(175 days)
The AC3TM 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
The AC3 Series Intra-Aortic Balloon Pump (IABP) System, which is the subject of this submission, is substantially equivalent to the previously cleared Arrow AutoCAT®2 IABP System which was previously cleared via K060309.
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.
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.
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 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.
This is a 510(k) premarket notification for an Intra-Aortic Balloon Pump (IABP) system called AC3 Series IABP. It argues for substantial equivalence to a previously cleared predicate device, the AutoCAT2 IABP System.
Here's an analysis of the provided information, focusing on acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly provide a table of acceptance criteria with corresponding performance metrics in a pass/fail format for clinical performance. Instead, it details various types of performance testing and states that the device "meets all requirements," "is in compliance with the standards," and "meets all acceptance criteria and specifications." The comparison table (Table 5.2) focuses on demonstrating that the new AC3 Series IABP is either "No change," "Same as AutoCAT2," or has "Greater range" or "Improved" features compared to the predicate device.
However, based on the descriptions of the tests, we can infer some implicit acceptance criteria and the device's reported performance:
| Aspect of Performance | Implicit Acceptance Criteria | Reported Device Performance and Study Summary |
|---|---|---|
| Electrical Safety & EMC | Compliance with IEC 60601-1 (3rd ed.), 60601-1-2 (3rd ed.), 60601-1-6 (3rd ed.), 60601-1-8 (2nd ed.), 60601-2-27 (3rd ed.), 60601-2-34 (3rd ed.), 60601-2-49 (2nd ed.), and RTCA DO-160 Section 20 Category R. | "Test reports provided confirm that the AC3 is in compliance with the standards as noted in Table 5.1." (Performed by an outside test house). |
| Software Verification | Compliance with IEC 62304:2006 (Medical device software-Software lifecycle processes) and FDA's guidance document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." Software requirements must be met. | "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 guidance document, 'Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices'." |
| Human Factors / Usability | Changes to the user interface should not negatively impact device performance. Compliance with FDA's "Applying Human Factors and Usability Engineering to Medical Devices" and IEC 62366:2007. No use errors observed during testing, and a high percentage of successful task completion (e.g., >95% successful completion with no operational difficulty). | 33 users participated in the evaluation, performing 22 use cases based on critical tasks and potential risk areas. "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 & Disinfection | Effectiveness of recommended cleaning methods (AAMI TIR12:2010, AAMI TIR30:2011). Disinfection method must result in a six log10 reduction in colony forming units (CFU) of selected organisms (AAMI TIR12:2010, ANSI/AAMI ST58:2013). | "Testing was completed to verify the effectiveness of the recommended cleaning methods." Components representing worst-case material/use profile were selected. "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 demonstrated the AC3 Series IABP system could effectively be cleaned and disinfected using the recommended methods." (Performed by an outside test house). |
| Environmental / Mechanical Testing | Device meets all requirements for operational parameters and reliability. Device is substantially equivalent to the predicate (AutoCAT2 IABP). | "The result of this testing confirms that the device meets all acceptance criteria and specifications as required." This testing confirmed that the AC3 is substantially equivalent to AutoCAT2. (No specific numerical results provided). |
| ECG Trigger Validation | ECG triggering of the AC3 Series IABP system is equivalent to the AutoCAT2 ECG Triggering. | "Testing was conducted using recordings of real Electro-Cardiogram (ECG) waveforms from the American Heart Association (AHA) database." An AutoCAT2 and AC3 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 | Device can run continuously and perform as intended. All acceptance criteria for continuous operation are met. | AC3 pumps were run continuously for 9 days (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 (Balloon Inflation/Deflation) | System successfully inflates and deflates various size IAB catheters (30cc, 35cc, 40cc, 50cc). Inflation and deflation meet all requirements. | "Testing confirmed that the inflation and deflation of connected balloons met all requirements." |
2. Sample Size Used for the Test Set and Data Provenance
- Human Factors / Usability Testing: 33 users participated. The data provenance is not explicitly stated (e.g., country of origin, retrospective/prospective), but given it's a usability test for a medical device seeking FDA clearance, it's highly likely to be prospective data collected in a controlled environment.
