UINCARE HOME

K172882 · Uincare Corp. · LXJ · May 10, 2018 · Physical Medicine

Device Facts

• Record ID: K172882
• Device Name: UINCARE HOME
• Applicant: Uincare Corp.
• Product Code: LXJ · Physical Medicine
• Decision Date: May 10, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5360
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The UINCARE software system used with the Microsoft Kinect is intended to be used to support the physical rehabilitation of adults in the clinic or at home. The system includes rehabilitation exercises for the lower and upper extremities with audio- visual feedback & graphic movement representations for patients as well as remotely accessible patient performance metrics for the medical professional. exercise guidance and approval by the medical professional is required prior to use.

Device Story

UINCARE HOME is a software system utilizing an off-the-shelf RGB-D (Microsoft Kinect) camera, computer, and monitor to support physical rehabilitation. It consists of three applications: UINCARE Client (patient-facing, monitors/reports exercise performance), UINCARE Manager (clinician-facing, defines therapy plans, monitors patient metrics), and UINCARE Server (cloud-based, facilitates communication and data storage). The system tracks patient movements in 3D space, counts repetitions, and provides real-time audio-visual feedback and graphic representations of exercise performance. Clinicians review performance metrics—including range of motion (ROM) for 25 joints and captured images—to assess adherence and progress. The device is intended for use by adults under the guidance of a medical professional, who prescribes the therapy and approves the exercise plan. It benefits patients by extending clinical expertise to the home environment and providing objective kinematic data for therapy adjustment.

Clinical Evidence

No clinical studies were performed. Substantial equivalence is supported by bench testing (Range of Motion assessment) and software validation. Performance tests confirmed the device meets design specifications and allowable deviations.

Technological Characteristics

Software-based system; utilizes off-the-shelf Microsoft Kinect RGB-D camera, monitor, and computer. Operates on Windows. Provides 3D motion tracking of 25 joints. Connectivity via internet to cloud-based server. Software level of concern: Moderate.

Indications for Use

Indicated for physical rehabilitation of adults 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

• Recovr Rehabilitation System (K151446)
• Vera™ (K150462)

Submission Summary (Full Text)

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

Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue box, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

May 10, 2018

UINCARE Corp. % Geum Hyeon Kim Lead Consultant DT&S Co., Ltd. #1206, Mario Tower, 28, Digital-ro 30-gil Guro-gu, Seoul, 08389 Kr

Re: K172882

Trade/Device Name: UINCARE Home Regulation Number: 21 CFR 890.5360 Regulation Name: Measuring Exercise Equipment Regulatory Class: Class II Product Code: LXJ Dated: April 2, 2018 Received: April 26, 2018

Dear Geum Hyeon Kim:

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

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

requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in 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.

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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Vivek J. Pinto -S

for 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) K172882

Device Name UINCARE HOME

#### Indications for Use (Describe)

The UINCARE software system used with the Microsoft Kinect is intended to be used to support the physical rehabilitation of adults in the clinic or at home. The system includes rehabilitation exercises for the lower and upper extremities with audio- visual feedback & graphic movement representations for patients as well as remotely accessible patient performance metrics for the medical professional. exercise guidance and approval by the medical professional is required prior to use.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> <span style="font-size: 16px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

#### 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}------------------------------------------------

> K172882 Page 1/6

### 510(k) Summary

[As required by 21 CFR 807.92]

#### 1. Date Prepared [21 CFR 807.92(a)(a)]

April.02. 2018

●

### 2. Submitter's Information [21 CFR 807.92(a)[1]]

- Name of Manufacturer: UINCARE Corp.
- Address: A-603, 131, Gasan digital 1-ro, Geumcheon-gu, Seoul, ●
- 08506, Republic of Korea
- Telephone No.: [phone]
- [phone] ● Fax No.:

#### 3. Submission Correspondent

- Name of company: ● DT&S Co., Ltd.
- Address: #1206, Mario Tower, 28, Digital-ro 30-gil, Guro-gu, Seoul,
- 08389, Republic of Korea
- Contact Name: GeumHyeon Kim ●
- Contact Title Lead Consultant
- E-mail Address [e-mail] ●
- . Telephone No.: [phone]
- Fax No.: [phone] ●

#### 3. Trade Name, Regulation Name, Classification [21 CFR 807.92(a)(2)]

| Trade Name | UINCARE HOME |
|-------------------|---------------------------------------------|
| Regulation Number | 21 CFR 890.5360 |
| Regulation Name | Measuring exercise equipment |
| Regulation Class | Class II |
| Product Code | LXJ |
| Product Code Name | System, Optical Position/Movement Recording |

