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510(k) Data Aggregation

    K Number
    K060034
    Device Name
    NIPRO HYDROPHILIC GUIDEWIRE FOR UROLOGICAL & LAPAROSCOPIC USE
    Manufacturer
    NIPRO MEDICAL CORPORATION
    Date Cleared
    2006-02-28

    (54 days)

    Product Code
    OCY,KOG
    Regulation Number
    876.1500
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    K001251,K926214,K923607
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Nipro Hydrophilic Guidewires are designed for use in urological, laparoscopic, and radiological procedures where a smooth guidewire is desired to introduce/position catheters, direct and maintain access, and be used to guide and exchange endoscopic accessories.

    Device Description

    The subject devices is contructed from a superelastic Nitinal core wire. A plastic cladding is applied over the core with a hydrophilic coating applied over that to provide a virtually frictionless surface when wet. The polymer cladding is impregnated with a radiopacive agent for enhanced contrast under fluoroscopy.

    AI/ML Overview

    The provided text describes a 510(k) premarket notification for a medical device, the Nipro Hydrophilic Guidewire. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting a new standalone clinical study to prove effectiveness. Therefore, many of the requested elements for a study proving device acceptance criteria are not directly applicable or explicitly stated in this document.

    However, I can extract the information relevant to the substantial equivalence comparison and performance testing that demonstrates the device meets certain criteria.

    Here's an analysis based on the provided text:

    1. Table of Acceptance Criteria and Reported Device Performance

    The submission states that the Nipro Hydrophilic Guidewire is either identical or very similar to predicate devices in materials, design, technological characteristics, and indications for use. It claims that "Performance, voluntary standards, and biocompatibility tests demonstrate that the devices are substantially equivalent." While specific quantitative acceptance criteria are not detailed in this summary, the general criterion is "Substantial Equivalence" to the predicate device.

    Acceptance Criteria (Implied)Reported Device Performance
    Substantial Equivalence: Materials, design, technological characteristics, and indications for use are identical or very similar to predicate devices.The Nipro subject device is either identical (K001251) or very similar to the predicate devices materials, design and technological characteristics, and indications for use.
    Performance: Meets the performance characteristics demonstrated by predicate devices.Performance tests demonstrate that the devices are substantially equivalent.
    Voluntary Standards: Complies with relevant voluntary standards.Voluntary standards tests demonstrate that the devices are substantially equivalent.
    Biocompatibility: Safe for biological contact as per established standards.Biocompatibility tests demonstrate that the devices are substantially equivalent.

    2. Sample Size Used for the Test Set and Data Provenance

    This document does not describe a "test set" in the context of a prospective clinical study with human patients for this 510(k) submission. The evaluation is based on comparisons to predicate devices and likely bench testing and biocompatibility assessments. Therefore, "sample size" and "data provenance" in the clinical study sense are not applicable here.

    3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

    Not applicable. The ground truth for a 510(k) relies on regulatory standards, established predicate device performance, and laboratory/biocompatibility testing, not expert consensus on a clinical test set.

    4. Adjudication Method for the Test Set

    Not applicable for a 510(k) submission based on substantial equivalence and non-clinical testing.

    5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

    No, an MRMC comparative effectiveness study is not mentioned as part of this 510(k) submission. This type of study is typically used for diagnostic devices to compare human reader performance with and without AI assistance, which is outside the scope of demonstrating substantial equivalence for a guidewire.

    6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

    No, this refers to a medical device (guidewire) and not an algorithm. Therefore, "standalone" algorithm performance is not applicable.

    7. The Type of Ground Truth Used

    The "ground truth" for this 510(k) submission is established by:

    • Predicate Device Characteristics: The established safety and effectiveness profile of the legally marketed predicate devices (Nipro Hydrophilic Guidewire (K001251) and Terumo Medical Corporation RadiFocus Guidewire (K926214, K923607)).
    • Voluntary Standards: Adherence to recognized industry standards for guidewires.
    • Biocompatibility Testing: Results of laboratory tests confirming material safety.
    • Performance Testing: Bench-top testing to verify physical and functional properties deemed equivalent to the predicate.

    8. The Sample Size for the Training Set

    Not applicable. This device is a physical guidewire and would not have a "training set" in the context of machine learning or AI models.

    9. How the Ground Truth for the Training Set Was Established

    Not applicable. See point 8.

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