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510(k) Data Aggregation

    K Number
    K181025
    Device Name
    I-Portal Neuro Otologic Test Center; I-Portal Video Nystagmography System; I-Portal Video Oculography Eye Tracking System
    Manufacturer
    Neuro Kinetics, Inc.
    Date Cleared
    2018-07-24

    (97 days)

    Product Code
    GWN
    Regulation Number
    882.1460
    Why did this record match?
    Applicant Name (Manufacturer) :

    Neuro Kinetics, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    I-Portal® Neuro Otologic Test Center (NOTC) is a rotary chair system used in vestibular and neuro-otologic diagnostic testing. The NOTC provides stimuli to a patient through motion profiles and/or visual cues, monitors the patient's response, and presents the data for interpretation by qualified medical personnel trained in vestibular diagnostic testing. This device provides no diagnoses nor does it provide diagnostic recommendations. l-Portal® Video-Nystagmography System (VNG) is used in vestibular and neuro otologic diagnostic testing. The VNG provides stimuli to a patient through visual cues, monitors the patient's response, and presents the data for interpretation by qualified medical personnel trained in vestibular diagnostic testing. This device provides no diagnoses nor does it provide diagnostic recommendations. I-Portal® Video Oculography (VOG) System is used to monitor and record eye movements from various stimuli used in vestibular diagnostic testing. The system measures and records horizontal, vertical, and torsional eve movements, as well as pupil area. It is used in conjunction with various stimuli (rotary chair, manual (done by clinician) positional maneuvers, caloric tests, external stimulus) to detect and record nystagmus and eye tracings for interpretation by qualified medical personnel trained in vestibular diagnostic testing. This device provides no diagnoses nor does it provide diagnostic recommendations.
    Device Description
    The I-Portal device functions as a nystagmograph, defined by 21 CFR 882.1460 as "a device used to measure, record, or visually display the involuntary movements (nystagmus) of the eyeball." Through its nystagmograph functionality, the device is indicated for use as a diagnostic tool to assist trained physicians in their analysis of vestibular disorders, which requires the separation of central and peripheral nervous system deficits. The I-Portal device is used in an institutional environment on the order of a clinician. To achieve safe and effective clinical operation, the I-Portal devices use an extensive battery of tests within a family of products: the I-Portal NOTC, the VNG, and the VOG. The I-Portal NOTC features a rotational chair, the optokinetics (OKN) optical stimulus, the Pursuit Tracker (PT) laser target generator, an I-Portal and VEST software, and a test enclosure equipped with a communication system. Through the use of these elements and the VEST™ analysis software, the physician is able to schedule a set of tests designed to help isolate, identify and understand oculomotor, neurologic and vestibular functions and related possible disorders. The I-Portal VNG offers a subset of the NOTC tests and different vestibular tests through a device with a smaller physical footprint. The VNG has many of the same elements used in the NOTC configuration: OKN optical stimulus, PT laser target generator, VOG, I-Portal and VEST software platforms. However, unlike the NOTC. it does not have either the rotational chair or the enclosure & communication system, but the VNG can collect and analyze data from caloric and position tests. The VNG configuration is typically used in smaller clinics or conditions requiring a smaller sized device or some mobility. The third NKI I-Portal configuration is a digital eve tracking system - the I-Portal VOG. The VOG is incorporated within the NOTC and VNG configurations; however, the VOG can be used as a stand-alone product with the VEST and I-Portal software, but offering a subset of the tests afforded by either the NOTC or VNG.
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    K Number
    K171884
    Device Name
    I-Portal Portable Assessment System - Nystagmograph (I-PAS)
    Manufacturer
    Neuro Kinetics, Inc
    Date Cleared
    2017-11-22

    (152 days)

    Product Code
    GWN
    Regulation Number
    882.1460
    Why did this record match?
    Applicant Name (Manufacturer) :

    Neuro Kinetics, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    I-Portal® Portable Assessment System™ - Nystagmograph (I-PAS™) is used in vestibular and neuro otologic diagnostic testing. The I-PAS provides stimuli to a patient through visual cues, monitors the patient's response, and presents the data for interpretation by qualified medical personnel trained in vestibular diagnosic testing. This device does not provide diagnoses nor does it provide diagnostic recommendations.
    Device Description
    The I-PAS is a head-mounted apparatus enclosing a digital display, infrared lights, dual mirrors, dual cameras, and optical focus knobs. It is attached to the head with straps. The head mounted goggle system displays independent stimuli separately to each eye on a small digital display while simultaneously recording motion from each eye independently with digital video cameras. The system also includes: a computer with Neuro Kinetics' I-Portal and VEST software packages: isolation transformer and connection cables; foot pedals and a hand-held control box with buttons that can be pressed to register motor responses. As with the I-Portal VNG, I-PAS includes the standard battery of VNG tests and can operate in conjunction with caloric test equipment.
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    K Number
    K143607
    Device Name
    I-Portal NOTC, VNG and VOG
    Manufacturer
    NEURO KINETICS, INC.
    Date Cleared
    2015-07-08

