The iPulse IABP Console is an electromechanical system used to inflate and deflate 8F 40 cc intra-aortic balloons (IABs). It provides temporary support to the left ventricle via the principle of counterpulsation. For this therapy, the IAB is placed in the descending aorta, just distal to the left subclavian artery. After positioning the balloon, the user can adjust the balloon to trigger in synchrony with either the ECG or arterial pressure waveform to ensure that both inflation and deflation occur at the proper point during the cardiac cycle.

Indications for Use:

Appropriate patient groups for IAB counterpulsation therapy using the iPulse IABP Console are adults suffering from:

Unstable refractory angina .
Impending infarction ●
Post Infarction Angina or Threatening Extension of Myocardial Infarction .
Refractory ventricular failure .
Mechanical complications because of myocardial infarction ●
Cardiogenic shock .
Support and stabilization of high risk patients undergoing diagnostic and non-surgical ● procedures
Ischemic related intractable ventricular arrhythmias .
Septic shock .
Interoperative pulsatile flow generation
Weaning from cardiopulmonary bypass .
Cardiac support for high risk surgical patients and coronary angiography and angioplasty ● patients
Prophylactic support in preparation for cardiac surgery .
. Post-surgical myocardial dysfunction
Cardiac Contusion .
Mechanical bridge to other assist devices ●
Cardiac support following correction of anatomical defects ●
Support for failed angioplasty and valvuloplasty

Device Description

The iPulse Intra-Aortic Balloon Pump (IABP) Console is a cardiac assist device. It supports the heart's left ventricle by increasing coronary perfusion and reducing left ventricular work. The iPulse IABP Console is designed to work in conditions which are unique to the operating room, catheterization laboratory, critical care unit and during transport. The iPulse IABP Console has two operation modes; auto and manual. The auto operation mode provides simplicity and minimizes operator intervention. The manual operation mode provides operators with flexibility for difficult clinical cases.

The iPulse IABP Console is an electro-mechanical system used to inflate and deflate 8 French, 40 cc intra-aortic balloon catheters.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information based on the provided text, using the requested format:

Acceptance Criteria and Device Performance Study

The iPulse Intra-Aortic Balloon Pump Console's acceptance criteria primarily revolved around demonstrating equivalence to two legally marketed predicate devices: the Datascope CS100 Intra-Aortic Balloon Pump (K031636) and the Arrow AutoCAT2 Intra-Aortic Balloon Pump (K002256).

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Derived from Predicate Equivalence)	Reported Device Performance (iPulse Console)	Relevant Section for Performance
Intended Duration of Use: Temporary use, approx. ≤ 30 days	Temporary use, Approx. ≤ 30 days	Table 1
IAB Catheter Tested: 8F, 40 cc	8F, 40 cc	Table 1
IABP Drive System: Electro-pneumatic with replaceable helium cylinder	Electro-pneumatic with replaceable helium cylinder	Table 1
User Interface/Display Type: Laptop	Laptop	Table 1
Maximum Beat Rate: ≥ 185 BPM (based on lower predicate)	200 BPM	Table 1
Trigger Signals Accepted: ECG, Aortic pressure	ECG, Aortic pressure	Table 1
Console Size (on Cart): Comparable dimensions to predicates	30"Hx23"Wx11"D	Table 1
Console Weight: Comparable weight to predicates	126 lbs	Table 1
Voltage Requirement: 120/240 Vac	120/240 Vac	Table 1
Battery Type: Sealed Lead Acid	Sealed Lead Acid	Table 1
Battery Runtime (minimum): ≥ 2.0 hours (based on lower predicate)	2.5 hours	Table 1
Safety and Effectiveness: Equivalent to predicates	Safe and effective	Section g & h
Performance and Reliability: In accordance with FDA guidance	Demonstrated equivalence to 2 predicate IABP consoles	Section g
Software Verification: Compliance with applicable standards	Demonstrated compliance	Section g
Electrical Standards (EMI, EMC, Electrical Safety): Compliance with applicable standards	Demonstrated compliance	Section g

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

The document does not explicitly state a "test set" in terms of patient data or a specific number of devices tested for comparative performance. The pre-clinical testing mentioned involves "laboratory tests" which are typically in-house engineering and performance evaluations.

