(442 days)
The Fresenius On Line Clearance Monitor is a module that is incorporated into the Fresenius 2008H hemodialysis equipment to be used during a dialysis treatment to determine dialyzer clearance efficiency using changes in conductivity of the dialysate solution.
The Fresenius On Line Clearance Monitor is intended to be used as a module with the Fresenius 2008H hemodialysis machine for determination of dialysis treatment urea clearance efficiency using Sodium conductivity as the surrogate solute marker.
The Fresenius On Line Clearance Monitor (OLC) is a module that is incorporated into the Fresenius 2008H hemodialysis equipment. The OLC consists of hardware modifications to the 2008H dialysate fluid circuit which includes a second conductivity probe in the effluent dialysate line and software. The dialyzer clearance determination is made using changes in dialysate conductivity (Sodium concentration). The software either increases or decreases the dialysate conductivity. This change in conductivity causes a sodium concentration gradient to be formed between the blood and dialysate sides of the dialyzer. Sodium is then either diffused into the blood or out of the blood depending whether the dialysate conductivity is high or low. Accurate conductivity readings of the inlet and outlet dialysate solution can be used to calculate the flux of sodium (or change in conductivity because of changes in sodium concentration) in the dialysate. This value can then be used to calculate the dialyzer clearance of sodium. The clearance of sodium has been used as a surrogate dialyzer performance solute since the beginning of dialysis since urea and Sodium (from NaCl) pass through the dialysis membrane at essentially the same rate.
The use of the On Line Clearance Monitor is non invasive and is performed automatically by the hemodialysis equipment with no effect to the patient or action of the operator and minimizes the need for blood based urea analysis and dialyzer performance determination.
The provided text does not contain a specific table of acceptance criteria or details of a study designed to explicitly meet quantitatively defined acceptance criteria for the Fresenius On Line Clearance Monitor.
However, based on the information provided, we can infer the acceptance criteria and study as follows:
Inferred Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Primary Goal: Substantial Equivalence to predicate devices and established methods for determining dialyzer performance. Specifically: |
- Equivalence to equipment adaptors using conductivity for dialyzer performance (K830190, K841153)
- Equivalence to manual invasive blood urea determinations. | Non-Clinical Testing: Statistically significant correlation between clearance values obtained using Sodium (conductivity) as a marker and urea.
Clinical Testing: No difference in clearance determinations between the OLC (using Sodium conductivity) and identical blood-side urea measurements. |
| Operational Impact: Non-invasive, automatic operation with no effect on the patient or operator, minimizing the need for blood-based urea analysis. | The On Line Clearance Monitor is non-invasive and performed automatically by the hemodialysis equipment with no effect to the patient or action of the operator. |
| Mechanism: Utilize conductivity (Sodium concentration) to calculate dialyzer clearance. | The OLC accurately measures inlet and outlet dialysate conductivity to calculate sodium flux, which is then used to calculate dialyzer clearance. |
Study Information
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Sample sizes used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated. The non-clinical testing involved "a number of different dialyzer membranes." The clinical testing used "a modified 2008H hemodialysis machine... clinically to evaluate dialyzer performance during dialysis." Specific patient or case numbers are not provided.
- Data Provenance: Not specified for non-clinical. For clinical testing, it was likely conducted in a clinical setting ("clinically to evaluate dialyzer performance during dialysis"), implying prospective or retrospective data collection from patients undergoing dialysis. Country of origin is not mentioned but can be inferred to be the USA, given the applicant's address.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified. The ground truth was established by comparing the OLC's performance to "identical blood side urea measurements" and "blood urea determinations," which are established clinical methods. It is implied that standard clinical laboratory practices and medical professionals would be involved in obtaining and interpreting these ground truth measurements, but no specific number or qualifications of experts are given for establishing the ground truth for the test set.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- No adjudication method is described. The comparison relies on direct measurements from the OLC versus established clinical methods (blood urea measurements).
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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:
- No MRMC comparative effectiveness study was done. The device (OLC) is an automated monitor, not a diagnostic aid requiring human interpretation of output in the traditional sense of an MRMC study.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, a standalone study was primarily done. The OLC is described as functioning "automatically by the hemodialysis equipment with no effect to the patient or action of the operator." The reported "statistically significant correlation" and "no difference in the clearance determinations" are evaluations of the device's performance directly against established methods.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
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The sample size for the training set:
- Not specified. The document does not describe a distinct "training set" in the context of machine learning model development. This device appears to be based on an algorithmic calculation from physical measurements rather than a machine learning model that would require a distinct training phase.
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How the ground truth for the training set was established:
- As there's no mention of a traditional machine learning training set, the concept of establishing ground truth for it is not applicable here. The device's underlying principles are based on established physiological and engineering principles (sodium/urea diffusion and conductivity).
§ 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.”