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The (X-Coated) Capiox® SX25 and SX18 Hollow Fiber Oxygenators with/without Detachable Hardshell Reservoirs are used to exchange gases between blood and a gaseous environment to satisfy the gas exchange needs of a patient during cardiopulmonary bypass surgery for periods up to 6 hours.

The integral heat exchanger is used to warm or cool blood or perfusion fluid as it flows through the device.

The (detachable) hardshell reservoir is used to store blood during extracorporeal circulation from both the venous line and the cardiotomy line. The reservoir contains a venous section that is comprised of a filter and defoamer to facilitate air bubble removal. The cardiotomy section of the reservoir contains a filter to remove particulate matter and a defoamer to facilitate air bubble removal.

The Hardshell Reservoir is also used for post-operative chest drainage and autotransfusion procedures to aseptically return the blood to the patient for blood volume replacement.

The Hardshell Reservoir is also used with the vacuum-assisted venous return technique during cardiopulmonary bypass.

(The X-Coating™ is a polymer coating that is applied to blood contacting surfaces of the oxygenator to reduce the adhesion of platelets to the surfaces of the device.)

The modified and predicate Capiox® SX18/25 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 and predicate Capiox® SX18/25 Oxygenator 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 blood, the modified and predicate Capiox® Hardshell Reservoir 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 Hardshell Reservoir. The reservoir component remains identical to the design of the original reservoir that was cleared by FDA with (K130359) - except the modified device will include PVC tubing (with TOTM plasticizer) for a flared venous inlet drop tube, auxiliary tube, sampling manifold tubing, and purge line tubing.

This document describes a Special 510(k) submission for modifications to the Terumo Capiox® SX18/25 Hollow Fiber Oxygenator with detachable Hardshell Reservoir. The submission aims to demonstrate substantial equivalence to the previously cleared predicate device (K130359).

1. Acceptance Criteria and Reported Device Performance

The application does not include specific numerical acceptance criteria for the modified device's performance compared to the predicate device. Instead, it states that performance evaluations were conducted to demonstrate "functional equivalence." The changes made were related to the design and material of the venous inlet drop tube, auxiliary tube, sampling manifold tubing, and purge line tubing within the hardshell reservoir. The primary changes are:

• Venous Inlet Drop Tube: Changed from Non-Flared (DEHP plasticizer) to Flared (TOTM plasticizer).
• Auxiliary Drop Tube, Sampling Manifold Tubing, Purge line Tubing: Changed from DEHP plasticizer to TOTM plasticizer.

The performance evaluations listed are:

• Hemolysis Testing
• Air Handling
• Reservoir Pressure Drop
• Venous Defoaming

The document explicitly states that the oxygenator design is unaffected, and the modifications to the hardshell reservoir are primarily to improve flow dynamics (flared venous drop tube) and adjust to pending regulatory requirements (TOTM plasticizer). The conclusion is that "the differences between the modified device and the predicate device do not affect the intended use of the device nor do they affect safety and effectiveness of the device when used as labeled."

Since the purpose of this submission is to demonstrate equivalence rather than a specific performance threshold against a clinical endpoint for a novel device, the acceptance criteria would implicitly be that the modified device's performance in these listed tests is comparable to or better than the predicate, and crucially, does not introduce new safety or effectiveness concerns. The document broadly concludes that the modified device "is substantially equivalent" and "does not raise new issues of patient/user safety or product effectiveness," implying these equivalency tests were met.

Due to the nature of the device (cardiopulmonary bypass oxygenator and associated reservoir) and the type of modification (material and minor design changes to tubing), the performance evaluation revolves around specific in-vitro tests relevant to blood compatibility and fluid dynamics within the device.

2. Sample size used for the test set and the data provenance

The document does not specify the sample sizes used for the in-vitro performance evaluations (Hemolysis Testing, Air Handling, Reservoir Pressure Drop, Venous Defoaming). It also does not explicitly state the data provenance (e.g., country of origin, retrospective or prospective), but given these are in-vitro tests for device performance, they would typically be conducted in a laboratory setting.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This device is a cardiopulmonary bypass oxygenator and reservoir system. The "ground truth" for its performance is established through controlled physical and chemical in-vitro tests, not through expert interpretation of medical images or clinical data. Therefore, there is no mention of experts establishing ground truth in the context of medical image interpretation.

4. Adjudication method for the test set

Not applicable. As noted in point 3, the evaluation of this device relies on in-vitro performance testing, not on expert adjudication of diagnostic outcomes.

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 device is a medical device used in cardiopulmonary bypass surgery, not an AI-assisted diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant.

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

Not applicable. This device is a physical medical device, not a software algorithm.

7. The type of ground truth used

The "ground truth" for evaluating this device's performance is based on objective measurements derived from the specified in-vitro tests (Hemolysis Testing, Air Handling, Reservoir Pressure Drop, Venous Defoaming). These tests measure physical and biocompatibility parameters that are critical for the safe and effective functioning of a cardiopulmonary bypass system. The ground truth is established by comparing the results of these tests for the modified device against established standards, regulatory requirements, and the performance characteristics of the predicate device.

8. The sample size for the training set

Not applicable. This device is a physical medical device, not a machine learning model that requires a training set.

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

Not applicable. As noted in point 8, this device is a physical medical device, not a machine learning model.

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