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The Capiox FX05 device is intended to be used during open heart surgical procedures to transfer oxygen and remove carbon dioxide from blood and to control the blood temperature during cardiopulmonary bypass for periods up to 6 hours. The Capiox FX05 is a Neonate/Infant oxygenator intended for use in procedures up to a maximum flow of 1.5 L/min. The patient weight and BSA should be considered upon use.

The FX05 Hardshell Reservoir is also intended for use in vacuum assisted venous drainage procedures.

The integrated arterial filter is intended to filtrate non-biologic particles and emboli and to facilitate air bubble removal from the blood flowing through the cardiopulmonary bypass circuit.

The modified Capiox FX05 Oxygenator utilizes porous fiber technology to facilitate the transfer of gases between a blood-phase environment and a gas-phase environment for the intent of satisfying the gas exchange needs of a patient during cardiopulmonary bypass surgery. A fiber bundle offers the porous membrane surface to sufficiently permit the movement of gases through the walls of the hollow fibers via diffusion.

The modified Capiox FX05 device has an integrated heat exchanger that is comprised of stainless steel encased in a polycarbonate housing. The stainless steel acts as a heat transfer material that permits heat that is generated from a temperature controlled external water bath to transverse across the walls of the stainless steel to effect the necessary temperature change upon circulating blood.

With respect to the filtration of arterial blood, the modified Capiox FX05 Oxygenator/Arterial Filter relies upon mechanical entrapment of particulates and emboli within the filter mesh as a means to remove those particulates from the blood.

The subject of this Special 510(k) is a modification being made to the detachable Hardshell Reservoir. The design of the Hardshell Reservoir component remains identical to the design of the original reservoir that was cleared by FDA with K071572 - except that a positive pressure relief valve will be included on the lid of the reservoir.

The materials that are used in the construction of the Capiox FX05 Hollow Fiber Oxygenator/Hardshell Reservoir includes, but are not limited to, nylon, polycarbonate, stainless steel, polyvinyl chloride, polyurethane, polyester, polypropylene, polyethylene terephthalate, polyethylene and X-Coating™.

This document is a 510(k) summary for a modified Capiox FX05 Oxygenator/Reservoir. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving a device meets predefined acceptance criteria through clinical studies. Therefore, many of the requested categories (such as sample size for test sets, number of experts for ground truth, MRMC studies, etc.) are not applicable to this kind of regulatory submission.

Here's the information that is available based on the provided text, primarily falling under the "Performance Evaluations" section and the "Substantial Equivalence Comparison":

1. Table of Acceptance Criteria and the Reported Device Performance

As this is a 510(k) submission demonstrating substantial equivalence rather than a de novo clinical trial with explicit acceptance criteria for efficacy, specific numerical acceptance criteria (e.g., "accuracy > 90%") are not defined in the way you might expect for an AI/diagnostic device. Instead, the "acceptance criteria" are implicitly that the modified device performs equivalently to the predicate device for various evaluated aspects.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This submission does not detail specific "test sets" in the context of clinical trials or large-scale data analysis. The performance evaluations were in-vitro tests (laboratory-based) to demonstrate the functional equivalence of the modified device to the predicate. Therefore, sample sizes for patient data or data provenance are not applicable.

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 is not applicable as the evaluations were in-vitro engineering tests, not dependent on expert clinical interpretation or ground truth establishment in a clinical sense.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable as the evaluations were in-vitro engineering tests.

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 is not applicable. This device is a medical device (oxygenator/reservoir), not an AI diagnostic or assistance tool that would involve human "readers" or AI-assisted interpretation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable as this device is not an algorithm or AI system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the in-vitro performance evaluations, the "ground truth" would be engineering specifications, established physical principles, and validated test methodologies to determine if the device performed as expected and equivalently to the predicate. For example:

• For pressure relief valve performance: The ground truth would be the expected pressure-relief characteristics and the predicate device's measured performance.
• For sterilization: The ground truth is the established SAL of 10⁻⁶ and acceptable residue limits.
• For biocompatibility: The ground truth is compliance with ISO 10993 standards and established toxicological profiles.

8. The sample size for the training set

This is not applicable. This is a hardware medical device, not an AI model that requires a training set.

9. How the ground truth for the training set was established

This is not applicable as a training set is not relevant for this device.

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