(339 days)
Not Found
No
The summary describes a system for motion tracking and performance monitoring using a Microsoft Kinect, but there is no mention of AI or ML being used for analysis, interpretation, or decision-making. The system appears to be based on direct motion sensing and data reporting.
Yes
Explanation: The device is intended to support the physical rehabilitation of adults in a clinical or home setting by providing rehabilitation exercises for the upper extremity and trunk, along with audio-visual feedback and graphic movement representations. It also enables medical professionals to monitor patient performance and assign or modify rehabilitation exercises, which directly contributes to therapy.
No
Explanation: The device is described as a software system for physical rehabilitation, providing exercises and performance metrics. While it tracks motion and provides data, its primary purpose is rehabilitation support and monitoring, not diagnosing medical conditions.
No
The device description explicitly states that the software is to be used with the Microsoft Kinect motion sensing technology, indicating a dependency on external hardware for its core functionality (motion tracking). While the device itself is software, it is not a standalone software-only medical device as it requires specific hardware to operate 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: This device uses optical motion sensing technology (Microsoft Kinect) to track the movement of a patient's body (upper extremity and trunk) during physical rehabilitation exercises. It provides feedback to the patient and performance metrics to the medical professional.
- Lack of Specimen Analysis: The device does not involve the collection, preparation, or analysis of any biological specimens from the patient. It directly interacts with and measures the patient's physical movements.
- Intended Use: The intended use is to support physical rehabilitation, not to diagnose, treat, or prevent disease through the analysis of biological samples.
The device falls under the category of a medical device, specifically one used for physical therapy and rehabilitation, but it does not meet the criteria for an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
A software system used with the Microsoft Kinect intended to support the physical rehabilitation of adults in the clinic/ at home. The system includes rehabilitation exercises for the upper extremity and trunk 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.
Product codes
LXJ
Device Description
The device or software comprises of a client application called JRS Wave and a web application or portal called JRS Portal. The JRS is to be used with the Microsoft Kinect motion sensing technology. JRS Wave includes medically recognized gaming exercises for rehabilitation, audio-visual feedback & graphic movement representations for patients. Using the Microsoft Kinect for Windows to track motion, JRS Wave records performance metrics providing them to qualified medical professionals via JRS Portal. Medical professionals can monitor patient performance, assign or modify rehabilitation exercises in JRS Wave for their patients through the JRS Portal allowing for patients to perform their prescribed rehabilitation program even from the comfort of their home.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
optical motion capture
Anatomical Site
upper extremity and trunk
Indicated Patient Age Range
Adults
Intended User / Care Setting
medical professional / clinic/ 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 conducted in Canada to study the movements recorded by the JRS and verify that they were rehabilitation movements. The clinical study involved a video recording of 20 healthy adult subjects, men and women of various ages that were required to perform the customized JRS rehabilitation program developed in consultation with clinicians. The video recording meant for clinician assessment focused on the subject and excluded the software and hardware involved, thereby eliminating potential clinician distraction and bias that may have occurred if the clinician liked the software seen in the video. The video was edited to remove unnecessary time gaps between JRS exercises and split into 4 videos for assessment by 4 clinicians (physical and occupational therapists). All raw and edited video footage were backed up and stored on a secure remote server. The 4 videos were uploaded to the web for clinicians to access through a private URL. Each clinician accessed one video and completed 50 online questionnaires (10 activity components per subject x 5 subjects). Each questionnaire asked clinicians:
- To select the movement(s) seen in the video from a list of all JRS supported rehabilitation movements
- Identify any potential risks for their patients posed by the movements seen in the video and
- Whether they would recommend the movement seen in the video to their patients.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical Study.
Sample Size: 20 healthy adult subjects, 4 clinicians.
Key Results: The clinical study results were predominantly 100% exceeding the 80% acceptance criterion for all JRS activity movements demonstrating that the JRS movements are clinician recognized rehabilitation movements and validating the accuracy of the JRS in data processing. The use of JRS movements in the rehabilitation of the intended patient populations have been supported by scientific literature and clinical guidelines.
As part of study, clinicians identified the following potential risks, their corresponding vulnerable patient populations and mitigation options (Table 2). As a result, Jintronix has updated labeling accordingly (section 15 Proposed Labeling).
