(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.
§ 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.”