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510(k) Data Aggregation
K Number
K163245Device Name
Virtual Occupational Therapy Application (VOTA)
Manufacturer
Barron Associates, Inc.
Date Cleared
2017-02-28
(102 days)
Product Code
LXJ
Regulation Number
890.5360Why did this record match?
Applicant Name (Manufacturer) :
Barron Associates, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A software system used with the Microsoft Kinect intended to support repetitive task practice for rehabilitation of adults under supervision of a medical professional in a clinical or home setting. The system includes simulated activities of daily living (ADLs) for the upper extremity with audio-visual feedback & graphic movement representations for patients as well as patient performance metrics for the medical professional. Patient assessment, exercise guidance, and approval by the medical professional is required prior to use.
Device Description
The VOTA software system comprises a VOTA patient-facing and a provider-facing Provider Dashboard. The VOTA patient-facing application supports repetitive task practice exercises for the upper extremity that are consistent with Standard of Care for physical rehabilitation of adults. The software runs on a personal computer under the Windows 8.1 operating system (or later) and uses a Microsoft Xbox One Kinect Sensor (hereafter referred to as Kinect Sensor) to track patient arm movements. These arm movements are translated into equivalent movements of a graphical avatar that represents the patient in a virtual environment. The patient is thus able to practice activities of daily living (ADLs) that involve meaningful tasks and evoke functional movements with graduated levels of difficulty. The activities are organized into a virtual "Road to Recovery" that traverses a series of four islands, each organized around a central theme. There is no physical contact between the patient and the device during exercises, and thus no energy is directed to the patient assessment by a medical professional, and selection of exercise and settings, is required prior to use.
The provider-facing VOTA Provider Dashboard application enables the medical professional to view patient performance metrics and participation history using data produced by the VOTA patient-facing application. The application runs on the same personal computer and operating system as the patientfacing application.
All hardware associated with VOTA are commercial-of-the-shelf, consumer hardware items. The VOTA system ships with the following:
- Microsoft Xbox One Kinect Sensor and Kinect power supply;
- Microsoft Xbox Kinect Adapter for Xbox One ;
- Kinect TV Mount for Xbox One;
- Personal computer (preloaded with VOTA software) and computer power supply;
- Wireless keyboard;
- HDMI cable;
- Getting Started Guide; and
- Third-party Labeling Package
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