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

> K172882 Page 2/6

### 4. Identification of Predicate Device(s) [21 CFR 807.92(a)(3)]

The identified predicate devices within this submission are shown as follow;

| Contents | Primary Predicate | Reference Predicate |
|-----------------|------------------------------|------------------------------|
| 510(k) Number | K151446 | K150462 |
| Device Name | Recovr Rehabilitation System | Vera™ |
| Applicant | Recovr, Inc. | Reflexion Health, Inc. |
| Regulation Name | Measuring exercise equipment | Measuring exercise equipment |
| Product Code | LXJ | LXJ |
| Device Class | Class II | Class II |

#### 5. Description of the Device [21 CFR 807.92(a)(4)]

The UINCARE HOME software system used with the RGB-D Camera is intended to be used to support the physical rehabilitation of adults in the clinic or at home. The system includes rehabilitation exercises for the lower and upper extremities with audio- visual feedback & graphic movement representations for patients as well as remotely accessible patient performance metrics for the medical professional. Patient assessment, exercise guidance and approval by the medical professional is required prior to use.

The UINCARE HOME 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.

UINCARE HOME software provides medical professionals the tools to record and track movements in threedimensional 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 patient performance metrics can be reviewed by medical professionals to assess exercise movements and adherence to the prescribed exercise. The UINCARE HOME is a software tool that helps extend that expertise.

The UINCARE HOME software has three separate applications.

- (1) UINCARE Client: Patient Application. This application prompts and monitors patients in the 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.
- (2) UINCARE Manager: 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.
- (3) UINCARE Server: Cloud-based Server. It provides to communicate between the UINCARE Client and UINCARE Manager by the internet as well as to deliver and store the patient information, exercise program information and the result of exercise performed by the patient.

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

> K172882 Page 3/6

### 6. Indications for Use [21 CFR 807.92(a)(5)]

The UINCARE software system used with the RGB-D Camera is intended to be used to support the physical rehabilitation of adults in the clinic or at home. The system includes rehabilitation exercises for the lower and upper extremities with audio-visual feedback & graphic movement representations for patients as well as remotely accessible patient performance metrics for the medical professional. Patient assessment, exercise guidance and approval by the medical professional is required prior to use.

#### 7. Determination of Substantial Equivalence

The UINCARE HOME software system is substantially equivalent to legally marketed predicate devices with respect to indications for use and technology characteristics. The proposed device also has similar designs, operation mode, function and accessories with the predicate devices. The Patient Performance Metrics includes continuous ROM tracking graph of major 25 joints and the captured images of patient at designated point of each session. The performance metrics is accessible for the medical professional through the internet. The contents of performance metrics are mostly the same as the reference predicate device, but the UINCARE HOME does include the picture of patient instead of the video. However this is only an additional information to confirm the patient's exercise status. This does not raise of safety or effectiveness. Therefore, the UINCARE HOME software system is substantially equivalent to the predicate device. The below table presents the comparisons for predicate devices:

| | Proposed Device | Primary Predicate | Reference Predicate | SE note |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| K Number | K172882 | K151446 | K150462 | - |
| Model | UINCARE HOME | Recovr Rehabilitation System | Vera™ | - |
| Manufacturer | UINCARE Corp. | Recovr, Inc. | Reflexion Health, Inc. | - |
| Indications<br>for Use | The UINCARE software<br>system used with the<br>RGB-D Camera is<br>intended to be used to<br>support the physical<br>rehabilitation of adults<br>in the clinic or at home.<br>The system includes<br>rehabilitation exercises<br>for the lower and upper<br>extremities with audio-<br>visual feedback &<br>graphic movement<br>representations for<br>patients as well as | The Recovr<br>Rehabilitation System is<br>software for use with<br>the Microsoft Kinect<br>motion tracking system<br>that is indicated to<br>support physical<br>rehabilitation of adults<br>in the clinic and at home<br>via performance of<br>therapist-assigned<br>reach exercises for the<br>upper extremities.<br>Patient assessment,<br>exercise guidance, and | A software system used<br>with the Microsoft<br>Kinect v2 intended to<br>support the physical<br>rehabilitation of adults<br>in the clinic and at<br>home. The system<br>includes rehabilitation<br>exercises for the lower<br>extremity with audio-<br>visual feedback &<br>graphic movement<br>representations for<br>patients as well as<br>remotely accessible | Same |
| | Proposed Device | Primary Predicate | Reference Predicate | SE note |
| | remotely accessible<br>patient performance<br>metrics for the medical<br>professional. Patient<br>assessment, exercise<br>guidance and approval<br>by the medical<br>professional is required<br>prior to use. | approval by the medical<br>professional are<br>required prior to use. | patient performance<br>video. Patient<br>assessment, exercise<br>guidance and approval<br>by a medical<br>professional is required<br>prior to use. | |
| Operation<br>Mode | Analysis Mode<br>Rehabilitation exercise<br>Mode<br>Rehabilitation Game | Analysis Mode<br>Rehabilitation exercise<br>Mode<br>Rehabilitation Game | Analysis Mode<br>Rehabilitation exercise<br>Mode<br>Rehabilitation Game | Same |
| Energy Used/<br>Delivered | Not applicable as<br>UINCARE HOME is a<br>software product | Not applicable as Recovr<br>Rehabilitation System is<br>a software product | Not applicable as Vera™<br>is a software product | Same |
| Design | UINCARE HOME design<br>requires optical motion<br>sensing technology and<br>computer operating<br>system for operation. | Recovr Rehabilitation<br>System design requires<br>optical motion sensing<br>technology and<br>computer operating<br>system for operation. | Vera™ design requires<br>optical motion sensing<br>technology and<br>computer operating<br>system for operation. | Same |
| Application<br>software | Patient Application<br>Clinician Application<br>Server Application | Not Known | Patient Application<br>Clinician Application<br>Server Application | Same |
| Motion-<br>Tracking<br>Technology | Kinect camera | Kinect camera | Kinect camera | Same |
| Operating<br>conditions | Windows | Not Known | Windows | Same |
| Accessories | 1) Monitor<br>2) Computer<br>3) Microsoft Kinect<br>Sensor camera | 1) primary display<br>monitor, secondary<br>monitor<br>2) computer<br>3) Microsoft Kinect<br>motion-tracking sensor | 1) Monitor with touch<br>screen<br>2) Computer<br>3) Microsoft Kinect<br>Sensor camera | Same |
| Characteristics | Proposed Device<br>UINCARE HOME | Primary Predicate,<br>Recovr Rehabilitation<br>System, K151446 | Reference Predicate,<br>Vera™, K150462 | SE note |
| Electrical<br>Safety | Not applicable as<br>UINCARE HOME is a<br>software product | Not applicable as<br>Recovr Rehabilitation<br>System is a software<br>product | Not applicable as<br>Vera™ is a software<br>product | Same |
| Mechanical<br>Safety | Not applicable as<br>UINCARE HOME is a<br>software product | Not applicable as<br>Recovr Rehabilitation<br>System is a software<br>product | Not applicable as<br>Vera™ is a software<br>product | Same |
| Thermal<br>Safety | Not applicable as<br>UINCARE HOME is a<br>software product | Not applicable as<br>Recovr Rehabilitation<br>System is a software<br>product | Not applicable as<br>Vera™ is a software<br>product | Same |
| Chemical<br>Safety | Not applicable as<br>UINCARE HOME is a<br>software product | Not applicable as<br>Recovr Rehabilitation<br>System is a software<br>product | Not applicable as<br>Vera™ is a software<br>product | Same |
| Radiation<br>Safety | Not applicable as<br>UINCARE HOME is a<br>software product | Not applicable as<br>Recovr Rehabilitation<br>System is a software<br>product | Not applicable as<br>Vera™ is a software<br>product | Same |
| Sterility | Not applicable as<br>UINCARE HOME is a<br>software product | Not applicable as<br>Recovr Rehabilitation<br>System is a software<br>product | Not applicable as<br>Vera™ is a software<br>product | Same |

#### Table 1. Technological Characteristics Comparison

{6}------------------------------------------------

# 906 UINCARE

A-603, 131, Gasan digital 1-ro, Geumcheon-gu, Seoul, 08506, Republic of Korea Tel) [phone], Fax) [phone]

> K172882 Page 4/6

{7}------------------------------------------------

## Ubuincure

A-603, 131, Gasan digital 1-ro, Geumcheon-gu, Seoul, 08506, Republic of Korea Tel) [phone], Fax) [phone]

> K172882 Page 5/6

#### Table 2. Safety Comparison

#### Non-Clinical Test Summary

- 1) Performance Test Range of Motion Assessment Test
Performance tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device complies with the allowable deviation.

- 2) Software Validation
UINCARE HOME contains MODERATE level of concern software was designed and developed according to a software development process and was verified and validated.

Software information is provided in accordance with FDA guidance: the content of premarket submissions for software contained in medical devices, issued on May 11, 2005.

{8}------------------------------------------------

> K172882 Page 6/6

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 device.

#### Clinical Test Summary:

No clinical studies were considered necessary and performed.

### 9. Conclusion [21 CFR 807.92(b)(3)]

The UINCARE HOME and the predicate devices are substantially equivalent in terms of intended use and performance, technology and safety. Both platforms are software systems utilizing optical position recording for physical rehabilitation exercises that use the Microsoft Kinect Sensor. Both systems require patient assessment and exercise guidance 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 Sensor.