- ECG Trigger Validation: "Recordings of real Electro-Cardiogram (ECG) waveforms from the American Heart Association (AHA) database." This suggests a retrospective dataset of real patient ECGs. The specific sample size (number of ECG waveforms or patients) is not provided.
- Reliability Testing: The "sample" here refers to the number of AC3 pumps. "AC3 pumps were run continuously for 9 days." The exact number of pumps is not specified, but it implies multiple units were used for the continuous run test.
- Cleaning/Disinfection & Electrical Safety/EMC: Sample sizes are not specified, but these are typically tested on a limited number of device units or components.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Human Factors / Usability Testing: There is no mention of "experts" establishing ground truth in the context of clinical outcomes or diagnoses. The "ground truth" for this test is successful task completion and absence of use errors, which is assessed by the participants' performance and observations by the test administrators.
- ECG Trigger Validation: The "ground truth" for ECG triggering would be the accurate detection and timing of specific cardiac events within the AHA ECG waveforms. While the AHA database provides these waveforms, the process for establishing the "truth" of these events (e.g., expert cardiologists annotating them) is inherent to the database itself and not detailed here as part of the AC3 study. The study compares the AC3's detection accuracy against the already established and accepted timing in the database, and against the predicate device.
- For other tests (Electrical Safety, Software, Cleaning, Mechanical), ground truth is established by adherence to recognized standards and specifications, not typically by expert consensus of individual cases.
4. Adjudication Method for the Test Set
- Human Factors / Usability Testing: Not explicitly an adjudication method in the sense of reconciling clinical interpretations. The observed "minor operational difficulty" for 4% of use cases was likely directly observed and categorized by the test administrators, rather than requiring formal adjudication among multiple reviewers.
- ECG Trigger Validation: The comparison seems to be direct against the AHA database and the predicate device. There is no mention of an adjudication panel.
- For other tests, adjudication methods are not applicable as they involve objective measurements against predefined standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
- Not Applicable: This document describes a traditional 510(k) submission for an Intra-Aortic Balloon Pump system, which is a hardware device with embedded software. It is not an AI-driven diagnostic or interpretative software device. Therefore, MRMC studies and the concept of "human readers improving with AI vs without AI assistance" are not relevant to this submission. The "AI" mentioned ("primary algorithms that control the therapeutic function") in this context refers to the device's control logic, not AI in the sense of machine learning for interpretation or diagnostic aid.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Yes, implicitly for some aspects: The "algorithm" here refers to the embedded control software.
- Software Verification Testing: This is effectively a standalone test of the software's functionality and adherence to requirements.
- ECG Trigger Validation: The comparison of the AC3 system's (algorithm's) ECG triggering against the AHA database and the predicate device is a standalone performance assessment of a key algorithmic function.
- Reliability Testing: The pumps running continuously and performing as intended is a standalone assessment of the device's overall function, which includes its internal algorithms determining inflation/deflation.
7. The Type of Ground Truth Used
- Industry Standards and Specifications: For Electrical Safety & EMC, Software Verification, Cleaning & Disinfection, and Environmental/Mechanical Testing, the ground truth is established by the requirements of the cited international standards (IEC, AAMI, ANSI/AAMI, RTCA DO-160) and the device's own design specifications.
- AHA Database ECG Waveforms: For ECG Trigger Validation, the "ground truth" for cardiac event timing is derived from the established and validated waveforms within the American Heart Association (AHA) database.
- Observed Performance / Absence of Errors: For Human Factors/Usability Testing, the "ground truth" for usability is based on direct observation of user interaction and successful task completion, as defined by the study protocol.
