THE KINEGRAPH VMA (VERTEBRAL MOTION ANALYZER) SOFTWARE VERSION 2.2, THE MOTION NORMALIZER PATIENT HANDLING AND DATA

Q: Who is the manufacturer of THE KINEGRAPH VMA (VERTEBRAL MOTION ANALYZER) SOFTWARE VERSION 2.2, THE MOTION NORMALIZER PATIENT HANDLING AND DATA?

Ortho Kinematics, Inc. filed the 510(k) submission for THE KINEGRAPH VMA (VERTEBRAL MOTION ANALYZER) SOFTWARE VERSION 2.2, THE MOTION NORMALIZER PATIENT HANDLING AND DATA (K133875).

Q: What is the FDA product code for THE KINEGRAPH VMA (VERTEBRAL MOTION ANALYZER) SOFTWARE VERSION 2.2, THE MOTION NORMALIZER PATIENT HANDLING AND DATA?

LLZ. It is classified under 21 CFR 892.2050 as a Class 2 device in the Radiology panel.

Q: What is the regulatory pathway for THE KINEGRAPH VMA (VERTEBRAL MOTION ANALYZER) SOFTWARE VERSION 2.2, THE MOTION NORMALIZER PATIENT HANDLING AND DATA?

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

Q: What are the predicate devices for THE KINEGRAPH VMA (VERTEBRAL MOTION ANALYZER) SOFTWARE VERSION 2.2, THE MOTION NORMALIZER PATIENT HANDLING AND DATA?

KineGraph VMA System v2.0 (K130743).

Q: Who can help prepare an FDA 510(k) submission like THE KINEGRAPH VMA (VERTEBRAL MOTION ANALYZER) SOFTWARE VERSION 2.2, THE MOTION NORMALIZER PATIENT HANDLING AND DATA?

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.

K133875 · Ortho Kinematics, Inc. · LLZ · Jan 17, 2014 · Radiology

Device Facts

Record ID	K133875
Device Name	THE KINEGRAPH VMA (VERTEBRAL MOTION ANALYZER) SOFTWARE VERSION 2.2, THE MOTION NORMALIZER PATIENT HANDLING AND DATA
Applicant	Ortho Kinematics, Inc.
Product Code	LLZ · Radiology
Decision Date	Jan 17, 2014
Decision	SESE
Submission Type	Special
Regulation	21 CFR 892.2050
Device Class	Class 2

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.

Device Story

System comprises KineGraph VMA software and Motion Normalizer hardware; used for quantitative analysis of spinal motion. Motion Normalizer (electromechanical device) assists patient lumbar/cervical bending during standard fluoroscopic imaging; captures radiographic and motion data. Data uploaded to online servers via internet-connected computer. Ortho Kinematics employees operate software to process images and facilitate template placement. Prescribers access results via online account; can configure alerts for user-defined measurement thresholds. Output includes motion analysis reports with graphics, charts, and text. Benefits include objective assessment of vertebral motion to aid clinical decision-making.

Clinical Evidence

Bench testing only. Repeatability and accuracy testing performed for the integrated system. Software validation and verification conducted per FDA recognized standards. No clinical data presented.

Technological Characteristics

System includes KineGraph VMA software and Motion Normalizer electromechanical hardware. Operates with standard fluoroscope and procedure table. Data output as DICOM files. Connectivity via internet-connected computer to online servers. Software runs on OTS workstations; utilizes custom processing algorithms.

Indications for Use

Indicated for physicians and clinical professionals requiring quantitative analysis of vertebral motion in digital lumbar and cervical spine images. Used in conjunction with the Motion Normalizer device for patient bending and data collection during fluoroscopic imaging.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

KineGraph VMA System v2.0 (K130743)

Related Devices

K130743 — THE KINEGRAPH VMA (VERTEBRAL MOTION ANALYZER) SOFTWARE VERSION 2.0; THE MOTION NORMALIZER PATIENT HANDLING AND DATA COLL · Ortho Kinematics, Inc. · Aug 6, 2013
K172327 — VMA System version 3.0 · Ortho Kinematics, Inc. · Aug 25, 2017
K112109 — THE KINEGRAPH VMA SOFTWARE, THE MOTION NORMALIZER PATIENT HANDLING AND DATA COLLECTION DEVICE · Ortho Kinematics, Inc. · Dec 22, 2011
K092427 — SPINAL GUIDES PACS (PACS MEDICAL IMAGING DISPLAY WORKSTATION) · Albert Davydov Dds PC Professional · Mar 16, 2010
K231668 — Spine CAMP (1.1) · Medical Metrics, Inc. · Jul 7, 2023

Submission Summary (Full Text)

{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 Page 112 of 120 Phone: (512) 334-5490 {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. 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