THE KINEGRAPH VMA (VERTEBRAL MOTION ANALYZER) SOFTWARE VERSION 2.0; THE MOTION NORMALIZER PATIENT HANDLING AND DATA COLL

Q: Who is the manufacturer of THE KINEGRAPH VMA (VERTEBRAL MOTION ANALYZER) SOFTWARE VERSION 2.0; THE MOTION NORMALIZER PATIENT HANDLING AND DATA COLL?

Ortho Kinematics, Inc. filed the 510(k) submission for THE KINEGRAPH VMA (VERTEBRAL MOTION ANALYZER) SOFTWARE VERSION 2.0; THE MOTION NORMALIZER PATIENT HANDLING AND DATA COLL (K130743).

Q: What is the FDA product code for THE KINEGRAPH VMA (VERTEBRAL MOTION ANALYZER) SOFTWARE VERSION 2.0; THE MOTION NORMALIZER PATIENT HANDLING AND DATA COLL?

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 2.0; THE MOTION NORMALIZER PATIENT HANDLING AND DATA COLL?

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

Q: What are the predicate devices for THE KINEGRAPH VMA (VERTEBRAL MOTION ANALYZER) SOFTWARE VERSION 2.0; THE MOTION NORMALIZER PATIENT HANDLING AND DATA COLL?

KineGraph VMA System v1.1 (K112109); KIMAX OMA Radiological Image Processing System (K022585); Steris 5085 SRT (K090136).

Q: Who can help prepare an FDA 510(k) submission like THE KINEGRAPH VMA (VERTEBRAL MOTION ANALYZER) SOFTWARE VERSION 2.0; THE MOTION NORMALIZER PATIENT HANDLING AND DATA COLL?

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.

K130743 · Ortho Kinematics, Inc. · LLZ · Aug 6, 2013 · Radiology

Device Facts

Record ID	K130743
Device Name	THE KINEGRAPH VMA (VERTEBRAL MOTION ANALYZER) SOFTWARE VERSION 2.0; THE MOTION NORMALIZER PATIENT HANDLING AND DATA COLL
Applicant	Ortho Kinematics, Inc.
Product Code	LLZ · Radiology
Decision Date	Aug 6, 2013
Decision	SESE
Submission Type	Traditional
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 patient handling device; used by imaging technicians to assist patient lumbar/cervical bending during fluoroscopic image capture. System records radiographic image data and patient handling data; outputs DICOM-compatible files. Software processes digital images to perform quantitative assessment of vertebral motion; generates motion analysis reports with graphics, charts, and text for physician review. Clinical utility includes objective assessment of spinal motion to aid clinical decision-making; benefits include standardized, repeatable measurements of intervertebral translation.

Clinical Evidence

Bench and clinical testing performed. Accuracy and repeatability studies for lumbar measurements (from K112109) were re-run; new accuracy and repeatability testing performed for cervical measurements and intervertebral translation in millimeters. Results confirmed performance met specifications and was equivalent to predicate devices.

Technological Characteristics

System consists of software on OTS imaging workstation and electromechanical patient handling device. Connectivity via DICOM. Complies with IEC 60601-1, 60601-1-2, 60601-1-4, 60601-2-32, and NEMA PS 3.1-3.18 standards.

Indications for Use

Indicated for physicians and clinical professionals requiring quantitative motion analysis of musculoskeletal spine images (lumbar and cervical). 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 v1.1 (K112109)
KIMAX OMA Radiological Image Processing System (K022585)
Steris 5085 SRT (K090136)

Related Devices

K133875 — THE KINEGRAPH VMA (VERTEBRAL MOTION ANALYZER) SOFTWARE VERSION 2.2, THE MOTION NORMALIZER PATIENT HANDLING AND DATA · Ortho Kinematics, Inc. · Jan 17, 2014
K112109 — THE KINEGRAPH VMA SOFTWARE, THE MOTION NORMALIZER PATIENT HANDLING AND DATA COLLECTION DEVICE · Ortho Kinematics, Inc. · Dec 22, 2011
K172327 — VMA System version 3.0 · Ortho Kinematics, Inc. · Aug 25, 2017
K113344 — STEREOS WORKSTATION · Eos Imaging · Nov 16, 2012
K092427 — SPINAL GUIDES PACS (PACS MEDICAL IMAGING DISPLAY WORKSTATION) · Albert Davydov Dds PC Professional · Mar 16, 2010

