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.

Summary

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SECTION 5 – 510(k) Summary

Modified Capiox® RX Oxygenator/Reservoir

MAR 1 3 2013

Submitter Information	22
Device Names/Classifications	22
Identification of Predicate Device	22
Intended Use	23
Principles of Operation and Technology	23
Design and Materials	24
Performance Evaluations	24
Substantial Equivalence Comparison	25
Substantial Equivalence Statement	25
Conclusion for 510(k) Summary	25

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Image /page/1/Picture/0 description: The image shows the logo for Terumo. The logo consists of a circle with the letter T inside of it. To the right of the circle is the word "TERUMO" in all capital letters.

Submitter Information:

Contact: This submission was prepared in February 2013 by: Suzanne Grenier, RAC Sr. Regulatory Affairs Specialist Terumo Cardiovascular Systems Corp. 125 Blue Ball Road Elkton, MD 21921 Telephone: 1-800-262-3304, Ext. 7688

This submission was prepared for: Terumo Cardiovascular Systems Corporation 125 Blue Ball Road Elkton, MD 21921 Registration #1124841

Device Names/Classifications: Proprietary Name

Classification Name

Common Name

Blood Gas Oxygenator

Capiox® RX Hollow Fiber Oxygenator with/without Hardshell Reservoir

Cardiopulmonary Bypass Oxygenator (Code: DTZ)

Blood Reservoir

Cardiopulmonary Bypass 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:

CAPIOX® RX Hollow Fiber Oxygenator with/without Hardshell Reservoir (K062381)

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Intended Use:

The intended use remains the same as the intended use in the cleared submission (K062381). There have been no changes to the indications or intended use of the modified devices.

The (modified) CAPIOX® RX Hollow Fiber Oxygenator with/without Hardshell Reservoir Intended Use:

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

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

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

Principles of Operation and Technology:

The technological characteristics and principles of operation remain the same as that of the predicate device (K062381). There have been no changes to the fundamental scientific technology of the modified devices.

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TERUMO

Design and Materials:

With respect to the design of the oxygenator, the design of the modified Capiox RX 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 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 (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.

The materials that are used in the construction of the Capiox RX Hollow Fiber Oxygenator may include, but are not limited to, nylon, polycarbonate, stainless steel, polyvinyl chloride, polyurethane, polyester, polypropylene, polyethylene and X-Coating™.

Terumo Cardiovascular Systems concludes that the differences between the modified device and the predicate device do not affect the intended use of the device nor do they affect safety and effectiveness of the device when used as labeled.

Performance Evaluations:

Clinical studies involving patients are not necessary to demonstrate substantial equivalence of the subject device to the predicate device. Terumo Cardiovascular Systems conducted the following in-vitro performance evaluations to demonstrate the functional equivalence of the subject device to the predicate device.

Substantial equivalence is demonstrated with the following in-vitro performance evaluations:

Assessment of Reservoir Pressure during Simulated Bypass Procedures .
Positive and Negative Pressure Testing of the Reservoir .
Pressure Relief Valve performance following application of vacuum to the reservoir .
Pressure Relief Valve-to-Reservoir Interface Testing .
Usability Testing .
. Sterilization Assessment
Shock Drop and Vibration Testing .
Artificial Conditioning to Shelf-Life of the product .

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Substantial Equivalence Comparison:

In demonstrating substantial equivalence of the modified CAPIOX® RX Hollow Fiber Oxygenator with/without Hardshell Reservoir to the predicate CAPIOX® RX Hollow Fiber Oxygenator with/without Hardshell Reservoir, a comparative study and/or assessment was performed in each of the following areas:

Intended use .
Target Population .
Duration of use .
. Product labeling
Product design .
Materials .
Principles of Operation and Technology .
Device Performance #

Substantial Equivalence Statement:

The modified CAPIOX® RX Hollow Fiber Oxygenator with/without Hardshell Reservoir is substantially equivalent in intended use, target population of use, labeling, design, materials, principles of operation and technology, and performance to the predicate CAPIOX® RX Hollow Fiber Oxygenator with/without Hardshell Reservoir. Any noted differences between the subject device and the predicate devices do not raise new issues of safety and effectiveness.

Conclusion:

Based upon the comparative studies and analyses, 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. It is further concluded that any recognized differences noted during the assessments do not raise new issues of patient/user safety or product effectiveness.

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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 Suzanne Grenier 125 Blue Ball Road Elkton, MD 21921

Re: K130333

Trade/Device Name: CAPIOX RX Hollow Fiber Oxygenators with/without Hardshell Reservoirs Regulation Number: 21 CFR 870.4350 Regulation Name: Cardiopulmonary Bypass Oxygenator Regulatory Class: Class II Product Code: DTZ Dated: February 8, 2013 Received: February 14, 2013

Dear Ms. Grenier:

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 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 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/Resourcesfor You/Industrv/default.htm.

Sincerely yours.

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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Image /page/7/Picture/0 description: The image shows the logo for Terumo. The logo consists of a circle with the letter 'T' inside, followed by the word 'TERUMO' in bold, sans-serif font. There is a small degree symbol after the word 'TERUMO'.

SECTION 4 - Indications for Use Modified Capiox RX Oxygenators/Reservoirs

K130333

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

CAPIOX® RX Hollow Fiber Oxygenator with/without Hardshell Device Name: Reservoir

Indications For Use:

Indications for Use as presented in the Instructions for Use:

The CAPIOX RX is intended to be used during open heart surgical procedures requiring cardiopulmonary bypass for periods up to 6 hours.

The CAPIOX RX25 is used with patients when required blood flow rate will not exceed 7 L/min. The CAPIOX RX15 is for use with patients when required blood flow rate will not exceed 5 L/min (4L/min if using product codes CXRX15RW30 or CXRX15RE30). The CAPIOX RX Hardshell Reservoir is also intended for use in vacuum assisted venous drainage procedure, in post-operative chest drainage and autotransfusion procedures to aseptically return the blood to the patient for blood volume replacement,

Indications for Use as described in the 510(k):

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

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

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

Prescription Use	XX
(Part 21 CFR 801 Subpart D)

Over-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.”