(87 days)
The PrisMax 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 PrisMax control unit must be prescribed by a physician.
The PrisMax System is intended for Continuous Renal Replacement Therapy (CRRT) for patients with acute renal failure and/or fluid overload. 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. PrisMax System offers four Continuous Renal Replacement Therapy (CRRT) options: Slow Continuous Ultrafiltration (SCUF), Continuous Veno-Venous Hemofiltration (CVVH), Continuous VenoVenous Hemodialysis (CVVHD), and Continuous Venovenous Hemodialfiltration (CVVHDF). The proposed device PrisMax System Version 3 uses the current marketed device PrisMax System Version 2 as the predicate.
This document is a 510(k) Pre-market Notification for a medical device, the PrisMax System Version 3. The document aims to demonstrate that the new device is substantially equivalent to a legally marketed predicate device (PrisMax System Version 2), and therefore does not require a new premarket approval application (PMA).
Here's an analysis of the provided information regarding acceptance criteria and the supporting study, organized by your requested points:
Acceptance Criteria and Device Performance
The acceptance criteria are implicitly defined by the technical specifications outlined in the "Substantial Equivalence Summary" tables (Table 3), comparing the PrisMax System Version 3 to the predicate PrisMax System Version 2. The reported device performance is stated as meeting these specifications, thereby achieving "substantial equivalence" to the predicate.
Table 1: Acceptance Criteria and Reported Device Performance
| Feature | Acceptance Criteria (Predicate PrisMax Version 2) | Reported Device Performance (PrisMax Version 3) |
|---|---|---|
| Indications for Use | Continuous Renal Replacement Therapy (CRRT) for patients ≥ 20 kg with acute renal failure/fluid overload; Therapeutic Plasma Exchange (TPE) for patients ≥ 20 kg where plasma component removal is indicated. All treatments by physician prescription. | Identical to predicate. |
| Dedicated Disposable Sets Available | For CRRT: M60/M100/M150, HF1000 & HF1400; For TPE: TPE 2000 Set. | Identical to predicate. |
| Syringe Sizes | 20 & 50 ml | Identical to predicate. |
| Anticoagulation | User-controllable (continuous or bolus) | Identical to predicate. |
| Dialysate Flow Rate (CVVH & CVVHDF) | Range: 0 to 8000 ml/hr, Increment: 10 ml/hr | Identical to predicate. |
| Dialysate Flow Rate Accuracy | ± 30 ml/hr | Identical to predicate. |
| Replacement solution / Fluid Flow Rate (CVVH & CVVHDF) | Range: 0 to 8000 ml/hr, Increment: 10 ml/hr | Identical to predicate. |
| Replacement solution / Fluid Flow Rate (TPE) | Range: 0 to 5000 ml/hr, Increment: 10 ml/hr | Identical to predicate. |
| Replacement Flow Rate Accuracy | ± 30 ml/hr | Identical to predicate. |
| Blood Flow Rate | Range: 10-450 ml/min | Identical to predicate. |
| Blood Flow Rate Accuracy | ± 10 % of user set rate at nominal blood flow of 450 ml/min or highest achievable disposable blood flow, 37°C, access pressure -200 mmHg, without PBP flow. | Identical to predicate. |
| Pre-Blood Pump Flow Rate (SCUF) | Range: 0 to 2000 ml/hr | Identical to predicate. |
| Pre-Blood Pump Flow Rate (CVVH, CVVHD, CVVHDF) | Range: 0 to 4000 ml/hr | Identical to predicate. |
| Pre-Blood Pump Flow Rate (TPE) | Range: 0 to 1000 ml/hr (Note: PBP Volume 2000 ml/treatment for TPE2000) | Identical to predicate. |
| Pre-Blood Pump Accuracy | ± 30 ml/hr | Identical to predicate. |
| Effluent Pump Flow Rate | Range: 0 to 10,000 ml/h (depending on therapy) | Identical to predicate. |
| ECG Discharger | YES | Identical to predicate. |
| Therapies | SCUF, CVVH, CVVHD, CVVHDF, TPE | Identical to predicate. |
| Pumps | PBP solution, Replacement solution, Dialysate solution, Effluent, Blood. | Identical to predicate. |
| Scales | Dialysate, Replacement, Effluent, Pre Blood Pump (PBP) | Identical to predicate. |
| Trans Membrane Pressure (TMP) Alarms (CRRT) | Default: +300 mmHg | Identical to predicate. |
| TMPa (TPE) | User settable; +50 to +100 mmHg; Default: +100 mmHg | Identical to predicate. |
| Dialysate Conductivity and Temperature Control | Not controlled by PrisMax | Identical to predicate. |
| Patient Fluid Removal (CRRT) Range | 0 to 2000 ml/hr, Increment: 5 ml/hr | Identical to predicate. |
| Patient Fluid Removal (TPE) Range | 0 to 1000 ml/hr, Increment: 5 ml/hr | Identical to predicate. |
| Patient Fluid Removal Performance (Accuracy) | ± 30 ml/hr; ± 70 ml/3hr; ± 300 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.”