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510(k) Data Aggregation

    K Number
    K021996
    Device Name
    BOLTON PTA CATHETER
    Manufacturer
    Bolton Medical, Inc.
    Date Cleared
    2002-08-23

    (66 days)

    Product Code
    LIT
    Regulation Number
    870.1250
    Type
    Traditional
    Panel
    Cardiovascular (CV)
    Reference & Predicate Devices
    K972512,K003972,K001087,K000101,K983830,K973012
    Why did this record match?
    Device Name :

    BOLTON PTA CATHETER

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

    The Bolton PTA Catheter is indicated for percutaneous transluminal angioplasty of narrowed or obstructed peripheral arteries such as the iliac, femoral, iliofemoral, renal, popliteal, tibial, tibioperoneal, infrapopliteal, peroneal, and profunda vessels and for treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is not intended for use in the coronary arteries.

    Device Description

    The Bolton PTA Catheter is a single use, dual lumen, percutaneous, angioplasty catheter with a distally mounted semi-compliant balloon for the dilatation of narrowed peripheral vessels. The dual lumen consists of a balloon lumen and a guidewire lumen with two radiopaque to aid in balloon positioning. The catheter is packaged sterile and is nonpyrogenic.

    AI/ML Overview

    The provided text is a 510(k) summary for the "Bolton PTA Catheter". This document outlines the premarket notification for a medical device and its substantial equivalence to previously approved devices. It is a regulatory filing, not a study report. Therefore, it does not contain any information regarding acceptance criteria, device performance metrics, sample sizes, expert involvement, or any form of clinical study data as typically described in the context of AI/ML models.

    The document specifically states:

    • "Summary of Non-Clinical Testing: Bench testing was conducted... The results of the bench and biocompatibility tests demonstrate that the Bolton PTA catheter is safe and effective for its intended use."

    This indicates that non-clinical (bench and biocompatibility) testing was performed to demonstrate safety and effectiveness, which is typical for a Class II medical device undergoing 510(k) clearance. However, it does not provide the specific acceptance criteria or the study results in the format requested, particularly concerning diagnostic performance metrics like those for an AI/ML device.

    Therefore, I cannot provide the requested table or answer the specific questions about acceptance criteria, study details, sample sizes, expert involvement, or multi-reader multi-case studies, as this information is not present in the provided text.

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