Search Results
Found 1 results
510(k) Data Aggregation
(284 days)
PS 15 POLYSULFONE HOLLOW FIBER MEMBRANE HEMODIALYZER, MODEL 239-015
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 |
Ask a specific question about this device
Page 1 of 1