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510(k) Data Aggregation

    K Number
    K023463
    Device Name
    CVSI PERIPHERAL BALLOON CATHETER; CVSI CATHETER INFLATION UNIT
    Manufacturer
    CRYOVASCULAR SYSTEMS, INC.
    Date Cleared
    2003-02-19

    (127 days)

    Product Code
    DQY,LIT
    Regulation Number
    870.1250
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K022061,K971448
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The CVSi™ Peripheral Balloon Catheter and the CVSi™ Catheter Inflation Unit are indicated for percutaneous, transluminal angioplasty of stenotic lesions in the superficial femoral and popliteal arteries. The CVSi™ Peripheral Balloon Catheter System is not indicated for use in other vasculature, including coronary arteries, carotid arteries, synthetic vascular grafts, and vein grafts. The CVSi™ Peripheral Balloon Catheter System is not indicated for stent delivery or stent expansion.

    Device Description

    The CVSi™ Peripheral Balloon Catheter System consists of a CVSi™ Peripheral Balloon Catheter, CVSj™ Catheter Inflation Unit, connecting cable, and a rechargeable battery pack with recharging unit and battery receptacle. The inflation medium (liquid nitrous oxide) is provided in a disposable 14 gram cylinder.

    AI/ML Overview

    The provided text describes a 510(k) premarket notification for the CVSi™ Peripheral Balloon Catheter System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a performance study with detailed acceptance criteria and standalone algorithm performance as would be expected for AI/ML-based devices.

    Therefore, many of the requested details, such as sample sizes for test/training sets, the number and qualifications of experts, adjudication methods, MRMC studies, standalone performance, and detailed ground truth establishment for the training set, are NOT applicable to this submission.

    Here's an analysis based on the available information:

    1. Table of Acceptance Criteria and Reported Device Performance

    The submission does not explicitly state quantitative acceptance criteria in the format typically seen for AI/ML device performance. Instead, it relies on demonstrating function and safety through a series of tests and showing substantial equivalence to predicate devices.

    Acceptance Criteria (Implied)Reported Device Performance
    Functional Performance:"All testing conducted confirmed the acceptability of the CVSi Peripheral Balloon Catheter System to perform as intended."
    - Device functions according to its Instructions for Use.
    Biocompatibility:"The CVSi Peripheral Balloon Catheter System materials passed the necessary biocompatibility tests, in conformance with ISO 10993-1..."
    - Materials are acceptable for contact duration A-Limited (< 24 hours) with circulating blood.
    Substantial Equivalence:"The CVSi Peripheral Balloon Catheter System is substantially equivalent to the predicate devices with regard to intended use, function, materials, and sterilization method."
    - Device is comparable to predicate devices (K022061 and K971448) in intended use, function, materials, and sterilization."Testing performed... demonstrates the device is substantially equivalent... and does not raise new questions regarding safety and effectiveness..."

    2. Sample size used for the test set and the data provenance

    • Sample Size for Test Set: Not applicable. This submission describes testing for substantial equivalence of a physical medical device, not a diagnostic algorithm with a "test set" of data. The "testing" refers to functional and biocompatibility tests on the physical catheter system.
    • Data Provenance: Not applicable. The "data" are results from engineering and biocompatibility tests, not clinical data from patients.

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

    • Not applicable. This is not an AI/ML diagnostic device where ground truth is established by experts for a test set.

    4. Adjudication method for the test set

    • Not applicable.

    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 not an AI-assisted device.

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

    • Not applicable. This is a physical medical device (balloon catheter).

    7. The type of ground truth used

    • The "ground truth" for this device's acceptance would be derived from:
      • Engineering specifications and standards: For functional tests (e.g., balloon inflation/deflation times, burst pressure, trackability).
      • ISO 10993-1 Biocompatibility Standards: For chemical and biological safety.
      • Predicate Device Characteristics: For comparison of design, materials, and intended use to establish substantial equivalence.

    8. The sample size for the training set

    • Not applicable. This is not an AI/ML device that requires a training set.

    9. How the ground truth for the training set was established

    • Not applicable.
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