(176 days)
Hemodialysis with an ELISIO™-H or an ELISIO™-M hemodialyzer is indicated for patients with acute or chronic renal failure when conservative therapy is judged to be inadequate. It also may be indicated in the treatment of patients intoxicated with poisons or drugs.
The device is for prescription use only. This product is intended for single use only. The performance properties of reused dialyzers have not been established.
The ELISIO-H and ELISIO-M hemodialyzers are medical devices used as an artificial kidney system for the treatment of patients with renal failure. 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 ELISIO-H and ELISIO-M dialyzers are composed of polyethersulfone fiber and are available in various sizes, which are differentiated by membrane surface area.
The provided text describes a 510(k) summary for Nipro ELISIO™-H and ELISIO™-M Hemodialyzers, which are medical devices used for hemodialysis in patients with renal failure.
Based on the provided text, there is no information related to acceptance criteria, device performance tables, sample sizes, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone algorithm performance, or training set details.
The document is a regulatory submission (510(k) summary) and primarily focuses on:
- Device Identification: Trade names, classification, common name.
- Device Description: What the device is, how it works, and its components (polyethersulfone fiber membrane, polypropylene casing).
- Intended Use: Conditions for which the device is indicated (acute or chronic renal failure, drug/poison intoxication).
- Technological Aspects and Substantial Equivalence: Comparison to predicate devices, noting the membrane composition is identical and the modification is a change in casing material from polycarbonate to polypropylene. It mentions non-clinical studies for biocompatibility demonstrating substantial equivalence.
- Conclusion: States that testing indicates the ELISIO™-H and ELISIO™-M dialyzers are safe, effective, and perform as well as predicate devices.
- FDA Communication: Formal letter from the FDA granting substantial equivalence.
Therefore, I cannot provide the requested information regarding acceptance criteria, study details, or ground truth establishment as it is not present in the provided text. The document focuses on regulatory approval based on demonstrating equivalence to an existing predicate device, primarily through material changes and biocompatibility testing, rather than detailed performance metrics against specific acceptance criteria.
§ 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.”