AUTOCAT INTRA-AORTIC BALLOON PUMP SERIES

K060309 · Arrow Intl., Inc. · DSP · Apr 6, 2006 · Cardiovascular

Device Facts

• Record ID: K060309
• Device Name: AUTOCAT INTRA-AORTIC BALLOON PUMP SERIES
• Applicant: Arrow Intl., Inc.
• Product Code: DSP · Cardiovascular
• Decision Date: Apr 6, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.3535
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The AutoCAT Intra-Aortic Balloon Pump Series is clinically indicated for the following conditions: a. Acute Coronary Syndrome b. Cardiac and Non-Cardiac Surgery c. Complications of Heart Failure

Device Story

The AutoCAT Intra-Aortic Balloon Pump (IABP) provides cardiac assist therapy via counterpulsation to support patients with impaired left ventricular function; it increases coronary/systemic perfusion while decreasing afterload and preload. The system takes physiological patient data as input to control IAB inflation and deflation timing. It features two operational modes: 'Autopilot' (automatic selection/control of functions) and 'Operator' (manual control). Used in clinical settings, the device assists physicians in managing hemodynamics. The system processes signals to optimize timing, handle arrhythmias, and manage noise, providing automated support to improve patient cardiac function.

Clinical Evidence

Bench testing only. The device was evaluated against FDA guidance documents for IABP consoles and software validation, as well as international standards including IEC 60601-1-4 (programmable electrical medical systems), EN 55024 (immunity), and EN 55022 (radio disturbance). No clinical trial data was required for this 510(k) submission.

Technological Characteristics

The system is a programmable electrical medical device utilizing computer-controlled pneumatic actuation for IAB inflation/deflation. It features software-driven timing and triggering based on physiological inputs. Connectivity includes RS232 output and modem functionality. Standards met include IEC 60601-1-4, EN 55024, and EN 55022.

Indications for Use

Indicated for patients with acute coronary syndrome, those undergoing cardiac or non-cardiac surgery, or patients experiencing complications of heart failure.

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

• AutoCAT (K983866)
• ACAT 1 (K965209)
• ACAT 2 (K002256)
• FOS / FOMS IAB Black Box (K021462)

Submission Summary (Full Text)

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June 17, 2022

Arrow Intl., Inc. Karen Provencher Senior Regulatory Affairs Specialist 9 Plymouth St. Everett, Massachusetts 02149

Re: K060309

Trade/Device Name: Autocat Intra-Aortic Balloon Pump Series Regulation Number: 21 CFR 870.3535 Regulation Name: Intra-aortic balloon and control system Regulatory Class: Class II Product Code: DSP

Dear Karen Provencher:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated April 6, 2005. Specifically, FDA is updating this SE Letter to reflect an administrative correction corresponding to the reclassification of intra-aortic balloon and control system (1ABP) devices when indicated for acute coronary syndrome, cardiac and non-cardiac surgery, or complications of heart failure, a preamendments class III device, into class II (special controls), as detailed in the final order published on December 20, 2019 (see here for more information: https://www.federalregister.gov/documents/2013/12/30/2013-31218/cardiovascular-devicesreclassification-of-intra-aortic-balloon-and-control-systems-foracute#:~:text=The%20Food%20Drug%20Administration%20(FDA)%20is%20issuing%20a%20fina 1,(special%20controls)%2C%20and%20to). In addition, IABP devices indicated for septic shock or pulsatile flow generation will remain Class III devices and would not be appropriate for the premarket notification pathway(510(k)), instead requiring a premarket approval (PMA).

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Alejandra Cambonchi, OHT2: Office of Cardiovascular Devices, 301-796-0552, Alejandra.Cambonchi(@fda.hhs.gov.

> Sincerely, Nicole M. Gillette -S

Nicole Gillette Assistant Director DHT2B: Division of Circulatory Support, Structural and Vascular Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

6 2006 APR

6 2006

Arrow International, Inc. c/o Ms. Karen Provencher Senior Regulatory Affairs Specialist 9 Plymouth Street Everett, MA 02149

Re: K060309

K000507
Arrow AutoCAT Intra-Aortic Balloon Pump (IABP) Series Regulation Number: 21 CFR 870.3535 Regulation Name: Balloon, Intra-Aortic and Control System Regulatory Class: Class III Product Code: DSP Dated: March 17, 2006 Reccived: March 23, 2006

Dear Ms. Provencher:

We have reviewed your Section 510(k) premarket notification of intent to market the device . we nave reviewed your bection >10(tr) premation is substantially equivalent (for the indications ferenced above and nave determined ly marketed predicate devices marketed in interstate for use stated in the encreative to regard) the enactment date of the Medical Device Amendments, or to commerce prior to May 20, 7776, the encordance with the provisions of the Federal Food, Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). and Cosmette Herefore, market the device, subject to the general controls provisions of the Act. The r our may, therefore, market the act include requirements for annual registration, listing of general controls provisions of uactice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA). it may be subject to such additional controls. Existing major regulations affecting your device can may ve subject to back to begulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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# Page 2 - Ms. Karen Provencher

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please oe advised that 1 Dri 3 issuation of a vith other requirements of the Act that TDA has made a determination that your in the Federal agencies. You must or any I ederal statutes and regulations and united to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFK Fart 807), ademig (21 CFR Part 820), and if applicable, the electronic forth in the quality systems (QD) regulation (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (2001) on the vice as described in your Section 510(k) This letter with anow you to obgin maneting your and equivalence of your device to a legally premarket notification. The PDA miding of Saccanada 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), please If you desire specific acries ion 708 101 - 101 - 120 - 120. Also, please note the regulation entitled, Connact the Office of Compulline and (21) (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general information on your responser Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.

