(34 days)
The INSPIRE 6M is intended for use in adult surgical procedures requiring cardiopulmonary bypass (CPB). It provides gas exchange support and blood temperature control. The INSPIRE 6M is intended to be used for 6 hours or less.
The INSPIRE 7M is intended for use in adult surgical procedures requiring cardiopulmonary bypass (CPB). It provides gas exchange support and blood temperature control. The INSPIRE 7M is intended to be used for 6 hours or less.
The INSPIRE 8M is intended for use in adult surgical procedures requiring cardiopulmonary bypass (CPB). It provides gas exchange support and blood temperature control. The INSPIRE 8M is intended to be used for 6 hours or less.
The INSPIRE 6M, INSPIRE 7M and INSPIRE 8M oxygenators (hereinafter identified as INSPIRE) consist of an oxygenator with an integrated heat exchanger.
The INSPIRE devices 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 consist of the following main components
- a heat exchanger consisting of a bundle of polyurethane hollow fibers that are wound on a cylindrical core. it controls blood temperature and allows the use of hypothermia or aids in the maintenance of normothermia during surgery.
- an oxygenating module element made of a coiled bundle of polypropylene microporous hollow fibers rolled on the heat exchanger sub assembly. The hollow fiber membrane provides oxygenation and carbon dioxide removal from venous blood or suction blood.
The modified devices are modified versions of the currently marketed INSPIRE 6M, INSPIRE 7M and INSPIRE 8M products.
The provided documents describe the Inspire 6M, 7M, and 8M Hollow Fiber Oxygenators, which are modifications of previously cleared devices. The submission focuses on demonstrating substantial equivalence to the predicate devices, rather than proving that the device meets acceptance criteria as would typically be done for a novel device. The primary change is the replacement of a purge line unidirectional valve.
Therefore, the study focuses on showing that the modified device performs equivalently to the unmodified predicate device, rather than establishing absolute performance metrics against a defined set of acceptance criteria for a new device.
Here's the information extracted from the document, tailored to your request, with an emphasis on the equivalence study:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria for this specific submission. Instead, it relies on demonstrating that the modified device performs equivalently to the predicate devices, which are already presumed to meet established safety and effectiveness criteria. The acceptance is based on the modified device successfully meeting performance expectations in comparison to the unmodified (predicate) device.
| Performance Metric Demonstrated | Acceptance Criteria (Implied by equivalence to predicate) | Reported Device Performance (Modified device vs. Unmodified predicate) |
|---|---|---|
| Recirculation Line Handling (specifically related to the purge line unidirectional valve) | System successfully handles recirculation line operation, including gas exchange support and blood temperature control, as per predicate performance. | The oxygenating module with the modified purge line unidirectional valve successfully met all acceptance criteria for the recirculation line handling. (This implies it performed equivalently to the unmodified device). |
| All other relevant functional parameters (e.g., gas exchange, blood temperature control) | Equivalent to predicate device. | The results of in vitro studies demonstrate that the subject INSPIRE performs in a manner substantially equivalent to the Unmodified INSPIRE predicate device with respect to the relevant functional parameters. |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size: The document implies that "devices" were tested, but it does not specify the exact number of modified and unmodified devices used in the in vitro testing.
- Data Provenance: The study was retrospective in the sense that it compared a modified device to an existing predicate. The testing itself was in-vitro. The country of origin of the data is not specified, but the applicant is Sorin Group Italia S.r.l. in Italy, suggesting the testing likely occurred there or at a contract lab.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. This was an in-vitro performance study comparing a modified medical device component to its predecessor, not a diagnostic or AI-driven study requiring expert interpretation or ground truth establishment in the traditional sense.
4. Adjudication Method for the Test Set
Not applicable. This was an in-vitro performance study. "Adjudication" typically refers to resolving disagreements among experts in establishing ground truth for diagnostic studies, which is not relevant here.
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. This is not an AI/diagnostic device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/diagnostic device.
7. The Type of Ground Truth Used
The "ground truth" for this study was the established performance of the predicate (unmodified) devices as assessed through their own previous regulatory clearances and real-world usage. The study aimed to demonstrate that the modified device's performance was equivalent to this established "ground truth." The specific tests (e.g., for recirculation line handling, gas exchange, temperature control) are based on performance standards for cardiopulmonary bypass oxygenators (ISO 7199, FDA guidances).
8. The Sample Size for the Training Set
Not applicable. This is not an AI device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
§ 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.”