(28 days)
No
The description focuses on quantitative image analysis and motion tracking, without mentioning AI or ML algorithms. The image processing is described as being performed by human operators.
No
The device is described as a quantitative imaging software application intended for the analysis of motion in medical images to generate a 'motion analysis' report. It does not exert any direct therapeutic action on the patient.
Yes
The KINEGRAPH VMA™ software is intended for the analysis of motion in medical images (particularly musculoskeletal images of the spine) to generate a "motion analysis" report for physicians and clinical professionals, which implies a diagnostic purpose. The system also allows prescribers to configure alerts when user-defined measurement thresholds are exceeded, which directly supports diagnostic interpretation.
No
While the KINEGRAPH VMA™ is described as software, the overall system includes the MOTION NORMALIZER™ device, which is a powered, electromechanical patient handling device. The 510(k) submission covers the integrated system, not just the software component in isolation.
Based on the provided information, the KINEGRAPH VMA™ software is not an In Vitro Diagnostic (IVD) device.
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, tissue) to provide information for the diagnosis, monitoring, or treatment of disease.
- KINEGRAPH VMA™ Function: The KINEGRAPH VMA™ software processes digital image files acquired from a fluoroscope, which is an in vivo imaging modality (imaging within the living body). It analyzes the motion of structures within these images, specifically in the spine.
- No Specimen Analysis: The device does not involve the analysis of any biological specimens taken from the patient.
Therefore, the KINEGRAPH VMA™ software falls under the category of medical imaging software or a medical device that processes imaging data, rather than an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The KINEGRAPH VMA™ software is a quantitative imaging software application intended to be used to process digital image files. It is designed for physicians and clinical professionals who are interested in the analysis of motion in medical images, particularly in musculoskeletal images of the spine. KINEGRAPH VMA™ software permits users to review static and dynamic digital lumbar and cervical spine images acquired with the assistance of the MOTION NORMALIZER™ patient handling and data collection device, which is designed for use by imaging technicians and intended to assist with patient lumbar and cervical bending and data collection during imaging. KINEGRAPH VMA™ software also facilitates quantitative assessment of vertebral motion in digital medical images. Information about the motion of selected objects, such as bone structures, can be generated and presented in the form of a 'motion analysis' report containing graphics, charts, and text.
Product codes
LLZ
Device Description
The subject device consists of the KINEGRAPH VMA™ software that analyzes images from the MOTION NORMALIZER™ on an Off-the-Shelf ("OTS") imaging workstation. The MOTION NORMALIZER patient handling and data collection device is an accessory device to the KINEGRAPH VMA™ software that is used to assist with subject lumbar bending and data collection while images are captured with a standard fluoroscope. The MOTION NORMALIZER is comprised of two powered, electromechanical patient handling devices connected to and controlled by a console-mounted OTS computer running custom software connected to various OTS hardware accessories. The subject system is able to capture and record radiographic image data, as well as data from the patient handling devices, and to output this data into DICOM compatible digital image files for analysis using the KINEGRAPH VMA™ software. Once images have been created, they can be uploaded to online servers using running KINEGRAPH VMA™ software using an internet connected computer. All software operation and data storage that occurs subsequent to uploading occurs via online servers running KINEGARPH VMA software. Image processing operators, who are Ortho Kinematics, Inc. employees, operate the KINEGRAPH VMA™ software to process images and facilitate template placement for the prescriber. Prescriber users are able to access processed image and measurement results via an online account administered by Ortho Kinematics, Inc. Prescriber users are able to configure account settings that enable the prescriber to be alerted any time specific user-defined measurement thresholds are exceeded.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Spine (lumbar and cervical)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physicians and clinical professionals; imaging technicians.
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)
The KINEGRAPH VMA™ software and its accessory device, the MOTION NORMALIZER™ , have been designed and developed in accordance with FDA regulations, including validation and verification testing per FDA recognized standards. In addition, repeatability and accuracy testing was performed for the integrated system. In all instances, the KINEGRAPH VMA ™ software and its accessory device, the MOTION NORMALIZER ™, functioned as intended.
