CAPIOX SX18 HOLLOW FIBER OXYGENATOR WITH DETACHABLE HARDSHELL RESERVOIR, CAPIOX SX25 HOLLOW FIBER OXGENATOR WITH DETACHA

{0}------------------------------------------------ | SECTION 5 - 510(k) Summary<br>Modified Capiox® SX Oxygenator and Hardshell Reservoir | MAR 1 3 2013 | |--------------------------------------------------------------------------------------|--------------| | Submitter Information | 24 | | Device Names | 24 | | Identification of Predicate Device | 25 | | Intended Use | 25 | | Principles of Operation and Technology | 27 | | Design and Materials | 27 | | Performance Evaluations | 28 | | Substantial Equivalence Comparison | 28 | | Substantial Equivalence Statement | 28 | | Conclusion for 510(k) Summary | 28 | - . . : . {1}------------------------------------------------ ## 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 | |-----------------------------|-----------------------------|----------------------| | Capiox® SX18 Hollow Fiber | Cardiopulmonary Bypass | Blood Gas Oxygenator | | Oxygenator with detachable | Oxygenator (Code: DTZ) | | | Hardshell Reservoir | Cardiopulmonary Bypass | Blood Reservoir | | | Blood Reservoir (Code: DTN) | | | | | | | Capiox® SX25 Hollow Fiber | Cardiopulmonary Bypass | Blood Gas Oxygenator | | Oxygenator with detachable | Oxygenator (Code: DTZ) | | | Hardshell Reservoir | Cardiopulmonary Bypass | Blood Reservoir | | | Blood Reservoir (Code: DTN) | | | | | | | X-Coated Capiox® SX18 | Cardiopulmonary Bypass | Blood Gas Oxygenator | | Hollow Fiber Oxygenator | Oxygenator (Code: DTZ) | | | with/without detachable | Cardiopulmonary Bypass | Blood Reservoir | | Hardshell Reservoir | Blood Reservoir (Code: DTN) | | | | | | | X-Coated Capiox® SX25 | Cardiopulmonary Bypass | Blood Gas Oxygenator | | Hollow Fiber Oxygenator | Oxygenator (Code: DTZ) | | | with/without detachable | Cardiopulmonary Bypass | Blood Reservoir | | Hardshell Reservoir | Blood Reservoir (Code: DTN) | | | | | | | Capiox® Hardshell Reservoir | Cardiopulmonary Bypass | Blood Reservoir | | | Blood Reservoir (Code: DTN) | | | | | | {2}------------------------------------------------ ### Predicate Devices: 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® SX18 Hollow Fiber Oxygenator with Detachable Hardshell Reservoir (K961000) CAPIOX® SX25 Hollow Fiber Oxygenator with Detachable Hardshell Reservoir (K962667) X-Coated CAPIOX® SX18 and SX25 Hollow Fiber Oxygenators with/without Detachable Hardshell Reservoirs (K993772) > Capiox® RX Hardshell Reservoir (K013526) {3}------------------------------------------------ ### Intended Use: The intended use remains the same as the intended use in the cleared submissions (K961000, K962667, K993772, and K013526). There have been no changes to the indications or intended use of the modified devices as a result of the addition of the positive pressure relief valve. # Intended Use for Oxygenator/Reservoir Product: 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 priods 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 sectiventhat 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 asir 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. ) ## Intended Use for Reservoir Only Product: The Capiox® Hardshell Reservoir is a hardshell reservoir used to store blood during extracorporeal circulation from both the venous line and the cardiotomy line. The reservoir contains filters to remove particulate matter and defoamers to facilitate air bubble removel. The Hardshell Reservoir is also used for post-operative chest drainage and autotransfusion procedures to aseptically return 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 Hardshell Reservoir contains X-Coating, which is intended to reduce platelet adhesion on the surfaces of the device. The device may be used for procedures lasting up to 6 hours. {4}------------------------------------------------ # Principles of Operation and Technology: # The technological characteristics and principles of operation remain the same as that of the predicate devices previously cleared (K961000, K962667, K993772, and K013620, for all devices in this submission. There have been no changes to the fundaments lof ivi an technology of the modified devices. The modified and predicate Capiox SX 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 by the A 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 SX Oxygenator has an integrated heat exchanger that is comprised of stainless steel encased in a polycarbonate housing. The stainless steel acts as heat transfer material that permits heat that is generated from a temperature controlled external i 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 messive its a means to remove those particulates from the blood. ## Design and Materials: With respect to the design of the oxygenator, the design of the modified Capiox SX 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 (K961000, K962667, K993772, and K013526) ~ except that a