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 70 L/min.

Device Description

The design of the Capiox RX Hollow Fiber Oxygenator/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.

The materials that are used in the construction of the Capiox RX Hollow Fiber Oxygenator/ Reservoir includes, but are not limited to, polycarbonate, stainless steel, polyviny] chloride, polyurethane, polyester, polypropylene, polyethylene and X-Coating™.

AI/ML Overview

Here's a summary of the acceptance criteria and study information for the Capiox RX Hollow Fiber Oxygenator/Reservoir, based on the provided text:

1. Acceptance Criteria and Reported Device Performance

The submission states that "The comparisons demonstrated that there are no clinically significant performance differences between the devices" when comparing the new Capiox RX device to predicate devices. While specific numerical acceptance criteria and reported performance metrics are not explicitly detailed in a table format in the provided text, the document indicates performance evaluations were conducted for the following aspects:

Acceptance Criteria (Evaluated against predicate devices)	Reported Device Performance (Implied)
Gas Transfer	No clinically significant performance differences
Effects on Blood Components (Hemolysis)	No clinically significant performance differences
Pressure Drop	No clinically significant performance differences
Mechanical Integrity	No clinically significant performance differences
Static Priming Volume	No clinically significant performance differences
Heat Exchanger Performance	No clinically significant performance differences
Defoaming	No clinically significant performance differences
Filtration Efficiency	No clinically significant performance differences
Flow Rate	No clinically significant performance differences
Tubing Connection Strength	No clinically significant performance differences
Biocompatibility (ISO 10993)	Blood contacting materials found to be biocompatible
Sterility Assurance Level (SAL)	10⁻⁶ (validated per AAMI guidelines)
Ethylene Oxide Residues	Will not exceed maximum residue limits
X-Coating Safety and Effectiveness (In-vivo animal study)	Well documented for being safe and effective; no adverse conditions noted in animal study

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not explicitly stated in the provided text for each performance evaluation.
Data Provenance: The studies were in-vitro performance evaluations. No information is given regarding the country of origin, but as it's a submission to the FDA, it's presumed to be conducted by the manufacturer, Terumo Cardiovascular Systems Corporation. The studies are not described as retrospective or prospective clinical studies, but rather laboratory-based performance tests.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not applicable to this type of submission. The performance evaluations are in-vitro studies comparing the device to predicate devices, not studies requiring expert interpretation of medical images or data from human subjects for ground truth establishment.

4. Adjudication Method for the Test Set

This information is not applicable. The performance evaluations are in-vitro studies that do not involve adjudication by experts.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The submission explicitly states: "Clinical studies involving patients are not necessary to demonstrate substantial equivalence of the subject device to the predicate devices." The evaluations performed were in-vitro.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This information is not applicable. The device is a medical device (oxygenator/reservoir), not an AI algorithm. The performance evaluations were conducted on the physical device's characteristics and function.

7. Type of Ground Truth Used

The "ground truth" for the performance evaluations (e.g., Gas Transfer, Hemolysis, Pressure Drop) would likely be established scientific and engineering principles, industry standards, and the validated performance characteristics of the predicate devices. The goal was to demonstrate that the new device performed "without clinically significant differences" compared to these established benchmarks and predicate devices. For biocompatibility, ISO 10993 standards served as the ground truth.

8. Sample Size for the Training Set

This information is not applicable. There is no mention of a "training set" as this device is a physical medical device, not an AI model requiring machine learning training.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the same reason as point 8.

