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510(k) Data Aggregation

    K Number
    K172751
    Device Name
    iVitri Straw
    Manufacturer
    Reprobitech Corp.
    Date Cleared
    2018-02-09

    (150 days)

    Product Code
    MQK,MOK
    Regulation Number
    884.6160
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    K162640
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The iVitri®Straw is a cryopreservation storage device that is intended for use in vitrification procedures to contain and maintain human 4-8 cell and blastocyst stage embryos.

    Device Description

    The iVitri® Straw device is a cryopreservation storage device that is intended for use in vitrification procedures to contain and maintain human 4-8 cell and blastocyst stage embryos. The iVitri® Straw device consists of a square-shaped polystyrene stick and acrylonitrile butadiene styrene (ABS) cap. As part of the vitrification procedure, the embryos are loaded on the tip of the stick, and capped for subsequent storage following vitrification. The tip of the storage device is curved to aid in maintaining and securing the embryos during handling procedures. The stick and cap include a tapered design that creates a hermetic seal, forming a closed storage system. Markings on the stick and tip of the device are used to aid in the proper orientation during embryo loading procedures. The device is provided sterile and is for single use only.

    AI/ML Overview

    Here's an analysis of the acceptance criteria and the study that proves the device meets the acceptance criteria, based on the provided FDA 510(k) summary for the iVitri® Straw.

    Acceptance Criteria and Device Performance for iVitri® Straw

    1. Table of Acceptance Criteria and Reported Device Performance

    ParameterAcceptance CriteriaReported Device Performance
    Cooling RateNot explicitly stated as a separate acceptance criterion, but implicitly comparable to predicate.-3,022°C/min (Predicate: -3,020°C/min - considered comparable)
    Warming RateNot explicitly stated as a separate acceptance criterion, but implicitly comparable to predicate.+40,976°C/min (Predicate: +40,694°C/min - considered comparable)
    Sterility Assurance Level (SAL)10⁻⁶ (as per ISO 11137-1:2006(R)2011 and ISO 11137-2:2013)10⁻⁶
    Endotoxin≤0.5 EU/device (per USP )**
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