(189 days)
The membrane oxygenator QUADROX-i Neonatal is intended for use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery. It is designed for a blood flow rate of 0.2 - 1.5 //min and is intended for the treatment of pediatric (neonate and infant) patients. Within the specified flow rate range, the device oxygenates the blood, removes carbon dioxide and regulates the blood temperature.
The QUADROX-i Neonatal (HMO 11000) model with integrated arterial filter also filters air bubbles and particles larger than 33 um.
The utilization period of this device is restricted to six hours.
Responsibility for deciding whether to use an oxygenator rests solely with the attending physician.
The QUADROX-i Neonatal Oxygenator is a blood-gas exchanger with integrated heat exchanger and optional integrated arterial filter, intended for the treatment of neonate and infant patients. The Oxygenator is designed for a blood flow range from 0.2 to 1.5 Ilmin. Since these patients have a very small blood volume of their own, the small priming volume of the oxygenator is an important parameter. The priming volume is 38 ml for the version without integrated arterial filter. The version with integrated arterial filter has a priming volume of 40 ml.
The effective gas exchange surface is 0.38 m²; the one for the heat exchanger is 0.07 m². The integrated arterial filter is composed of a planar area from a woven 33 micron filter. The filter surface is 20 cm2.
The blood contacting surfaces are coated with SOFTLINE coating or with BIOLINE Coating.
The QUADROX-i Neonatal oxygenator is a sterile and non-pyrogenic device, for single use only and is not to be re-sterilized by the user.
The provided text describes a 510(k) premarket notification for the QUADROX-i Neonatal Microporous Membrane Oxygenator. This document is for a medical device that performs oxygenation, carbon dioxide removal, and temperature regulation for neonatal and infant patients during cardiopulmonary bypass. It does not contain information related to an AI/ML device or a software-as-a-medical-device (SaMD). Therefore, I cannot extract the requested information regarding acceptance criteria and studies for an AI/ML device.
The document discusses the following:
- Device Description: QUADROX-i Neonatal Oxygenator, a blood-gas exchanger with integrated heat exchanger and optional integrated arterial filter for neonate and infant patients.
- Intended Use: Extracorporeal circulation during cardiopulmonary bypass in cardiac surgery for pediatric (neonate and infant) patients, with a blood flow rate of 0.2 - 1.5 l/min.
- Predicate Devices: Several previously cleared oxygenators and arterial filters.
- Non-clinical Testing: Compliance with ISO 10993-1 (Biologic Evaluation), ISO 7199 (Oxygenators), and ISO 15675 (Arterial line blood filters).
- Determination of Substantial Equivalence: Based on indications for use, integrity, performance, biocompatibility, and sterility compared to predicate devices.
§ 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.”