(186 days)
The Prismaflex® System is intended for Continuous Renal Replacement Therapy (CRRT) for patients with acute renal failure and/or fluid overload weighing 20 Kilograms or more. All treatments administered via the Prismaflex® must be prescribed via a physician.
The Prismaflex® System is intended for Continuous Renal Replacement Therapy (CRRT) for patients with acute renal failure and/or fluid overload weighing 20 Kilograms or more. All treatments administered via the Prismaflex® must be prescribed via a physician. The goals of acute renal failure treatments are removal of waste products, restoration of acid-base balance; correction of electrolyte imbalances (e.g., hyperkalemia), patient fluid balance, nutritional support, and other conditions in which fluid removal is needed. Prismaflex® System 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 Hemodialfiltration (CVVHDF).
The provided text is a 510(k) summary for the Prismaflex® System 3.20. It details the device's intended use, comparison to a predicate device, and non-clinical testing. However, it does not include the specific information requested about acceptance criteria for device performance studies, such as sample sizes for test and training sets, expert qualifications, ground truth establishment, or any information regarding multi-reader multi-case studies or standalone algorithm performance.
The document states that the non-clinical testing for the Prismaflex® System 3.20 demonstrated its safety and effectiveness and that it "performs as well as or better than the legally marketed predicate device." This implies that the acceptance criteria for the new device were alignment with or improvement upon the performance of the predicate device (Prismaflex™ System 1.04).
Below is a summary of the available information and an explicit statement of what is missing based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
The document implicitly uses the performance of the predicate device as the acceptance criteria for the modified device. The table below compares the specifications of the modified device to the predicate device. For some parameters, the modified device's performance aligns with the predicate, while for others (like Dialysate Flow Rate Accuracy, Replacement Flow Rate Accuracy, Pre-Blood Pump Accuracy, and Patient Fluid Removal Performance Range Accuracy), the modified device states a specific accuracy, which could be considered its performance target (acceptance criteria) and reported performance.
| Parameter | Predicate Device (Prismaflex™ System 1.04) Acceptance Criteria (Implied) | Modified Device (Prismaflex® System 3.20) Reported Performance |
|---|---|---|
| Indications for Use | For continuous solute and/or fluid removal in patients with acute renal failure or fluid overload. | For Continuous Renal Replacement Therapy (CRRT) for patients with acute renal failure and/or fluid overload weighing 20 Kilograms or more. Prescribed by a physician. |
| Dedicated Disposable Sets Available in U.S. | M60/M100, HF1000 & HF1400 | M60/M100, HF1000 & HF1400 |
| Syringe Sizes | 10, 20 & 30 ml | 10, 20, 30 & 50 ml |
| Anticoagulation | User-controllable as continuous or bolus | User-controllable as continuous or bolus |
| Dialysate Flow Rate (CVVHD & CVVHDF) | 0 to 8000 ml/hr (CVVHD), 0 to 4000 ml/hr (CVVHDF); Increment: 50 ml/hr | 0 to 8000 ml/hr; Increment: 50 ml/hr |
| Dialysate Flow Rate Accuracy | ±10% of user-set rate | ± 30 ml/hr |
| Replacement Flow Rate (CVVH & CVVHDF) | 0 to 8000 ml/hr (CVVH), 0 to 4000 ml/hr (CVVHDF); Increment: 50 ml/hr | 0 to 8000 ml/hr; Increment: 50 ml/hr |
| Replacement Flow Rate Accuracy | ±10% of user-set rate | ± 30 ml/hr |
| Blood Flow Rate | 10-450 ml/min. (depends on therapy/set combination) | 10-450 ml/min. (depends on therapy/set combination) |
| Blood Flow Rate Accuracy | ±10% of user set point (maintained under specific pressure conditions) | ±10% of user set point (maintained under specific pressure conditions) |
| Pre-Blood Pump Flow Rate (SCUF) | 0 to 1,000 ml/hr | 0 to 1,000 ml/hr |
| Pre-Blood Pump Flow Rate (CVVH, CVVHD, CVVHDF) | 0 to 8,000 ml/hr | 0 to 8,000 ml/hr |
| Pre-Blood Pump Accuracy | ±10% of user-set rate | ± 30 ml/hr |
| Effluent Pump Flow Rate | 0 to 10,000 ml/hr (depending on therapy) | 0 to 10,000 ml/hr (depending on therapy) |
| ECG Discharger | YES | YES |
| Therapies | SCUF, CVVH, CVVHD, CVVHDF | SCUF, CVVH, CVVHD, CVVHDF |
| Pumps | Blood access line, Dialysate inlet line, Effluent outlet line, Replacement solution line, Pre blood pump line | Blood access line, Dialysate inlet line, Effluent outlet line, Replacement solution line, Pre blood pump line |
| Scales | Dialysate, Replacement, Effluent, Pre blood pump | Dialysate, Replacement, Effluent, Pre blood pump |
| Transmembrane Pressure | User settable: +70 to +300 mmHg; Default: +300 mmHg | User settable: +70 to +300 mmHg; Default: +300 mmHg |
| Dialysate Conductivity and Temperature | Not controlled by Prismaflex | Not controlled by Prismaflex |
| Patient Fluid Removal Performance Range | 0 to 2,000 ml/hr; Increment: 10 ml/hr | 0 to 2,000 ml/hr; Increment: 10 ml/hr |
| Patient Fluid Removal Performance Range Accuracy | ± 30 ml/hr, ± 600 ml/24hr (Scales calibrated at ambient temperature, change |
§ 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.”