- Falls: Vulnerable Patient Population(s): Balance Deficits. % Clinicians' responses [n=200]: 24.5%. Mitigation option(s) for clinicians: Modify JRS rehabilitation program to reduce movement range, Clinician intervention prior to JRS use, Clinician advises non use of sitting balance, standing and pop clap activities of JRS.
- Shoulder Pain / Impingement: Vulnerable Patient Population(s): Geriatric. % Clinicians' responses [n=200]: 21%. Mitigation option(s) for clinicians: Clinician intervention prior to JRS use.
- Back Pain: Vulnerable Patient Population(s): Patients with back injuries. % Clinicians' responses [n=200]: 2.5%.
- Knee Injury: Vulnerable Patient Population(s): Geriatric, Patients with knee injury / surgery. % Clinicians' responses [n=200]: 5%. Mitigation option(s) for clinicians: Modify JRS rehabilitation program to reduce movement range, number of movement repetitions, Clinician intervention prior to JRS use, Clinician advises non use of standing activity of JRS.
Clinicians Recommendation of JRS Movements: 88% Fully recommended, 8.5% Recommendation depends on patient ability, 3.5% Not recommended without clinician intervention.
No adverse effects were reported as expected by study subjects.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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
K130847
Image /page/0/Picture/2 description: The image shows the logo for Jintronix. The logo consists of a square with rounded corners, inside of which are several smaller squares arranged in a pattern. Below the square is the word "JINTRONIX" in a bold, sans-serif font.
JINTRONIX REHABILITATION SYSTEM (JRS) TRADITIONAL 510(k)
7. 510(k) Summary
7.1 Owner Information
| Name: | Jintronix Inc. |
|---|---|
| Device common name: | Jintronix Rehabilitation System (JRS) |
| Address: | 999 3rd Avenue, Suite 3400, Seattle, WA 98104 |
| Phone: | 1-514-754-6688 |
| Fax: | None |
| Contact: | Mark Evin |
| Title: | Regulatory Affairs & Quality Assurance Head (RAQA) |
| Email: | mark@jintronix.com |
| Date of Preparation: | Jun 03, 2013 |
7.2 Regulatory Correspondent Information
| Name: | AxSource Consulting Inc. |
|---|---|
| Address: | 336 Bronte Street South, Suite 224-225 Milton, Ontario, L9T 7W6 |
| Office Phone: | 905-854-6059 |
| Cell: | 416-452-0100 |
| Contact Person: | Ms. Navneet Sekhon, President |
| Contact Person: | Rachelle D'Souza, Regulatory Affairs Consultant |
| Email: | nav.sekhon@axsource.ca |
| rachelle@axsource.ca |
7.3 Device Information
| Trade Name | Jintronix Rehabilitation System (JRS) | ||
|---|---|---|---|
| Common Name | software system utilizing optical position recording for rehabilitation | ||
| exercises | |||
| Classification | System, optical position/movement recording | ||
| name | |||
| Model Number | Version 1.0 | ||
| 510(k) Submitter / | Jintronix Inc. | ||
| Holder | |||
| 510(k) Number | K130847 | ||
| Device Panel | Physical Medicine | ||
| Product Code | LXJ | ||
| Classification | None. | ||
| Regulation | Reason: JRS is substantially equivalent to predicates in product code | ||
| LXJ. The product code is 'unclassified' in FDA's product classification | |||
| database with the reason being 'pre-amendment'. Refer to URL: | |||
| http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification. | |||
| cfm?ID=4731 |
The device or software comprises of a client application called JRS Wave and a web application or portal called JRS Portal. The JRS is to be used with the Microsoft Kinect motion sensing technology.
