(85 days)
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.
| Acceptance Criteria (Implied by Predicate Performance) | Reported Device Performance (Prismaflex® v5.10) |
|---|---|
| Dialysate Flow Rate Accuracy | ± 30 ml/hr |
| Replacement Flow Rate Accuracy | ± 30 ml/hr |
| Blood Flow Rate Accuracy (CRRT) | ±10% of user set point |
| Blood Flow Rate Accuracy (TPE) | ±10% of user set rate (if inlet pressure > -250 mmHg, outlet pressure |
§ 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.”