Terumo Capiox SX18 Oxygenator/ Hardshell Reservoir, Terumo Capiox SX18 Oxygenator/ Hardshell Reservoir with Xcoating, Terumo Capiox SX25 Oxygenator/Hardshell Reservoir, Terumo Capiox SX25 Oxygenator/Hardshell Reservoir with Xcoating

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of three human profiles facing to the right, stacked on top of each other. The profiles are simple and abstract, with flowing lines suggesting hair or clothing. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. ### DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 December 02, 2015 Terumo Cardiovascular Systems Corp. Joshua Ewing Senior Regulatory Affairs Associate 125 Blue Ball Road Elkton, Maryland 21921 Re: K153140 Trade/Device Name: Capiox SX18 Hollow Fiber Oxygenator with detachable Hardshell Reservoir. Capiox SX25 Hollow Fiber Oxygenator with detachable Hardshell Reservoir. X-Coated Capiox SX18 Hollow Fiber Oxygenator with/without detachable Hardshell Reservoir, X-Coated Capiox SX25 Hollow Fiber Oxygenator with/without detachable Hardshell Reservoir Regulation Number: 21 CFR 870.4350 Regulation Name: Cardiopulmonary Bypass Oxygenator Regulatory Class: Class II Product Codes: DTZ, DTN, DTR, DTP Dated: October 28, 2015 Received: October 30, 2015 Dear Joshua Ewing: 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. {1}------------------------------------------------ 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 of medical devicerelated 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 contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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 yours, M.A. Hilleman for for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows the Terumo company logo. The logo consists of a green circle with a stylized "T" inside, followed by the word "TERUMO" in green, sans-serif capital letters. A small circle is present to the upper right of the word "TERUMO". #### SECTION 4 Indications for Use 510(k) Number (if known): K153140 Capiox® SX18 Hollow Fiber Oxygenator with detachable Hardshell Device Name: Reservoir > Capiox® SX25 Hollow Fiber Oxygenator with detachable Hardshell Reservoir X-Coated Capiox® SX18 Hollow Fiber Oxygenator with/without detachable Hardshell Reservoir X-Coated Capiox® SX25 Hollow Fiber Oxygenator with/without detachable Hardshell Reservoir # Indications for Use: The (X-Coated) Capiox® SX25 and SX18 Hollow Fiber Oxygenators with/without Detachable Hardshell Reservoirs are used to exchange gases between blood and a gaseous environment to satisfy the gas exchange needs of a patient during cardiopulmonary bypass surgery for periods up to 6 hours. The integral heat exchanger is used to warm or cool blood 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. 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 Hardshell Reservoir is also used for post-operative chest drainage and autotransfusion procedures to aseptically return the blood to the patient for blood volume replacement. The Hardshell Reservoir is also used with the vacuum-assisted venous return technique during cardiopulmonary bypass. (The X-Coating™ is a polymer coating that is applied to blood contacting surfaces of the oxygenator to reduce the adhesion of platelets to the surfaces of the device.) OR 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) {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the Terumo Corporation logo. The logo consists of a green circle with a stylized "T" inside, followed by the word "TERUMO" in green, block letters. A registered trademark symbol is present to the right of the word. ### Submitter Information: Primary Contact: This submission was prepared in October 2015 by: Joshua Ewing Senior Regulatory Affairs Associate Terumo Cardiovascular Systems Corporation 125 Blue Ball Road Elkton, MD 21921 Telephone: 1-800-262-3304, Ext. 7473 Fax: 410-392-7171 Alternate Contact: Garry A. Courtney, MBA, RAC Senior Manager, Regulatory Affairs Terumo Cardiovascular Systems Corporation 125 Blue Ball Road Elkton, MD 21921 Telephone: 1-800-262-3304, Ext. 7486 Fax: 410-392-7171 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 | |-----------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------| | Capiox® SX18/25 Hollow<br>Fiber Oxygenator with<br>detachable Hardshell<br>Reservoir | Cardiopulmonary Bypass<br>Oxygenator (Code: DTZ)<br>Cardiopulmonary Bypass<br>Blood Reservoir (Code: DTN)<br>Cardiopulmonary Bypass<br>Heat Exchanger (Code: DTR)<br>Cardiopulmonary Bypass<br>Defoamer (Code: DTP) | Blood Gas Oxygenator<br>Blood Reservoir<br>Heat Exchanger<br>Defoamer | | X-Coated Capiox® SX18/25<br>Hollow Fiber Oxygenator<br>with detachable Hardshell<br>Reservoir | Cardiopulmonary Bypass<br>Oxygenator (Code: DTZ)<br>Cardiopulmonary Bypass<br>Blood Reservoir (Code: DTN)<br>Cardiopulmonary Bypass<br>Heat Exchanger (Code: DTR)<br>Cardiopulmonary Bypass<br>Defoamer (Code: DTP) | Blood Gas Oxygenator<br>Blood Reservoir<br>Heat Exchanger<br>Defoamer | {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the Terumo logo. The logo consists of a green circle with a stylized "T" inside, followed by the word "TERUMO" in green, sans-serif font. The logo is simple and modern, and the green color suggests health and vitality. ## Predicate Device(s): The device submitted in this 510(k) maintains characteristics that are substantially equivalent to the following devices: - CAPIOX SX18 and SX25 Hollow Fiber Oxygenators (with/without X-Coating), with/without Detachable Reservoirs (K130359) ### Indications for Use: The intended use remains the same as the intended use in the cleared submission (K130359). There have been no changes to the indications or intended use of the modified devices as a result of the modifications to the hardshell reservoir. There are no modifications to the SX oxygenator. The (X-Coated) Capiox® SX25 and SX18 Hollow Fiber Oxygenators with/without Detachable Hardshell Reservoirs are used to exchange gases between blood and a gaseous environment to satisfy the gas exchange needs of a patient during cardiopulmonary bypass surgery for periods up to 6 hours. The integral heat exchanger is used to warm or cool blood 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. 