LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K250541
    Device Name
    Self-Forming Magnet (Flexagon Plus OTOLoc)
    Manufacturer
    GI Windows, Inc.
    Date Cleared
    2025-08-01

    (158 days)

    Product Code
    SAH
    Regulation Number
    878.4816
    Type
    Traditional
    Panel
    General and Plastic Surgery (SU)
    Reference & Predicate Devices
    K913411,K931056,K243482,K043115
    Why did this record match?
    Device Name :

    Self-Forming Magnet (Flexagon Plus OTOLoc)

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

    The GI Windows Flexagon Plus OTOLoc System is intended for use in the creation of side-to-side jejunum-jejunum and ileum-ileum anastomoses in minimally invasive and laparoscopic surgery. Once wound strength is sufficient to maintain the anastomosis, the device is passed from the body. The effects of this device on weight loss were not studied. The GI Windows Flexagon SFM Plus OTOLoc is intended for use in adult patients > 21 years.

    Device Description

    The Flexagon SFM Plus OTOLoc device is a magnetic compression anastomosis system, which is a surgical device used for the creation of anastomoses in minimally invasive surgery in the gastrointestinal tract. The system is comprised of self-forming magnets and includes the delivery system. The OTOLoc component provides enterotomy preservation for immediate fluidic flow upon implant, while the alternating dipoles of the Flexagon magnet drives magnetic self-alignment to prevent apposition. The anastomosis formation occurs over time once the remodeling of the targeted tissues is complete. The Flexagon magnets compress the opposing tissues which allows the body to dictate the time required for re-epithelialization. Compression and necrosis of tissue is achieved between magnet devices and is created by the polar attraction of the magnet devices with subsequent healing of tissue around the devices. Once the anastomosis is formed, the magnet device is expelled naturally in approximately 3-6 weeks.

    AI/ML Overview

    The provided text does not contain acceptance criteria or study details for an AI/software device. The document is an FDA 510(k) clearance letter for a physical medical device, the "Flexagon Plus OTOLoc System," which is a magnetic compression anastomosis system.

    Therefore, I cannot fulfill the request to describe the acceptance criteria and study proving an AI device meets them, as the input document is not about an AI device.

    The document discusses:

    • Acceptance criteria (implicitly met through "Pass" results) for various non-clinical performance tests (biocompatibility, sterilization, packaging, shelf-life, magnetic properties, etc.) and animal studies.
    • Clinical performance data for the physical device based on patient outcomes, but not related to an AI's diagnostic or assistive capabilities.

    To answer your request, I would need a document detailing the clearance of an AI-powered medical device.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1