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The CAPIOX® RX Hollow Fiber Oxygenators with/without Hardshell Reservoir are 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(s) is (are) used to store blood during extra-corporeal circulation from both 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 reservoir may also be used for Post Operative Chest Drainage Procedures.

The CAPIOX® RX Oxygenators with/without Hardshell Reservoirs can be used in procedures lasting up to 6 hours.

The CAPIOX® RX15 is for use with patients when the required blood flow rate will not exceed 5.0 L/min when used with a 4 Liter Reservoir; and when the required blood flow rate will not exceed 4.0 L/min when used with a 3 Liter Reservoir).

The CAPIOX® RX25 is for use with patients when the required blood flow rate will not exceed 7.0 L/min.

Device Description

The modified and predicate Capiox RX Oxygenator utilize a 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 wound 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 RX device have 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 Capiox RX 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 design of the Hardshell Reservoir component remains identical to the design of the original reservoir that was cleared by FDA with (K062381) - 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.

AI/ML Overview

The provided text describes a 510(k) summary for the modified Capiox® RX Oxygenator/Reservoir. This is a medical device submission focused on demonstrating substantial equivalence to a predicate device, rather than a clinical study evaluating the performance of an AI algorithm or a diagnostic device.

Therefore, many of the requested categories for AI/diagnostic device studies (such as sample size for test/training sets, experts for ground truth, adjudication methods, MRMC studies, standalone performance, and data provenance) are not applicable to this type of submission.

However, I can extract information related to the performance evaluations conducted for the device.

Here's a summary based on the provided text:

Acceptance Criteria and Device Performance for Modified Capiox® RX Oxygenator/Reservoir

The submission is for a modified version of an existing device (CAPIOX® RX Hollow Fiber Oxygenator with/without Hardshell Reservoir, K062381). The modification is a change to the Hardshell Reservoir to include a positive pressure relief valve. As such, the performance evaluations are focused on demonstrating that this modification does not affect the substantial equivalence of the device and maintains its safety and effectiveness. The acceptance criteria generally revolve around maintaining the performance characteristics of the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Performance Evaluation Type	Acceptance Criteria (Implied by "Substantial Equivalence")	Reported Device Performance (Implied by Conclusion)
Assessment of Reservoir Pressure during Simulated Bypass Procedures	The modified device's reservoir pressure performance during simulated bypass procedures should be equivalent to or within acceptable limits compared to the predicate device, ensuring no adverse impact from the new relief valve.	Terumo Cardiovascular Systems "concludes that the modified CAPIOX® RX Hollow Fiber Oxygenator with/without Hardshell Reservoir is substantially equivalent to the predicate modified CAPIOX® RX Hollow Fiber Oxygenator with/without Hardshell Reservoir." This implies the device met the criteria by performing equivalently to the predicate device in these in-vitro tests.
Positive and Negative Pressure Testing of the Reservoir	The reservoir, with the new relief valve, should withstand specified positive and negative pressures without compromise to its integrity or function, consistent with the predicate device.	(Implied: Met substantial equivalence)
Pressure Relief Valve performance following application of vacuum to the reservoir	The newly incorporated pressure relief valve must function correctly under vacuum conditions, as intended, to prevent excessive pressure accumulation.	(Implied: Met substantial equivalence)
Pressure Relief Valve-to-Reservoir Interface Testing	The interface between the relief valve and the reservoir must be robust and ensure proper sealing and function.	(Implied: Met substantial equivalence)
Usability Testing	The modification should not negatively impact the usability of the device, maintaining an equivalent level of user interaction and safety as the predicate.	(Implied: Met substantial equivalence)
Sterilization Assessment	The device must remain sterile and maintain its functional integrity after sterilization, consistent with the predicate device.	(Implied: Met substantial equivalence)
Shock Drop and Vibration Testing	The device must withstand typical transportation and handling stresses without damage or compromise to its function.	(Implied: Met substantial equivalence)
Artificial Conditioning to Shelf-Life of the product	The device must maintain its specified performance characteristics and integrity throughout its intended shelf-life, as demonstrated through accelerated aging or similar methods, equivalent to the predicate device.	(Implied: Met substantial equivalence)

Additional Information (as applicable to this type of submission):

Sample size used for the test set and the data provenance: This information is not provided in the summary. The studies were described as "in-vitro performance evaluations," meaning they were conducted in a laboratory setting, not with human patients. Thus, data provenance in terms of country of origin or retrospective/prospective is not applicable in the typical sense for clinical data. The exact number of units tested per evaluation is also not specified.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not applicable. The evaluations are in-vitro physical and functional tests of a medical device, not diagnostic interpretations requiring expert consensus.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: This information is not applicable. There's no interpretive task requiring adjudication.
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. This submission is for a cardiopulmonary bypass oxygenator, not an AI-powered diagnostic device.
If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done: This information is not applicable. This is not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for these in-vitro tests would be established engineering specifications, performance standards, and the known performance characteristics of the predicate device. The goal was to demonstrate that the modified device's performance aligns with these objective criteria and is "substantially equivalent."
The sample size for the training set: This information is not applicable. This is a physical medical device, not a machine learning model, so there is no "training set."
How the ground truth for the training set was established: This information is not applicable for the same reason as above.

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