BELMONT PORTABLE BALLOON PUMP, BARD TRANSACT IABP by BELMONT INSTRUMENT CORP.

There are no changes to the intended use of the IABP for which a 510(k) was approved in October 1992 [510(k) number K915580]. The balloon pump is an electromechanical system used to drive intra-aortic balloons. It provides temporary support to the left ventricle via the principle of counterpulsation. The intra-aortic balloon is placed in the descending aorta, just distal to the left subclavian artery. Once the balloon is positioned, the pump is adjusted to trigger in synchrony with the ECG or arterial pressure waveform to ensure that inflation and deflation occur at the appropriate points during the cardiac cycle.

Device Description

Belmont Instrument Corporation intends to revise software used in the Intra-Aortic Balloon Pump (IABP). There are no other changes to the IABP for which a 510(k) was approved in October 1992. The revised software provides a more convenient way for Operators of the pump to set the ECG gain. In particular, the change will accommodate high gain settings by the operator, in which the ECG R-Wave amplitude is set far higher than the triggering threshold. Setting the ECG gain too high can lead to noise affecting triggering. In the existing software, the thresholds for ECG R-Wave detection, pacer spike detection, and noise detection are all fixed values. In the upgraded version, the R-Wave trigger threshold is scaled to a moving average of prior R-Wave amplitudes with the most recent R-Wave amplitude weighted the most heavily. The pacer detection and noise detection threshold are. in turn, scaled to the new R-Wave threshold.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Belmont Portable Balloon Pump's revised software:

This document, K982538, describes a software revision for an Intra-Aortic Balloon Pump (IABP) and focuses on demonstrating its substantial equivalence to the previously approved IABP software. The study presented here is not a complex clinical trial but rather a series of verification and validation tests for the software functionality.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly listed in a table format in the original text, but they can be inferred from the "Summary of Nonclinical Tests and Results" section. The reported device performance is presented as a confirmation that these criteria were met.

Acceptance Criteria (Inferred from Section 12)	Reported Device Performance
A. Software algorithms satisfied quantitatively	Verification of software algorithms was performed and deemed satisfied.
B. Effective triggering over a heart rate range of 30 - 200 BPM	The revised software enables the IABP to trigger effectively over the full specified range of heart rate, 30 - 200 BPM.
C. Effective triggering over a wide range of clinical conditions, including arrhythmias and varied ECG morphologies	The revised software enables IABP to trigger effectively over a wide range of clinical conditions as demonstrated by performance with the American Heart Association ECG Database, and by deliberately synthesizing specific arrhythmias, and ECG morphologies, using ECG Arrhythmia Simulators, and clinical tapes.
D. Improved performance at very high ECG gain settings and proper function at low gain, including lower amplitude ECG than current software	The revised software demonstrates improved performance at very high ECG gain setting, and still function properly at low gain, including lower amplitude ECG than is possible with the current (unmodified) software.
E. Rapid and effective response to sudden changes in ECG gain from Operator	The revised software is designed to function in the present Belmont PBP system, with an ECG gain control set by the Operator. The system must therefore, respond quickly and effectively to sudden changes in ECG gain.
F. All safety features function properly.	All safety features function properly.
G. System stops operation safely at all identified adverse conditions.	The system will stop operation in a safe manner at all identified conditions which could adversely affect safety or efficacy.
H. System passes all applicable tests defined in "Final Functional Test Procedure, PBP-Q108".	The system passes all applicable tests using the "Final Functional Test Procedure, PBP-Q108".

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state a numerical sample size for the test set in terms of individual patients or ECG recordings. Instead, it refers to:

American Heart Association ECG Database: This implies a retrospective collection of diverse ECG data.
Deliberately synthesizing specific arrhythmias and ECG morphologies: This indicates simulated data, likely prospective in its generation for testing purposes.
Clinical tapes: This suggests retrospective recordings of patient ECGs.

The country of origin for the AHA database and clinical tapes is not specified, but typically the AHA database originates from the US. The 'clinical tapes' could be from various sources.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

The document does not mention the use of human experts to establish ground truth for the test set. The focus is on the algorithmic detection of ECG R-waves, pacer spikes, and noise, and comparison against expected behavior given the input ECG signals (from databases or simulators).

4. Adjudication Method for the Test Set

No adjudication method is described, as the evaluation primarily relies on the physical and electrical characteristics of the ECG signals and the expected behavior of the algorithm, rather than human interpretation.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This study is focused on the performance of the software itself in processing ECG signals, not on the improvement of human reader performance with or without AI assistance.

