(14 days)
Synthesis Mimesys is intended for use in cardiopulmonary bypass circuits as substitute for the lungs (transfer of oxygen and removal of carbon dioxide), to control the arterial/venous temperature, and as venous blood reservoir and filter element to eliminate gas emboli and remove blood component aggregates larger than 40 um. Synthesis Mimesys is an adult oxygenator intended for use in operations on adult patients. Synthesis Mimesys must not be used for longer than 6 hours. Contact with blood for longer periods is inadvisable.
SYNTHESIS MIMESYS Adult Membrane Oxygenator With Integrated Arterial Filter and Hardshell Venous/Cardiotomy Reservoir Mimesys treated is a high efficiency microporous hollow fiber membrane oxygenator integrated with a heat exchanger and an arterial filter and connected to a hardshell cardiotomy venous reservoir.
Here's an analysis of the provided text to extract the acceptance criteria and study information for the Dideco S.p.A. Synthesis Mimesys Hollow Fiber Oxygenator:
Acceptance Criteria and Device Performance
The provided document describes the SYNTHESIS MIMESYS Adult Membrane Oxygenator and its substantial equivalence to predicate devices. The acceptance criteria for this device are primarily demonstrated through in vitro testing and biocompatibility assessments, aligning with established industry standards and FDA guidance. The reported device performance indicates that the SYNTHESIS MIMESYS met these established specifications.
Table 1: Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test/Requirement | Acceptance Metric (Implied) | Reported Device Performance |
|---|---|---|---|
| Biocompatibility | Hemolysis | Met established specifications | Results met established specifications |
| Cytotoxicity | Met established specifications | Results met established specifications | |
| Irritation | Met established specifications | Results met established specifications | |
| Acute Systemic Toxicity | Met established specifications | Results met established specifications | |
| Mutagenicity | Met established specifications | Results met established specifications | |
| Sterility | Met established specifications | Results met established specifications | |
| Pyrogenicity | Met established specifications | Results met established specifications | |
| ETO residuals | Met established specifications | Results met established specifications | |
| Package Integrity | Met established specifications | Results met established specifications | |
| In Vitro Performance | Operating Blood Volume | Met established specifications | Results met established specifications |
| Mechanical Integrity | Met established specifications | Results met established specifications | |
| Connection Testing | Met established specifications | Results met established specifications | |
| Pressure Drop | Met established specifications | Results met established specifications | |
| Arterial Filter Characterization | Met established specifications | Results met established specifications | |
| Hemolysis/Cell Depletion | Met established specifications | Results met established specifications | |
| Softshell Venous Reservoir Microembolic Activity | Met established specifications | Results met established specifications | |
| Filtration Efficiency | Met established specifications | Results met established specifications | |
| Uniformity Test | Met established specifications | Results met established specifications | |
| Flaking/Leaching | Met established specifications | Results met established specifications | |
| Functional Performance | Gas Transfer Studies | Comparable to predicate device | Characteristics comparable to SYNTHESIS predicate |
| Heat Exchanger Performance | Comparable to predicate device | Characteristics comparable to SYNTHESIS predicate | |
| Venous Cardiotomy Characterization | Comparable to predicate device | Characteristics comparable to SYNTHESIS predicate | |
| Coating Performance | Phosphorylcholine (PC) coating Biocompatibility & Functionality | Biocompatible and functional equivalent to predicate device coating | Biocompatible and functional, equivalent to SYNTHESIS predicate device |
Study Details
The provided text describes a submission for a 510(k) premarket notification, which focuses on demonstrating substantial equivalence to legally marketed predicate devices. This is not a study designed to prove the device meets pre-defined acceptance criteria in the same way a clinical trial might, but rather to show it performs as safely and effectively as existing devices.
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Sample sizes used for the test set and data provenance:
- Test Set (In Vitro): The document references testing performed on the "device aged up to 3 years." It does not specify the exact number of devices tested in the in vitro studies.
- Data Provenance: The studies are described as "in vitro testing" carried out in accordance with FDA guidance and ISO standards. The location of these labs is not explicitly stated, but the manufacturer is Dideco S.p.A. in Italy, suggesting the primary testing was likely conducted in Europe or by contracted labs. The data is retrospective in the sense that it refers to testing of the manufactured product.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This type of information (expert review for ground truth) is not applicable to this submission, as it relates to a medical device's engineering and biological performance rather than diagnostic accuracy.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods are typically employed in clinical studies or imaging-based diagnostic trials where expert consensus is needed to establish ground truth for a subjective assessment. This submission relies on objective, measurable performance characteristics.
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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:
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic tools, not for a hollow fiber oxygenator.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a medical device, not an algorithm. Its performance is assessed independently of human operators for its intrinsic function.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the in vitro tests was established by pre-defined specifications and established scientific and engineering standards (e.g., ISO 10993-1:1995 for biocompatibility, ISO 7199 (1996) and FDA guidances for oxygenators for performance). For biocompatibility, this involves laboratory analysis against toxicity thresholds. For in vitro performance, it involves direct measurement of physical and physiological parameters against engineering targets.
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The sample size for the training set:
- Not applicable. This submission is for a physical medical device. There is no "training set" in the context of machine learning algorithms for this product. The design and manufacturing processes are refined through engineering development and testing, not algorithmic training.
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How the ground truth for the training set was established:
- Not applicable for the reasons stated above.
§ 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.”