(91 days)
The D101 KIDS Infant Hollow Fiber Membrane Oxygenator With Integrated Hardshell Cardiotomy/ Venous Reservoir, is a sterile, nonpyrogenic device intended for use in infants who undergo cardiopulmonary bypass surgery requiring extracorporeal circulation with a maximum blood flow rate of 2.5 liters/minute. It provides oxygenation and carbon dioxide removal from venous or suctioned blood. The integrated heat exchanger provides blood temperature control and allows the use of hypothermia, or aids in the maintenance of normothermia during surgery. The venous reservoir is intended to collect blood aspirated from the operating field during surgical procedures and the blood from patient's veins (gravity or vacuum assisted) during normal operation to assure the proper oxygenation capability of the device. The D101 KIDS should not be used longer than 6 hours. Contact with blood for longer periods is not advised.
The D101 KIDS Hollow Fiber Membrane Oxygenator With Integrated Hardshell Cardiotomy/Venous Reservoir with phosphorylcholine coating (hereafter referred to as the D101 KIDS) is a high efficiency infant microporous hollow fiber membrane oxygenator integrated with an heat exchanger and connected to an hardshell cardiotomy/venous reservoir. The device is a modified version of the currently marketed D902 Lilliput 2 Ph.I.S.I.O (K001021) predicate device (hereafter referred to as the D902 Ph.I.S.I.O.). The modification is limited to an overall reduction in the size of the device, design change to the integrated heat exchanger and hardshell venous cardiotomy/venous reservoir, and consequent updating of product specifications in the inclusion of vacuum assisted venous drainage in the Intended use. The reduction in size enables the device to be better suited for the infant patient population.
The provided document is a 510(k) summary for a medical device called the D101 KIDS Infant Hollow Fiber Membrane Oxygenator. It describes the device, its intended use, and the studies conducted to demonstrate its substantial equivalence to predicate devices. However, it does not involve an AI device, therefore, the information requested about acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set details, or how ground truth was established for a training set cannot be extracted from this document as no AI/Machine Learning component is mentioned.
The document discusses in vitro test results carried out according to FDA guidance and ISO standards to demonstrate the device's safety and effectiveness and its substantial equivalence to predicate devices. These tests assessed gas transfer characteristics, pressure drop, plasma leakage, operating blood volumes, heat exchanger performance, hemolysis, mechanical integrity, and venous cardiotomy reservoir characteristics. The results of these tests "met established specifications" and showed the device to be comparable or sometimes better than predicate devices.
Summary of studies for the D101 KIDS Infant Hollow Fiber Membrane Oxygenator:
1. Acceptance Criteria and Reported Device Performance:
The document states that in vitro test results "met established specifications" and that the device is "substantially equivalent or sometimes better than" the D902 hollow fiber oxygenator for relevant functional parameters. However, specific numerical acceptance criteria and detailed reported device performance values are not explicitly tabulated in this summary. Instead, a qualitative comparison to the predicate device is provided.
| Acceptance Criteria (Qualitative) | Reported Device Performance (Qualitative) |
|---|---|
| Established specifications for: gas transfer characteristics, pressure drop, plasma leakage, operating blood volumes, heat exchanger performance, hemolysis/cell depletion, mechanical integrity, venous cardiotomy reservoir characterization (including breakthrough times and volumes, reservoir graduated scale accuracy, residual blood volume, defoaming capacity, filtration efficiency and reservoir housing integrity) and leaching studies characterization. | Met established specifications for all tested characteristics. Comparable to predicate devices. |
| Sometimes better than the D902 hollow fiber oxygenator for: reduced operating blood volumes, breakthrough time and volume, and improved heat exchanger efficiency. | |
| Biocompatibility standards (ISO 10993-1:2003 and FDA May 1, 1995 Memorandum) for: Hemolysis, Cytotoxicity, Irritation, Acute Systemic Toxicity, Mutagenicity. | Met established specifications for all biocompatibility tests. Substantially equivalent to the D902 Ph.I.S.I.O. with respect to biocompatibility. |
| Sterility, Pyrogenicity, ETO residuals, and package integrity. | Met established specifications. Effectiveness of production techniques to ensure sterility and non-pyrogenicity demonstrated. |
2. Sample size used for the test set and the data provenance:
The document references "in vitro testing" and mentions that the device "aged up to 3 (+1 year considered as worst case) years was tested." This implies multiple devices were tested over time, but the specific number of units or samples used in these tests is not provided. The data provenance is from in vitro laboratory testing conducted by Sorin Group Italia S.r.l. or its contracted laboratories, following international standards and FDA guidance. This is a prospective test in the sense that newly manufactured devices (and aged ones) were subjected to these tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable as the studies are focused on the physical and functional performance of a medical device (oxygenator), not on interpretations of data by human experts for a diagnostic purpose. The "ground truth" here is determined by objective measurements against established engineering and biological specifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable for the same reason as point 3. There is no human interpretation or ground truth to adjudicate.
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 as the device is an oxygenator, not an AI-based diagnostic tool that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
This information is not applicable as the device does not involve an algorithm or AI. The tests performed are standalone in the sense that they assess the device's physical performance independently.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for the device's performance is established by objective engineering specifications, biological tolerance limits, and regulatory standards outlined in documents like ISO 7199 (1996) and various FDA guidance documents for cardiopulmonary bypass devices. For biocompatibility, it's the established thresholds for toxicity, hemolysis, etc.
8. The sample size for the training set:
This information is not applicable as this is a physical medical device and not an AI/Machine Learning model that requires a training set.
9. How the ground truth for the training set was established:
This information is not applicable for the same reason as point 8.
§ 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.”