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510(k) Data Aggregation

    K Number
    K180807
    Device Name
    Celling Aspiration Needle
    Manufacturer
    SpineSmith Holdings, LLC
    Date Cleared
    2018-05-24

    (57 days)

    Product Code
    KNW
    Regulation Number
    876.1075
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    K980196,K131157
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Celling Aspiration Needle is intended for use in aspirating bone marrow.

    Device Description

    The Celling Aspiration Needle is a single-use aspiration needle comprised of a stainless steel cannula with a molded plastic handle, and a stainless steel stylet with a molded plastic handle which mates with the cannula handle when the stylet is inserted through the cannula. While holding the mated handles, the user rotates the needle using a clockwise-counter clockwise motion while applying pressure on the bone. The needle bores into the marrow cavity. Once there the stylet is removed and aspiration is accomplished by attaching a luer syringe (not included) to the needle and applying negative pressure.

    AI/ML Overview

    This document is a 510(k) premarket notification for the Celling Aspiration Needle. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study of diagnostic performance against acceptance criteria for an AI-powered device. Therefore, much of the requested information regarding AI device performance, sample sizes for training/test sets, ground truth establishment, expert adjudication, and MRMC studies is not applicable or available within this document.

    However, I can extract information related to the device's functional performance testing, which is a form of acceptance criteria for this type of medical device.

    1. Table of Acceptance Criteria and Reported Device Performance:

    Acceptance Criteria (Type of Testing)Reported Device Performance
    Mechanical TestingPerformed, supports safety and effectiveness. (Details not provided in this summary, but implied to be acceptable based on SE determination).
    Physical TestingPerformed, supports safety and effectiveness. (Details not provided).
    Component Biocompatibility AnalysisPerformed, supports safety and effectiveness. (Details not provided).
    Performance CharacteristicsPerformed, supports safety and effectiveness. (Details not provided, but implies the device functions as intended for bone marrow aspiration).
    Substantial Equivalence to Predicate Device (Argon Bone Marrow Harvest Needle, K980196)The Celling Aspiration Needle is "substantially equivalent" in materials, design (stainless steel cannula/stylet, plastic molded handles, side holes, luer lock connections). The only differences are handle color, needle length, and added depth markings.
    Equivalence to Secondary Predicate (Ranfac Bone Marrow Aspiration Needle, K131157)Testing was performed to ensure performance equivalent to the Ranfac needle for current customers.
    Compliance with FDA Special Controls Guidance (Class II Special Controls Guidance Document for Biopsy Devices in Gastroenterology and Urology)"meets all of the requirements" of the guidance.

    2. Sample size used for the test set and the data provenance:

    • Not applicable for an AI device. This document describes testing for a mechanical bone marrow aspiration needle.
    • The "testing" mentioned is non-clinical (mechanical, physical, biocompatibility, performance characteristics) rather than clinical studies with human subjects or retrospective data analysis for a diagnostic algorithm. The specific "sample sizes" for these non-clinical tests (e.g., how many needles were subjected to bending tests, etc.) are not provided in this summary.
    • Data provenance is not provided for these engineering tests.

    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

    • Not applicable. This relates to algorithmic performance and ground truth for diagnostic accuracy, which is not the focus of this 510(k) for a physical medical device. The "ground truth" for this device's performance would be engineering specifications and functional testing outcomes.

    4. Adjudication method for the test set:

    • Not applicable. This refers to adjudication in diagnostic studies, not engineering verification and validation testing for a physical device.

    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:

    • No, an MRMC study was not done. This is not an AI device.

    6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

    • Not applicable. This is not an AI device.

    7. The type of ground truth used:

    • For the non-clinical testing of the Celling Aspiration Needle, the "ground truth" would be established engineering specifications, performance standards, biocompatibility testing results (e.g., meeting ISO standards), and direct comparisons to the physical and functional characteristics of the identified predicate devices.

    8. The sample size for the training set:

    • Not applicable. This device does not use a training set as it is not an AI device.

    9. How the ground truth for the training set was established:

    • Not applicable. This device does not use a training set.
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