positive pressure relief valve will be included in 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® SX Oxygenator/Hardshell Reservoir may include, but are not limited to, nylon, polycarbonate, stainless steel, rollyvinyl 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 softev and effectiveness of the device when used as labeled. {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: - 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 . ### Substantial Equivalence Comparison: In demonstrating substantial equivalence of the modified CAPIOX® SX Oxygenator/Hardshell Reservoir to the predicate CAPIOX® SX Oxygenator/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® SX Oxygenator/Hardshell Reservoir and the predicate CAPIOX® SX 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 safere and effectiveness. ### Conclusion: Based upon the comparative studies and analyses, Terumo Cardiovascular Systems concludes that the modified CAPIOX® SX Oxygenator/Hardshell Reservoir is substarrights equivalent to the predicate modified CAPIOX® SX 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. {6}------------------------------------------------ Image /page/6/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular arrangement of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in all caps. Inside the circle is a stylized image of an eagle or bird-like figure with three curved lines representing its wings or body. ### Public Health Service 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: K130359 Trade/Device Name: CAPIOX SX18 and SX25 Hollow Fiber Oxygenators (with/without X-Coating), with/without Detachable Hardshell Reservoirs; and CAPIOX RX Hardshell Reservoir Regulation Number: 21 CFR 870.4350 -Regulation Name: Cardiopulmonary Bypass Oxygenator Regulatory Class: Class II Product Code: DTZ Dated: February 12, 2013 Received: February 13, 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 indictions 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 misleding. 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 Righter. 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 {7}------------------------------------------------ Page 2 -- Ms. Suzanne Grenier 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 100-1050, 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.html for the Center for Devices and Radiological Health's (CDRH) s) Office of Compliance. Also, please note the regulation entitled, "Misbanding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of telefone to premation" (21CFR Part CFR Part 803), please go to 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 the Act from the (800) 638-2041 or (301) 706-7100 continer Assistance at its toll-free num (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Sincerely yours. # Matthew G. Hillebrenner for Bram D. Zuckerman, M.D. Director Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {8}------------------------------------------------ # SECTION 4 - Indications for Use Modified Capiox® SX Oxygenator and Hardshell Reservoir #### 510(k) Number (if known): Unknown at time of Submission 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 ## 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 buble 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.) | Prescription Use _____________________________________________________________________________________________________________________________________________________________ | OR OR | ം | |--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------|-----------------------------| | (Part 21 CFR 801 Subpart D) | | (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 {9}------------------------------------------------ # t TERUMO # SECTION 4 – Indications for Use Modified Capiox® SX Oxygenator and Hardshell Reservoir 510(k) Number (if known): Unknown at time of Submission Device Name: # Capiox® Hardshell Reservoir ### Indications For Use: The Capiox® Hardshell Reservoir is a hardshell reservoir used to store blood during extracorporeal circulation from both the venous line. And the cardiotomy line. The reservoir contains filters to remove particulate matter and defoamers to facilitate air bubble removal. The Hardshell Reservoir is also used for post-operative chest drainage and autotransfusion procedures to aseptically return 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 Hardshell Reservoir contains X-Coating, which is intended to reduce platelet adhesion on the surfaces of the device of the device. The device may be used for procedures lasting up to 6 hours. | Prescription Use XX __________________________________________________________________________________________________________________________________________________________ | OR OR SE | ം | |--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------|-----------------------------| | (Part 21 CFR 801 Subpart D) | | (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