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 Hardshell Reservoir is also used for post-operative chest drainage and autotransfusion procedures to aseptically return the blood to the patient for blood volume replacement. The Hardshell Reservoir is also used with the vacuum-assisted venous return technique during cardiopulmonary bypass. (The X-Coating™ is a polymer coating that is applied to blood contacting surfaces of the oxygenator to reduce the adhesion of platelets to the surfaces of the device.) #### Principles of Operation and Technology: The technological characteristics and principles of operation remain the same as that of the predicate devices previously cleared (K130359) for all devices in this submission. There have been no changes to the fundamental scientific technology of the modified devices. The modified and predicate Capiox® SX18/25 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. {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the Terumo company logo. The logo consists of a green circle with a stylized "T" inside it, followed by the word "TERUMO" in green, sans-serif font. A small registration mark is present to the right of the word. The modified and predicate Capiox® SX18/25 Oxygenator 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. With respect to the filtration of blood, the modified and predicate Capiox® Hardshell Reservoir relies upon mechanical entrapment of particulates and emboli within the filter mesh as a means to remove those particulates from the blood. ### Design and Materials: With respect to the design of the oxygenator, the design of the Capiox® SX18/25 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, the reservoir component remains identical to the design of the original reservoir that was cleared by FDA with (K130359) - except the modified device will include PVC tubing (with TOTM plasticizer) for a flared venous inlet drop tube, auxiliary tube, sampling manifold tubing, and purge line tubing. There are no other modifications being made to the device. The materials that are used in the construction of the CAPIOX® SX18/25 Oxygenator/Hardshell Reservoir may include, but are not limited to, nylon, polycarbonate, stainless steel, polyvinyl chloride (TOTM plasticizer and DEHP plasticizer), polyurethane, polyester, polyester, polyethylene, and X-Coating™. | Device Characteristics | Modified Device | Predicate Device | |--------------------------|----------------------------|------------------------------| | Venous Inlet Drop Tube | Flared, TOTM plasticizer | Non-Flared, DEHP plasticizer | | Auxiliary Drop Tube | Straight, TOTM plasticizer | Straight, DEHP plasticizer | | Sampling Manifold Tubing | TOTM plasticizer | DEHP plasticizer | | Purge line Tubing | TOTM plasticizer | DEHP plasticizer | The flared venous drop tube will improve flow dynamics within the reservoir. The use of a TOTM plasticizer instead of a DEHP plasticizer allows Terumo to adjust to pending regulatory requirements. No modifications are being made to the oxygenator. No additional modifications, other than what is listed above, are being made to the hardshell reservoir. Terumo Cardiovascular Systems Corporation 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: Terumo Cardiovascular Systems Corporation conducted the following in-vitro performance evaluations to demonstrate the functional equivalence of the subject device to the predicate device: - Hemolysis Testing - Air Handling - Reservoir Pressure Drop ● - Venous Defoaming ● {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the Terumo Corporation logo. The logo consists of a green circle with a stylized "T" inside, followed by the word "TERUMO" in green, sans-serif font. A small circle is present to the right of the word "TERUMO". ## Substantial Equivalence Comparison: In demonstrating substantial equivalence of the modified CAPIOX® SX18/25 Oxygenator/Hardshell Reservoir to the predicate CAPIOX® SX18/25 Oxygenator/Hardshell Reservoir, a comparative study and/or assessment was performed in each of the following areas: - Intended use . - Target Population . - Duration of use o - . Product design - Materials used in device construction . - Principles of Operation and Technology . - Device Performance o - Product labeling . ### Substantial Equivalence Statement: The modified CAPIOX® SX18/25 Oxygenator/Hardshell Reservoir and the predicate CAPIOX® SX18/25 Oxygenator/Hardshell Reservoir 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 for CAPIOX® SX18/25 Oxygenator/Hardshell Reservoirs are validated to meet the requirements established in EN ISO 11135-1:2007. The validated processes ensure a minimum Sterility Assurance Level of 10th. Product sterilization is controlled through strict maintenance of the processing parameters and, in some cases, post-sterilization biological indicator testing (if required for routine processing). Post-sterilization release for use is determined with consideration to maximum. Ethylene Oxide and Ethylene Chlorhydrin residue limits and maximum levels of exposure in accord with ANSI/AAMI/ISO 10993-7. ### Conclusion: Based upon the comparative studies and analyses, Terumo Cardiovascular Systems Corporation concludes that the modified CAPIOX® SX18/25 Oxygenator/Hardshell Reservoir is substantially equivalent to the predicate modified CAPIOX® SX18/25 Oxygenator/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.