K Number
K002256
Device Name
ARROW ACAT 2 INTRA-AORTIC BALLOON PUMP
Manufacturer
Date Cleared
2001-05-03

(282 days)

Product Code
Regulation Number
870.3535
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended 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 Description
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.
More Information

Not Found

Unknown
The description mentions "new software algorithms" and an "Optimized mode" that employs "greater device involvement in detecting the patient's heartbeat and timing the inflation and deflation". While this suggests automated decision-making based on patient data, the summary does not explicitly use terms like AI, ML, or describe the characteristics of such algorithms (e.g., training data, model type). It's possible these algorithms are rule-based or traditional signal processing, not necessarily AI/ML.

Yes
The device is an Intra-Aortic Balloon Pump (IABP), which is explicitly indicated for treating medical conditions such as Acute Coronary Syndrome, Cardiac and Non-Cardiac Surgery, and Complications of Heart Failure, directly demonstrating its therapeutic purpose.

No

The device description indicates that the ACAT 2 Intra-Aortic Balloon Pump is an assistive device that helps the heart function more efficiently by timing the inflation and deflation of an Intra-Aortic Balloon. Its primary function is therapeutic (assisting blood circulation), not diagnostic (identifying or characterizing disease).

No

The device is described as a software update to an existing hardware device (ACAT 1 IABP) and explicitly states that the existing hardware, electronics, pump assembly, and packaging designs are the same for the ACAT 2 IABP. Therefore, it is not a software-only medical device.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use describes the device's application in treating conditions like Acute Coronary Syndrome, Cardiac and Non-Cardiac Surgery, and complications of Heart Failure. These are clinical conditions treated directly within the patient's body.
  • Device Description: The description clearly states it's an Intra-Aortic Balloon Pump (IABP) system. IABPs are devices that are inserted into the aorta to assist the heart's pumping function. This is an in-vivo (within the living body) application.
  • Anatomical Site: The anatomical site is "Intra-Aortic," which is inside the patient's body.
  • IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. This device does not perform such tests on samples.

The ACAT 2 IABP is a therapeutic device used to directly support cardiac function within the patient's circulatory system.

N/A

Intended Use / 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

Product codes (comma separated list FDA assigned to the subject device)

DSP

Device Description

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K983866, K965209, K905313, K942454, K961509, K915580

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 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.

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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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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 (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" (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

(800) 638-2041 or (301) 443-6597 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)
☒Prescription Use (Part 21 CFR 801 Subpart D)☐Over-The-Counter Use (21 CFR 801 Subpart C)

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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: 612-263-2065

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)
    1. ACAT 1, Arrow International (K965209)
    1. KAAT II Plus IABP, Arrow International (K905313)
    1. System 95 and 97 IABP, Datascope Corporation (K942454, K961509)
    1. 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.