(249 days)
Not Found
No
The description focuses on motion tracking, video recording, and data processing for review by medical professionals. There is no mention of AI/ML terms, training data for an AI/ML model, or performance metrics typically associated with AI/ML. The "data processing" mentioned appears to be related to identifying motion and counting repetitions based on the optical motion capture, not complex pattern recognition or prediction using AI/ML.
Yes
The device is intended to "support the physical rehabilitation of adults" and "prescribe customized physical therapy plans for patients," which falls under the scope of therapeutic devices. It is used in conjunction with a medical professional and aims to improve a patient's physical condition.
No
The device is described as a software system supporting physical rehabilitation, providing tools for exercise guidance, movement tracking, and performance review by medical professionals, which aligns with therapeutic rather than diagnostic use. While it assesses exercise movements and adherence, its primary purpose is not to diagnose a medical condition.
No
The device description explicitly states that the Vera™ software utilizes three off-the-shelf accessories: a motion sensing camera, a monitor, and a computer. While the core of the device is software, it requires specific hardware components to function as intended.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: The Vera™ software system uses motion sensing and video recording to support physical rehabilitation exercises. It tracks movement, counts repetitions, and allows medical professionals to review performance.
- Lack of Specimen Analysis: The device does not involve the collection, preparation, or analysis of any biological specimens from the patient. Its function is based on external observation of movement.
- Intended Use: The intended use is to support physical rehabilitation, not to diagnose or provide information based on the analysis of bodily fluids or tissues.
Therefore, the Vera™ software system falls outside the scope of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
LXJ
Device Description
-
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. -
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)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Image capture
Anatomical Site
lower extremity
Indicated Patient Age Range
adults
Intended User / Care Setting
physical therapists and physicians (Clinicians); clinic and 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
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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical Study.
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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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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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.
1
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/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 (800) 638-2041 or (301) 796-7100 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
2
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) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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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: | huan@reflexionhealth.com |
| Date of Preparation: | 10/28/15 |
2. Device Information
| Trade Name | Vera™ |
|---|---|
| Common Name | Software system utilizing optical recording for |
| 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.
4
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.
5
6. Comparative Summary of Technological Characteristics
| Characteristics | Predicate, Jintronix
Rehabilitation System,
K130847 | Vera™ | Substantial
Equivalence
Claim |
|-----------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------|
| Principles of
Operation | The JRS allows a medical
professional to assign
movement activities to
patients. | Vera™ allows medical
professionals to assign
movement activities to
patients. | Equivalent |
| | JRS tracks upper extremity
and trunk movement
providing visual feedback of a
patient movement and
reports on kinematic
parameters like velocity and
joint angular changes during
movement. | Vera™ tracks rehabilitation
movements providing visual
feedback of a patient
movement and reports on
kinematic parameters like joint
angular changes during
movement. | |
| Energy Used /
Delivered | Not applicable as JRS is a
software product. | Not applicable as Vera™ is a
software product. | Equivalent |
| Human Factors | No safety concern as no direct
contact of JRS / Kinect with
patients. | No safety concern as no direct
contact of Vera™ / motion
sensing device with patients. | Equivalent |
| | JRS prescription and remote
medical professional
monitoring of patients allows
safe home based
rehabilitation exercises.
JRS has been validated for
accuracy / performance
effectiveness both clinically
and through software testing
with appropriate change
management and design
controls. The JRS also | Vera™ prescription and remote
medical professional
monitoring of patients allows
safe home based rehabilitation
exercises.
Vera™ has been validated for
accuracy / performance
effectiveness both clinically
and through software testing
with appropriate change
management and design
controls. The Vera™ also
incorporates correction of | |
| | incorporates correction of
error in Kinect motion sensing
to achieve optimal Kinect
accuracy. | error in Kinect motion sensing
to achieve optimal Kinect
accuracy. | |
| | Usability & Effectiveness
consideration: JRS was
predominantly recommended
by medical professionals for
the physical rehabilitation of
their patients. | Usability & Effectiveness
consideration: Vera™ was
predominantly recommended
by medical professionals for
the physical rehabilitation of
their patients. | |
| Design | JRS design requires optical
motion sensing technology
and computer operating
system with Windows for
operation. | Vera™ design requires optical
motion sensing technology
and computer operating
system for operation. | Equivalent |
| Materials /
Technology
used | JRS comprises of JRS Wave
(client application software) &
JRS Portal (web portal). The
JRS is to be used with the
Kinect for optical motion
capture and a Microsoft
Windows computer
workstation. | Vera™ System consists of a
Patient Application, Clinician
Application and Server
Application. The Vera™ is to be
used with a motion sensing
device for optical motion
capture and a computer
workstation. | Equivalent |
| Biocompatibility | Not applicable as JRS is a
software product. | Not applicable as Vera™ is a
software product. | Equivalent |
| Compatibility
with the
environment
and other
devices /
System
Compatibility | The compatibility of JRS
software with Kinect
hardware and computer
operating system
requirements have been
validated. Suitable change
management and design
controls have been
implemented. | The compatibility of Vera™
software with Kinect hardware
and computer operating
system requirements have been
validated. Suitable
change management and
design controls have been
implemented. | Equivalent |
| Characteristics | Predicate, Jintronix Rehabilitation System, K130847 | Vera™
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.
8
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
Mitigation |
|----------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1 | The exercise was determined to be
unsafe if the user was using unsafe
accessories such as using a chair with
wheels which could compromise
balance and increase risk of falling or
poor form. | Recommend that clinicians
advise patients on the
appropriate use of ancillary
equipment to promote proper
balance, achieve good form and
avoid risk of falling prior to and
during the use of Vera. |
| 2 | The exercise was deemed unsafe to be
prescribed by a physical therapist for
the patient due to patient's functional
ability, level of impairment, or diagnosis. | Recommend that clinicians
thoroughly evaluate the patient's
functional status and assign a
rehabilitation program most
suitable to the patients functional
ability, level of impairment, and
diagnosis |
| 3 | The exercise was deemed unsafe to be
prescribed by a physical therapist for
the patient due to patient's health
history. | Prior to enrollment of a patient
into a rehabilitation exercise
program and the use of Vera we
recommend that clinicians
conduct and/or review a patient
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.