JRS Wave includes medically recognized gaming exercises for rehabilitation, audio-visual feedback & graphic movement representations for patients. Using the Microsoft Kinect for Windows to track motion, JRS Wave records performance metrics providing them to qualified medical
1
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professionals via JRS Portal. Medical professionals can monitor patient performance, assign or modify rehabilitation exercises in JRS Wave for their patients through the JRS Portal allowing for patients to perform their prescribed rehabilitation program even from the comfort of their home.
| General 510(k)
information | Predicate Device(s)
[510(k) summaries attached - Appendices 5 & 12] | |
|-------------------------------|------------------------------------------------------------------------|---------------------------------|
| Trade Name | Peak Motus Motion Measurement System
| Coda cx1 Motion Analysis System |
| Model Number | unknown | unknown |
| 510(k) Submitter /
Holder | Peak Performance Technologies
Inc. | Charnwood Dynamics Limited |
| 510(k) Number | K030714 | K033514 |
| Device Panel | Physical Medicine | Physical Medicine |
| Product Code | LXJ | LXJ |
7.4 Predicate(s) / Substantially Equivalent Device(s)
7.5 Intended Use
A software system used with the Microsoft Kinect intended to support the physical rehabilitation of adults in the clinic/ at home. The system includes rehabilitation exercises for the upper extremity and trunk 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.
| Differences in indications statements | | Why differences do not
affect safety &
effectiveness of Jintronix
device when used as
labeled |
|----------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| JRS | Predicates | |
| Gaming exercises intended to
elicit medically recognized
rehabilitation exercises from
patients | Do not provide gaming
exercises intended to
elicit medically
recognized rehabilitation
exercises from patients. | All JRS gaming
exercises are medically
recognized (by clinicians
/ medical professionals)
to be physical
rehabilitation exercises.
This is supported by a
clinical study and
scientific references
(refer to Performance –
Clinical section). |
| | | Safety & Effectiveness
were considered in the
device risk hazard
analysis & in the |
2
Image /page/2/Picture/0 description: The image contains a logo for Jintronix. The logo features a stylized graphic above the company name. The graphic consists of interconnected squares, resembling a network or circuit design, enclosed within a rounded square border. The word "JINTRONIX" is printed in a bold, sans-serif font below the graphic.
| | | Performance sections of
the 510(k) package |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Provides audio feedback | Do not provide audio
feedback | Does not impact safety /
effectiveness of JRS |
| Require patient assessment
and exercise guidance from
clinician / medical professional
prior to any exercise
prescription. Exercises
prescribed include original
JRS medically recognized
exercises recommended and
JRS exercises modified /
customized by the medical
professional. | Do not include such
requirement | Extra precaution to
ensure proper movement
technique for home-use
of JRS. This puts the
JRS at an equivalent
level of clinical
supervision as clinician-
directed home based
rehabilitation exercises,
which are widely
recommended by
scientific literature. |
7.6 Comparative Summary of Technological Characteristics
The JRS and predicates are software / hardware systems that share in common an intended use / indications for use, target populations, anatomical sites, location of use and technological characteristics like principle of operation, design and technology used. All the devices are intended for the physical rehabilitation of patients with orthopedic and neurological conditions. All the devices track limb and body motion, however, JRS body motion tracking is limited to the upper extremity and trunk. All the devices provide visual feedback, process and report on kinematic parameters measured like velocity and joint angular change during movement. JRS provides additional safety and convenience of use in being a prescription use device that enables home based rehabilitation exercises with remote medical professional control. JRS and predicates make use of optical motion sensing technology and a computer operating system. JRS and the predicates also neither deliver energy to patients nor pose any issues in terms of electrical, chemical, mechanical, thermal, radiation safety or compatibility. JRS is validated for system compatibility and performance. There were no issues for JRS in relation to human factors as safety, accuracy performance / effectiveness and usability were thoroughly considered.
| | Predicate Device(s)
[510(k) summaries attached] | | Jintronix | JRS and |
|------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | | Rehabilitation
System (JRS) | Predicate(s)
Discussion |
| | Peak Motus
Motion
Measurement
System1 | Coda cx1 Motion
Analysis
System2 | | |
| | Technological Characteristics Comparison | | | |
| | Predicate Device(s) | | Jintronix
Rehabilitation
System (JRS) | JRS and
Predicate(s)
Discussion |
| | [510(k) summaries attached] | | | |
| | Peak Motus
Motion
Measurement
System1 | Coda cx1 Motion
Analysis
System2 | | |
| Principles of
Operation | This system
tracks and
provides visual
feedback of
patient
movement while
reporting on
kinematic
parameters such
as velocity and
joint angles
measured during
movement.1 | Information from
the Coda
website reveals
human
performance
under
professional
supervision. As
there are no
visual movement
cues provided
by the Coda, it is
possible to
assume, from
the location of
use and lab set
up video that the
guiding clinician
tells the patient
what movement
activities to
perform.7, 8
Movements
performed are
tracked,
recorded, and
analyzed by the
Coda2. | The JRS system
allows a medical
professional to
assign
movement
activities to
patients. Like
the Peak Motus1
and the Coda2, 7,
the JRS tracks
upper extremity
and trunk
movement
providing visual
feedback of
patient
movement and
reports on
kinematic
parameters like
velocity and joint
angular changes
during
movement. | No
difference
between
JRS and
predicates. |
| Energy Used /
Delivered | Electrical energy
used by
hardware is
variable due to
various video
input
technologies. No
energy is | Electrical energy
is used by both
CODA units and
by the active
infra-red emitting
markers.6 No
energy is
delivered into
the subject as
there is no | Not applicable
as JRS is a
software
product. The
Kinect for use
with the JRS for
optical motion
capture is
owned and | Not
applicable to
JRS, a
software
product.