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
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
0
K133875
Page 1 of 5
JAN 1 7 2014
510(k) SUMMARY
ORTHO KINEMATICS, INC.
INTEGRATED SYSTEM COMPRISED OF THE KINEGRAPH VMA™ (VERTEBRAL MOTION ANALYZER) SOFTWARE AND ITS ACCESSORY DEVICE, THE MOTION NORMALIZER IMAGE™ PATIENT HANDLING AND DATA COLLECTION DEVICE (VERSION 2.2)
| SUBMITTED BY | John Smith, M.D, J.D.
Hogan Lovells US LLP
555 13th Street, NW
Washington, DC 20004 | |
|---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|
| CONTACT PERSON | Primary:
John Smith, M.D, J.D.
Partner
Hogan Lovells US LLP
Phone: (202) 637-5600
Fax: (202) 637-5910 | Alternate:
Adam Deitz
Chief Technology Officer
Ortho Kinematics
Phone: (415) 699-1736
Fax: (512) 334-5500 |
| DATE PREPARED | December 20, 2013 | |
| DEVICE PROPRIETARY NAME | The integral system comprised of:
- the KINEGRAPH VMA™ (VERTEBRAL MOTION
ANALYZER) software (version 2.0), and its accessory
device, - the MOTION NORMALIZER™ patient handling and data
collection device (version 2.0) | |
| DEVICE COMMON NAME | The VMA system; the MOTION NORMALIZER device | |
| CLASSIFICATION NAME /
PRODUCT CODE | System, Image Processing, Radiological / LLZ | |
| DEVICE CLASS | Class II | |
| REGULATION NUMBER | 21 C.F.R. 892.2050 | |
| PREDICATE DEVICE | Version 2.0 of the VMA system (K130743) | |
| | | |
PURPOSE OF THE SPECIAL 510K NOTICE
Version 2.2 of the VMA system is a modification to version 2.0 of the system, which was the originally cleared version.
7004 Bee Caves Road Building Three, Suite 315 Austin, Texas 78746 Fax: (512) 334-5500 Ortho Kinematics
Page 110 of 120 Phone: (512) 334-5490
1
INTENDED USE
The KINEGRAPH VMA™ software is a quantitative imaging software application intended to be used to process digital image files. It is designed for physicians and clinical professionals who are interested in the analysis of motion in medical images, particularly in musculoskeletal images of the spine. KINEGRAPH VMA™ software permits users to review static and dynamic digital lumbar and cervical spine images acquired with the assistance of the MOTION NORMALIZER™ patient handling and data collection device, which is designed for use by imaging technicians and intended to assist with patient lumbar and cervical bending and data collection during imaging. KINEGRAPH VMA™ software also facilitates quantitative assessment of vertebral motion in digital medical images. Information about the motion of selected objects, such as bone structures, can be generated and presented in the form of a 'motion analysis' report containing graphics, charts, and text.
TECHNOLOGICAL CHARACTERISTICS
The subject device consists of the KINEGRAPH VMA™ software that analyzes images from · the MOTION NORMALIZER™ on an Off-the-Shelf ("OTS") imaging workstation. The MOTION NORMALIZER patient handling and data collection device is an accessory device to the KINEGRAPH VMA™ software that is used to assist with subject lumbar bending and data collection while images are captured with a standard fluoroscope. The MOTION NORMALIZER is comprised of two powered, electromechanical patient handling devices connected to and controlled by a console-mounted OTS computer running custom software connected to various OTS hardware accessories. The subject system is able to capture and record radiographic image data, as well as data from the patient handling devices, and to output this data into DICOM compatible digital image files for analysis using the KINEGRAPH VMA™ software. Once images have been created, they can be uploaded to online servers using running KINEGRAPH VMA™ software using an internet connected computer. All software operation and data storage that occurs subsequent to uploading occurs via online servers running KINEGARPH VMA software. Image processing operators, who are Ortho Kinematics, Inc. employees, operate the KINEGRAPH VMA™ software to process images and facilitate template placement for the prescriber. Prescriber users are able to access processed image and measurement results via an online account administered by Ortho Kinematics, Inc. Prescriber users are able to configure account settings that enable the prescriber to be alerted any time specific user-defined measurement thresholds are exceeded.
