Vera

K150462 · Reflexion Health, Inc. · LXJ · Oct 30, 2015 · Physical Medicine

Device Facts

• Record ID: K150462
• Device Name: Vera
• Applicant: Reflexion Health, Inc.
• Product Code: LXJ · Physical Medicine
• Decision Date: Oct 30, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5360
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

A software system used with the Microsoft Kinect v2 intended to support the physical rehabilitation of adults in the clinic and at home. The system includes rehabilitation exercises for the lower extremity with audio-visual feedback & graphic movement representations for patients as well as remotely accessible patient performance video. Patient assessment, exercise guidance and approval by a medical professional is required prior to use.

Device Story

Vera is a software system for home/clinic physical rehabilitation; utilizes Microsoft Kinect v2 motion sensing camera, monitor, and computer. System comprises Patient, Clinician, and Server applications. Clinicians prescribe exercise plans; patients perform exercises guided by audio-visual feedback and graphic movement representations. Kinect sensor uses structured infrared light to track 3D movement/depth. System records video and tracks kinematic parameters (joint angular changes) to monitor adherence and repetition counts. Data transmitted via server to clinician for review. Does not provide automated quality assessment; clinician performs all clinical assessments. Benefits include increased patient motivation and remote monitoring capabilities. Requires clinician oversight for safety and prescription.

Clinical Evidence

Clinical study verified that movements delivered by Vera are recognized by physical therapists (PTs) as valid rehabilitation exercises. 10 PTs reviewed 230 video recordings of volunteers performing exercises. Results: 97.0% (223/230) of exercises correctly identified by PTs; 96.7% of PTs agreed exercises were typical for rehabilitation and would recommend them to patients. Study confirmed Vera movements are medically recognized and safe when used under clinician supervision. No automated quality assessment performed by device.

Technological Characteristics

Software-based system; requires Microsoft Kinect v2 (structured infrared light sensing) and Windows-based computer workstation. Non-sterile. Moderate level of concern software. Connectivity via server application for data transmission. No direct patient contact.

Indications for Use

Indicated for adults requiring physical rehabilitation of the lower extremity in clinic or home settings. Requires medical professional assessment, exercise guidance, and approval prior to use.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Jintronix Rehabilitation System (K130847)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is an abstract image of a human face in profile, with three overlapping faces.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 30, 2015

Reflexion Health, Inc. Huan Tran Quality and Regulatory Manager 223 Broadway, Suite 650, San Diego, CA 92130

Re: K150462 Trade/Device Name: Vera Regulatory Class: Unclassified Product Code: LXJ Dated: 9/29/2015 Received: 9/30/2015

Dear Huan Tran:

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-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.

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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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Carlos L. Pena -S

Carlos Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K150462

Device Name Vera

Indications for Use (Describe)

A software system used with the Microsoft Kinect v2 intended to support the physical rehabilitation of adults in the clinic and at home. The system includes rehabilitation exercises for the lower extremity with audio-visual feedback & graphic movement representations for patients as well as remotely accessible patient performance video. Patient assessment, exercise guidance and approval by a medical professional is required prior to use.

| Type of Use (Select one or both, as applicable) | |
|---------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------|
| <div><input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</div> | <div><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</div> |

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Image /page/3/Picture/0 description: The image shows the logo for Reflexion Health. The logo consists of a blue circle with a green and blue abstract shape inside, followed by the words "reflexion health" in a light blue sans-serif font. The logo is simple and modern, and the colors are calming and professional.

