(88 days)
The Inspire 7F M is intended for use in adult surgical procedures requiring cardiopulmonary bypass. It provides gas exchange support and blood temperature control. The integrated arterial filter provides additional protection against air and solid emboli. The Inspire 7F M is intended to be used for 6 hours or less.
The Inspire 7F is intended for use in adult and small adult surgical procedures requiring cardiopulmonary bypass. It provides gas exchange support and blood temperature control. The integrated arterial filter provides additional protection against air and solid emboli. The Inspire 7F is intended to be used for 6 hours or less.
The Inspire 7F Dual is intended for use in adult surgical procedures requiring cardiopulmonary bypass. It provides gas exchange support and blood temperature control. The integrated arterial filter provides additional protection against air and solid emboli. The Inspire 7F Dual is intended to be used for 6 hours or less.
The INSPIRE 7F M, INSPIRE 7F and INSPIRE 7F Dual oxygenators (hereinafter identified as INSPIRE 7F) are intended for use in adult and small adult surgical procedures requiring cardiopulmonary bypass (CPB). It provides gas exchange support and blood temperature control.
The INSPIRE 7F 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.
- Hardshell venous/cardiotomy reservoir to collect, filter, . and send venous blood and suction blood to the oxygenator (only models INSPIRE 7F/ 7F DUAL)
- Arterial filter: the integrated arterial filter surrounds the . oxygenating module and has been designed with a specific geometry that provides protection against air and solid emboli.
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. For the versions 7F/ 7F DUAL 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- underll 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 3/8ll, 1/4ll and female luer inlet connectors and through the venous inlet 1/2ll connector provided with female luer connector. Both cardiotomy turret and venous inlet connectors can rotate 360°. The reservoir lid also has additional unfiltered luer ports
The integrated arterial filter has a toroidal shape and a 38 um linear filter screen. It is molded to the shell of the oxygenator. It has been designed with a specific geometry that provides protection against air and solid emboli. The arterial filter has a twocompartment design, including pre- and post- filter chambers. Each one of the two compartments is provided with a dedicated purge site that enhances air purging. The pre-filter chamber removes air bubbles trapped by the filter screen. The post-filter collection chamber is located at the top of the filter and allows air bubble collection of the air dragged through the filter screen. In case of massive air embolism, the air bubbles can be removed through the purge sites located both in the pre- and post- filter collection chamber
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.
The provided text describes a 510(k) premarket notification for the INSPIRE 7F series of hollow fiber oxygenators. This submission aims to demonstrate substantial equivalence to previously cleared predicate devices. The document explicitly states that no clinical performance data was conducted in support of the INSPIRE 7F Oxygenator series. The evaluation of the device relied solely on non-clinical performance data to ensure it meets safety and effectiveness requirements.
Therefore, the following information regarding the acceptance criteria and study that proves the device meets the acceptance criteria is based on in vitro testing and not on a clinical study involving human subjects or AI performance.
1. Table of Acceptance Criteria and Reported Device Performance
The document states that "The INSPIRE 7F met all acceptance criteria for each of the tests listed in the table below." However, the exact acceptance criteria values for each test are not explicitly provided in the given text. It only lists the tests performed. The table below represents the tests conducted with a general statement of compliance.
| Test Title | Test Classification | Reported Device Performance |
|---|---|---|
| Oxygenating module structural integrity | Physical/Mechanical | Met acceptance criteria |
| Oxygenating module blood, water, gas pathway integrity | Physical/Mechanical | Met acceptance criteria |
| Oxygenating module blood volume capacity | Functional/Performance | Met acceptance criteria |
| Oxygenating module heat exchange performance/water side pressure drop | Functional/Performance | Met acceptance criteria |
| Oxygenating module gas transfer performance/blood side pressure drop | Functional/Performance | Met acceptance criteria |
| Oxygenating module air handling capability | Functional/Performance | Met acceptance criteria |
| Oxygenating module filtration efficiency | Functional/Performance | Met acceptance criteria |
| Oxygenating module blood trauma (hemolysis and blood compatibility) | Functional/Performance | Met acceptance criteria |
| Oxygenating module leaching of coating | Functional/Performance | Met acceptance criteria |
| Integrated device flaking of coating | Functional/Performance | Met acceptance criteria |
| Oxygenating module uniformity of coating | Functional/Performance | Met acceptance criteria |
| Flow rate capacity | Functional/Performance | Met acceptance criteria |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample size for each in vitro test. The data provenance is stated as non-clinical performance data (bench testing), conducted in accordance with relevant ISO standards and FDA guidance documents. The country of origin of the data is not explicitly stated, but the applicant is Sorin Group Italia S.R.L., Mirandola, Italy, suggesting the testing likely occurred in Italy or a certified lab. The testing is considered prospective as it was conducted to demonstrate the safety and effectiveness of the new device formulation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This was an in vitro, non-clinical study for a medical device (oxygenator) and not an AI/imaging device requiring expert interpretation for ground truth establishment. The "ground truth" for these tests would be established by physical measurements and adherence to engineering specifications and regulatory standards.
4. Adjudication Method for the Test Set
Not applicable. This was an in vitro, non-clinical study for a medical device (oxygenator) and not an AI/imaging device requiring expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
Not applicable. No MRMC study was conducted as this is not an AI/imaging device. The study focused on the physical and functional performance of a medical device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is not an AI algorithm; it is a physical medical device. The "standalone" performance refers to the device's functional characteristics as measured in vitro.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
The "ground truth" for the non-clinical performance data was based on:
- Established engineering specifications and design requirements for oxygenators.
- Compliance with international standards such as ISO 10993-1 (biocompatibility), ISO 7199 (Blood-gas exchangers), and relevant FDA guidance documents.
- Physical measurements and laboratory analyses to quantify performance characteristics (e.g., blood flow, pressure drop, heat exchange, filtration efficiency, material properties).
8. The Sample Size for the Training Set
Not applicable. This is not an AI model requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This is not an AI model requiring a training set.
§ 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.”