The CAPIOX® SX25 Hollow Fiber Oxygenator is 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 the blood or perfusion fluid flowing through the device.

The CAPIOX SX25 Hardshell Reservoir (detachable) is used to store blood during extracorporeal circulation from both the venous line and the cardiotomy line. The reservoir contains filters to remove particulate matter and defoamers to facilitate air bubble removal.

Device Description

CAPIOX® SX25 Hollow Fiber Oxygenator contains an integrated heat exchanger and a detachable Hardshell Reservoir. This design permits an integrated system for ease of use as well as independent use of the oxyegnator and of the Hardshell reservoir to accommodate a variety of circuit configurations.

The SX25 oxygenator is a membrane oxygenator consisting of microporous hollow fibers with an integrated heat exchanger, consisting of stainless steel tubes.

The detachable Hardshell reservoir has a rotatable connection with the oxygenator which permits optimum positioning for connections in the circuit. The venous blood inlet port is also rotatable to permit minimizing tubing lengths which could result in lower circuit priming volumes.

The Hardshell reservoir contains a defoamer and a screen filter in the venous blood inlet section. The total capacity of the reservoir is 4,000 mL.

The cardiotomy section of the hardshell reservoir contains a defoamer and a cardiotomy filter to facilitate gas bubble removal and the removal of particulates/emboli from suctioned blood entering the reservoir.

A detachable sampling system is positioned at the top of the hardshell reservoir which contains 3 three-way stopcocks. These stopcocks can be used for sampling. The sampling system contains a one-way valve permitting withdrawal of liquid samples but prohibiting entry of air into the blood exiting the oxygenator.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the CAPIOX® SX25 Hollow Fiber Oxygenator, based on the provided text:

Acceptance Criteria and Reported Device Performance

The submission demonstrates substantial equivalence primarily through comparison to the predicate device, the CAPIOX SX18. The acceptance criteria are largely implied by demonstrating that the SX25 meets or exceeds the performance of the SX18 for critical functions, or that differences do not raise new safety or effectiveness concerns.

Acceptance Criteria Category	Specific Criteria (from SX18) / Performance Target	Reported Device Performance (SX25)
Intended Use	Same as SX18	Same
Design and Materials	Same as SX18 (basic design & materials)	Same, but larger membrane surface area
Technology/Principles of Operation	Same as SX18	Same
Gas Transfer	Equivalent or better than SX18	Expected increase (due to larger surface area)
Effect on Blood Components	Substantially equivalent to SX18	Substantially equivalent
Pressure Drop	Equivalent or better than SX18 (lower is better)	Expected decrease (due to larger surface area)
Priming Volume	Within clinically acceptable range	Slightly higher than SX18 (340 mL vs 270 mL), considered acceptable
Membrane Surface Area	Provides adequate gas exchange for clinical use	2.5 m² (vs 1.8 m² for SX18)
Maximum Blood Flow Rate	7 LPM (venous), 5 LPM (cardiotomy)	Same
Heat Exchanger Performance	Same as SX18 (K922799 reference)	Same
Hardshell Reservoir Performance	Same as SX18 (K922799 reference)	Same
Sterilization	SAL of 10⁻⁶	Validated to provide SAL of 10⁻⁶
Ethylene Oxide Residuals	Not exceed max residue limits (21 CFR Part 821)	Will not exceed limits
Manufacturing Control	100% performance and leak testing	Includes 100% performance and leak testing
Blood Contacting Materials	Acceptable per FDA General Program Memorandum #G95-1 (ISO-10993)	Acceptable

Study Information

Sample size used for the test set and the data provenance:
- The document does not specify explicit sample sizes for the performance tests (Gas Transfer, Effect on Blood Components, Pressure Drop). It states "Comparison of the SX25 and SX18 performance was conducted."
- Data Provenance: Not specified, but likely laboratory testing conducted by the manufacturer, Terumo Medical Corporation. There is no indication of retrospective or prospective clinical data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This submission is a premarket notification (510(k)) primarily focused on bench testing and substantial equivalence to a predicate device. There is no mention of human-expert-established ground truth in the context of clinical observations or interpretations, which is typical for device performance assessments like gas transfer or blood compatibility. The "ground truth" here is the performance of the predicate device (SX18) as established in its own clearance, and the known physiological principles of oxygenation.
Adjudication method for the test set:
- Not applicable as this is bench testing comparing objective performance parameters, not subjective expert assessment of medical images or conditions.
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:
- No. This is not an AI/software device. It's a medical device for cardiopulmonary bypass.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable as this is not an AI/software device. The performance data presented are "standalone" in the sense that they are intrinsic device performance metrics (gas transfer, pressure drop, effect on blood components) determined through laboratory testing.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the performance characteristics (gas transfer, pressure drop, effect on blood components) is established by validated laboratory testing methods and engineering principles. The performance of the predicate device (SX18) serves as the primary reference point. For sterilization and materials, the ground truth is adherence to established regulatory standards (SAL, EO residuals, ISO-10993).
The sample size for the training set:
- Not applicable. This is not a machine learning/AI device, so there is no concept of a "training set."
How the ground truth for the training set was established:
- Not applicable for the same reason as above.

