AC3 Series IABP System

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other. Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 March 31, 2017 Arrow International, Inc. Alifiya Jagmag Manager, Regulatory Affairs 16 Elizabeth Dr. Chelmsford, Massachusetts 01824 Re: K162820 Trade/Device Name: AC3 Series IABP System Regulation Number: 21 CFR 870.3535 Regulation Name: Intra-Aortic Balloon and Control System Regulatory Class: Class II Product Code: DSP Dated: March 3, 2017 Received: March 6, 2017 Dear Alifiya Jagmag: 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. 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in {1}------------------------------------------------ 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, M.A. Hillebrenner for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K162820 Device Name AC3TM Series IABP System #### Indications for Use (Describe) The AC31M Series IABP (Intra-Aortic Balloon Pump) System is clinically indicated for the following conditions: - a. Acute Coronary Syndrome - b. Cardiac and Non-Cardiac Surgery - c. Complications of Heart Failure Type of Use (Select one or both, as applicable) | <span style="font-size:12px">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | |------------------------------------------------------------------------------------| | <span style="font-size:12px">☐</span> 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." {3}------------------------------------------------ # Section 5- 510(k) Summary | 5.1<br>Statement | This 510(k) summary is being submitted in accordance with the<br>requirements of Safe Medical Device Act (SMDA) 1990 and CFR<br>807.92. | |---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 5.2<br>Submitter | Arrow International, Inc. (Subsidiary of Teleflex, Inc.)<br>16 Elizabeth Drive<br>Chelmsford, MA 01824<br>Establishment Registration: 3010532612<br>Arrow International, Inc. (Subsidiary of Teleflex, Inc.)<br>Reading, PA 19605:<br>Owner/ Operator: 2518433 | | 5.3<br>Company<br>Contact | Alifiya Jagmag<br>Manager, Regulatory Affairs<br>Arrow International, Inc.<br>16 Elizabeth Drive<br>Chelmsford, MA 01824<br>Alifiya.Jagmag@teleflex.com<br>Phone: 978-250-5100 extension 725172<br>Date Prepared: 30 March 2017 | | 5.4 | Proprietary Name: AC3TM Series IABP System | | Device Name | Common Name: Intra-Aortic Balloon Control System | | | Classification Name: Intra-aortic balloon and control system<br>(21 CFR 870.3535), Regulatory Class: II, Product Code: DSP | | 5.5 | The AC3 Series Intra-Aortic Balloon Pump (IABP) System, which is | |---------------------|--------------------------------------------------------------------| | Predicate | the subject of this submission, is substantially equivalent to the | | Legally | previously cleared Arrow AutoCAT®2 IABP System which was | | Marketed<br>Devices | previously cleared via K060309. | {4}------------------------------------------------ 5.6 The AC3 Series IABP System is the next generation platform which is based on the existing AutoCAT2 IABP System; cleared Device via K060309 on 6 April 2006. Description > The AC3 Series IABP System (AutoCAT3) includes a new Graphical User Interface. The primary algorithms that control the therapeutic function of the device have not been altered from the AutoCAT2. This premarket notification is applicable to the following part numbers: Versions utilizing the Fiber Optic Sensor (FOS) or WAVE (Wind Kessel Aortic Valve Equation) capabilities: - IAP-0700 AC3 Optimus™ IABP ● - IAP-0701 AC3 Optimus™ IABP . Versions without the FOS or WAVE capabilities: - IAP-0600 AC3™ IABP ● - IAP-0601 AC3™ IABP . Note: The 01 ending indicates physical language labeling only. The part numbers IAP-0700 and IAP-0600 include the North American (NA) and European (EU) languages and the part numbers IAP-0701 and IAP-0601 include the NA, Asia, Japan and Latin America (AJLA) languages. All the part numbers will be commercially released OUS (outside of United States of America) after respective country registrations have been received. Functionally all the above mentioned part numbers are equivalent in performance and specifications. #### System Description: The