(102 days)
Not Found
No
The document describes the use of a Microsoft Kinect sensor for tracking movement and translating it into a graphical avatar, along with software for exercise practice and performance metrics. There is no mention of AI, ML, or related concepts like training sets for algorithms. The focus is on standard motion tracking and software functionality.
Yes
The device is described as a "software system ... intended to support repetitive task practice for rehabilitation of adults" and clinical testing "demonstrated that use of VOTA is effective for supporting the rehabilitation of UE motor function". This directly indicates a therapeutic purpose.
No
The device is described as a software system "intended to support repetitive task practice for rehabilitation of adults". While it provides "patient performance metrics", these are for monitoring progress during rehabilitation, not for diagnosing a medical condition. The "patient assessment" functionality mentioned is for a medical professional and is related to the rehabilitation process rather than initial diagnosis.
No
The device description explicitly states that the system ships with hardware components, including a Microsoft Xbox One Kinect Sensor, power supplies, adapter, TV mount, personal computer, wireless keyboard, and HDMI cable. While the software is a key component, the system is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The VOTA system uses a Microsoft Kinect to track patient arm movements for rehabilitation purposes. It provides feedback to the patient and performance metrics to the medical professional.
- Lack of Biological Sample Analysis: The device does not analyze any biological samples from the patient. Its function is based on external movement tracking and software processing.
- Intended Use: The intended use is for supporting repetitive task practice for rehabilitation, not for diagnosing or monitoring a medical condition through the analysis of biological samples.
Therefore, the VOTA system, as described, falls outside the scope of an In Vitro Diagnostic device. It is a therapeutic and monitoring device used in a clinical or home setting for physical rehabilitation.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
LXJ
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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
optical motion sensing technology
Anatomical Site
upper extremity
Indicated Patient Age Range
adults
Intended User / Care Setting
medical professional in a clinical or home setting.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical Testing: Clinical testing of the VOTA system was conducted by the University of Virginia (UVa) Department of Physical Medicine and Rehabilitation and the UVa HealthSouth Rehabilitation Hospital under the approval and governance of the UVa Institutional Review Board for Human Subject Research (IRB-HSR). In the IRB-approved protocol, stroke survivors with upper extremity (UE) impairment were asked to attend three one-hour sessions per week over eight weeks (24 total sessions for each subject) in the Outpatient Clinic of the UVa HealthSouth Rehabilitation Hospital. In these sessions, the patients employed the VOTA patient-facing application to practice virtual activities of daily living (ADLs) to exercise their upper extremity in repetitive task practice, consistent with Standard of Care for occupational therapy. Licensed occupational therapists supervised the sessions. Rubrics and success criteria included: (1) establishing clinically significant improvement in pre-/post- functional gain using gold-standard measures of UE motor performance; (2) assessment of usability using a widely-accepted instrument; (3) systematic comparison of VOTA to Standard of Care by licensed therapists, and (4) assessment of safety by experienced therapists with over 200 hours of actual patient contact time using the VOTA system.
Clinical testing demonstrated that use of VOTA is effective for supporting the rehabilitation of UE motor function, as measured by pre-/post- assessment using the Fugl-Meyer UE assessment (FMUE) - a widelyrecognized, accepted, and clinically-relevant measure of post-stroke functional impairment. Results of clinical testing demonstrated that stroke patients (n = 15, > 3 months since stroke, and no longer in rehabilitation outside of the study) using the VOTA system for approximately one hour, three times per week, over an 8-week period achieved an average FMUE improvement of 6 points. Additionally, there were no adverse incidents or injuries over the entire period of actual VOTA use by the stroke patients in the clinical testing spanning 240 total sessions of approximately 1 hour each. The results demonstrate that VOTA, used as intended for repetitive task practice, supports the rehabilitation of upper extremity motor function in stroke patients.
Clinical testing, published in peer-reviewed literature by the VOTA team, has demonstrated that VOTA's Kinect-based upper extremity tracking produces valid results for the intended application. The VOTA Kinect-based tracking solution was found to be sufficient, both to permit patients to successfully perform virtual ADL exercises and to support derivation of speed-based motor performance metrics. References have also been provided for existing literature demonstrating the accuracy of Kinect-based upper extremity tracking.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
FMUE improvement of 6 points (average); no adverse incidents or injuries over 240 total sessions.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 890.5360 Measuring exercise equipment.