Energy used
by external
hardware
(Microsoft |
| | Predicate Device(s) | | Jintronix | JRS and |
| | [510(k) summaries attached] | | Rehabilitation
System (JRS) | Predicate(s)
Discussion |
| | Peak Motus
Motion
Measurement
System¹ | Coda cx1 Motion
Analysis
System² | | |
| | delivered into
the subject. 1 | electrical
connection to
the patient.² | distributed by
Microsoft Inc.
and uses only
12 watts of
energy. No
energy is
delivered into
the subject. | Kinect) has
no negative
impact to
safety. |
| Human Factors | No comment on
human factors in
510(k)
summary.¹
Erroneous
marker / sensor
placement on
patients can
pose safety
hazard in
parametric data
analysis. Multi-
component
system may
pose usability
issues. | No comment on
human factors in
510(k)
summary.²
Erroneous
marker / sensor
placement on
patients can
pose safety
hazard in
parametric data
analysis. Multi-
component
system may
pose usability
issues. | No safety
concern as no
direct contact of
JRS / Kinect with
patients.
External
hardware,
Microsoft Kinect
is a Class I laser
posing no safety
issue.
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
(section 22) and
through software
testing with
appropriate
changes. | Safety,
accuracy,
effectiveness
and usability
have been
considered
thoroughly
by Jintronix. |
| Predicate Device(s) | | Jintronix
Rehabilitation
System (JRS) | JRS and
Predicate(s)
Discussion | |
| [510(k) summaries attached] | | | | |
| Peak Motus
Motion
Measurement
System1 | Coda cx1 Motion
Analysis
System2 | management and
design controls
(section 18). The
JRS also
incorporates
correction of
error in Kinect
motion sensing to
achieve optimal
Kinect accuracy
(section 18.4).
Usability &
Effectiveness
consideration:
JRS was
predominantly
recommended by
medical
professionals for
the physical
rehabilitation of
their patients
(section 22.1,
table 3). | | |
| Design | The system uses
off-the-shelf
video cameras,
sensors, and
computers to
collect, quantify,
and document
human
movement in
two-dimensional
or three-
dimensional
space. It
includes | The technology
includes
components for
capturing three-
dimensional
movements of
patients,
acquiring the
data into a host
PC, analyzing
and processing
the data, and
displaying the | Refer to section
18.3. Like the
predicates, JRS
design also
requires optical
motion sensing
technology and
computer
operating
system with
Windows for
operation. | Similar
design
consideratio
ns employed
by JRS and
predicates. |
| | Predicate Device(s)
[510(k) summaries attached] | Jintronix Rehabilitation System (JRS) | JRS and Predicate(s) Discussion | Coda cx1 Motion Analysis System2 |
| Peak Motus Motion Measurement System1
components for processing the kinematic data, and displaying it graphically.1 | Materials / Technology used | The system comprises of various software and hardware components which are used with a Microsoft Windows computer workstation. Refer to 510(k) summary for details.1 | Codamotion software with following hardware:
• the 'CODA' unit3: the optical capture component
• the active infrared-emitting markers3 mounted on the user's body
• marker drivebox3: required in order to power the markers
• charger tray3
• codamotion hub3: in order to provide power to the CODA unit
• RS422 data cable3 | Jintronix Rehabilitation System (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. |
| Biocompatibility | Not Applicable to JRS and predicates. JRS / Kinect has no direct contact with patient. | | | Materials as indicated. Optical motion sensing technology and computer system common to JRS and predicates. |
The following is a comparison of the technological characteristics between the JRS and those of the predicate devices.
