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510(k) Data Aggregation

    K Number
    K070091
    Device Name
    COAXIAL BONE AND VERTEBRAL BODY BIOPSY NEEDLE MODEL# JBC1213, JBC1208
    Manufacturer
    CARDINAL HEALTH, INC.
    Date Cleared
    2007-04-18

    (98 days)

    Product Code
    KNW
    Regulation Number
    876.1075
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    K813338,K032943
    Why did this record match?
    Device Name :

    COAXIAL BONE AND VERTEBRAL BODY BIOPSY NEEDLE MODEL# JBC1213, JBC1208

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    This device is intended for use by a physician performing a bone or vertebral body biopsy using a coring, cutting, or aspiration technique.

    Device Description

    This device can be used as a standalone device to remove a sample of bone tissue from a vertebral body or bone for diagnostic purposes using a coring, cutting or aspiration technique for diagnostic purposes as well as to provide and maintain access to the same surgical site. The access cannula sizes are 8, 11 and 13 gauge with coaxial needle of 11, 14, and 15.5 gauges. The needle lengths are 19 and 22 cm. This product is a single use, sterile prescriptive device.

    AI/ML Overview

    This document describes the Coaxial Bone and Vertebral Body Biopsy Needle. It is a medical device intended for use by a physician to perform bone or vertebral body biopsies using coring, cutting, or aspiration techniques.

    Here is the information about its acceptance criteria and the study:

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance CriteriaReported Device Performance
    Biocompatibility: Materials must be acceptable for contact with the human body.All materials used in fabrication were evaluated through biological qualification safety tests as outlined in ISO 10993 Part-1 "Biological Evaluation of Medical Devices" and found to be acceptable for the intended use.
    Performance Attributes: The device must demonstrate equivalent performance to its predicate devices.The device's performance attributes were determined to be equivalent to the Cardinal Health Jamshidi Coaxial Bone Biopsy Needle (K813338) and the Stryker Bone and Vertebral Body Biopsy Kit (K032943).
    Industry Recognized Test Methods: Testing must be performed in accordance with industry-recognized methods.Materials were tested in accordance with "industry recognized test methods."
    Intended Use: Device must be suitable for its stated intended use.The device is intended for use by a physician performing a bone or vertebral body biopsy using a coring, cutting, or aspiration technique, and testing confirmed its suitability for this purpose.
    Substantial Equivalence: The device must be substantially equivalent to legally marketed predicate devices.The FDA reviewed the 510(k) and determined the device is substantially equivalent to its predicate devices.

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

    The summary states that "All materials used in the fabrication... were evaluated," and "These materials also were tested." However, it does not specify the sample size of materials tested or the specific number of devices tested. It also does not explicitly state the data provenance (e.g., country of origin or whether the data was retrospective or prospective). The testing appears to be primarily laboratory-based material and performance testing rather than clinical data from human subjects.

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

    This type of information is not typically applicable for a device like a biopsy needle, where "ground truth" often refers to clinical diagnoses or outcomes. The testing described focuses on material properties and device performance characteristics against established benchmarks and predicate devices, not on diagnostic accuracy requiring expert panel review. Therefore, no information on experts establishing ground truth for a test set is provided.

    4. Adjudication Method for the Test Set

    Not applicable, as this device's testing relates to material properties and performance rather than diagnostic accuracy that would typically involve adjudication of clinical data.

    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 device is a manual biopsy needle, not an AI-powered diagnostic or imaging tool, so MRMC studies involving human readers and AI assistance are not relevant.

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

    Not applicable. This device is a manual surgical instrument, not an algorithm, so standalone algorithm performance testing is not relevant.

    7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

    The "ground truth" in this context is based on:

    • Established Material Standards: Compliance with ISO 10993 Part-1 for biocompatibility.
    • Industry Recognized Test Methods: Performance against generally accepted test protocols for medical device materials and functionality.
    • Predicate Device Performance: Equivalence to the performance attributes of previously cleared predicate devices (Cardinal Health Jamshidi Coaxial Bone Biopsy Needle and Stryker Bone and Vertebral Body Biopsy Kit).

    8. The Sample Size for the Training Set

    Not applicable. This device is a physical medical instrument, not an AI/machine learning model that requires a training set.

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

    Not applicable, as there is no training set for this device.

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