The CAPIOX® RX25 Hollow Fiber Oxygenator with/without Hardshell Reservoir 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 extra-corporcal circulation from both venous line and the cardiotomy line (via gravity or vacuum assisted venous drainage nom over vollows internairs a venous section that is comprised of a filter and defoamer to procedured). The 1000 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® RX25 Oxygenator with/without Hardshell Reservoir can be used in proccdures lasting up to 6 hours.

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

Device Description

The design of the CAPIOX® RX25 Hollow Fiber Oxygenator with/without Hardshell Reservoir is such that blood is collected into the reservoir via gravity or external vacuum. Blood may enter is such that brood is confect 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 devices to remove partisance by 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.

AI/ML Overview

The provided text describes the Terumo CAPIOX® RX25 Hollow Fiber Oxygenator with/without Hardshell Reservoir, a medical device used during cardiopulmonary bypass surgery. It details the device's intended use, principles of operation, design, materials, and performance evaluations to demonstrate substantial equivalence to predicate devices.

Here's an analysis of the acceptance criteria and study aspects based on the given information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly list acceptance criteria values. Instead, it states that performance evaluations were conducted and "no noted, product-related, clinically significant performance differences between the devices" were found when compared to predicate devices. This implies that the acceptance criteria were met by demonstrating similar performance to the already cleared predicate devices.

Performance Evaluation Category	Reported Device Performance
Gas Transfer	No clinically significant differences compared to predicate devices.
Effects on Blood Components (Hemolysis)	No clinically significant differences compared to predicate devices.
Pressure Drop	No clinically significant differences compared to predicate devices.
Mechanical Integrity	No clinically significant differences compared to predicate devices.
Static Priming Volume	No clinically significant differences compared to predicate devices.
Heat Exchanger Performance	No clinically significant differences compared to predicate devices.
Defoaming	No clinically significant differences compared to predicate devices.
Filtration Efficiency	No clinically significant differences compared to predicate devices.
Flow Rate	No clinically significant differences compared to predicate devices.
Tubing Connection Strength	No clinically significant differences compared to predicate devices.
Biocompatibility	Blood contacting materials found to be biocompatible, consistent with ISO 10993.
Sterilization	Validated in accordance with AAMI guidelines to achieve a Sterility Assurance Level (SAL) of 10⁻⁶. Ethylene oxide residue limits met.
Polymer Coating (X-Coating)	Evaluated in an in-vivo animal study; no adverse conditions noted.

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

The document states that "Clinical studies are not necessary to demonstrate substantial equivalence of the subject device to the predicate devices." Therefore, there is no specific test set sample size or data provenance (country of origin, retrospective/prospective) for clinical data provided. The evaluations were in-vitro performance evaluations, material characterizations, and a limited in-vivo animal study for the coating.

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

Since no clinical studies were performed for the test set, there is no mention of experts establishing ground truth. The evaluations were primarily laboratory-based and compared to established performance of predicate devices.

4. Adjudication Method for the Test Set

As there was no clinical test set requiring human interpretation, no adjudication method is described.

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

No MRMC comparative effectiveness study was done. The submission explicitly states that clinical studies were not necessary as substantial equivalence was demonstrated through in-vitro performance evaluations and comparison to predicate devices. Therefore, there is no effect size related to human reader improvement with or without AI assistance.

6. Standalone (Algorithm Only) Performance Study

Not applicable. This device is a mechanical oxygenator, not an AI-driven algorithm. The performance studies evaluated the physical and functional aspects of the device itself.

7. Type of Ground Truth Used

The "ground truth" for the device's performance was established through:

In-vitro performance evaluations: Measurements of physical parameters (gas transfer, pressure drop, flow rate, etc.) under controlled laboratory conditions.
Biocompatibility testing: Adherence to established standards (ISO 10993).
Sterilization validation: Adherence to AAMI guidelines.
Comparison to predicate device performance: The performance of the new device was deemed substantially equivalent if it did not show "clinically significant performance differences" from the established performance of the predicate devices.
In-vivo animal study for coating: Directly observed outcomes in an animal model.

8. Sample Size for the Training Set

Not applicable. This device is a physical medical device, not an AI or machine learning model that requires a training set.

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

Not applicable. As there is no training set, there is no ground truth established for it.

Summary

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K040210

MAR - 3 2004

Section II 510(k) Summary and Certification Terumo Corporation Capiox RX25 Oxygenator/Reservoir

CAPIOX® RX25 Hollow Fiber Oxygenator with/without Hardshell Reservoir

Submitter Information:

Submitter Information was prepared in January 2002 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® RX25 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)	SämplingManifold withStopcocks

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Predicate Device:

Predicale Device.
The device submitted in this 510(k) maintains characteristics that are substantially equivalent in I he device submitted in this 910(x) mainless of operation, materials and specifications to the following devices:

Terumo's CAPIOX® SX25 Oxygenator w/wo Hardshell Reservoir K962667. .

Intended Use:

The CAPIOX® RX25 Hollow Fiber Oxygenator with/without Hardshell Reservoir is intended to The CATION® RA25 Honor Process on James on James 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 extra-corporeal circulation The (detachable) hardshen to servity or vacuum assisted venous assisted venous drainage If on both vellous inno and the and section that is comprised of a filter and defoamer to procedures). The reservor comains a vincomy 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® RX25 Oxygenator with/without Hardshell Reservoir 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 I /min.

Principles of Operation and Technology:

Design and Materials:

Design of the CAPIOX® RX25 Hollow Fiber Oxygenator with/without Hardshell Reservoir The dosign of the Orice 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® RX25 Hollow Fiber Oxygenator with/without Hardshell Reservoir include, but are not limited to, polycarbonate, stainless steel, with without Trafficity Iretting, polyester, polypropylenc, polyethylene and X-Coating.

