(284 days)
The PS 150 Hemodialyzer is intended for hemodialysis in patients with acute or chronic renal failure, when conservative therapy is judged to be inadequate.
The PS 158 Hemodialyzer consists of approximately 13,000 polysulfone hollow fibers encapsulated in polyurethane resin with an outer housing and headers made of Polycarbonate. The device is packaged in a blister package composed of Glycol modified Polyethylene Terephtalate for the bottom web, and a foil laminater for the top web. The PS 15® Hemodialyzer has two compartments, the blood compartment and the dialysate compartment, separated by the polysulfone permeable membrane and and flows from the patient access site through the tubing of the extracorporeal. system and accessories to the blood compartment of the dialyzer. From the blood compartment, undesirable substances in the blood pass through the membrane into the dialysate compartment of the dialyzer. Circulation and monitoring of dialysate into flow through the dialysate compartment is controlled by the dialysate delivery system, while the ultrafiltration controller prevents excessive loss of yeater from the patient's blood.
This document describes the acceptance criteria and study that proves the PS 15® Hemodialyzer meets these criteria. The device is intended for hemodialysis in patients with acute or chronic renal failure.
1. Acceptance Criteria and Reported Device Performance
The PS 15® Hemodialyzer was evaluated against a predicate device, the Altrex 170 Hemodialyzer, and in some functional tests, also against the Fresenius F60 Polysulfone Dialyzer. The acceptance criteria are implicitly defined by demonstrating substantial equivalence to these legally marketed predicate devices through comparable functional and biocompatibility test results.
Table: Acceptance Criteria (as demonstrated by predicate device performance) and PS 15® Hemodialyzer Performance
| Feature/Test | Acceptance Criteria (based on predicate Altrex 170 / Fresenius F60) | PS 15® Hemodialyzer Reported Performance |
|---|---|---|
| Functional Tests | ||
| Total Blood Volume Measured (ml) | Altrex 170: 91 ml; Fresenius F60: 83 ml | 79 ml |
| Effective Membrane Surface Area (m²) | Altrex 170: 1.61 m²; Fresenius F60: 1.25 m² | 1.5 m² |
| Wall Thickness (μ) | Altrex 170: 30 μ; Fresenius F60: 40 μ | 20 μ |
| Maximum TMP | Altrex 170: 500; Fresenius F60: 650 | 500 |
| Clearance (ml/min) - Urea | Altrex 170: 178; Fresenius F60: 185 | 171 |
| Clearance (ml/min) - Creatinine | Altrex 170: 163; Fresenius F60: 172 | 155 |
| Clearance (ml/min) - Phosphate | Altrex 170: 155; Fresenius F60: 170 | 141 |
| Clearance (ml/min) - B12 | Altrex 170: 106; Fresenius F60: 118 | 73 |
| Hemolysis |
§ 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.”