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    K Number
    K960983
    Device Name
    MEDTRONIC EVERST 30 INFLATION DEVICE/SURVIVAL KIT
    Manufacturer
    MEDTRONICS INTERVENTIONAL VASCULAR
    Date Cleared
    1996-05-30

    (80 days)

    Product Code
    MAV
    Regulation Number
    870.1650
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K942269
    Why did this record match?
    Reference Devices :

    K942269

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Indications for the Medtronic® Everest™ 30 Inflation Device / Survival Kit are identical to those for commercially available inflation devices. The devices are used for the inflation / deflation of balloon dilatation catheters. These devices are intended for single use.

    Device Description

    The Medtronic® Everest™ 30 Inflation Device is a sterilized, single use device intended as an accessory to balloon dilatation catheters. The Everest™ 30 Inflation Device will be used to inflate and deflate balloon dilatation catheters during angioplasty procedures. The device contains an analog pressure gauge which will read the inflation pressure of the balloon catheter. The pressure gauge is isolated from the syringe fluid with use of a bouron tube and is graduated in 0.5 atmosphere / bar increments to a 30 atmosphere / bar maximum. The device has a twenty (20) cubic centimeter syringe to hold a contrast medium for balloon inflation. The device has a plunger engaging mechanism. When engaged, the plunger, which applies contrast medium to the syringe, is rotated in a clockwise direction by the user to slowly increase the syringe pressure or in a counter clockwise direction to slowly decrease the syringe pressure. When disengaged, the plunger can be manually retracted to rapidly apply vacuum and advanced to rapidly apply syringe pressure. The inflation device is connected to the balloon catheter manifold via a high pressure connecting tube which terminates into a male luer fitting. The inflation device also contains an accessory three way stopcock for preparation procedures.

    The inflation device may also be provided as a Survival Kit. The Survival Kit includes one (1) Y -Adapter with Hemostasis Valve, one (1) Guide Wire Introducer and one (1) Guide Wire Torque Handle.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and study information for the Medtronic® Everest™ 30 Inflation Device / Survival Kit, based on the provided text:

    Acceptance Criteria and Device Performance

    Acceptance CriteriaReported Device Performance
    Pressure Gauge Accuracy Test: Gauge accuracy at 3 settings (4 ATM, 15 ATM, and 27 ATM) compared to a calibrated pressure gauge.Device's gauge reading at 4 ATM, 15 ATM, and 27 ATM (corresponding to 235 psi, and 397 psi respectively for what's given) was compared to a calibrated gauge. "This testing showed results comparable to other commercially available inflation devices."
    Leak Test: No water leakage when pressurized with water at 200 psi, 350 psi, and 500 psi for two (2) minutes.Device was pressurized with water at 200 psi, 350 psi, and 500 psi. Pressure was held for two (2) minutes, and the device was observed. "This testing showed results comparable to other commercially available inflation devices."
    Pressure Test: Ability to inflate until a calibrated high-pressure gauge reads 600 psi.Device was inflated until the calibrated high-pressure gauge read 600 psi. "This testing showed results comparable to other commercially available inflation devices."

    Study Details

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

      • The provided text does not specify the exact number of devices tested for each test (Pressure Gauge Accuracy, Leak Test, Pressure Test). It states "All samples were previously EtO sterilized" for the Pressure Gauge Accuracy Test and "Each device was filled with water" for the Leak and Pressure Tests, implying multiple devices were tested, but precise numbers are not given.
      • Data Provenance: This was a retrospective, in-house laboratory study conducted by Medtronic, focusing on the physical performance of the device.

    2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

      • This type of device (inflation device) does not typically involve expert interpretation of results for its functional performance tests. The ground truth (accurate pressure readings, absence of leaks, achievement of pressure) is established by calibrated instruments.
      • Therefore, no human experts (e.g., radiologists) were used to establish the ground truth for these engineering performance tests.

    3. Adjudication method for the test set:

      • Not applicable. The tests involve direct measurement and observation against predefined physical criteria using calibrated equipment. There is no subjective human interpretation requiring adjudication.

    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:

      • No. This is a medical device (an inflation device), not an AI-powered diagnostic tool or imaging system. Therefore, an MRMC study and assessment of AI assistance for human readers is not applicable.

    5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

      • Not applicable. This device is a physical tool, not an algorithm. Its performance is inherent to its design and manufacturing, not an independent algorithm.

    6. The type of ground truth used:

      • The ground truth for these tests was established by calibrated instruments (e.g., calibrated pressure gauges) and direct observation against engineering specifications (e.g., visual inspection for leaks).

    7. The sample size for the training set:

      • Not applicable. This device does not use machine learning or AI, and therefore does not have a "training set" in the computational sense. The design and manufacturing processes are refined through engineering principles and quality control, not data-driven training.

    8. How the ground truth for the training set was established:

      • Not applicable, as there is no training set for this device.
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