ACAT 1 (ARROW CARDIAC ASSIST TECHNOLOGY 1)

K965209 · Arrow Intl., Inc. · DSP · Jan 23, 1998 · Cardiovascular

Device Facts

• Record ID: K965209
• Device Name: ACAT 1 (ARROW CARDIAC ASSIST TECHNOLOGY 1)
• Applicant: Arrow Intl., Inc.
• Product Code: DSP · Cardiovascular
• Decision Date: Jan 23, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.3535
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Cardiogenic shock, Pre- shock syndrome, Post- infarction angina (Threatening extension of MI) Unstable refractory angina, or impending infraction, Ischemia related intractable ventricular dysrhythmias, Septic shock syndrome, Cardiac contusion, Support for diagnostic interventional procedures including: (Cardiac Angiography, Coronary Angioplasty (PTCA), Coronary Atherectomy, Failed Mitral Valvuloplasty), Mechanical complications due to acute myocardial infraction: (Valvular stenosis - Mitral stenosis, Mitral Valve insufficiency - Mitral regurgitation, Ventricular Septal Defect (VSD), Papillary muscle rupture), Prophylactic support in preparation for cardiac surgery or high risk cardiac patients undergoing non-cardiac surgical procedures, Post-surgical myocardial dysfunction, Cardiac support following correction of anatomical defects, Maintenance of graft patency post-coronary bypass surgery, Pulsatile flow during cardiopulmonary bypass, Mechanical bridge to other assist devices.

Device Story

ACAT 1 is an advanced multi-microprocessor-based intra-aortic balloon pump (IABP) system for in-hospital and transport use. It provides circulatory support by inflating/deflating a balloon in the aorta. Inputs include patient physiological signals for triggering; system maintains helium levels and monitors balloon pressure waveforms. Operates via a lifetime metal bellows drive system. Features include cold trap vapor removal and alarm systems. Used by clinicians to manage cardiogenic shock, post-MI complications, and surgical support. Output provides pulsatile flow and hemodynamic assistance, aiding clinical decision-making by stabilizing hemodynamics. Benefits include improved cardiac output and graft patency.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Multi-microprocessor-based IABP control system. Features a lifetime metal bellows drive system, helium-based balloon inflation, cold trap vapor removal, and continuous balloon pressure waveform monitoring. Designed for portability (smaller/lighter than predecessor).

Indications for Use

Indicated for patients experiencing cardiogenic shock, pre-shock syndrome, post-infarction angina, unstable refractory angina, impending infarction, ischemia-related intractable ventricular dysrhythmias, septic shock, cardiac contusion, mechanical complications of MI (e.g., VSD, mitral regurgitation), post-surgical myocardial dysfunction, or requiring prophylactic support for cardiac/non-cardiac surgery, diagnostic interventional procedures, or as a mechanical bridge to other assist devices.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• KAAT II Plus IABP (K905313)
• System 95 & 97 IABP
• TransAct H-8000 IABP

Submission Summary (Full Text)

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K965209

# SECTION 2 - 510(k) SUMMARY and CERTIFICATION

510(k) SUMMARY

JAN 23 1998

This device is substantially equivalent to the following legally marketed intra-aortic balloon pumps:

1. The KAAT II Plus IABP catalog no. IAP-00025, from Arrow International, Everett, MA, Premarket Notification K905313.
2. The System 95 & 97 IABP, from Datascope Corporation, Paramus, NJ.
3. The TransAct H-8000 IABP, from C. R. Bard, Inc. Haverhill, MA.

The ACAT 1 IABP is the next generation of the Arrow/Kontron KAAT II Plus IABP manufactured by Arrow International. The ACAT 1 system is an advanced multi microprocessor based system that provides flexibility of operation and extended patient care capabilities, designed for in hospital and transport applications.

The ACAT 1 is a completely new industrial design package from the KAAT II Plus. Several new features have been incorporated which have continued to be customer requirements or preferences. The physical design of the ACAT 1 is smaller and lighter in weight than the current KAAT II Plus design. Overall we have incorporated new updates while maintaining the current product strengths of the KAAT II Plus system which are:

- Unique lifetime metal bellows drive system
- Wide range of triggering options
- Continuous assessment/maintenance of helium
- Safe alarming system
- Calibrated, continuous usable Balloon Pressure Waveform
- Cold trap, vapor removal system
- Ease of use

The device is indicated for the following conditions:

Cardiogenic shock, Pre- shock syndrome, Post- infarction angina (Threatening extension of MI)
Unstable refractory angina, or impending infraction, Ischemia related intractable ventricular dysrhythmias, Septic shock syndrome, Cardiac contusion, Support for diagnostic interventional procedures including: (Cardiac Angiography, Coronary Angioplasty (PTCA), Coronary Atherectomy, Failed Mitral Valvuloplasty), Mechanical complications due to acute myocardial infraction: (Valvular stenosis - Mitral stenosis, Mitral Valve insufficiency - Mitral regurgitation, Ventricular Septal Defect (VSD), Papillary muscle rupture), Prophylactic support in preparation for cardiac surgery or high risk cardiac patients undergoing non-cardiac surgical procedures, Post-surgical myocardial dysfunction, Cardiac support following correction of anatomical defects, Maintenance of graft patency post-coronary bypass surgery, Pulsatile flow during cardiopulmonary bypass, Mechanical bridge to other assist devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

Mr. Michael Jesi
Manager, Regulatory Affairs
and Quality Assurance
Arrow International, Inc.
9 Plymouth Street
Everett, MA 02149

Re: K965209
ACAT 1 (Arrow Cardiac Assist Technology 1)
Regulatory Class: II (Two)
Product Code: DSP
Dated: October 24, 1997
Received: October 27, 1997

Dear Mr. Jesi:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

JAN 23 1998

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Page 2 - Mr. Michael Jesi

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for *in vitro* diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html."

Sincerely yours,


Thomas J. Callahan, Ph.D.
Director
Division of Cardiovascular, Respiratory, and Neurological Devices
Office of Device Evaluation
Center for Devices and Radiological Health

Enclosure

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870.3535 DSP III Intra-aortic Balloon and Control System

510(k) Number (if known): K965209

Indications for IABP use are as follows:

- Cardiogenic shock
- Pre-shock syndrome
- Post- Infarction angina (Threatening extension of MI)
- Unstable refractory angina, or impending infraction
- Ischemia related intractable ventricular dysrhythmias
- Septic shock syndrome
- Cardiac contusion
- Support for diagnostic interventional procedures including:
- Cardiac Angiography
- Coronary Angioplasty (PTCA)
- Coronary Atherectomy
- Failed Mitral Valvuloplasty
- Mechanical complications due to acute myocardial infarction:
- Valvular stenosis - Mitral stenosis
- Mitral Valve insufficiency - Mitral regurgitation
- Ventricular Septal Defect (VSD)
- Papillary muscle rupture
- Prophylactic support in preparation for cardiac surgery or high risk cardiac patients undergoing non cardiac surgical procedures
- Post-surgical myocardial dysfunction
- Cardiac support following correction of anatomical defects
- Maintenance of graft patency post coronary bypass surgery
- Pulsatile flow during cardiopulmonary bypass
- Mechanical bridge to other assist devices.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number K965209

Prescription Use ☑
(Per 21 CFR 801.109)

OR

Over-The-Counter Use ☐

(Optional Format 1-2-96)