the hemodialysis system and accessories (§ 876.5820), with the addition of an ultrafiltration controller and mechanisms that monitor and/or control such parameters as fluid balance, dialysate composition, and patient treatment parameters (e.g., blood pressure, hematocrit, urea, etc.).
(3) The high permeability hemodialysis system accessories include, but are not limited to, tubing lines and various treatment related monitors (e.g., dialysate pH, blood pressure, hematocrit, and blood recirculation monitors).
(b)
Classification. Class II. The special controls for this device are FDA's:(1) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Device—Part I: Evaluation and Testing,’ ”
(2) “Guidance for the Content of 510(k)s for Conventional and High Permeability Hemodialyzers,”
(3) “Guidance for Industry and CDRH Reviewers on the Content of Premarket Notifications for Hemodialysis Delivery Systems,”
(4) “Guidance for the Content of Premarket Notifications for Water Purification Components and Systems for Hemodialysis,” and
(5) “Guidance for Hemodialyzer Reuse Labeling.”