(140 days)
No
The summary describes quantitative image processing and analysis of motion, but does not mention AI, ML, or related terms like deep learning or neural networks. The focus is on standard image processing techniques and measurement.
No
The device is described as a quantitative imaging software application and an accessory device for data collection and patient handling during imaging. Its function is to process digital image files, analyze motion in medical images (specifically musculoskeletal images of the spine), and generate reports. There is no mention of it being used for treatment or diagnosis, only for providing information for analysis.
Yes
The device processes digital image files and provides "quantitative assessment of vertebral motion" and a "motion analysis report" to physicians, indicating its use in aiding diagnosis.
No
The device description explicitly states that the subject device consists of the KINEGRAPH VMA™ software and the MOTION NORMALIZER™ patient handling and data collection device, which is described as a powered, electromechanical device. This indicates the system includes hardware components beyond just the software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The KINEGRAPH VMA™ software and its accessory, the MOTION NORMALIZER™, are used to process and analyze medical images (specifically radiographic images of the spine) to assess motion of anatomical structures. They do not analyze biological samples from the patient.
The device is clearly focused on image analysis and patient positioning during imaging, which falls under the category of medical imaging software and devices, 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 and cervical spine images acquired with the assistance of the MOTION NORMALIZER™ patient handling and data collection device, which is designed for use by imaging technicians and intended to assist with patient lumbar and cervical bending and data collection during imaging. KINEGRAPH VMA™ software also facilitates quantitative assessment of vertebral motion in digital medical images. Information about the motion of selected objects, such as bone structures, can be generated and presented in the form of a 'motion analysis' report containing graphics, charts, and text.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
The subject device consists of the KINEGRAPH VMA™ software that analyzes images from the MOTION NORMALIZER™ on an Off-the-Shelf ("OTS") imaging workstation. The MOTION NORMALIZER patient handling and data collection device is an accessory device to the KINEGRAPH VMA™ software that is used to assist with subject lumbar bending and data collection while images are captured with a standard fluoroscope. The MOTION NORMALIZER is comprised of two powered. electromechanical patient handling devices connected to and controlled by a 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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
digital image files, radiographic image data, fluoroscope
Anatomical Site
musculoskeletal images of the spine, lumbar and cervical 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 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).
- 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,
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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