- Predicate Device Performance: In many instances, the "ground truth" or benchmark for demonstrating substantial equivalence is the performance of the legally marketed predicate device (AutoCAT2), particularly for aspects like ECG triggering where direct simultaneous comparison was performed.
8. The Sample Size for the Training Set
- Not Applicable in the traditional ML sense: Since this is not an AI/Machine Learning diagnostic device, there isn't a "training set" in the conventional meaning. The "primary algorithms that control the therapeutic function" are described as largely unchanged from the predicate device (AutoCAT2 IABP System). These are likely deterministic control algorithms developed through engineering design, rather than machine learning models trained on data.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable: As there is no traditional ML training set described, the concept of establishing ground truth for it is not relevant to this submission. The "ground truth" that guided the development of the device's core algorithms would have been established through physiological understanding, engineering principles, and clinical/pre-clinical testing over the development cycles of this device and its predicate.
{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)
| ☑ 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."
{3}------------------------------------------------
Section 5- 510(k) Summary
| 5.1Statement | This 510(k) summary is being submitted in accordance with therequirements of Safe Medical Device Act (SMDA) 1990 and CFR807.92. |
|---|---|
| 5.2Submitter | Arrow International, Inc. (Subsidiary of Teleflex, Inc.)16 Elizabeth DriveChelmsford, MA 01824Establishment Registration: 3010532612Arrow International, Inc. (Subsidiary of Teleflex, Inc.)Reading, PA 19605:Owner/ Operator: 2518433 |
| 5.3CompanyContact | Alifiya JagmagManager, Regulatory AffairsArrow International, Inc.16 Elizabeth DriveChelmsford, MA 01824Alifiya.Jagmag@teleflex.comPhone: 978-250-5100 extension 725172Date 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(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 |
| MarketedDevices | 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.
| 5.7Device | Indications For Use: |
|---|---|
| Indicationsand Intendeduse | The AC3 IABP (Intra-Aortic Balloon Pump) System is clinicallyindicated for the following conditions:a. Acute Coronary Syndromeb. Cardiac and Non-Cardiac Surgeryc. 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 60601-13rd edition | Medical electrical equipment - Part 1: Generalrequirements for basic safety and essentialperformance |
| IEC 60601-1-23rd edition | Medical Electrical Equipment - Part 1-2:General Requirements for Basic Safety andEssential Performance - Collateral Standard:Electromagnetic Compatibility - Requirementsand Tests |
| IEC 60601-1-63rd edition | Medical Electrical Equipment - Part 1-6:General Requirements for Basic Safety andEssential Performance - Collateral Standard:Usability |
| IEC 60606-1-82nd edition | Medical electrical equipment - Part 1-8:General requirements for basic safety andessential performance - Collateral Standard:General requirements, tests and guidance foralarm systems in medical electrical equipmentand medical electrical systems |
| IEC 60601-2-273rd edition | Medical electrical equipment - Part 2-27:Particular requirements for the basic safetyand essential performance ofelectrocardiographic monitoring equipmentmedical electrical equipment - Part 2-27:Particular requirements for the basic safetyand essential performance ofelectrocardiographic monitoring equipment |
Table 5.1: IEC Standards Applicable to the AC3 IABP
{7}------------------------------------------------
| Standard | Description |
|---|---|
| IEC 60601-2-343rd edition | Medical electrical equipment. Particularrequirements for the basic safety andessential performance of invasive bloodpressure monitoring equipment |
| IEC 60601-2-492nd edition | Medical electrical equipment. Particularrequirements for the basic safety andessential performance of multifunction patientmonitoring equipment |
