(231 days)
No
The summary describes motion tracking and data recording, but does not mention AI or ML algorithms for analysis or interpretation.
Yes.
The device is intended to support the physical rehabilitation of adults, including rehabilitation exercises for the lower and upper extremities, which directly relates to therapy.
No.
The device is intended to support physical rehabilitation by providing exercises, feedback, and tracking patient performance metrics for medical professionals to review. Its functions revolve around exercise guidance, monitoring, and tracking, rather than diagnosing a disease or condition. While it certainly monitors patient performance, this monitoring is for assessing adherence to prescribed exercise and movement, not for diagnosing.
No
The device description explicitly states that the UINCARE HOME software system is "used with the RGB-D Camera" and "utilizes three off-the-shelf accessories: a motion sensing camera, a monitor and a computer". While the core functionality is software, it requires specific hardware components (camera, monitor, computer) to operate as intended for its medical purpose.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- UINCARE's Function: The UINCARE system uses a camera to track the movement of a patient's body during physical rehabilitation exercises. It provides feedback to the patient and performance metrics to the medical professional.
- Lack of Specimen Analysis: The system does not analyze any biological specimens from the patient. Its function is based on external observation and measurement of physical movement.
Therefore, the UINCARE system falls under the category of a medical device used for physical therapy and rehabilitation, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes
LXJ
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
RGB-D Camera
Anatomical Site
lower and upper extremities
Indicated Patient Age Range
adults
Intended User / Care Setting
medical professional; clinic or at home
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)
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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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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.: +82-2-6265-0944
- +82-2-6265-0945 ● 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 gh.kim@dtns.co.kr ●
- . Telephone No.: +82-2-357-8401
- Fax No.: +82-2-357-8027 ●
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 | ||||
| for Use | 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 | 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 | ||||
| therapist-assigned | ||||
| reach exercises for the | ||||
| upper extremities. | ||||
| Patient assessment, | ||||
| exercise guidance, and | 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 | Same | |||
| Proposed Device | Primary Predicate | Reference Predicate | SE note | |
| remotely accessible | ||||
| patient performance | ||||
| metrics for the medical | ||||
| professional. Patient | ||||
| assessment, exercise | ||||
| guidance and approval | ||||
| by the medical | ||||
| professional is required | ||||
| prior to use. | approval by the medical | |||
| professional are | ||||
| required prior to use. | patient performance | |||
| video. Patient | ||||
| assessment, exercise | ||||
| guidance and approval | ||||
| by a medical | ||||
| professional is required | ||||
| prior to use. | ||||
| Operation | ||||
| Mode | Analysis Mode | |||
| Rehabilitation exercise | ||||
| Mode | ||||
| Rehabilitation Game | Analysis Mode | |||
| Rehabilitation exercise | ||||
| Mode | ||||
| Rehabilitation Game | Analysis Mode | |||
| Rehabilitation exercise | ||||
| Mode | ||||
| Rehabilitation Game | Same | |||
| Energy Used/ | ||||
| Delivered | Not applicable as | |||
| UINCARE HOME is a | ||||
| software product | Not applicable as Recovr | |||
| Rehabilitation System is | ||||
| a software product | Not applicable as Vera™ | |||
| is a software product | Same | |||
| Design | UINCARE HOME design | |||
| requires optical motion | ||||
| sensing technology and | ||||
| computer operating | ||||
| system for operation. | Recovr Rehabilitation | |||
| System design requires | ||||
| optical motion sensing | ||||
| technology and | ||||
| computer operating | ||||
| system for operation. | Vera™ design requires | |||
| optical motion sensing | ||||
| technology and | ||||
| computer operating | ||||
| system for operation. | Same | |||
| Application | ||||
| software | Patient Application | |||
| Clinician Application | ||||
| Server Application | Not Known | Patient Application | ||
| Clinician Application | ||||
| Server Application | Same | |||
| Motion- | ||||
| Tracking | ||||
| Technology | Kinect camera | Kinect camera | Kinect camera | Same |
| Operating | ||||
| conditions | Windows | Not Known | Windows | Same |
| Accessories | 1) Monitor |
- Computer
- Microsoft Kinect
Sensor camera | 1) primary display
monitor, secondary
monitor - computer
- Microsoft Kinect
motion-tracking sensor | 1) Monitor with touch
screen - Computer
- Microsoft Kinect
Sensor camera | Same |
| Characteristics | Proposed Device
UINCARE HOME | Primary Predicate,
Recovr Rehabilitation
System, K151446 | Reference Predicate,
Vera™, K150462 | SE note |
| Electrical
Safety | Not applicable as
UINCARE HOME is a
software product | Not applicable as
Recovr Rehabilitation
System is a software
product | Not applicable as
Vera™ is a software
product | Same |
| Mechanical
Safety | Not applicable as
UINCARE HOME is a
software product | Not applicable as
Recovr Rehabilitation
System is a software
product | Not applicable as
Vera™ is a software
product | Same |
| Thermal
Safety | Not applicable as
UINCARE HOME is a
software product | Not applicable as
Recovr Rehabilitation
System is a software
product | Not applicable as
Vera™ is a software
product | Same |
| Chemical
Safety | Not applicable as
UINCARE HOME is a
software product | Not applicable as
Recovr Rehabilitation
System is a software
product | Not applicable as
Vera™ is a software
product | Same |
| Radiation
Safety | Not applicable as
UINCARE HOME is a
software product | Not applicable as
Recovr Rehabilitation
System is a software
product | Not applicable as
Vera™ is a software
product | Same |
| Sterility | Not applicable as
UINCARE HOME is a
software product | Not applicable as
Recovr Rehabilitation
System is a software
product | Not applicable as
Vera™ is a software
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) +82-2-6265-0944, Fax) +82-2-6265-0945
K172882 Page 4/6
7
Ubuincure
A-603, 131, Gasan digital 1-ro, Geumcheon-gu, Seoul, 08506, Republic of Korea Tel) +82-2-6265-0944, Fax) +82-2-6265-0945
K172882 Page 5/6
Table 2. Safety Comparison
Non-Clinical Test Summary
-
- 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.
- Performance Test Range of Motion Assessment Test
-
- 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 Validation
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.