INSPIRE 6 DUAL HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RESERVIOR

{0}------------------------------------------------ |21909 Special 510(k) June 27, 2012 JUL 26 2012 # 510(k) SUMMARY SUBMITTER: Sorin Group Italia 86, Via Statale 12 Nord · 41037 Mirandola (MO) Italy June 27, 2012 CONTACT PERSON: Luigi Vecchi Phone: 39 0535 29811 Fax: 39 0535 25229 DATE PREPARED: DEVICE TRADE NAME: INSPIRE 6 DUAL hollow fiber oxygenator with integrated hardshell venous/cardiotomy reservoir INSPIRE 6F DUAL hollow fiber oxygenator with integrated arterial filter and hardshell venous/cardiotomy reservoir ### COMMON NAMES: Hollow Fiber Oxygenator with integrated hardshell venous/cardiotomy reservoir Hollow Fiber Oxygenator Hardshell Venous/Cardiotomy Reservoir ### INSPIRE 6F DUAL: INSPIRE 6 DUAL: Hollow Fiber Oxygenator with integrated arterial filter and hardshell venous/cardiotomy reservoir Hollow Fiber Oxygenator with integrated arterial filter Hardshell Venous/Cardiotomy Reservoir ### CLASSIFICATION NAME: INSPIRE 6 DUAL: Cardiopulmonary Bypass Oxygenator/ Cardiopulmonary Bypass Heat Exchanger/ Cardiopulmonary Bypass Blood Reservoir/ Cardiopulmonary Bypass Defoamer #### INSPIRE 6F DUAL: Cardiopulmonary Bypass Oxygenator/ Cardiopulmonary Bypass Heat Exchanger/ Cardiopulmonary Bypass Blood Reservoir/ Cardiopulmonary Bypass Defoamer/ Cardiopulmonary Bypass Arterial Line Blood Filter {1}------------------------------------------------ Special 510(k) . June 27, 2012 # UNMODIFIED DEVICES: - INSPIRE 6 hollow fiber oxygenator with integrated hardshell venous/cardiotomy reservoir (K113626) INSPIRE 6F hollow fiber oxygenator with integrated arterial filter and hardshell venous/cardiotomy reservoir (K120185) # DEVICE DESCRIPTION: The INSPIRE 6 DUAL and INSPIRE 6F DUAL are high efficiency microporous hollow fiber membrane oxygenators integrated with heat exchanger (INSPIRE 6M and INSPIRE 6F M, respectively) and connected to a hardshell venous/cardiotomy reservoir (INSPIRE HVR DUAL). A molded fitting joint connects the oxygenator to the reservoir. As compared to the INSPIRE 6 DUAL, the INSPIRE 6F DUAL oxygenating module is also integrated with an arterial filter. The device can be operated at flow rates up to 6 liters per minute (I/min). The hollow fiber membrane oxygenator provides oxygenation and carbon dioxide removal from venous blood or suctioned blood. The integrated heat exchanger controls blood temperature and allows the use of hypothermia or aids in the maintenance of normothermia during surgery. The integrated arterial filter provides additional protection against air and solid emboli and the integrated hardshell reservoir collects, defoams, filters venous and suctioned blood, and can be used post-operatively for chest drainage. The INSPIRE 6 DUAL and INSPIRE 6F DUAL are a modified version of the currently marketed INSPIRE 6 and INSPIRE 6F integrated oxygenator/hardshell venous cardiotomy reservoir systems: #### INDICATION FOR USE: The intended use for the two elements that constitute the integrated device are: #### INSPIRE 6M: Hollow Fiber Oxygenator INSPIRE 6M is intended for use in adult and small adult surgical procedures requiring cardiopulmonary bypass. It provides gas exchange support and blood temperature control. INSPIRE 6M is intended to be used for 6 hours or less. ### INSPIRE 6F M: Hollow Fiber Oxygenator The INSPIRE 6F M is intended for use in adult and small adult surgical procedures requiring cardiopulmonary bypass. It provides gas exchange support and blood temperature control. INSPIRE 6F M integrated arterial filter provides additional protection against air and solid emboli. INSPIRE 6F M is intended to be used for 6 hours or less. {2}------------------------------------------------ INSPIRE 6 DUAL, INSPIRE 6F DUAL Special 510(k) June 27, 2012 Sorin Group Italia S.r.I. #### INSPIRE HVR DUAL: Hardshell Venous/Cardiotomy Reservoir INSPIRE HVR DUAL is intended for use in adult and small adult surgical procedures requiring cardiopulmonary bypass. It collects, defoams and filters venous blood and suction blood. INSPIRE HVR DUAL can be used post-operatively for chest drainage. INSPIRE HVR DUAL is intended to be used for 6 hours or less. ### TECHNOLOGICAL