AC3 Series IABP system provides counter-pulsation therapy to adult patients with impaired Left Ventricular (LV) Function. It provides hemodynamic support of blood pressure and reduced cardiac work through volume displacement principles. The IABP is attached to an IAB (Intra-aortic Balloon) catheter which is inserted into the femoral artery and positioned in the descending thoracic aorta. The IABP delivers Helium (HE) into the IAB during diastole to displace blood above and below the IAB, increasing blood pressure and perfusion to organs close to the IAB catheter. The {5}------------------------------------------------ IABP deflates or removes HE from the IAB just prior to or in the early phase of systole, reducing the pressure in the aorta and therefore the pressure the LV must generate to open the aortic valve and eject its contents into the circulatory system. This results in a decrease in work and oxygen demand. The AC3 Series IABP System consists of two main components: - The pump control / display module which incorporates a . touch screen and keypad for system operation - . The pneumatic drive module which is incorporated into the body of the device. The AC3 is designed to be used with 30, 35, 40, and 50cc Intra-Aortic Balloons with the appropriate connectors. (UltraFlex™, Ultra 80, NarrowFlex®, and RediGuard® Catheters). The system offers two modes of operation: - . Autopilot Mode, where most functions are automatically selected and controlled by the IABP - Operator mode, where an operator can control most . settings and selections. | 5.7<br>Device | Indications For Use: | |------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications<br>and Intended<br>use | The AC3 IABP (Intra-Aortic Balloon Pump) System is clinically<br>indicated for the following conditions:<br>a. Acute Coronary Syndrome<br>b. Cardiac and Non-Cardiac Surgery<br>c. Complications of Heart Failure | {6}------------------------------------------------ 5.8 Extensive performance testing has been completed to demonstrate that the AC3 is substantially equivalent to the AutoCAT2 device Performance previously cleared via K060309. Testing > Following is a summary of the testing that has been completed to demonstrate substantial equivalence. > Electrical Safety and Electromagnetic Compatibility Testing Electrical Safety and Compliance testing was conducted by an outside test house. > Test reports provided confirm that the AC3 is in compliance with the standards as noted in Table 5.1 below. | Standard | Description | |-------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | IEC 60601-1<br>3rd edition | Medical electrical equipment - Part 1: General<br>requirements for basic safety and essential<br>performance | | IEC 60601-1-2<br>3rd edition | Medical Electrical Equipment - Part 1-2:<br>General Requirements for Basic Safety and<br>Essential Performance - Collateral Standard:<br>Electromagnetic Compatibility - Requirements<br>and Tests | | IEC 60601-1-6<br>3rd edition | Medical Electrical Equipment - Part 1-6:<br>General Requirements for Basic Safety and<br>Essential Performance - Collateral Standard:<br>Usability | | IEC 60606-1-8<br>2nd edition | Medical electrical equipment - Part 1-8:<br>General requirements for basic safety and<br>essential performance - Collateral Standard:<br>General requirements, tests and guidance for<br>alarm systems in medical electrical equipment<br>and medical electrical systems | | IEC 60601-2-27<br>3rd edition | Medical electrical equipment - Part 2-27:<br>Particular requirements for the basic safety<br>and essential performance of<br>electrocardiographic monitoring equipment<br>medical electrical equipment - Part 2-27:<br>Particular requirements for the basic safety<br>and essential performance of<br>electrocardiographic monitoring equipment | Table 5.1: IEC Standards Applicable to the AC3 IABP {7}------------------------------------------------ | Standard | Description | |-----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------| | IEC 60601-2-34<br>3rd edition | Medical electrical equipment. Particular<br>requirements for the basic safety and<br>essential performance of invasive blood<br>pressure monitoring