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

Refractory Unstable Angina. .
Impending Infarction. .
. Acute Myocardial Infarction.
. Refractory Ventricular Failure.
Complications of Acute MI (ie. 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 cardiopulmonary 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 SENSATION® PLUS 8 Fr. 50cc IAB Catheter (SENSATION Plus) is an enhanced SENSATION 7Fr IAB Catheter which includes a catheter with accessories, an insertion kit and two STATLOCK® IAB Stabilization Devices. This device incorporates the fiber optic technology of the SENSATION 7Fr IAB Catheter with the increased membrane volume and French size of the Mega" 50cc 8Fr. IAB Catheter (K091449). The SENSATION® Plus Insertion kit contains the same components as currently used with the Mega 50cc 8Fr IAB Catheter with the sole exception that the SENSATION® Plus Insertion Kit does not contain two lengths (4-ft) of pressure tubing, due to the fact that pressure monitoring is accomplished via the fiber optic cable. In addition, the SENSATION® Plus Insertion Kit contains six extender tubing clips, similar to the predicate SENSATION® Insertion Kit.

The SENSATION™ PLUS 8Fr. 50cc Intra-Aortic Balloon Catheter is a cardiac assist device. It supports the heart's left ventricle by increasing coronary perfusion and reducing left ventricular work. Coronary perfusion is increased by augmenting blood pressure during the diastolic phase of the cardiac cycle. This increase in aortic pressure promotes more blood flow through the coronary arteries. Left ventricular work is reduced by decreasing aortic end-diastolic pressure and reducing resistance to ventricular ejection, resulting in a decrease in blood pressure during the systolic phase of the cardiac cycle. These beneficial effects are caused by the inflation and deflation of the intra-aortic balloon (IAB) Catheter placed in the patient's descending aorta just below the subclavian artery. The balloon's inflation and deflation must be properly synchronized with the cardiac cycle. IAB Catheter inflation is initiated at the onset of the diastole at the dicrotic notch and remains inflated through diastole. The IAB Catheter is then deflated at, or just prior to, the onset of systole and the balloon remains deflated throughout systole. Hence, the therapy is also referred to as counterpulsation. This is the same intended use as other IAB Catheters.

AI/ML Overview

The provided document refers to a Special 510(k) premarket notification for the SENSATION™ PLUS 8Fr. 50cc Intra-Aortic Balloon Catheter. This device is presented as substantially equivalent to existing predicate devices based on non-clinical tests. No clinical studies are mentioned for this device, and therefore, there is no information on acceptance criteria based on clinical performance, nor any studies proving the device meets such criteria.

The document explicitly states: "There was no clinical evaluation of the modified device."

Therefore, I cannot provide the requested information regarding acceptance criteria and studies proving the device meets them from the provided text, as this medical device's approval appears to be based on substantial equivalence demonstrated through non-clinical testing.

However, I can extract information about the non-clinical tests conducted, which are used to demonstrate substantial equivalence.

Non-Clinical Test Information (from the document):

A table of acceptance criteria and the reported device performance:
The document does not provide a table with specific acceptance criteria or quantitative performance results for the device. It generally states that the "results of the in-vitro tests conducted demonstrate that the functionality and performance characteristics of the device are comparable to the currently marketed IAB Catheters."
Sample size used for the test set and the data provenance: Not applicable, as detailed information about in-vitro test sets or data provenance is not provided. The tests are "in-vitro," meaning they are not conducted on living organisms and thus have no country of origin or retrospective/prospective nature in the clinical sense.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth, in the context of clinical studies and expert consensus, is not relevant for in-vitro non-clinical tests.
Adjudication method: Not applicable for non-clinical in-vitro tests.
If a multi reader multi case (MRMC) comparative effectiveness study was done: No. The document explicitly states: "There was no clinical evaluation of the modified device."
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical intra-aortic balloon catheter, not an AI algorithm.
The type of ground truth used: Not applicable in the context of clinical or AI performance. For non-clinical tests, "ground truth" would relate to engineering specifications and physical measurements, which are not detailed here.
The sample size for the training set: Not applicable. There is no mention of a training set for an AI algorithm or a clinical study.
How the ground truth for the training set was established: Not applicable.

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.