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510(k) Data Aggregation

    K Number
    K113469
    Device Name
    NIPRO HUBER INFUSION, EXCEL HUBER NEEDLE
    Manufacturer
    NIPRO MEDICAL CORPORATION
    Date Cleared
    2012-10-18

    (331 days)

    Product Code
    FMI
    Regulation Number
    880.5570
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K895769
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    This device is intended for administration of drug solutions, or blood sampling into or from a Reservoir implanted in the body.

    Device Description

    This device consists of a cannula affixed to a hub with a needle cap. Both straight and 900 angled types are available.

    AI/ML Overview

    This document describes the performance testing of the NIPRO Huber Needle.

    1. Table of Acceptance Criteria and Reported Device Performance:

    Performance TestsSpecificationReported Device Performance
    Stiffness TestMust conform to ISO 9626 (SU = 0.55 mm)NIPRO Huber Needle successfully met the requirements.
    Bending Breakage Resistance TestMust conform to ISO 9626 (Shall not break)NIPRO Huber Needle successfully met the requirements.
    ElasticityMust conform to JIS T 3209 (Shall go back to the original position)NIPRO Huber Needle successfully met the requirements.
    Bending StrengthMust conform to JIS T 3209 (Shall not break)NIPRO Huber Needle successfully met the requirements.
    Corrosive ResistanceMust conform to ISO 9626 (No corrosion shall be allowed)NIPRO Huber Needle successfully met the requirements.
    Cannula Dirt TestMust conform to the internal test (No dirt shall be allowed)NIPRO Huber Needle successfully met the requirements.
    Coring TestMust conform to FDA Coring Test Method (No coring shall occur)NIPRO Huber Needle successfully met the requirements and was "significantly better" than the predicate device.
    Cannula/Hub adhesive strength19G: ≥ 69 N; 20G: ≥ 54 N; 22G: ≥ 34 NNIPRO Huber Needle successfully met the requirements.
    Popping needle tip inspectionNo sound of puncture popping noise.NIPRO Huber Needle successfully met the requirements.
    Test for particulate matterContamination Index i = Na - Nb ≤ 90NIPRO Huber Needle successfully met the requirements.
    Transportation TestingWithstand distribution environmentNIPRO Huber Needle successfully met the requirements.

    2. Sample size used for the test set and the data provenance:
    The document does not explicitly state the sample sizes used for each individual performance test. The data provenance is not specified, but the testing was conducted by Nipro Medical Corporation. As this is a 510(k) summary, the tests are typically performed by the manufacturer.

    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
    Not applicable. The "ground truth" for the performance tests consists of adherence to established international and internal standards (ISO, JIS, USP, FDA methods). These are objective measurements against defined criteria, not subjective expert interpretations.

    4. Adjudication method for the test set:
    Not applicable. The tests are objective measurements against predefined specifications, not requiring human adjudication of results in the traditional sense.

    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 a study involving human readers or AI assistance. It is a performance evaluation of a medical device (Huber Needle).

    6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
    Not applicable. This is not an algorithm or AI device; it's a physical medical device.

    7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
    The "ground truth" for these performance tests is based on established international and industry standards and specific quantifiable specifications. For example:
    * Mechanical properties (Stiffness, Bending Breakage Resistance, Elasticity, Bending Strength, Corrosive Resistance) are measured against ISO and JIS standards.
    * Biological compatibility tests are conducted according to ISO 10993 series.
    * Sterilization efficacy is evaluated against ISO 11135-1.
    * Coring Test follows an "FDA Coring Test Method."
    * Other tests like Particulate Matter and Pyrogen tests conform to USP standards.
    These are objective, measurable criteria, not subjective expert consensus or pathology.

    8. The sample size for the training set:
    Not applicable. This document describes performance testing for a physical medical device, not an AI/ML algorithm. There is no training set in this context.

    9. How the ground truth for the training set was established:
    Not applicable, as there is no training set.

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