The Capiox RX15 is intended to be used during open-heart surgical procedures requiring cardiopulmonary bypass for period up to 6 hours. The Capiox RX15 is for use with patients when required blood flow rate will not exceed 5 L/min (4 L/min if using the CXRX15RW30 product code or CXRX15RE30 Product code).

The Capiox RX15 Hardshell Reservoir is also intended for use in vacuum assisted venous drainage procedures, in post-operative chest drainage, and autotransfusion procedures to aseptically return the blood to the patient for blood volume replacement.

Device Description

The design of the CAPIOX® RX15 Hollow Fiber Oxygenator with/without Hardshell Reservoir provides a semi-integral device whereby the oxygenator and heat exchanger are joined together, while the hardshell reservoir can be detached from the device assembly.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the CAPIOX® RX15 Hollow Fiber Oxygenator with/without Hardshell Reservoir, based on the provided text:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Performance Evaluations)	Reported Device Performance
Gas Transfer	Compared to predicate devices; no clinically significant differences.
Effects on Blood Components (Hemolysis)	Compared to predicate devices; no clinically significant differences.
Pressure Drop	Compared to predicate devices; no clinically significant differences.
Mechanical Integrity	Compared to predicate devices; no clinically significant differences.
Static Priming Volume	Compared to predicate devices; no clinically significant differences.
Heat Exchanger Performance	Compared to predicate devices; no clinically significant differences.
Defoaming	Compared to predicate devices; no clinically significant differences.
Filtration Efficiency	Compared to predicate devices; no clinically significant differences.
Flow Rate	Compared to predicate devices; no clinically significant differences.
Tubing Connection Strength	Compared to predicate devices; no clinically significant differences.
Sterility Assurance Level (SAL)	In accordance with AAMI guidelines to provide an SAL of 10^-6.
Ethylene Oxide Residues	Will not exceed maximum residue limits.
Biocompatibility (blood-contacting materials)	Biocompatible as per ISO 10993, "Biological Evaluation of Medical Devices -- Part 1: Evaluation and Testing" for External Communicating Devices, Circulating Blood, Limited Exposure (≤ 24 hours) Contact Duration.
Polymer Coating (X-Coating)	Evaluated in an in-vivo animal study; no adverse conditions noted.

Study Details:

Sample size used for the test set and the data provenance:
- The document does not specify explicit sample sizes for each "in-vitro performance evaluation." Instead, it refers to "comparisons of the performance of the CAPIOX® RX15 Hollow Fiber Performance Oxygenator with/without Hardshell Reservoir and the predicate devices were conducted."
- The origin of the data is not explicitly stated as "country of origin," but the submitter information lists "Ashitaka Factory of Terumo Corporation 150 Maimaigi-cho Fujinomiya city, Shizuoka Pref. Japan 418-0015," suggesting the tests were likely conducted in Japan or under the supervision of the Japanese entity.
- All performance evaluations listed are described as "in-vitro performance evaluations," and there is an additional "in-vivo animal study" for the polymer coating. These would be considered prospective studies for the purpose of this submission.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the document. The studies performed are primarily objective engineering and biological performance tests, not subjective evaluations requiring expert interpretation of results for ground truth.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This information is not applicable/provided as the performance evaluations are objective measurements (e.g., gas transfer rates, pressure drops, etc.) rather than subjective assessments that would require 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:
- No, an MRMC comparative effectiveness study was not done. This device is a medical oxygenator, not an AI-assisted diagnostic or interpretive tool that would involve human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, the performance evaluations listed are standalone device evaluations. The device's performance is measured directly against predefined criteria or compared to predicate devices, without human in-the-loop performance as part of the primary evaluation.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the in-vitro performance evaluations is based on engineering and biological performance specifications and measurements. For example, gas transfer is measured quantitatively, and biocompatibility is assessed against established ISO standards.
- For the biocompatibility of the polymer coating, an in-vivo animal study was conducted, where the "ground truth" would be the observed biological response or lack thereof in the animal model.
The sample size for the training set:
- This is not applicable as the device is a medical hardware device (oxygenator) and not an AI/machine learning algorithm that requires a training set.
How the ground truth for the training set was established:
- This is not applicable as there is no training set for this type of medical device submission.