3
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4
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7-5
・
.
5
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.
6
Image /page/6/Picture/0 description: The image contains the word "JINTRONIX" in a bold, sans-serif font. Above the word is a logo that appears to be a stylized representation of interconnected squares or nodes, enclosed within a rectangular border with rounded corners. The logo and text are both in black, set against a white background.
7
Image /page/7/Picture/0 description: The image shows the logo for JINTRONIX. The logo consists of the word "JINTRONIX" in a bold, sans-serif font. Above the word is a square with rounded corners containing a stylized image of connected squares. The logo is simple and modern, and the use of bold font and geometric shapes gives it a strong and recognizable presence.
| | Predicate Device(s)
[510(k) summaries attached] | | Jintronix
Rehabilitation
System (JRS) | JRS and
Predicate(s)
Discussion |
|-----------------------------------------------------------------------------------------|------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Peak Motus
Motion
Measurement
System¹ | Coda cx1 Motion
Analysis
System² | | |
| Compatibility with
the environment
and other devices /
System
Compatibility | The system is
compatible with
Microsoft
Windows.¹ | The system is
compatible with
any standard
desktop or
laptop machine
running
Microsoft
Windows 98,
NT, ME, 2000,
XP. A processor
speed of at least
500MHz is
recommended.
The host PC
must have one
serial port
interface for
each CODA unit;
these can be
RS-232 or RS-
422.⁴ | 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
(see section 17). | JRS is
validated
software. |
| Safety | | | | |
| Electrical safety | No energy is
delivered into
the subject.¹ | No energy is
delivered into
the subject as
the system is
non-invasive
with no electrical
connection to
the user.² Refer
to standards
below. | Not applicable
as JRS is a
software
product. Like
both predicates,
no energy is
delivered into
the subject. Like
both predicates¹
², the JRS is
non-invasive.
The Kinect for
use with JRS is | Not
applicable to
JRS, a
software
product.
Energy used
by external
hardware
(Microsoft
Kinect) has
no negative
impact to
safety. |
8
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| | Predicate Device(s)
[510(k) summaries attached] | | Jintronix
Rehabilitation
System (JRS) | JRS and
Predicate(s)
Discussion |
|-------------------|----------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|---------------------------------------------------------|
| | Peak Motus
Motion
Measurement
System1 | Coda cx1 Motion
Analysis
System2 | | |
| | | | owned and
distributed by
Microsoft Inc.
and uses only
12 watts of
energy. | |
| Mechanical safety | Per the 510(k)
summary, safety
is not an issue.1 | Markers and
their associated
drive boxes are
attached to the
subject being
studied using
medical double
sided adhesive
tape.5 | Not applicable
as JRS is
software. | No issue of
mechanical
safety to
JRS system. |
| | | Codamotion
documentation2,
4,5 does not cite
issues regarding
mechanical
safety. | | |
| Thermal safety | Undisclosed in
510(k)
summary1 but
system
components do
not provide for
thermal safety
concern. | Per the 510(k)
summary2, this
system does not
produce sources
of localized heat
so no thermal
safety hazard
arises. | Not applicable
as JRS is
software. | No issue of
thermal
safety for the
JRS system. |
| Chemical safety | Not applicable.
Software and
hardware
system.1 | Not applicable.
Software and
hardware
system.2 | Not applicable.
Software only. | No
differences |
.
9
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| | Predicate Device(s)
[510(k) summaries attached] | | Jintronix
Rehabilitation | JRS and
Predicate(s) |
|------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------|
| | Peak Motus
Motion
Measurement
System1 | Coda cx1 Motion
Analysis
System2 | System (JRS) | Discussion |
| Radiation safety | Passive sensors
are used. Per
the 510(k)
summary, safety
is not an issue.1 | LED markers
are used4,5. No
ionizing radiation
generated.2 | Microsoft TM
Kinect used with
the JRS emits
infra-red
radiation but
complies with
Class 1 laser
standard. | No adverse
impact to
safety of
patients
using JRS |
| Sterility | JRS and predicates1.2 are non-sterile products. JRS is a software
system that uses Microsoft Kinect and a computer operating system.
