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.

Device Description

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™.

AI/ML Overview

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:

Acceptance Criteria (Inferred from Performance Evaluations)	Reported Device Performance (Summary)
Pressure Relief Valve Function:
Proper function of the pressure relief valve at the reservoir interface.	Demonstrated through "Pressure Relief Valve-to-Reservoir Interface Testing".
Proper function of the relief valve after application of vacuum to the reservoir.	Demonstrated through "Relief Valve performance following application of vacuum to the reservoir".
Maintenance of appropriate reservoir pressure during simulated bypass.	Demonstrated through "Assessment of reservoir pressure during simulated bypass procedure at flow rates of 1, 2, 3, 4, and 5 liters per minute".
Sterilization:
Sterility Assurance Level (SAL) of 10⁻⁶.	"`Sterilization conditions have been validated to provide and ensure a Sterility Assurance Level (SAL) of 10⁻⁶.`"
Ethylene oxide residue within maximum limits.	"`Terumo further asserts that the ethylene oxide resident will not exceed the maximum residue limits at the time of product distribution.`"
Physical Integrity/Durability:
Device integrity after drop.	Demonstrated through "Drop Testing".
Device integrity after vibration.	Demonstrated through "Vibration Testing".
Biocompatibility:
Biocompatibility of blood-contacting materials.	Adheres to ISO 10993 standards; "`The blood contacting materials were found to be biocompatible.`"
Overall Performance (with modification):
Equivalent performance to the unmodified predicate device.	"`The modified Capiox® RX05 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.`"

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.

Summary

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MAR 1 3 2013

SECTION 5 – 510(k) Summary Modified Capiox® RX05 Oxygenator/Reservoir

Submitter Information	26
Device Names	26
Identification of Predicate Device	26
Intended Use	27
Principles of Operation and Technology	27
Design and Materials	27
Performance Evaluations	28
Substantial Equivalence Comparison	28
Substantial Equivalence Statement	29
Additional Safety Information	29
Conclusion for 510(k) Summary	30

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TERUMO

Submitter Information: This submission was prepared in February 2013 by: Garry A. Courtney, MBA, RAC Sr. 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® RX05 HollowFiber Oxygenator/Reservoir	Cardiopulmonary BypassOxygenator (Code: DTZ)	Oxygenator
	Cardiopulmonary Bypass	Blood Reservoir

Blood Reservoir (Code DTN)

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® RX05 Oxygenator/Reservoir - K022115. .

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Image /page/2/Picture/0 description: The image shows the logo for Terumo Corporation. The logo consists of a stylized letter 'T' enclosed in a circle, followed by the word 'TERUMO' in capital letters. The font appears to be a bold, sans-serif typeface, and there is a small mark above and to the right of the 'O'.

Intended Use:

The (nodified) 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 cardiotony school 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 Capion " RX05 is for use with neonatal and infant patients when the required blood flow rate will not exceed 1.5L/min.

Principles of Operation and Technology:

Design and Materials:

With respect to the design of the oxygenator, the modified Capiox® RX05 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.

If ith respect to the design of the 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™

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Performance Evaluations:

Clinical studies involving human 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® RX05 Oxygenator/Reservoir, and the predicate (unindified) Capiox® RX05 Oxygenator/Reservoir.

Comparison of Intended Use: .

The modified Capiox® RX05 devices and the predicate Capiox® RX05 devices are exact in their intended uses:

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

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.

Duration of Use: .

The modified Capiox® RX05 device and the predicate device can both be used in procedures lasting up to 6 hours.

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TERUMO

Comparison of Labeling: t

Both the modified Capiox® RX05 devices and the predicate Capiox® RX05 devices are offered with adequate Instructions for Use and other product labeling as required by regulation. The Instructions for Use for the modified Capiox® RX05 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® RX05 Hollow Fiber Oxygenator and the predicate Capiox® RX05 devices utilize the exact same technologies and principles of operation. The technology of the Capiox RX05 has not changed as a result of the product modification that is the subject of this application.

The predicate Capiox® RX05 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® RX05 device, there have been no significant 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® RX05 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.

Substantial Equivalence Statement:

The modified Capiox® RX05 devices and the predicate Capiox® RX05 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 resident will not exceed the maximum residue limits at the time of product distribution.

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Image /page/5/Picture/0 description: The image shows the word "TERUMO" in a bold, sans-serif font. To the left of the word is a circle with a "T" inside. There is a small asterisk to the right of the word.

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.

Conclusion:

In summary, Teruno deems the modified Capiox® RX05 device is substantially equivalent to the predicate unmodified Capiox® RX05 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 unatended issues of paient/user safety or product effectiveness.

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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 stylized eagle with three stripes representing human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

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: K130493

Trade/Device Name: CAPIOX RX05 Hollow Fiber Oxygenator/Reservoir (with X-Coating) - Models CXRX05RE and CXRX05RW Regulation Number: 21 CFR 870.4350 Regulation Name: Cardiopulmonary Bypass Oxygenator Regulatory Class: Class II Product Code: DTZ Dated: February 25, 2013 Received: February 28, 2013

Dear Mr. Courtney:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced 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 of medical

{7}------------------------------------------------

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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 1000-1050.

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/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 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/ReportaProblem/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 toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Matthew G. Hillebrenner

for

Bram D. Zuckerman, M.D. 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® RX05 Oxygenator/Reservoir

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

CAPIOX® RX05 Hollow Fiber Oxygenator with Hardshell Reservoir Device Name:

Indications For Use:

The Capios® RX05 Hollow Fiber Oxygenator/Reservoir device is intended to be used to exchange gases between blood and a gaseous environment to saisfy 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 cardiotony 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 51 /min not exceed 1.5L/min.

Prescription Use ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------(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.”