equipment | | IEC 60601-2-49<br>2nd edition | Medical electrical equipment. Particular<br>requirements for the basic safety and<br>essential performance of multifunction patient<br>monitoring equipment | | RTCA DO-160<br>Section 20<br>Category R | Radio Frequency Susceptibility (Conducted<br>and Radiated) | | N/A | Design Considerations for Devices Intended<br>for Home Use Guidance Document | #### Software Verification Testing The software has been developed in accordance with IEC 62304:2006, Medical device software-Software lifecycle processes. Software Verification testing has been completed to demonstrate that the software requirements have been met. Documentation has been supplied to also comply with FDA's quidance document, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices". ## Human Factors Testing / Usability Testing Testing was completed to demonstrate that the changes to the user interface did not negatively impact the performance of the device. Testing was completed in accordance with FDA's Final Guidance document, Applying Human Factors and Usability Engineering to Medical Devices and in accordance with IEC 62366:2007. As part of this evaluation 33 users participated in the evaluation. Each participant was asked to perform 22 uses cases that were developed based on critical tasks and areas for potential risk due to potential use errors. There were no use errors observed during testing and 96% of the use cases were completed successfully with no operational difficulty (on the first attempt) whereas 4% of the use cases were completed with only minor operational difficulty. #### Cleaning and Disinfection {8}------------------------------------------------ Cleaning: A study was conducted by an outside test house in accordance with the following recognized standards: - AAMI TIR12:2010 - Designing, testing, and labeling reusable medical devices for reprocessing in health care facilities. AAMI TIR30:2011 - A compendium of processes, materials, ● test methods, and acceptance criteria for cleaning reusable medical devices, and Reprocessing Medical Devices in Health Care Settings Testing was completed to verify the effectiveness of the recommended cleaning methods. Components of the device that represented the worst case based on the material and the use profile of the components were selected for inclusion in the protocol.. Disinfection: Testing was also completed to demonstrate the recommended method of disinfection would result in a six log10 reduction in colony forming units (CFU) of selected organisms. Testing was completed in accordance with the following recognized standards: AAMI TIR12:2010 - Designing, testing, and labeling ● reusable medical devices for reprocessing in health care facilities. ANSI/AAMI ST58:2013 - Chemical sterilization and high-. level disinfection in health care facilities, and Reprocessing Medical Devices in Health Care Settings. Testing demonstrated the AC3 Series IABP system could effectively be cleaned and disinfected using the recommended methods. ## Environmental/ Mechanical Testing Mechanical design verification testing was conducted to confirm that the AC3 Series IABP System meets all requirements with respect to operational parameters and reliability and is substantially equivalent to the predicate device, AutoCAT2 IABP. The result of this testing confirms that the device meets all acceptance criteria and specifications as required. #### Design Validation Testing ECG trigger validation Testing was conducted using recordings of real Electro-Cardiogram (ECG) waveforms from the American Heart Association (AHA) database to confirm that the AC3 Series IABP system ECG Triggering was equivalent to the AutoCAT2 ECG Triggering. As part of this testing an AutoCAT2 and AC3 {9}------------------------------------------------ Series IABP system were simultaneously assessed using the same ECG input. The data confirmed that the devices are substantially equivalent with regard to their triggering reliability. Reliability testing was also completed to confirm that the AC3 Series IABP system could run continuously and perform as intended. As part of this test AC3 pumps were run continuously