PERFORMANCE DATA
The KINEGRAPH VMA™ software and its accessory device, the MOTION NORMALIZER™ , have been designed and developed in accordance with FDA regulations, including validation and verification testing per FDA recognized standards. In addition, repeatability and accuracy testing was performed for the integrated system. In all instances, the KINEGRAPH VMA ™ software and its accessory device, the MOTION NORMALIZER ™, functioned as intended.
7004 Bee Caves Road Building Three, Suite 315 Austin, Texas 78746 Fax: (512) 334-5500 Ortho Kinematics
Page 111 of 120 Phone: (512) 334-5490
2
SUBSTANTIAL EQUIVALENCE
The KINEGRAPH VMA™ software and its accessory device, the MOTION NORMALIZER™, has the same intended use and indications for use, technological characteristics, and principles of operation as the identified predicate device. The minor technological differences between the KINEGRAPH VMA™ software and its accessory device, the MOTION NORMALIZER™ , and the predicate device raise no new issues of safety or effectiveness. Validation and verification data (including software validation) demonstrate that the subject device functions as intended, and performs functions substantially equivalent to the predicate device.
| | KineGraph VMA™ System v2.2
(subject device) | KineGraph VMA™ System v2.0
(K130743, the cleared device) |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification Name | System, Image Processing, Radiological | System, Image Processing, Radiological |
| Product Code | LLZ | LLZ |
| | KineGraph VMA™ System v2.2
(subject device) | KineGraph VMA™ System v2.0
(K130743, the cleared device) |
| Indications for
Use | The KINEGRAPH VMA™ software is a
quantitative imaging software
application intended to be used to
process digital image files. It is
designed for physicians and clinical
professionals who are interested in the
analysis of motion in medical images,
particularly in musculoskeletal images
of the spine. KINEGRAPH VMA™
software permits users to review static
and dynamic digital lumbar and cervical
spine images acquired with the
assistance of the MOTION
NORMALIZER™ patient handling and
data collection device, which is
designed for use by imaging
technicians and intended to assist with
patient lumbar and cervical bending
and data collection during imaging.
KINEGRAPH VMA™ software also
facilitates quantitative assessment of
vertebral motion in digital medical
images. Information about the motion
of selected objects, such as bone
structures, can be generated and
presented in the form of a 'motion
analysis' report containing graphics,
charts, and text. | The KINEGRAPH VMA™ software is a
quantitative imaging software
application intended to be used to
process digital image files. It is
designed for physicians and clinical
professionals who are interested in the
analysis of motion in medical images,
particularly in musculoskeletal images
of the spine. KINEGRAPH VMA ™
software permits users to review static
and dynamic digital lumbar and cervical
spine images acquired with the
assistance of the MOTION
NORMALIZER™ patient handling and
data collection device, which is
designed for use by imaging technicians
and intended to assist with patient
lumbar and cervical bending and data
collection during imaging. KINEGRAPH
VMA™ software also facilitates
quantitative assessment of vertebral
motion in digital medical images.
Information about the motion of
selected objects, such as bone
structures, can be generated and
presented in the form of a 'motion
analysis' report containing graphics,
charts, and text. |
| Technological
Characteristics
/ Functionality | • Lumbar, cervical intervertebral motion
measurements
• Lumbar, cervical device assisted
bending | • Lumbar, cervical intervertebral motion
measurements
• Lumbar, cervical device assisted
bending |
| Principles of
Operation | • Produce digital imaging output files
with the use of the MOTION
NORMALIZER device in
combination with a standard,
commercially available fluoroscope
and standard radiological procedure
table.
