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510(k) Data Aggregation

    K Number
    K213623
    Device Name
    iTEAR100 Neurostimulator
    Manufacturer
    Olympic Ophthalmics
    Date Cleared
    2022-03-16

    (120 days)

    Product Code
    QKV
    Regulation Number
    886.5305
    Type
    Traditional
    Panel
    Ophthalmic
    Reference & Predicate Devices
    DEN190026
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The iTEAR100 Neurostimulator is an electromechanical nerve stimulator device, indicated for temporary use (up to 30 days) to increase acute tear production during vibratory stimulation of the external nasal nerve in adults, under prescription of an eye care provider.

    Device Description

    The iTEAR100 device is a prescription only, non-implantable, electromechanical stimulator intended to increase tear production acutely (over 30 days) through vibratory stimulation of the external nasal nerve in adult patients. The device's technological principle is the application of mechanical vibration to specific sensory neurons on the side of the nose. The device is battery-operated with a single vibratory tip. As the tip is pushed against the tissue, the beam deflects inward until it is deflected fully into the device consists of a handheld unit with a plastic shell, power button, charging port, and effector tip accessible from the exterior. The interior includes mechanical and electrical subsystems comprised of a motor, supercapacitor, printed circuit board assembly (PCBA) including driver board, control board and Bluetooth microprocessor, vibrating cantilever beam attached to the effector tip, and real-time clock. The iTEAR100 Neurostimulator connects via Bluetooth Low Energy to a mobile application downloaded onto the user's mobile device (compatible with iOS or Android operating system). The mobile application is necessary to activate the device for initial use and collects device usage data which the user may upload to a cloud database at the user's discretion.

    AI/ML Overview

    The Olympic Ophthalmics iTEAR100 Neurostimulator is a medical device for temporarily increasing tear production. The provided text, a 510(k) Summary, focuses on demonstrating substantial equivalence to a previously cleared predicate device (iTEAR100 Neurostimulator, DEN190026), rather than presenting a study designed to prove the device meets specific clinical acceptance criteria for effectiveness in human subjects.

    The core of the acceptance criteria described in the document is the claim of "substantial equivalence" to the predicate device. This is primarily demonstrated through comparative performance testing of mechanical outputs and other technical specifications, alongside adherence to relevant safety standards.

    Here's a breakdown of the requested information based on the provided text:

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

    The document doesn't explicitly define "acceptance criteria" in terms of specific clinical outcomes for tear production for this submission. Instead, the acceptance criteria are implicitly that the subject device's performance regarding safety and technical characteristics is comparable to, or improved from, the predicate device, and that these changes do not raise new questions of safety or effectiveness. The reported device "performance" is primarily a demonstration of this equivalence across various technical aspects.

    Acceptance Criteria (Implicit for Substantial Equivalence)Reported Device Performance and Comparison to Predicate
    Intended Use / Indications for Use: Maintain the same clinical purpose and target population as the predicate.Same: The iTEAR100 Neurostimulator is indicated for temporary use (up to 30 days) to increase acute tear production during vibratory stimulation of the external nasal nerve in adults, under prescription of an eye care provider.
    Key Technological Characteristics: Changes should not raise different questions of safety or effectiveness.Change from wired to Bluetooth communication: The subject device uses Bluetooth Low Energy for wireless communication, a mobile app, and a cloud database, while the predicate used wired (USB) communication. This change is deemed not to raise different questions of safety or effectiveness. Other core components (cantilever, weighted motor, PCBA, etc.) remain the same.
    Physical Dimensions: Be similar to the predicate.Similar: Subject device: 80 mm x 58 mm x 25 mm. Predicate device: 80 mm x 58 mm x 23.5 mm. Tip Protrusion: Subject device 5.1 mm, Predicate 5.0 mm.
    Effector Tip Thickness: Remain the same.Same: 2.9 mm for both.
    Power Source: Remain the same.Same: 3.7 V rechargeable battery for both.
    Frequency and Amplitude of Vibration: Remain within specified ranges and be comparable to the predicate.Same: Frequency: 200 - 300 Hz (270 unloaded) for both. Amplitude:
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