# 510(k) Summary

# 1. Owner Information

| Name: | Reflexion Health, Inc. |
|----------------------|---------------------------------------------------|
| Address: | 225 West Broadway, Suite 650, San Diego, CA 92101 |
| Phone: | 619-202-4222 |
| Fax: | None |
| Contact | Huan Tran |
| Title: | Manager, Regulatory Affairs & Quality |
| Email: | [e-mail] |
| Date of Preparation: | 10/28/15 |

### 2. Device Information

| Trade Name | Vera™ |
|---------------------------|-----------------------------------------------------------------------------|
| Common Name | Software system utilizing optical recording for<br>rehabilitation exercises |
| Classification Name | System, optical position / movement recording |
| Model Number | Version 2 |
| 510(k) Submitter / Holder | Reflexion Health |
| 510(k) Number | K150462 |
| Predicate 510(k) Number | K130847 |
| Device Panel | Physical Medicine |
| Product Code | LXJ |
| Classification Regulation | Unclassified |

# 3. Description of Device

- A. The main goal for the Vera™ software is to motivate patients to engage in their home physical therapy exercise program. The Reflexion Health team has done this by augmenting the "paper handouts" currently supplied to patients with purpose-built, mobile medical applications. The Vera™ software utilizes three off-the-shelf accessories: a motion sensing camera, a monitor and a computer; to provide physical therapists and physicians with a software system to prescribe customized physical therapy plans for patients. Vera™ software provides medical professionals the tools to record video and track movements in three-dimensional space in order to identify motion and count repetitions during patient participation with a prescribed exercise. Data derived from motion tracking as well as the recorded video can be reviewed by medical professionals to assess exercise movements and adherence to the prescribed exercise; Vera™ is a software tool that helps extend that expertise.
The hazard analysis of the Vera™ software also indicates low risk to the end user. Pursuant to the FDA's Guidance Document for the Content of Premarket Submissions for Software Contained in Medical Devices (May 11, 2005), the Vera™ software level of concern is Moderate.

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Image /page/4/Picture/0 description: The image shows the logo for Reflexion Health. The logo consists of a blue circle with a green and blue abstract design inside, followed by the words "reflexion health" in blue. The text is in a sans-serif font and is aligned to the right of the circle.

- B. Device Components
The Vera™ software has three separate applications.

- Patient Application. This application prompts and monitors patients in the i. performance of a therapy prescribed by their Clinician, monitors and reports exercise data to the Clinician for analysis, and permits a Patient to communicate with that Clinician.
- ii. Clinician Application. This application allows a Clinician to define and update a patient's personal data, a patient's therapy prescription, to monitor a patient's performance of that therapy, and permits a Clinician to communicate with a patient.
- iii. Server Application. This application provides services needed by the various applications to move the necessary data between themselves accurately and securely. It also permits an IT professional to monitor and maintain the infrastructure needed by the different applications.
- C. Device Accessories
- Motion Sensing Camera: i. The Kinect Sensor from Microsoft uses structured infrared light to determine the position of objects in its field of view in three dimensions including distance, or "depth", from the camera.
- Microsoft Kinect Sensor Driver App v2.0 ..= A software, provided by Microsoft, that tells the computer's operating system exactly how to work with the Microsoft Kinect Sensor.
- iii. Computer (minimum configurations):
- iv. Monitor with touch screen (or standard monitor with keyboard)

| General 510(k) Information | Predicate Device |
|----------------------------|---------------------------------|
| Trade Name | Jintronix Rehabilitation System |
| 510(k) Number | K130847 |
| Device Panel | Physical Medicine |
| Product Code | LXJ |
| 510(k) Submitter | Jintronix, Inc. |

# 4. Predicate / Substantially Equivalent Device

#### 5. Intended Use

A software system used with the Microsoft Kinect v2 intended to support the physical rehabilitation of adults in the clinic and at home. The system includes rehabilitation exercises for the lower extremity with audio-visual feedback & graphic movement representations for patients as well as remotely accessible patient performance video. Patient assessment, exercise guidance and approval by a medical professional is required prior to use.

The device does not provide patient-specific feedback or assessment of the quality of the movement. The clinician who monitors the exercises provides the assessment.