Summary

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SEP 15 2005

SECTION II 510(k) SUMMARY OF SAFETY And EFFECTIVENESS

Submitter Information	13
Device Names	13
Identification of Predicate Device	14
Intended Use	14
Principles of Operation and Technology	14
Design and Materials	14
Performance Evaluations	15
Substantial Equivalence Comparison	15
Substantial Equivalence Summary	16
Additional Safety Information	16
Conclusion for 510(k) Summary	17

K051997

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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® SX10 Oxygenator K960074. *
Terumo's CAPIOX® SX10 Hardshell Reservoir -- K030449. .
Medtronic Minimax Plus Oxygenator K933586. .

Intended Use:

The CAPIOX® RX15 Hollow Fiber Oxygenator with/without Hardshell Reservoir is intended to I ho entrolenee 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(s) may also be used for Post-Operative Chest Drainage procedures.

The CAPIOX® RX15 Oxygenator with/without Hardshell Reservoir 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 Umin. 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).

Principles of Operation and Technology:

The design of the CAPIOX® RX15 Hollow Fiber Oxygenator with/without Hardshell Reservoir is such that blood is collected into the reservoir via gravity or external vacuum. Blood may enter via the venous inlet port and/or the cardiotomy inlet port. The reservoir contains filtering devices to remove particulate matter and air. Blood is then pumped from the reservoir into the heat exchanger device whereby blood temperature is controlled. After the blood exits the heat exchanger, it enters the oxygenator device whereby gas transfer (introduction of oxygen and removal of carbon dioxide) occurs. After gas transfer has occurred, the blood exits the device and is pumped towards the patient.

Design and Materials:

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Section II 510(k) Summary and Certification Terumo Corporation Capiox RX15 Oxygenator/Reservoir

CAPIOX® RX15 Hollow Fiber Oxygenator with/without Hardshell Reservoir

Submitter Information:

This submission was prepared in July 2005 by: Garry A. Courtney, MBA, RAC Sr. Regulatory Affairs Specialist Terumo Cardiovascular Systems Corp. 125 Blue Ball Road Elkton, MD 21921 Telephone: 1-800-283-7866, Ext. 7420

This submission was prepared for: Ashitaka Factory of Terumo Corporation 150 Maimaigi-cho Fujinomiya city, Shizuoka Pref. Japan 418-0015

Device Names/Classifications:Proprietary Name	Classification Name	Common Name
CAPIOX® RX15 HollowFiber Oxygenatorwith/without HardshellReservoir	Cardiopulmonary BypassOxygenator (Code: DTZ)	Oxygenator
	Cardiopulmonary BypassHeat Exchanger (Code: DTR)	Heat Exchanger
	Cardiopulmonary BypassBlood Reservoir (Code: DTN)	Blood Reservoir
	Cardiopulmonary BypassDefoamer (Code: DTP)	Defoamer
	Cardiopulmonary BypassCardiotomy Suction LineBlood Filter (Code: JOD)	Blood Filter
	Cardiopulmonary BypassStopcock, Manifold, Fitting(Code: DTL)	SamplingManifold withStopcocks

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The materials that are used in the construction of the CAPIOX® RX15 Hollow Fiber Oxygenator with without Hardshell Reservoir include, but are not limited to, polycarbonate, stainless steel, polyvinyl chloride, polyurethane, polyester, polypropylene, polyethylene and X-Coating.

Performance Evaluations:

It cryor mance francessary to demonstrate substantial equivalence of the subject device to the predicate devices. Substantial equivalence is demonstrated with the following in-vitro performance evaluations:

Gas Transfer .
Effects on Blood Components (Hemolysis) .
Pressure Drop .
Mechanical Integrity •
Static Priming Volume .
Heat Exchanger Performance .
Defoaming .
Filtration Efficiency .
Flow Rate .
Tubing Connection Strength .

Substantial Equivalence Comparison:

The CAPIOX® RX15 Hollow Fiber Oxygenator with/without Hardshell Reservoir is substantially equivalent to the predicate devices as follows:

Intended Use: The intended uses of the subject device and the predicate devices (Terumo's . SX10 devices) are essentially the same. The oxygenator devices are used to provide for gas exchange between blood and a gaseous environment to satisfy the gas exchange needs of a patient during cardiopulmonary bypass surgery.
Each of the integral heat exchangers is used to warm or cool blood and/or perfusion fluid as it flows through the device.

The respective hardshell reservoirs are each used to collect and store blood during the bypass procedure. Filters are present in each device to facilitate air and particulate removal.

