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™ 7.5 Fr. 40cc IAB Catheter is an enhanced MEGA® 7.5Fr IAB Catheter (K120868) device which includes a catheter, an insertion kit and two STATLOCK® IAB Stabilization Devices. This device incorporates the fiber-optic technology of the SENSATION PLUS™ 8Fr 50cc IAB Catheter (K112327) into the MEGA® 7.5Fr. 40cc IAB Catheter (K120868) design, with one additional change - the stylet wire (a packaging component) was removed. The SENSATION PLUS™ 7.5Fr. 40cc Insertion kit contains the same components as currently used with the MEGA® 7.5Fr 40cc IAB Catheter (K120868), with the sole exception that the SENSATION PLUS™ 7.5Fr. 40cc Insertion Kit contains six extender tubing clips, similar to the predicate SENSATION PLUS™ 8Fr. 50cc Insertion Kit (K112327).

The SENSATION PLUS™ 7.5Fr. 40cc 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 counterpuisation. This is the same intended use as other IAB Catheters.

AI/ML Overview

Here's an analysis of the acceptance criteria and study information for the Datascope Corp. SENSATION PLUS™ 7.5Fr. 40cc Intra-Aortic Balloon Catheter, based on the provided text:

This device is not an AI/ML device, therefore, some of the requested information (like MRMC study, effect size of human improvement with AI, standalone algorithm performance, number of experts for ground truth, adjudication method, and sample size for training set) is not applicable. The device relies on non-clinical testing for substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a Special 510(k) for a modified device, the "acceptance criteria" are primarily based on demonstrating substantial equivalence to predicate devices through non-clinical testing. The device's performance is demonstrated by its comparability to these established devices.

Acceptance Criteria (Implicit)	Reported Device Performance
Material/Design Comparability	The SENSATION PLUS™ 7.5Fr. 40cc IAB Catheter incorporates the fiber-optic technology of the SENSATION PLUS™ 8Fr 50cc IAB Catheter (K112327) into the MEGA® 7.5Fr. 40cc IAB Catheter (K120868) design, with one additional change (stylet wire removed). The insertion kit components are substantially similar.
Compliance with Voluntary Standards	Complies with voluntary standards identified in Section 3 of the submission (details not provided in the extract).
Functionality and Performance Comparability (In-vitro)	Results of in-vitro tests demonstrate that the functionality and performance characteristics are comparable to currently marketed IAB Catheters.
Biocompatibility	Biocompatibility testing was completed.
Sterility	Sterility testing was completed.
Shelf Life	Shelf life testing was completed.
Package Integrity	Package testing was completed.
Design Validation	Design validations were completed.
Safety and Effectiveness (Relative to Predicate Devices)	Design verification and validation testing established that the SENSATION PLUS™ 7.5Fr. 40cc IAB Catheter is safe, effective, and performs as well as the predicate devices.

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

Sample Size: Not explicitly stated as a separate "test set" in the context of a traditional clinical study with patients. The performance was established through in-vitro tests. The exact number of samples or trials for each type of in-vitro test (e.g., performance, biocompatibility, sterility, shelf life, package) is not provided.
Data Provenance: The data comes from non-clinical (in-vitro) testing conducted by Datascope Corp. The location of the testing is not specified, but the company is based in Fairfield, NJ, USA. The testing would be considered prospective in the sense that it was performed specifically for this submission.

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

Not applicable for this type of non-clinical device submission. Ground truth for device performance was established through engineering specifications, material standards, and benchmark testing against predicate devices, rather than expert consensus on clinical cases.

4. Adjudication Method for the Test Set

Not applicable. There was no clinical test set requiring expert adjudication.

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 is a medical device, not an AI/ML diagnostic or assistive tool.

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

Not applicable. This is a medical device, not an algorithm. Its performance is inherent to its physical design and materials.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is derived from:

Engineering Specifications: Adherence to design requirements and specifications.
Voluntary Standards: Compliance with recognized industry standards for IAB catheters.
Predicate Device Performance: Benchmarking against the known performance characteristics of the legally marketed MEGA® 7.5Fr 40cc IAB Catheter (K120868) and SENSATION PLUS™ 8Fr. 50cc IAB Catheter (K112327).
In-vitro Test Results: Physical, chemical, and mechanical testing results (biocompatibility, sterility, shelf life, package, and functional performance tests).

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device; there is no "training set" in the context of machine learning.

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

Not applicable. There is no training set. The "ground truth" for the device's design and manufacturing is established through standard engineering, quality control, and regulatory compliance processes typical for medical 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.