(942 days)
The SAFE MINI hollow fibre oxygenator is intended for use in an extracorporeal circuit to oxygenate and remove carbon dioxide from blood and to regulate the blood temperature during cardiopulmonary bypass procedures up to 6 hours in duration.
The SAFE MINI venous/cardiotomy reservoir is intended for use with an oxygenator in an extracorporeal circuit to store venous return blood and filter and defoam intra-thoracic suction blood prior to returning it to the extracorporeal circuit.
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The provided text is a 510(k) premarket notification letter from the FDA to Polystan AS for their SAFE MINI Membrane Oxygenator with Integrated Heat Exchanger. It states that the device is substantially equivalent to legally marketed predicate devices and is thus cleared for marketing. However, the document does not contain any information regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert qualifications for a study proving the device meets acceptance criteria.
The letter explicitly states the Indications For Use for the device:
- SAFE MINI hollow fibre oxygenator: intended for use in an extracorporeal circuit to oxygenate and remove carbon dioxide from blood and to regulate the blood temperature during cardiopulmonary bypass procedures up to 6 hours in duration.
- SAFE MINI venous/cardiotomy reservoir: intended for use with an oxygenator in an extracorporeal circuit to store venous return blood and filter and defoam intra-thoracic suction blood prior to returning it to the extracorporeal circuit.
To answer the request, information from a separate study report or regulatory submission, which is not part of this document, would be required.
§ 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.”