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510(k) Data Aggregation

    K Number
    K121415
    Device Name
    MOLLRING MULTITASC
    Manufacturer
    LEMAITRE VASCULAR, INC.
    Date Cleared
    2012-09-05

    (117 days)

    Product Code
    DWX
    Regulation Number
    870.4875
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K950813
    Why did this record match?
    Device Name :

    MOLLRING MULTITASC

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

    This device is intended for remote endarterectomy of peripheral blood vessels during vascular reconstruction.

    Device Description

    The MollRing MultiTASC is a single use, sterile and disposable device designed for vascular surgeons use during remote endarterectomy procedures for the facilitation of dissecting, cutting and removing atheromatous plaque core within the peripheral vascular system.

    The Subject Device is a fixed, circumferential, blunt-edged, sterile, single use cutting tool. It consists of two stainless steel coaxial metal rings (proximal and distal rings) which are connected by a stainless steel rod and hypo tube system. The modular rod and hypo tube system connects to a plastic operator's handle with selective positions for ring alignment (cutting/dissecting phase).

    The device is introduced over the proximal end of the atheromatous plaque core of a peripheral vascular vessel. With the two stainless steel coaxial metal rings in "alignment position", they are advanced to the distal end of the plaque core. As the device transverses the vessel it acts as a conventional circumferential dissection ring stripper, removing the plaque core to the distal endpoint. The device is then switched via the operator handle to "un-alignment position", which spreads the distal and proximal rings, thus cutting and securing the plaque core. Once secured, the device is withdrawn, facilitating the core removal.

    AI/ML Overview

    Based on the K121415 document, here's a breakdown of the acceptance criteria and the study conducted:

    This document is a 510(k) summary for a medical device (MollRing MultiTASC Dissection/Transection Device), not a study report for an AI/ML device. Therefore, the questions related to AI/ML specific aspects (like expert consensus for ground truth, sample sizes for training/test sets, MRMC studies, standalone performance, and human reader improvement with AI) are not applicable to this document. This submission focuses on non-clinical performance and substantial equivalence to a predicate device.

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria (Product Design Specifications)Reported Device Performance
    Dimensional VerificationMet product design specifications
    Ring Weld StrengthMet product design specifications
    Weld Flex StrengthMet product design specifications
    Inner and Outer Hypo Tube Bond StrengthMet product design specifications
    Coupler Attachment StrengthMet product design specifications
    T-Handle Pull ForceMet product design specifications
    T-Handle Torsion StrengthMet product design specifications
    Device ActuationMet product design specifications
    Shaft BendMet product design specifications
    Ring Cutting ForceMet product design specifications
    Compression FatigueMet product design specifications
    Shelf Life TestingMet product design specifications
    Sterilization (Ethylene Oxide)Validated according to ANSI/AAMI/ISO 11135-1:2007
    BiocompatibilityMet ISO 10993 guidelines for an externally communicating device with limited contact duration (
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