for 9 days; from 216 to 218 hours. All pumps successfully inflated and deflated the attached IAB catheter and met all acceptance criteria for this test. Rate limit testing was completed to verify that the AC3 Series IABP system was able to successfully inflate and deflate the various size IAB catheters i.e. 30cc, 35cc, 40cc and 50cc that were connected to the IABP system. Testing confirmed that the inflation and deflation of connected balloons met all requirements. Table 5.2 provides a comparison of the AutoCAT2 IABP cleared via K060309 and the AC3 Series IABP system that is the subject of this submission. {10}------------------------------------------------ | Attribute | AutoCAT2 Series IABP<br>(Predicate Device) | AC3 Series IABP system<br>(Subject Device) | Comparison | |---------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for<br>Use | The AutoCAT2 Intra-<br>Aortic Balloon Pump<br>(IABP) is clinically<br>indicated for the<br>following conditions:<br>a. Acute Coronary<br>Syndrome<br>b. Cardiac and Non-<br>Cardiac Surgery<br>c. Complications of<br>Heart Failure | The AC3 Series Intra-<br>Aortic Balloon Pump<br>(IABP) System is<br>clinically indicated for<br>the following conditions:<br>a. Acute Coronary<br>Syndrome<br>b. Cardiac and<br>Non-Cardiac<br>Surgery<br>c. Complications of<br>Heart Failure | No change.<br>Same as<br>AutoCAT2 | | Intended Use | The AutoCAT2 IABP is<br>intended to provide<br>counter-pulsation<br>therapy to adult patients<br>with impaired Left<br>ventricular function.<br>The users consist of<br>trained hospital<br>personnel in Intensive<br>care areas, Cardiac Cath<br>Labs, Cardiac Operating<br>Rooms and emergency<br>departments. This<br>device is for in-hospital<br>use and for transport<br>between departments in<br>a specific hospital or<br>between facilities as<br>required by the patient<br>condition and treatment<br>required. | The AC3 Series IABP<br>system is intended to<br>provide counter-<br>pulsation therapy to<br>adult patients with<br>impaired Left ventricular<br>function.<br>The users consist of<br>trained hospital<br>personnel in Intensive<br>care areas, Cardiac<br>Cath Labs, Cardiac<br>Operating Rooms and<br>emergency<br>departments. This<br>device is for in-hospital<br>use and for transport<br>between departments in<br>a specific hospital or<br>between facilities as<br>required by the patient<br>condition and treatment<br>required. | No change.<br>Same as<br>AutoCAT2 | | Compatible<br>Disposable | 30, 35, 40, and 50cc<br>Intra-aortic balloons | 30, 35, 40, and 50cc<br>Intra-aortic balloons | No change.<br>Same as | | Attribute | AutoCAT2 Series IABP<br>(Predicate Device) | AC3 Series IABP system<br>(Subject Device) | Comparison | | Sets | marked with Arrow | marked with Arrow | AutoCAT2 | | Sterility | Non-sterile | Non-sterile | No change.<br>Same as<br>AutoCAT2 | | Environmental<br>Specifications | Operating Temperature:<br>5°C to 45°C (without<br>Fiber Optic Sensor)<br>5°C to 35°C (with Fiber<br>Optic Sensor) | Operating Temperature:<br>0°C to 45°C (without<br>Fiber Optic Sensor)<br>0°C to 35°C (with Fiber<br>Optic Sensor) | Greater range<br>of operating<br>temperature<br>and storage<br>and transport<br>humidity<br>conditions all<br>other<br>specifications<br>remains the<br>same. | | | Specification Storage<br>and transport<br>Temperature: -15°C to<br>40°C | Specification Storage<br>and transport<br>Temperature: -15°C to<br>40°C | | | | Storage and transport<br>Atmospheric Pressure:<br>200 hPa - 1060 hPa<br>(150mmHg - 796mmHg) | Storage and transport<br>Atmospheric Pressure:<br>200 hPa - 1060 hPa<br>(150mmHg - 796mmHg) | | | | Storage and Transport<br>Humidity: 15% - 80% | Storage and Transport<br>Humidity: 15% - 85% | | | | Stepper motor driven<br>bellows pneumatic<br>system with augmented<br>deflation and no<br>disposable parts. | Stepper motor driven<br>bellows pneumatic<br>system with augmented<br>deflation and no<br>disposable parts. | No change.