(a)
Identification. Measuring exercise equipment consist of manual devices intended for medical purposes, such as to redevelop muscles or restore motion to joints or for use as an adjunct treatment for obesity. These devices also include instrumentation, such as the pulse rate monitor, that provide information used for physical evaluation and physical planning purposes., Examples include a therapeutic exercise bicycle with measuring instrumentation, a manually propelled treadmill with measuring instrumentation, and a rowing machine with measuring instrumentation.(b)
Classification. Class II (special controls). The device, when it is a measuring exerciser or an interactive rehabilitation exercise device for prescription use only, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 28, 2017
Barron Associates, Inc. Bruce G. Wilson Business Manager 1410 Sachem Place, Suite 202 Charlottesville, Virginia 22901
Re: K163245
Trade/Device Name: Virtual Occupational Therapy Application (VOTA) Regulation Number: Unclassified Regulation Name: Unclassified Regulatory Class: Unclassified Product Code: LXJ Dated: February 1, 2017 Received: February 2, 2017
Dear Mr. Wilson:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device
1
related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Michael J. Hoffmann -S
Carlos L. Peña, PhD, MS for Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K163245
Device Name
Virtual Occupational Therapy Application (VOTA)
Indications for Use (Describe)
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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) SUMMARY
Submitting Organization and Owner 5.1
| Name: | Barron Associates, Inc. |
|---|---|
| Address: | 1410 Sachem Place, Suite 202 |
| Charlottesville, VA 20191 | |
| Phone: | (434) 973-1215 |
| FAX: | (434) 973-4686 |
| Regulatory Contact: | Bruce Wilson, Business Manager |
| Email: | wilson@barron-associates.com |
| Date of preparation: | 16 November 2016 |
5.2 Device
| Trade Name | Virtual Occupational Therapy Application (VOTA) |
|---|---|
| Model Number | VOTA-1.0 |
| Common Name | Software system utilizing optical position recording for supporting |
| repetitive task practice for rehabilitation | |
| Classification Name | System, Optical Position/Movement Recording |
| Review Panel | Physical Medicine |
| Product Code | LXJ |
| Device Class | Unclassified. VOTA is substantially equivalent to the predicate in |
| Product Code LXJ. The Product Code is identified as "Unclassified" in | |
| the FDA database. Reason given is "Pre-Amendment." This information | |
| can be found at the flowing link: | |
| http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classificatio | |
| n.cfm?ID=LXJ |
5.3 Predicate Device
| Predicate Trade Name | Jintronix Rehabilitation System (JRS) |
|---|---|
| Model Number | Version 1.0 |
| 510(k) Number | K130847 |
| 510(k) Holder | Jintronix, Inc. |
| Device | System, Optical Position/Movement Recording |
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| Review Panel | Physical Medicine |
|---|---|
| Product Code | LXJ |
| Device Class | Product Code LXJ is Unclassified. Reason given is "Pre-Amendment." |
Device Description 5.4
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
VOTA Indications for Use Statement 5.5
A software system used with the Microsoft Kinetic 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 audiovisual 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.
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5.6 Substantial Equivalence with Predicate - Intended Use
The VOTA Indications for Use Statement is highly similar to that of the Jintronix Rehabilitation System (JRS) (hereafter referred to as "the Predicate"). The following is the Predicate's Indications for Use Statement with a strikethrough line showing the words eliminated, and underlined text is used to show words added to form the VOTA Indications for Use Statement.
A software system used with the Microsoft Kinect intended to be used to support the physical rehabilitation of adults in the clinic/ at home repetitive task practice for rehabilitation of adults under supervision of a medical professional in a clinical or home setting. The system includes rehabilitation exercises simulated activities of daily living (ADLs) for the upper extremity and trunk with audio-visual feedback & graphic movement representations for patients as well as remotely accessible patient performance metrics for the medical professional. Patient assessment, exercise quidance and approval by the medical professional is required prior to use.
| Differences in Indications for Use Statements | | Why differences do not affect safety and
effectiveness of VOTA when used as labeled. |
|---------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| VOTA | Predicate(s) | |
| repetitive task practice for
rehabilitation of adults
under supervision of a
medical professional in a
clinical or home setting | the physical
rehabilitation of
adults in the
clinic/ at home | Repetitive task practice is a more precise definition
of the element of standard of care implemented by
VOTA. The clear statement that VOTA will be used
under supervision reduces the VOTA risk profile
compared to the Predicate. |
| simulated activities of
daily living (ADLs) | rehabilitation
exercises | Simulated ADLs is a more precise definition of the
way the VOTA system supports rehabilitation.
