(168 days)
The single use dialyzer with pre-attached blood tubing set is indicated for use with the Fresenius 2008 Series Hemodialysis systems for the treatment of acute and chronic renal failure.
The proposed device provides for the treatment of acute or chronic renal failure when used with the commercially available Fresenius 2008 Series hemodialysis systems. The device is a single use high flux (permeability) hollow-fiber dialyzer pre-attached to a blood tubing set.
The provided text describes a 510(k) premarket notification for the NxStage® Streamline Express for Fresenius 2008 Series Hemodialysis Systems. This submission focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study with a test set, expert ground truth, or a multi-reader, multi-case study. Therefore, many of the requested criteria cannot be directly extracted from the provided document.
Here's a breakdown of what can and cannot be answered:
1. A table of acceptance criteria and the reported device performance
The document provides a comparative table of technological characteristics and in-vitro performance between the proposed device and predicate devices. The acceptance criteria are implicitly that the proposed device should have "Same" or comparable performance to the predicate devices, as well as meeting general safety and performance standards for hemodialysis components.
| Parameter | Acceptance Criteria (Implicit: "Same" as predicate in K113023) | Reported Device Performance (NxStage Streamline Express) |
|---|---|---|
| Dialyzer | ||
| Number of fibers | 10,900 ± 200 | Same |
| Fiber internal diameter | 200 μm | Same |
| Fiber wall thickness | 30 μm | Same |
| Fiber length | 23 cm | Same |
| Effective surface area | 1.6 m² | Same |
| Priming volume | 91 ml | Same |
| Max. Transmembrane Pressure | 500 mmHg | Same |
| In-vitro Performance | ||
| Pressure Drop Blood Compartment |
§ 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.”