ARROW ACAT 2 INTRA-AORTIC BALLOON PUMP

K002256 · Arrow Intl., Inc. · DSP · May 3, 2001 · Cardiovascular

Device Facts

• Record ID: K002256
• Device Name: ARROW ACAT 2 INTRA-AORTIC BALLOON PUMP
• Applicant: Arrow Intl., Inc.
• Product Code: DSP · Cardiovascular
• Decision Date: May 3, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.3535
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The ACAT 2 Intra-Aortic Balloon Pump 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 ACAT 2 is an intra-aortic balloon pump (IABP) control system designed as a software-based upgrade to the existing ACAT 1 IABP. It functions by monitoring patient heartbeats to time the inflation and deflation of an intra-aortic balloon. The device operates in either manual or 'Optimized' automatic mode; the latter utilizes software algorithms to detect heartbeats and manage balloon timing, reducing the need for constant manual monitoring by a cardiologist or perfusionist. The system uses the same hardware, electronics, and pump assembly as the ACAT 1. It is intended for use in clinical settings to provide circulatory support, benefiting patients by automating timing adjustments and potentially improving hemodynamic stability.

Clinical Evidence

No clinical data provided; the submission relies on the technological similarity to the predicate ACAT 1 and the implementation of software updates to achieve automated timing functionality.

Technological Characteristics

The device is an electromechanical control system for intra-aortic balloons. It maintains the hardware, electronics, and pump assembly of the ACAT 1. The primary technological change is the integration of software algorithms to support an 'Optimized' automatic mode for balloon inflation/deflation timing. The device is intended for professional clinical use.

Indications for Use

Indicated for patients with acute coronary syndrome, those undergoing cardiac or non-cardiac surgery, or those 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

• Belmont Model NGPBP IABP (K983866)
• ACAT 1 (K965209)
• KAAT II Plus IABP (K905313)
• System 95 and 97 IABP (K942454, K961509)
• Bard Transact System H8000 (K915580)

Submission Summary (Full Text)

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August 4, 2022

Arrow Intl., Inc. William Paquin Quality Assurance/Regulatory Affairs 9 Plymouth St. Everett, Massachusetts 02149

Re: K002256

Trade/Device Name: Arrow ACAT 2 Intra-Aortic Balloon Pump Regulation Number: 21 CFR 870.3535 Regulation Name: Intra-aortic balloon and control system Regulatory Class: Class II Product Code: DSP

Dear William Paquin:

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 May 3, 2001. Specifically, FDA is updating this SE Letter to reflect an administrative correction corresponding to the reclassification of intra-aortic balloon and control system (IABP) 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-devices-reclassification-of-intra-aortic-balloon-and-control-systems-foracute#:~:text=The%20Food%20Drug%20Administration%20(FDA)%20is%20issuing%20%%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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1

MAY - 3 2001

ARROW INTERNATIONAL, INC. c/o Mr. William Paquin Quality Assurance/Regulatory Affairs Manager 9 Plymouth Street Everett, MA 02149

Re: K002256

Trade Name: ARROW ACAT 2 INTRA-AORTIC BALLOON PUMP Regulatory Class: III (three) Product Code: DSP Dated: January 30, 2001 Received: February 2, 2001

Dear Mr. Paquin:

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 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). 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.

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Page 2 - Mr. William Paquin

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" (21CFR 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/dsma/dsmamain.html".

Sincerely yours,

Stupt Rhodes

James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

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# Indications for Use

510(k) Number (if known) K002256

Device Name

Arrow ACAT 2 Intra-Aortic Balloon Pump

#### Indications for Use (Describe)

The ACAT 2 Intra-Aortic Balloon Pump 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) | |
|------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|
| <div style="display:flex; align-items:center;"><span>☒</span><span>Prescription Use (Part 21 CFR 801 Subpart D)</span></div> | <div style="display:flex; align-items:center;"><span>☐</span><span>Over-The-Counter Use (21 CFR 801 Subpart C)</span></div> |

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Image /page/4/Picture/0 description: The image shows the word "Teleflex" in a stylized, bold, blue font. The "T" in "Teleflex" is unique, with a horizontal line extending to the left. A registered trademark symbol is present to the right of the "x" in "Teleflex", indicating that the name is legally protected.

Arrow International LLC (Subsidiary of Teleflex Inc.) 3015 Carrington Mill Blvd Morrisville, NC 27560

# 510(k) Summary K002256

Arrow ACAT 2 Intra-Aortic Balloon Pump

Date Prepared: May 23, 2001 Date Summary Updated: July 27, 2022

# A. Submitter

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

## Updated Correspondent Address:

Arrow International LLC (Subsidiary of Teleflex Inc.) 3015 Carrington Mill Blvd Morrisville, NC 27560

### B. Contact Person

Brenda Johnson, Director of Requlatory Phone: [phone]

### C. Device Name

| Trade Name: | Arrow ACAT 2 Intra-Aortic Balloon Pump |
|----------------------|-----------------------------------------------------------|
| Common Name: | Intra-Aortic Balloon Pump (IABP) |
| Classification Name: | Intra-Aortic Balloon and Control System (21 CFR 870.3535) |

### D. Predicate Devices

The ACAT 2 is substantially equivalent to the following devices:

- 1. Belmont Model NGPBP IABP, Belmont Instruments Corporation (K983866)
- 2. ACAT 1, Arrow International (K965209)
- 3. KAAT II Plus IABP, Arrow International (K905313)
- 4. System 95 and 97 IABP, Datascope Corporation (K942454, K961509)
- 5. Bard Transact System H8000, Belmont Instruments Corporation (K915580)

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Image /page/5/Picture/0 description: The image shows the word "Teleflex" in a stylized, bold, blue font. The word is written in all capital letters except for the "e"s, which are lowercase. To the right of the word "Teleflex" is a small, superscripted "R" in a circle, which is the registered trademark symbol. The background of the image is white.

# E. Description of Device

The ACAT 2 IABP is the next generation of the Arrow ACAT 1 IABP manufactured by Arrow International.

The purpose of the new ACAT 2 is to convert the original ACAT 1, which is a manual adjustment system, into a one button automatic or manual IABP system. This will be accomplished through the development of new software algorithms. The existing ACAT 1 hardware, electronics, pump assembly and packaging designs are the same for the ACAT 2 IABP.

NOTE: This is a software update to the existing ACAT 1 IABP only.

This software has been developed to meet customer requirements and/or preferences. The software is identical to the ACAT 11 software, with the addition of an "Optimized" mode. The Optimized mode employs greater device involvement in detecting the patient's heartbeat and timing the inflation and deflation of the Intra-Aortic Balloon (IAB), thus reducing the requirements for intense monitoring by a qualified Cardiologist or Perfusionist.

### F. Indications for Use

The Arrow ACAT 2 Intra-Aortic Balloon Pump is clinically indicated for the following conditions:

- a. Acute Coronary Syndrome
- b. Cardiac and Non-Cardiac Surgery
- c. Complications of Heart Failure

#### G. Technological Characteristics

The device has comparable technological characteristics as its predicates.