(90 days)
The Fresenius 2008K is indicated for acute and chronic dialysis therapy.
The Fresenius 2008K and the Fresenius 3008 proportion concentrate and prepare and deliver deaerated dialysate fluid at the desired conductivity, temperature and specified pressure. The ultrafiltration control method is identical in both the Fresenius 2008K and the Fresenius 3008. which control ultrafiltration during dialysis by withdrawing a defined volume of fluid from the closed dialysate circuit. The primary difference between the Fresenius 2008K and the 3008 is the new user interface.
The provided text is a 510(k) Premarket Notification for the Fresenius 2008K Dialysate Delivery System. This submission focuses on demonstrating substantial equivalence to a predicate device (Fresenius 3008 Dialysate Delivery System) rather than proving performance against specific acceptance criteria for a new type of diagnostic or AI-powered device.
Therefore, many of the requested categories related to acceptance criteria, study design for performance, ground truth establishment, expert involvement, and AI-specific metrics (like MRMC studies or effect size of AI assistance) are not applicable to this type of regulatory submission.
Here's an analysis based on the available information:
1. A table of acceptance criteria and the reported device performance
- Not Applicable. This 510(k) submission for the Fresenius 2008K Dialysate Delivery System does not establish new performance acceptance criteria in the way a submission for a novel diagnostic or AI device would. Instead, it aims to demonstrate that its performance is equivalent to an already legally marketed predicate device (Fresenius 3008). The "acceptance criteria" are effectively that the new device performs fundamentally the same and for the same intended use as the predicate.
- The document states: "The technological characteristics of the Fresenius 2008K are equivalent to those of the Fresenius 3008. Both the Fresenius 2008K and the Fresenius 3008 proportion concentrate and prepare and deliver deaerated dialysate fluid at the desired conductivity, temperature and specified pressure. The ultrafiltration control method is identical in both the Fresenius 2008K and the Fresenius 3008. which control ultrafiltration during dialysis by withdrawing a defined volume of fluid from the closed dialysate circuit."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. There is no mention of a "test set" in the context of clinical data or patient samples as would be used for a diagnostic device. The evaluation relied on "software validation, functional testing, and release testing" of the device itself.
- The data provenance is industrial testing, not patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. As there is no test set based on clinical cases requiring expert interpretation, no experts were used for this purpose. The device's functionality was evaluated against engineering and design specifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No clinical test set or human adjudication process is described.
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 is not an AI-powered device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an AI-powered device. The device operates independently for its intended function (dialysate delivery).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Operational Ground Truth: The "ground truth" for this device's performance is its ability to correctly proportion concentrate, prepare, and deliver dialysate fluid at specified conductivity, temperature, and pressure, and to perform ultrafiltration control as designed. This is verified through "software validation, functional testing, and release testing" conducted by the manufacturer, rather than clinical outcomes or expert labels.
8. The sample size for the training set
- Not Applicable. This is not a machine learning device, so there is no "training set." The device is built following established engineering principles and validated through testing.
9. How the ground truth for the training set was established
- Not Applicable. There is no training set for this device.
§ 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.”