    (201 days)

    Product Code
    GWN
    Regulation Number
    882.1460
    Why did this record match?
    Applicant Name (Manufacturer) :

    NEURO KINETICS, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    I-Portal® Neuro Otologic Test Center (NOTC) is a rotary chair system used in vestibular and neuro-otologic diagnostic testing. The NOTC provides stimuli to a patient through motion profiles and/or visual cues, monitors the patient's response, and presents the data for interpretation by qualified medical personnel trained in vestibular diagnostic testing. This device provides no diagnoses nor does it provide diagnostic recommendations. I-Portal® Video-Nystagmography System (VNG) is used in vestibular and neuro otologic diagnostic testing. The VNG provides stimuli to a patient through visual cues, monitors the patient's response, and presents the data for interpretation by qualified medical personnel trained in vestibular diagnostic testing. This device provides nor does it provide diagnostic recommendations. I-Portal® Video Oculography (VOG) System is used to monitor and record eye movements from various stimuli used in vestibular diagnostic testing. The system measures and records horizontal, vertical, and torsional eve movements, as well as pupil area. It is used in conjunction with various stimuli (rotary chair, manual (done by clinician) positional maneuvers, caloric tests, external stimulus) to detect and record nystagmus and eye tracings for interpretation by qualified medical personnel trained in vestibular diagnostic testing. This device provides nor does it provide diagnostic recommendations.
    Device Description
    The I-Portal device functions as a nystagmograph, defined by 21 CFR 882.1460 as "a device used to measure, record, or visually display the involuntary movements (nystagmus) of the eyeball." Through its nystagmograph functionality, the device is indicated for use as a diagnostic tool to assist trained physicians in their analysis of vestibular disorders, which requires the separation of central and peripheral nervous system deficits. The I-Portal is used in an institutional environment on the order of a physician. To achieve safe and effective clinical operation, the I-Portal device uses a battery of tests within a family of products: the NOTC, the VNG, and the VOG. The I-Portal NOTC features a rotational chair, the OKN optical stimulus, the PT laser target generator, the I-Portal VOG, and a test enclosure equipped with a communication system. Through the use of these elements and the VEST™ analysis software, the physician is able to schedule a set of tests isolating oculomotor and vestibular functions to help the physician understand possible vestibular disorders. The I-Portal VNG offers a subset of the NOTC tests and different vestibular tests through a device with a smaller physical footprint. The VNG has many of the same elements used in the NOTC configuration: the OKN optical stimulus, the PT laser target generator, the VOG, and the VEST software platform. However, unlike the NOTC, it does not have the rotational chair, and does not utilize the enclosure / communication system, but the VNG can collect and analyze data from caloric and position tests. The VNG configuration is typically used in smaller clinics or conditions requiring device mobility. The third configuration of the NKI I-Portal is a digital eye tracking system - the I-Portal VOG. The VOG is incorporated within the NOTC and VNG configurations; however, the VOG can be used as a stand-alone product with the VEST software, but offering a subset of the tests afforded by either the NOTC or VNG.
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    K Number
    K083603
    Device Name
    I-PORTAL 4D VIDEO OCULOGRAPHY EYE TRACKING SYSTEM (VOG), I-PORTAL VIDEO NYSTAGMOGRAPHY SYSTEM (VNG), I-PORTAL NEURO OTOL
    Manufacturer
    NEURO KINETICS
    Date Cleared
    2009-08-06

    (244 days)

    Product Code
    GWN
    Regulation Number
    882.1460
    Why did this record match?
    Applicant Name (Manufacturer) :

    NEURO KINETICS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    I-Portal® 4D Video Oculography (VOG) System is used to monitor and record eye movements from various stimuli used in vestibular diagnostic testing. The system measures and records horizontal, vertical, and torsional eye movements, as well as pupil area. It is used in conjunction with various stimuli (rotary chair, manual (done by clinician) positional maneuvers, caloric tests, external stimulus) to detect and record nystagmus and eye tracings for interpretation by qualified medical personnel trained in vestibular diagnostic testing. This device provides no diagnoses nor does it provide diagnostic recommendations.
    Device Description
    Not Found
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