(153 days)
Not Found
No
The summary describes quantitative image processing and analysis of motion, but there is no mention of AI, ML, or related terms like deep learning or neural networks. The focus is on processing existing digital image files and generating reports based on measured motion.
No.
The device is described as a quantitative imaging software application that processes digital image files for analysis of motion in medical images. It assists with data collection and provides reports, but it does not directly treat or diagnose a disease or condition, which are characteristic functions of a therapeutic device.
No
The KINEGRAPH VMA™ software is described as a "quantitative imaging software application intended to be used to process digital image files" and to "facilitate quantitative assessment of vertebral motion in digital medical images." It generates "motion analysis reports" but there is no explicit mention of diagnosis provided by the device, rather it provides information to physicians for their analysis.
No
While the KINEGRAPH VMA™ is described as software, the submission explicitly states it is part of a system that includes the MOTION NORMALIZER™ device, which is a powered, electromechanical patient handling device with its own hardware and software. The performance studies also evaluate the "integral system," indicating the software is not intended to function as a standalone medical device without the associated hardware.
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, such as blood, urine, or tissue, to provide information about a person's health.
- Device Function: The KINEGRAPH VMA™ software and its accessory, the MOTION NORMALIZER™, are used to process and analyze medical images (specifically fluoroscopic images of the spine) acquired directly from the patient. They do not analyze specimens taken from the patient.
- Intended Use: The intended use is to analyze motion in medical images, particularly musculoskeletal images of the spine, for physicians and clinical professionals. This is a function related to medical imaging analysis, not in vitro testing.
Therefore, the device falls under the category of medical imaging software and related accessories, not In Vitro Diagnostics.
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 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 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 standard fluoroscopes. 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 fluoroscopic 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.
Mentions image processing
System, Image Processing, Radiological
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
fluoroscopes
Anatomical Site
musculoskeletal images of the spine, lumbar spine
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 integral 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
510(k) SUMMARY
DEC 2 2 2011
ORTHO KINEMATICS, INC.
INTEGRAL SYSTEM COMPRISED OF THE KINEGRAPH VMA™ (VERTEBRAL MOTION ANALYZER) SOFTWARE AND ITS ACCESSORY DEVICE, THE MOTION NORMALIZER IMAGE™ PATIENT HANDLING AND DATA COLLECTION DEVICE
| SUBMITTED BY | Ortho Kinematics, Inc.
7004 Bee Caves Rd.,
Bldg. 3, Ste. 315
Austin, Texas 78746 |
| -------------- | ------------------------------------------------------------------------------------------- |
|---|
| CONTACT PERSON | Primary:
Adam Deitz
CEO
Ortho Kinematics
Phone: (415) 699-1736
Fax: (512) 334-5500 | Alternate:
Brian J. Bergeron
Engineering
Ortho Kinematics
Phone: (508) 735-1590
Fax: (512) 382-6372 |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|
| DATE PREPARED | December 2, 2011 | |
| 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, and its accessory device, - the MOTION NORMALIZER™ patient handling and | |
PREDICATE DEVICE
Medical Metrics, Inc.'s KIMAX QMA Radiological Image Processing System (K022585) Villa Sistemi Medicali, spa's Apollo (K050190) Steris Corporation's Steris 5085 SRT (K090136)
data collection device
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
1
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 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 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 standard fluoroscopes. 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 fluoroscopic 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 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 integral system. In all instances, the KINEGRAPH VMA™ software and its accessory device, the MOTION NORMALIZER™, functioned as intended.
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.
2
Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features the department's name encircling a stylized eagle emblem. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The eagle emblem is composed of three curved lines, representing the department's mission to protect the health of all Americans and provide essential human services.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Ortho Kinematics, Inc. % Mr. John J. Smith. M.D., J.D. Regulatory Counsel Hogan Lovells US LLP 555 13th Street, NW WASHINGTON DC, 20004
DEC 2 2 2011
Re: K112109
Trade/Device Name: KINEGRAPH VMA™ (VERTEBRAL MOTION ANALYZER) software and its accessory, the MOTION NORMALIZER™ patient handling and data collection device Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: December 5th, 2011 Received: December 50, 2011
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.
If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of
3
medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed nouticate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/cdrh/industry/support/index.html.
Sincerely Yours.
Mary Pastel
Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K112109
Device Name: KINEGRAPH VMA™ (VERTEBRAL MOTION ANALYZER) software and its accessory, the MOTION NORMALIZER™ patient handling and data collection 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 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 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.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) |
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| (Division Sign-Off) |
| Division of Radiological Devices |
| Office of In Vitro Diagnostic Device Evaluation and Safety |
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| Annual of control condition | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
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