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510(k) Data Aggregation
(125 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 Edwards Aquarius System needs to be used in conjunction with a tubing set and a filter to provide Hemofiltration treatment to the patient.
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.
Acceptance Criteria and Device Performance for Edwards Aquarius System
The Edwards Aquarius System is an Automated Fluid Balance Monitor designed for extracorporeal treatments in renal replacement therapies or plasma therapies. The device's performance was evaluated against a set of specifications to demonstrate substantial equivalence to predicate devices (Baxter Accura System, Gambro Prisma System, B. Braun Diapact).
1. Acceptance Criteria and Reported Device Performance
The provided document details various performance specifications for the Edwards Aquarius System. The study supporting these claims is described as "Bench Testing."
| Parameter | Acceptance Criteria (Low Blood Flow) | Reported Device Performance (Low Blood Flow) | Acceptance Criteria (Regular Blood Flow) | Reported Device Performance (Regular Blood Flow) |
|---|---|---|---|---|
| Fluids Management | ||||
| Pump accuracy | ±5% | ±5% (Implied, as reported performance matches criteria) | ±5% | ±5% (Implied, as reported performance matches criteria) |
| Blood Flow | 10 to 200 ml/min by 2 ml/min | 10 to 200 ml/min by 2 ml/min | 30 to 450 ml/min by 10 ml/min | 30 to 450 ml/min by 10 ml/min |
| Pre-dilution | 0-100 to 6000 ml/h | 0-100 to 6000 ml/h | 0-100 to 10000 ml/h | 0-100 to 10000 ml/h |
| Post-dilution | 0-100 to 4000 ml/h | 0-100 to 4000 ml/h | 0-100 to 10000 ml/h | 0-100 to 10000 ml/h |
| Dialysate (CVVHD only) | 0-100 to 10000 ml/h | 0-100 to 10000 ml/h | 0-100 to 10000 ml/h | 0-100 to 10000 ml/h |
| Filtrate | 0-100 to 11000 ml/h | 0-100 to 11000 ml/h | 0-100 to 12000 ml/h | 0-100 to 12000 ml/h |
| Net fluid loss | 0-10 to 1000 ml/h by 1 ml | 0-10 to 1000 ml/h by 1 ml | 0-10 to 2000 ml/h | 0-10 to 2000 ml/h |
| Heparin pump accuracy | ± 0.2 ml/h | ± 0.2 ml/h | ± 0.2 ml/h | ± 0.2 ml/h |
| Heparin pump settings | 0-15 ml/h by 0.5 ml/h | 0-15 ml/h by 0.5 ml/h | 0-15 ml/h by 0.5 ml/h | 0-15 ml/h by 0.5 ml/h |
| Heparin syringe size | 30 or 50 ml | 30 or 50 ml | 30 or 50 ml | 30 or 50 ml |
| Bolus function | 0.5 to 2.5 ml by 0.5 ml bolus increment | 0.5 to 2.5 ml by 0.5 ml bolus increment | 0.5 to 2.5 ml by 0.5 ml bolus increment | 0.5 to 2.5 ml by 0.5 ml bolus increment |
| Scales | ||||
| Fluid balance alarm | 20g | 20g | 50g | 50g |
| Substitution scale capacity (max. load) | 0-30kg (max. load: 23kg) | 0-30kg (max. load: 23kg) | 0-30kg (max. load: 23kg) | 0-30kg (max. load: 23kg) |
| Filtrate scale capacity (max. load) | 0-30kg (max. load: 23kg) | 0-30kg (max. load: 23kg) | 0-30kg (max. load: 23kg) | 0-30kg (max. load: 23kg) |
| Fluid Warmer | ||||
| Accuracy | ± 0.3 °C | ± 0.3 °C | ± 0.3 °C | ± 0.3 °C |
| Working range | Off or 35°C to 39°C by 0.5°C | Off or 35°C to 39°C by 0.5°C | Off or 35°C to 39°C by 0.5°C | Off or 35°C to 39°C by 0.5°C |
| Pressure Monitoring | ||||
| Sensor accuracy | ± 5 mmHg | ± 5 mmHg | ± 5 mmHg | ± 5 mmHg |
| Access Pressure | -250 to +200 mmHg | -250 to +200 mmHg | -250 to +200 mmHg | -250 to +200 mmHg |
| Return Pressure | -50 to +350 mmHg | -50 to +350 mmHg | -50 to +350 mmHg | -50 to +350 mmHg |
| Pre-filter Pressure | -150 to +500 mmHg | -150 to +500 mmHg | -150 to +500 mmHg | -150 to +500 mmHg |
| Filtrate Pressure | -250 to +400 mmHg | -250 to +400 mmHg | -250 to +400 mmHg | -250 to +400 mmHg |
| Degassing unit Pressure | -300 to +30 mmHg | -300 to +30 mmHg | -300 to +30 mmHg | -300 to +30 mmHg |
| Gas removal Max. | 10 ml/min | 10 ml/min | 10 ml/min | 10 ml/min |
