FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

Refractory unstable angina .
. Impending infarction
Acute MI .
. Refractory ventricular failure
Complications of acute MI (i.e. Acute MR or VSD, or papillary muscle rupture) ●
Cardiogenic shock ●
Support for diagnostic, percutaneous revascularization, and interventional procedures. .
Ischemia related intractable ventricular arrhythmias .
. Septic shock
Intraoperative pulsatile flow generation ●
. Weaning from bypass
. Cardiac support for non-cardiac surgery
Prophylactic support in preparation for cardiac surgery .
Post surgical myocardial dysfunction/low cardiac output syndrome .
. Myocardial contusion
Mechanical bridge to other assist devices .
Cardiac support following correction of anatomical defects .

Device Description

The intra-aortic balloon is placed in the descending aorta just below the subclavian artery and is intended to improve cardiovascular functioning during the following situations:

Refractory unstable angina .
Impending infarction
Acute MI .
. Refractory ventricular failure
Complications of acute MI (i.e. Acute MR or VSD, or papillary muscle rupture) .
. Cardiogenic shock
. Support for diagnostic, percutaneous revascularization, and interventional procedures.
Ischemia related intractable ventricular arrhythmias ●
. Septic shock
. Intraoperative pulsatile flow generation
Weaning from bypass
Cardiac support for non-cardiac surgery
. Prophylactic support in preparation for cardiac surgery
Post surgical myocardial dysfunction/low cardiac output syndrome ●
. Myocardial contusion
Mechanical bridge to other assist devices .
. Cardiac support following correction of anatomical defects

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Datascope Intra-Aortic Balloon Catheter Systems:

Regarding the Acceptance Criteria and Study to Prove the Device Meets Them:

Based on the provided K020257 510(k) summary, it's clear that this submission is for a modification to the Indications for Use for an already marketed device, not for a new device requiring novel performance testing.

Therefore, the typical structure for proving a new device meets specific quantitative performance acceptance criteria through a dedicated study, as you've outlined in your input request, is not applicable to this submission.

Instead, the acceptance criteria here are qualitative: "substantially equivalent" to predicate devices in terms of expanded Indications for Use. The "study" proving this is an argument of equivalence based on existing data and prior FDA approvals.

Here's a breakdown of the requested information, adapted to fit the nature of this 510(k):

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Qualitative Equivalence)	Reported Device Performance (Argument for Equivalence)
The expanded Indications for Use for the Datascope IAB Catheter System are substantially equivalent to the Indications for Use of legally marketed predicate devices, and do not affect the safety and effectiveness of the device.	The Datascope IAB Catheter Systems' technological characteristics and all existing Indications for Use are already established as safe and effective through prior 510(k) clearances (e.g., K013326, K003598, K980780, K964987, K965236, K002256).

The current submission argues that the expanded Indications for Use are also substantially equivalent to these predicate devices based on "supporting published data" (though specifics of this data are not provided in this summary) and the inherent equivalence of the technology. |

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

Not applicable in the traditional sense. This 510(k) does not present a new test set from a primary study.
The "data" that supports the expanded indications would be previously published literature and clinical experience with intra-aortic balloon pump therapy generally, and likely with the predicate devices specifically. The document mentions "Supporting published data," implying a review of existing literature rather than new data collection.
Provenance: This would be from various clinical studies and publications (country of origin unspecified in this summary, but typically global clinical literature). The nature would be retrospective in terms of reviewing existing information.

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

Not applicable in the traditional sense. There was no independent adjudication of a test set for this 510(k). This is not equivalent to establishing a clinical ground truth for a diagnostic device.
The "ground truth" for substantial equivalence is effectively the FDA's regulatory framework and the decisions on previously cleared predicate devices. The "experts" involved are the FDA reviewers and potentially the authors of the "supporting published data" that informed the expanded indications.

4. Adjudication Method for the Test Set

Not applicable. No test set requiring adjudication was used. The determination of substantial equivalence is made by the FDA based on the submission.

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 (IAB) Catheter System, a medical device for circulatory support, not a diagnostic imaging or AI-assisted interpretation tool. Therefore, MRMC studies and AI performance metrics are irrelevant to this submission.

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

Not applicable. This is a physical medical device, not an algorithm, so standalone performance is not a relevant concept here.

7. The Type of Ground Truth Used

The "ground truth" for this 510(k) is the established safety and effectiveness of the existing predicate devices and the general medical understanding of the conditions for which IAB therapy is indicated. The expansion of indications is argued to fit within this existing "truth" without introducing new risks or questions of effectiveness.

8. The Sample Size for the Training Set

Not applicable. This 510(k) does not involve machine learning or specific training sets in the context of device performance. The "training" here would metaphorically be the cumulative clinical experience and published data that underpins the understanding and use of IAB therapy.

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

Not applicable. (See point 8) The ground truth about the efficacy and safety of IAB therapy in various clinical scenarios is established through decades of medical research, clinical trials, and widespread clinical use, as reflected in medical literature and established practice guidelines. This collective body of evidence informs the "acceptable" indications for such devices.

Summary

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.