(248 days)
The Edwards Aquarius System is indicated for continuous solute and/or fluid removal in patients with acute renal failure or fluid overload. The Edwards Aquarius system may also be used in Therapeutic Plasma Exchange (TPE) therapies.
The Edwards Aquarius system is indicated for use in a clinical setting and not for home use.
The Aquarius system is an Automated Fluid Balance Monitor, designed to be used with various extracorporeal treatments in the field of renal replacement therapies or plasma therapies. All therapies must be prescribed by a physician. The Aquarius system is divided into three circuits: the extracorporeal (blood) circuit, the substitution/dialysate circuit and the filtrate circuit. Toxic substances are removed by filters and clean blood is returned to the patient. The Aquarius system allows the patient to be positioned left or right of the instrument. The Aquarius system uses two scales to accurately measure and precisely balance filtration and substitution volumes. Heparin may be supplied to the extracorporeal circuit via an anticoagulant pump (Heparin pump). The prescribing physician may select continuous or intermittent options. The Aquarius protective system is designed as a 2-channel system to protect the patient from foreseeable danger. At the back of the scale system a removable hand-crank is mounted. This can be used to manually turn the blood pump in case a pump stops. The Aquarius system is portable. It has a wheeled base connected with a handle to move or carry the Aquarius.
The provided text is a 510(k) summary for the Edwards Aquarius system, detailing changes to software and labeling. It explicitly states that no clinical or non-clinical data is presented as part of this submission, and it is a special 510(k). Therefore, the document does not contain information about acceptance criteria or a study proving the device meets them in the context of performance metrics like accuracy, sensitivity, or specificity.
Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (Edwards Aquarius system cleared under K070320) despite software and labeling updates.
Here's a breakdown based on the information provided and what is not present:
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Table of acceptance criteria and the reported device performance:
- Not provided. The document does not define specific performance acceptance criteria (e.g., for fluid management accuracy, solute removal efficiency) for this special 510(k) submission, nor does it report specific device performance results against such criteria. The "Technology Characteristics" table (starting on page 3) compares general technical specifications (weight, dimensions, power supply, etc.) between the predicate and proposed device, noting they are largely the same or that updates (like software version) do not alter fundamental technology.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not applicable / Not provided. No test set data or study details are provided in this special 510(k) submission.
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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):
- Not applicable / Not provided. No test set or ground truth establishment is described.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable / Not provided. No adjudication method for a test set is described.
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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 / Not provided. This device is a high permeability hemodialysis system, not an AI diagnostic imaging tool that would typically involve human readers.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable / Not provided. Performance data, whether standalone or with human-in-the-loop, is not presented. The software updates are described as "performing the same functions as the predicate software."
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The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- Not applicable / Not provided. No ground truth is described because no performance study is detailed.
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The sample size for the training set:
- Not applicable / Not provided. No training set for an algorithm is discussed in the context of performance. This special 510(k) is about software updates for an existing device.
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How the ground truth for the training set was established:
- Not applicable / Not provided. No ground truth for a training set is described.
Summary of Device Performance and Acceptance Criteria (Based on the Document's Content):
Since this is a special 510(k) for software and labeling updates, the "acceptance criteria" and "proof" primarily revolve around demonstrating that these changes do not alter the fundamental scientific technology or the intended use and that the device continues to meet safety requirements of UL and EMC standards.
The key "performance" metrics implicitly accepted for this submission are the equivalence of the updated software's functions to the predicate, and that the physical and functional characteristics remain substantially similar.
Table of Acceptance Criteria and Reported Device Performance (as inferred from the document's purpose):
| Acceptance Criteria (Stated/Implied) | Reported Device Performance (Summary from Document) |
|---|---|
| Maintain Intended Use | The proposed device has the "same intended use." (Page 3) |
| Maintain Indications for Use | The proposed device has the "same indications for use." (Page 3) |
| Maintain Fundamental Scientific Technology | The proposed device has the "same fundamental scientific technology with the exception of the algorithm improvements." The algorithms perform the "same functions" as the predicate software. (Page 3) |
| Maintain Hardware Equivalence | The proposed device has the "same hardware." (Page 3) |
| Software Performs Same Functions | "updated software (6.02.00) performing the same functions as the predicate software (version 6.00.04)." (Page 3). The submission mentions "a summary of design control activities and risk/hazard analysis for software changes is presented." (Page 4). |
| Maintain Performance Specifications | The proposed device has the "same performance specifications." (Page 3). However, specific performance metrics are not detailed in this 510(k) summary; they are referenced as being contained in the predicate's 510(k) summary (K070320). |
| Meet Safety Requirements (UL and EMC standards) | The device "continues to meet the safety requirements of UL and EMC standards." (Page 3) |
| Physical Dimensions and Characteristics (No significant change) | "No physical change" to dimensions, "Same as predicate" for weight, scales, fluid warmer, pressure monitoring, degassing unit, monitor/detection parameters. Minor change in power supply range and fluid management (50ml syringe only vs. 30ml/50ml on predicate). (Page 3) The modified device's maximum measured power consumption (350W) is lower than the predicate's theoretical value (500VA). (Page 3) |
The study that "proves" the device meets these criteria is essentially the design control activities and risk/hazard analysis for software changes (Page 4) referenced in the document, which confirm that the modifications do not negatively impact safety or effectiveness or alter the fundamental technology and intended use, thus maintaining substantial equivalence. No separate performance study is described or provided in this special 510(k).
§ 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.”