ACAT 1 (ARROW CARDIAC ASSIST TECHNOLOGY 1) by ARROW INTL., INC.

Cardiogenic shock, Pre- shock syndrome, Post- infarction angina (Threatening extension of MI) Unstable refractory angina, or impending infraction, Ischemia related intractable ventricular dvsrhythmias. 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 Description

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

AI/ML Overview

This 510(k) summary describes a device (ACAT 1 IABP) and its substantial equivalence to previously marketed devices. However, it does not contain the information necessary to describe the acceptance criteria, the study that proves the device meets the acceptance criteria, or any of the specific points requested (Tables of acceptance criteria, sample sizes, ground truth establishment, MRMC studies, standalone performance, etc.).

The document focuses on:

Identifying predicate devices (Arrow International KAAT II Plus IABP, Datascope Corporation System 95 & 97 IABP, C. R. Bard, Inc. TransAct H-8000 IABP).
Highlighting new features and design changes of the ACAT 1 compared to the KAAT II Plus, such as being smaller and lighter, while maintaining existing strengths.
Listing the indications for use for the intra-aortic balloon pump.
Providing the FDA's clearance letter, confirming substantial equivalence based on the provided information.

To answer your request, a different type of document, likely a test report or a clinical study report that was part of the 510(k) submission (but not included in this publicly available summary), would be needed. This 510(k) summary explicitly states that the device is "substantially equivalent" to predicate devices, which implies that the performance requirements are met by demonstrating similarity to already cleared devices, rather than necessarily performing a new study against explicit, novel acceptance criteria defined in this document. Often, for substantial equivalence, the "acceptance criteria" are implicitly met by demonstrating that the new device operates similarly to the predicate device and does not raise new questions of safety or effectiveness.

Summary

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SECTION 2 - 510(k) SUMMARY and CERTIFICATION

510(k) SUMMARY

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.
1. The System 95 & 97 IABP, from Datascope Corporation, Paramus, NJ.
1. The TransAct H-8000 IABP, from C. R. Bard, Inc. Haverhill, MA.

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:

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.

JAN 2 3 1998

1965209

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 3 1998

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

Re: K965209 ACAT 1 (Arrow Cardiac Assist Technology 1) Requlatory 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 Requlations, 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 requlation (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 requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obliqation 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.

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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 (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 or at its internet ----address "http://www.fda.gov/cdrh/dsmamain.html."

Sincerely yours,

Thomas J. Callahan

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 II	Intra-aortic Balloon and Control System
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510(k) Number (if known):	K965209
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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 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.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Berie R. Campbell
Division Sign-Off

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

Prescription Use_X (Per 21 CFR 801.109)

Over-The-Counter Use_

:・.

(Optional Format 1-2-96)

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Regulation Number and Section

§ 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.