Who is the manufacturer of JINTRONIX REHABILITATION SYSTEM (JRS)?

Jintronix, Inc. filed the 510(k) submission for JINTRONIX REHABILITATION SYSTEM (JRS) (K130847).

What is the FDA product code for JINTRONIX REHABILITATION SYSTEM (JRS)?

LXJ. It is classified under 21 CFR 890.5360 as a Class 2 device in the Physical Medicine panel.

What is the regulatory pathway for JINTRONIX REHABILITATION SYSTEM (JRS)?

510(k) clearance (submission type: Traditional).

What are the predicate devices for JINTRONIX REHABILITATION SYSTEM (JRS)?

Peak Motus Motion Measurement System (K030714); Coda cx1 Motion Analysis System (K033514).

Who can help prepare an FDA 510(k) submission like JINTRONIX REHABILITATION SYSTEM (JRS)?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

JINTRONIX REHABILITATION SYSTEM (JRS)

K130847 · Jintronix, Inc. · LXJ · Feb 28, 2014 · Physical Medicine

Device Facts

Record ID	K130847
Device Name	JINTRONIX REHABILITATION SYSTEM (JRS)
Applicant	Jintronix, Inc.
Product Code	LXJ · Physical Medicine
Decision Date	Feb 28, 2014
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 890.5360
Device Class	Class 2
Attributes	Therapeutic

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.

Device Story

Jintronix Rehabilitation System (JRS) is a software-based system utilizing Microsoft Kinect motion sensing technology to support physical rehabilitation. System consists of 'JRS Wave' (client application) and 'JRS Portal' (web application). Input: optical motion data captured by Kinect. Processing: software tracks upper extremity and trunk movement; calculates kinematic parameters (velocity, joint angular change); provides audio-visual feedback and graphic representations to patients. Output: performance metrics accessible to clinicians via JRS Portal. Used in clinics or home settings under clinician supervision. Clinicians use output to monitor progress, assign, or modify exercises. Benefits: enables remote monitoring and home-based rehabilitation with clinician oversight; provides objective kinematic data to guide therapy.

Clinical Evidence

Clinical study involved 20 healthy adult subjects performing JRS exercises. Video recordings were assessed by 4 clinicians (physical/occupational therapists) via 200 questionnaires. Primary endpoint: clinician recognition of movements as valid rehabilitation exercises. Results: 100% of movements exceeded the 80% acceptance criterion. 88% of movements were fully recommended by clinicians. No adverse effects reported. Bench testing validated system compatibility and Kinect motion tracking accuracy against Optotrak gold standard.

Technological Characteristics

Software-based system; utilizes Microsoft Kinect for Windows (optical motion sensing). Operates on Microsoft Windows computer workstations. Non-invasive; no energy delivered to patient. Connectivity: networked (web portal for remote access). Validated for system compatibility and kinematic accuracy.

Indications for Use

Indicated for physical rehabilitation of adults with orthopedic and neurological conditions. Requires clinician assessment, exercise guidance, and approval prior to use.

Regulatory Classification

Identification

Measuring exercise equipment consist of manual devices intended for medical purposes, such as to redevelop muscles or restore motion to joints or for use as an adjunct treatment for obesity. These devices also include instrumentation, such as the pulse rate monitor, that provide information used for physical evaluation and physical planning purposes., Examples include a therapeutic exercise bicycle with measuring instrumentation, a manually propelled treadmill with measuring instrumentation, and a rowing machine with measuring instrumentation.

Special Controls

*Classification.* Class II (special controls). The device, when it is a measuring exerciser or an interactive rehabilitation exercise device for prescription use only, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.

Predicate Devices

Peak Motus Motion Measurement System (K030714)
Coda cx1 Motion Analysis System (K033514)

Submission Summary (Full Text)

{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 | | Email | 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}------------------------------------------------ Image /page/1/Picture/0 description: The image shows the logo for Jintronix. The logo consists of the word "JINTRONIX" in a bold, sans-serif font, with a stylized graphic above it. The graphic features a square outline with a collection of black squares of varying sizes arranged inside. 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}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the word "JINTRONIX" in all capital letters. Above the word is a logo that appears to be a series of connected squares. The logo is enclosed in a rounded rectangle. The text is bold and sans-serif. {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for JINTRONIX. The logo consists of a square with rounded corners containing a network-like design of connected squares. Below the square is the company name, "JINTRONIX," in a bold, sans-serif font. 7-5 ・ . {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for Jintronix. The logo consists of a stylized graphic above the word "JINTRONIX". The graphic is a rounded rectangle containing a network of connected squares. The word "JINTRONIX" is written in a bold, sans-serif font. . {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}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the logo for Jintronix. The logo consists of the word "JINTRONIX" in a bold, sans-serif font, with a line above and below the word. Above the word is a graphic of connected squares, resembling a network or circuit diagram. | | 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}------------------------------------------------ Image /page/9/Picture/0 description: The image shows the logo for Jintronix. The logo consists of a square with rounded corners containing a stylized image of connected squares. Below the square is the word "JINTRONIX" in a sans-serif font. The logo is black and white. | | 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}------------------------------------------------ Image /page/10/Picture/0 description: The image contains the logo for Jintronix. The logo consists of a square with rounded corners containing a pattern of connected squares. Below the square is the word "JINTRONIX" in a bold, sans-serif font. #### * 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 {11}------------------------------------------------ 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 - 1. To select the movement(s) seen in the video from a list of all JRS supported rehabilitation movements - 2. 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 {12}------------------------------------------------ Image /page/12/Picture/0 description: The image shows the logo for Jintronix. The logo consists of a square with rounded corners, inside of which is a stylized image of connected squares. Below the square is the word "JINTRONIX" in a bold, sans-serif font. 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. . {13}------------------------------------------------ Image /page/13/Picture/0 description: The image shows the logo for Jintronix. The logo consists of the word "JINTRONIX" in a bold, sans-serif font, with a horizontal line underneath. Above the word is a square containing a stylized image of connected squares, resembling a network or circuit diagram. {14}------------------------------------------------ Image /page/14/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. 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. {17}------------------------------------------------ This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Of…

JINTRONIX REHABILITATION SYSTEM (JRS)

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