(24 days)
No
The document describes image processing and quantitative analysis of alignment and motion, but there is no mention of AI, ML, or related terms like deep learning or neural networks. The processing appears to be based on pre-defined algorithms and user-assisted template placement.
No
The device is a quantitative imaging software and an accessory device for patient handling during imaging. It processes images and provides analysis of alignment and motion, but it does not treat or cure a disease or condition. Its purpose is diagnostic and analytical, not therapeutic.
Yes
The device is a quantitative imaging software application that processes diagnostic imaging modalities to analyze alignment and motion in medical images, particularly musculoskeletal images of the spine, and generates a 'motion analysis' report. This functionality directly supports clinical diagnosis by providing quantitative assessment of anatomical conditions.
No
The device description explicitly states that the subject device consists of both VMA software and the MOTION NORMALIZER patient handling and data collection device, which is comprised of hardware components (Upright and Table devices, and Control Console). While the software is a key part of the system, it is not the only component.
Based on the provided text, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze biological samples: IVDs are designed to examine specimens taken from the human body, such as blood, urine, tissue, etc., to provide information about a person's health.
- This device analyzes medical images: The VMA software processes digital image files (DICOM format) from diagnostic imaging modalities. It analyzes the alignment and motion within these images, particularly of the spine. It does not interact with or analyze biological samples.
The device is clearly focused on image processing and analysis for diagnostic purposes, but this falls under the category of medical imaging devices and software, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The VMA software is a quantitative imaging software application intended to be used to process any diagnostic imaging modality except mammography from digital image files in DICOM format. It is designed for physicians and clinical professionals who are interested in the analysis of alignment and motion in medical images, particularly in musculoskeletal images of the spine. VMA software permits users to review static and dynamic digital lumbar, thoracic, and cervical spine images. In the case of fluoroscopic images, these are 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. VMA software also facilitates quantitative assessment of vertebral alignment and motion in digital medical images. Information about the alignment and 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 following components and accessories: VMA™ software (for data transfer, post-image processing and analysis), and its accessory device, the MOTION NORMALIZER™ patient handling and data collection device, which is comprised of the MOTION NORMALIZER Upright and Table devices (for patient assistance during image acquisition), and Control Console (for user interface during imaging).
The subject VMA™ software, and its accessory device, the MOTION NORMALIZER patient handling and data collection device, operate as a system ("the VMA™ System") in conjunction with other commercially-available accessory devices to produce quantitative analysis of inter-vertebral motion in adult patients.
None of the software associated with the subject device performs functions that create radiographic images, nor does the software control, operate, or govern the functionality of the imaging device (i.e., C-Arm Fluoroscopy Device).
With respect to the MOTION NORMALIZER™ hardware, this hardware is configured to assist with lumbar and cervical data collection while images are captured with a standard fluoroscope, and this remains unchanged in the modified device relative to the cleared system (K133875). The additional inclusion of the ability to process thoracic images in the modified device pertains to a new ability to process thoracic images that come from a source other than the MOTION NORMALIZER™ hardware.
Image processing operators, who are Ortho Kinematics, Inc. employees, operate the VMA™ software to process images and facilitate template placement for the prescriber. Prescriber users are able to access processed images 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
any diagnostic imaging modality except mammography from digital image files in DICOM format. For fluoroscopic images, these are acquired with the assistance of the MOTION NORMALIZER patient handling and data collection device.
Anatomical Site
musculoskeletal images of the spine, particularly lumbar, thoracic, and cervical spine images.
Indicated Patient Age Range
adult patients
Intended User / Care Setting
Physicians and clinical professionals. Imaging technicians for acquiring fluoroscopic images with the MOTION NORMALIZER.
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)
Repeatability and accuracy testing was performed for the integrated system. In all instances, the subject system functioned as intended.
Software validation testing was performed and documentation was provided for moderate level of concern software.
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).
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Public Health Service
Image /page/0/Picture/2 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 image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 25, 2017
Ortho Kinematics, Inc. % John J. Smith, M.D., J.D. Regulatory Counsel Hogan Lovells US LLP 555 13th Street. NW WASHINGTON DC 20004
Re: K172327
Trade/Device Name: VMA System™ version 3.0 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: August 1, 2017 Received: August 1, 2017
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
1
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (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 Industry and Consumer Education (DICE) 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,
Michael D. O'Hara For
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 6/30/2020 See PRA Statement below.
