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.

Device Description

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™.

AI/ML Overview

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.

Performance Evaluation Aspect	Device Performance (Modified Capiox FX05 Oxygenator/Reservoir)	"Acceptance Criteria" (Implicit)
Pressure Relief Valve-to-Reservoir Interface Testing	Performed (Specific results not detailed, but considered equivalent to predicate)	Functionally sound interface, preventing leaks or disconnections.
Relief Valve performance following application of vacuum to the reservoir	Performed (Specific results not detailed, but considered equivalent to predicate)	Valve actuates correctly under vacuum conditions.
Assessment of reservoir pressure during simulated bypass procedure at flow rates of 1, 2, 3, 4 and 5 liters per minute	Performed (Specific results not detailed, but considered equivalent to predicate)	Maintains acceptable pressure levels within the reservoir during simulated bypass at various flow rates.
Sterilization Assessment	Validated to provide a Sterility Assurance Level (SAL) of 10⁻⁶; ethylene oxide residues will not exceed maximum limits.	SAL of 10⁻⁶ and acceptable residue levels.
Drop Testing	Performed (Specific results not detailed, but considered equivalent to predicate)	Device integrity maintained after simulated drop.
Vibration Testing	Performed (Specific results not detailed, but considered equivalent to predicate)	Device integrity maintained after simulated vibration.
Biocompatibility	Blood contacting materials found to be biocompatible according to ISO 10993.	Materials are biocompatible for the intended use and contact duration.
Intended Use	Same as predicate device.	No change in intended use from predicate.
Duration of Use	Same as predicate device (up to 6 hours).	No change in duration of use from predicate.
Principles of Operation & Technology	Exact same as predicate device.	No change in principles of operation or technology from predicate.
Design	Only change is addition of a positive pressure relief valve to the Hardshell Reservoir; oxygenator module and other components unaffected.	The design modification does not negatively impact overall device function or performance, and the added valve functions as intended.
Materials	Subject reservoir and predicate reservoir constructed of exact same materials. Positive pressure relief valve constructed of polycarbonate and nylon.	New materials for the valve are compatible and do not introduce new safety concerns.
Overall Performance	Exhibits equivalent performance to the unmodified predicate device, as no changes were made that would alter device performance.	Performance is equivalent to the predicate device.

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.

Summary

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TERUMO

MAR 1 3 2013

SECTION 5 – 510(k) Summary Modified Capiox FX05 Oxygenator/Reservoir

Submitter Information	24
Device Names	24
Identification of Predicate Device	24
Intended Use	25
Principles of Operation and Technology	25
Design and Materials	25
Performance Evaluations	26
Substantial Equivalence Comparison	26
Substantial Equivalence Statement	27
Additional Safety Information	27
Conclusion for 510(k) Summary	28

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TERUMO

Submitter Information:

This submission was prepared in December 2012 by: Garry A. Courtney, MBA, RAC Manager, Regulatory Affairs Terumo Corporation/Terumo CVS 125 Blue Ball Road Elkton, MD 21921 Telephone: 1-800-283-7866, Ext. 7486

This submission was prepared for: Terumo Corporation (Ashitaka Factory) Manufacturer/Sterilizer 150 Maimaigi-cho Fujinomiya City, Shizuoka Pref. Japan 418-0015 Registration #9681834

Device Names/Classifications: Proprietary Name

Classification Name

Common Name

Capiox FX05 Hollow Fiber Oxygenator/Reservoir

Cardiopulmonary Bypass Oxygenator (Code: DTZ) Oxygenator

Cardiopulmonary Bypass Blood Reservoir (Code DTN) Blood Reservoir

Predicate Device:

The device submitted in this 510(k) maintains characteristics that are substantially equivalent in intended use, design, technology/principles of operation, materials and specifications to the following devices:

. Terumo's Capiox® FX05 Oxygenator/Reservoir - K071572.

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Intended Use:

The (modified) 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 uring cardiopulmonary bypass for periods up to 6 hours. The Capiox FX05 is a Neonate/Infant orgenator intended for use in procedures up to a maximum flow of 1.5 L/min. The roatient 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.

Principles of Operation and Technology:

Design and Materials:

With respect to the design of the oxygenator, the design of the modified Capiox FX05 oxygenator device is unaffected by the changes being incorporated at this time. The subject of this Special 510(k) is a modification being made to the detachable Hardshell Reservoir.

With respect to the design of the Arterial Filter, the filter contained within the oxygenator module is unaffected by the changes being incorporated at this time. The subject of this Special 510(k) is a modification being made to the detachable Hardshell Reservoir.

With respect to 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 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 FX05 Hollow Fiber Oxygenator/Hardshell Reservoir includes, but are not limited to, nylon, polycarbonate, stainless

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steel, polyvinyl chloride, polyurethane, polyester, polypropylene, polyethylene terephthalate, polyethylene and X-Coating™.

Performance Evaluations:

Clinical studies involving patients are not necessary to demonstrate substantial equivalence of the subject device to the predicate devices. Substantial equivalence is demonstrated with the following in-vitro performance evaluations:

Pressure Relief Valve-to-Reservoir Interface Testing .
Relief Valve performance following application of vacuum to the reservoir .
Assessment of reservoir pressure during simulated bypass procedure at flow rates of . 1,2,3,4 and 5 liters per minute
Sterilization Assessment .
Drop Testing .
Vibration Testing .

