(28 days)
No
The description focuses on image enhancement, tracking, and registration algorithms, which are traditional image processing techniques, not explicitly AI/ML. There is no mention of AI, ML, or related concepts like training or test sets.
No
The device aids diagnosis and treatment by enhancing fluoroscopic images and assisting with instrument/fluoroscope positioning, but it does not directly apply therapy to a patient.
No
The "Intended Use / Indications for Use" states that the LessRay System is "intended for use in any application where a fluoroscope is incorporated to aid in diagnosis and treatment of disease." However, the "Device Description" clarifies that LessRay is a software application that enhances and displays images from a fluoroscope, improves image quality, aids in positioning the fluoroscope, and tracks instruments. Its primary function is to improve the quality and utility of existing fluoroscopic images and guide procedures, rather than to independently provide a diagnosis. The device "aids in diagnosis" by making fluoroscopic images clearer, not by performing diagnostic analysis itself.
No
The device is described as a software application, but the description explicitly states it interfaces with a fluoroscope via a video cable and utilizes a frame grabber in the computer running the software. Furthermore, the performance studies include Electrical Safety and Electromagnetic Compatibility (EMC) testing per IEC 60601-1 and IEC 60601-1-2, which are standards typically applied to electrical medical equipment, not purely software. This indicates the device includes hardware components beyond just the software itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the LessRay System is used in conjunction with a fluoroscope to aid in the diagnosis and treatment of disease. This involves processing and enhancing medical images obtained from the patient's body.
- Device Description: The description details a software application that interfaces with a fluoroscope to enhance images and aid in positioning. This is focused on image processing and guidance during medical procedures.
- Lack of In Vitro Activities: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) outside of the body. IVD devices are specifically designed for these types of tests.
The LessRay System is a medical device that processes and enhances in-vivo imaging data (fluoroscopic x-rays) to assist in diagnosis and treatment, which falls under the category of medical imaging software or image processing systems, not IVD.
N/A
Intended Use / Indications for Use
LessRay® System is intended for use in any application where a fluoroscope is incorporated to aid in diagnosis and treatment of disease.
Product codes
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. LessRay provides 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.
LessRay System 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. LessRay System uses this information to aid the user in positioning the instrument.
The purpose of this premarket notification is addition of a wired remote to the LessRay System and the integration of instrument tracking functionality previously cleared in K170800.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Fluoroscope
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
Nonclinical testing was performed to demonstrate that the subject LessRay System 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 Alignment Accuracy to confirm that the alignment algorithm performs according to specifications.
- Verification of Image Registration Performance to confirm that the software performs image registration according to specifications.
- Software Validation to validate the functionality and user operations of LessRay System.
- Electrical Safety and Electromagnetic Compatibility (EMC) testing of LessRay System per IEC 60601-1 and IEC 60601-1-2 respectively.
The results demonstrate that the subject LessRay System is substantially equivalent to the predicate.
Key Metrics
Not Found
Predicate Device(s)
LessRay® with Tracking (K142243), LessRay® with Enhanced Tracking (K170800)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
November 16, 2017
Image /page/0/Picture/1 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the FDA acronym in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.
NuVasive, Incorporated % Manthan Damani Senior Regulatory Affairs Specialist 7475 Lusk Boulevard SAN DIEGO CA 92121
Re: K173314
Trade/Device Name: LessRay® System Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OWB, LLZ, and JAA Dated: October 17, 2017 Received: October 19, 2017
Dear Manthan Damani:
We have reviewed vour 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 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.
1
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.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone
(1-800-638-2041 or 301-796-7100).
Sincerely,
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)
K173314
Device Name LessRay® System
Indications for Use (Describe)
LessRay® System 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)
Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Image /page/3/Picture/1 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 split 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: October 17, 2017
B. Device Name
| Trade or Proprietary Name: | LessRay® System |
|---|---|
| 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 |
Predicate Devices C.
The subject device is substantially equivalent to the predicate devices LessRay® with Tracking (K142243) and LessRay® with Enhanced Tracking (K170800).
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 provides 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.
LessRay System 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. LessRay System uses this information to aid the user in positioning the instrument.
4
Image /page/4/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 capital letters to the right of the leaf. The leaf is colored purple on the top and gray on the bottom. The word "NUVASIVE" is gray.
The purpose of this premarket notification is addition of a wired remote to the LessRay System and the integration of instrument tracking functionality previously cleared in K170800.
LessRay System is designed per recommendations provided in the following FDA guidance documents:
- o Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices
- Off-The-Shelf Software Use in Medical Devices ●
- o Content of Premarket Submissions for Management of Cybersecurity in Medical Devices
Indications for Use E.
