INSPIRE 7 Hollow Fiber Oxygenator with integrated Hardshell/Venous Cardiotomy Reservoir, INSPIRE 7M Hollow Fiber Oxygenator, INSPIRE 7 Dual Hollow Fiber Oxygenator with integrated Hardshell/Venous Cardiotomy Reservoir

{0}------------------------------------------------ # 510(k) Summary (in accordance with 21 CFR 807.92) 510(k) Number: K190690 ### l. Applicant Information | Applicant: | SORIN GROUP ITALIA S.R.L.<br>Via Statale 12 Nord, 86<br>Mirandola (MO)<br>41037 Italy | |----------------------------|-------------------------------------------------------------------------------------------| | Contact Person: | Luigi Vecchi<br>RA Director<br>Tel: +39-346-391-0707<br>e-mail: luigi.vecchi@livanova.com | | Application Correspondent: | LivaNova USA, Inc.<br>14401 West 65th Way | 14401 West 65th Way Arvada, CO 80004 USA Contact Person: Scott Light Senior Manager, Regulatory Affairs Tel: +1-303-467-6313 e-mail: scott.light@livanova.com Date Prepared: March 8, 2019 #### II. Subject Devices Identification | Proprietary Name: | INSPIRE 7 Hollow Fiber Oxygenator with<br>Integrated Hardshell Venous/Cardiotomy<br>Reservoir | |-----------------------|-----------------------------------------------------------------------------------------------| | Common/Usual Name: | INSPIRE 7 | | Classification Name: | Cardiopulmonary Bypass Oxygenator | | Regulation Number: | 21 CFR 870.4350 | | Product Code: | DTZ | | Classification: | Class II | | Classification Panel: | Cardiovascular | | Proprietary Name: | INSPIRE 7M Hollow Fiber Oxygenator | | Common/Usual Name: | INSPIRE 7M | | Classification Name: | Cardiopulmonary Bypass Oxygenator | | Regulation Number: | 21 CFR 870.4350 | | Product Code: | DTZ | | Classification: | Class II | {1}------------------------------------------------ | Classification Panel: | Cardiovascular | |-----------------------|----------------------------------------------------------------------------------------------------| | Proprietary Name: | INSPIRE 7 Dual Hollow Fiber Oxygenator with<br>Integrated Hardshell Venous/Cardiotomy<br>Reservoir | | Common/Usual Name: | INSPIRE 7 Dual | | Classification Name: | Cardiopulmonary Bypass Oxygenator | | Regulation Number: | 21 CFR 870.4350 | | Product Code: | DTZ | | Classification: | Class II | | Classification Panel: | Cardiovascular | #### lll. Predicate Devices The INSPIRE 7 Hollow Fiber Oxygenator with Integrated Hardshell Venous/Cardiotomy Reservoir is substantially equivalent to the following cleared predicate device. Both models have the same fundamental scientific technology and intended use: | 510(k) Number: | K130433 | |-----------------------|-----------------------------------------------------------------------------------------------| | Proprietary Name: | INSPIRE 8 Hollow Fiber Oxygenator with<br>Integrated Hardshell Venous/Cardiotomy<br>Reservoir | | Common/Usual Name: | INSPIRE 8 | | Classification Name: | Cardiopulmonary Bypass Oxygenator | | Regulation Number: | 21 CFR 870.4350 | | Product Code: | DTZ | | Classification: | Class II | | Classification Panel: | Cardiovascular | The INSPIRE 7M Hollow Fiber Oxygenator device is substantially equivalent to the following cleared predicate device. Both models have the same fundamental scientific technology and intended use: | 510(k) Number: | K180448 | |----------------------|------------------------------------| | Proprietary Name: | INSPIRE 8M Hollow Fiber Oxygenator | | Common/Usual Name: | INSPIRE 8M | | Classification Name: | Cardiopulmonary Bypass Oxygenator | | Regulation Number: | 21 CFR 870.4350 | | Product Code: | DTZ | | Classification: | Class II | The INSPIRE 7 Dual Hollow Fiber Oxygenator with Integrated Hardshell Venous/Cardiotomy Reservoir device is substantially equivalent to the following cleared predicate device. Both models have the same fundamental scientific technology and intended use: | 510(k) Number: | K121229 | |--------------------|----------------------------------------------------------------------------------------------------| | Proprietary Name: | INSPIRE 8 Dual Hollow Fiber Oxygenator with<br>Integrated Hardshell Venous/Cardiotomy<br>Reservoir | | Common/Usual Name: | INSPIRE 8 Dual | {2}------------------------------------------------ Classification Name: Cardiopulmonary Bypass Oxygenator Requlation Number: 21 CFR 870.4350 Product Code: DTZ Classification: Class II #### IV. Devices Description The intended use of the three subject devices is identical to the intended use of the three respective predicates devices. The devices are used during cardiopulmonary bypass surgery to remove carbon dioxide, provide oxygenation and control blood temperature. They consist of the following main components: - a heat exchanger consisting of a bundle of polyurethane hollow ● fibers that are wound on a cylindrical core; - . an oxygenating module element made of a coiled bundle of