| RTCA DO-160Section 20Category R | Radio Frequency Susceptibility (Conductedand Radiated) |
| N/A | Design Considerations for Devices Intendedfor 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(Predicate Device) | AC3 Series IABP system(Subject Device) | Comparison |
|---|---|---|---|
| Indications forUse | The AutoCAT2 Intra-Aortic Balloon Pump(IABP) is clinicallyindicated for thefollowing conditions:a. Acute CoronarySyndromeb. Cardiac and Non-Cardiac Surgeryc. Complications ofHeart Failure | The AC3 Series Intra-Aortic Balloon Pump(IABP) System isclinically indicated forthe following conditions:a. Acute CoronarySyndromeb. Cardiac andNon-CardiacSurgeryc. Complications ofHeart Failure | No change.Same asAutoCAT2 |
| Intended Use | The AutoCAT2 IABP isintended to providecounter-pulsationtherapy to adult patientswith impaired Leftventricular function.The users consist oftrained hospitalpersonnel in Intensivecare areas, Cardiac CathLabs, Cardiac OperatingRooms and emergencydepartments. Thisdevice is for in-hospitaluse and for transportbetween departments ina specific hospital orbetween facilities asrequired by the patientcondition and treatmentrequired. | The AC3 Series IABPsystem is intended toprovide counter-pulsation therapy toadult patients withimpaired Left ventricularfunction.The users consist oftrained hospitalpersonnel in Intensivecare areas, CardiacCath Labs, CardiacOperating Rooms andemergencydepartments. Thisdevice is for in-hospitaluse and for transportbetween departments ina specific hospital orbetween facilities asrequired by the patientcondition and treatmentrequired. | No change.Same asAutoCAT2 |
| CompatibleDisposable | 30, 35, 40, and 50ccIntra-aortic balloons | 30, 35, 40, and 50ccIntra-aortic balloons | No change.Same as |
| Attribute | AutoCAT2 Series IABP(Predicate Device) | AC3 Series IABP system(Subject Device) | Comparison |
| Sets | marked with Arrow | marked with Arrow | AutoCAT2 |
| Sterility | Non-sterile | Non-sterile | No change.Same asAutoCAT2 |
| EnvironmentalSpecifications | Operating Temperature:5°C to 45°C (withoutFiber Optic Sensor)5°C to 35°C (with FiberOptic Sensor) | Operating Temperature:0°C to 45°C (withoutFiber Optic Sensor)0°C to 35°C (with FiberOptic Sensor) | Greater rangeof operatingtemperatureand storageand transporthumidityconditions allotherspecificationsremains thesame. |
| Specification Storageand transportTemperature: -15°C to40°C | Specification Storageand transportTemperature: -15°C to40°C | ||
| Storage and transportAtmospheric Pressure:200 hPa - 1060 hPa(150mmHg - 796mmHg) | Storage and transportAtmospheric Pressure:200 hPa - 1060 hPa(150mmHg - 796mmHg) | ||
| Storage and TransportHumidity: 15% - 80% | Storage and TransportHumidity: 15% - 85% | ||
| Stepper motor drivenbellows pneumaticsystem with augmenteddeflation and nodisposable parts. | Stepper motor drivenbellows pneumaticsystem with augmenteddeflation and nodisposable parts. | No change.Same asAutoCAT2 | |
| Pumping volume: 0.5cc –50cc, adjustable in 0.5ccincrements | Pumping volume: 0.5cc– 50cc, adjustable in0.5cc increments | ||
| PerformanceSpecifications | Sealed Lead Acid battery(minimum of 90 minutes)with an optional batteryupgrade to doublebattery life. | Sealed Lead Acidbattery (minimum of 90minutes) with anoptional battery upgradeto double battery life. | |
| Power supply 85 to 265V47 to 63HzPower consumption225W or 3.1A | Power supply 85 to265V 47 to 63HzPower consumption110V- 5.1A220V- 2.8A | ||
| Attribute | AutoCAT2 Series IABP(Predicate Device) | AC3 Series IABPsystem(Subject Device) | Comparison |
| Universal Power Supply | Universal Power Supply | specifications. | |
| 10.3 Inch Color LCDdisplay.26 Hard keys available | 13.3 Inch HighResolution touchscreendisplay | AC3 SeriesIABP systemhas a larger, | |
| for all functions. Notouch screen. | 6 hard keys forfrequently used orsafety functions. | high resolutiontouchscreenwith animproved userinterface | |
| Display | Hard keys are backlitLEDs for selection. | Hard keys and text areboth backlit LEDs andcolor coded | Improvedvisibility of keysin dark |