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

Yes, a standalone study of the algorithm's performance was done. The "Summary of Nonclinical Tests and Results" directly describes the testing and verification of the revised software's ability to:

Satisfy software algorithms quantitatively.
Trigger effectively over specified heart rates.
Trigger effectively over a wide range of clinical conditions using databases and simulators.
Demonstrate improved performance at high ECG gain and proper function at low gain.
Respond quickly and effectively to sudden changes in ECG gain.
Ensure safety features function correctly and stop operation safely.
Pass system tests.

These are all evaluations of the algorithm's intrinsic performance without human interaction during the operational testing itself.

7. The Type of Ground Truth Used

The ground truth for the performance tests appears to be:

Reference ECG Data: Provided by recognized databases like the American Heart Association ECG Database. These databases typically have annotations or known characteristics of the ECG signals.
Synthesized Arrhythmias and ECG Morphologies: Created using ECG Arrhythmia Simulators, where the "true" characteristics (e.g., presence and timing of R-waves, pacer spikes, noise) are precisely known by design.
Clinical Tapes: Real-world ECG recordings, likely with established truth based on the recording conditions and potentially expert annotation from their original use, though this is not explicitly detailed.

8. The Sample Size for the Training Set

The document does not specify a sample size for a training set. This is because the software revision described is primarily an algorithmic change to how thresholds are scaled, not a machine learning model that requires a distinct training and testing phase. The "algorithm" itself is a set of predefined rules and calculations.

9. How the Ground Truth for the Training Set Was Established

Since there is no mention of a separate training set, the concept of establishing ground truth for a training set is not applicable in this context. The core change is a deterministic algorithmic adjustment (scaling R-wave trigger threshold to a moving average, and subsequent scaling of pacer and noise detection thresholds), not a learned model from data. The tests described are validation tests against known or synthesized ECG patterns.

Summary

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K982538

Attachment 5

OCT 2 1998

Belmont Instrument Corporation

780 Boston Road, Billerica, MA 01821 (978)663-0212, Fax: (978)663-0214

Registered In Accordance with Iso-9001 (Certificate # 041007407)

PREMARKET NOTIFICATION 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS [As Required By 21 CFR 807.92(c)]

Date prepared: June 25, 1998

1. Belmont Instrument Corporation Submitter & 780 Boston Road Manufacturing Site: Billerica, MA 01821
  Establishment Registration Number: 1219702
Uraiwan P. Labadini, Quality Assurance/Regulatory Affairs 2. Contact Person: Manager
(978) 663-0212 Ext. 28 Fax: (978) 663-0214 Telephone:
1. Trade Name: Belmont Portable Balloon Pump, Bard TransAct IABP
Intra-Aortic Balloon Pump Control System 4. Common name:
Component of the Intra-Aortic Balloon Pump (per 21 CFR ട്. Classification name: section 870.3535)
74DSP: Intra-Aortic Balloon Pump ଚ. Product Code: Device Class: Class III: Intra-Aortic Balloon Pump

Performance Standards:

No performance standards have been officially adopted by the F.D.A.

Belmont Instrument Corporation intends to revise software used in the Intra-Aortic 8. Balloon Pump (IABP). There are no other changes to the IABP for which a 510(k) was approved in October 1992. The revised software provides a more convenient way for Operators of the pump to set the ECG gain. In particular, the change will accommodate high gain settings by the operator, in which the ECG R-Wave amplitude is set far higher than the triggering threshold. Setting the ECG gain too high can lead to noise affecting triggering. In the existing software, the thresholds for ECG R-Wave detection, pacer spike detection, and noise detection are all fixed

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510(k) Summary of Safety and Effectiveness Page 2 of 4 June 25, 1998

values. In the upgraded version, the R-Wave trigger threshold is scaled to a moving average of prior R-Wave amplitudes with the most recent R-Wave amplitude weighted the most heavily. The pacer detection and noise detection threshold are. in turn, scaled to the new R-Wave threshold.

Brief Description: The IABP software program has been compiled and linked to run from the system EPROM. In the current system. the thresholds for ECG R-Wave detection, pacer spike detection, and noise detection are all fixed values. In the revised software, the R-Wave trigger threshold is scaled to a moving average of prior R-Wave amplitudes with the most recent R-Wave amplitude weighted the most heavily. The pacer detection and noise detection thresholds are, in turn, scaled to the new R-Wave amplitude.

If the user sets the ECG gain low, the new triggering threshold will be low. If the ECG gain is raised, the new triggering threshold is raised. Triogering threshold is computed by first computing the moving average of R-Wave amplitude. The detection threshold is a fixed fraction of the moving average, where the fraction is higher (0.75) during up to 400ms after the last R-Wave and lower (0.57) during the period after 400ms. For most beats the threshold for ECG triggering is just over 1/2 that of the previous beats.

