(52 days)
The Hollow Fibre Membrane Oxygenator HMO 1010 is intended for use in an extracorporeal perfusion circuit to oxygenate blood and remove carbon dioxide and to temper blood during short duration cardiopulmonary bypass procedures lasting 6 hours or less.
The Hollow Fibre Membrane Oxygenator Quadrox HMO 1010 is a blood gas exchanger with integrated heat exchanger. In open heart surgery it is used in an extracorporeal perfusion circuit first to oxygenate blood and remove carbondioxide second to regulate the blood temperature during short duration cardiopulmonary bypass procedures lasting 6 hours or less.
The oxygenation system is principally based on microporous polypropylene hollow fiber membranes. The heat exchanger is made of thight polyethylene fibers. The QUADROX consists of two membrane compartments. In the first chamber of the oxygenator, sheets of heat exchanger fibers and sheets of microporous oxygenation fibers are arranged crosswise. In the second chamber only sheets of the oxygenation fibers are arranged.
Blood enters the housing via the inlet connector and is distributed into a pre-chamber. Then the blood streams through the membrane package. In the first section it is tempered and oxygenated. In the second part only oxygenation and removal of carbondioxide takes place.
Positioned and integrated at the top of the oxygenator is a de-airing membrane. This membrane is a hydrophobic membrane allowing only gaseous substances to pass through the membrane but fluids are held back. The de-airing membrane allows easier priming, deairing and elimination of air throughout the whole procedure. To prime the oxygenator the Luer cap has to be removed. It should be kept open during perfusion to eliminate air continuously.
Acceptance Criteria and Device Performance for Jostra Medizintechnik AG Hollow Fibre Membrane Oxygenator Quadrox HMO 1010
This document outlines the acceptance criteria and performance data for the Hollow Fibre Membrane Oxygenator Quadrox HMO 1010, based on the provided 510(k) summary. The device was found to be substantially equivalent to the Affinity Hollow Fiber Oxygenator by Avecor Cardiovascular, Inc.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by the substantial equivalence determination to the predicate device. The performance data for the Quadrox HMO 1010 are compared to the predicate device's specifications.
| Parameter | Acceptance Criteria (Predicate Device: Affinity Hollow Fiber Oxygenator) | Reported Device Performance (Quadrox HMO 1010) |
|---|---|---|
| Membrane Type | Microporous Polypropylene Hollow Fibers | Microporous Polypropylene Hollow Fibre |
| Membrane Surface Area | $2.5 m^2$ | $1.8 m^2$ |
| Static Priming Volume | 270 ml | 250 ml |
| Recommended Blood Flow Rate | 1-7 liters/minute | 0.5-7 liters/minute |
| Maximum Water Side Pressure | 30 psi | 14 psi |
| Material of Heat Exchanger | Stainless steel | Polyethylene |
| Arterial Outlet Port | 3/8" | 3/8" |
| Venous Inlet Port | 3/8" | 3/8" |
| Arterial Sample Port | Female Luer Port | Luer-Port |
| Recirculation Port | 1/4" | 1/4" |
| Gas Inlet Port | 1/4" | 1/4" |
| Gas Outlet Port | 3/8" non-barbed | 1/4" |
| Water Ports | ½" quick disconnects | ½" Quick-Connect Fittings (Hansen) |
| Method of Sterilization | unknown | Ethylene Oxide |
| Use | Single-use device | Single-use device |
| Biocompatibility | Biocompatible and non-toxic | Biocompatible and non-toxic |
| Sterility Assurance Level (SAL) | 10-6 | 10-6 |
| EtO Residuals (Ethylene Oxide) |
§ 870.4350 Cardiopulmonary bypass oxygenator.
(a)
Identification. A cardiopulmonary bypass oxygenator is a device used to exchange gases between blood and a gaseous environment to satisfy the gas exchange needs of a patient during open-heart surgery.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for Cardiopulmonary Bypass Oxygenators 510(k) Submissions.”