(182 days)
No
The description focuses on motion tracking, data recording, and remote monitoring, without mentioning any AI/ML techniques for analysis, feedback generation, or exercise customization.
Yes
The device is intended to be used for the physical rehabilitation of adults and supports therapeutic exercises, which explicitly indicates a therapeutic purpose.
No
Explanation: The device is described as a software system "to support the physical rehabilitation of adults." While it records performance metrics and allows clinicians to monitor progress, its primary function is to facilitate rehabilitation exercises, not to diagnose a medical condition or provide a diagnostic output. The "Patient assessment, exercise guidance and approval by the medical professional is required prior to use" further indicates that clinical diagnosis occurs independently of this device.
No
The device description explicitly states that the software system is "to be used with the Microsoft Kinect version 2," and the performance study focuses on the accuracy of the Microsoft Kinect v2 hardware. This indicates the device relies on and incorporates a specific hardware component (the Kinect v2) for its intended function, making it a system that includes both software and hardware, not a software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Jintronix Function: Jintronix is a software system that uses optical motion capture (Microsoft Kinect v2) to track a patient's physical movements during rehabilitation exercises. It provides feedback and performance metrics based on these movements.
- Lack of Specimen Analysis: The description clearly states that Jintronix does not involve the analysis of any biological specimens from the patient. It interacts with the patient externally through motion tracking.
Therefore, Jintronix falls under the category of a medical device used for physical rehabilitation, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Jintronix is a software system used with the Microsoft Kinect v2 intended to be used to support the physical rehabilitation of adults in the clinic/ at home. The system includes rehabilitation exercises for the upper extremity, trunk, and lower extremity 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
Jintronix Version 2.0.140905, a software system comprising of a client application and a web application is to be used with the Microsoft Kinect version 2 to support the physical rehabilitation of adults in the clinic/ at home.
Through the client application, the patient engages in their rehabilitation exercises. Using the Microsoft Kinect for Windows, which tracks the patient's upper extremity, trunk, and lower body joint positions as they move, the software provides a graphic representation of the patient's movements, as well as activities that include visual and audio feedback to support the patient in performing therapeutic exercise.
As the patient engages in exercises, the system records performance metrics, such as the speed and precision of their movements. These metrics are then sent to a remote web application.
Clinicians, through a "clinician interface" of the Client application, securely access the remote web application to remotely monitor the progress of their patients, and modify the exercise program through program customizations (for example, difficulty level) based on patients' needs.
Patient assessment, exercise guidance and approval by the medical professional is required prior to use. There is no direct contact with the patient since the device is a software product. No energy is delivered to the subject.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
optical motion capture
Anatomical Site
upper extremity, trunk, and lower extremity
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench Study - Kinect v2 Performance Accuracy / Effectiveness:
Jintronix Inc. commissioned an independent study to determine the performance accuracy of Microsoft Kinect v2, the optical motion capture technology for use with Jintronix. 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 v2 was compared to the Optotrak, a gold standard in motion sensing technology with a reported precision of less than 0.5mm. Kinect v2 performance was compared to that of Kinect v1 and goniometry, the clinical standard for range of motion measurements. The bench study found that Jintronix range of motion (ROM) assessments using the Kinect v2 can be consistently reproduced within an error tolerance that is comparable to intra-rater precision error of goniometry.
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 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.
0
Image /page/0/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 often associated with medicine and healthcare. The caduceus is composed of three abstract human profiles facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 22, 2015
Jintronix Inc. c/o Navneet Sekhon AxSource Consulting Inc. 336 Bronte Street South, Suite 224-225 Milton, Ontario L9T 7W6
Re: K143034
Trade/Device Name: Jintronix Version 2.0 Regulatory Class: Unclassified Product Code: LXJ Dated: March 19, 2015 Received: March 20, 2015
Dear Ms. 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. Isting 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/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 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,
Felipe Aquel -S
Carlos L. Peña, PhD, MS for Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
2
Indications for Use
510(k) Number (if known) K143034
Device Name Jintronix Version 2.0
Indications for Use (Describe)
Jintronix is a software system used with the Microsoft Kinect v2 intended to be used to support the physical rehabilitation of adults in the clinic/ at home. The system includes rehabilitation exercises for the upper extremity, trunk, and lower extremity 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.
