(29 days)
The Fresenius Ultraflux dialyzer is designed for single use acute and chronic hemodialysis.
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The presented document is a 510(k) Premarket Notification for the Fresenius Ultraflux Single Use Hemodialyzer. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving a new device's efficacy through a clinical study with detailed acceptance criteria as one might find in a PMA application or for novel software devices.
Here's a breakdown based on the provided text, addressing your questions where possible:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present a formal table of acceptance criteria with specific thresholds for performance metrics. Instead, it states that "In vitro testing was performed to determine the following: priming volume, bloodside and dialysate-side pressure drops, ultrafiltration coefficient, urea clearance, creatinine clearance, Vitamin B12 clearance, phosphate and lysozyme clearance." The acceptance criteria for these tests are implicitly that the Ultraflux dialyzer performs "substantially equivalent" to the predicate devices (Fresenius Optiflux 200NR and Gambro Polyflux 17S) for its intended use.
Therefore, for this device, a direct table of numerical "acceptance criteria" and "reported device performance" in the way you might expect for a diagnostic or AI device is not available in the provided text. The "acceptance criteria" here is met by demonstrating performance equivalent to legally marketed predicate devices through in vitro testing.
2. Sample Size for the Test Set and Data Provenance
- Sample Size for the Test Set: Not explicitly stated in the document. The testing described is "in vitro testing," which generally refers to laboratory bench tests.
- Data Provenance: The data is generated from in vitro testing of the Fresenius Ultraflux hemodialyzers. The document does not specify the country of origin for these specific tests, but it's for a device from "Fresenius Medical Care North America." The testing is analogous to prospective data collection in a lab setting, as the tests are performed on the device itself to assess its characteristics.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable to this 510(k) submission. The ground truth for this medical device is established by its physical and functional characteristics measured through standardized in vitro tests, not by expert consensus on interpretations of data (like medical images).
4. Adjudication Method for the Test Set
Not applicable. There is no "adjudication method" in the context of expert consensus as described for an AI/diagnostic device, since the testing is in vitro and objective.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. An MRMC comparative effectiveness study is not relevant for this type of medical device (a hemodialyzer). This type of study investigates the performance of human readers, sometimes with AI assistance, in interpreting medical data. The hemodialyzer is a therapeutic device, not a diagnostic one involving human interpretation.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. This is not a software algorithm or AI device; it is a physical medical device (hemodialyzer). Its performance is assessed directly through in vitro measurements.
7. Type of Ground Truth Used
The ground truth is based on objective measurements from in vitro testing of the device's physical and functional properties (e.g., priming volume, pressure drops, clearance rates, ultrafiltration coefficient). These measurements are then compared to the known performance characteristics of the predicate devices to demonstrate substantial equivalence.
8. Sample Size for the Training Set
Not applicable. There is no "training set" as this is not a machine learning or AI device that requires training data.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of 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.”