(154 days)
Not Found
No
The description focuses on image enhancement, tracking, and positioning based on traditional image processing and tracking technologies, with no mention of AI or ML algorithms for image analysis, diagnosis, or prediction.
No.
The device enhances and displays fluoroscopic images and aids in positioning, which are diagnostic and procedural guidance functions, not direct therapeutic actions on the body.
No
The device is described as a software application that enhances and displays images from a fluoroscope, aiding in treatment and instrument positioning. It does not generate a diagnosis itself, but rather improves the quality of images used by medical professionals for diagnosis and treatment.
No
The device description explicitly states it interfaces with a fluoroscope via a video cable and uses a frame grabber in a computer. It also mentions a tracking system and attaching a tracker to an instrument. These are hardware components beyond just software.
Based on the provided information, the NuVasive® LessRay® with Enhanced Tracking device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases or other conditions.
- LessRay's Function: The description clearly states that LessRay is a software application that interfaces with a fluoroscope to enhance and display medical images. It aids in positioning the fluoroscope and instruments during procedures.
- Lack of Biological Sample Analysis: There is no mention of the device analyzing any biological samples from the patient. Its function is solely related to processing and displaying medical images acquired through a fluoroscope.
Therefore, LessRay falls under the category of medical imaging software or image processing systems, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
NuVasive® LessRay® with Enhanced Tracking is intended for use in any application where a fluoroscope is incorporated to aid in diagnosis and treatment of disease.
Product codes (comma separated list FDA assigned to the subject device)
OWB, LLZ, JAA
Device Description
LessRay is a software application which can be interfaced to a fluoroscope with a video cable. The images produced by the fluoroscope are transmitted to a frame grabber in the computer running LessRay where the images are enhanced and then displayed. When used in connection with the low dose and/or pulse setting on the fluoroscope, the user can improve the quality (clarity, contrast, noise level, and usability-) of a noisy (low-quality) image. Using this system, much of the graininess of low radiation dose images can be eliminated. This allows for greater utility of low dose imaging.2 LessRay with Tracking provided the additional feature of being able to interface LessRay with a tracking system in order to aid the C-arm technician in positioning the fluoroscope between the various views of the patient necessary for the intervention. LessRay with Tracking ensures that the fluoroscope is centered over the correct anatomy prior to taking any additional x-ray images.
NuVasive LessRay with Enhanced Tracking has additional capability of instrument tracking to aid the user in positioning an instrument using prior baseline x-rays. A tracker is attached to the instrument and as the instrument moves, the tracking system connected to LessRay tracks the location of the instrument. NuVasive LessRay with Enhanced Tracking uses this information to aid the user in positioning the instrument.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Image-intensified fluoroscopic x-ray system
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Nonclinical testing was performed to demonstrate that the subject NuVasive LessRay with Enhanced Tracking is substantially equivalent to the predicate device. The following testing was performed:
- . Verification of Instrument Tracking to confirm that subject device allows the user to position the instrument back to where it was located when the desired image is taken.
- Verification of Graphical User Interface (GUI) to confirm that the GUI performs ● according to specifications.
- Validation of Instrument Tracking to confirm that using subject device instruments ● can be relocalized with less number of x-ray images, greater accuracy, and less time than when using conventional fluoroscopy.
- Regression Testing to verify image alignment, glyph tracking, and image registration . performance functionalities.
The results demonstrate that the subject NuVasive LessRay with Enhanced Tracking is substantially equivalent to the predicate.
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
§ 892.1650 Image-intensified fluoroscopic x-ray system.
(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
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" arranged around the perimeter. Inside the circle is an abstract symbol composed of three stylized human profiles facing to the right, with flowing lines beneath them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 18, 2017
NuVasive, Incorporated % Manthan Damani Senior Regulatory Affairs Specialist 7475 Lusk Boulevard SAN DIEGO CA 92121
Re: K170800
Trade/Device Name: NuVasive® LessRay® with Enhanced Tracking Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OWB, LLZ and JAA Dated: July 25, 2017 Received: July 26, 2017
Dear Manthan Damani:
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) 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 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 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
2
Indications for Use
510(k) Number (if known)
K170800
Device Name
NuVasive® LessRay® with Enhanced Tracking
Indications for Use (Describe)
NuVasive® LessRay® with Enhanced Tracking is intended for use in any application where a fluoroscope is incorporated to aid in diagnosis and treatment of disease.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the logo for Nuvasive. The logo consists of a stylized leaf shape on the left, with the word "NUVASIVE" in gray letters to the right of the leaf. The leaf shape is divided into two parts, with the top part being purple and the bottom part being gray.
510(k) Summary
In accordance with Title 21 of the Code of Federal Regulations, Part 807, and in particular 21 CFR §807.92, the following summary of information is provided:
Submitted by: A.
