(89 days)
The Baxter Meridian machine is part of a high permeability hemodialysis system which consists of a controlled dialysate delivery system that incorporates an ultrafitration controller to prevent excessive loss of water from the patient's blood, an extracomoreal blood set and a high permeability dialyzer. The standard features of the Meridian machine include high blood flow rate capacity (for shortened hemodialysis treatment time), automatic ultrafiltration control, standard nearchardialysis treatment capabilities and automated chemical disinfection. The Meridian machine will operate in either the bicarbonate or acctate mode for concentrates .
The Meridian Hemodialysis Machine is designed to operate in the chronic and acute dialysis environment.
The Baxter Meridian is a single patient hemodialysis instrument that prepares dialysis solution, circulates blood through an extracorporeal circuit of blood tubing and hemodialyzer, and monitors the system for safe operating conditions. Its features include high blood flow rates, automatic ultrafiltration control, variable sodium and bicarbonate dialysis capabilities, and patient prescription entry through a patient data card. Optional features include automated patient blood pressure monitoring, a heparin pump and a sodium administration button.
The provided text does not contain information about acceptance criteria or a study proving that the device meets those criteria. It is a 510(k) summary for the Baxter Meridian Hemodialysis Machine, which focuses on the device's description, intended use, and substantial equivalence to predicate devices, rather than detailed performance study results against specific acceptance criteria.
No information is available regarding:
- A table of acceptance criteria and reported device performance.
- Sample sizes or data provenance for a test set.
- Number and qualifications of experts for ground truth establishment.
- Adjudication method.
- Multi-reader multi-case (MRMC) comparative effectiveness study, or effect size of AI improvement.
- Standalone algorithm performance.
- Type of ground truth used.
- Training set sample size.
- Ground truth establishment for the training set.
§ 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.”