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510(k) Data Aggregation

    K Number
    DEN140017
    Device Name
    SENSIMED TRIGGERFISH
    Manufacturer
    SENSIMED AG
    Date Cleared
    2016-03-04

    (668 days)

    Product Code
    PLZ
    Regulation Number
    886.1925
    Type
    Direct
    Panel
    Ophthalmic
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The SENSIMED Triggerfish® is a prescription device indicated to detect the peak patterns of variation in intraocular pressure over a maximum period of 24 hours to identify the window of time to measure intraocular pressure by conventional clinical methods. The SENSIMED Triggerfish® is indicated for patients 22 years of age and older.

    Device Description

    SENSIMED Triggerfish® diurnal recording system (hereinafter "STF") is a small patient-worn electronic device intended for use in the home and clinic settings for recording diurnal patterns of IOP fluctuations. The components of the STF are as follows: a hydrophilic, single-use soft contact lens with a strain gauge sensor, antenna with a telemetry chip embedded within it, allowing for continuous wireless recording of changes in ocular dimension, an external adhesive antenna worn around the eye is used to send power to, and receive measurement data from, the embedded system, a pocket-sized, battery-operated recorder worn by the patient during the 24-hour recording session, which is connected to the external adhesive antenna by a data cable. Additional components: charger to recharge the Recorder, Bluetooth universal serial bus (USB) adapter for communication between Recorder and doctor's personal computer (PC), and software for initiation recording sessions, and retrieval & display of the recorded data. The operating principle of the STF is based on the measurement of circumferential changes of the eye ball at the corneoscleral interface by an active strain gauge embedded into the periphery of a soft silicone contact lens ("ocular telemetry sensor"). During the 24-hour recording session, the sensor wirelessly transfers the data to the recording system. At the end of the recording session, all data can be transferred to the PC for review and analysis by a healthcare professional.

    AI/ML Overview

    The SENSIMED Triggerfish® is a prescription device indicated to detect the peak patterns of variation in intraocular pressure over a maximum period of 24 hours to identify the window of time to measure intraocular pressure by conventional clinical methods. It is indicated for patients 22 years of age and older.

    Here's an analysis of the acceptance criteria and the studies that prove the device meets these criteria:

    1. Table of Acceptance Criteria and Reported Device Performance:

    Acceptance Criteria (from "Special Controls")Reported Device Performance
    1. Clinical performance data must demonstrate that the device and all of its components perform as intended under anticipated conditions of use. The following performance characteristics must be demonstrated:
    a. ability of the device to detect diurnal changesStudy TF-1005: Demonstrated repeatability of the mean 24-hour STF profiles in 31 glaucoma and glaucoma suspect subjects, with a strong intraclass correlation (ICC) (0.99) between the mean profiles from two different sessions one week apart. This indicates consistent detection of diurnal patterns.
    Study TF-1009: Showed that a positive slope was detected on STF profiles in the transition period from wake to sleep (W/S slope) in the study population. Although the results are inconclusive for quantitative characterization of W/S slopes, they show the ability of the device to qualitatively capture "larger and slower patterns" (diurnal changes). A strong correlation (r=0.956, p
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