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510(k) Data Aggregation

    K Number
    K172614
    Device Name
    Caldera Medical Transobturator Helical Introducer, Left; Caldera Medical Transobturator Helical Introducer, Right; Caldera Medical Transobturator Large Helical Introducer, Left; Caldera Medical Transobturator Large Helical Introducer, Right; Caldera Medical Transobturator Inside-Out Introducer, Left
    Manufacturer
    Caldera Medical, Inc.
    Date Cleared
    2018-05-04

    (246 days)

    Product Code
    PWJ
    Regulation Number
    884.4910
    Type
    Traditional
    Panel
    Gastroenterology-Urology (GU)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    Caldera Medical Transobturator Helical Introducer, Left; Caldera Medical Transobturator Helical Introducer

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

    The Caldera Medical surgical mesh instruments are intended to be used in surgical procedures for the insertion and placement of Desara surgical mesh indicated for treatment of Genuine Stress Urinary Incontinence (SUI) and mixed incontinence.

    Caldera Medical Outside-In introducers may be used with the following Desara implants: Desara® (CAL-DS01), Desara® Blue (CAL-DS01B), Desara® Blue OV (CAL-DS01BOV), Desara® SL (CAL-DS01SL), Desara® Blue SS (CAL-DS01BS)

    Caldera Medical Inside-Out introducers may be used with or without the Winged Guide Accessory with the following Desara implants:

    Desara® (CAL-DS01), Desara® Blue (CAL-DS01B), Desara® Blue OV (CAL-DS01BOV), Desara® SL (CAL-DS01SL)

    Caldera Medical Suprapubic introducers may be used with the following Desara implants: Desara® (CAL-DS01), Desara® Blue (CAL-DS01B), Desara® Blue OV (CAL-DS01BOV), Desara® Blue SS (CAL-DS01BS)

    Caldera Medical Transvaginal introducers may be used with the following Desara implants: Desara® (CAL-DS01), Desara® Blue (CAL-DS01B), Desara® Blue OV (CAL-DS01BOV)

    Desara® TV (CAL-DS01TV), Desara® Blue TV (CAL-DS01BTV) implants may only be used with Caldera Medical Transvaginal introducers, CAL-TV32

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) clearance letter from the FDA for Caldera Medical Surgical Mesh Instruments. It does not contain any information about acceptance criteria, device performance metrics, clinical study design, sample sizes, expert qualifications, ground truth establishment, or any details related to an AI/algorithm-based medical device.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the input provided. The document is strictly administrative in nature, confirming the substantial equivalence of the surgical instruments to previously marketed predicate devices.

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