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510(k) Data Aggregation

    K Number
    K211211
    Device Name
    Sterile syringes for single use with/without needle
    Manufacturer
    Azur Medical Company Inc.
    Date Cleared
    2021-10-07

    (167 days)

    Product Code
    FMF
    Regulation Number
    880.5860
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Predicate For
    K252033
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Sterile syringes for single use with/without needle are intended to be used for medical purposes to inject fluid into or withdraw fluid from body.

    Device Description

    The Sterile Syringes for Single Use with/without Needle is a three-piece, sterile, single use hypodermic syringe with a 6% (Luer) male connector/lock fitting in various sizes. The syringe assembly consists of a lubricated polypropylene barrel with a graduated scale, a lubricated synthetic rubber stopper and a polypropylene plunger rod. The plunger rod is pulled back to aspirate fluids or depressed to inject or expel fluids.

    AI/ML Overview

    The document describes the acceptance criteria and performance data for the "Sterile syringes for single use with/without needle," but it does not involve a study with a test set of data, ground truth, or expert consensus in the way that AI/ML device studies typically do. This is a traditional medical device (syringes) rather than an AI/ML diagnostic or prognostic tool.

    Therefore, many of the requested fields are not applicable.

    Here's the information extracted from the provided text, focusing on the available details:

    1. Table of Acceptance Criteria and Reported Device Performance

    The device's performance is demonstrated by compliance with various international standards and specific tests. The "acceptance criteria" are implied by the requirements of these standards.

    Test/CharacteristicAcceptance Criteria (Implied by standard compliance)Reported Device Performance
    BiocompatibilityMeets requirements of ISO 10993-1:2018 for "External communication device - Blood path indirect" (contact duration < 24 hours)All evaluation acceptance criteria were met for Cytotoxicity, Skin sensitization, Hemolysis, Intracutaneous reactivity, Acute systemic toxicity, Pyrogenicity.
    Sterilization (EO residue)Complies with ISO 10993-7:2008Testing performed and results imply compliance.
    Sterilization (ECH residue)Complies with ISO 10993-7:2008Testing performed and results imply compliance.
    Package IntegrityAcceptable for protection of product and sterility maintenance after environmental conditioning and simulated transportationAll packaging was deemed acceptable.
    Shelf LifeDetermined based on stability studies and aging test (ASTM F1980-16)5-year shelf life determined.
    Seal StrengthComplies with ASTM F88/F88M-15Testing performed and results imply compliance.
    Dye PenetrationComplies with ASTM F 1929-2015Testing performed and results imply compliance.
    Hypodermic NeedlesComplies with ISO 7864:2016Testing performed and results imply compliance.
    Stainless Steel TubingComplies with ISO 9626:2016Testing performed and results imply compliance.
    Small-bore ConnectorsComplies with ISO 80369-7:2016Testing performed and results imply compliance.
    Hypodermic Syringes (Manual Use)Complies with ISO 7886-1:2017Testing performed and results imply compliance.
    Particulate MatterComplies with USP <788>Testing performed and results imply compliance.

    2. Sample size used for the test set and the data provenance

    • Sample Size: Not explicitly stated. The document refers to "testing" and "evaluations" according to various standards, which would define the sample sizes for those specific tests.
    • Data Provenance: Not explicitly stated, but the testing was conducted to comply with international standards (ISO, ASTM, USP), indicating standard laboratory and manufacturing quality control procedures. The manufacturer is Zhejiang Kangkang Medical-Devices CO., Ltd. in China, so likely some testing occurred there.

    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

    Not applicable. This is a physical medical device, not an AI/ML system requiring expert interpretation for ground truth.

    4. Adjudication method for the test set

    Not applicable. This does not involve adjudication of expert readings.

    5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

    Not applicable. This is not an AI/ML device.

    6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

    Not applicable. This is not an AI/ML device.

    7. The type of ground truth used

    The "ground truth" for this device's performance is established by its adherence to the technical and safety specifications outlined in the referenced international standards (e.g., ISO, ASTM, USP). For instance, the ground truth for "sterilization" is the result of tests confirming a certain sterility assurance level; for "biocompatibility," it's the outcome of biological tests.

    8. The sample size for the training set

    Not applicable. This is not an AI/ML device; there is no "training set."

    9. How the ground truth for the training set was established

    Not applicable. This is not an AI/ML device.

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