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510(k) Data Aggregation

    K Number
    K222503
    Device Name
    Resolution Clip, Resolution 360 Clip, Resolution 360 ULTRA Clip
    Manufacturer
    Boston Scientific Corporation
    Date Cleared
    2022-09-14

    (27 days)

    Product Code
    PKL
    Regulation Number
    876.4400
    Type
    Special
    Panel
    Gastroenterology-Urology (GU)
    Reference & Predicate Devices
    K142973,K151802,K193424
    Why did this record match?
    Device Name :

    Resolution Clip, Resolution 360 Clip, Resolution 360 ULTRA Clip

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

    The proposed Resolution™ Clip, Resolution 360™ Clip and Resolution 360™ ULTRA Clip are 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, Resolution 360™ Clip and Resolution 360™ ULTRA Clip are sterile devices 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 delivery system of Resolution 360™ Clip and Resolution 360™ ULTRA Clip will allow for the device to rotate at the distal end. The clip delivery system is offered in a 155cm and 235cm working length for Resolution Clip and Resolution 360 Clip but only 235 cm for Resolution 360 ULTRA Clip. 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, closing, and rotation capability (only for Resolution 360 Clip and Resolution 360 ULTRA Clip) may be limited by clinical circumstances and patient anatomy. There are no associated accessories included with this device. The Resolution™ Clip, Resolution 360™ Clip and Resolution 360™ ULTRA Clip are designed to be compatible with endoscopes with working channels equal to or greater than 2.8 mm.

    AI/ML Overview

    This document is a 510(k) premarket notification for the Resolution™ Clip, Resolution 360™ Clip, and Resolution 360™ ULTRA Clip. It concerns an update to existing devices, specifically regarding MRI safety information in the Instruction for Use and Patient Information. As such, the study described focuses on demonstrating MRI safety, rather than broad clinical performance or a comparative effectiveness study with AI.

    Here's the breakdown of the information requested, based on the provided text:

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria (Bench Test Standards)Reported Device Performance
    Magnetically Induced Displacement Force:
    (ASTM F2052, Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment)The testing was successfully completed and demonstrated compliance with the FDA MR Safety Guidance. This implies the device met the acceptable limits for displacement force.
    Magnetically Induced Torque:
    (ASTM F2213, Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment)The testing was successfully completed and demonstrated compliance with the FDA MR Safety Guidance. This implies the device met the acceptable limits for torque.
    Heating by Radio Frequency (RF) Fields:
    (ASTM F2182, Standard Test Method for Measurement of Radio Frequency Induced Heating Near Passive Implants During Magnetic Resonance Imaging)The testing was successfully completed and demonstrated compliance with the FDA MR Safety Guidance. This implies the device's heating in an MR environment was within acceptable limits.
    Image Artifact:
    (ASTM F2119, Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants)The testing was successfully completed and demonstrated compliance with the FDA MR Safety Guidance. This implies the device did not produce unacceptable image artifacts in an MR environment.
    Overall compliance with the FDA MR Safety Guidance Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment issued on May 20, 2021The performance (bench) testing demonstrated that the proposed Resolution™ Clip, Resolution 360™ Clip and Resolution 360™ ULTRA Clip comply with the FDA MR Safety Guidance Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment. This confirms the devices are considered "MR Conditional" or "MR Safe" as per the guidance.

    2. Sample Size Used for the Test Set and the Data Provenance

    The document describes "bench testing" which refers to laboratory-based evaluations. It does not mention a "test set" in the context of patient data.

    • Sample size: Not explicitly stated as a number of devices or subjects. For bench testing, typically a representative sample of devices would be used.
    • Data provenance: Not applicable in the context of "country of origin of the data, retrospective or prospective," as this was bench testing (laboratory-based evaluations) for physical characteristics related to MRI compatibility of the devices themselves, not patient data.

    3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

    Not applicable. The ground truth for this type of testing (MRI safety) is established by adherence to recognized ASTM standards and the FDA MR Safety Guidance, not by expert consensus on clinical data. The tests are objective measurements of physical properties.

    4. Adjudication Method for the Test Set

    Not applicable, as this was bench testing against standardized criteria, not clinical data requiring adjudication.

    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 submission is for an updated medical device (hemostatic clip) and focuses solely on its MRI safety, not on AI algorithms or human reader performance.

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

    Not applicable. This is not an AI-powered device or algorithm.

    7. The Type of Ground Truth Used

    The "ground truth" for this study was established by recognized international standards (ASTM) and regulatory guidance (FDA MR Safety Guidance) for evaluating medical device safety in a Magnetic Resonance (MR) environment. It's based on objective physical measurements, not clinical outcomes, expert consensus, or pathology.

    8. The Sample Size for the Training Set

    Not applicable. This is not a study involving machine learning or AI, so there is no "training set."

    9. How the Ground Truth for the Training Set was Established

    Not applicable, as there is no training set for this type of device and study.

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