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510(k) Data Aggregation
(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.
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(61 days)
The System 100 is indicated for temporary (up to eight hours) ultrafiltration treatment of patients with fluid overload.
The Aquadex System 100 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.
Here's an analysis of the provided text regarding the Aquadex System 100, focusing on acceptance criteria and the supporting study:
Aquadex System 100 Adjustable Blood Flow Rate - K04-0489
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary does not explicitly state quantitative acceptance criteria or detailed performance metrics from a study related to "adjustable blood flow rate" for the Aquadex System 100.
However, based on the Safety & Performance and Conclusion sections, the implicit acceptance criteria are that the device remains safe and effective for its intended use, specifically with the software change to allow for adjustable blood flow rate and compatibility with various catheters.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Device safety | Demonstrated through bench testing, applying ISO 14971:2000 principles. Data demonstrated the Aquadex System 100 continues to be safe. |
| Device effectiveness | Demonstrated through bench testing. Data demonstrated the Aquadex System 100 continues to be effective. |
| Software change validation | Bench testing was performed to validate the software change. |
| Catheter compatibility | Bench testing generated data in support of the labeling change which incorporates a catheter compatibility chart. |
| Substantial Equivalence | The software revision has been shown to be safe and effective for its intended use, making it substantially equivalent to the predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
The document states that "Bench testing was performed". This typically means testing conducted in a laboratory environment, not on human subjects.
- Sample Size for Test Set: Not specified. Bench testing usually involves multiple iterations or units, but a specific number is not provided.
- Data Provenance: The data is generated from bench testing. This implies a controlled laboratory setting. It is not patient or clinical data, and thus, provenance in terms of country of origin or retrospective/prospective is not applicable in the human-clinical sense.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the document. Bench testing typically relies on engineering specifications and validated test methods rather than expert consensus on a "ground truth" derived from human interpretation.
4. Adjudication Method for the Test Set
This information is not applicable/not provided. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies where human readers interpret data (e.g., medical images) and their agreements/disagreements need to be resolved to establish ground truth. Bench testing does not involve such human interpretation for its primary results.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. The study described is bench testing, not a clinical study involving human readers or cases. Therefore, no effect size for human readers improving with AI vs. without AI assistance can be reported.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
The device is a medical system (Aquadex System 100) with proprietary software, not an AI algorithm in the typical sense of standalone performance analysis. The "software change" was validated through bench testing, which evaluates the system's (including its software's) operational performance directly. Therefore, while the software's function was tested, it's not a "standalone performance" study of a diagnostic AI algorithm in the way that term is usually applied.
7. Type of Ground Truth Used
The ground truth for the bench testing would be based on engineering specifications, established physical principles, and measurement standards. For example, if testing blood flow rate, the ground truth would be the accurately measured flow rate using calibrated equipment, compared to the device's reported flow rate under various conditions. For catheter compatibility, the "truth" would be successful and safe operation with different catheters as defined by design specifications. It is not expert consensus, pathology, or outcomes data.
8. Sample Size for the Training Set
This information is not applicable/not provided. The "software change" was validated through bench testing. This typically involves software verification and validation activities against requirements, rather than an AI model "training set."
9. How the Ground Truth for the Training Set was Established
This information is not applicable/not provided for the same reasons as point 8. The concept of a "training set" and establishing ground truth for it is relevant to machine learning/AI models, which is not the nature of the described software validation.
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