<br>Same as<br>AutoCAT2 | | | Pumping volume: 0.5cc –<br>50cc, adjustable in 0.5cc<br>increments | Pumping volume: 0.5cc<br>– 50cc, adjustable in<br>0.5cc increments | | | | Performance<br>Specifications | Sealed Lead Acid battery<br>(minimum of 90 minutes)<br>with an optional battery<br>upgrade to double<br>battery life. | Sealed Lead Acid<br>battery (minimum of 90<br>minutes) with an<br>optional battery upgrade<br>to double battery life. | | | | Power supply 85 to 265V<br>47 to 63Hz<br>Power consumption<br>225W or 3.1A | Power supply 85 to<br>265V 47 to 63Hz<br>Power consumption<br>110V- 5.1A<br>220V- 2.8A | | Attribute | AutoCAT2 Series IABP<br>(Predicate Device) | AC3 Series IABP<br>system<br>(Subject Device) | Comparison | | | Universal Power Supply | Universal Power Supply | specifications. | | | 10.3 Inch Color LCD<br>display.<br>26 Hard keys available | 13.3 Inch High<br>Resolution touchscreen<br>display | AC3 Series<br>IABP system<br>has a larger, | | | for all functions. No<br>touch screen. | 6 hard keys for<br>frequently used or<br>safety functions. | high resolution<br>touchscreen<br>with an<br>improved user<br>interface | | Display | Hard keys are backlit<br>LEDs for selection. | Hard keys and text are<br>both backlit LEDs and<br>color coded | Improved<br>visibility of keys<br>in dark | | | No Alarm indication<br>corner switch | AC3 Display head has a<br>color coded corner<br>switch that illuminates<br>when an alarm is active. | The Corner<br>switch acts as a<br>visual indicator<br>for the priority<br>of alarm and<br>also allows the<br>user to reset<br>alarm. | | | 2 Operational Modes:<br>Autopilot and Operator<br>mode | 2 Operational Modes:<br>Autopilot and Operator<br>mode | No change.<br>Same as<br>AutoCAT2 | | Operational<br>Modes | Autopilot mode Includes:<br>• Automatic trigger<br>selection<br>• Automatic<br>ECG/Arterial Pressure<br>(AP) source selection<br>• Automatic timing<br>method selection and<br>timing control<br>• Best Signal Analysis<br>• Deflation Timing<br>Management | Autopilot mode<br>Includes:<br>• Automatic trigger<br>selection<br>• Automatic ECG/<br>Arterial Pressure (AP)<br>source selection<br>• Automatic timing<br>method selection and<br>timing control<br>• Best Signal Analysis<br>• Deflation Timing<br>Management | AC3 and<br>AutoCAT2<br>series IABP<br>systems have<br>the same<br>Autopilot mode<br>functionality. | | | Operator mode includes:<br>• 7 modes for trigger<br>selection | Operator mode<br>includes:<br>• 7 modes for trigger | AC3 and<br>AutoCAT2<br>series IABP | | Attribute | AutoCAT2 Series IABP<br>(Predicate Device) | AC3 Series IABP system<br>(Subject Device) | Comparison | | | • ECG Source: 2 selections and 1 key press to change leads<br>• ECG gain: Automatic, Manual and User adjustable<br>• AP Source: 3 selections<br>• AP Scaling: Automatic, Manual and User selectable<br>• Timing can be selected using Soft keys and the selected timing setting is displayed on the screen. | selection<br>• ECG Source: 2 selections and 1 key press to change leads<br>• ECG gain: Automatic, Manual and User adjustable<br>• AP Source: 3 selections<br>• AP Scaling: Automatic, Manual and User selectable<br>• Touchscreen has the timing controls under the Timing Key. A reminder message is shown if the user leaves the timing screen in 1:2 or lower assist. | systems have the same Operator mode functionality. | | FiberOptix® Technology | AutoCAT2 WAVE® only:<br>Allows Arterial Pressure (AP) to be measured by Fiber Optic method while using Arrow FiberOptix® IAB catheter. | AC3 Optimus™ only:<br>Allows Arterial Pressure (AP) to be measured by Fiber Optic method while using Arrow FiberOptix® IAB catheter. The AC3 Series IABP system has an updated position for the FOS connection. | New position for the FOS connection will facilitate connection | {11}------------------------------------------------ {12}------------------------------------------------ {13}------------------------------------------------ 5.9 The AC3 Series IABP System has the same indications for use and incorporates the same fundamental technology as the legally Conclusion marketed predicate devices. Performance test results and verification Regarding activities demonstrate that the proposed device meets its intended Substantial use. It is for these reasons that the proposed device can be found Equivalence substantially equivalent to the predicate device.