LessRay® System 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 LessRay System 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.
| Specifi
cation/
Proper
ty | Predicate Device
LessRay with Tracking
(K142243) | Predicate Device
NuVasive LessRay with
Enhanced Tracking
(K170800) | Subject Device
LessRay System | Discus
sion |
|--------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------|
| Intende
d Use /
Indicati
ons 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. | LessRay® System 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 | II | Same |
| Produc
t Code | OWB, JAA, LLZ | OWB, JAA, LLZ | OWB, JAA, LLZ | Same |
| Regula
tion
Numbe
r
(21CF
R) | §892.1650 | §892.1650 | §892.1650 | Same |
| Device
Classifi
cation
Name | Interventional Fluoroscopic
X-Ray System | Interventional Fluoroscopic
X-Ray System | Interventional
Fluoroscopic X-Ray
System | Same |
| Specifi
cation/
Proper
ty | Predicate Device
LessRay with Tracking
(K142243) | Predicate Device
NuVasive LessRay with
Enhanced Tracking
(K170800) | Subject Device
LessRay System | Discus
sion |
| Device
Functio
nalities
(image
acquisi
tion,
enhanc
ement,
and
display
) | Software based device
used to provide computer
display systems interfaced
to a fluoroscope through a
video cable. Images
produced by fluoroscope
are transmitted through a
cable to a frame capture
board in computer where
images are enhanced and
then displayed on the
monitor.
Enhanced images are
displayed on computer
monitor at the same time
that corresponding original
image is displayed on
fluoroscope monitor(s).
Uses software to control
frame capture,
intermediate image
manipulation, and image
display.
Delay between frame
acquisition and frame
display is less than the
time between frames, i.e.
33 msec.
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 a fluoroscope through a
video cable. Images
produced by fluoroscope
are transmitted through a
cable to a frame capture
board in computer where
images are enhanced and
then displayed on the
monitor.
Enhanced images are
displayed on computer
monitor at the same time
that corresponding original
image is displayed on
fluoroscope monitor(s).
Uses software to control
frame capture, intermediate
image manipulation, and
image display.
Delay between frame
acquisition and frame
display is less than the time
between frames, i.e. 33
msec.
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 a
fluoroscope through a
video cable. Images
produced by
fluoroscope are
transmitted through a
cable to a frame capture
board in computer
where images are
enhanced and then
displayed on the
monitor.
Enhanced images are
displayed on computer
monitor at the same
time that corresponding
original image is
displayed on
fluoroscope monitor(s).
Uses software to
control frame capture,
intermediate image
manipulation, and
image display.
Delay between frame
acquisition and frame
display is less than the
time between frames,
i.e. 33 msec.
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 |
| | | Page 3 of 6 | | |
| Specifi
cation/
Proper
ty | Predicate Device
LessRay with Tracking
(K142243) | Predicate Device
NuVasive LessRay with
Enhanced Tracking
(K170800) | Subject Device
LessRay System | Discus
sion |
| Algorit
hms | - 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 | - Image quality
improvement using
averaging algorithm - Contrast and brightness
enhancement with
simultaneous reduction
of random noise | Same |
| C-arm
Trackin
g | - 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
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, 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,
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 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,
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, 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
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, visual cues
are provided which
help guide the user in
positioning the C-arm
back to where a prior
Baseline was taken. | Same |
| Trackin
g
options | Electromagnetic or optical | Electromagnetic or optical | Optical | Same |
| Specifi
cation/
Proper
ty | Predicate Device
LessRay with Tracking
(K142243) | Predicate Device
NuVasive LessRay with
Enhanced Tracking
(K170800) | Subject Device
LessRay System | Discus
sion |
| Compa
tible
hardwa
re
platfor
ms | 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
8.1 | LessRay computer
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 8.1 | Same |
| Instru
ment
Trackin
g | No | Yes- NuVasive LessRay
with Enhanced Tracking has
additional capability of
instrument tracking to aid the
user in positioning an
instrument using prior
baseline x-rays. | Yes- LessRay System has
additional capability of
instrument tracking to aid
the user in positioning an
instrument using prior
baseline x-rays. | Same |
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Image /page/5/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 a sans-serif font to the right. The leaf shape is divided into two parts, with the top part in purple and the bottom part in gray. The word "NUVASIVE" is in gray.
Traditional 510(k) Submission NuVasive® LessRay® System
6
Traditional 510(k) Submission NuVasive® LessRay® System
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Image /page/7/Picture/0 description: The image shows the Nuvasive logo. The logo consists of a stylized leaf shape on the left and the word "NUVASIVE" on the right. The leaf shape is divided into two parts, with the top part being purple and the bottom part being gray. The word "NUVASIVE" is written in a simple, sans-serif font and is also gray.
Traditional 510(k) Submission Nu Vasive® LessRay® System
G. Performance Data
Nonclinical testing was performed to demonstrate that the subject LessRay System 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 Alignment Accuracy to confirm that the alignment algorithm performs ● according to specifications.
- Verification of Image Registration Performance to confirm that the software performs ● image registration according to specifications.
- Software Validation to validate the functionality and user operations of LessRay System.
- Electrical Safety and Electromagnetic Compatibility (EMC) testing of LessRay ● System per IEC 60601-1 and IEC 60601-1-2 respectively.
The results demonstrate that the subject LessRay System is substantially equivalent to the predicate.
H. Conclusions
The subject LessRay System has been shown to be substantially equivalent to legally marketed predicate devices for their intended use.
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Image /page/8/Picture/0 description: The image shows the logo for Nuvasive. The logo consists of a stylized leaf shape on the left and the word "NUVASIVE" on the right. The leaf shape is split into two colors, with the top portion being purple and the bottom portion being gray. The word "NUVASIVE" is written in gray, sans-serif font.
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.