Principles of Operation and Technology: The technology of the subject device and the . predicate devices is essentially identical. The devices operate in a manner where blood is collected into the reservoir. The blood may enter the reservoir via the venous inlet or the cardiotomy inlet. The reservoirs each contain filtering/defoaming devices that facilitate the removal of particulate matter and air. Blood is then pumped from the reservoir into the heat exchanger device whereby blood temperature is controlled with the use of an external water bath. After the blood exits the heat exchanger, it enters the oxygenator device whereby gas transfer occurs (i.e., introduction of oxygen; removal of carbon dioxide). The transfer process occurs via diffusion across the walls of the hollow fiber membranes contained within the oxygenator. After gas transfer has occurred, the blood exits the devices and is pumped towards the patient.

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Design and Materials: The design and the materials of the CAPIOX® RX15 Hollow Fiber . Oxygenator with/without Hardshell Reservoir and the predicate devices are essentially the same. The design of each device is similar in that they each contain a hardshell reservoir for collection of blood, a heat exchanger for temperature control, and an oxygenator for gas transfer. Such a design is common among oxygenating systems in the marketplace.
The devices are manufactured with variations of plastics, adhesives, urethanes, polypropylene, stainless steel, etc. The CAPIOX® RX15 device contains X-Coating, which poryproprenty alaxurface coating that reduces platelet adhesion to the device. The predicate device does not contain X-coating, although X-Coating is present on many Terumo devices that have been cleared by FDA. The use of X-Coating is well documented for being safe and effective, and it's inclusion in the proposed device raises no new issues of safety and/or effectiveness.

Another difference between the new CAPIOX® RX15 and the predicate device is the orientation of the polypropylene fibers that comprise the oxygenator module. The predicate SX10 device is comprised of a fiber bundle, which is essentially a collection of individual fibers that are captured in urethane adhesive at either end of the bundle. By contrast, the new CAPIOX® RX15 design utilizes a wound fiber design whereby single strands of fiber are continuously wrapped around a supporting core. The noted difference in the fiber bundle orientation does not present any new and/or additional risk or safety issues with the new design.

Comparisons of the performance of the CAPIOX® RX15 Hollow Fiber Performance: . Oxygenator with/without Hardshell Reservoir and the predicate devices were conducted. The comparisons demonstrated that there were no clinically significant performance differences between the devices.

Substantial Equivalence Summary:

In summary, the CAPIOX® RX15 Hollow Fiber Oxygenator with/without Hardshell Reservoir and the predicate SX10 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 in accordance with AAMI guidelines to provide . 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.
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.

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The polymer coating material that is applied to the blood-contacting surfaces of the device . was also evaluated in an in-vivo animal study. No adverse conditions were noted.

Conclusion:

In summary, the CAPIOX® RX15 Hollow Fiber Oxygenator with/without Hardshell Reservoir is substantially equivalent in intended use, principles of operation and technology, design and succeminance to the predicate Terumo SX10 Hollow Fiber Oxygenator (K960074) Terumo SX10 Hardshell Reservoir (K030449), and Medtronic Minimax Plus Oxygenator (K933586).

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/6/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

SEP 1 5 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Terumo Cardiovascular Systems Corp. c/o Mr. Garry A. Courtney, MBA, RAC Senior Regulatory Affairs Specialist 125 Blue Ball Road Elkton, MD 21921

Re: K051997

Capiox RX15 Hollow Fiber Oxygenator with/without Hardshell Reservoir Regulation Number: 21 CFR 870.4350 Regulation Name: Cardiopulmonary Bypass Oxygenator Regulatory Class: II (two) Product Code: DTZ Dated: July 21, 2005 Received: July 25, 2005

Dear Mr. Courtney:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave teviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreated of the enactment date of the Medical Device Amendments, or to Conniner of May 20, 1978, 2017, 11:25 am accordance with the provisions of the Federal Food, Drug, devices that have boon require approval of a premarket approval application (PMA). and Cosmetic Treef the device, subject to the general controls provisions of the Act. The Tourmaly, therefore, thance and act include requirements for annual registration, listing of general controlly provisions of visitions and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is clubstion (sover of ols. Existing major regulations affecting your device can may be subject to saterial Regulations, Title 21, Parts 800 to 898. In addition, FDA may ou found in the OOD acements concerning your device in the Federal Register.

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Page 2 - Mr. Garry A. Courtney, MBA, RAC

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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

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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Indications for Use

K051997 510(k) Number (if known):

Device Name:__Capiox RX15 Hollow Fiber Oxygenator with/without Hardshell Reservoir

Indications For Use:

Garry A. Courtney Requlatory Affairs

Prescription Use XX (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (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)

510(k) Number 203177

Page 1 of 1 -

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.”