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    K Number
    K972918
    Device Name
    RAPID FIRE HAIR IMPLANTER CAROUSEL
    Manufacturer
    APEX MEDICAL PRODUCTS, LLC.
    Date Cleared
    1997-10-27

    (81 days)

    Product Code
    GAH,PAN
    Regulation Number
    878.4800
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    RAPID FIRE HAIR IMPLANTER CAROUSEL

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

    The RAPID FIRE HAIR IMPLANTER CAROUSEL™ is in ended to be used for hair transplantation on the scalp. The RAPID FIRE HAIR IMPLANTER CAROUSEL™ is indicated where patients require one or more hair grafting sessions during which multiple grafts have to be implanted.

    Device Description

    The RAPID FIRE HAIR IMPLANTER CAROUSEL™ (Carousel) is a disposable mechanical device designed to facilitate a hair transplant. It consists of a circular Carousel designed to house hair grafts, a sharp end designed to create an opening in the skin of the scalp and a button end that activates the moving parts within the Carousel. The CAROUSEL consists of a stainless steel blade and the body composed of Lustran 348 resin.

    AI/ML Overview

    The provided submission describes limited studies to support the device. Here's a breakdown based on the information provided and how it aligns with your requested criteria:

    Device: RAPID FIRE HAIR IMPLANTER CAROUSEL™ (Carousel)

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria (Implied)Reported Device Performance
    Safety: Device does not overtly harm tissue or patient compared to predicate/manual method.In vitro: No difference in gross morphology, intact and undamaged implants, no significant histological difference (Carousel resulted in more uniform depth).
    In vivo (human): No reported adverse events, "much less bleeding by the Carousel method" (implying less trauma), "no difference between those made with the Carousel and those made with the conventional appeared" (referring to post-operative wounds).
    Effectiveness/Functionality: Device facilitates hair transplantation.In vitro: Successfully implanted grafts.
    In vivo (human): Successfully implanted grafts, "much shorter time needed for graft placement" with Carousel (compared to manual), "no difference in the rate of growth or the number of hairs" between Carousel and manual methods.
    Substantial Equivalence: Device is equivalent to predicate devices in terms of safety and effectiveness.Performance tests validated its safety and effectiveness and support the claim of substantial equivalence to the Calivitron Hair Transplant System and Padgett Hair Transplant Punch. The Carousel's differences (carousel feature for graft storage and speed) do not impact safety and effectiveness negatively.

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

    • In vitro study: Not explicitly stated, but involved "biopsy specimens of groups implanted manually and with the Carousel under loop magnification".
    • In vivo (human) study: One (1) human subject.
    • Data Provenance: Not explicitly stated, but the human study involved a patient. Given the context of a 510(k) submission to the FDA, it is retrospective in nature (reporting on completed studies). The country of origin is not specified but is likely the U.S. as it's an FDA submission.

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

    Not explicitly stated. The "visual inspection" and "histologic evaluation" were likely performed by medical professionals, but their number, qualifications, and role in establishing ground truth (e.g., comparing to a gold standard) are not detailed.

    4. Adjudication method for the test set

    Not applicable/not explicitly stated. The studies describe observations and evaluations, but not a process of adjudicating differing expert opinions on a specific outcome (e.g., presence of a disease).

    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 surgical instrument, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was performed.

    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.

    7. The type of ground truth used

    • In vitro study: Gross morphology and histological evaluation of porcine skin biopsy specimens. The comparison was against manually implanted grafts.
    • In vivo (human) study: Clinical observations of bleeding, operative time, post-operative wound appearance, rate of hair growth, and number of hairs. The comparison was against a manual implantation method (Nokor needle and manual forceps).

    8. The sample size for the training set

    Not applicable. This device is a physical surgical instrument, not a learned algorithm. There is no concept of a "training set" in the context of this submission.

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

    Not applicable. See point 8.

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