(247 days)
The Centrysystem® 3 +plus™ Dialysis Control Unit is indicated for patients in acute or chronic renal failure and when hemodialysis is prescribed by the physician. Both high flux and low flux dialyzers may be used with the Centrysystem® 3 +plus™. The modifications to the Centrysystem® 3 do not significantly affect the intended uses previously claimed for this device. This device is a totally self contained machine that provides the necessary control functions for hemodialysis therapy, including:
- automatically primes the extracorporeal blood circuit (dialyzer and blood tubing set); ●
- . prepares dialysate;
- monitors machine subsystems for proper performance and unsafe conditions; .
- pumps blood, dialysate and anticoagulant at predetermined rates; ●
- controls fluid removal from the patient; and .
- automatically cleans, disinfects and rinses dialysate flow path. .
The Centrysystem Cartridge Blood Tubing Set is intended to be used and an extracorporeal circuit accessory to the Centrysystem® 3 +plus™ Dialysis Control Unit described above.
This device is a totally self contained machine that provides the necessary control functions for hemodialysis therapy, including:
- automatically primes the extracorporeal blood circuit (dialyzer and blood tubing set); ●
- . prepares dialysate;
- monitors machine subsystems for proper performance and unsafe conditions; .
- pumps blood, dialysate and anticoagulant at predetermined rates; ●
- controls fluid removal from the patient; and .
- automatically cleans, disinfects and rinses dialysate flow path. .
The Centrysystem Cartridge Blood Tubing Set is intended to be used and an extracorporeal circuit accessory to the Centrysystem® 3 +plus™ Dialysis Control Unit described above.
I am sorry, but the provided text does not contain the detailed information necessary to complete the request. The documents are a 510(k) clearance letter and an Indications For Use statement for a dialysis control unit. They confirm the device's substantial equivalence to a predicate device and its intended uses, but do not include any acceptance criteria, study details, performance data, sample sizes, expert qualifications, or ground truth information relevant to an AI/ML powered device.
Therefore, I cannot provide the requested table or answer the specific questions about device performance and study methodology based on the input text.
§ 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.”