(58 days)
The AutoCAT Intra-Aortic Balloon Pump Series is clinically indicated for the following conditions:
a. Acute Coronary Syndrome
b. Cardiac and Non-Cardiac Surgery
c. Complications of Heart Failure
The Intra-Aortic Balloon Pump (IABP) provides cardiac assist therapy. The IABP provides temporary support to patients with impaired left ventricular function through the therapeutic method referred to as counterpulsation increases coronary and systemic profusion, decreasing after load (myocardial work) and decreasing preload.
The AutoCAT Series IABP System utilizes computer technology to select and maintain precise IAB inflation and deflation timing and triggering based on current physiological data from the patient. The system offers two modes of operation, the Autopilot mode, where functions are automatically selected and controlled by the IABP and the Operator mode where the user has control over settings and selections.
The provided documents are a 510(k) summary and FDA clearance letters for the Arrow AutoCAT Intra-Aortic Balloon Pump Series. These documents typically focus on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets specific acceptance criteria in the manner one might expect for a novel AI/ML device.
However, based on the information provided, I can infer and reconstruct some aspects relevant to your request, especially regarding performance data and regulatory compliance.
Here's an analysis of the provided text in relation to your questions:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria and reported numerical device performance metrics (e.g., sensitivity, specificity, accuracy). Instead, it states that the device, with modified software, "meets all the same performance standards of the unmodified device." It then lists the regulatory and guidance documents it complies with, implying that performance is evaluated against these standards.
Inferred Acceptance Criteria / Performance:
| Acceptance Criteria Category | Reported Device Performance | Comments |
|---|---|---|
| Functional Equivalence | The AutoCAT Series IABP System (with V2.22 software) is substantially equivalent in Intended Use and Fundamental Scientific Technology to the predicate devices (AutoCAT K983866, ACAT 1 K965209, ACAT 2 K002256, FOS / FOMS IAB Black Box K021462). | This is the primary "acceptance criterion" for a 510(k) submission. The new device must perform comparably to a legally marketed predicate device. The performance is assessed through various tests to show the modifications (software V2.22) do not raise new questions of safety and effectiveness. |
| Performance Standards | "The AutoCAT IABP Series with modified software meets all the same performance standards of the unmodified device." | This is a general statement. Specific numerical performance data is not provided in a table. It implicitly means the device performs its intended therapeutic function (counterpulsation, increasing coronary/systemic perfusion, decreasing afterload/preload) at a level comparable to the predicate devices. |
| Software Validation | Complies with "FDA Guidance: 'General Principles of Software Validation - Final Guidance' January 11, 2002" and "FDA Guidance: 'Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices - Final Guidance' May 11, 2005". | This ensures that the software modifications (V2.22) were developed and tested according to FDA's standards for medical device software, implying safety and reliability. |
| Electrical Safety/EMC | Complies with IEC 60601-1-4:1997 (Medical Electrical Equipment- General Requirements for Safety-Collateral Standard: Programmable Electrical Medical Systems), EN 55024:1998 (Information Technology Equipment-Immunity Characteristics), and EN 55022:1998 (Information Technology Equipment- Radio Disturbance Characteristics Limits and Methods of Measurement). | These are international standards for electrical safety and electromagnetic compatibility (EMC) in medical devices, ensuring the device operates safely and without interference in a medical environment. |
| Clinical Indications | Cleared for: a. Acute Coronary Syndrome, b. Cardiac and Non-Cardiac Surgery, c. Complications of Heart Failure. | The device's performance must be sufficient to support these clinical indications for use, as demonstrated by equivalence to predicate devices and adherence to relevant standards. |
2. Sample size used for the test set and the data provenance
The document does not provide specific details on the sample size for a test set (e.g., number of patients, number of cases) or the data provenance (e.g., country of origin, retrospective/prospective). This type of detail is typical for studies involving clinical data, which is not the primary focus of this 510(k) summary for a software update to an established device. The assessment here is centered on the software modifications and adherence to engineering/safety standards rather than a new clinical trial with a "test set" of patient data in the AI/ML sense.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. As this is a 510(k) for an Intra-Aortic Balloon Pump software update, the "ground truth" concept as applied to AI/ML devices for diagnostic or interpretive tasks (e.g., imaging diagnosis) is not relevant here. The "ground truth" for IABP function would be physiological parameters and the device's ability to accurately sense and provide counterpulsation based on those parameters according to established medical principles. These are assessed through engineering tests and simulations rather than expert consensus on diagnostic images.
4. Adjudication method for the test set
Not applicable. There is no mention of an adjudication method, as it does not appear that a "test set" requiring expert adjudication (common in AI/ML diagnostic studies) was used. Testing would involve engineering verification and validation.