510(k) Number (if known)
K172327
Device Name
VMA™ System version 3.0
Indications for Use (Describe)
The VMA software is a quantitative imaging software application intended to be used to process any diagnostic imaging modality except mammography from digital image files in DICOM format. It is designed for physicians and clinical professionals who are interested in the analysis of alignment and motion in medical images, particularly in musculoskeletal images of the spine. VMA software permits users to review static and dynamic digital lumbar, thoracic, and cervical spine images. In the case of fluoroscopic images, these are 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. VMA software also facilitates quantitative assessment of vertebral alignment and motion in digital medical images. Information about the alignment and 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.
Type of Use (Select one or both, as applicable)
� Prescription Use (Part 21 CFR 801 Subpart D)
□ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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510(k) SUMMARY
Ortho Kinematics, Inc. VMA™ System
Submitter
Ortho Kinematics, Inc. 110 Wild Basin Road, Suite #250 Austin, Texas 78746 Phone: (512) 334-5490 Facsimile: (512) 334-5500 Contact Person: Adam Deitz, Chief Technology Officer
Date Prepared: August 18, 2017
Name of Device: VMA™ System version 3.0
Classification Name: Picture archiving and communications system (21 C.F.R. 892.2050)
Regulatory Class: Class II
Product Code: LLZ
Predicate Device
Ortho Kinematics, Inc.'s VMA System, version 2.2 (K133875)
Device Description
The subject device consists of the following components and accessories: VMA™ software (for data transfer, post-image processing and analysis), and its accessory device, the MOTION NORMALIZER™ patient handling and data collection device, which is comprised of the MOTION NORMALIZER Upright and Table devices (for patient assistance during image acquisition), and Control Console (for user interface during imaging).
The subject VMA™ software, and its accessory device, the MOTION NORMALIZER patient handling and data collection device, operate as a system ("the VMA™ System") in conjunction with other commercially-available accessory devices to produce quantitative analysis of inter-vertebral motion in adult patients.
None of the software associated with the subject device performs functions that create radiographic images, nor does the software control, operate, or govern the functionality of the imaging device (i.e., C-Arm Fluoroscopy Device).
With respect to the MOTION NORMALIZER™ hardware, this hardware is configured to assist with lumbar and cervical data collection while images are captured with a standard fluoroscope, and this remains unchanged in the modified device relative to the cleared system (K133875). The additional inclusion of the ability to process thoracic images in the
4
modified device pertains to a new ability to process thoracic images that come from a source other than the MOTION NORMALIZER™ hardware.
Image processing operators, who are Ortho Kinematics, Inc. employees, operate the VMA™ software to process images and facilitate template placement for the prescriber. Prescriber users are able to access processed images 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.
Intended Use / Indications for Use
The VMA software is a quantitative imaging software application intended to be used to process any diagnostic imaging modality except mammography from digital image files in DICOM format. It is designed for physicians and clinical professionals who are interested in the analysis of alignment and motion in medical images, particularly in musculoskeletal images of the spine. VMA software permits users to review static and dynamic digital lumbar, thoracic, and cervical spine images. In the case of fluoroscopic images, these are 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. VMA software also facilitates quantitative assessment of vertebral alignment and motion in digital medical images. Information about the alignment and 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.
Summary of Technological Characteristics
The cleared and modified VMA Systems are substantially equivalent with the similarities and minor differences noted in the comparison table below:
| | Ortho Kinematics, Inc.'s VMA™
Software and MOTION
NORMALIZER System, Version 2.2
(K133875) | Ortho Kinematics, Inc.'s VMA™ Software
and MOTION NORMALIZER System,
Version 3.0
(additions are underlined) |
|------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification
Name
Product Code | System, Image Processing,
Radiological
LLZ | System, Image Processing, Radiological
LLZ |
| Required OTS
Components for
Image
Acquisition | Fluoroscope Radiological Table Fixed Media Access to an internet connected
computer terminal installed with
internet browsing software | If MOTION NORMALIZER is being used
Fluoroscope Radiological Table Fixed Media Access to an internet connected
computer terminal installed with internet
browsing software If MOTION NORMALIZER is NOT being
used, then there are no required accessories
for image acquisition. |
| | Ortho Kinematics, Inc.'s VMAT™
Software and MOTION
NORMALIZER System, Version 2.2
(K133875) | Ortho Kinematics, Inc.'s VMAT™ Software
and MOTION NORMALIZER System,