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Performance Evaluations:

Clinical studies 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® RX25 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 . SX25 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.

The new device and the predicate devices may each be used in Vacuum Assisted Venous Drainage and Post-Operative Chest Drainage procedures.

Principles of Operation and Technology: The technology of the subject device and the . predicate devices are 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® RX25 Hollow Fiber . Design and Materials: The design and the predicate devices are essentially the Oxygenator with/Without Hardshen Reservon and they cach contain a hardshell reservoir for use same. The design of each device is similar in thar ally control, and an oxygenator for gas
collection of blood, a heat exchanger for temperature control, and any and states transfer. Such a design is common among oxygenating devices in the marketplace.
The devices are manufactured with variations of plastics, adhesives, wrethanes, The devices stainless steel, etc. The RX25 device contains X-Coating, which is a biocompatible surface coating that reduces platelet adhesion to the device. of cofety, and/or Coating has been demonstrated as safe and raises no new issues of safety and/or Coating has been demonshated as sare the rasso no the predicate SX25 Oxygenators and Reservoirs cleared by FDA in K993772.

The most notable design difference between the new device and the predicate is the The most the polypropylene fibers that comprise the oxygenator module. The predicated orientation of the porypropyithe frocts that cempion is essentially a collection of individual SX25 device is represenced by a Jroer ounder, which end of the bundle. By contrast, the new RX25 design utilizes a wound fiber design whereby single strands of fiber are new KX2> design uninzes a "wand" free" dong" and surface area of fibers that are continuously wrapped around a supporting vere. remains identical for the new RX25 device that fiber buyedly exposed to blood and gas during bypass surgery telled difference in the fiber builde and predicate SX23 device at approximatery E15 m + + 1 x = 1 safety issues with the new design.

Comparisons of the performance of the CAPIOX® RX25 Hollow Fiber Performance: . Performance: Comparisons of the performation of the predicate devices were conducted.
Oxygenator with/without Hardshell Reservoir and the producted, professmance Oxygenator with/Winfour Hardshen reserver and clinically significant performance differences between the devices.

Substantial Equivalence Summary:

Substantial Equivatence Sammary.
In summary, the CAPIOX® RX25 Hollow Fiber Oxygenator with/without Hardshell Reservoir In summary, the CAYION® RX23 Yours Provent in intended use, principle of operation the and the predicale devices are substancials, and performance. Any noted differences between the and technology, design and materials, and possible in the person safety and effectiveness.

Additional Safety Information:

Sterilization conditions have been validated in accordance with AAM guidelines to provide . Sterility Assurance Level (SAL) of 10%. Terumo further asserts that the ethylene oxide a Sterlify Assurance Dever (DAD) of Your residue limits at the time of product distribution.
Terumo conducted biocompatibility studies as recommended in the FDA General Program . I erumo conducted blocompatibutity statics as reational Standard 150 10993, "Diological Memorandulin #G9591 (3/1773). Oso J : Evaluation and Testing." [External Communicating Evaluation of Medical Devices – Far T. Branachen and Cost Contact Duration]. The blood contacting materials were found to be biocompatible.
Terumo conducted studies for materials characterization, including physico-chemical profiles . of aged and nonaged cevices.

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

Conclusion:

Conclusion:
In summary, the CAPIOX® For the local incincincincincincinci has of one and technology, design and In summary, the CAPIOX® EX2. Hollow Fiber Of operation and technology, design and
substantially equivalent in intended use, principles of operation and technology, design and substantially equivalent in intended use, principies of openition and working of the only of the Oxygenator
materials, and performance to the prodicated devices, Terumo SX25 materials, and performance to the presentation of K993772).

. .

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Public Health Service

Image /page/5/Picture/2 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR - 3 2004

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

Re: K040210

Capiox® RX25 Oxygenator/Reservoir Regulation Number: 21 CFR 870.4350 Regulation Name: Cardiopulmonary Bypass Oxygenator Regulatory Class: Class II (two) Product Code: DTZ Dated: January 28, 2004 Reccived: January 30, 2004

Dear Mr. Courtney:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave rovewed your becamined the device is substantially cquivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use thated in the 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 Please be advised that FDA 3 issuation of a budenia complies with other requirements of the Act that IDA has made a determinations administered by other Federal agencies. You must of any Pederal Statutes and regulations daminders of registration and listing (21 comply with an the Act 3 requirements, 01); good manufacturing practice requirements as set CrK Part 807), labeling (21 CFR Part 820); and if applicable, the electronic forum in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product laulation control provisions (over device as described in your Section 510(k) I ms letter will anow you to oegin maxically your and equivalence of your device to a legally premaired notheadon: "The PDF Intelligstification 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 If you desire specific at no 10 - 30 - 301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to (201) 394-4039. Also, please note the regation may obtain. Other general information on your prematics nonneation - (210) NY fare obtained from the Division of Small Manufacturers, responsionnies under the Are They over out its toll-free number (800) 638-2041 or (301) 443-6597 incernational and Oonbainttp://www.fda.gov/cdrh/dsma/dsmamain.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

510(k) Number (if known):

K040210

Device Name:

Capiox® RX25 Oxygenator/Reservoir

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® RX25 Oxygenator with/without Hardshell Reservoir can be used in proccdures lasting up to 6 hours.

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

X = Prescription Use ____ (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)

(Division Sig. Off)
Division of Cardiovas	Page 1 of 1

510(k) Number	K040 210
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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.”