| 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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3
JINTRONIX TRADITIONAL 510(k)
7. 510(k) Summary
7.1 Owner Information
| Name: | Jintronix Inc. |
|---|---|
| Device common name: | System, optical position/movement recording |
| 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: | March 13, 2015 |
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 |
| Contact Person: | Ms. Navneet Sekhon, President |
| Email: | nav.sekhon@axsource.ca |
7.3 Device Information
| Trade Name | Jintronix |
|---|---|
| Common Name | System, optical position/movement recording |
| Classification name | System, optical position/movement recording |
| Model Number | Version 2.0.140905 |
| 510(k) Submitter / Holder | Jintronix Inc. |
| Device Panel | Physical Medicine |
| Product Code | LXJ |
| Classification Regulation | Unclassified |
7.4 Predicate(s) / Substantially Equivalent Device(s)
| General
information | 510(k) | Predicate Device(s)
[510(k) summaries attached – Appendices 6 & 7] |
|------------------------|-------------|-----------------------------------------------------------------------|
| Trade Name | Jintronix | Peak Motus Motion
Measurement System |
| Model Number | Version 1.0 | Unknown |
4
Image /page/4/Picture/0 description: The image contains the logo for Jintronix. The logo features a stylized square shape with interconnected blue and green squares inside, resembling a network or circuit board. Below the graphic is the company name, "JINTRONIX," in a bold, sans-serif font, with "JINTRON" in blue and "IX" in green, mirroring the colors used in the square graphic above.
| General
information | 510(k) | Predicate Device(s)
[510(k) summaries attached – Appendices 6 & 7] | |
|---------------------------|-------------------|-----------------------------------------------------------------------|--|
| 510(k) Submitter / Holder | Jintronix Inc. | Peak
Technologies Inc. | |
| 510(k) Number | K130847 | K030714 | |
| Device Panel | Physical Medicine | Physical Medicine | |
| Product Code | LXJ | LXJ | |
7.5 Device Description
Jintronix Version 2.0.140905, a software system comprising of a client application and a web application is to be used with the Microsoft Kinect version 2 to support the physical rehabilitation of adults in the clinic/ at home.
Through the client application, the patient engages in their rehabilitation exercises. Using the Microsoft Kinect for Windows, which tracks the patient's upper extremity, trunk, and lower body joint positions as they move, the software provides a graphic representation of the patient's movements, as well as activities that include visual and audio feedback to support the patient in performing therapeutic exercise.
As the patient engages in exercises, the system records performance metrics, such as the speed and precision of their movements. These metrics are then sent to a remote web application.
Clinicians, through a "clinician interface" of the Client application, securely access the remote web application to remotely monitor the progress of their patients, and modify the exercise program through program customizations (for example, difficulty level) based on patients' needs.
Patient assessment, exercise guidance and approval by the medical professional is required prior to use. There is no direct contact with the patient since the device is a software product. No energy is delivered to the subject.
7.6 Indications for Use
Jintronix is a software system used with the Microsoft Kinect v2 intended to be used to support the physical rehabilitation of adults in the clinic/ at home. The system includes rehabilitation exercises for the upper extremity, trunk, and lower extremity 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.
