LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K071180
    Device Name
    SCINTILLANT SURGICAL LIGHT, MODEL 2644-01-0001
    Manufacturer
    ENGINEERED MEDICAL SOLUTIONS CO. LLC
    Date Cleared
    2007-06-20

    (51 days)

    Product Code
    FTD
    Regulation Number
    878.4580
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K041621,K041681
    Why did this record match?
    Device Name :

    SCINTILLANT SURGICAL LIGHT, MODEL 2644-01-0001

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

    The Scintillant light is intended to provide localized illumination of surgical sites.
    The Scintillant Surgical Light is intended to provide localized illumination of surgical sites.

    Device Description

    The Scintillant Surgical Light is an untethered, self-contained medical lighting device that allows illumination inside the surgical field. The light can be hand-held and is provided with accessories which allow it to be attached to almost any surgical tool or instrument.
    The light is provided sterile and is battery powered. The light consists of light-emitting diode (LED) mounted on the end of a flexible wand. A single button turns the light on and off. A battery and circuit board are contained in the device handle.

    AI/ML Overview

    This is a 510(k) premarket notification for the Scintillant Surgical Light, a surgical lamp. The provided documents establish substantial equivalence to predicate devices, but do not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

    The 510(k) summary (K071180) merely states that:

    • The Scintillant Surgical Light is an untethered, self-contained medical lighting device for illumination inside the surgical field.
    • It's hand-held, sterile, battery-powered, and uses an LED on a flexible wand.
    • Its intended use is to provide localized illumination of surgical sites.
    • It is technologically similar to predicate devices (AtriCure Dissector, Light Port Surgical Illuminator, VersaLight Multi-Function Surgical Illuminator, LightMat Surgical Illuminator), all being sterile, hand-held, battery-powered surgical field illuminating devices with the same overall intended use.
    • The conclusion is that the device is as safe and effective as the predicate device and does not raise any new questions regarding safety and effectiveness.

    Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets them because this information is not present in the provided text. The 510(k) process primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring new clinical studies with defined acceptance criteria and performance metrics for all new devices.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1