• KineGraph VMA™ Image
Processing software is operated by
Ortho Kinematics, Inc. staff as a
service to facilitate template
placement for prescriber users.
• Transfer output files from the
MOTION NORMALIZER device to | • Produce digital imaging output files
with the use of the MOTION
NORMALIZER device in combination
with a standard, commercially
available fluoroscope and standard
radiological procedure table.
• KineGraph VMA™ Image Processing
software is operated by Ortho
Kinematics, Inc. staff as a service to
facilitate template placement for
prescriber users.
• Transfer output files from the
MOTION NORMALIZER device to |
| KineGraph VMA™ System v2.2
(subject device) | KineGraph VMA™ System v2.0
(K130743, the cleared device) | |
| the company by uploading to a
server using the KineGraph VMA™
DataLink Software. | the Company using removable
media that is shipped to the
Company. | |
| • KineGraph VMA™ Image
processing and Image Review
software, as well as patient results
which have been processed by
Ortho Kinematics, Inc., are available
via any internet connected computer
terminal running installed with
internet browsing software. | • KineGraph VMA™ Image processing
software runs on standard off-the-
shelf image review workstations
installed with certain specific off the
shelf software (Matlab runtime
compiler, Microsoft Excel, others) | |
| • Prescribers can use online user
accounts to store alert preferences,
such that they can be alerted upon
login whenever patient results
exceed the user-defined thresholds. | • Patient results transferred from the
company to the prescriber via
removable media. | |
| | • KineGraph VMA™ Image Review
software runs on standard off-the-
shelf image review workstations
installed with certain specific off the
shelf software (Adobe Flash,
ghostscript, others) | |
| | • No alerting features. | |
7004 Bee Caves Road Building Three, Suite 315 Austin, Texas 78746 Fax: (512) 334-5500 Ortho Kinematics
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3
Ortho Kinematics
7004 Bee Caves Road
Building Three, Suite 315
Austin, Texas 78746 Fax: (512) 334-5500
.
.
·
Page 113 of 120 Phone: (512) 334-5490
・
、
:
4
K133875
Page 5 of 5
7004 Bee Caves Road
Building Three, Suite 315
Austin, Texas 78746 Fux: (512) 334-5500
Ortho Kinematics
・
5
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 17, 2014
Ortho Kinematics, Inc. % John Smith, M.D., J.D. Hogan Lovells US LLP 555 13th Street, NW WASHINGTON DC 20004
Re: K133875
Trade/Device Name: KineGraph VMA™ (Vertebral Motion Analyzer) Software, and the Motion Normalizer™ Patient Handling and Data Collection Device (Version 2.2) Regulation Number: 21 CFR 892,2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: December 20, 2013 Received: December 20, 2013
Dear Dr. Smith:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
6
Page 2-Dr. Smith Section of the Research and Career of the Ca
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/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Smh.7)
for
Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
7
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K133875
Device Name
KINEGRAPH VMA™ (VERTEBRAL MOTION ANALYZER) and MOTION NORMALIZER (version 2.2)
Indications for Use (Describe)
The KineGraph VMA™ sollware is a quantitative imaging software application intended to be used to process digital image files. It is designed for physicians and clinical professionals who are interested in the analysis of motion in in musculoskeletal images of the spine. KineGraph VMA™ software permits users to review static and dynamic digital lumbar and cervical spine images acquired with the assistance of the Motion Normalizer patient handling and data collection device, which is designed for use by imaging technicians and intented to assist with patient lumbar and cara collection during imaging. KineGraph VMA™ software also facilitates quantitative assessment of vertebral motion in digital images. Information about the motion of selected objects, such as bone structures, can be generated in the form of a `motion analysis' report containing graphics, charts. and text.
Type of Use (Select one or both, as applicable)
[X] 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)
Sm.h.f)
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
8
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