(88 days)
Synthesis Ph.I.S.I.O. is a sterile, nonpyrogenic device 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 m. SYNTHESIS Ph.I.S.I.O. is an adult oxygenator intended for use in operations on adult patients. SYNTHESIS Ph.I.S.I.O. must not be used for longer than 6 hours. Contact with blood for longer periods is inadvisable.
Synthesis M Ph.I.S.I.O. 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 filter element to eliminate gas emboli and remove blood component aggregates larger than 40 µm. Synthesis M Ph.I.S.I.O. is an adult oxygenator intended for use in operations on adult patients. Synthesis M Ph.I.S.I.O. must not be used for longer than 6 hours. Contact with blood for longer periods is inadvisable.
Synthesis R Ph.I.S.I.O. has been specifically designed for cardiovascular procedures requiring cardiopulmonary by-pass. It collects venous blood and it defoams, filters and stores the blood from the operating field through thoracic, intracardiac and general suction. Synthesis R Ph.I.S.I.O. can be used postoperatively for chest drainage. It is suggested not to use Synthesis R Ph.I.S.I.O. for more than 6 hours,
Synthesis C Ph.I.S.I.O. 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 µm. Synthesis C Ph.I.S.I.O. is an adult oxygenator intended for use in operations on adult patients. Synthesis C Ph.I.S.I.O. must not be used for longer than 6 hours. Contact with blood for longer periods is inadvisable,
SYNTHESIS Ph.I.S.I.O. Adult Membrane Oxygenator With Integrated Arterial Filter and Hardshell Venous/Cardiotomy Reservoir with PhosphoryIcholine (Ph.I.S.I.O.) hereinafter called the SYNTHESIS Ph.I.S.I.O., 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. The SYNTHESIS Ph.I.S.I.O. (and other modified versions) have been modified for the change in coating material applied to the arterial filter and for some ergonomic and cosmetic enhancements. The arterial filter of the device is now coated with a new coating containing the same phosphorylcholine monomer currently used for coating of the device. No modification to the intended use has been made as result of the modifications.
The provided text describes a medical device, the SYNTHESIS Ph.I.S.I.O. Adult Oxygenator, and its clearance through a 510(k) submission. This type of submission relies on demonstrating substantial equivalence to a predicate device, rather than a full clinical trial with acceptance criteria and a human-in-the-loop study as would be seen for AI/ML devices.
Therefore, many of the requested sections pertaining to AI/ML device studies (such as sample size for test sets, ground truth establishment, expert adjudication, MRMC studies, standalone performance, training set size) are not applicable to this document because it describes a physical medical device (an oxygenator) and its regulatory clearance process, not a software-based diagnostic or therapeutic AI/ML device.
However, I can extract information related to the device's performance and the testing conducted to demonstrate its substantial equivalence to a predicate device, which serves a similar function to acceptance criteria and demonstration of meeting them.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The "acceptance criteria" for this device are primarily based on demonstrating substantial equivalence to the predicate device (SYNTHESIS MIMESYS) and meeting established specifications outlined in relevant ISO standards and FDA guidances. The performance is reported in terms of meeting these specifications and comparability to the predicate.
| Acceptance Criteria / Performance Metric | Reported Device Performance |
|---|---|
| Biocompatibility: | |
| Hemolysis | Met established specifications |
| Hemocompatibility (including thrombosis & blood compatibility) | Met established specifications (new coating biocompatible) |
| Cytotoxicity | Met established specifications |
| Irritation | Met established specifications |
| Acute Systemic Toxicity | Met established specifications |
| Mutagenicity | Met established specifications |
| Sterility | Met established specifications (production techniques effective) |
| Pyrogenicity | Met established specifications (device non-pyrogenic) |
| ETO residuals | Met established specifications |
| Package integrity | Met established specifications (shipping carton provided adequate protection) |
| In Vitro Performance (Arterial Filter Characterization): | |
| Priming Efficiency | Met established specifications |
| Pressure Drop | Met established specifications |
| Hemolysis/Cell Depletion | Met established specifications |
| Visual Inspection | Met established specifications |
| Filtration Efficiency | Met established specifications |
| Air Handling | Met established specifications |
| Structural Integrity | Met established specifications |
| Pressure Integrity | Met established specifications |
| In Vitro Performance (Stability of Coating): | |
| Leaching Flaking of Coating | Met established specifications |
| Cracking of Coating | Met established specifications |
| In Vitro Performance (Hardshell Cardiotomy/Venous Reservoir Characterization): | |
| Breakthrough Time and Volume | Met established specifications |
| Graduated Scale Accuracy | Met established specifications |
| Hemolysis/Cell Depletion | Met established specifications |
| Filtration Efficiency | Met established specifications |
| Overall Comparison to Predicate Device: | |
| Technological characteristics, operating principles, and materials | Essentially identical, characteristics comparable |
| Performance (gas transfer, operating blood volumes, heat exchanger, PC coating | Performance is equivalent to predicate device |
| uniformity, softshell reservoir, residual blood volume, defoaming capacity) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify exact sample sizes for each in vitro test. It generally refers to "a complete battery of tests" and "the device was aged up to 3 (+1 year considered as a worst case) was tested for...". For comparative purposes, "the same testing, when applicable, has been conducted also on the SYNTHESIS MIMESYS predicate device."
- Data Provenance: The testing was conducted in vitro, in accordance with international standards (ISO 10993-1:1995, ISO 15675:2001, ISO 15674:2001) and FDA guidances ("Guidance for Cardiopulmonary Bypass Arterial line Blood Fitter 510(k) Submission," "Guidance for Blood Extracorporeal Blood Circuit Defoamer 510(k) Submission"). The country of origin of the data is not explicitly stated but implied to be from the manufacturer's testing facilities, likely in Italy (Sorin Group Italia S.r.l.). The data is retrospective in the sense that it's laboratory testing results rather than dynamically generated patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. This pertains to an AI/ML device relying on expert-labeled data for ground truth. This document describes a physical medical device and its laboratory performance testing, which does not typically involve experts establishing a "ground truth" in the same way as, for example, image interpretation. The "truth" is established by the performance against pre-defined engineering and safety specifications within the testing standards.
4. Adjudication Method for the Test Set
- Not applicable. No adjudication method, such as 2+1 or 3+1, is mentioned because this is not a study involving human interpretation or subjective assessment that would require 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. This is not an AI/ML device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This is not an AI/ML device.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" here is the adherence to pre-defined engineering specifications, safety parameters, and performance benchmarks as established by relevant international standards (ISO 10993, ISO 15675, ISO 15674) and FDA guidances. The device's performance is compared against these objective criteria and shown to be substantially equivalent to a predicate device that also meets these criteria. For example, "Hemolysis... met established specifications" means the measured hemolysis fell within the acceptable range defined by the standard.
8. The Sample Size for the Training Set
- Not applicable. This is not an AI/ML device that requires a training set in the machine learning sense.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. This is not an AI/ML device.
§ 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.”