Sample Size: Not specified in terms of number of devices or clinical cases. The testing was conducted on the iPulse IABP Console itself.
Data Provenance: The testing was "pre-clinical laboratory testing" conducted by ABIOMED, Inc. (manufacturer). There is no mention of country of origin for any external data, and it is entirely retrospective in the sense that it's a report of completed internal testing.

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

Not applicable. The ground truth for this device's performance relies on engineering specifications, adherence to functional requirements, and comparison to the published specifications and performance characteristics of predicate devices. There is no mention of human expert evaluation in establishing a "ground truth" for the device's technical performance in the way one would for diagnostic imaging.

4. Adjudication Method for the Test Set

Not applicable, as there was no "test set" requiring adjudication by human experts in a clinical context. The "adjudication" for the device's performance was an assessment against established engineering and regulatory standards and comparison to predicate device 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 Intra-Aortic Balloon Pump Console, not an AI-powered diagnostic tool requiring a MRMC study for human reader performance. Its effectiveness is measured by its mechanical and electrical performance in assisting the heart, not by improving human interpretation of medical images or data.

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

Not applicable. This is a medical device (hardware and embedded software) that operates in conjunction with human operation (human-in-the-loop is inherent to its use in a clinical setting). It is not solely an "algorithm" in the sense of an AI model being evaluated for standalone diagnostic performance. The pre-clinical testing did evaluate its standalone technical performance against specifications.

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

The ground truth for evaluating the iPulse IABP Console's performance was:

Engineering specifications and functional requirements: The device was tested against its design specifications for parameters like maximum beat rate, battery runtime, drive system, etc.
Regulatory standards: Compliance with applicable electrical standards (EMI, EMC, Electrical Safety) and software verification methods.
Predicate device performance: The performance of the iPulse console was specifically compared to the Datascope CS100 and Arrow AutoCAT2, aiming for "equivalence" in performance and reliability. FDA guidance for IABP catheters and consoles was also referenced.

8. The sample size for the training set

Not applicable. This document describes a medical device, not a machine learning model that requires a training set.

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

Not applicable. This document describes a medical device, not a machine learning model that requires a training set and corresponding ground truth.

Summary

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Section 5.0- 510(k) Summary (Prepared in accordance with 21 CFR Part 807.92)

a. Submitted
Applicant Name:	ABIOMED, Inc.22 Cherry Hill Drive, Danvers, MA 01923
Contact Person:	Robert T.V. Kung, Ph.D.
Date Summary Prepared:	December 7, 2007
b. Device information
Trade Name:	iPulse Intra-Aortic Balloon Pump Console
Common Name:	Intra-Aortic Balloon Pump
Classification Name:	Intra-Aortic Balloon and Control System(Class III under CFR870.3535)
Product Code:	74DSP

c. Legally Marketed Predicate Devices

Datascope CS100 Intra-Aortic Balloon Pump (K031636)

Arrow AutoCAT2 Intra-Aortic Balloon Pump (K002256)

d. Device Description:

e. Intended Use:

The iPulse IABP Console can be used to provide temporary support to the left ventricle via the principle of counter-pulsation. An intra-aortic balloon (IAB) catheter is placed in the descending aorta, just distal to the left subclavian artery. Once the IAB is positioned, the iPulse IABP Console is adjusted to trigger in synchrony with either the ECG or arterial pressure waveform to ensure that inflation and deflation occur at the appropriate points during the cardiac cycle. The iPulse IABP Console is intended for use in health care facilities to improve cardiovascular functioning during the following situations:

Unstable refractory angina .
Impending infarction t
Post Infarction Angina or Threatening Extension of Myocardial Infarction .
Refractory ventricular failure .

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Mechanical complications because of myocardial infarction
. Cardiogenic shock
Support and stabilization of high risk patients undergoing diagnostic and . non-surgical procedures
. Ischemic related intractable ventricular arrhythmias
Septic shock ◆
Interoperative pulsatile flow generation .
. Weaning from cardiopulmonary bypass
Cardiac support for high risk surgical patients and coronary angiography . and angioplasty patients
. Prophylactic support in preparation for cardiac surgery
Post-surgical myocardial dysfunction .
◆ Cardiac Contusion
. Mechanical bridge to other assist devices
Cardiac support following correction of anatomical defects .
. Support for failed angioplasty and valvuloplasty

f. Technological Characteristics and Comparison to Predicate Device(s):

The iPulse IABP Console is an electro-mechanical system used to inflate and deflate 8 French, 40 cc intra-aortic balloon catheters. The iPulse console and the predicate consoles have equivalent performance for counter-pulsation therapy

Table 1 provides a comparison of the iPulse IABP Console with the with predicate IABP consoles. This table illustrates the equivalency of the iPulse IABP Console with its predicates.

