(26 days)
All INSPIRE oxygenators - the three subject devices (i.e., the INSPIRE 7 Hollow Fiber Oxygenator with Integrated Hardshell Venous/Cardiotomy Reservoir, the INSPIRE 7M Hollow Fiber Oxygenator and the INSPIRE 7 Fiber Oxygenator with Hardshell Dual Hollow Integrated Venous/Cardiotomy Reservoir), as well as the three predicate devices (i.e., the INSPIRE 8 Hollow Fiber Oxvgenator with Integrated Hardshell Venous/Cardiotomy Reservoir, the INSPIRE 8M Hollow Fiber Oxygenator and the INSPIRE 8 Dual Hollow Fiber Oxygenator with Integrated Hardshell Venous/Cardiotomy Reservoir) - are intended for use in adult and small adult surgical procedures requiring cardiopulmonary bypass. They all provide gas exchange support and blood temperature control and are intended to be used for 6 hours or less.
The devices are used during cardiopulmonary bypass surgery to remove carbon dioxide, provide oxygenation and control blood temperature. They consist of the following main components:
- a heat exchanger consisting of a bundle of polyurethane hollow ● fibers that are wound on a cylindrical core;
- . an oxygenating module element made of a coiled bundle of polypropylene microporous hollow fibers rolled on the heat exchanger sub assembly.
- a hardshell venous/cardiotomy reservoir to collect, filter, and send . venous blood and suction blood to the oxygenator (only models INSPIRE 8/8DUAL and INSPIRE 7/7DUAL).
The heat exchanger consists of a bundle of polyurethane hollow fibers rolled on a cylindrical core. The heat transfer is obtained through the flow of water inside the fibers and the flow of blood outside them. The heat exchanger is inserted in the gas exchanger and surrounded by the oxygenating module element, which is constructed of a coiled bundle of polypropylene microporous hollow fibers rolled on the heat exchanger sub assembly. The blood path is around the outside of the fibers, while the gas path is through the lumen of the fibers. In the versions 8/8DUAL and 7/7DUAL the oxygenator module is integrated with a hardshell/venous reservoir via a molded fitting joint.
The hardshell/venous reservoir is comprised of rigid polycarbonate housing. Venous and cardiotomy filtering systems are physically distinct to allow a good filtration efficiency of venous and suction blood (one filters venous blood, the other filters suction blood). The reservoir is provided with a vent/vacuum port together with an over-under valve that prevents excess of negative or positive pressure, avoiding implosion and over pressurization of the reservoir itself. The blood enters the reservoir through the cardiotomy section through the rotating turret equipped with 3/8", 1/4" and female luer inlet connectors and through the venous inlet 1/2" connector provided with female luer connector. Both cardiotomy turret and venous inlet connectors can rotate 360°. The reservoir lid has also additional unfiltered luer ports.
The oxygenating module of all the INSPIRE oxygenators include a dedicated outlet with a one way valve that provides access to arterial blood throughout the procedure for cardioplegia, perfusion or blood concentration. The outlet is placed close to the arterial outlet of the oxygenator and opposite to the temperature probe port. Arterial and venous temperature probe sites are also provided: the former is located close to the arterial blood outlet, while the latter is placed on the venous inlet of the reservoir.
This 510(k) summary does not contain information about studies for acceptance criteria or device performance as it pertains to AI/ML or diagnostic image analysis. Instead, it describes a medical device (cardiopulmonary bypass oxygenator) and its substantial equivalence to predicate devices based on fundamental scientific technology and intended use.
Therefore, I cannot provide the requested information regarding:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set and data provenance.
- Number of experts used to establish ground truth and their qualifications.
- Adjudication method for the test set.
- MRMC comparative effectiveness study results (effect size).
- Standalone (algorithm only) performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
This document focuses on the regulatory submission for a physical medical device, not a diagnostic AI/ML system.
§ 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.”