The AutoCAT®2 Intra-Aortic Balloon Pump (IABP) and AC3™ Series Intra-Aortic Balloon Pump (IABP) arc clinically indicated for use for the following conditions:

Acute Coronary Syndrome
Cardiac and Non-Cardiac Surgery
Complications of Heart Failure

Device Description

The AutoCAT Series IABP System, including the AutoCAT®2 and AC3™ Series IABP's, provide counter-pulsation therapy to adult patients with impaired left ventricular (LV) function. They provide hemodynamic support of blood pressure and reduced cardiac work through volume displacement principles. The IABP is attached to an intra-aortic balloon (IAB) catheter which is inserted into the femoral artery and positioned in the descending thoracic aorta.

The IABP delivers helium (He) into the IAB catheter during diastole to displace blood above and below the IAB. increasing blood pressure and perfusion to organs close to the IAB catheter. The IABP deflates or removes He from the IAB catheter just prior to or in the early phase of systole, reducing the pressure in the aorta and therefore the LV must generate to open the aortic valve and eject its contents into the circulatory system. This results in a decrease in work and oxygen demand.

The AutoCAT Series IABP Systems consists of two main components:

The pump control/display module which incorporates a touch screen and keypad for . system operation, and
. The pneumatic drive module which is incorporated into the body of the device

The AutoCAT Series IABP are designed to be used with 30, 40 and 50cc IAB catheters with the appropriate connectors. The primary difference between the AutoCAT®2 IABP and AC3TM series IABP is the user interface, where the display is a touchscreen.

AI/ML Overview

This document describes the FDA's 510(k) clearance for the AutoCAT®2 and AC3™ Series Intra-Aortic Balloon Pump (IABP) systems. The clearance is based on the substantial equivalence to predicate devices, and the document primarily focuses on design modifications and verification testing rather than an AI-driven diagnostic or prognositc device.

Therefore, many of the requested categories related to medical AI applications, such as expert consensus, ground truth establishment, sample sizes for training sets, multi-reader multi-case studies, and specific performance metrics like sensitivity, specificity, and AUC, are not applicable to this document. This document describes a medical device (an intra-aortic balloon pump) and its mechanical/electrical performance, not an AI/ML algorithm.

However, I can extract information related to the acceptance criteria and study that proves the device meets the criteria based on the provided text, focusing on the device's functional integrity as a medical pump.

Here's a breakdown of the available information:

1. A table of acceptance criteria and the reported device performance

The document states:

"The proposed modification to the IABP systems were verified through design verification testing as outlined on the following page."
"The results of the verification tests met the specified acceptance criteria and performed similar to the predicate device."

While specific numerical acceptance criteria (e.g., pressure ranges, flow rates) and the exact reported performance values are not detailed within this document, the statement confirms that such criteria existed and were met. The "performance" is implicitly stated as "similar to the predicate device."

2. Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Sample Size: Not specified in the provided document.
Data Provenance: Not specified. Given it's a device modification verification for a US-based manufacturer, it's highly likely the testing was conducted internally or with US-based facilities. The document describes "design verification testing" which implies lab or bench testing, not clinical studies with patient data.
Retrospective or Prospective: Not applicable as this refers to a device's performance verification, not analysis of patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not applicable. This is a medical device (pump) clearance, not an AI/ML algorithm requiring expert interpretation of medical images or data to establish ground truth. The "ground truth" for a pump is its physical and electrical reliability and performance metrics, which would be established by engineering specifications and testing.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable. Adjudication methods are relevant for human interpretation of medical data (e.g., radiologists reviewing images). For device verification, engineers perform tests against predefined specifications.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is an IABP, a mechanical pump, not an AI product designed to assist human readers in tasks like image interpretation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an AI algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

The "ground truth" for this device's performance validation is derived from engineering specifications and established performance characteristics of the predicate devices. The testing verifies that the modified device performs according to these engineering and functional standards, similar to the predicate device. It's about meeting designed-for-purpose operational parameters, not diagnostic accuracy against a clinical reference.

8. The sample size for the training set

Not applicable. This is not an AI/ML driven device that requires a training set.

9. How the ground truth for the training set was established

Not applicable. This is not an AI/ML driven device.

