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510(k) Data Aggregation

    K Number
    K971673
    Device Name
    40 CC SUMO
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Date Cleared
    1997-08-05

    (90 days)

    Product Code
    DSP
    Regulation Number
    870.3535
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K963187,K954431,K952221,K943919,K940298
    Predicate For
    K974247
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    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.

    Device Description

    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.

    AI/ML Overview

    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

    Test TypeAcceptance CriteriaReported Device Performance
    1. Sheathed Insertion TestSubstantially equivalent to predicate 40 cc NICATH™Force required for 40 cc SUMO: 41.7 oz. Force required for predicate 40 cc NICATH™: 40.7 oz.
    2. Sheathless Insertion TestSubstantially equivalent to predicate BSC/CA devices, Datascope 9.5 F Percor-Stat, and Kontron/Arrow IAB (all well below 0.118 inch dilator size)Tightest restriction the 40 cc SUMO can pass through 100% of the time: 0.100 inch. Predicate BSC/CA devices: 0.095 inch. 40 cc Datascope 9.5 F Percor-Stat: 0.100 inch. 40 cc 9 F Kontron/Arrow IAB: > 0.105 inch.
    3. Maximum Pumping Rate Limit TestSubstantially equivalent to predicate 40 cc NICATH™ and Model 940Maximum pumping rate limit (≥ 90% nominal volume inflate/deflate) for 40 cc SUMO: 170 bpm. Predicate 40 cc NICATH™: 164 bpm. Model 940: 140 bpm.
    4. Reliability/Integrity TestAble to cycle as reliably as predicate 40 cc NICATH™ (minimum 3.6 million cycles); post-reliability maximum pumping rate limit and inflate/deflate times comparable to pre-reliability; no changes in dimensions or surface wear; pass leak test.40 cc SUMO test samples cycled for a minimum of 3.6 million cycles as reliably as the predicate 40 cc NICATH™. Post-reliability maximum pumping rate limit for 40 cc SUMO: 166 bpm (compared to 170 bpm pre-reliability). Inflate and deflate times were comparable pre- and post-reliability. No changes in dimensions or signs of surface wear were noted. One sample was damaged during removal and leaked; all other test samples passed the leak test.
    5. Trackability TestAble to track guidewire into place without incidence (no kinks, problems inserting/removing)All 40 cc SUMO and predicate devices were able to track their guidewire into place without incidence. No catheter kinks, no guidewire kinks, and no problems encountered inserting or removing catheters through their introducer.
    6. Aneurization and Burst TestAneurization and burst pressures substantially equivalent to predicate devices.40 cc SUMO mean aneurization pressure: 8.0 psi. Predicate 40 cc Sensation™ mean aneurization pressure: 8.3 psi. 40 cc SUMO burst pressure: 6.3 psi. Predicate 40 cc NICATH™ mean burst pressure: 6.1 psi.
    7. Transmembrane Pressure and Volume MeasurementVolume at transmembrane pressure of 50 mmHg: 40 cc +/-5%. Transmembrane pressure at 40 cc displacement:
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