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    K Number
    K992687
    Device Name
    MILLENIUM MICROKERATOME, MODEL IMD-001
    Manufacturer
    INDUSTRIAL & MEDICAL DESIGN, INC.
    Date Cleared
    1999-09-24

    (45 days)

    Product Code
    HMY
    Regulation Number
    886.4370
    Type
    Traditional
    Panel
    Ophthalmic
    Reference & Predicate Devices
    K980924,K970377
    Why did this record match?
    Reference Devices :

    K980924,K970377

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

    Millenium Microkeratome is indicated for use in refractive surgery, or other treatment requiring initial lamellar resection of the cornea, circular and predetermined diameter and thickness.

    Device Description

    Millenium Microkeratome is electrically powered manual mechanical cutting instrument for severing a thin layer of corneal tissue (flap) from the surface of the eve. Microkeratome includes Fixation Ring, cutting Head and operates by Control Unit. The Fixation Ring is placed against the eye. Cutting blade oscillate inside special Insert placed in to the Head. Electric Motor is used to drive the blade. Forward manual movement of the Head against Fixation Ring creates resection of cornea tissue. Different Fixation Rings and Inserts determinate diameter and thickness of resection. Control Unit - power independent with built-in rechargeable battery provide vacuum to hold Fixation Rind on the eye and electric power to control Electric Motor.

    AI/ML Overview

    The Millenium Microkeratome is an electrically powered mechanical cutting instrument for severing a thin layer of corneal tissue (flap) from the surface of the eye. Its intended use is in refractive surgery or other treatments requiring initial lamellar resection of the cornea, circular and of predetermined diameter and thickness.

    Acceptance Criteria and Device Performance:

    ParameterAcceptance Criteria (based on predicate devices)Reported Device Performance (Millenium Microkeratome)
    Indication for useTo perform microlamellar keratoplastyTo perform initial resection of the cornea
    Operation principleGas turbine driven oscillating bladeElectric motor driven oscillating blade
    Safety test functionNone (for K970377) / Self-checking (for K980924)Self-checking
    System compositionControl unit, motor, head, blade, rings, lensesControl unit, motor, head, blade, rings, lens
    Control unitVacuum pump, valve, regulator, gauges, connectorsVacuum pump, valve, motor controller, sensors, display, connectors
    Keratome motorGas powered, adjustable speed up to 20,000 RPM (recommended 14,000 RPM)Electric motor, adjustable speed up to 28,000 RPM (pre-set 14,000 RPM)
    Keratome headFixed single piece head, depth depends on modificationFixed Base and different Inserts to produce predetermined depth of cut
    Equivalence in corneal lamellar resectionEquivalent to predicate devices (implied)Equivalent to predicate devices

    Study Details:

    1. Sample Size and Data Provenance:

      • Test Set Sample Size: Not explicitly stated as a number of "cases" or "patients." The study was conducted on "porcine eyes." The number of porcine eyes is not specified.
      • Data Provenance: The study was non-clinical and conducted on porcine eyes. There is no mention of country of origin, as it's an animal model study. It is a prospective study in the sense that the device was used on these eyes for testing.

    2. Number of Experts and Qualifications:

      • No information provided regarding the number or qualifications of experts used to establish ground truth.

    3. Adjudication Method:

      • No information provided on an adjudication method. The assessment appears to be a direct comparison of the corneal lamellar resection to that achieved by predicate devices.

    4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

      • No MRMC comparative effectiveness study was done. This study is for a medical device (a microkeratome) that performs a surgical procedure, not an imaging or diagnostic device that requires human interpretation.

    5. Standalone Performance Study:

      • Yes, a standalone study was performed. The device was tested directly on porcine eyes to evaluate its ability to perform corneal lamellar resection. The results were then compared to the performance of predicate devices.

    6. Type of Ground Truth Used:

      • The ground truth was established by comparing the corneal lamellar resection produced by the Millenium Microkeratome to that produced by "predicated devices." The equivalence was determined based on the physical characteristics of the resected tissue. This implicitly refers to device performance characteristics rather than a clinical ground truth like pathology or patient outcomes.

    7. Training Set Sample Size:

      • Not applicable/not provided. This is a non-clinical device performance study, not a machine learning model.

    8. How Ground Truth for Training Set was Established:

      • Not applicable/not provided. This is a non-clinical device performance study, not a machine learning model.

    Summary of the Study:

    The study was a non-clinical test on porcine eyes to demonstrate that the Millenium Microkeratome could achieve corneal lamellar resection equivalent to that produced by predicate devices (Plancon microlamellar keratome and Evolution power unit). The fundamental conclusion was that the technological differences (primarily electric motor vs. gas turbine) did "not raise any new issues of safety, effectiveness, or performance of the product." The focus was on establishing functional equivalence for the intended use rather than clinical efficacy or human-in-the-loop performance.

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