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510(k) Data Aggregation

    K Number
    K193273
    Device Name
    Insulin Syringe
    Manufacturer
    Promisemed Hangzhou Meditech Co., Ltd.
    Date Cleared
    2021-01-05

    (406 days)

    Product Code
    FMF
    Regulation Number
    880.5860
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K181447,K162180
    Why did this record match?
    Reference Devices :

    K181447

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

    Insulin Syringe is intended for subcutaneous injection of U-40 and U-100 insulin in the treatment of diabetes.

    Device Description

    The proposed device Insulin Syringe, a sterile device consisting of a calibrated barrel with plunger, is intended to be used to administer an injection of insulin to a patient subcutaneously. A non-retractable integrated needle is included. The syringe is made of plastic and silicone materials and allowing smooth plunger movement. This is a single-use device.

    AI/ML Overview

    The provided document is a 510(k) summary for an Insulin Syringe and does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria in the context of an AI/ML medical device.

    Key points from the document regarding studies and testing:

    • No AI/ML Component: The device described is an "Insulin Syringe," a physical medical device, not an AI/ML algorithm. Therefore, none of the requested information regarding AI/ML performance, sample sizes for test/training sets, ground truth establishment, expert adjudication, or MRMC studies are applicable or present in this document.
    • Non-Clinical Studies: The document details non-clinical studies performed to demonstrate substantial equivalence to a predicate device. These include:
      • Performance Testing: Conducted according to ISO 8537:2016 for sterile single-use syringes for insulin.
      • Biocompatibility Testing: Conducted according to ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 10993-11, ISO 10993-4, ASTM F 756-17, and USP (Pyrogen test), USP (Particulate matters).
      • Sterilization and Shelf-life Testing: Validated according to ISO 11135, with residue levels meeting ISO 10993-7. Shelf-life testing supported a 5-year shelf life.
    • No Clinical Studies: The document explicitly states: "No prospective clinical trials were conducted in support of this 510(K)."

    Since the request pertains to the acceptance criteria and study proving an AI/ML device meets them, and the provided document describes a conventional medical device (insulin syringe), the requested information cannot be extracted.

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