Both predicates are software and hardware systems. | | | |
References in SE Discussion
1 FDA 510(k) Database. Peak Motion Measurement System. 510(k) Summary (attached), Retrieved May 1, 2013, from http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=11114
2 FDA 510(k) Database. Coda cx1 Motion Analysis System. 510(k) Summary (attached). Retrieved May 1, 2013, from http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=13571
3 Codamotion website. Hardware Components. Retrieved Mav 16, 2013. from http://www.codamotion.com/product-catalogue/hardware-components.html
4 Codamotion System User Guide .. Retrieved May 19, 2013 .. from http://www.codamotion.com/forum/docs/uploads/Codamotion%20System%20UserGuide-7%20Sept%202011.pdf. 9.
5 Codamotion System User Guide. Retrieved May 19, 2013, fromhttp://www.codamotion.com/forum/docs/uploads/Codamotion%20System%20UserGuide-7%20Sept%202011.pdf. 11.
6 Codamotion website. Technology Overview. Retrieved May 16, 2013, from http://www.codamotion.com/systems/technology-overview.html
7 Codamotion website. Clinical Movement Analysis. Retrieved May 16, 2013, from http://www.codamotion.com/applications/clinical.html
8 Codamotion website. Advantages and Capabilities. Retrieved May 16, 2013, from http://www.codamotion.com/applications/clinical/advantages-and-capabilities.html
10
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* Notation on the Motus 10 web references (3, 4, 5):
The design of the Peak Motus Motion Measurement System approved by CDRH on May 16, 20031 allowed the use of off-the-shelf cameras technologies and was compatible to run on Microsoft Windows. It is in these areas that the system was changed when acquired by Vicon Inc. Beside a name change to Vicon Motus 10, the system was made adaptable to the latest computer operating systems, Windows 7 and 8 and incorporated camera technologies of Contemplas Templo .
The Motus 10 web references # 4 and # 5 concur with the information in the 510(k) summary approved by CDRH1. Only reference # 3 is solely relied on to indicate target patients with orthopedic and neurologic conditions. As the approved 510(k) summary1 lists physical rehabilitation in the indications for use, it is reasonable to assume that the original Peak Motus Motion Measurement System was used for patients with neurologic and orthopedic conditions. Therefore, the changes to the CDRH approved Peak Motus Motion Measurement System does not impact the SE demonstration.
7.7 Predicate Device(s) Non Clinical Summary for Substantial Equivalence Determination
This section is not applicable as no non clinical study for either predicate was used for substantial equivalence determination.
7.8 Clinical Performance Data
Clinical Trial Design
A clinical study was conducted in Canada to study the movements recorded by the JRS and verify that they were rehabilitation movements. The clinical study involved a video recording of 20 healthy adult subjects, men and women of various ages that were required to perform the customized JRS rehabilitation program developed in consultation with clinicians. The video recording meant for clinician assessment focused on the subject and excluded the software and hardware involved, thereby eliminating potential clinician distraction and bias that may have occurred if the clinician liked the software seen in the video. The video was edited to remove unnecessary time gaps between JRS exercises and split into 4 videos for assessment by 4 clinicians (physical and occupational therapists). All raw and edited video footage were backed up and stored on a secure remote server. The 4 videos were uploaded to the web for clinicians to access through a private
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Image /page/11/Picture/0 description: The image shows the logo for Jintronix. The logo consists of a stylized square made up of smaller squares, with the word "JINTRONIX" written in capital letters below it. The logo is black and white and appears to be a company logo.
URL. Each clinician accessed one video and completed 50 online questionnaires (10 activity components per subject x 5 subjects). Each questionnaire asked clinicians
-
- To select the movement(s) seen in the video from a list of all JRS supported rehabilitation movements
-
- Identify any potential risks for their patients posed by the movements seen in the video and
- Whether they would recommend the movement seen in the video to their patients. 3.
Safety & Effectiveness Summary
The clinical study results were predominantly 100% exceeding the 80% acceptance criterion for all JRS activity movements demonstrating that the JRS movements are clinician recognized rehabilitation movements and validating the accuracy of the JRS in data processing. The use of JRS movements in the rehabilitation of the intended patient populations have been supported by scientific literature and clinical guidelines. Please refer to section 22.3 Performance Testing -Clinical.