Submission Summary (Full Text)

{0}------------------------------------------------ ### 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 2.0) | SUBMITTED BY | Ortho Kinematics, Inc. 7004 Bee Caves Rd., Bldg. 3, Ste. 315 Austin, Texas 78746 | AUG 06 2013 | |---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------| | CONTACT PERSON | Primary: Adam Deitz Chief Technology Officer Ortho Kinematics Phone: (415) 699-1736 Fax: (512) 334-5500 | Alternate: Paul Gunnoe CEO Ortho Kinematics Phone: (205) 229-9328 Fax: (512) 334-5490 | | DATE PREPARED | July 31, 2013 | | | 510(K) NUMBER | K130743 | | | CLASSIFICATION NAME / PRODUCT CODE | System, Image Processing, Radiological / LLZ | | | DEVICE CLASS | Class II | | | REGULATION NUMBER | 21 C.F.R. 892.2050 | | | 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) | | #### PREDICATE DEVICE Ortho Kinematics, Inc. is integrated system comprised of the KINEGRAPH VMA™M (VERTEBRAL MOTION ANALYZER) software, and its accessory device, the MOTION NORMALIZER™ patient handling and data collection device (K112109) (version 1.0) {1}------------------------------------------------ Medical Metrics, Inc.'s KIMAX OMA Radiological Image Processing System (K022585) Steris Corporation's Steris 5085 SRT (K090136) ### 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. ### TECHNOLOGICAL CHARACTERISTICS / PRINCIPLES OF OPERATION 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 consolemounted 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. ### PERFORMANCE DATA The KINEGRAPH VMA™ software and its accessory device, the MOTION NORMALIZERTM, have been designed and developed in accordance with FDA regulations. including validation and verification testing per the following FDA recognized standards: - IEC 60601-1: Medical Electrical Equipment- Part 1: General requirements for safety . (including Amendments 1 and 2) (1995). - IEC 60601-1-2: Medical Electrical Equipment Part 1-2: General requirements for . safety - Collateral Standard: Electromagnetic Compatibility - requirements and rests (2007). {2}------------------------------------------------ - IEC60601-1-4: Medical Electrical Equipment. Part 1: General requirements for . safety. Part 1-4: Collateral Standard: Programmable electrical medical systems (2000). - IEC60601-2-32: Medical Electrical Equipment. Part 2: Particular requirements for . the safety of associated equipment of X-ray equipment (1994). - NEMA PS 3.1 3.18: Digital Imaging and Communications in Medicine (DICOM) . Set (2009). In addition, the company performed a complete validation for the modified KineGraph VMA software version 2.0. Each element of the Software Requirements Specifications (SWRS) was tested and found to meet the requirements. Finally, comparable performance and safety of the subject device to the current standard of care and/or predicate devices were verified via bench and clinical testing. Specifically: - The accuracy and repeatability studies included in the submission of the previously-. cleared version of the KineGraph VMA System (K112109) for lumbar measurements were re-run with the modified device. - Accuracy and repeatability testing was performed for the new cervical measurements. . - . Accuracy and repeatability testing on the new function to produce measurements of intervertebral translation in millimeter units was performed. The modified KINEGRAPH VMA™ software and its accessory device, the MOTION NORMALIZER™. performed according to specifications. and equivalently to the previously-cleared device, in all bench and clinical tests, # 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 devices. The minor technological differences between the KINEGRAPH VMA™ software and its accessory device, the MOTION NORMALIZER™, and the predicate devices 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 devices. | | KineGraph VMA System v2.0 (subject device) | KineGraph VMA System v1.1 (K112109) | KIMAX QMA (K022585) | Steris 5085 SRT (K090136) | |-----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Classification Name | System, Image Processing, Radiological | System, Image Processing, Radiological | System, Image Processing, Radiological | Operating Room, Powered Table | | Product Code | LLZ | LLZ | LLZ | FQO | | Indications for | The KINEGRAPH | The KINEGRAPH | KIMAX QMA is a | The STERIS 5085 | | | KineGraph VMA System v2.0 (subject device) | KineGraph VMA System v1.1 (K112109) | KIMAX QMA (K022585) | Steris 5085 SRT (K090136) | | Use | VMATM 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 VMATM software permits users to review static and dynamic digital lumbar and cervical spine images acquired with the assistance of the MOTION NORMALIZERTM 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 VMATM software also facilitates quantitative assessment of vertebral motion in digital medical images. Information about the motion of selected objects, such as bone | VMATM 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 VMATM software permits users to review static and dynamic digital lumbar spine images acquired with the assistance of the MOTION NORMALIZERTM patient handling and data collection device, which is designed for use by imaging technicians and intended to assist with patient lumbar bending and data collection during imaging. KINEGRAPH VMATM 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. | quantitative imaging software application. It is designed for physicians and clinical professionals who are interested in the analysis of motion in medical images, particularly in musculoskeletal images. KIMAX QMA permits users to review static and dynamic digital images acquired from a variety of radiographic sources. It also facilitates quantitative assessment of motion in radiographic 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, texts. | SRT is a general surgical table with high patient weight capacity, extended width capability, and lower minimal table top elevation. The STERIS 5085 SRT accommodates all general surgical procedures including but not limited to, cardiac and vascular, endoscopic, gynecology, urology, nephrectomy, neurology, ophthalmologic, orthopedics and other procedures requiring intraoperative fluoroscopic C-arm imaging and also supports laparoscopic surgical technique for the largest surgical patients. The STERIS 5085 SRT enables patient transport on hard level surfaces within the surgical suite (from pre- operative areas to the operating room and again from the operating room to post operative recovery). | | | KineGraph VMA System v2.0 (subject device) | KineGraph VMA System v1.1 (K112109) | KIMAX QMA (K022585) | Steris 5085 SRT (K090136) | | | 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 intervertebral motion measurements • Lumbar device assisted bending | • Cervical inter- vertebral motion measurements • Calibration of images to create measurements of intervertebral translation in millimeter units | • Cervical device assisted bending | | Principles of Operation | | • Same measurements with similar level of measurement accuracy and repeatability • Assists patients through a similar range of lumbar bending | • Same measurements with similar level of measurement accuracy and repeatability | • Assists patients through a similar range of cervical bending | {3}------------------------------------------------ . . {4}------------------------------------------------ ・ · : : {5}------------------------------------------------ Image /page/5/Picture/0 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 a stylized symbol that resembles a bird or a human figure with outstretched arms. #### DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 August 6, 2013 ORTHO KINEMATICS, INC. C/O JOHN J SMITH PARTNER 555 13TH STREET NW WASHINGTON DC 20005-3096 Re: K130743 Trade/Device Name: Kinegraph VMA (Vertebral Motion Analyzer) Software Version 2.0: Motion Normalizer Patient Handling and Data Collection Version 2.0 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: July 08, 2013 Received: July 08, 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 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, 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}------------------------------------------------ #### Indications for Use 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ #### KINEGRAPH VMA™ (VERTEBRAL MOTION ANALYZER) Device Name: software and its accessory, the MOTION NORMALIZER™ patient handling and data collection device (version 2.0) 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 in the form of a 'motion analysis' report containing graphics, charts, and text. Prescription Use × (Part 21 CFR 801 Subpart D) Over-The-Counter Use AND/OR (21 CFR 801 Subpart C) ### (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of Center for Devices and Radiological Health (CDRH) Smh.7) 510(k) K130743 Page I of