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The Aquadex FlexFlow® System is indicated for:

Continuous ultrafiltration therapy for temporary (up to 8 hours) or extended (longer than 8 hours in patients who require hospitalization) use in adult and pediatic patients weighing 20 kilograms or more whose fluid overload is unresponsive to medical management, including diuretics.

All treatments must be administered by a healthcare provider, within an outpatient clinical setting, under physician prescription, both of whom having received training in extracorporeal therapies.

The Aquadex FlexFlow system comprises the following components:

• . Aquadex FlexFlow console, microprocessor-controlled
• . Blood Circuit Set with integral hemofilter, disposable
• . Venous access catheter

The Aquadex FlexFlow console includes a blood pump, ultrafiltrate pump, control panel, weight scale, air detector, blood leak detector, electrical connectors for the circuit pressure sensors, and mechanical interfaces that hold the circuit in place. The console controls the rate at which the blood pump removes blood from the patient, and the clinician sets the maximum rate at which the ultrafiltrate pump extracts ultrafiltrate from the blood. Patient access is obtained either peripherally or through the central venous veins. Blood is withdrawn from a vein and passes through a withdrawal pressure sensor before entering the blood pump tubing loop. The rotating rollers propel the blood through the the air detector, then into the hemofilter before being returned to the patient. The console screen displays information to help the clinician prime, set up, and operate the system. All system alarm limits are set by the console.

The Aquadex FlexFlow blood circuit is a preassembled, sterile (EtO), single-patient use set. There are two models of the blood circuit: A06162 and A06163. The blood circuit set A06162 consists of a filter, tubing, pressure sensors, connectors, pinch clamps, a priming spike, an ultrafiltrate connecting bag and data key. The blood circuit set A06163 has the same components, except that it also has an inline blood chamber for use in monitoring the patient's hematocrit (Hct) during therapy.

CHF Solutions Inc. offers a dual lumen extended length catheter (dELC) for use with the Aquadex FlexFlow System. The catheter is a peripheral venous access device with stainless steel coil reinforcement. The venous access catheter was not reviewed in K192756 as it was already cleared for safe and effective use under K041791 with no changes since the original clearance affecting its safety and effectiveness.

The provided text describes acceptance criteria and the study conducted to prove the device, the Aquadex FlexFlow System 2.0, meets these criteria.

1. Table of Acceptance Criteria and Reported Device Performance

Device: Aquadex FlexFlow System 2.0

2. Sample Size and Data Provenance for the Test Set

The reported clinical data for the clarified indication for use (which seems to function as the "test set" for real-world performance) comes from:

• Sample Size: 93 Aquadex blood circuits were used on 26 pediatric patients (21 years or younger) weighing 20 kilograms or more from 28 hospitalizations.
• Data Provenance: This was a retrospective study conducted in three centers (countries not specified, but likely within the US given FDA submission). The study was performed by investigators independent of the manufacturer.

For the bench performance testing comparing the Aquadex systems and Prismaflex, the "test set" details are not explicitly given as a patient count but involved "all three systems" being tested "at the same therapy settings" to derive a direct comparison of fluid removal accuracies. This implies a controlled laboratory environment rather than patient data for this specific comparison.

3. Number of Experts and Qualifications for Ground Truth for the Test Set

For the retrospective clinical study:

• The text does not explicitly state the number of experts used to establish ground truth or their specific qualifications (e.g., radiologist with 10 years of experience).
• However, it does mention that "All treatments must be administered by a healthcare provider, within an outpatient clinical setting, under physician prescription, both of whom having received training in extracorporeal therapies." This implies that the initial assessment and treatment decisions were made by qualified healthcare professionals and physicians. The independent investigators who analyzed the retrospective data would also be experts in their field.

4. Adjudication Method for the Test Set

The adjudication method is not explicitly stated in the provided text. For the retrospective clinical study data, it's implied that the clinical outcomes were observed and reported, but a formal adjudication process (like 2+1 or 3+1 for discrepancies) by a panel of experts is not described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done. The device is a physical medical device (ultrafiltration system), not an AI-powered diagnostic tool that assists human readers. Therefore, the concept of "how much human readers improve with AI vs without AI assistance" does not apply here.

6. Standalone (Algorithm Only) Performance

Not applicable. The Aquadex FlexFlow System 2.0 is a medical device for ultrafiltration therapy, not an algorithm. Its performance is evaluated through its physical function, accuracy, and clinical outcomes, not as an "algorithm only" product. Bench testing was performed on the device itself, not a separate algorithm.

7. Type of Ground Truth Used

• For the bench performance testing (fluid removal accuracy), the ground truth was based on measured actual ultrafiltration amount in a controlled laboratory setting.
• For the retrospective clinical study, the ground truth was based on clinical outcomes data (treatment course survival, hospital survival, complications, adverse events) as observed and recorded by healthcare providers during routine patient care.

8. Sample Size for the Training Set

The document does not mention a training set as this product is a physical medical device and not an AI/ML algorithm that requires training data. The study primarily focuses on verifying the device's performance against specifications and clinical safety/effectiveness.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as no training set (in the context of AI/ML) is mentioned or implied.

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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.

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.

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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."

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.

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