Version 3.0
(additions are underlined) |
| Digital Image
Processing
Function | Digitizes analog fluoroscopy video
feeds to enable digital image
processing
Utilizes a manual vertebral body
templating process, plus a semi-
automated tracking process | Digitizes analog fluoroscopy video feeds to
enable digital image processing
Utilizes a semi-automated vertebral body
templating process, plus a manual tracking
process |
| Assists w/ Lying
vs. Standing
Postures | Standing and Lying | Standing and Lying |
| Range of
Assisted Lumbar
Articulation | Maximum achievable lumbar AND
cervical bending
range = $-40° to +60°$ | Maximum achievable lumbar AND cervical
bending
range = $-40° to +60°$ |
| User/Operator
During Imaging | Credential radiation technologists
(AART) or other clinical professionals
credentialed to operate a fluoroscope | Credential radiation technologists (AART) or
other clinical professionals credentialed to
operate a fluoroscope |
| Materials of
Patient Handling
Device | Welded tube and sheet stainless steel; Standard powder coating; Standard ABS plastic; 4-way nylon stretch fabric; Vinyl covered synthetic leather. | Welded tube and sheet stainless steel; Standard powder coating; Standard ABS plastic; 4-way nylon stretch fabric; Vinyl covered synthetic leather. |
| Dimensions of
Component
Occupying the
Plane
Perpendicular to
Imaging Beam | Table: 87" x 52"
Upright: 80" x 45" | Table: 87" x 52"
Upright: 80" x 45" |
| Required OTS
components | Image review workstation (PC): Process: Pentium 4 equivalent or better Ram Memory: 4 GB Monitor: Resolution of 1280x800 pixels or greater suitable for medical diagnostic image review Required installed software Internet Browser i.e. Internet Explorer, Firefox, etc. that supports HTML5 | Image review workstation (PC): Process: Pentium 4 equivalent or better Ram Memory: 4 GB Monitor: Resolution of 1280x800 pixels or greater suitable for medical diagnostic image review Required installed software Internet Browser i.e. Internet Explorer, Firefox, etc. that supports HTML5 |
| User/Operator | Physicians and clinical professionals | Physicians and clinical professionals |
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| | Ortho Kinematics, Inc.'s VMA™
Software and MOTION
NORMALIZER System, Version 2.2
(K133875) | Ortho Kinematics, Inc.'s VMA™ Software
and MOTION NORMALIZER System,
Version 3.0
(additions are underlined) |
|-------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Input Data Files | DICOM files created using the
MOTION NORMALIZER System | DICOM files created using the
MOTION NORMALIZER System DICOM files generated using any
modality. |
| Key
Functionality | Load image data Display & Playback Enhance Contrast Put templates on anatomy Auto and manual templating
features Forced manual review Quantitative graphical output
report generation | Load image data Display & Playback Edit DICOM header data Enhance Contrast Put templates on anatomy Auto and manual templating features Forced manual review Quantitative graphical output report
generation |
| Quantitative
Analysis &
Measurement | IVR & IVT measurements for
lumbar and cervical motion Image registration & tracking Clinical Reporting Calibration of translation data | IVR & IVT measurements for lumbar
and cervical motion Alignment measurements, including
millimeter based "Sagittal Vertical
Axis" measurements plus a range of
angular measurements Image registration & tracking Clinical Reporting Calibration of translation data Grid correction for fluoroscopic images |
Performance Data
The 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, such as the following:
- . IEC 60601-1: Medical Electrical Equipment- Part 1: General requirements for Basic Safety and Essential Performance (2012).
- IEC 60601-1-2: Medical Electrical Equipment Part 1-2: General requirements for . safety - Collateral Standard: Electromagnetic Compatibility - requirements and tests (2007).
- IEC 60601-1-3: Medical electrical equipment. Part 1: General requirements for . safety; Part 1-2: Collateral Standard: Radiation protection in diagnostic X-ray equipment (2013).
- . IEC 60601-1-6: Medical electrical equipment. Part 1: General requirements for safety; Part 1-4: Collateral Standard: Usability (2013).
- IEC 60601-2-54: Medical electrical equipment. Part 2: Particular requirements for . the basic safety and essential performance of X-ray equipment for radiography and radioscopy (2009).
- . NEMA PS 3.1 - 3.20: Digital Imaging and Communications in Medicine (DICOM) Set (2017).
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In addition, repeatability and accuracy testing was performed for the integrated system. In all instances, the subject system functioned as intended. Lastly, software validation testing was performed and documentation was provided for moderate level of concern software.
Substantial Equivalence Conclusion
The VMA™ software and its accessory device, the MOTION NORMALIZER, have the same intended use and similar indications for use, technological characteristics, and principles of operation as the company's own identified predicate device. The minor technological differences between the subject system and the predicate system raise no new or different questions 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. Thus, the subject device is substantially equivalent.