(171 days)
The Prismaflex is indicated for the following use:
- continuous solute and/or fluid removal in patients with acute renal failure or fluid overload
All treatments administered by the Prismaflex must be prescribed by a physician.
The Prismaflex System is an acute renal failure treatment device for removal of waste products, restoration of acid-base balance, correction of electrolyte imbalances (eg, hyperkalemia), patient fluid balance, nutritional support, and other conditions in which fluid removal is needed. The system consists of a control unit and a sterile disposable set with a hemofilter/dialyzer. Prismaflex offers four Continuous Renal Replacement Therapy (CRRT) options: Slow Continuous Ultrafiltration (SCUF), Continuous Veno-venous Hemofiltration (CVVH), Continuous Veno-venous Hemodialysis (CVVHD), and Continuous Veno-venous Hemodiafiltration (CVVHDF).
SCUF - Provides fluid removal by ultrafiltration.
CVVH - Provides convective solute clearance by hemofiltration. Can provide net fluid removal if desired.
CVVHD - Provides solute clearance by hemodialysis. Can provide net fluid removal if desired.
CVVHDF - Provides solute clearance by both convection and diffusion. Can provide net fluid removal if desired.
The Prismaflex performs the following functions related to the administration of supported therapies:
- Automatically loads the Gambro Cartridge blood tubing/hemofilter set.
- Primes the Gambro Cartridge set. Automatic or Manual priming may be done. Automatic priming also provides the Gambro Cartridge-specific settings for UFR, priming volume and other process parameters. Manual priming allows the operator to manually select and control these priming parameters.
- Pumps blood through the blood flowpath of the Gambro Cartridge and delivers anticoagulant to the blood flowpath. Anticoagulant may be delivered continuously from an anticoagulant-filled syringe loaded into the syringe pump or via infusion using the Pre-Blood Pump infusion pump.
- Controls fluid removal from the patient. Calculates and controls the effluent pump rate required to achieve the current patient Fluid Removal Rate set by the operator from various inputs including the dialysate and/or replacement pump flow(s).
- Delivers sterile replacement solution from pre-prepared bags.
- Pumps dialysate solution from pre-prepared bags.
- Monitors, displays, and charts treatment data.
- Monitors the system and alerts the operator to abnormal situations through alarms. An alarm is indicated by the alarm name and appropriate control buttons appearing on the machine display; by a red or yellow alarm light; and by an audible alarm (beeping sound).
- Provides automatic rinseback of blood in the Gambro Cartridge, if desired. If enabled, Auto Rinseback controls the blood pump rate and saline volume pumped, according to preset values. Manual Rinseback can also return blood, where the operator controls the blood pump and saline volume.
- Records patient prescription data on a removable storage media.
The provided document is a 510(k) premarket notification for a medical device (Gambro Prismaflex™ System) and does not contain information about a study proving the device meets specific acceptance criteria in the context of an AI/ML model for diagnostic or predictive purposes.
Instead, the document describes the regulatory approval process for a medical device that performs continuous renal replacement therapy (CRRT). The "acceptance criteria" and "study" mentioned in the document relate to the device's engineering specifications, safety standards, and performance to ensure it functions as intended for patient treatment.
Therefore, I cannot populate the requested table and answer the study-related questions (2-9) in the context of an AI/ML model. The information present focuses on:
- Device Description: What the Prismaflex System does and its different therapeutic modes (SCUF, CVVH, CVVHD, CVVHDF).
- Technological Characteristics: General comparison to predicate devices regarding flow rates, pressures, and anticoagulation.
- Non-Clinical Tests: Verification and validation against design specifications and adherence to international safety and quality standards (e.g., IEC 60601 series, IEC 14971, ISO/IEC 12207, ISO 10993-1, AAMI/ISO 1135). These tests confirm the device's electrical safety, electromagnetic compatibility, software lifecycle processes, risk management, and the biocompatibility and sterility of the disposable sets.
- Clinical Tests: Stated as "Not applicable," meaning a separate clinical trial for the device's effectiveness or safety in a human population beyond what was needed for predicate equivalence was not required for this 510(k) submission. For medical devices, substantial equivalence to a legally marketed predicate device is often established through non-clinical performance testing without new clinical studies.
In summary, the document addresses the regulatory approval of a hardware medical device, not an AI/ML diagnostic or predictive tool.
§ 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.”