Simulated ADLs are highly consistent with standard
of care and at least as safe as the Predicate's more
generic rehabilitation exercises. |
| Does not include "and
trunk" | Includes "and
trunk" | Does not adversely affect the safety or effectiveness
of the device |
| Does not include
"remotely accessible"
patient performance
metrics | Includes
"remotely
accessible"
patient
performance
metrics | Does not adversely affect the safety or effectiveness
of the device |
5.7 Technological Characteristics
VOTA device and the predicate have very similar technical characteristics. Both are software-based devices intended for the Windows operating system on a personal computer, and both use a Microsoft Kinect sensor for tracking patient upper extremity movements. Both translate movements to moving
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images on the display, along with audio-visual feedback. Both systems provide performance metrics for the medical professional. Both systems are non-invasive, do not contact the patient, and do not direct energy toward the patient. Both systems are non-sterile in their requirements. Neither system poses concerns over electrical, chemical, thermal or radiation safety. The following chart provides a substantial equivalence comparison.
| Area of
| Comparison | Predicate | Applicant Device | Discussion |
|---|---|---|---|
| Principles of | |||
| Operation | This system allows a | ||
| medical professional to | |||
| assign movement activities | |||
| to patients. It tracks | |||
| patient movement | |||
| providing visual feedback | |||
| and reports on kinematic | |||
| parameters like velocity | |||
| and joint angular changes | |||
| during movement. | Same | No difference between | |
| VOTA and predicate. | |||
| Energy Used | |||
| and/or | |||
| delivered | As a software system, | ||
| energy usage is low, and | |||
| no energy is directed into | |||
| patient. | As a software system, | ||
| energy usage is low, and | |||
| no energy is directed | |||
| into patient. | No difference between | ||
| VOTA and predicate. | |||
| Design | Per its 510(k) Summary, | ||
| the Predicate system | |||
| requires optical motion | |||
| sensing technology and | |||
| computer operating | |||
| system with Windows for | |||
| operation. | VOTA is a software | ||
| system using Microsoft | |||
| Kinect optical position | |||
| sensor and a Windows | |||
| personal computer | |||
| operating system | |||
| platform. | VOTA and the predicate | ||
| employ substantially the | |||
| same design | |||
| considerations. | |||
| Materials / | |||
| Technology | |||
| used | The Predicate in its 510(k) | ||
| Summary identifies two | |||
| software modules, a | |||
| Microsoft Kinect optical | |||
| motion capture | |||
| component and a | |||
| Microsoft Windows | |||
| computer workstation. | VOTA is a software | ||
| system using Microsoft | |||
| Kinect optical position | |||
| sensor and a Windows | |||
| personal computer | |||
| operating system | |||
| platform. | VOTA and the predicate | ||
| employ substantially the | |||
| same materials and | |||
| technology. | |||
| Biocompatibility | The Predicate in its 510(k) | ||
| Summary notes that it has | |||
| no direct contact with | VOTA and its | ||
| components including | |||
| Microsoft Kinect has no | VOTA and the predicate | ||
| do not come into contact | |||
| with the patient. Neither | |||
| patient and | |||
| biocompatibility concerns | |||
| are not applicable. | direct contact with | ||
| patient. Biocompatibility | |||
| concerns are not | |||
| applicable. | presents biocompatibility | ||
| safety concerns. | |||
| Compatibility | |||
| with the | |||
| environment | |||
| and other | |||
| devices / | |||
| System | |||
| Compatibility | The Predicate in its 510(k) | ||
| Summary notes that its | |||
| software and operating | |||
| system requirements have | |||
| been validated, and | |||
| suitable change | |||
| management and design | |||
| controls have been | |||
| implemented. | VOTA is a software | ||
| system using Microsoft | |||
| Kinect and the Windows | |||
| personal computer | |||
| platform. Together they | |||
| have been validated to | |||
| meet design | |||
| requirements and | |||
| conform to Standard of | |||
| Care for the intended | |||
| use. Appropriate | |||
| GMP/QSR design | |||
| controls and change | |||
| management controls | |||
| have been implemented. | Both VOTA and its | ||
| predicate have been | |||
| validated as compatible | |||
| with a Windows personal | |||
| computer and Microsoft | |||
| Kinect sensor. |
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5.8 Safety Characteristics
The BAI-VOTA-SYS-003 Risk Analysis document (see Appendix E) describes the safety characteristics of VOTA, analyzed in accordance with ISO 14971 Medical Devices – Application of Risk Management to Medical Devices. This analysis informs the comparison to the predicate device that follows below.