Sincerely yours,

Befremdender for

Bram D. Zuckerman. M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K060309

Device Name

AutoCAT Intra-Aortic Balloon Pump Series

Indications for Use (Describe)

The AutoCAT Intra-Aortic Balloon Pump Series 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)

2 Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

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Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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Image /page/4/Picture/0 description: The image shows the word "Teleflex" in a stylized, sans-serif font. The word is a dark blue color, and the "R" in "Teleflex" has a circle around it, indicating that it is a registered trademark. The font is bold and the letters are close together.

### Arrow International, Inc

9 Plymouth Street Everett, MA 02149 USA Phone: [phone] Fax:

www.teleflex.com

# 510(k) Summary K060309

AutoCAT Series IABP Series Date Prepared: February 3, 2006 Date Summary Updated: July 28, 2015

# A. Submitter's Name:

Arrow International, Inc. 9 Plymouth Street, Everett, MA 02149

### Updated Correspondent Address:

Fusun Tufan Senior Requlatory Affairs Manager Arrow International, Inc. 16 Elizabeth Drive, Chelmsford, MA 01824 Phone [phone] Fax [phone]

### B. Company Contact

Michael Malis Director RA/QA Arrow International, Inc. 16 Elizabeth Drive, Chelmsford, MA 01824 Phone [phone] Fax [phone]

### C. Device Name

Trade Name: AutoCAT Intra-Aortic Balloon Pump Series Common Name: Intra-Aortic Balloon Pump (IABP) Classification Name: Intra-Aortic Balloon and Control System

#### Predicate Devices D.

Arrow International AutoCAT Series IABP System represents the integration of four Arrow IABP technologies which is substantially equivalent in Intended Use and Fundamental Scientific Technology to the following legally marketed device in commercial distribution:

- · AutoCAT, cleared in K983866, (1/6/00)
- · ACAT 1, cleared in K965209, (1/23/98)
- · ACAT 2, cleared in K002256, (5/3/01)
- · FOS / FOMS IAB Black Box, cleared in K021462, (6/6/02)

#### Description of Device ய்

The Intra-Aortic Balloon Pump (IABP) provides cardiac assist therapy. The IABP provides temporary support to patients with impaired left ventricular function through the therapeutic method referred to as counterpulsation increases coronary and systemic profusion, decreasing after load (myocardial work) and decreasing preload.

The AutoCAT Series IABP System utilizes computer technology to select and maintain precise

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Image /page/5/Picture/0 description: The image shows the word "Teleflex" in a stylized, sans-serif font. The word is in a dark blue color, and there is a registered trademark symbol to the right of the "x". The logo appears to be for a company called Teleflex.

IAB inflation and deflation timing and triggering based on current physiological data from the patient. The system offers two modes of operation, the Autopilot mode, where functions are automatically selected and controlled by the IABP and the Operator mode where the user has control over settings and selections.

#### F. Indications for Use

The AutoCAT Intra-Aortic Balloon Pump Series is clinically indicated for the following conditions:

- a. Acute Coronary Syndrome
- Cardiac and Non-Cardiac Surgerv ﻘ
- Complications of Heart Failure C.

#### G. Comparison of Technological Characteristics

Software V2.22 features the modifications to the following- Clarification I The modified Modification to Pre-set Start-up Settings, General Improvements in AutoPilot Timing, Modifications to AP Zero and Calibration Function, Improvements in AutoPilot Signal Switching & Selection, General Improvements in Triggering, Improved Purge Cycle & Helium Refill Function, Recognition of IAB Connector Volumes, Improved Noise Recognition and Handling, Modifications to Arrhythmia Timing Function, Alarm Handling Improvements, Additions to Help Text. Activation of Modem Function. Reqular Output of RS232

#### Summary Performance Data H.

The AutoCAT IABP Series with modified software meets all the same performance standards of the unmodified device including the following:

- 1. FDA Guidance: "Guidance for the Preparation and Content of Applications to the Food and Drug Administration for Determining the Equivalence of Intra-Aortic Balloon Catheters and Consoles under the 510(k) Requlations - Preliminary Draft. December 8.1993
- FDA Guidance: "General Principles of Software Validation -Final Guidance' January 11, 2002 2.
- 3. FDA Guidance: "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices - Final Guidance' May 11, 2005
- 4. IEC 60601-1-4:1997: Medical Electrical Equipment- General Requirements for Safety-Collateral Standard: Programmable Electrical Medical Systems
- 5. EN 55024:1998: Information Technology Equipment-Immunity Characteristics
- 6. EN 55022:1998: Information Technology Equipment- Radio Disturbance Characteristics Limits and Methods of Measurement