(239 days)
The device is indicated for patients who undergo cardiopulmonary bypass surgery requiring extracorporeal circulation for six hours or less with a maximum blood flow rate of 4 liters/minute. PATIENT POPULATION: Pediatric / small adults.
AMG PMP PEDIATRC is an oxygenator used to exchange gases between blood and gaseous environment to satisfy the gas exchange needs of a patient during open-heart surgery. It is composed by PMP (Polymethylpentene) hollow fiber membrane with an integrated heat exchanger. It is provided together with the accessories that are the gas line and the convenience kit. Oxygenator module, AMG PMP PEDIATRIC consist of three path, blood path, water path. These three paths, thanks to the particular configuration, allow the bloodtemperature control and gas exchange. The device center consists stainless steel tubes that allow the control of the temperature of the blood. The exchange of heat is between the water (with controlled temperature) that flows outside of steel tubes and the blood that flows inside the steel tubes. The device is surrounded by an outer compartment that contains a microporous membrane of Polymethy|pentene (PMP) consisting of capillary allow fibers that allows gas exchange. The air from the gas mixer is rich in O2 and follows the gas path. It enters through the gas inlet port on the top of the device, goes through microporous PMP fibers and exits from gas escape port, at the same time blood flows outside the microporous fibers. The design of heat exchangers for cooling and rewarming blood in the oxygenator utilizes a biologically inert surface to achieve the desired rate of heat exchange without producing any localized overheating of the blood.
The provided text is a 510(k) Summary for the AMG PMP PEDIATRIC device and primarily focuses on demonstrating substantial equivalence to predicate devices rather than detailing a specific study proving the device meets acceptance criteria. However, it does list the types of performance tests conducted and states that the device met safety and performance requirements.
Here's an attempt to derive the requested information based on the provided text, acknowledging that much of it is not explicitly stated in detail:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table with specific numerical acceptance criteria and corresponding reported device performance values. It generally states that the device "met the safety and performance requirements." It does, however, indirectly compare some technical features to predicate devices, which implies an expectation for performance within a similar range.
| Performance Characteristic | Acceptance Criteria (Implied/General) | Reported Device Performance (Implied/General) |
|---|---|---|
| Blood cell damage | Acceptable levels (as per ISO 7199 & FDA guidance) | Met safety and performance requirements |
| Gas transfer rate | Acceptable levels (as per ISO 7199 & FDA guidance) | Met safety and performance requirements |
| Pressure drop | Acceptable levels (as per ISO 7199 & FDA guidance) | Met safety and performance requirements |
| Blood pathway integrity | Maintain integrity (as per ISO 7199 & FDA guidance) | Met safety and performance requirements |
| Heat exchanger fluid pathway integrity | Maintain integrity (as per ISO 7199 & FDA guidance) | Met safety and performance requirements |
| Gas pathway integrity | Maintain integrity (as per ISO 7199 & FDA guidance) | Met safety and performance requirements |
| Blood volume capacity (static priming volume) | Comparable to predicate devices (e.g., ≤200ml for EOS PMP) | 190ml (within comparable range, implying acceptance) |
| Residual blood volume | Acceptable levels (as per ISO 7199 & FDA guidance) | Met safety and performance requirements |
| Blood pathway connectors (tensile strength) | Sufficient strength (as per ISO 7199 & FDA guidance) | Met safety and performance requirements |
| Heat exchanger fluid pathway connectors | Maintain integrity (as per ISO 7199 & FDA guidance) | Met safety and performance requirements |
| Heat exchanger performance evaluation | Efficient heat exchange (as per ISO 7199 & FDA guidance) | Met safety and performance requirements |
| Gas pathway connectors integrity (tensile strength) | Sufficient strength (as per ISO 7199 & FDA guidance) | Met safety and performance requirements |
Study details are not provided in the document for any specific study proving these criteria. The document only lists the types of tests performed.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The text mentions "design verification and validation testing" but does not detail the sample sizes, data provenance, or study design (retrospective/prospective) for these tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the document. The device is a cardiopulmonary bypass oxygenator, not an imaging or diagnostic AI device that would typically involve human expert consensus for "ground truth" in the way described. Its performance is evaluated through engineering and biocompatibility tests against established standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/not provided as the performance evaluation is based on objective measurements against engineering and biological standards, not on subjective interpretations requiring 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
This information is not applicable/not provided. The device is a medical device for extracorporeal circulation, not an AI-assisted diagnostic tool involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable/not provided. The device is an oxygenator, not an algorithm. Its performance is inherent to its physical design and materials, not software.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance evaluation would be established by objective measurements against the requirements set by recognized standards like ISO 7199:2016 and the "Guidance for Cardiopulmonary Bypass Oxygenators 510(k) Submissions; Final Guidance for Industry and FDA Staff, November 13, 2000." These standards specify methodologies and acceptance criteria for measuring parameters like gas transfer, pressure drop, blood cell damage, priming volume, etc.
8. The sample size for the training set
This information is not applicable/not provided. The device is a physical medical device, not an AI model that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable/not provided for the same reason as 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.”