(105 days)
The TandemLung Oxygenator (TLO) is intended to be used for adult patients for extracorporeal circulation during cardiopulmonary bypass in the field of open-heart surgery. Within the indicated flow rates, blood is oxygenated and carbon dioxide is removed. The utilization period of this device is restricted to six hours.
The TandemLung Oxygenator TLO consists of an injection molded exterior shell containing a bundle of Polymethylpentene (PMP) hollow fiber membranes in which blood is oxygenated and decarbonated. Sweep gas, primarily oxygen, is supplied to interior lumens of the fibers and diffuses from the fiber wall to the blood plasma via simple diffusion. Similarly, carbon dioxide diffuses from the blood into the inner lumen of the fibers and is exhausted. Arterialized blood exits out of the blood outlet port and is delivered to the patient.
A two part polyurethane "potting" compound is used to both mechanically fix the end of the hollow fiber membranes in place and to create a barrier between the blood and gas pathways within the TLO.
Use of the TLO requires use of a pump and cannula(s), as well as tubing and connectors/fittings.
This document does NOT contain information about a study based on AI/ML. The provided text is a 510(k) premarket notification for a medical device (TandemLung Oxygenator), which is a physical device, not an AI/ML algorithm. Therefore, I cannot extract the requested information as it pertains to AI/ML study methodologies, acceptance criteria for AI/ML performance, or human-in-the-loop studies involving AI.
The "Performance Data" section explicitly states: "In vitro bench tests were carried out to demonstrate performance and substantial equivalence to the predicate Novalung, according to the requirements of FDAs document 'Guidance for Cardiopulmonary Bypass Oxygenators 510(k) Submission', issued on November 13, 2000. Specifically hemolysis, gas exchange, pressure drop, blood pathway integrity, gas pathway integrity, and physical properties were tested."
This confirms that the testing was for a physical device's performance characteristics, not an AI/ML algorithm.
§ 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.”