| Area of
| Comparison | Predicate | Applicant Device | Discussion |
|---|---|---|---|
| Electrical safety | The Predicate is a | ||
| software device that | |||
| does not touch the | |||
| patient. Its electrical | |||
| components are a | |||
| personal computer | |||
| and Microsoft Kinect | |||
| sensor that the | |||
| patient does not | |||
| touch. These | |||
| components comply | |||
| with consumer | |||
| electrical safety | |||
| standards such as UL. | VOTA is a software | ||
| device that does not | |||
| touch the patient. Its | |||
| electrical | |||
| components are a | |||
| personal computer | |||
| and Microsoft Kinect | |||
| sensor that the | |||
| patient does not | |||
| touch. These | |||
| components comply | |||
| with consumer | |||
| electrical safety | |||
| standards such as UL. | No differences in electrical | ||
| technology and safety between | |||
| VOTA and predicate. | |||
| Mechanical | |||
| safety | As a software system, | ||
| the Predicate does not | |||
| utilize any mechanical | |||
| components that the | |||
| patient touches. | As a software | ||
| system, VOTA does | |||
| not utilize any | |||
| mechanical | |||
| components that the | |||
| patient touches. | No differences in mechanical | ||
| safety between VOTA and | |||
| predicate. There are no | |||
| mechanical safety concerns in | |||
| either product. | |||
| Chemical safety | Not applicable to a | ||
| software system. | Not applicable to a | ||
| software system. | No differences between VOTA and | ||
| predicate. Chemical safety is not | |||
| an issue that applies to either | |||
| product. | |||
| Thermal safety | No issues of thermal | ||
| safety are identified in | |||
| the Predicate's 510(k) | |||
| Summary. | VOTA is a software | ||
| system that uses a | |||
| Windows personal | |||
| computer and | |||
| Microsoft Kinect. | |||
| There are no known | |||
| sources of heat | |||
| except a small | |||
| amount of warmth | |||
| generated by the | |||
| personal computer. | No differences between VOTA and | ||
| predicate. Thermal safety is not | |||
| an issue that applies to either | |||
| product. No adverse impact to | |||
| patient safety. | |||
| Radiation safety | The Predicate uses | ||
| Microsoft Kinect that | |||
| has an infra-red | |||
| sensor that per the | |||
| 510(k) Summary | |||
| complies with laser | |||
| Class 1 standard. | VOTA uses Microsoft | ||
| Kinect that has an | |||
| infra-red sensor that | |||
| complies with the | |||
| laser Class 1 standard | |||
| and IEC safety | |||
| standard 60825- | |||
| 1:2007. | No differences between VOTA and | ||
| predicate. No adverse impact to | |||
| the safety of patients using VOTA. | |||
| Sterility | The Predicate is a | ||
| non-sterile product | |||
| per the 510(k) | |||
| Summary. It is a | |||
| software system that | |||
| uses Microsoft Kinect. | VOTA is a non-sterile | ||
| product. It is a | |||
| software system that | |||
| uses Microsoft | |||
| Kinect. | No differences between VOTA and | ||
| predicate. Neither is intended to | |||
| be a sterile product. No adverse | |||
| impact to the intended use. |
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5.8.1 Level of Concern
The VOTA software system has a Moderate Level of Concern, which is the same as the Predicate. The rationale for the Moderate Level of Concern is that, prior to the mitigation of hazards, there is a small, but non-zero risk of Minor Injury (e.g. joint/muscle injury due to overexertion) for a patient if instructed to perform an inappropriate movement for the patient's specific therapy. This risk is
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mitigated by the supervision of a medical professional that is stipulated in the device's Indications for Use. Since the supervision of a medical professional is considered a control, we must assert a Moderate Level of Concern.
