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The Capiox® RX05 Hollow Fiber Oxygenator/Reservoir device is intended to be used to exchange gases between blood and a gaseous environment to satisfy the gas exchange needs of a patient during cardiopulmonary bypass surgery.

The integral heat exchanger is used to warm or cool blood and/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 (via gravity or vacuum assisted venous drainage procedures). 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 Capiox® RX05 Oxygenator/Reservoir can be used in procedures lasting up to 6 hours.

The Capiox® RX05 is for use with neonatal and infant patients when the required blood flow rate will not exceed 1.5L/min.

The modified Capiox® RX05 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® RX05 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.

The subject of this Special 510(k) is a modification being made to the detachable Hardshell Reservoir. The reservoir component remains identical to the design of the original reservoir that was cleared by FDA with K022115 - except that a positive pressure relief valve will be included on the lid of the reservoir. The intent of the relief valve is to eliminate excessive pressure that could accumulate in a reservoir during bypass procedures.

The materials that are used in the construction of the Capiox® RX05 Hollow Fiber Oxygenator/Hardshell Reservoir includes, but are not limited to, nylon, polycarbonate, stainless steel, polyvinyl chloride, polyester, polyester, polyester, polyethylene terephthalate, stainless, polyethylere and X CastingTN polyethylene and X-Coating™.

This document is a 510(k) Summary for a modified medical device, the Capiox® RX05 Oxygenator/Reservoir. It describes a modification to an existing, cleared device, specifically the addition of a positive pressure relief valve to the hardshell reservoir. The submission focuses on demonstrating substantial equivalence to the predicate device (Terumo's Capiox® RX05 Oxygenator/Reservoir - K022115).

Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a table of predetermined acceptance criteria with corresponding performance results. Instead, it lists performance evaluations conducted to demonstrate substantial equivalence, implying that the acceptance criteria are met if these evaluations show performance equivalent to the predicate device or demonstrate the proper functioning of the new feature.

Based on the "Performance Evaluations" section and "Comparison of Performance," here's an inferred table:

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

The document mentions several "in-vitro performance evaluations" but does not specify the sample sizes used for any of the tests. It also does not provide details on the data provenance in terms of country of origin or whether studies were retrospective or prospective. All studies described are in-vitro (laboratory) tests, not human or animal studies.

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 section is not applicable to this submission. The device is a medical oxygenator/reservoir, and the evaluations are engineering/performance tests, not image-based diagnostics requiring expert interpretation to establish ground truth. The "ground truth" here is the physical and functional performance of the device against predefined engineering specifications or equivalence to the predicate.

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

This section is not applicable. The evaluations are described as objective performance tests (e.g., pressure measurements, sterility tests, physical integrity tests), which typically do not involve human adjudication in the sense of consensus reading or conflict resolution. The results are likely binary (pass/fail) or quantitative measurements against a standard.

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 section is not applicable. The device is a physical medical device (an oxygenator/reservoir), not an AI-powered diagnostic tool, and the submission does not involve human readers or AI assistance.

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

This section is not applicable. The device is a physical medical device, not an algorithm.

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

The "ground truth" for the performance evaluations described consists of:

• Engineering specifications/standards: For parameters like pressure relief, flow rates, and physical integrity.
• Predicate device performance data: For demonstrating substantial equivalence in performance where applicable.
• Validated sterilization protocols: To achieve the specified SAL.
• International standards (ISO 10993): For biocompatibility assessment.

This is primarily performance-based and regulatory standard-based ground truth, not clinical or diagnostic ground truth.

8. The sample size for the training set

This section is not applicable. The submission describes a device modification and performance testing, not the development or training of an algorithm or AI model.

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

This section is not applicable for the same reason as point 8.

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