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The Prismaflex® control unit is intended for:

• Continuous Renal Replacement Therapy (CRRT) for patients weighing 20 kilograms or more with acute renal failure and/or fluid overload.
• Therapeutic Plasma Exchange (TPE) therapy for patients weighing 20 kilograms or more with diseases where removal of plasma components is indicated.
  All treatments administered via the Prismaflex® control unit must be prescribed by a physician.

The Prismaflex control unit is a software controlled device that performs the following functions:

• Loads and primes the Prismaflex disposable set automatically.
• Pumps blood through the blood flow path of the Prismaflex disposable set.
• Delivers anticoagulant solution into the blood flow path.
• Pumps sterile infusion solutions into the blood flow path of the Prismaflex disposable set according to therapy in use.
• Pumps sterile dialysate into the fluid compartment of the filter in CRRT therapies.
• Controls the patient fluid removal or plasma loss according to the therapy in use.
• Monitors the system and alerts the operator to abnormal situations through alarms.
  The Prismaflex® has a touch screen user interface that provides operating instructions.
  The Prismaflex® provides color coding and bar-code identification of the filter sets that are automatically loaded. The Prismaflex continually monitors the operation of the machine and displays one of four (4) types of alarms if an abnormal situation occurs. The Prismaflex® has five (5) pumps that allow multiple therapeutic combinations; including a "pre-blood pump" that allows infusion of a supplemental solution for hemodilution or anticoagulation of the extracorporeal circuit.

The provided text describes a 510(k) submission for the Prismaflex® System, a hemodialysis delivery system. This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving a device meets specific clinical acceptance criteria through a comparative effectiveness study in the same way an AI/ML device might. Therefore, many of the requested elements for an AI/ML study, such as sample size for test sets and training sets, expert qualifications, adjudication methods, and MRMC studies, are not applicable or not provided in the document.

The "acceptance criteria" here are implicitly the performance specifications of the device as compared to its predicate devices, along with compliance with relevant international standards for medical electrical equipment. The "study that proves the device meets the acceptance criteria" is broadly referred to as "Complete software and system verification and validation including functional, performance and safety requirements" and "Compliance has been demonstrated to the following international standards."

Here's the information extracted and adapted to the best extent possible given the nature of the document:

1. Table of Acceptance Criteria (as implied by comparison to predicates) and Reported Device Performance

The device's performance is implicitly evaluated against the predicate devices for key operational parameters. The document focuses on demonstrating that the Prismaflex® (Software Version 5.10) performs similarly to or within acceptable ranges of the predicate devices.

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