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

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 ventricular failure
Cardiogenic shock
Unstable refractory angina
Impending infarction
Mechanical complications due to acute myocardial infarction
Ischemic related intractable ventricular arrhythmias
Cardiac support for high risk surgical patients and coronary angiography or angioplasty patients
Septic shock
Weaning from cardiopulmonary bypass
Interoperative pulsatile flow generation
Support for failed angioplasty and valvuloplasty

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:

AI/ML Overview

The submitted text is a 510(k) premarket notification for a medical device, specifically an Intra-Aortic Balloon (IAB). This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than establishing new safety and effectiveness through extensive clinical trials as would be required for a Class III device requiring PMA. As such, the information typically requested in your prompt (acceptance criteria, study details, human reader performance, training sets, etc.) is not present in this document because it's not relevant to a 510(k) submission for this type of device.

Here's an analysis based on the provided text:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria: The document does not explicitly state specific quantitative acceptance criteria for the device's performance. The primary acceptance criterion for a 510(k) submission is to demonstrate "substantial equivalence" to a legally marketed predicate device. This is a regulatory standard, not a performance metric in the way you might define it for a diagnostic algorithm.
Reported Device Performance: The document states that "The results of in-vitro tests conducted demonstrate that the functionality and performance characteristics of the device are comparable to the currently marketed devices." However, no specific performance metrics or quantitative results from these in-vitro tests are provided.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not Applicable. No clinical test set data is described in this document. The device did not undergo clinical evaluation in the U.S. in this submission pathway.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable. No clinical test set requiring expert ground truth is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable. No clinical test set requiring adjudication is described.

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), a physical medical device. It is not an AI diagnostic algorithm, and therefore, MRMC studies or human reader improvement with AI assistance are not relevant to its evaluation.

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.

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

Not Applicable. No clinical data requiring "ground truth" establishment in this manner was used for this 510(k) submission. The equivalence was based on technological characteristics and in-vitro testing.

8. The sample size for the training set

Not Applicable. This submission is not for an AI/ML algorithm that requires a training set.

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

Not Applicable. This submission is not for an AI/ML algorithm that requires a training set.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The "study" that proves the device meets the acceptance criteria for a 510(k) submission is the demonstration of substantial equivalence to predicate devices through:

Technological Comparison: The company asserted that "Datascope's Percor STAT-DL® 9.5Fr. IAB is substantially equivalent to the predicate devices with regard to its indications for use." The only stated technological difference was "material grade and chemical composition of the membrane material," which they claimed "has been demonstrated not to affect safety or efficacy of the device."
Non-Clinical (In-vitro) Tests: "The results of in-vitro tests conducted demonstrate that the functionality and performance characteristics of the device are comparable to the currently marketed devices." These tests are not detailed in the provided summary.
Lack of Clinical Tests: Explicitly stated, "There has been no clinical evaluation of the new device in the U.S."

The FDA's acceptance of the 510(k) notification (K980780) means they concurred that, based on the provided information, the device is substantially equivalent to legally marketed predicate devices, and therefore can be marketed.

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.