Manthan J. Damani Senior Regulatory Affairs Specialist NuVasive, Incorporated 7475 Lusk Blvd. San Diego, California 92121 Telephone: (858) 909-1800
Date Prepared: August 17, 2017
B. Device Name
| Trade or Proprietary Name: | NuVasive® LessRay® with Enhanced Tracking |
|---|---|
| Common or Usual Name: | Image processing system |
| Classification Name: | Image-intensified fluoroscopic x-ray system |
| Device Class: | Class II |
| Classification: | 21 CFR § 892.1650 |
| Product Code: | OWB, LLZ, JAA |
C. Predicate Devices
The subject device is substantially equivalent to the predicate device LessRay® with Tracking (K142243).
D. Device Description
LessRay is a software application which can be interfaced to a fluoroscope with a video cable. The images produced by the fluoroscope are transmitted to a frame grabber in the computer running LessRay where the images are enhanced and then displayed. When used in connection with the low dose and/or pulse setting on the fluoroscope, the user can improve the quality (clarity, contrast, noise level, and usability-) of a noisy (low-quality) image. Using this system, much of the graininess of low radiation dose images can be eliminated. This allows for greater utility of low dose imaging.2 LessRay with Tracking provided the additional feature of being able to interface LessRay with a tracking system in order to aid the C-arm technician in positioning the fluoroscope between the various views of the patient necessary for the intervention. LessRay with Tracking ensures that the fluoroscope is centered over the correct anatomy prior to taking any additional x-ray images.
NuVasive LessRay with Enhanced Tracking has additional capability of instrument tracking to aid the user in positioning an instrument using prior baseline x-rays. A tracker is attached to the instrument and as the instrument moves, the tracking system connected to LessRay tracks the location of the instrument. NuVasive LessRay with Enhanced Tracking uses this information to aid the user in positioning the instrument.
4
NuVasive LessRay with Enhanced Tracking is designed per recommendations provided in the following FDA guidance documents:
- Guidance for the Content of Premarket Submissions for Software Contained in ● Medical Devices
- Off-The-Shelf Software Use in Medical Devices ●
- Content of Premarket Submissions for Management of Cybersecurity in Medical ● Devices
Indications for Use E.
NuVasive® LessRay® with Enhanced Tracking is intended for use in any application where a fluoroscope is incorporated to aid in diagnosis and treatment of disease.
F. Comparison of Technological Characteristics with Predicate Device
As was established in this submission, the subject NuVasive LessRay with Enhanced Tracking is substantially equivalent to other predicate devices cleared by the FDA for commercial distribution in the United States. The subject device was shown to be substantially equivalent to its predicate device through comparison in areas including design, labeling/intended use, and function.
| Specification
/
Property | Predicate Device
LessRay with Tracking (K142243) | Subject Device
NuVasive LessRay with Enhanced
Tracking | Discuss
ion |
|-------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------|
| Intended Use
/ Indications
for Use | LessRay® with Tracking is intended for
use in any application where a
fluoroscope is incorporated to aid in
diagnosis and treatment of disease. | NuVasive® LessRay® with Enhanced
Tracking is intended for use in any
application where a fluoroscope is
incorporated to aid in diagnosis and
treatment of disease. | Same |
| Device Class | II | II | Same |
| Product Code | OWB, JAA, LLZ | OWB, JAA, LLZ | Same |
| Regulation
Number
(21CFR) | §892.1650 | §892.1650 | Same |
| Device
Classification
Name | Interventional Fluoroscopic X-Ray
System | Interventional Fluoroscopic X-Ray
System | Same |
| Specification / Property | Predicate Device
LessRay with Tracking (K142243) | Subject Device
NuVasive LessRay with Enhanced Tracking | Discussion |
| Device
Functionalities (image
acquisition, enhancement,
and display) | - Software based device used to
provide computer display systems
interfaced to a fluoroscope through
a video cable. The images
produced by the fluoroscope are
transmitted through a cable to a
frame capture board in the
computer where the images are
enhanced and then displayed on the
monitor.