Summary

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K962067
Oct. 7, 1996

SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION PERTAINING TO SUBSTANTIAL EQUIVALENCE

Proprietary Device Name:	CAPIOX® SX25 Hollow Fiber Oxygenatorwith detachable Hardshell Reservoir
Classification Name:	Cardiopulmonary bypass oxygenator, heat exchanger, reservoir,defoamer, blood filter and manifold.

Intended Use:

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Description

The SX25 oxygenator is a membrane oxygenator consisting of microporous hollow fibers with an integrated heat exchanger, consisting of stainless steel tubes.

The Hardshell reservoir contains a defoamer and a screen filter in the venous blood inlet section. The total capacity of the reservoir is 4,000 mL.

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II - Summary and Certification Summary of Safety and Effectiveness

A detachable sampling system is positioned at the top of the hardshell reservoir which contains 3 three-way stopcocks. These stopcocks can be used for sampling. The sampling system contains a one-way valve permitting withdrawal of liquid samples but prohibiting entry of air into the blood exiting the oxygenator.

Substantial Equivalence

ー

The CAPIOX® SX25 Oxygenator and Hardshell Reservoir are substantially equivalent to the CAPIOX SX18 Oxygenator and Hardshell Reservoir as follows:

Intended use: same

Design and Materials:

The basic device design and all materials for the SX25 and the SX18 are the same.

The CAPIOX SX25 has a larger membrane surface area than the SX18.

Both the CAPIOX SX25 and the CAPIOX SX18 have the same integrated heat exchangers and the same detachable hardshell reservoir.

Technology and Principles of Operation

These devices (SX18 and SX25) use hollow fiber membrane technology and utilize gravity and/or external vacuum (cardiotomy) for blood collection into the reservoir. Air removal is facilitated by defoamers and the tendency of air to rise through liquid. Particulate removal is facilitated by the blood flow pathway through filters contained in the reservoirs. Some form of pumping mechanism is utilized to transfer blood from the reservoir component to the oxygenator component.

The technology and principles of operation for the SX25 and the SX18 are the same.

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II Summary and Certification Summary of Safety and Effectiveness

Specifications

The priming volume for the SX25 is slightly higher than that for the SX18 (340 versus 270 mL, respectively) because of the increased membrane area The membrane surface area of the SX25 is 2.5 m3 and that for the SX18 is 1.8 m2. This difference does not affect the substantial equivalence of the devices since both provide adequate gas exchange for clinical use.

Maximum blood flow rate for both devices is 7 LPM for venous flow and 5 LPM for cardiotomy flow.

The heat exchanger and the detachable hardshell reservoir are the same for both devices.

Performance

Comparison of the SX25 and SX18 performance was conducted. The following tests were performed:

·Gas Transfer (short term and 6-hour)
· Effect on Blood Components
·Pressure Drop

Note: The heat exchanger and the detachable hardshell reservoir are the same for both devices. Performance testing for these components was presented in K922799. Additionally, the effect on blood components of the cardiolomy section was presented.

In summary, the expected increase of gas transfer and decreased pressure drop was observed for the SX25 due to the increased surface area. F:ffect on blood components was substantially equivalent.

The SX25 and the SX18 are substantially equivalent in intended use, design and materials, technology/principles of operation, and specification with the exception of the increased membrane surface arca. Differences as described above do not taise new issues of safety or effectiveness.

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II Summary and Certification Summary of Safety and Effectiveness

Additional Safety Information

·Sterilization conditions have been validated to provide a Sterility Assurance Level (SAL) of 10 *

· Ethylene oxide residuals will not exceed the maximum residuc limits proposed for Part 821 of Title 21 in the Federal Register of June 23, 1978 (or as finalized or amended).

· Manufacturing control tests include 100% performance and leak testing.

•Blood contacting materials are acceptable in accordance with the FDA General Program Memorandum #G95-1 (5/1/95): Use of International Standard ISO-10993, " Biological Evaluation of Medical Devices Part 1: Evaluation and Testing (External communicating devices/Circulating Blood/Limited contact duration).

Date Prepared June 30, 1996

Prepared by:	Sandi Hartka, M.A.S., R.A.C.Submissions SupervisorRegulatory Affairs
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for : Terumo Medical Corporation 2100 Cottontail Lane Somerset, NJ 08873

Regulation Number and Section

§ 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.”