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510(k) Data Aggregation

    K Number
    K070801
    Device Name
    IMM HYPODERMIC NEEDLE SET
    Manufacturer
    INNOVATIVE MEDICAL MANUFACTURING CO.
    Date Cleared
    2007-05-24

    (62 days)

    Product Code
    FPA
    Regulation Number
    880.5440
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K955053,K771204
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The IMM Hypodermic Needle Set is to be used for sampling blood from or infusing fluid into body system underneath the skin.

    Device Description

    The IMM™ Hypodermic Needle Set consists of a conventional stainless steel needle, needle hub, extension tubing, clamp, and standard female 6% luer conical fitting for connection to a device contains a male luer fitting.

    AI/ML Overview

    The provided text describes the 510(k) premarket notification for the IMM Hypodermic Needle Set. It details the device, its intended use, and a summary of performance. However, this document does not describe a study involving AI or machine learning.

    Instead, it refers to:

    • Functional and performance tests demonstrating compliance with voluntary standards (ISO 594, ISO 7864).
    • Biocompatibility tests meeting requirements per ISO 10993.

    Therefore, many of the requested categories related to AI studies (such as sample size for test/training sets, experts for ground truth, MRMC studies, standalone performance with AI, etc.) cannot be answered from the provided text.

    Here's the information that can be extracted:

    Acceptance Criteria and Device Performance (Non-AI Study)

    Acceptance Criteria CategorySpecific Standard/Requirement MetReported Device Performance
    Functional & PerformanceISO 594 (Luer conical fittings)Meets specific requirements
    ISO 7864 (Sterile hypodermic needles for single use)Meets specific requirements
    BiocompatibilityISO 10993 ("Limited exposure, indirect blood path, external communicating device")Meets requirements

    Information Not Applicable/Available for an AI Study:

    Since this is a submission for a traditional medical device (hypodermic needle set) and not an AI/ML powered device, the following points are not applicable or cannot be answered from the provided document:

    1. Sample size used for the test set and the data provenance: Not applicable. Performance was demonstrated against engineering and biological standards, not a clinical test set in the context of AI.
    2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI test set is not relevant here.
    3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
    4. 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-assisted device.
    5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. There is no algorithm.
    6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to an AI study. The "ground truth" here involved physical and chemical properties assessed against established international standards.
    7. The sample size for the training set: Not applicable. There is no training set for an AI model.
    8. How the ground truth for the training set was established: Not applicable. There is no training set for an AI model.
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