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510(k) Data Aggregation

    K Number
    K211482
    Device Name
    Disposable Syringe with Needle
    Manufacturer
    Shandong Qinkai Medical Industry Co., Ltd.
    Date Cleared
    2022-01-24

    (257 days)

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

    Sterile single-use syringe with needle is intended to inject fluids into or withdraw fluids from the body.

    Device Description

    The subject device is for single use only, which is comprised of syringes and needles with various specifications. The syringe consists of barrel, plunger, piston, and the needle consist of needle hub, needle cap. The proposed devices shall be operated manually, and are not intended for use with syringe pumps. The proposed devices are available in a variety combination of needle size and syringe volume.

    AI/ML Overview

    This submission is for a medical device (Disposable Syringe with Needle) and does not involve AI or algorithms, nor does it present any studies that would involve human readers or experts to establish ground truth from a test set. Therefore, questions relating to AI performance criteria, sample sizes for test and training sets, expert qualifications, adjudication methods, multi-reader multi-case studies, or standalone algorithm performance are not applicable.

    The document describes the device's acceptance criteria in terms of performance testing against established international standards for syringes, needles, Luer connectors, sterile barrier packaging, sterilization, shelf life, and biocompatibility.

    Here's a breakdown of the requested information based on the provided text, focusing on the relevant parts for a medical device:

    1. Table of acceptance criteria and reported device performance:

      Test ItemStandardReported Device Performance
      Syringe PerformanceISO 7886-1: 2017 Sterile hypodermic syringes for single use - Part 1: Syringes for manual useComplies with the standard
      Needle PerformanceISO 9626: 2016 Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methodsComplies with the standard
      Needle PerformanceISO 7864: 2016 Sterile hypodermic needles for single use - Requirements and test methodsComplies with the standard
      Luer Connector PerformanceISO 80369-7: 2016 Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applicationsComplies with the standard
      Seal StrengthASTM F88/F88M-2015Complies with the standard
      Detecting Seal LeaksASTM F1929-2015Complies with the standard
      Determining Seal IntegrityASTM F1886/F1886M-2016Complies with the standard
      EO ResidueISO 10993-7:2008Complies with the standard
      ECH ResidueISO 10993-7:2008Complies with the standard
      Bacteria Endotoxin LimitUSP 36-NF 31Complies with the standard
      Shelf Life EvaluationPhysical, Mechanical, Chemical, Package and Sterility Tests performed on aging samples to verify the shelf lifeVerified shelf life of 3 years
      Hub Color ComplianceISO 6009:2016 (for different needle gauges)Complies with the standard (hub is made of pigmented material)
      Cytotoxicity TestISO 10993-5:2009Complies with the standard
      Skin Sensitization TestISO 10993-10:2010Complies with the standard
      Intracutaneous Reactivity TestISO 10993-10:2010Complies with the standard
      Acute Systemic Toxicity TestISO 10993-11:2017Complies with the standard
      Pyrogen TestISO 10993-11:2017Complies with the standard
      Hemolysis TestISO 10993-4:2017Complies with the standard
      ParticulateUSPComplies with the standard
      Sterilization (SAL)ISO 11135 (Sterilization of health-care products for ethylene oxide - requirements for the development, validation and routine control of a sterilization process)SAL of 10⁻⁶

    2. Sample size used for the test set and the data provenance: Not applicable. The testing described involves physical, chemical, mechanical, and biological evaluations of device components and finished products, not a "test set" in the context of an AI/algorithm study. The document does not specify exact sample sizes for each test but refers to compliance with the methodology outlined in the cited standards.

    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as this is a medical device and not an AI/algorithm study requiring expert review for ground truth.

    4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.

    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.

    6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.

    7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this device's performance is established by its adherence to the technical specifications and performance requirements outlined in published international and national standards (e.g., ISO, ASTM, USP). This involves objective measurements and assessments defined within these standards.

    8. The sample size for the training set: Not applicable, as this is a medical device and does not involve AI/machine learning training sets.

    9. How the ground truth for the training set was established: Not applicable.

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