(92 days)
The OLpūr™ HD 190 Dialyzer is indicated for hemodialysis and hemodiafiltration of patients with acute or chronic renal failure.
The OLpur"M HD 190 Dialyzer is a sterile, non-pyrogenic, single use, high permeability hemodialyzer intended to be used in providing hemodiafiltration to patients with acute or chronic renal failure. This dialyzer is designed for use only with UF controlled dialysis equipment and is compatible with all models of this generic type of equipment currently in use in the US. The individual dialyzers are packaged in a pouch constructed of Polyamide/Polyethylene film and a Tyvek® backing. The individually packaged dialyzers are packaged twelve to a carton and thirty-six to a shipping container. The dialyzer membranes used in this device consist of polyethersulfone (PES). The hollow fiber membranes are potted in a polyurethane compound at each end within a polycarbonate dialyzer casing to form a tubesheet. A polycarbonate blood inlet header attached to the end of the casing directs the incoming blood into the hollow fibers. The blood then flows through the inside of the hollow fibers and exits out through the polycarbonate blood outlet header attached to the other end of the casing. Inlet and outlet dialysate (Hansen) ports on the dialyzer casing allow for the flow of dialysate around the outside of the hollow fibers counter-current to the blood flow. Uremic toxins and excess plasma water are removed from the blood across the semi-permeable hollow fibers. A combination of diffusion, due to the concentration differences between the blood and dialysate, and convection, due to the transmembrane pressure differential across the hollow fibers, leads to the toxin removal. The spent dialysate exits the device via the dialysate outlet port. As received by the customer, the dialyzer's blood and dialysate ports are covered with polyethylene sterility caps. Silicone o-rings are included in the connections between the headers and the dialyzer tubesheet at each end of the dialyzer to provide a fluid-tight seal between the headers and the tubesheet.
The provided text is a 510(k) summary for the Nephros OLpūr™ HD 190 Dialyzer. It focuses on demonstrating substantial equivalence to predicate devices based on nonclinical testing (biocompatibility, sterility, pyrogenicity, shelf life, and in vitro performance).
Crucially, this document does not contain information about a study proving the device meets acceptance criteria related to a specific performance metric like diagnostic accuracy with human readers or a standalone algorithm performance. It describes a medical device (a dialyzer), not an AI/ML-driven diagnostic or image analysis tool.
Therefore, I cannot fulfill most of your request regarding acceptance criteria, study design, sample sizes, ground truth establishment, expert involvement, or MRMC comparative effectiveness, as these concepts are not applicable to the information provided in this 510(k) summary.
However, I can extract information relevant to the device's performance based on the nonclinical testing described:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implicitly based on predicate equivalence) | Reported Device Performance (Summary) |
|---|---|---|
| Biocompatibility | Equivalent to predicate devices | Testing supported substantial equivalence |
| Sterility | Equivalent to predicate devices | Testing supported substantial equivalence |
| Pyrogenicity | Equivalent to predicate devices | Testing supported substantial equivalence |
| Shelf Life | Equivalent to predicate devices | Testing supported substantial equivalence |
| In vitro Performance | Effective as a High Flux Hollow Fiber Hemodialyzer, comparable to predicate devices (e.g., clearance, ultrafiltration rates, etc.) | Testing supported substantial equivalence, device effective as a High Flux Hollow Fiber Hemodialyzer. |
The rest of the requested information cannot be provided from the given document:
- Sample sizes for test set and data provenance: Not applicable/not provided. The "test set" here refers to the dialyzer units themselves used for nonclinical testing, not patient data for an AI algorithm.
- Number of experts and qualifications for ground truth: Not applicable. Ground truth for a dialyzer involves lab measurements and existing standards, not expert clinical interpretation as would be for an AI diagnostic.
- Adjudication method: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable. This is for AI-assisted human performance in diagnostic tasks.
- Standalone (algorithm only) performance: Not applicable. This is a medical device, not an algorithm.
- Type of ground truth used: For in vitro performance, the ground truth would be established by controlled laboratory measurements and standard test methods for dialyzers, compared against the specifications or performance of predicate devices. For biocompatibility/sterility/pyrogenicity, it would be based on established international standards and test protocols.
- Sample size for the training set: Not applicable. This is not an AI/ML model.
- How the ground truth for the training set was established: Not applicable.
§ 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.”