Recovr Rehabilitation System

K151446 · Recovr,Inc · LXJ · Sep 18, 2015 · Physical Medicine

Device Facts

• Record ID: K151446
• Device Name: Recovr Rehabilitation System
• Applicant: Recovr,Inc
• Product Code: LXJ · Physical Medicine
• Decision Date: Sep 18, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5360
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Recove Rehabilitation System is software for use with the Microsoft Kinect motion tracking system that is indicated to support physical rehabilitation of adults in the clinic and at home via performance of therapist-assigned reach exercises for the upper extremities. Patient assessment, exercise guidance, and approval by the medical professional are required prior to use.

Device Story

Recovr Rehabilitation System (RRS) is a software platform utilizing Microsoft Kinect motion-tracking sensor to facilitate upper extremity rehabilitation. System includes computer, primary display, secondary monitor, and Kinect sensor. Users perform therapist-assigned reaching exercises presented as virtual reality games (e.g., carnival shooting gallery) to encourage repetitive movement. Therapist manages system via secondary monitor/keyboard/mouse. System captures kinematic data (velocity, joint angular changes) during sessions; provides audiovisual feedback to user; generates performance reports for therapist to track progress. Used in clinics or homes under professional guidance. Benefits include increased patient engagement and motivation through gamification, enabling objective tracking of rehabilitation progress.

Clinical Evidence

No clinical, animal, or biocompatibility testing performed. Substantial equivalence supported by software verification and validation testing conducted per FDA's 2005 guidance for software in medical devices.

Technological Characteristics

Software system utilizing Microsoft Kinect motion-tracking sensor. Operates on standard computer hardware with primary and secondary displays. Input: optical motion tracking. Output: audiovisual game-based feedback and kinematic performance reports. Software level of concern: minor. Non-sterile, non-single use.

Indications for Use

Indicated for physical rehabilitation of adults in clinic or home settings via therapist-assigned upper extremity reach exercises. Requires prior patient assessment, exercise guidance, and approval by a medical professional.

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)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with a flowing design element below them.

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

September 18, 2015

Recovr, Inc % Kathryn Cole Principle Translational Science Solutions LLC 92 Hasell Street, Suite 401 Charleston, South Carolina 29401

Re: K151446

Trade/Device Name: Recovr Rehabilitation System Regulatory Class: Unclassified Product Code: LXJ Dated: August 4, 2015 Received: August 10, 2015

Dear Kathryn Cole:

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

{1}------------------------------------------------

the quality systems (OS) 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 [phone] or [phone] 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 [phone] or [phone] or at its Internet address

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

Sincerely yours,

Carlos L. Pena -5D/Δ

Carlos L. Peña, PhD, MS 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) K151446

Device Name Recovr Rehabilitation System

### Indications for Use (Describe)

The Recove Rehabilitation System is software for use with the Microsoft Kinect motion tracking system that is indicated to support physical rehabilitation of adults in the clinic and at home via performance of therapist-assigned reach exercises for the upper extremities. Patient assessment, exercise guidance, and approval by the medical professional are required prior to use.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|
| <span style="font-family: Arial, sans-serif;"><input checked="true" type="checkbox"/></span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-family: Arial, sans-serif;"><input type="checkbox"/></span> Over-The-Counter Use (21 CFR 801 Subpart C) |

# CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

# *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

#### 5.0 510(K) SUMMARY

| Submission Date: | September 17, 2015 |
|------------------|--------------------|
|------------------|--------------------|

# Submitter Information:

| Submitted By: | Recovr, Inc.<br>Post Office Box 772<br>Clemson, SC 29633 |
|---------------|----------------------------------------------------------|
|---------------|----------------------------------------------------------|