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# 6. Comparative Summary of Technological Characteristics

| Characteristics | Predicate, Jintronix<br>Rehabilitation System,<br>K130847 | Vera™ | Substantial<br>Equivalence<br>Claim |
|-----------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------|
| Principles of<br>Operation | The JRS allows a medical<br>professional to assign<br>movement activities to<br>patients. | Vera™ allows medical<br>professionals to assign<br>movement activities to<br>patients. | Equivalent |
| | JRS tracks upper extremity<br>and trunk movement<br>providing visual feedback of a<br>patient movement and<br>reports on kinematic<br>parameters like velocity and<br>joint angular changes during<br>movement. | Vera™ tracks rehabilitation<br>movements providing visual<br>feedback of a patient<br>movement and reports on<br>kinematic parameters like joint<br>angular changes during<br>movement. | |
| Energy Used /<br>Delivered | Not applicable as JRS is a<br>software product. | Not applicable as Vera™ is a<br>software product. | Equivalent |
| Human Factors | No safety concern as no direct<br>contact of JRS / Kinect with<br>patients. | No safety concern as no direct<br>contact of Vera™ / motion<br>sensing device with patients. | Equivalent |
| | JRS prescription and remote<br>medical professional<br>monitoring of patients allows<br>safe home based<br>rehabilitation exercises.<br>JRS has been validated for<br>accuracy / performance<br>effectiveness both clinically<br>and through software testing<br>with appropriate change<br>management and design<br>controls. The JRS also | Vera™ prescription and remote<br>medical professional<br>monitoring of patients allows<br>safe home based rehabilitation<br>exercises.<br>Vera™ has been validated for<br>accuracy / performance<br>effectiveness both clinically<br>and through software testing<br>with appropriate change<br>management and design<br>controls. The Vera™ also<br>incorporates correction of | |
| | incorporates correction of<br>error in Kinect motion sensing<br>to achieve optimal Kinect<br>accuracy. | error in Kinect motion sensing<br>to achieve optimal Kinect<br>accuracy. | |
| | Usability & Effectiveness<br>consideration: JRS was<br>predominantly recommended<br>by medical professionals for<br>the physical rehabilitation of<br>their patients. | Usability & Effectiveness<br>consideration: Vera™ was<br>predominantly recommended<br>by medical professionals for<br>the physical rehabilitation of<br>their patients. | |
| Design | JRS design requires optical<br>motion sensing technology<br>and computer operating<br>system with Windows for<br>operation. | Vera™ design requires optical<br>motion sensing technology<br>and computer operating<br>system for operation. | Equivalent |
| Materials /<br>Technology<br>used | JRS comprises of JRS Wave<br>(client application software) &<br>JRS Portal (web portal). The<br>JRS is to be used with the<br>Kinect for optical motion<br>capture and a Microsoft<br>Windows computer<br>workstation. | Vera™ System consists of a<br>Patient Application, Clinician<br>Application and Server<br>Application. The Vera™ is to be<br>used with a motion sensing<br>device for optical motion<br>capture and a computer<br>workstation. | Equivalent |
| Biocompatibility | Not applicable as JRS is a<br>software product. | Not applicable as Vera™ is a<br>software product. | Equivalent |
| Compatibility<br>with the<br>environment<br>and other<br>devices /<br>System<br>Compatibility | The compatibility of JRS<br>software with Kinect<br>hardware and computer<br>operating system<br>requirements have been<br>validated. Suitable change<br>management and design<br>controls have been<br>implemented. | The compatibility of Vera™<br>software with Kinect hardware<br>and computer operating<br>system requirements have been<br>validated. Suitable<br>change management and<br>design controls have been<br>implemented. | Equivalent |
| Characteristics | Predicate, Jintronix Rehabilitation System, K130847 | Vera™<br>K150462 | Substantial Equivalence Claim |
| Electrical Safety | Not applicable as JRS is a software product. | Not applicable as Vera™ is a software product. | Equivalent |
| Mechanical Safety | Not applicable as JRS is a software product. | Not applicable as Vera™ is a software product. | Equivalent |
| Thermal Safety | Not applicable as JRS is a software product. | Not applicable as Vera™ is a software product. | Equivalent |
| Chemical Safety | Not applicable as JRS is a software product. | Not applicable as Vera™ is a software product. | Equivalent |
| Radiation Safety | Not applicable as JRS is a software product. | Not applicable as Vera™ is a software product. | Equivalent |
| Sterility | JRS is a non-sterile product. | Vera™ is a non-sterile product. | Equivalent |

# Table 1: Technological Characteristics Comparison

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Image /page/6/Picture/0 description: The image shows the logo for Reflexion Health. The logo consists of a blue circle with a stylized green and blue design inside. To the right of the circle is the text "reflexion health" in a light blue sans-serif font. The text is all lowercase.