Summary

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K062381
Page 1 of 5

510(k) Summary		AUG 2 4 2006Page
Submitter Information		19
Device Names		19
Identification of Predicate Device		19
Intended Use		20
Principles of Operation and Technology		20
Design and Materials		20
Performance Evaluations		21
Substantial Equivalence Comparison		21
Substantial Equivalence Summary		22
Additional Safety Information		22
Conclusion for 510(k) Summary		22

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K002381
Page 2 of 5

Submitter Information:

This submission was prepared in August 2006 by: Garry A. Courtney, MBA, RAC Sr. Regulatory Affairs Specialist Regulatory Management Terumo Cardiovascular Systems Corporation 125 Blue Ball Road Eikton, MD 21921 Telephone: 1-800-283-7866, Ext. 7420

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

Device Names/Classifications:Proprietary Name	Classification Name	Common Name
Capiox® RX 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	SamplingManifold with

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:

(Code: DTL)

Terumo's Capiox® SX10 Oxygenator K960074. .
. Terumo's Capiox® SX10 Hardshell Reservoir - K030449.
. Terumo's Capiox® SX25 Oxygenator/Reservoir - K993772
Terumo's Capiox® RX15 Oxygenator/Reservoir - K051997.
Terumo's Capiox® RX25 Oxygenator/Reservoir K040210. .
Terumo's Capiox® RX05 Oxygenator/Reservoir K022115.

Stopcocks

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K062381
Page 3 of 5

Intended Use:

The Capiox RX Hollow Fiber Oxygenators with/without Hardshell Reservoirs 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(s) may also be used for Post-Operative Chest Drainage procedures.

The Capiox RX 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 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.

Principles of Operation and Technology:

The design of the Capiox RX Hollow Fiber Oxygenator/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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K062381
Page 4 of 5

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:

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 RX Hollow Fiber Oxygenator/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 . SX and RX devices) are essentially identical. 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 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.
Design and Materials: The design and the materials of the Capiox RX Hollow Fiber . Oxygenator/Reservoir and the predicate devices are essentially identical. 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.

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The devices are manufactured with variations of plastics, adhesives, urethanes, polypropylene, stainless steel, etc. The Capiox RX devices contain X-Coating, which is a biocompatible surface coating that reduces platelet adhesion to the device. The predicate devices also contain X-coating - with the exception of the SX10 Oxygenator. The use of X-Coating is well documented for being safe and effective, and it's inclusion in this 510k application raises no new issues of safety and/or effectiveness.

A difference between the new Capiox RX and one of the predicate devices, the SX oxygenator, 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 Capiox RX design utilizes a wound fiber design whereby a continuous strand of fiber is uniformly wrapped around a supporting core structure. The noted difference in the fiber bundle orientation does not present new and/or additional risk or safety issues with the new design.

Performance: Comparisons of the performance of the Capiox RX Hollow Fiber . Oxygenator/Reservoir and the predicate devices were conducted. The comparisons demonstrated that there are no clinically significant performance differences between the devices.

Substantial Equivalence Summary:

In summary, the Capiox RX Hollow Fiber Oxygenator/Reservoir and the predicate 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.
. 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 RX Hollow Fiber Oxygenator/Reservoir is substantially equivalent in intended use, principles of operation and technology, design and materials, and performance to the predicate oxygenator and reservoir devices identified in this application.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized depiction of a human figure, with three wavy lines representing the head, body, and legs. The figure is positioned to the right of the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA", which is arranged in a circular fashion around the figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 4 2006

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

Re: K062381

CAPIOX® RX Hollow Fiber Oxygenators with/without Hardshell Reservoirs Regulation Number: 21 CFR 870.4350 Regulation Name: Cardiopulmonary Bypass Oxygenator Regulatory Class: Class II (two) Product Code: DTZ Dated: August 11. 2006 Received: August 15, 2006

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.

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Page 2 - Mr. Garry A. Courtney

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,

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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K062381/

SECTION 4 Indications for Use

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

Device Name:

CAPIOX® RX Hollow Fiber Oxygenators with/without Hardshell Reservoirs

Indications For 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 70 L/min.

Patty Maucker
Camilla Courtney, MDA, PAC

Courtney, MBA, RAC Cardiovasoular Systems

Prescription Use - XX (Part 21 CFR 801 Subpart D)

Over-T

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)

Donna R. Richner

(Division Sign-Off) (Division Sign-Old
Division of Cardiovascular Devices

510(k) number K063381

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.”