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510(k) Data Aggregation

    K Number
    K250066
    Device Name
    Resolution Clip (M00522600); Resolution Clip (M00522601); Resolution Clip (M00522602); Resolution Clip (M00522610); Resolution Clip (M00522611); Resolution Clip (M00522612)
    Manufacturer
    Boston Scientific Corporation
    Date Cleared
    2025-02-06

    (27 days)

    Product Code
    PKL
    Regulation Number
    876.4400
    Type
    Special
    Panel
    Gastroenterology-Urology (GU)
    Reference & Predicate Devices
    K222503
    Why did this record match?
    Reference Devices :

    K222503

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

    The Resolution™ Clip is indicated for clip placement within the gastrointestinal (GI) tract for the purpose of:

    1. Endoscopic marking
    2. Hemostasis for:
    • Mucosal/sub-mucosal defects
    Device Description

    The Resolution™ Clip is a sterile device consisting of a pre-loaded, radiopaque, single-use, endoscopic clipping device consisting of two main components: the delivery system and the clip.
    The delivery system consists of a handle assembly and delivery catheter. The clip delivery system is offered in a 155cm and 235cm working length. The clip consists of a stainless-steel capsule and clip arms, a cobalt chrome yoke, and a styrene tension breaker. The clip is deployed from the delivery system during use. The clip jaws are engineered such that they can be opened and closed up to five times prior to deployment, aiding in repositioning of the clip at the lesion site. Re-opening and closing may be limited by clinical circumstances and patient anatomy, among other factors. The Resolution™ Clip is designed to be compatible with endoscopes with working channels equal to or greater than 2.8 mm. There are no associated accessories included with this device.

    AI/ML Overview

    The provided text is a 510(k) summary for a medical device (Resolution Clip) and does not describe acceptance criteria or a study proving the device meets acceptance criteria for an AI/ML-driven medical device.

    The document discusses a physical medical device, specifically a hemostatic clip for the GI tract. The 510(k) submission is for a modification to an existing device (removal of an outer sheath component). The "performance data" mentioned refers to non-clinical bench testing to confirm that the modified physical device still meets performance requirements (e.g., proper device removal from endoscope, passability within endoscope, absence of endoscope damage).

    Therefore, I cannot extract the requested information about acceptance criteria or a study proving an **AI/ML-**driven device meets acceptance criteria from the provided text. The questions regarding sample size, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, training sets, and ground truth establishment for training sets are not applicable to this type of device modification submission.

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