-
Enhanced images are displayed on
a computer monitor at the same
time that the corresponding
original image is displayed on the
fluoroscope monitor(s). -
Serves only as an image display
which is in addition to the
fluoroscope's standard image
display device. Device is passive,
in that the operation depends only
on the video output of the
fluoroscope, and it does not
transmit any signals or images to
the fluoroscope. | - Software based device used to
provide computer display systems
interfaced to fluoroscope through a
video cable. The images produced
by the fluoroscope are transmitted
through a cable to a frame capture
board in the computer where the
images are enhanced and then
displayed on the monitor. -
Enhanced images are displayed on
a computer monitor at the same
time that the corresponding
original image is displayed on the
fluoroscope monitor(s). -
Serves only as an image display
which is in addition to the
fluoroscope's standard image
display device. Device is passive,
in that the operation depends only
on the video output of the
fluoroscope, and it does not
transmit any signals or images to
the fluoroscope. | Same |
| Algorithms | - Image quality improvement using
averaging algorithm -
Contrast and brightness
enhancement with simultaneous
reduction of random noise | - Image quality improvement using
averaging algorithm -
Contrast and brightness enhancement
with simultaneous reduction of
random noise | Same |
| Compatible
hardware
platforms | Any computer that meets the following
minimum specifications:
CPU: Intel Core 2 Duo
GPU: NVIDIA Quadro 4000
RAM: 8 GB
HDD: 256 GB
Frame Grabber: Aver Media H339 or
Elgato
Operating System: Windows 7 or 8.1 | Any computer that meets the following
minimum specifications:
CPU: Intel Core 2 Duo
GPU: NVIDIA Quadro 4000
RAM: 8 GB
HDD: 256 GB
Frame Grabber: Aver Media H339 or
Elgato
Operating System: Windows 7 or 8.1 | Same |
| Specification / Property | Predicate Device
LessRay with Tracking (K142243) | Subject Device
NuVasive LessRay with Enhanced
Tracking | Discussion |
| C-arm
Tracking | - When tracking is enabled, will
automatically choose the Baseline
when the fluoroscope is near the
location and orientation that the
Baseline was initially taken. -
When tracking is enabled, requires | - When tracking is enabled, will
automatically choose the Baseline
when the fluoroscope is near the
location and orientation that the
Baseline was initially taken. -
When tracking is enabled, requires | Same |
| | hardware components in order to
mount the off-the-shelf tracking
hardware to the C-arm and to the
operating table. | hardware components in order to
mount the off-the-shelf tracking
hardware to the C-arm and to the
operating table. | |
| | - When tracking is enabled, requires
the use of an off-the-shelf tracking
system in order to track the 6 DOF
location of the C-arm relative to the
operating table. | - When tracking is enabled, requires
the use of an off-the-shelf tracking
system in order to track the 6 DOF
location of the C-arm relative to the
operating table. | |
| | - When tracking is enabled, visual
cues are provided which help guide
the user in positioning the C-arm
back to where a prior Baseline was
taken. | - When tracking is enabled, visual
cues are provided which help guide
the user in positioning the C-arm
back to where a prior Baseline was
taken. | |
| Tracking
options | Electromagnetic or optical | Electromagnetic or optical | Same |
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Image /page/6/Picture/0 description: The image shows the logo for Nuvasive. The logo consists of a stylized leaf shape in purple and gray, followed by the word "NUVASIVE" in gray. The leaf shape is on the left side of the logo, and the word "NUVASIVE" is on the right side.
Speci
Traditional 510(k) Submission NuVasive® LessRay® with Enhanced Tracking
G. Performance Data
Instrument
Tracking
No
Nonclinical testing was performed to demonstrate that the subject NuVasive LessRay with Enhanced Tracking is substantially equivalent to the predicate device. The following testing was performed:
Enhanced Tracking has additional
capability of instrument tracking to aid
the user in positioning an instrument
using prior baseline x-rays.
- . Verification of Instrument Tracking to confirm that subject device allows the user to position the instrument back to where it was located when the desired image is taken.
- Verification of Graphical User Interface (GUI) to confirm that the GUI performs ● according to specifications.
- Validation of Instrument Tracking to confirm that using subject device instruments ● can be relocalized with less number of x-ray images, greater accuracy, and less time than when using conventional fluoroscopy.
Additio
nal
function
ality
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Image /page/7/Picture/0 description: The image shows the logo for Nuvasive. The logo consists of a stylized leaf shape on the left, with the word "NUVASIVE" in gray letters to the right of the leaf. The leaf shape is partially purple and partially gray. The logo is simple and modern.
- Regression Testing to verify image alignment, glyph tracking, and image registration . performance functionalities.
The results demonstrate that the subject NuVasive LessRay with Enhanced Tracking is substantially equivalent to the predicate.
H. Conclusions
The subject NuVasive LessRay with Enhanced Tracking has been shown to be substantially equivalent to legally marketed predicate devices for their intended use.
1 As evaluated by a human observer in a side by side visual comparison of 30 image pairs with and without LessRay processing.
2 In clinical practice, the amount of improvement achieved when a Pulsed and/or Low Dose image is processed with LessRay is dependent on the clinical task, patient size, anatomical location, and clinical practice. The dose should be set at a level to which the physician is able to achieve the adequate image quality needed for the particular clinical task. A consultation with a radiologist and a physicist may aid in determining the appropriate dose settings.