5.9 Summary of Testing
The VOTA software system has been extensively tested, including bench and clinical testing.
5.9.1 Bench Testing
Third-party bench testing of the VOTA patient-facing application was conducted to establish that the software system provides the capabilities necessary to support the product's Indications for Use. In addition to validating the core functionality of the software system, this testing also establishes substantial equivalency to the Predicate, which shares (nearly) identical indications.
Traceability has been provided between: (1) the VOTA Indications for Use Statement; (2) a core set of system-level requirements; (3) test plans (including rubrics and success criteria) to validate that these system-level requirements; and (4) documented test results showing success criteria are met. A major emphasis of bench testing is demonstration of the consistency of VOTA exercises with Standard of Care for occupational therapy. Therefore, a detailed explanation of Care is provided, along with linkages to test plans and results. Analysis of bench test results demonstrates that all success criteria are met.
5.9.2 Risk Controls
Verification of risk controls has been provided within the Device Hazard Analysis and the Risk Control Verification Plan. The results of third-party evaluations verifying the recommended controls are documented in the Risk Control Verification Report. All risk controls have been successfully verified by use of tests and/or demonstrations and/or document review and inspection, with traceability maintained between potential hazards and V&V results.
5.9.3 Clinical Testing
Clinical testing was performed to demonstrate and validate the accuracy of the device and repetitive tasks. Clinical testing of the VOTA system was conducted by the University of Virginia (UVa) Department of Physical Medicine and Rehabilitation and the UVa HealthSouth Rehabilitation Hospital under the approval and governance of the UVa Institutional Review Board for Human Subject Research (IRB-HSR). In the IRB-approved protocol, stroke survivors with upper extremity (UE) impairment were asked to attend three one-hour sessions per week over eight weeks (24 total sessions for each subject) in the Outpatient Clinic of the UVa HealthSouth Rehabilitation Hospital. In these sessions, the patients employed the VOTA patient-facing application to practice virtual activities of daily living (ADLs) to exercise their upper extremity in repetitive task practice, consistent with Standard of Care for occupational therapy. Licensed occupational therapists supervised the sessions. Rubrics and success criteria included: (1) establishing clinically significant improvement in pre-/post- functional gain using gold-standard measures of UE motor performance; (2) assessment of usability using a widely-accepted instrument; (3) systematic comparison of VOTA to Standard of Care by licensed therapists, and (4) assessment of safety by experienced therapists with over 200 hours of actual patient contact time using the VOTA system.
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Clinical testing demonstrated that use of VOTA is effective for supporting the rehabilitation of UE motor function, as measured by pre-/post- assessment using the Fugl-Meyer UE assessment (FMUE) - a widelyrecognized, accepted, and clinically-relevant measure of post-stroke functional impairment. Results of clinical testing demonstrated that stroke patients (n = 15, > 3 months since stroke, and no longer in rehabilitation outside of the study) using the VOTA system for approximately one hour, three times per week, over an 8-week period achieved an average FMUE improvement of 6 points. Additionally, there were no adverse incidents or injuries over the entire period of actual VOTA use by the stroke patients in the clinical testing spanning 240 total sessions of approximately 1 hour each. The results demonstrate that VOTA, used as intended for repetitive task practice, supports the rehabilitation of upper extremity motor function in stroke patients.
Clinical testing, published in peer-reviewed literature by the VOTA team, has demonstrated that VOTA's Kinect-based upper extremity tracking produces valid results for the intended application. The VOTA Kinect-based tracking solution was found to be sufficient, both to permit patients to successfully perform virtual ADL exercises and to support derivation of speed-based motor performance metrics. References have also been provided for existing literature demonstrating the accuracy of Kinect-based upper extremity tracking.
These results demonstrate that VOTA is as safe and as effective as the predicate device.