(244 days)
The Aquadex 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 healthcare 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 Aquadex™ FlexFlow™ System, manufactured by CHF Solutions, Inc., is a high permeability dialysis system designed to remove excess fluid from patients with fluid overload who have failed diuretic therapy. The device received 510(k) clearance (K050609) from the FDA on November 9, 2005.
Here's an analysis of the acceptance criteria and the study used to demonstrate the device's performance:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document describes the safety and performance evaluation for the Aquadex™ System, particularly in support of an expanded indication for use to include extended ultrafiltration treatment (longer than 8 hours). However, explicit, quantifiable acceptance criteria with specific thresholds for parameters like effectiveness or safety outcomes are not explicitly stated in the provided 510(k) summary. Instead, the summary concludes that the device "continues to be safe and effective" based on the data.
Therefore, the table below reflects what can be inferred as the general performance goal based on the clinical study's outcome rather than pre-defined numerical acceptance criteria.
| Acceptance Criteria (Inferred from Study Goal) | Reported Device Performance (Summary) |
|---|---|
| Safety for extended use (>8 hours) | The data demonstrated the Aquadex™ System continues to be safe through 24 hours of continuous use. |
| Effectiveness for extended use (>8 hours) | The data demonstrated the Aquadex™ System continues to be effective through 24 hours of continuous use. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: A subset of 60 patients with 89 extended use (>8 hours) UF500 circuits.
- Data Provenance: This was a post-market on-label prospective study. The country of origin is not explicitly stated, but the manufacturer is based in Brooklyn Park, MN, USA, and the FDA review is for the US market, suggesting the study was likely conducted in the US.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The provided document does not specify the number of experts used or their qualifications to establish ground truth for this study. Given that it's a post-market clinical study evaluating safety and effectiveness, the "ground truth" would likely be based on clinical outcomes assessed by treating physicians and medical staff, rather than a panel of independent reviewers establishing a "ground truth" for diagnostic accuracy.
4. Adjudication Method for the Test Set
The document does not describe an adjudication method for the clinical study data. Clinical studies typically rely on predefined endpoints and statistical analysis to evaluate outcomes, rather than an adjudication method in the context described for diagnostic accuracy.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is primarily relevant for diagnostic imaging devices where the performance of an AI algorithm is compared against human readers, with or without AI assistance. The Aquadex™ FlexFlow™ System is a therapeutic device (dialysis system), and its evaluation focuses on its direct physiological effects.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
No, a standalone (algorithm only) performance study was not done. The Aquadex™ FlexFlow™ System is a medical device that involves hardware, software, and human clinician interaction for its operation and effectiveness. Its performance is inherently tied to its function in a clinical setting with human oversight. The evaluation focused on the device's overall safety and effectiveness during extended use.
7. The Type of Ground Truth Used
The "ground truth" for this study would be derived from clinical outcomes data related to patient safety and the device's effectiveness in performing ultrafiltration. This would include measurements of fluid removal, patient vital signs, adverse events, and other clinical indicators relevant to the treatment of fluid overload.
8. The Sample Size for the Training Set
The document does not mention a training set in the context of an algorithm or AI. This is because the device is a medical apparatus with a software component, but information provided does not suggest it employs machine learning or AI algorithms requiring a separate training set for model development. The "software changes" mentioned relate to functional enhancements rather than AI model training.
9. How the Ground Truth for the Training Set Was Established
As no training set (for an AI algorithm) is mentioned, the method for establishing its ground truth is not applicable here.
§ 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.”