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510(k) Data Aggregation

    K Number
    K972317
    Device Name
    MONTGOMERY THYROPLASTY IMPLANT SYSTEM
    Manufacturer
    BOSTON MEDICAL PRODUCTS, INC.
    Date Cleared
    1997-09-18

    (90 days)

    Product Code
    MIX
    Regulation Number
    874.3620
    Type
    Traditional
    Panel
    Ear Nose & Throat
    Reference & Predicate Devices
    K955368,K955370,K955433,K970910
    Why did this record match?
    Device Name :

    MONTGOMERY THYROPLASTY IMPLANT SYSTEM

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

    The Boston Medical Products, Inc. Montgomery® Thyroplasty Implant is indicated for medialization thyroplasty in patients with unilateral vocal cord paralysis to improve voice quality.

    Device Description

    The Montgomery® Thyroplasty Implant System consists of the Implant and associated accessory surgical instruments which are used for selection of implant size and for the surgical thyroplasty procedure.

    The Montgomery® Thyroplasty Implant is a one-piece device consisting of a threetiered base and an obtuse triangular top. It is provided in five sizes for males and five for females. The difference in size relates to the height of the triangular portion of the Implant. There is a single base size for all five male implants and a smaller base size for all five female implants.

    Accessories to the System include the sterile, single use Measuring Kits for selection of the correct implant size at the time of surgery, the Procedure Kit for determining the correct position of the Implant and marking the window in the thyroid cartilage, and various elevators, hooks, etc. which are provided to facilitate both the surgical procedure and the placement of the Implant.

    AI/ML Overview

    The provided document, K97223/7, is a 510(k) summary for the Montgomery® Thyroplasty Implant System. It describes the device, its intended use, and claims substantial equivalence to legally marketed predicate devices. The section on "CLINICAL STUDIES" briefly mentions a clinical study, but it does not provide detailed acceptance criteria or a comprehensive report of device performance against specific metrics.

    Here's an analysis of the information available and what is missing based on your requested format:

    1. A table of acceptance criteria and the reported device performance

    Acceptance Criteria (Stated or Implied)Reported Device Performance
    Safety: Low number of complications"low number of complications"
    Effectiveness: Improvement of voice quality"improvement of voice quality, as demonstrated by responses to the patient survey, acoustic analysis, and stroboscopy."

    Missing Information:

    • Specific numerical targets or thresholds for "low number of complications" (e.g., complication rate
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