(30 days)
Not Found
No
The description mentions software for precise timing and triggering based on real-time data and an "AutoPilot" mode, but it does not explicitly mention or describe the use of AI or ML algorithms for these functions. The focus is on automated control based on physiological data, which can be achieved through traditional programming and control systems.
Yes
The device is explicitly described as providing "counter-pulsation therapy" and "hemodynamic support of blood pressure and reduced cardiac work," indicating its direct involvement in treating medical conditions.
No
The device provides counter-pulsation therapy and hemodynamic support. While it uses real-time physiological data, its primary function is therapy delivery, not diagnosis.
No
The device description explicitly states the system consists of two hardware components: a pump control/display module and a pneumatic drive module. While software is used for control and timing, it is integral to the operation of these physical components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a device used for counter-pulsation therapy to support impaired Left Ventricular function and provide hemodynamic support. This is a therapeutic intervention performed directly on the patient, not a diagnostic test performed on a sample taken from the patient.
- Device Description: The description details a pump system that interacts directly with an intra-aortic balloon catheter inserted into the patient's aorta. It uses physiological data from the patient to control the balloon's inflation and deflation. This is a life-support and therapeutic device, not a device for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The AC3™ Range™ Intra-Aortic Balloon Pump (IABP is clinically indicated for use for the following conditions:
-
- Acute Coronary Syndrome
-
- Cardiac and Non-Cardiac Surgery
-
- Complications of Heart Failure
Product codes
DSP
Device Description
The AC3 Range IABP system is a professional use device that provides counter-pulsation therapy to adult patients with impaired Left Ventricular (LV) Function. It provides hemodynamic support of blood pressure and reduced cardiac work through volume displacement principles.
The AC3 Range 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 for easy transport.
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 pump display incorporates a high-definition touchscreen with color coded icons and a keypad for system operation. The AC3 Range IABP uses software to select and maintain precise IAB catheter inflation timing and triggering based on real time physiological data from the patient. The system offers two modes of operation, (1) the AutoPilot mode, where most functions are automatically selected and controlled by IABP and (2) the Operator mode where the user has control over most settings and selections.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
descending thoracic aorta
Indicated Patient Age Range
adult patients
Intended User / Care Setting
professional use device
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)
The technological differences between the subject and predicate device have been evaluated through Mechanical and General Safey Testing to provide evidence of substantial equivalence for the AC3 Range IABP. The results of these tests raised no new questions of safety or effectiveness and demonstrated that the subject AC3 Range IABP is substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
March 26, 2025
Arrow International LLC Apurva Gokhale Pr. Regulatory Product Specialist (Subsidiary of Teleflex Incorporated) 3015 Carrington Mill Boulevard Morrisville, North Carolina 27560
Re: K250542
Trade/Device Name: AC3TM RangeTM 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 Dated: February 24, 2025 Received: February 24, 2025
Dear Apurva Gokhale:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 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).
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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
3
Indications for Use
Submission Number (if known)
TBD
Device Name
AC3 TM Range TM Intra-Aortic Balloon Pump
Indications for Use (Describe)
The AC3™ Range ™ Intra-Aortic Balloon Pump is 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)
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Image /page/4/Picture/0 description: The image shows the word "Teleflex" in a bold, blue font. The word is written in all lowercase letters except for the first letter, which is capitalized. There is a registered trademark symbol to the right of the word. The logo is simple and modern.
510(k) Summary [As required by 21 CFR 807.92] Date Prepared: February 21, 2025 510(k) Number: K250542
Submitter's Name/Contact Person Manufacturer
Arrow International LLC Subsidiary of Teleflex, Inc. 16 Elizabeth Drive Chelmsford, MA 01824 Establishment Registration #3010532612
Contact Person Apurva N. Gokhale Principal Regulatory Affairs Specialist InterventionalPMRA@teleflex.com Tel. +1 905-808-5313
General Information
| Trade Name | AC3™ Range™ Intra-Aortic Balloon Pump (IABP) |
|---|---|
| Common Name | Intra-Aortic Balloon and Control System |
| Product Code | DSP |
| Classification | Class II |
| Regulation | 21 C.F.R. §870.3535 |
| Panel | Cardiovascular |
| Predicate Device | K232343 - AC3™ Series IAB Pump (cleared 30 August |
- |
Device Description
The AC3 Range IABP system is a professional use device that provides counter-pulsation therapy to adult patients with impaired Left Ventricular (LV) Function. It provides hemodynamic support of blood pressure and reduced cardiac work through volume displacement principles.
The AC3 Range 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 for easy transport.
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 pump display incorporates a high-definition touchscreen with color coded icons and a keypad for system operation. The AC3 Range IABP uses software to select and maintain precise IAB catheter inflation timing and triggering based on real time physiological data from the patient. The system offers two modes of operation, (1) the AutoPilot mode, where most functions are automatically selected and controlled by IABP and (2) the Operator mode where the user has control over most settings and selections.
Intended Use/Indications for Use
The AC3™ Range™ Intra-Aortic Balloon Pump (IABP is clinically indicated for use for the following conditions:
-
- Acute Coronary Syndrome
-
- Cardiac and Non-Cardiac Surgery
-
- Complications of Heart Failure
Technological Characteristics Comparison
The AC3 Range IABP is a compact version of the AC3 Optimus IABP that has a low profile for improved transportability within air and ground transport modes (helicopter, plane, ambulance).
Arrow International LLC - a subsidiary of Teleflex Inc.
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Image /page/5/Picture/0 description: The image contains the word "Teleflex" in a stylized, bold, blue font. The word is followed by the registered trademark symbol. The font is sans-serif and the letters are closely spaced together. The overall impression is of a corporate logo.
Substantial Equivalence and Summary of Studies
The technological differences between the subject and predicate device have been evaluated through Mechanical and General Safey Testing to provide evidence of substantial equivalence for the AC3 Range IABP.
Conclusion
The AC3 Range IABP has identical indications for use, fundamental technologies, principles of operation and performance compared to the predicate device. Substantial equivalence was demonstrated through Mechanical and General Safey Testing. The results of these tests raised no new questions of safety or effectiveness and demonstrated that the subject AC3 Range IABP is substantially equivalent to the predicate device.