5
Image /page/5/Picture/0 description: The image contains a logo for a company called Jintronix. The logo features a stylized square shape with rounded corners, filled with a pattern of blue and green squares. Below the square is the company name, "JINTRONIX," written in a bold, sans-serif font, with the "JIN" in blue and the "TRONIX" in green.
| | Predicate Device(s)
[510(k) summaries attached] | | Jintronix
(v2.0.140905) | Jintronix and
Predicate(s)
Discussion |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Jintronix
Rehabilitation
System (JRS) | Peak Motus | | |
| Indications
for Use | A software system
used with the
Microsoft Kinect
intended to be
used 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. 1 | Computer and
video system used
to quantify and
graphically display
human movement
patterns
and techniques for
uses such as
assessment and
training of limb or
body motion in gait
analysis, prosthetic
design, pre/post
rehabilitation
evaluation, physical
therapy, and the
like.2 | A software
system used
with the
Microsoft Kinect
version 2
intended to be
used to support
the physical
rehabilitation of
adults in the
clinic/ at home.
The system
includes
rehabilitation
exercises for the
upper extremity,
trunk, and lower
extremity, 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. | Jintronix shares
the same
indications for
use as the
predicates. All
devices are
intended for
physical
rehabilitation. All
devices include
graphic
movement
representations
and performance
metrics for
assessment.
Like the JRS,
Jintronix is for
clinic/at home
physical
rehabilitation of
the upper
extremity and
trunk.
Like predicate
Peak Motus,
Jintronix is
indicated for
limbs and full
body.
No difference
between
Jintronix and
predicates. |
6
Image /page/6/Picture/0 description: The image contains a logo for Jintronix. The logo features a blue and green square with a network of blue squares inside. Below the square is the word "JINTRONIX" in green, with the letters in a bold, sans-serif font. The logo appears to be for a technology or software company.
1 FDA 510(k) Database. Jintronix Rehabilitation System. 510(k) Summary (attached). Retrieved August 30, 2014, from http://www.accessdata.fda.gov/cdrh_docs/pdf13/[K130847](https://510k.innolitics.com/search/K130847).pdf 2 FDA 510(k) Database. Peak Motus Motion Measurement System. 510(k) Summary (attached). Retrieved September 23, 2014, from http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?lD=11114
7.7 Comparison of Technological Characteristics with Predicate Device(s)
Principles of operation and fundamental design and technology considerations are shared by Jintronix and its predicates.
Specifically, Jintronix and its predicate(s)
- Are software / hardware systems or computer systems using optical capture motion technology 1.
-
- Track movement and provide visual feedback or graphic movement representations
-
- Report on kinematic parameters or provide performance metrics for assessment
-
- Are non-invasive devices and so do not deliver energy to patients
-
- Do not pose any issues in terms of electrical, chemical, thermal or radiation safety
-
- Are non-sterile devices
Jintronix is validated for system compatibility and performance.
The following technological differences exist between Jintronix and its predicates.
-
- Jintronix improves usability with its new design features which include enhanced software user interfaces and a simple range of motion assessment feature desired by clinicians.
-
- Jintronix surpasses predicate JRS in performance. Jintronix uses the Kinect v2 for optical motion capture. The Kinect v2 is more precise over a greater tracking range than Kinect v1 used with predicate JRS.
7.8 Performance Data
7.8.1 Performance Data Summary / Conclusions
Jintronix system performance is validated as suitable for its indications for use surpassing the performance of predicate JRS. With improved performance accuracy, Jintronix has a better safety and effectiveness profile when compared to predicate JRS.
7
Image /page/7/Picture/0 description: The image contains a logo with the word "JINTRONIX" in green, with the top half of the logo containing a blue and green square design. The blue squares are connected to each other, and the green squares are on the top right of the design. The logo is surrounded by a green border.
TRADITIONAL 510(k)
| Jintronix
System | Supporting
Performance Data | Performance Conclusions & SE Comparison
to Predicate(s) |
|------------------------------------------------------|-------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Data Processing
Accuracy | 1. System Validation | 1. Jintronix data processing accuracy verified
by software testing.