| Monitor / Detection Parameters | ||||
| Blood leak detector | 2 or 4 ml blood/1l filtrate at HCT 32% | 2 or 4 ml blood/1l filtrate at HCT 32% | 2 or 4 ml blood/1l filtrate at HCT 32% | 2 or 4 ml blood/1l filtrate at HCT 32% |
Note: The reported device performance aligns perfectly with the acceptance criteria as presented, which is typical for a summary demonstrating compliance. The "Bench Testing" section explicitly states "This concludes that the two machines [Edwards Aquarius and Baxter Accura] have substantially equivalent performance," indicating the Edwards Aquarius met these criteria.
2. Sample size used for the test set and the data provenance
The document specifies "Comparative bench testing" was conducted using the Edwards Aquarius System and the Baxter Accura System, along with an Edwards Aqualine Sterile Tubing Set K063293.
- Sample size: The specific number of tests or runs performed during the bench testing is not explicitly stated in the provided text.
- Data provenance: The testing appears to be internal lab testing ("bench testing"). The parent company, Edwards Lifesciences, is based in Germany, and the device has been "marketed and developed in Europe for six years," suggesting the testing was likely conducted in Europe. The document does not specify if the data is retrospective or prospective, but bench testing typically involves prospective data collection under controlled conditions.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This device is a medical machine with performance specifications related to fluid management, pressure monitoring, temperature control, and detection of operational issues (e.g., blood leak). The ground truth for such technical performance is established through engineering and calibration standards, not typically through expert consensus from medical professionals. The document does not mention any expert review process for establishing the ground truth of the technical specifications.
4. Adjudication method for the test set
Not applicable. As described above, the ground truth for performance specifications in bench testing is based on engineering standards and measurements, not subjective expert judgment that would require 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. The Edwards Aquarius System is a hardware medical device (Hemofiltration System) and does not involve AI or human "readers" in its primary function, nor does it generate diagnostic images requiring interpretation. The study mentioned is a "comparative bench testing" for performance against a predicate device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a Hemofiltration System, a medical machine, not an algorithm. Bench testing evaluates the machine's inherent functionality and performance characteristics.
7. The type of ground truth used
The ground truth used for the performance parameters would be absolute physical measurements and engineering specifications. For example, a pump's accuracy is measured against known flow rates, scales are calibrated against known weights, and temperature sensors are verified against standard temperature references. The document explicitly mentions "Bench Testing" and "Electrical Safety and Electromagnetic Compatibility: Testing has been conducted following the IEC 60601 series of standards," further supporting the use of objective technical standards as ground truth.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI-driven device, so there is no concept of a "training set" in the context of its performance validation. The device is validated based on its physical design and adherence to manufacturing and performance specifications.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device.
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