Summary relevant to the document:

The device clearance relies on the "design verification testing" performed on the modified IABP systems. The document states that "The results of the verification tests met the specified acceptance criteria and performed similar to the predicate device." The primary "study" proving the device met acceptance criteria was this internal engineering and performance testing against established technical and functional specifications. The acceptance criteria themselves are implicitly the functional and safety requirements for an intra-aortic balloon pump, ensuring the modified parts do not introduce new safety concerns or degrade performance compared to the previously cleared predicate devices.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

May 27, 2020

Arrow International Inc. Shajunath Nirupama Senior Reguilatory Affairs Specialist 16 Elizabeth Drive Chelmsford, Massachusetts 01824

Re: K201112

Trade/Device Name: AC3 IABP, AC3 Optimus IABP, AutoCAT2 Wave IABP, AutoCAT2 IABP Regulation Number: 21 CFR 870.3535 Regulation Name: Intra-Aortic Balloon And Control System Regulatory Class: Class II Product Code: DSP Dated: April 24, 2020 Received: April 27, 2020

Dear Shajunath Nirupama:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrb/ofdocs/cfpmp/pmn.cfm_identifies_combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal

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statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance)and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Fernando Aguel 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

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known)

K201112

Device Name

AutoCAT@2 Intra-Aortic Balloon Pump (IABP) and AC3™ Series Intra-Aortic Balloon Pump (IABP)

Indications for Use (Describe)

The AutoCAT®2 Intra-Aortic Balloon Pump (IABP) and AC3™ Series Intra-Aortic Balloon Pump (IABP) arc clinically indicated for use for the following conditions:

Acute Coronary Syndrome
Cardiac and Non-Cardiac Surgery
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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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510(K) SUMMARY 2

[As required by 21 CFR 807.92]

Date Prepared: April 24, 2020

510(k) Number: K201112

Submitter's Name / Contact Person

Manufacturer Arrow International, Inc. Subsidiary of Teleflex, Inc. 16 Elizabeth Drive Chelmsford, MA 01824 Establishment Registration: 3010532612

Contact Person Shajunath Nirupama Sr. Regulatory Affairs Specialist Shajunath.Nirupama@teleflex.com usmin-vsireg@teleflex.com Phone: 978-250-5100 ext. 725187

General Information

	General Predicate Device Information
Trade Name	AutoCAT2® Intra-Aortic Balloon PumpAC3 ™ Series Intra-Aortic Balloon Pump
Common Name	Intra-Aortic Balloon Pump
510(k) Number	AutoCAT2 ® IABPK060309	AC3 ™ Series IABPK192238
Reference 510(k) Number	K002256	K162820
510(k) Holder	Arrow International, Inc.
Classification	II
Regulatory Description	21 CFR 870.3535, Intra-aortic balloon and control system
Product Code	DSP
Panel	Cardiovascular

Device Description

The AutoCAT Series Intra-Aortic Balloon Pump (IABP) System

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(IAB) catheter which is inserted into the femoral artery and positioned in the descending thoracic aorta.

The AutoCAT Series IABP Systems consists of two main components:

The pump control/display module which incorporates a touch screen and keypad for . system operation, and
. The pneumatic drive module which is incorporated into the body of the device

Indication for Use

The AutoCAT®2 Intra-Aortic Balloon Pump (IABP) and AC3™ Series Intra-Aortic Balloon Pump (IABP) are clinically indicated for use for the following conditions:

1. Acute Coronary Syndrome
1. Cardiac and Non-Cardiac Surgery
1. Complications of Heart Failure

Technological Characteristics Comparison

The AutoCAT Series IABP system, including AutoCAT®2 IABP and AC3TM Series IABP, are similar in design and identical in Indications for Use to the predicate IABP system. The motor connector on the MForce motor driver to IABP stepper motor, used in both the AutoCAT®2 and AC3™ Series, are being modified to increase the robustness of the IAB pump system.

The differences between the subject AutoCAT®2 and AC3™ systems and the predicate IABP systems were evaluated to provide evidence that the modification is substantially equivalent to the predicate systems.

The proposed modification to the IABP systems were verified through design verification testing as outlined on the following page.

. System Level Verification Testing
Manufacturing Process Verification Test ●
Performance / Durability Verification Testing .

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The results of the verification tests met the specified acceptance criteria and performed similar to the predicate device. The testing demonstrates that the subject devices are substantially equivalent to the predicate devices.

Substantial Equivalence Conclusion

The subject AutoCAT®2 and AC3™ series Intra-Aortic Balloon Pump (IABP) are substantially equivalent to the specified predicate devices (cleared under K060309 and K192238, respectively) based on a comparison of the device functionality, technological characteristics, and indications for use.

The device modifications and results of design verification tests do not raise new or different questions of safety or effectiveness; therefore, the subject devices are substantially equivalent to the predicate devices.

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.