(30 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. This 510(k) is to add an alternate blood pump circuit which has a standard male and female luer adapter just before the filter on the withdrawal line to allow the optional use of a blood chamber cuvette to interface with a stand alone Hct monitor.
Here's a breakdown of the acceptance criteria and study information for the Aquadex FlexFlow™ System, based on the provided 510(k) summary:
This submission is for an alteration to an existing device (K050609), specifically to add an alternate blood pump circuit. Therefore, the focus of the testing is on validating this change, not re-proving the core functionality of the entire system from scratch.
1. Table of Acceptance Criteria and Reported Device Performance:
The provided 510(k) summary does not explicitly state quantitative acceptance criteria (e.g., specific thresholds for flow rates, pressure, or other performance metrics). Instead, it states that "The data demonstrated the Aquadex FlexFlow System continues to be safe and effective."
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Safety: Device operates without introducing new hazards or compromising existing safety features. | "The data demonstrated the Aquadex FlexFlow System continues to be safe..." |
| Effectiveness: Device maintains its intended functionality for ultrafiltration despite the modification. | "...and effective." |
| Functionality of alternate blood pump circuit with standard luer adapters and interface with stand-alone Hct monitor. | Bench tests were performed to validate the incorporation of the blood chamber placement in-line on the withdrawal line of the blood circuit. |
| No software change required due to the modification. | "No software change was required." |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not specified. The summary only mentions "Bench tests were performed." It does not provide the number of units tested or the number of test runs.
- Data Provenance: Not specified, but by nature of "bench tests," this would be laboratory-generated data, not from human subjects. It would be prospective in the sense that the tests were conducted specifically for this 510(k) submission, but it's not clinical data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- This question is not applicable to this specific 510(k) submission. The validation was based on "bench tests" for engineering performance, not on clinical interpretation or subjective assessment requiring expert review to establish ground truth.
4. Adjudication Method for the Test Set:
- Not applicable. Bench tests typically involve objective measurements against engineering specifications or established performance characteristics, and thus do not usually require a consensus or adjudication process like clinical studies with subjective endpoints.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:
- No, an MRMC comparative effectiveness study was not done. This 510(k) is for a minor modification to an existing device validated through bench testing, not a new diagnostic or therapeutic device requiring a clinical comparison of human reader performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a medical system (hardware and software for ultrafiltration) and not an algorithm or AI system subject to "standalone performance" testing in the AI context. While it has proprietary software, the testing described is on the mechanical and functional integration of a new blood circuit.
7. The Type of Ground Truth Used:
- For the bench testing, the "ground truth" would be engineering specifications, established performance parameters of the original device, and objective measurements of the modified system (e.g., flow rates, pressure integrity, absence of leaks, compatibility with the Hct monitor). It's not expert consensus, pathology, or outcomes data.
8. The Sample Size for the Training Set:
- Not applicable. This is not an AI/machine learning device that requires a training set in the conventional sense. The "proprietary software" is mentioned, but no changes were made to it, and its development would have preceded this specific 510(k).
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. As this is not an AI/machine learning device with a training set, the question of how ground truth was established for it is irrelevant in this context.
§ 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.”