2. Clinician feedback. |
| System
Compatibility | System Validation
(software testing) | System compatibility of Jintronix software,
Microsoft Kinect v2 hardware and the
recommended computer operating system in
Jintronix labeling assured by software testing. |
| Kinect
Performance
Accuracy /
Effectiveness | Bench Study | Jintronix surpasses predicate JRS in
performance. Jintronix uses the Kinect v2 (for
optical motion capture) which is more precise
over a greater tracking range than Kinect v1
used with predicate JRS.
Jintronix can be consistently reproduced within
an error tolerance that is comparable to intra-
rater precision error1 of goniometry. Shoulder
range of motion measurements can only be used
to describe a patient's relative change in joint
angle, not absolute joint angle. Shoulder range of
motion measurements have not been validated
in standardized postures associated with
goniometric measurements.
Bench study recommendations for optimal
performance have been incorporated or
accounted for. |
| Kinect Electrical
Safety | Refer to FDA
recognized standard
and test reports for
Class I laser (section
7.8.3 below) | Kinect deemed electrically safe. |
7.8.2 System Validation for System Compatibility & Performance Accuracy
Jintronix system accuracy in data processing was validated by software testing. Jintronix software is of "moderate" level of concern. All potential device hazards have been mitigated through appropriate controls. Jintronix software has been validated with Windows Defender, anti-virus software.
Jintronix conforms partially to the following FDA recognized standards and associated FDA guidance documents.
-
- Medical device software Software life cycle processes AAMI / ANSI / IEC 62304:2006
1 Defined as the degree of agreement among repeated administrations of a diagnostic test performed by a single rater
- Medical device software Software life cycle processes AAMI / ANSI / IEC 62304:2006
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Image /page/8/Picture/0 description: The image contains the logo for Jintronix. The logo features a stylized graphic of interconnected squares in shades of blue and green, enclosed within a rounded rectangular border, also in blue and green. Below the graphic, the word "JINTRONIX" is written in a bold, sans-serif font, with "JINTRON" in blue and "IX" in green.
-
- Guidance on the use of AGILE practices in the development of medical device software AAMI TIR45:2012
-
- Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices - Guidance for Industry and FDA Staff, May 2005
-
- General Principles of Software Validation; Final Guidance for Industry and FDA Staff, January 2002
7.8.3 Electrical Safety
Jintronix is software for use with Microsoft Kinect v2 hardware. The Microsoft Kinect v2 used with Jintronix software is electrically safe. The Kinect for Windows v2 hardware conforms to the International Standard IEC 60825-1:2007:03 for a Class 1 laser product and with 21 CFR 1040.10 & 1040.11 except for deviations pursuant to Laser Notice No. 50, dated June 24, 2007.
7.8.4 Bench Study - Kinect v2 Performance Accuracy / Effectiveness
Jintronix Inc. commissioned an independent study to determine the performance accuracy of Microsoft Kinect v2, the optical motion capture technology for use with Jintronix. 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 v2 was compared to the Optotrak, a gold standard in motion sensing technology with a reported precision of less than 0.5mm. Kinect v2 performance was compared to that of Kinect v1 and goniometry, the clinical standard for range of motion measurements.
The bench study found that Jintronix range of motion (ROM) assessments using the Kinect v2 can be consistently reproduced within an error tolerance that is comparable to intra-rater precision error2 of goniometry.
7.9 Other Information
7.9.1 Jintronix Compliance to FDA Quality System Regulation (QSR) 21 CFR 820
Jintronix has been implemented with appropriate design and change controls per Jintronix Inc.'s quality system which is compliant with FDA's Quality System Regulation 21 CFR 820. Standard Operating Procedures relevant to this 510(k) have been referenced herein.
7.9.2 Jintronix Labeling Controls
Jintronix is a prescription use device and various labeling precaution statements further serve as potential device hazard mitigation controls. This includes requiring an in person patient-exercise suitability assessment prior to Jintronix prescription.
2 Defined as the degree of agreement among repeated administrations of a diagnostic test performed by a single rater
9
7.10 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. .