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    K Number
    K212659
    Device Name
    More-Cell-System
    Manufacturer
    Agency for Medical Innovations GmbH
    Date Cleared
    2021-11-10

    (79 days)

    Product Code
    PMU
    Regulation Number
    884.4050
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    K192898
    Why did this record match?
    Device Name :

    More-Cell-System

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

    More-Cell-System is intended for use as a tissue containment system during minimally invasive gynecologic laparoscopic surgery to enable the isolation and containment of tissue considered benign, resected during multi-site laparoscopic surgery for power morcellation and removal.

    When used in women with fibroids, the More-Cell System is for women who are pre-menopausal and under age 50. More-Cell-System is compatible with electromechanical laparoscopic power morcellators that are between 12 mm and 20 mm in shaft outer diameter and between 95 mm and 170 mm in shaft working length.

    Device Description

    The More-Cell-System device is used as a receptacle for collection and extraction of tissue during laparoscopic surgical procedures (e.g., hysterectomy and myomectomy). The key components of the device include the following:

    • A. More-Cell Bag: A single use, insufflatable, transparent, EO sterilized bag made of 50 µm thick polyurethane film that is biocompatible and cell-tight. The bag includes printed lines to aid in visualization during surgery. There are two openings to the bag: one opening that is 16 cm in diameter where a morcellator can be inserted (and where tissue can be removed), and a second opening that is 16 mm in diameter x 190 mm in length where a laparoscope can be inserted to visualize the surgical procedure. The bag capacity is 2.5 L (340 x 250 mm).

    • B. Visi-Shield: A metal sleeve with a polycarbonate window for lens protection (comes in 0° or 30° angle) that is cell-tight to protect the laparoscopic camera during a surgical procedure. Using the Visi-Shield the surgical procedure can be visualized without compromising the integrity of the bag, laparoscopic view, or safety of the laparoscopic camera.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and the studies that prove the device meets them, based on the provided text:

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria CategorySpecific Acceptance CriteriaReported Device Performance
    SterilizationSterility assurance level of 10^-6Validated per ANSI/AAMI/ISO 11135 and ISO 10993-7.
    Shelf LifeContinued sterility, package integrity, and device functionality over intended shelf life (2 years)Package integrity (visual inspection, dye penetration, peel strength, microbiological stability) and device functionality maintained after 2 years accelerated aging, shipping, and handling (per ASTM F1980 and ISO 11607).
    BiocompatibilityDevice not cytotoxic, sensitizing, irritating, or acutely toxicAll tests (Cytotoxicity, Sensitization, Intracutaneous irritation, Acute systemic toxicity) demonstrated the device was not cytotoxic, sensitizing, irritating, or acutely toxic.
    Impermeability (Tissue/Cells/Fluids)No evidence of permeability to E. coli under worst-case clinical pressures.No evidence of permeability in 36 More-Cell bags after 2-years aging and simulated use conditions; positive and negative controls performed as intended. Met acceptance criteria for
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