CHARACTERISTICS: The INSPIRE 6 DUAL and INSPIRE 6F DUAL have the same fundamental technological characteristics, principles of operation and control mechanisms as the unmodified devices. The INSPIRE 6 DUAL and INSPIRE 6F DUAL integrated devices will be provided with a dual chamber venous/cardiotomy reservoir (INSPIRE HVR DUAL) rather than a single chamber venous/cardiotomy reservoir (INSPIRE HVR) as for the INSPIRE 6 and INSPIRE 6F unmodified devices. No change to the oxygenating modules has been made as a result of this modification. The INSPIRE 6 DUAL and INSPIRE 6F DUAL modified devices are provided with oxygenating modules identical with respect to the unmodified devices. No change to the intended use has been made as a result of these modifications. The INSPIRE 6 DUAL and INSPIRE 6F DUAL and the unmodified devices share the same fundamental technological characteristics except for some modifications that do not affect the basic device function. These differences do not raise any new issues of safety and effectiveness. Sorin believes that the INSPIRE 6 DUAL and INSPIRE 6F DUAL are substantially equivalent to the INSPIRE 6 and INSPIRE 6F on the basis of operating principles and basic function. There are no differences in packaging type and material between unmodified and the modified devices. The INSPIRE 6 DUAL and INSPIRE 6F DUAL are ethylene oxide sterilized and have a non-pyrogenic fluid path. They are for single use only. #### NON CLINICAL TEST RESULTS: Applicable tests were conducted in accordance with the requirements of ISO 10993-1 and the FDA May 1st, 1995 Memorandum on the use of the ISO 10993 standard for biocompatibility testing of materials. {3}------------------------------------------------ # IN VITRO TEST RESULTS: In vitro testing was conducted in accordance with the relevant requirements of "Guidance for Extracorporeal Blood Circuit Defoamer 510(k) Submissions; Final Guidance for Industry and FDA" issued on November 29, 2000; ISO 15674, "Cardiovascular implants and artificial organs — Hard-shell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bags". In vitro testing was conducted on hardshell venous/cardiotomy reservoir to demonstrate unmodified devices substantial equivalency and compliance to safety and effectiveness requirements. The modified INSPIRE 6 DUAL, INSPIRE 6F DUAL and unmodified INSPIRE 6. INSPIRE 6F utilize identical oxygenating modules integrated with heat exchanger and arterial filter (only for INSPIRE 6F unmodified device and INSPIRE 6F DUAL modified device). This 510(k) cross references performance data previously submitted in the INSPIRE 6 (K113626) and INSPIRE 6F (K120185) for the following aspects: Oxygenating module structural integrity, Oxygenating module blood, water, gas pathway integrity, Oxygenating module blood volume capacity, Oxygenating module gas transfer performance/blood side pressure drop, Oxygenating module heat exchange performance/water side pressure drop, Oxygenating module air handling capability, Oxygenating module filtration efficiency, Oxygenating module hemolysis, Oxygenating module blood compatibility, Oxygenating module leaching of coating, Oxygenating module flaking of coating, Oxygenating module uniformity of coating, The following table lists the performance and physical/mechanical integrity tests conducted to demonstrate compliance to the product's performance specifications. The INSPIRE 6 DUAL and INSPIRE 6F DUAL successfully met all acceptance criteria for each test. | TEST | TEST CLASSIFICATION | TEST TITLE | |------|------------------------|-----------------------------------------------| | 1 | Physical/Mechanical | Structural integrity | | 2 | Physical/Mechanical | Blood pathway integrity | | 3 | Functional/Performance | Blood rest volume | | 4 | Functional/Performance | Air handling | | 5 | Functional/Performance | Break-through time and volume | | 6 | Functional/Performance | Defoaming efficiency | | 7 | Functional/Performance | Dynamic priming volume / Hold-up | | 8 | Functional/Performance | Filtration efficiency - venous section | | 9 | Functional/Performance | Filtration efficiency - cardiotomy<br>section | | 10 | Functional/Performance | Flow rate capacity | {4}------------------------------------------------ 510(k) Page 125 | TEST | TEST CLASSIFICATION | TEST TITLE | |------|------------------------|-----------------------| | 11 | Functional/Performance | Pressure drop | | 12 | Functional/Performance | Hemolysis | | 13 | Functional/Performance | Blood compatibility | | 14 | Functional/Performance | Leaching of coating | | 15 | Functional/Performance | Flaking of coating | | 16 | Functional/Performance | Uniformity of coating | ### CONCLUSIONS: The results of in vitro studies demonstrate that the modified devices perform in a manner substantially equivalent to the unmodified devices with respect to the relevant functional parameters. Test results of this study demonstrate the INSPIRE 6 DUAL and INSPIRE 6F DUAL are equivalent to the INSPIRE 6 and INSPIRE 6F unmodified devices with respect to device function. Additional testing has also demonstrated the effectiveness of production techniques to assure that the device is sterile and non-pyrogenic. {5}------------------------------------------------ Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 JUL 26 2012 Sorin Group USA, Inc. c/o Mr. Scott Light Regulatory Affairs Manager 14401 W. 65th Way Arvada. CO 80004 Re: K121909 Trade/Device Names: INSPIRE 6 DUAL Hollow Fiber Oxygenator with Integrated Hardshell Venous/Cardiotomy Reservoir and INSPIRE 6F DUAL Hollow Fiber Oxygenator with Integrated Arterial Filter and Hardshell Venous/Cardiotomy Reservoir Regulation Number: 21 CFR 870.4350 Regulation Name: Cardiopulmonary Bypass Oxygenator Regulatory Class: Class II Product Code: DTZ, DTN Dated: June 27, 2012 Received: June 29, 2012 Dear Mr. Light: We have reviewed your Section 510(k) premarket notification of intent to market the devices referenced above and have determined the devices are 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 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}------------------------------------------------ ### Page 2 - Mr. Scott Light 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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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, Bram D. Zuckerman. M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {7}------------------------------------------------ 510(k) Number (if known): Device Name: INSPIRE 6 DUAL hollow fiber oxygenator with integrated hardshell venous/cardiotomy reservoir Indication for Use: #### INSPIRE 6M: Hollow Fiber Oxygenator INSPIRE 6M is intended for use in adult and small adult surgical procedures requiring cardiopulmonary bypass. It provides gas exchange support and blood temperature control. INSPIRE 6M is intended to be used for 6 hours or less. #### INSPIRE HVR DUAL: Hardshell Venous/Cardiotomy Reservoir INSPIRE HVR DUAL is intended for use in adult and small adult surgical procedures requiring cardiopulmonary bypass. It collects, defoams and filters venous blood and suction blood. INSPIRE HVR DUAL can be used postoperatively for chest drainage. INSPIRE HVR DUAL is intended to be used for 6 hours or less. Device Name: INSPIRE 6F DUAL hollow fiber oxygenator with integrated arterial filter and hardshell venous/cardiotomy reservoir Indication for Use: #### INSPIRE 6F M: Hollow Fiber Oxygenator The INSPIRE 6F M is intended for use in adult and small adult surgical procedures requiring cardiopulmonary bypass. It provides gas exchange support and blood temperature control. INSPIRE 6F M integrated arterial filter provides additional protection against air and solid emboli. INSPIRE 6F M is intended to be used for 6 hours or less. ### INSPIRE HVR DUAL: Hardshell Venous/Cardiotomy Reservoir INSPIRE HVR DUAL is intended for use in adult and small adult surgical procedures requiring cardiopulmonary bypass. It collects, defoams and filters venous blood and suction blood. INSPIRE HVR DUAL can be used postoperatively for chest drainage. INSPIRE HVR DUAL is intended to be used for 6 hours or less. {8}------------------------------------------------ Special 510(k) June 27, 2012 Prescription Use X (Part 21CFR 801 Subpart D) Over-the- Counter Use AND/OR (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 Sign: 0%) Division of Carderascular Devices 510(k; Numbor 21 90