Property	iPulse Console	CS100 Console-K031636	AutoCAT2 Console-K002256
Intended Duration of Use	Temporary use:Approx. ≤ 30 days	Temporary use:Approx. ≤ 30 days	Temporary use:Approx. ≤ 30 days
IAB Catheter Tested	8F, 40 cc	8F, 40 cc	8F, 40 cc
IABP Drive System	Electro-pneumaticwith replaceablehelium cylinder	Electro-pneumatic withreplaceable heliumcylinder	Electro-pneumaticwith replaceablehelium cylinder
User Interface/Display Type	Laptop	Laptop	Laptop
Maximum Beat Rate	200 BPM	185 BPM	200 BPM
Trigger Signals Accepted	ECG, Aortic pressure	ECG, Aortic pressure	ECG, Aortic pressure
Console Size (on Cart)	30"Hx23"Wx11"D	26.6"Hx20.5"Wx10.8"D	37.8"Hx14"Wx20"D
Console Weight	126 lbs	126 lbs	86 lbs
Voltage Requirement	120/240 Vac	120/240 Vac	120/240 Vac
Battery Type	Sealed Lead Acid	Sealed Lead Acid	Sealed Lead Acid
Battery Runtime (minimum)	2.5 hours	2.25 hours	2.0 hours

Table 1- Comparison Table for iPulse IABP Console

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g. Pre-clinical Test Results:

Three different types of pre-clinical testing were completed for the iPulse IABP Console: laboratory, software verification and electrical standards testing. The laboratory tests demonstrated equivalence to the 2 predicate IABP consoles, and included performance and reliability testing in accordance with the FDA's recommendations, as provided in: "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) Regulations", Preliminary Draft, 12/9/93. The software verification and electrical standards (EMI, EMC and Electrical Safety) testing demonstrated compliance with the applicable standards required for device clearance.

The pre-clinical test results demonstrate that the iPulse IABP Console is safe and effective, and performs equivalently to the 2 predicate IABP consoles.

h. Conclusion:

Based on the information presented in this 510(k) pre-market notification, the iPulse IABP Console is considered substantially equivalent to the currently marketed predicate devices.

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Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" arranged in a circular fashion around the symbol. The text is in all caps and is evenly spaced around the circle.

DEC 1 3 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Abiomed. Inc. c/o Dr. Robert T.V. Kung Senior Vice President Chief Scientific Officer 22 Cherry Hill Drive Danvers, MA 01923

K070225 Re:

iPulse IABP Console Regulation Number: 21 CFR 870.3535 Regulation Name: Intra-aortic Balloon and Control System Regulatory Class: Class III Product Code: DSP Dated: December 7, 2007 Received: December 10, 2007

Dear Dr. Kung:

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. 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 (PMA), it may be subject to such 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.

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Page 2- Dr. Robert T.V. Kung

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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Cl.S.M.

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 070225

510(k) Number (if known):

Device Name: iPulse Intra-aortic Balloon Pump Console

Intended Use:

Indications for Use:

Appropriate patient groups for IAB counterpulsation therapy using the iPulse IABP Console are adults suffering from:

Unstable refractory angina .
Impending infarction ●
Post Infarction Angina or Threatening Extension of Myocardial Infarction .
Refractory ventricular failure .
Mechanical complications because of myocardial infarction ●
Cardiogenic shock .
Support and stabilization of high risk patients undergoing diagnostic and non-surgical ● procedures
Ischemic related intractable ventricular arrhythmias .
Septic shock .
Interoperative pulsatile flow generation
Weaning from cardiopulmonary bypass .
Cardiac support for high risk surgical patients and coronary angiography and angioplasty ● patients
Prophylactic support in preparation for cardiac surgery .
. Post-surgical myocardial dysfunction
Cardiac Contusion .
Mechanical bridge to other assist devices ●
Cardiac support following correction of anatomical defects ●
- Support for failed angioplasty and valvuloplasty

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 807 Subpart C)

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

AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ko70225
(Division Sign-Off

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number

Page 1 of 1

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.