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 is not an AI-assisted diagnostic or interpretive device for human readers. It's an automated therapeutic device (an Intra-Aortic Balloon Pump) with software for controlling its operation. Therefore, an MRMC study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device, an Intra-Aortic Balloon Pump, operates in both "Autopilot mode, where functions are automatically selected and controlled by the IABP" and "Operator mode where the user has control over settings and selections." While the Autopilot mode represents a form of "standalone" algorithm operation, the context is the device's performance of its therapeutic function, not an algorithm's diagnostic performance. The 510(k) submission assesses the safety and effectiveness of this standalone capability (Autopilot) as part of the overall device. The performance is assessed against engineering standards and comparison to predicate devices, not typically through metrics like sensitivity/specificity derived from a clinical dataset (unless a significant change warranted a new clinical study, which is not indicated here).
7. The type of ground truth used
For an IABP, the "ground truth" would be the actual physiological state of the patient (e.g., continuous arterial pressure waveforms, ECG signals) and the correct physiological response the device should generate (e.g., precise timing of balloon inflation/deflation relative to the cardiac cycle for optimal counterpulsation).
This "ground truth" is typically established through:
- Physiological models and simulations: Using calibrated simulators that mimic human cardiovascular dynamics.
- Animal studies: If novel physiological interactions are being investigated (less likely for a software update to an established device).
- Bench testing: Verifying that sensors accurately detect physiological signals and that the pump mechanism correctly inflates/deflates the balloon according to software commands.
- Clinical experience and medical consensus: The fundamental principles of counterpulsation and the desired physiological outcomes are well-established in cardiology.
The document implicitly refers to this type of ground truth by stating it meets "performance standards" and is "substantially equivalent" to predicate devices, which have already clinically demonstrated their ability to achieve these physiological goals.
8. The sample size for the training set
Not applicable. This is not an AI/ML device in the sense of requiring a "training set" of data for a machine learning model. The software update (V2.22) involves modifications to pre-set start-up settings, autopilot timing, calibration, signal switching, triggering, purge cycle, noise recognition, arrhythmia timing, alarm handling, and help text. These are likely based on engineering design, refinement, and bug fixes rather than a machine learning training paradigm.
9. How the ground truth for the training set was established
Not applicable, as there is no "training set" in the AI/ML context for this type of software update. The "ground truth" for the software's logic and parameters would be derived from:
- Engineering specifications and requirements: Defining how the device should operate.
- Physiological data and models: Understanding cardiovascular mechanics and optimal counterpulsation strategies.
- Clinical feedback and empirical data: Data from previous device versions and clinical practice informing improvements and error correction.
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Image /page/0/Picture/0 description: The image contains 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.
June 17, 2022
Arrow Intl., Inc. Karen Provencher Senior Regulatory Affairs Specialist 9 Plymouth St. Everett, Massachusetts 02149
Re: K060309
Trade/Device Name: Autocat Intra-Aortic Balloon Pump Series Regulation Number: 21 CFR 870.3535 Regulation Name: Intra-aortic balloon and control system Regulatory Class: Class II Product Code: DSP
Dear Karen Provencher:
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 April 6, 2005. Specifically, FDA is updating this SE Letter to reflect an administrative correction corresponding to the reclassification of intra-aortic balloon and control system (1ABP) 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-devicesreclassification-of-intra-aortic-balloon-and-control-systems-foracute#:~:text=The%20Food%20Drug%20Administration%20(FDA)%20is%20issuing%20a%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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
6 2006 APR
6 2006
Arrow International, Inc. c/o Ms. Karen Provencher Senior Regulatory Affairs Specialist 9 Plymouth Street Everett, MA 02149
Re: K060309
K000507
Arrow AutoCAT Intra-Aortic Balloon Pump (IABP) Series Regulation Number: 21 CFR 870.3535 Regulation Name: Balloon, Intra-Aortic and Control System Regulatory Class: Class III Product Code: DSP Dated: March 17, 2006 Reccived: March 23, 2006
Dear Ms. Provencher:
We have reviewed your Section 510(k) premarket notification of intent to market the device . we nave reviewed your bection >10(tr) premation is substantially equivalent (for the indications ferenced above and nave determined ly marketed predicate devices marketed in interstate for use stated in the encreative to regard) the enactment date of the Medical Device Amendments, or to commerce prior to May 20, 7776, the encordance with the provisions of the Federal Food, Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). and Cosmette Herefore, market the device, subject to the general controls provisions of the Act. The r our may, therefore, market the act include requirements for annual registration, listing of general controls provisions of uactice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA). it may be subject to such additional controls. Existing major regulations affecting your device can may ve subject to back to begulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Ms. Karen Provencher