| No Alarm indicationcorner switch | AC3 Display head has acolor coded cornerswitch that illuminateswhen an alarm is active. | The Cornerswitch acts as avisual indicatorfor the priorityof alarm andalso allows theuser to resetalarm. | |
| 2 Operational Modes:Autopilot and Operatormode | 2 Operational Modes:Autopilot and Operatormode | No change.Same asAutoCAT2 | |
| OperationalModes | Autopilot mode Includes:• Automatic triggerselection• AutomaticECG/Arterial Pressure(AP) source selection• Automatic timingmethod selection andtiming control• Best Signal Analysis• Deflation TimingManagement | Autopilot modeIncludes:• Automatic triggerselection• Automatic ECG/Arterial Pressure (AP)source selection• Automatic timingmethod selection andtiming control• Best Signal Analysis• Deflation TimingManagement | AC3 andAutoCAT2series IABPsystems havethe sameAutopilot modefunctionality. |
| Operator mode includes:• 7 modes for triggerselection | Operator modeincludes:• 7 modes for trigger | AC3 andAutoCAT2series IABP | |
| Attribute | AutoCAT2 Series IABP(Predicate Device) | AC3 Series IABP system(Subject Device) | Comparison |
| • ECG Source: 2 selections and 1 key press to change leads• ECG gain: Automatic, Manual and User adjustable• AP Source: 3 selections• AP Scaling: Automatic, Manual and User selectable• Timing can be selected using Soft keys and the selected timing setting is displayed on the screen. | selection• ECG Source: 2 selections and 1 key press to change leads• ECG gain: Automatic, Manual and User adjustable• AP Source: 3 selections• AP Scaling: Automatic, Manual and User selectable• 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:Allows Arterial Pressure (AP) to be measured by Fiber Optic method while using Arrow FiberOptix® IAB catheter. | AC3 Optimus™ only: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.
§ 870.3535 Intra-aortic balloon and control system.
(a)
Identification. An intra-aortic balloon and control system is a prescription device that consists of an inflatable balloon, which is placed in the aorta to improve cardiovascular functioning during certain life-threatening emergencies, and a control system for regulating the inflation and deflation of the balloon. The control system, which monitors and is synchronized with the electrocardiogram, provides a means for setting the inflation and deflation of the balloon with the cardiac cycle.(b)
Classification. (1) Class II (special controls) when the device is indicated for acute coronary syndrome, cardiac and non-cardiac surgery, or complications of heart failure. The special controls for this device are:(i) Appropriate analysis and non-clinical testing must be conducted to validate electromagnetic compatibility and electrical safety of the device;
(ii) Software verification, validation, and hazard analysis must be performed;
(iii) The device must be demonstrated to be biocompatible;
(iv) Sterility and shelf-life testing must demonstrate the sterility of patient-contacting components and the shelf life of these components;
(v) Non-clinical performance evaluation of the device must demonstrate mechanical integrity, durability, and reliability to support its intended purpose; and
(vi) Labeling must include a detailed summary of the device- and procedure-related complications pertinent to use of the device.
(2) Class III (premarket approval) when the device is indicated for septic shock and pulsatile flow generation.
(c)
Date premarket approval application (PMA) or notice of completion of product development protocol (PDP) is required. A PMA or notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before March 31, 2014, for any intra-aortic balloon and control system indicated for septic shock or pulsatile flow generation that was in commercial distribution before May 28, 1976, or that has, on or before March 31, 2014, been found to be substantially equivalent to any intra-aortic balloon and control system indicated for septic shock or pulsatile flow generation that was in commercial distribution before May 28, 1976. Any other intra-aortic balloon and control system indicated for septic shock or pulsatile flow generation shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.