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Image /page/7/Picture/0 description: The image shows the logo for Reflexion Health. The logo consists of a blue circle with a green and blue design inside, followed by the words "reflexion health" in blue. The design inside the circle appears to be two triangles pointing towards each other.

### Table 2: Safety Comparison

Substantial Equivalence Conclusion:

As described under Tables 1-2 above, the Vera™ system is substantially equivalent to the predicate device in terms of intended use, principles of operation, human factors, design, materials, technology used, compatibility with the environment and / other devices, and safety. There are no differences between the Vera™ software and the predicate device and Vera™ is at least as safe and effective as the predicate.

# 7. Clinical Performance Data

A clinical study was performed to analyze the clinical relevance of exercises delivered by the Vera System. The study verified that physical movements delivered by Vera, executed by an individual interacting with the system, and captured by video are recognized by Clinicians to be physical rehabilitation exercises. Clinicians reviewed a series of video recordings of healthy volunteers performing rehabilitation movements to verify that the movement seen in the video is recognized as physical therapy exercise and determine if they would recommend the movement to their patients. Potential risks for their patients posed by the movements seen in the video were identified by the Clinicians.

#### Safety & Effectiveness Summary

The clinical study results were predominantly 100% exceeding the 95% acceptance criterion for all Vera activity movements demonstrating that the Vera movements are clinician recognized rehabilitation movements and validating the accuracy of the Vera in data processing.

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Image /page/8/Picture/0 description: The image shows the logo for Reflexion Health. The logo consists of a blue circle with a green and blue abstract design inside, followed by the words "reflexion health" in blue. The text is in a sans-serif font and is aligned to the right of the circle.

Of the 230 exercises observed (10 PTs x 23 Exercises/PT), 223 (97.0%) were correctly described by the PTs.

96.7% of therapists agreed that the exercises viewed were typical of those prescribed for rehabilitation purposes and 96.7% would recommend the exercises demonstrated to appropriate patients. The data presented in this report confirm that when users perform exercises delivered by Vera, these exercises are considered rehabilitation exercises by physical therapists.

| Category | Potential Risks | Recommendations for Risk<br>Mitigation |
|----------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1 | The exercise was determined to be<br>unsafe if the user was using unsafe<br>accessories such as using a chair with<br>wheels which could compromise<br>balance and increase risk of falling or<br>poor form. | Recommend that clinicians<br>advise patients on the<br>appropriate use of ancillary<br>equipment to promote proper<br>balance, achieve good form and<br>avoid risk of falling prior to and<br>during the use of Vera. |
| 2 | The exercise was deemed unsafe to be<br>prescribed by a physical therapist for<br>the patient due to patient's functional<br>ability, level of impairment, or diagnosis. | Recommend that clinicians<br>thoroughly evaluate the patient's<br>functional status and assign a<br>rehabilitation program most<br>suitable to the patients functional<br>ability, level of impairment, and<br>diagnosis |
| 3 | The exercise was deemed unsafe to be<br>prescribed by a physical therapist for<br>the patient due to patient's health<br>history. | Prior to enrollment of a patient<br>into a rehabilitation exercise<br>program and the use of Vera we<br>recommend that clinicians<br>conduct and/or review a patient<br>health history. |

The risks that were identified by the Clinicians were classified into three categories:

The risks identified by the clinicians are considered "universal risks" that physical therapists must consider when prescribing rehabilitation exercises to patients. Such risks are inherent in prescribing any rehabilitation exercises and it is the clinician's responsibility to evaluate a patient and prescribe exercises appropriate for the patient's health status and ability.

# 8. Non Clinical & Clinical Conclusions

The clinical study demonstrates that the Vera movements are medically recognized rehabilitation movements and is as safe, as effective, and performs as well or as better than the Predicate, K130847.