(90 days)
The Renaflo® II HF 2000 Hemofilter is intended for use in patients with fluid overload, uremia and/or electrolyte disturbances associated with oligoanuria acute renal failure. It may also be used when removal of excess fluid is indicated, such as patients in pulmonary edema or congestive heart failure refractory to diuretic therapy.
The Minntech Renaflo® II HF 2000 Hemofilter is made of glycerin-free, microporous, hollow fiber, polysulfone membrane encased in a polycarbonate housing having molded ultrafiltration ports and polycarbonate blood port header caps.
While the document provides a 510(k) summary for the Renaflo II HF 2000 Hemofilter, it does not contain the detailed information required to answer your specific questions about acceptance criteria and how a study proved the device meets them.
The document states that "The following performance testing was conducted to determine device effectiveness as a hemofilter: Ultrafiltration Rate vs. Transmembrane Pressure, Pressure Drop vs. Blood Flow Rate, Protein Rejection, Minimum Blood Flow Rate & Blood Path Integrity." However, it does not provide the acceptance criteria for these tests, nor does it present the actual test results or details about the study design.
Therefore, I cannot provide the information requested in your numbered points.
To answer your questions, I would need a document that includes:
- Specific numerical acceptance criteria for each performance metric (e.g., "Ultrafiltration Rate must be X ml/hr/mmHg ± Y%").
- Reported performance values from the testing conducted.
- Details about the test set: actual values from the tests conducted, and a description of the test conditions and methods.
- Information about training data (if applicable to a machine learning context, which this device is not): This device is a physical medical filter, not an AI/ML diagnostic tool, so concepts like "test set," "training set," "ground truth experts," or "adjudication methods" as typically applied to AI studies are not relevant here.
The provided document is a regulatory submission demonstrating substantial equivalence to a predicate device, which usually involves comparing specifications and performance (often indirectly by demonstrating similar design and materials, and then showing new device meets established performance characteristics, which are usually not fully disclosed in summaries like this). It is not a detailed clinical or performance study report.
§ 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.”