Search Results

The BSC/CA IABC's are indicated for use in patients with the following conditions: Refractory power failure. Cardiogenic shock. Unstable refractory angina. Hemodynamically significant mechanical complications secondary to acute MI: Ventricular septal defect. Mitral valve regurgitation. Papillary muscle rupture. Cardiac support for high risk general surgical and coronary angiography/angioplasty patients. Septic shock. The intended use of the 40 cc SUMO remains identical to that of the currently marketed IABC's. All of the devices are intended to provide temporary circulatory support of the left ventricle through controlled mechanical displacement of a volume of blood in the aorta. The mechanical action of the IAB catheter therapy lowers the cardiac workload by two means : 1. Systolic unloading, as noted by a reduction in the patient's systolic pressure, which provides reduced myocardial oxygen consumption (MVO,). 2. Diastolic augmentation which provides an increase in the mean aortic pressure and leads to an improvement in systemic and coronary arterial perfusion. Balloon pump therapy is achieved by inserting an intra-aortic balloon catheter into the descending thoracic aorta via the common femoral artery. Balloon inflation is timed to occur during diastole, beginning with the aortic valve closure. The balloon remains inflated until the onset of left ventricular ejection or systole, then rapidly deflates, reducing the aortic pressure, which in turn reduces the afterload.

The proposed 40 cc SUMO consists of a polyurethane blend symmetrical balloon at the distal end of a polyurethane-covered nylon shaft. The balloon is coated with a thin layer of silicone fluid. A Nitinol central lumen runs throughout the length of the catheter and terminates at the distal tip. This central lumen may be used to pass the device over a quidewire. The balloon is supplied prewrapped for insertion.

Here's a breakdown of the acceptance criteria and study information for the 40 cc SUMO device, based on the provided 510(k) summary:

Acceptance Criteria and Reported Device Performance

Study Details

This submission relies on nonclinical (bench/laboratory) testing to demonstrate substantial equivalence, rather than clinical studies. Therefore, many of the typical clinical study parameters (like human reader performance, ground truth establishment on patient data, training set sizes from patient data) are not applicable.

1. Sample sizes used for the test set and the data provenance:

   • Test set samples: The exact number of individual devices tested for each nonclinical test is not explicitly stated in all cases. However, the text refers to "test samples" for the Reliability/Integrity Test and Trackability Test, implying multiple units were tested. For example, "The 40 cc SUMO test samples were all able to cycle..." and "40 cc SUMO test samples were inserted..." For the other tests, results are presented as single figures (e.g., "the 40 cc SUMO at 41.7 oz," "the 40 cc SUMO maximum pumping rate limit was 170 bpm," "mean aneurization pressure of 8.0 psi"), or comparisons to predicate devices, which typically represent averages or representative results from sample sets.
   • Data provenance: The data is retrospective in the sense that it refers to testing performed on the device and its predicates prior to the submission date. The "country of origin of the data" is not explicitly stated but would be assumed to be conducted by Boston Scientific Corporation/Cardiac Assist, Inc. in the US.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This was a nonclinical engineering and performance study, not a study involving human interpretation of medical images or patient data. Ground truth was established through engineering measurements and comparisons to predetermined specifications or predicate device performance.

3. Adjudication method for the test set: Not applicable. As this was a nonclinical study, there was no adjudication of expert opinions. Performance was measured objectively.

4. 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 was not a study involving AI or human readers of medical cases.

5. 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 algorithm.

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

   • The "ground truth" for these tests was derived from objective engineering measurements and established performance characteristics of the device and its predicate devices. For example, comparing measured insertion force, maximum pumping rate, burst pressure, and volume displacement to predefined specifications or to the established performance of existing legally marketed devices.

7. The sample size for the training set: Not applicable. This was a physical device, and the evaluation was based on nonclinical performance testing, not on data used to train an AI algorithm.

8. How the ground truth for the training set was established: Not applicable, as there was no training set in the context of AI.

Ask a specific question about this device