polypropylene microporous hollow fibers rolled on the heat exchanger sub assembly. - a hardshell venous/cardiotomy reservoir to collect, filter, and send . venous blood and suction blood to the oxygenator (only models INSPIRE 8/8DUAL and INSPIRE 7/7DUAL). The heat exchanger consists of a bundle of polyurethane hollow fibers rolled on a cylindrical core. The heat transfer is obtained through the flow of water inside the fibers and the flow of blood outside them. The heat exchanger is inserted in the gas exchanger and surrounded by the oxygenating module element, which is constructed of a coiled bundle of polypropylene microporous hollow fibers rolled on the heat exchanger sub assembly. The blood path is around the outside of the fibers, while the gas path is through the lumen of the fibers. In the versions 8/8DUAL and 7/7DUAL the oxygenator module is integrated with a hardshell/venous reservoir via a molded fitting joint. The hardshell/venous reservoir is comprised of rigid polycarbonate housing. Venous and cardiotomy filtering systems are physically distinct to allow a good filtration efficiency of venous and suction blood (one filters venous blood, the other filters suction blood). The reservoir is provided with a vent/vacuum port together with an over-under valve that prevents excess of negative or positive pressure, avoiding implosion and over pressurization of the reservoir itself. The blood enters the reservoir through the cardiotomy section through the rotating turret equipped with 3/8", 1/4" and female luer inlet connectors and through the venous inlet 1/2" connector provided with female luer connector. Both cardiotomy turret and venous inlet connectors can rotate 360°. The reservoir lid has also additional unfiltered luer ports. The oxygenating module of all the INSPIRE oxygenators include a dedicated outlet with a one way valve that provides access to arterial blood throughout the procedure for cardioplegia, perfusion or blood concentration. The outlet is placed close to the arterial outlet of the oxygenator and opposite to the temperature probe port. Arterial and venous temperature probe sites are also {3}------------------------------------------------ provided: the former is located close to the arterial blood outlet, while the latter is placed on the venous inlet of the reservoir. Figure 7-1 shows the oxygenating modules with the visible ports identified. Image /page/3/Figure/1 description: The image shows two diagrams of a medical device, likely a blood oxygenator or similar device used in cardiopulmonary bypass. The diagrams label various ports and connectors on the device, including the Luer connector for purge/recirculation line, gas inlet, gas scavenging connector, temperature probe port, cardioplegia port, blood inlet, and blood outlet. The diagram on the right also labels the water port and arterial sampling connector. Figure 7-1: Oxygenating module integrated with heat exchanger ### Indications for Use > All INSPIRE oxygenators - the three subject devices (i.e., the INSPIRE 7 Hollow Fiber Oxygenator with Integrated Hardshell Venous/Cardiotomy Reservoir, the INSPIRE 7M Hollow Fiber Oxygenator and the INSPIRE 7 Fiber Oxygenator with Hardshell Dual Hollow Integrated Venous/Cardiotomy Reservoir), as well as the three predicate devices (i.e., the INSPIRE 8 Hollow Fiber Oxvgenator with Integrated Hardshell Venous/Cardiotomy Reservoir, the INSPIRE 8M Hollow Fiber Oxygenator and the INSPIRE 8 Dual Hollow Fiber Oxygenator with Integrated Hardshell Venous/Cardiotomy Reservoir) - are intended for use in adult and small adult surgical procedures requiring cardiopulmonary bypass. They all provide gas exchange support and blood temperature control and are intended to be used for 6 hours or less. #### VI. Summary of Technical Characteristics The technical characteristics of the subject INSPIRE oxygenators (i.e., 7, 7M and 7 Dual) are identical to those of the predicate INSPIRE oxygenators (i.e., 8, 8M and 8 Dual). Blood aspirated from the patient and from the operating field (by gravity or by vacuum applied through an external source) enters the reservoir flowing through the venous and the cardiotomy filter, respectively. Blood is then filtered in order to remove solid particles, micro-aggregates, blood foam, and air bubbles. The blood volume in the reservoir is monitored by graduations on the hardshell. {4}------------------------------------------------ Filtered blood is then pumped from the hardshell venous/cardiotomy reservoir to the venous inlet port of the gas oxygenating module. Incoming blood enters the heat exchange module, which is inserted inside the gas oxygenating module. The blood temperature is controlled by adjusting the temperature of the circulating water that flows inside the heat exchanger fibers, partially counter-flow in respect to blood flow direction. Blood then flows into the gas module; gas