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510(k) Data Aggregation
(90 days)
The BSC/CA INBC's are indicated for use in patients with the following conditions *Refractory power failure. *Cardiogenic shock. *Unstable refractory angina. *Impending or extending myocardial infarction (MI). *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 Grande. " remains identicalto 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 : Systolic unloading, as noted by a reduction in the patient's systolic pressure, which provides reduced myocardial oxygen consumption (MVO,). 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 and intra-aortic balloon catheter into the descending thoracic aorta via the common femoral arterv. 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 Grande™ 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 polvurethane 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 guidewire. The balloon is supplied prewrapped for insertion and supplied with a 0.025 inch extra stiff quidewire and 10 F introducer.
The provided text describes the non-clinical performance testing of the 40 cc Grande™ Intra-Aortic Balloon Catheter. There are no clinical studies or human reader studies reported for this device. Therefore, information regarding MRMC studies, human reader improvement with AI, or standalone algorithm performance cannot be provided.
Here's an analysis of the acceptance criteria and study findings based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance | Substantially Equivalent To Predicate Device |
|---|---|---|---|
| Initial Performance Testing (Unwrapping & Integrity) | Device unwraps according to Directions for Use & QA final acceptance criteria. Maintains integrity after insertion/removal (twice) & re-insertion. | All proposed 40 cc Grande™ IABs opened (unwrapped) as per DFU and QA final acceptance criteria. Demonstrated integrity post insertion/removal. | Not explicitly stated as "substantially equivalent" for this test, but implies satisfactory performance against defined criteria. |
| Sheathed Insertion Test (Force) | Not explicitly stated with a numerical criterion, but implied to be comparable to predicate. | 34.8 oz force required. | Substantially equivalent to predicate Model 940 (30.1 oz). |
| Sheathless Insertion Test (Tightest Restriction) | Device passes through 0.100 inch restriction 100% of the time. (Note: Dilator size 0.118 inch provided). | 0.100 inch (100% of the time). | Substantially equivalent to: - predicate 40 cc Grande NT™ (0.100 inch) - 40 cc Datascope 9.5 F Percor-Stat (0.100 inch) - 40 cc 9 F Kontron/Arrow IAB (> 0.105 inch). |
| Maximum Pumping Rate Limit Test | ≥ 90% of nominal volume inflated/deflated. | 175 bpm. | Substantially equivalent to predicate 40 cc Grande NT™ (170 bpm) and greater than Model 940 (140 bpm). |
| Combined Inflation/Deflation Time | Not explicitly stated with a numerical criterion, but implied to be comparable to predicate. | 245 msec. | Compares favorably with predicate Model 940 (275 msec) and 40 cc Grande NT™ (264 msec). |
| Reliability and Integrity Test | Minimum 3.6 million cycles without failure (dimensional changes, surface wear, leaks). | All 40 cc Grande™ test samples able to cycle reliably. No changes in dimensions, signs of surface wear, or leaks noted after 3.6 million cycles. Pre-reliability maximum pumping rate (175 bpm) nearly identical to post-reliability (176 bpm). Inflation/deflation times comparable post-reliability. | As reliably as the predicate devices (40 cc Grande NT™ and Model 940). |
| Trackability Test | Catheters and insertion accessories perform without incident (no kinks, problems inserting/removing). | All 40 cc Grande™ and predicate devices tracked their guidewire into place without incident. No catheter kinks, no guidewire kinks, no problems encountered inserting or removing. | Implied to be equivalent to predicate devices. |
| Transmembrane Pressure and Volume Measurement Test (Volume at 50 mmHg) | 40 cc +/- 5%. | 41.6 cc. | Substantially equivalent to predicate 40 cc Grande NT™ (41.7 cc). |
| Transmembrane Pressure and Volume Measurement Test (Pressure at 40 cc displacement) | < 50 mmHg. | Average 21.5 mmHg. | Substantially equivalent to predicate 40 cc Grande NT™ (26.7 mmHg). |
| Kink Resistance Test | Not explicitly stated with a numerical criterion, but implied to be comparable or better than predicate. | Mean kink radius of 0.51 inch. | Less than predicate Model 940 (0.54 inch). (Indicates better kink resistance). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a precise numerical sample size for each test (e.g., "N=10 devices were tested"). Instead, it generally refers to "test samples." For example, "test samples were tested on the BSC/CA 3001 IABP" for initial performance, and "The 40 cc Grande™ test samples were all able to cycle as reliably..." for reliability testing.
- Sample Size: Not explicitly stated as a single number for each test. Referred to as "test samples."
- Data Provenance: The tests conducted are non-clinical, in-vitro bench tests performed by the manufacturer, Boston Scientific Corporation / Cardiac Assist (BSC/CA). The country of origin for the data is not specified, but it would be from the manufacturer's testing facilities. The data is prospective in the sense that the tests were conducted specifically to support this premarket notification.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the described tests are non-clinical, in-vitro performance tests for a medical device (intra-aortic balloon catheter). There is no "ground truth" in the clinical sense established by human experts for these types of mechanical performance evaluations. The "ground truth" is typically defined by engineering specifications, regulatory standards, and comparative performance against established predicate devices.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies or expert consensus reviews, especially for diagnostic or prognostic assessments, to resolve discrepancies in expert opinions. The tests described are objective, quantitative measurements of device performance, not subjective assessments requiring 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
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. This document describes the non-clinical performance of a medical device, not a diagnostic or AI-assisted interpretation tool for human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable. The device being described is a physical medical device (an intra-aortic balloon catheter), not a software algorithm or AI.
7. The Type of Ground Truth Used
The "ground truth" for these non-clinical tests is based on:
- Engineering Specifications and Design Requirements: The device is designed to meet specific performance parameters (e.g., volume, pressure, maximum pumping rate).
- Predicate Device Performance: The primary "ground truth" or benchmark for many tests is the performance of legally marketed predicate devices (40 cc Grande NT™ and Model 940). The goal is to demonstrate "substantial equivalence" to these devices.
- Internal QA Final Acceptance Criteria: For some tests, such as initial unwrapping, the device's performance is measured against the manufacturer's internal Quality Assurance (QA) final acceptance criteria.
- Regulatory Standards: Implied adherence to general regulatory standards for medical device safety and effectiveness.
8. The Sample Size for the Training Set
This information is not applicable. There is no "training set" as this is not an AI/machine learning study. The data relates to the physical testing of a medical device.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reasons as point 8.
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