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please oe advised that 1 Dri 3 issuation of a vith other requirements of the Act that TDA has made a determination that your in the Federal agencies. You must or any I ederal statutes and regulations and united to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFK Fart 807), ademig (21 CFR Part 820), and if applicable, the electronic forth in the quality systems (QD) regulation (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (2001) on the vice as described in your Section 510(k) This letter with anow you to obgin maneting your and equivalence of your device to a legally premarket notification. The PDA miding of Saccanada 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), please If you desire specific acries ion 708 101 - 101 - 120 - 120. Also, please note the regulation entitled, Connact the Office of Compulline and (21) (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general information on your responser Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours,
Befremdender for
Bram D. Zuckerman. M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K060309
Device Name
AutoCAT Intra-Aortic Balloon Pump Series
Indications for Use (Describe)
The AutoCAT Intra-Aortic Balloon Pump Series 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)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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Arrow International, Inc
9 Plymouth Street Everett, MA 02149 USA Phone: 617-389-6400 617-387-2157 Fax:
510(k) Summary K060309
AutoCAT Series IABP Series Date Prepared: February 3, 2006 Date Summary Updated: July 28, 2015
A. Submitter's Name:
Arrow International, Inc. 9 Plymouth Street, Everett, MA 02149
Updated Correspondent Address:
Fusun Tufan Senior Requlatory Affairs Manager Arrow International, Inc. 16 Elizabeth Drive, Chelmsford, MA 01824 Phone (978)250-5100 Fax (978)250-5105
B. Company Contact
Michael Malis Director RA/QA Arrow International, Inc. 16 Elizabeth Drive, Chelmsford, MA 01824 Phone (978)250-5100 Fax (978)250-5105
C. Device Name
Trade Name: AutoCAT Intra-Aortic Balloon Pump Series Common Name: Intra-Aortic Balloon Pump (IABP) Classification Name: Intra-Aortic Balloon and Control System
Predicate Devices D.
Arrow International AutoCAT Series IABP System represents the integration of four Arrow IABP technologies which is substantially equivalent in Intended Use and Fundamental Scientific Technology to the following legally marketed device in commercial distribution:
- · AutoCAT, cleared in K983866, (1/6/00)
- · ACAT 1, cleared in K965209, (1/23/98)
- · ACAT 2, cleared in K002256, (5/3/01)
- · FOS / FOMS IAB Black Box, cleared in K021462, (6/6/02)
Description of Device ய்
The Intra-Aortic Balloon Pump (IABP) provides cardiac assist therapy. The IABP provides temporary support to patients with impaired left ventricular function through the therapeutic method referred to as counterpulsation increases coronary and systemic profusion, decreasing after load (myocardial work) and decreasing preload.
The AutoCAT Series IABP System utilizes computer technology to select and maintain precise
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IAB inflation and deflation timing and triggering based on current physiological data from the patient. The system offers two modes of operation, the Autopilot mode, where functions are automatically selected and controlled by the IABP and the Operator mode where the user has control over settings and selections.
F. Indications for Use
The AutoCAT Intra-Aortic Balloon Pump Series is clinically indicated for the following conditions:
- a. Acute Coronary Syndrome
- Cardiac and Non-Cardiac Surgerv ﻘ
- Complications of Heart Failure C.
G. Comparison of Technological Characteristics
Software V2.22 features the modifications to the following- Clarification I The modified Modification to Pre-set Start-up Settings, General Improvements in AutoPilot Timing, Modifications to AP Zero and Calibration Function, Improvements in AutoPilot Signal Switching & Selection, General Improvements in Triggering, Improved Purge Cycle & Helium Refill Function, Recognition of IAB Connector Volumes, Improved Noise Recognition and Handling, Modifications to Arrhythmia Timing Function, Alarm Handling Improvements, Additions to Help Text. Activation of Modem Function. Reqular Output of RS232
Summary Performance Data H.
The AutoCAT IABP Series with modified software meets all the same performance standards of the unmodified device including the following:
-
- FDA Guidance: "Guidance for the Preparation and Content of Applications to the Food and Drug Administration for Determining the Equivalence of Intra-Aortic Balloon Catheters and Consoles under the 510(k) Requlations - Preliminary Draft. December 8.1993
- FDA Guidance: "General Principles of Software Validation -Final Guidance' January 11, 2002 2.
-
- FDA Guidance: "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices - Final Guidance' May 11, 2005
-
- IEC 60601-1-4:1997: Medical Electrical Equipment- General Requirements for Safety-Collateral Standard: Programmable Electrical Medical Systems
-
- EN 55024:1998: Information Technology Equipment-Immunity Characteristics
-
- EN 55022:1998: Information Technology Equipment- Radio Disturbance Characteristics Limits and Methods of Measurement
§ 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.