1. Intended Use: The balloon pump is an electromechanical system used to drive intra-aortic balloons. It provides temporary support to the left ventricle via the principle of counterpulsation. The intra-aortic balloon is placed in the descending aorta, just distal to the left subclavian artery. Once the balloon is positioned, the pump is adjusted to trigger in synchrony with the ECG or arterial pressure waveform to ensure that inflation and deflation occur at the appropriate points during the cardiac cycle.
  There are no changes to the intended use of the IABP for which a 510(k) was approved in October 1992.
1. Summary of the technological characteristics of the revised software compared to the current software used in the JABP.
- A. Comparison of Software Specifications:

The original software and the revised software specification are compared side-by-side. There are no changes, other than those pertaining to ECG triggering threshold levels.

B. Software Quality Assurance Plan
The Software Quality Assurance Plan described the software quality assurance requirements to be applied to the software to be used in the Belmont IABP. This document addressed the software quality assurance functions implemented by Belmont Instrument Corp. to conform to FDA requirements contained in the Reviewer Guidance for Computer Controlled Medical Devices. This Software Quality Assurance Plan (SQAP) has been

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510(k) Summary of Safety and Effectiveness Page 3 of 4 June 25, 1998

designed to address the requirements of ANSI/IEEE Standard 730.1-1989 "IEEE Standard for Software Quality Assurance Plans" with regard to the preparation and content of Software Quality Assurance Plans.

Search of Existing Devices for Problems relating to Safety and/or C. Effectiveness:
In this phase, a hazard analysis was performed by analyzing all possible hazardous conditions on the software, system, and device. A computerized literature search was performed encompassing all reported hazards encountered in balloon pumping including problems resulting from the balloon, the control system, user error, insertion problems, or physician error. All problems which relate in any way to the control system were tabulated, including problems due to the balloon and poor insertion, etc., which could be detected by the control system. After tabulating potential hazards of the system, we implemented a series of safety measures to ensure that the machine would stop operation and alarm at all hazards, and that the failure of no one component could cause a serious problem.
1. Summary of Nonclinical Tests and Results
  We verify that the revised software performs according to specifications as follow:
A. The software algorithms are satisfied, quantitatively.
B. The revised software enables the IABP to trigger effectively over the full specified range of heart rate, 30 - 200 BPM.
். The revised software enables IABP to trigger effectively over a wide range of clinical conditions as demonstrated by performance with the American Heart Association ECG Database, and by deliberately synthesizing specific arrhythmias, and ECG morphologies, using ECG Arrhythmia Simulators, and clinical tapes.
The revised software demonstrates improved performance at very high ECG D. gain setting, and still function properly at low gain, including lower amplitude ECG than is possible with the current (unmodified) software.
The revised software is designed to function in the present Belmont PBP ப் system, with an ECG gain control set by the Operator. The system must therefore, respond quickly and effectively to sudden changes in ECG gain.

Finally, we perform the system testing which is a test of the integrated hardware and software system to ensure that all system requirements are met including:

i) all safety features function properly,
the system will stop operation in a safe manner at all identified ii)

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510(k) Summary of Safety and Effectiveness Page 4 of 4 June 25, 1998

conditions which could adversely affect safety or efficacy,

using the "Final Functional Test Procedure, PBP-Q108".

The system passes all applicable tests.

1. Conclusion: We believe that our revised software is substantial equivalent to the current software. The claim of substantial equivalence is based on the following:
- A. Same intended use - both systems are capable of appropriately trigger balloon inflation and deflation from ECG waveforms, even in the presence of artifacts, pacing spikes, and arrhythmias.
- B. Both systems alarm, display an alarm message, and stop at all unsafe conditions.
- ். The differences between the two software do not raise new types of safety or effectiveness questions.
- D. Our performance tests to support substantial equivalence have demonstrated that the revised software is as safe, as effective, and performs as well as the current software used in the legally marketed device.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 1998

Mr. Uraiwan P. Labadini Quality Assurance/Requlatory Affairs Manager Belmont Instrument Corporation 780 Boston Road Billerica, MA 01821

K982538 Re: Intra-Aortic Balloon Pump (IABP) Software Requlatory Class: III Product Code: 74 DSP September 3, 1998 Dated: Received: September 4, 1998

Dear Mr. Labadini:

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 leqally 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, Druq, 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 requlations affecting your device can be found in the Code of Federal Requlations, 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 requlatory 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 requlations.

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Page 2 - Mr. Uraiwan P. Labadini

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™ (21 CFR 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,

Thomas J. Callahan

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices --Office of Device Evaluation Center for Devices and Radiological Health

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Attachment I

Page 1 Of 1

510(k) number: ____ 上 98 25 38

Device Name: Software to be used in the IABP

Indications For Use:

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Y Vera L. Cooper M

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices

510(k) Number_

Prescription Use 1
(Per 21 CFR 801.109) OR Over-The-Counter Use_

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.