Substantial Equivalence Comparison:

The information presented in this section depicts a comparison between the subject of this 510(k) submission, the modified Capiox FX05 Oxygenator/Reservoir, and the predicate (unmodified) Capiox FX05 Oxygenator/Reservoir.

. Comparison of Intended Use:

The modified Capiox FX05 devices and the predicate Capiox FX05 devices are exact in their intended uses:

Use during open heart surgical procedures to transfer oxygen and remove carbon dioxide from blood and to control the blood temperature during cardiopulmonary bypass procedures for periods up to 6 hours. Both the new and predicate devices are neonate/infant oxygenators intended for use in procedures requiring a maximum blood flow rate of 1.5 L/min. Both devices indicate that the patient weight and BSA should be considered upon use.

The Hardshell Reservoir that is used with both the modified FX05 device and the predicate FX05 device may be used in vacuum assisted venous drainage procedures.

The indications for arterial blood filtration between the modified Capiox FX05 devices and the predicate devices are exactly the same. Both filters are intended to filter non-biologic particles and emboli and to facilitate air bubble removal from the blood flowing through a cardiotomy bypass circuit.

Duration of Use: .

The modified Capiox FX05 device and the predicate device can both be used in procedures lasting up to 6 hours.

. Comparison of Labeling:

Both the modified Capiox FX05 devices and the predicate Capiox FX05 devices are offered with adequate Instructions for Use and other product labeling as required by regulation. The

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TERUMO

Instructions for Use for the modified Capiox FX05 device are presented in the Appendices of this submission; the Instructions for Use for the predicate Capiox devices are also presented in the Appendices of this submission.

Comparison of Principles of Operation & Technology: .

Both the modified Capiox FX05 Hollow Fiber Oxygenator and the predicate Capiox FX05 devices utilize the exact same technologies and principles of operation. The technology of the Capiox FX05 has not changed as a result of the product modification that is the subject of this application.

The predicate Capiox FX05 and the predicate device are exactly the same with respect to operation and technology.

. Comparison of Design:

With respect to the design of the modified Capiox FX05 device, there have been no design changes except that the modified device will be available with a pressure relief valve attached to the lid assembly of the hardshell reservoir.

The design of the oxygenator module and other components of the assembled device remain unaffected by the modification to include a pressure relief valve.

. Comparison of Materials:

With respect to materials of construction, the subject reservoir and the predicate reservoir are constructed of the exact same materials. The positive pressure relief valve that is included with the modified reservoir is constructed of polycarbonate and nylon.

. Comparison of Performance:

The modified Capiox FX05 device exhibits equivalent performance to the unmodified predicate device - as there have been no changes made to the finished device that would alter the performance of the device.

Conclusion:

In summary, Terumo deems the modified Capiox FX05 device is substantially equivalent to the predicate unmodified Capiox FX05 device with respect to intended use, duration of use, design, materials, principles of operation, performance and specifications. It is further noted that any recognized differences do not raise any unattended issues of patient/user safety or product effectiveness.

Substantial Equivalence Statement:

The modified Capiox FX05 devices and the predicate Capiox FX05 devices are substantially equivalent in intended use, principles of operation and technology, design and materials, and performance. Any noted differences between the subject device and the predicate devices do not raise new issues of safety and effectiveness.

Additional Safety Information:

Sterilization conditions have been validated to provide and ensure a Sterility Assurance . Level (SAL) of 10°. Terumo further asserts that the ethylene oxide residues will not exceed the maximum residue limits at the time of product distribution.

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Terumo maintains biocompatibility studies as recommended in 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 Exposure (≤ 24 hours) Contact Duration]. The blood contacting materials were found to be biocompatible.
TERUMO

Conclusion:

In summary, the modified Capiox FX05 devices are substantially equivalent in intended use, principles of operation and technology, design and materials, and performance to the predicate devices (unmodified Capiox FX05) identified in this application.

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Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of what appears to be an abstract human form or symbol, composed of curved lines.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 13, 2013

Terumo Cardiovascular Systems Corporation c/o Garry A. Courtney 125 Blue Ball Road Elkton, MD 21921

Re: K130280

Trade/Device Name: CAPIOX FX05 Hollow Fiber Oxygenators/Reservoirs with Integrated Arterial Filter (with X-Coating) Regulation Number: 21 CFR 870.4350 Regulation Name: Cardiopulmonary Bypass Oxygenator Regulatory Class: Class II Product Code: DTZ Dated: February 14, 2013 Received: February 19, 2013

Dear Mr. Courtney:

We have reviewed your Section 510(k) premarket notification of intent to market the device for use stated above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 100-1000.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOR (2) 11 11 10 17 for for for for for for for for for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, Jease note the regulation entitled, "Misbranding by reference to premarket notification" (11CFR Preat 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its tolly free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm

Sincerely yours.

Matthew G. Hillebrenner

for
B.

for Director Division of Cardiovascular Devices Office of Device Evaluation

Center for Devices and Radiological Health

Enclosure

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SECTION 4 - Indications for Use Modified Capiox FX05 Oxygenator/Reservoir

K130280

510(k) Number (if known): Unknown at time of Submission

CAPIOX® FX05 Hollow Fiber Oxygenator with Integrated Arterial Filter Device Name: and Hardshell Reservoir

Indications For 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.

Prescription Use XX (Part 21 CFR 801 Subpart D) OROver-The-Counter Use (Part 21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Matthew G. Hillebrenner

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.”