- Contact Person: Austen Hayes, MS Chief Executive Officer Tel: [phone] Email: [e-mail]
# Device Information:

| Trade Name: | Recovr Rehabilitation System |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Software system utilizing optical position recording for<br>rehabilitation exercises |
| Classification Name: | System, Optical Position/Movement Recording (Product<br>Code LXJ) |
| Regulatory Class: | Unclassified |
| Predicate Device: | Jintronix Rehabilitation System (K130847)<br>Jintronix, Inc.<br>Unclassified (Product Code LXJ) |
| Device Description: | The Recovr Rehabilitation System (RRS) is a software<br>system that presents games to facilitate the completion<br>of therapist designed and prescribed upper extremity<br>repetitive reaching exercises and that collects data for<br>the therapist on the user's game play. The system was<br>designed in collaboration with an experienced<br>neurorehabilitation occupational therapist and<br>rehabilitation research team. The RRS is intended for<br>use in the clinic or at home. Patient assessment,<br>exercise guidance, and approval by the medical<br>professional are required prior to use.<br><br>The system consists of software, a computer, a primary<br>display monitor, a secondary monitor, and a Microsoft<br>Kinect motion-tracking sensor. Users sit on a bench or<br>stand 6-8 feet away from the primary display monitor.<br>The Kinect sensor is placed along the top or bottom<br>edge of the primary display monitor, and the therapist<br>controls the system from a secondary monitor, mouse,<br>and keyboard off to the side of the primary display<br>monitor. The games are based on a traditional carnival |

{4}------------------------------------------------

shooting gallery, with targets that pop–up to present reaching tasks. The virtual reality environment incorporates video game principles to engage and motivate users to perform the amount of rehabilitation assigned by the rehabilitation therapist. The system collects data on participant movement and actions throughout each session that allows therapists to track participant performance and improvement across therapy sessions.

The device is not supplied sterile or intended to be sterilized by the operator prior to use, and is not intended for single use.

Indications for Use: The Recovr Rehabilitation System is software for use with the Microsoft Kinect motion tracking system that is indicated to support physical rehabilitation of adults in the clinic and at home via performance of therapistassigned reach exercises for the upper extremities. Patient assessment, exercise quidance, and approval by the medical professional are required prior to use.

> The Indications for Use statement for RRS is not identical to the predicate device in that the Indications for Use for the subject device do not include "remotely accessible patient performance metrics for the medical professional" at this time. That minor difference does not affect the intended use of the subject device as a software system utilizing optical position recording for physical rehabilitation exercises nor do they affect the safety and effectiveness of the device relative to the predicate when used as labeled.

Comparison to The RRS and the predicate Jintronix Rehabilitation Predicate Device: System (JRS) are substantially equivalent in terms of intended use and performance and technology. Both platforms are software systems utilizing optical position recording for physical rehabilitation exercises that use the Microsoft Kinect motion tracking system. Both systems require patient assessment and exercise quidance from a clinical or medical professional prior to any exercise prescription. Both devices track the movements assigned by the clinician, providing audiovisual feedback and graphic representations of the user movement, as well as reporting to the clinician on kinematic parameters like velocity and joint angular changes during movement. The devices are also identical in safety, as they are software platforms for use with the Microsoft Kinect motion tracking system. At this point in time, the subject device does not include remotely accessibly patient performance metrics for the

{5}------------------------------------------------

medical professional, but that does not affect the safety or effectiveness of the device compared to the predicate.

Performance Testing: No mandatory performance standards have been established for this device (Section 514 of the Act). Software testing was conducted to verify performance in accordance with FDA's May 2005 quidance document entitled, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "minor" level of concern, as there is no risk of harm to the user or operator in the case of device failure or latent flaw.

> No biocompatibility, electrical safety and electromagnetic compatibility, animal, or clinical testing was deemed necessary to support the current finding of substantial equivalence to the predicate Jintronix device.

Conclusion: The RRS falls within the generic type of device regulated by the LXJ Product Code (System, Optical Position/Movement Recording). Differences in the design and presentation of the RRS from the predicate device do not affect the safety, effectiveness, or performance of the subject device for its intended use. Software verification and validation demonstrate that the subject device should perform as intended in the specified use conditions. Therefore, the RRS is substantially equivalent to the Jintronix Rehabilitation System.