flows through the interior of the hollow fibers and blood flows over the exterior of the hollow fibers. Arterial blood is collected in a collection chamber and flows back to the patient through the arterial outlet port. Gas exchange takes place inside the gas module. A mixture of air and oxygen flows inside the gas exchanger fiber lumen, allowing oxygen exchange with blood across fiber walls due to an oxygen partial pressure differential between the gas and blood compartments. Carbon dioxide, produced by patient metabolism, is removed from blood with the same exchange principle, passing from the blood to the gas compartment and exiting through the gas outlet port. By regulating blood flow rate, gas flow rate, and percentage of oxygen in the gas mixture, it is possible to requlate oxygen delivery to the patient. Requlation of the patient body temperature allows modification of the patient metabolism, and change in patient oxygen requirement. #### VII. Substantial Equivalence Discussion The following tables compare the features of each subject INSPIRE device (i.e., 7, 7M and 7 Dual) with those of their respective predicates (i.e., 8, 8M and 8 Dual), with respect to indications for use, environment of use, intended use, limitations of use, principles of operation and main performance characteristics. More detailed information regarding the basis for the determination of substantial equivalence can be found in Section 10 of this 510(k) submission. The three subject devices have the same fundamental scientific technology and intended use as their respective predicate devices. {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. April 13, 2019 Sorin Group Italia S.r.1. % Scott Light Senior Manager, Regulatory Affairs LivaNova USA, Inc. 14401 West 65th Way Arvada. Colorado 80004 Re: K190690 Trade/Device Name: INSPIRE 7 Hollow Fiber Oxygenator with integrated Hardshell/Venous Cardiotomy Reservoir, INSPIRE 7M Hollow Fiber Oxygenator, INSPIRE 7 Dual Hollow Fiber Oxygenator with integrated Hardshell/Venous Cardiotomy Reservoir Regulation Number: 21 CFR 870.4350 Regulation Name: Cardiopulmonary bypass oxygenator Regulatory Class: Class II Product Code: DTZ. DTZ. DTN Dated: March 8, 2019 Received: March 18, 2019 Dear Scott Light: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrl/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. {6}------------------------------------------------ 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 device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, fi applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@tda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {7}------------------------------------------------ # Indications for Use 510(k) Number (if known) ### K190690 Device Name INSPIRE 7 Dual Hollow Fiber Oxygenator with Integrated Hardshell Venous/Cardiotomy Reservoir Indications for Use (Describe) The INSPIRE 7 Dual is intended for use in adult surgical procedures requiring cardiopulmonary bypass. The INSPIRE 7 Dual provides gas exchange support and blood temperature control and is intended to be used for 6 hours or less. | Type of Use (Select one or both, as applicable) | | |----------------------------------------------------------------------------------------------------------|-----------------------------------------------| | <span style="font-family: DejaVu Sans, sans-serif">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {8}------------------------------------------------ # Indications for Use 510(k) Number (if known) ### K190690 Device Name INSPIRE 7 Hollow Fiber Oxygenator with Integrated Hardshell Venous/Cardiotomy Reservoir Indications for Use (Describe) The INSPIRE 7 is intended for use in adult surgical procedures requiring cardiopulmonary bypass. The INSPIRE 7 provides gas exchange support and blood temperature control and is intended to be used for 6 hours or less. X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {9}------------------------------------------------ # Indications for Use 510(k) Number (if known) ### K190690 Device Name INSPIRE 7M Hollow Fiber Oxygenator ### Indications for Use (Describe) The INSPIRE 7M is intended for use in adult surgical procedures requiring cardiopulmonary bypass. The INSPIRE 7M provides gas exchange support and blood temperature control and is intended to be used for 6 hours or less. Type of Use (Select one or both, as applicable) | <div> <input checked="true" type="checkbox"/> <span>Residential Use (Part 21 CFR 601 Subpart D)</span> </div> | |---------------------------------------------------------------------------------------------------------------| | <div> <input type="checkbox"/> <span>Over-The-Counter Use (21 CFR 601 Subpart D)</span> </div> | > Prescription Use (Part 21 CFR 801 Subpart D) | | Over-The-Counter Use (21 CFR 801 Subpart C) ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."