The AC3™ Series Intra-Aortic Balloon Pump (IABP) system is a professional use device that provides counterpulsation therapy to adult patients with impaired Left Ventricular (LV) Function. The AC3 Series IABP system consists of two (2) components: (1) the pump control/display module which incorporates a display, touch screen, and keypad for system operation and (2) the pneumatic drive module with attached wheels. It provides 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.

AI/ML Overview

The provided text describes a 510(k) submission for the AC3™ Series IABP device and outlines its substantial equivalence to a predicate device. However, the document does not contain information regarding detailed acceptance criteria or the specific study that proves the device meets those criteria in the context of a performance study with human readers or an AI algorithm, as described in the prompt.

The document focuses on demonstrating substantial equivalence through:

Identical Indications for Use: Acute Coronary Syndrome, Cardiac and Non-Cardiac Surgery, Complications of Heart Failure.
Identical Fundamental Technologies, Principles of Operation, and Performance compared to the predicate device (K201112 - AC3™ Series IAB Pump).
Minor modifications in the subject device, primarily an updated software revision addressing anomalies, an enhancement for disabling data transfer via USB, and other minor reliability/usability changes, along with an alternate SD Card and battery.
Conclusion based on software verification and validation testing, stating that these tests "raised no new questions of safety or effectiveness and demonstrated that the subject AC3™ IABP is substantially equivalent to the predicate device."

Therefore, I cannot provide the requested information for the following points as they are NOT present in the provided text:

A table of acceptance criteria and the reported device performance: This document does not describe performance metrics for a diagnostic or AI-assisted device. It's for an Intra-Aortic Balloon Pump.
Sample size used for the test set and the data provenance: Not applicable in this context.
Number of experts and their qualifications for ground truth: Not applicable.
Adjudication method for the test set: Not applicable.
MRMC comparative effectiveness study and effect size: Not applicable.
Standalone (algorithm only) performance: Not applicable.
Type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
Sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

The provided document is a 510(k) clearance letter for a medical device (Intra-Aortic Balloon Pump), focusing on demonstrating equivalence to an existing device rather than detailing a clinical performance study with AI or human readers. The "software verification and validation testing" mentioned is likely related to the functional integrity and safety of the pump's control system, not a diagnostic accuracy study.

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 seal of the Department of Health & Human Services. To the right of the seal is the FDA logo in blue, with the words "U.S. FOOD & DRUG" on one line and "ADMINISTRATION" on the line below. The logo is simple and professional, and it is easily recognizable.

August 30, 2023

Arrow International, LLC Subsidiary of Teleflex, Inc. Sheila Payzant Senior Regulatory Affairs Specialist 3015 Carrington Mill Blyd Morrisville, North Carolina 27560

Re: K232343

Trade/Device Name: AC3TM Series IABP Regulation Number: 21 CFR 870.3535 Regulation Name: Intra-Aortic Balloon And Control System Regulatory Class: Class II Product Code: DSP Dated: August 2, 2023 Received: August 4, 2023

Dear Sheila Payzant:

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/cdrh/cfdocs/cfpmn/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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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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 (OS) 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 mediation-emitting products, including information about labeling regulations, please see Device Advice (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,

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

Enclosure

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Indications for Use

Submission Number (if known)

K232343

Device Name

AC3 TM Series IABP

Indications for Use (Describe)

The AC3™ Intra-Aortic Balloon Pump is clinically indicated for use for the following conditions:

1. Acute Coronary Syndrome
1. Cardiac and Non-Cardiac Surgery
1. 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/3/Picture/0 description: The image shows the word "Teleflex" in a bold, blue font. The word is slightly stylized, with the "T" appearing as a stylized symbol. A registered trademark symbol is present to the right of the "x" in "Teleflex."

510(k) Summary [As required by 21 CFR 807.92] Date Prepared: August 30, 2023 510(k) Number: K232343

Submitter's Name/Contact Person Manufacturer

Arrow International, LLC Subsidiary of Teleflex, Inc. 3015 Carrington Mill Boulevard Morrisville, NC 27560 Establishment Registration #3010532612 Contact Person

Sheila Gretsch Payzant, J.D.,M.S. Sr. Regulatory Affairs Specialist usche-regulatory@teleflex.com Tel. 763.656.4290

General Information
Trade Name	AC3™ Series IABP
Common Name	Intra-Aortic Balloon and Control System
Product Code	DSP
Classification	Class II
Requlation	21 C.F.R. §870.3535
Panel	Cardiovascular
Predicate Device	K201112 - AC3™ Series IAB Pump (cleared 27 May 2020)

Device Description

Intended Use/Indications for Use

The AC3" Intra-Aortic Balloon Pump is clinically indicated for use for the following conditions:

1. Acute Coronary Syndrome
Cardiac and Non-Cardiac Surgery 2.
1. Complications of Heart Failure

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Image /page/4/Picture/0 description: The image shows the word "Teleflex" in a bold, sans-serif font. The word is in a dark blue color. There is a registered trademark symbol to the right of the word.

Technological Characteristics Comparison

The subject device incorporates an updated software revision of corrections to software anomalies, an enhancement permitting the disabling capability of the transfer of data via universal serial bus (USB), and other minor modifications for reliability and usability. The subject device also incorporates an alternate SD Card and battery .No changes introduced new risks to the user or the patient.

Conclusion

Compared with the predicate device, the AC3™ Series IABP has identical indications for use, fundamental technologies, principles of operation and performance. Substantial equivalence was demonstrated through software verification and validation testing. The results of these tests raised no new questions of safety or effectiveness and demonstrated that the subject AC3™ IABP is substantially equivalent to the predicate device.

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.