As part of study, clinicians identified the following potential risks, their corresponding vulnerable patient populations and mitigation options (Table 2). As a result, Jintronix has updated labeling accordingly (section 15 Proposed Labeling).
| Potential
Risk(s) | Vulnerable
Patient
Population(s) | % Clinicians'
responses [n=200
(20 subjects x 10
JRS activity
components)] | Mitigation option(s) for clinicians |
|--------------------------------|--------------------------------------------------------|----------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|
| Falls | Balance Deficits | 24.5% | Modify JRS rehabilitation program to
reduce movement range |
| | | | Clinician intervention prior to JRS
use |
| | | | Clinician advises non use of sitting
balance, standing and pop clap
activities of JRS. |
| Shoulder Pain /
Impingement | Geriatric | 21% | Clinician intervention prior to JRS
use |
| Back Pain | Patients
with
back injuries | 2.5% | |
| Knee Injury | Geriatric
Patients with
knee injury /
surgery | 5% | Modify JRS rehabilitation program to
reduce movement range, number of
movement repetitions |
| | | | Clinician intervention prior to JRS
use |
| | | | Clinician advises non use of
standing activity of JRS |
Table 2: JRS Movements - Potentials Risks, Vulnerable Patient Populations and Mitigation Options
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Feedback from clinicians as to whether they would recommend the JRS movements (demonstrated during the clinical trial) to their patients was reported (Table 3).
Table 3: Clinicians Recommendations of JRS Movements
| % Clinicians responses
[n=200, (20 subjects x
| 10 JRS activity components)] | Clinicians recommendations of JRS movements in videos |
|---|---|
| 88% | Fully recommended |
| 8.5% | Recommendation depends on patient ability |
| 3.5% | Not recommended without clinician intervention |
Adverse Effects
No adverse effects were reported as expected by study subjects.
7.9 Non Clinical & Clinical Conclusions
The Canadian clinical study demonstrates that the JRS movements are medically recognized rehabilitation movements. The study results also validate the accuracy of the JRS in data processing. Scientific literature in section 22.3 Performance Testing - Clinical further supports the use of JRS movements in the rehabilitation of the patient populations in the JRS intended use.
7.10 Other Information
Kinect Precision
Jintronix with McGill university researchers won a grant from the National Sciences and Engineering Research Council of Canada to conduct a study to determine the accuracy of the Kinect. Kinect's accuracy was determined in terms of kinematics over a range of distances between the Kinect and the user. In the study, the Kinect was compared to the Optotrak, a gold standard in motion sensing technology with a reported precision of less than 0.5mm.
Jintronix Compliance to FDA Quality System Regulation (QSR) 21 CFR 820
Jintronix has implemented a quality system in accordance with FDA's Quality System Requlation 21 CFR 820. Standard Operating Procedures relevant to this 510(k) have been referenced herein.
7.11 This summary
- . includes only information that is also covered in the body of the 510(k).
- . does not contain any puffery or unsubstantiated labeling claims.
- does not contain any raw data, i.e., contains only summary data. ●
- . does not contain any trade secret or confidential commercial information.
- does not contain any patient identification information. .
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 28, 2014
Jintronix, Inc. c/o Navneet Sekhon AxSource Consulting, Inc. 336 Bronte Street South, Suite 224-225 Milton, Ontario L9T 7W6 CANADA
Re: K130847
Trade/Device Name: Jintronix Rehabilitation System Regulatory Class: Unclassified Product Code: LXJ Dated: January 22, 2014 Received: January 23, 2014
Dear Mr. Sekhon:
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
15
Page 2 - Navneet Sekhon
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 (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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 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" (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 Small Manufacturers, International and Consumer Assistance 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 L. Peña, Ph.D., M.S. Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
16
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K130847
Device Name Jintronix Rehabilitation System
Indications for Use (Describe)
A software system used with the Microsoft Kined in be used to support the physical rehabilitation of advisio' at home. The system includes rehabilitation exercises for the upper extremity and trunk with audio-visual feedback & graphic movement representations for patients as well accessible patient performance metrics for the medical professional. Patient assessment, 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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Carlos L. Pena -S
FORM FDA 3881 (1/14)
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
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