(97 days)
Not Found
No
The description focuses on image processing techniques like image enhancement, noise reduction, and image merging based on a baseline image. It also describes a tracking system for fluoroscope positioning. There is no mention of AI, ML, or related concepts like deep learning, neural networks, or training data. The performance studies listed are related to image recognition (likely traditional methods) and tracking accuracy, not AI/ML model performance.
No
The device is a software application that enhances fluoroscopic images to aid in diagnosis and treatment, but it does not directly perform or provide therapy.
No.
The device is described as a software application that enhances fluoroscopic images to improve quality and facilitate treatment, not for making a medical diagnosis. Its primary function is to aid in visualizing instruments and anatomy during procedures, and in positioning the fluoroscope.
No
The device is described as a software application that interfaces with a fluoroscope and a frame grabber, implying a dependency on and interaction with hardware components beyond just a general-purpose computing platform.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to aid in the diagnosis and treatment of disease by enhancing fluoroscopic images and assisting with fluoroscope positioning. This is related to medical imaging and procedural guidance, not the examination of specimens derived from the human body for the purpose of providing information for diagnosis, monitoring, or treatment.
- Device Description: The device is a software application that processes and enhances fluoroscopic images. It works with a fluoroscope and a tracking system. This is a medical imaging and navigation tool.
- Input Imaging Modality: The input is fluoroscopic x-ray images, which are generated from within the patient's body, not from a specimen taken from the body.
IVD devices are specifically designed to perform tests on biological specimens (like blood, urine, tissue) to provide diagnostic information. This device operates on live imaging data from a patient during a medical procedure.
N/A
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.
Product codes (comma separated list FDA assigned to the subject device)
OWB, JAA, LLZ
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® works by combining the current image being taken with a prior "Baseline" image of the same anatomy. The initial image, taken at regular radiation dose settings, serves as a baseline to which images taken at lower dose radiation settings can be compared and enhanced.
In procedures where instruments are introduced into the field of view, LessRay® images provide information that is not available with conventional images. By merging an image of interest containing tools with the unencumbered Baseline image, the radio dense metallic tools and implants that obscure the underlying anatomy can be rendered partially translucent in the merged image. In addition, by alternating the new image with the Baseline a user can make these metallic tools or implants disappear and reappear from the image, revealing the anatomy blocked by the tool.
The subject of this 510(k) is the addition of tracking capability to be used with LessRay LessRay can be interfaced 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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Fluoroscope / X-ray
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)
To establish the substantial equivalence of the modified LessRay® with Tracking to the predicate LessRay® device, the following performance tests were performed:
- Regression/Image Recognition Compared to LessRay v1.0 •
- Verification of Glyph Tracking
- Tracking Accuracy with the NDI Vicra Optical Tracking System •
- Tracking Accuracy with the Patriot M Electromagnetic Tracking System
- Tracking Accuracy with the Patriot M Electromagnetic Tracking System and Dynamic Metal Distortion
- . Collar Assembly Vertical Pull-Off Safety Test
- Validation of Fluoroscope Navigation
Key results: The performance testing demonstrated substantial equivalence of LessRay with Tracking to the previously cleared LessRay device.
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
Image /page/0/Picture/1 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 an abstract symbol that resembles three stylized 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
November 18, 2014
SafeRay Spine, LLC % Ms. Calley Herzog Consultant Biologics Consulting Group, Inc. 400 N. Washington Street, Suite 100 ALEXANDRIA VA 22314
Re: K142243
Trade/Device Name: LessRay with Tracking Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OWB, JAA, LLZ Dated: October 17, 2014 Received: October 20, 2014
Dear Ms. Herzog:
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.
1
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/Resourcesfor You/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 yours,
Robert A Ochs
for
Janine M. Morris 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) K142243
Device Name LessRay® with Tracking
Indications for Use (Describe)
LessRay® with 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)
Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(K) SUMMARY
In accordance with 21 CFR 807.87(h) and (21 CFR 807.92) the 510(k) Summary for the LessRay with Tracking is provided below.
| Device Common Name: | Image Processing System |
|---|---|
| Device Proprietary Name: | LessRay® with Tracking |
| Submitter: | SafeRay Spine, LLC |
| 5102 Durham Chapel Hill Blvd., Suite 203 | |
| Durham, NC 27707 | |
| Phone: 877-814-7509 | |
| Contact: | Calley Herzog |
| Consultant | |
| Biologics Consulting Group, Inc. | |
| Phone: 720-883-3633 | |
| Fax: 703-548-7457 | |
| Email: cherzog@bcg-usa.com | |
| Classification Regulation: | 21 CFR 892.1650, Class II |
| Classification Name: | Image-intensified fluoroscopic x-ray system |
| Panel: | Radiology |
| Primary Product Code: | OWB - interventional fluoroscopic x-ray system |
| Secondary Product Codes: | LLZ - system, image processing, radiological |
| JAA – system, x-ray, fluoroscopic, image-intensified | |
| Date Prepared: | October 17, 2014 |
| Predicate Device: | K132970, LessRay® |
Indication 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.
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. -
4
LessRay® works by combining the current image being taken with a prior "Baseline" image of the same anatomy. The initial image, taken at regular radiation dose settings, serves as a baseline to which images taken at lower dose radiation settings can be compared and enhanced.
In procedures where instruments are introduced into the field of view, LessRay® images provide information that is not available with conventional images. By merging an image of interest containing tools with the unencumbered Baseline image, the radio dense metallic tools and implants that obscure the underlying anatomy can be rendered partially translucent in the merged image. In addition, by alternating the new image with the Baseline a user can make these metallic tools or implants disappear and reappear from the image, revealing the anatomy blocked by the tool.
The subject of this 510(k) is the addition of tracking capability to be used with LessRay LessRay can be interfaced 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.
Performance Data:
To establish the substantial equivalence of the modified LessRay® with Tracking to the predicate LessRay® device, the following performance tests were performed:
- Regression/Image Recognition Compared to LessRay v1.0 ●
- Verification of Glyph Tracking
- Tracking Accuracy with the NDI Vicra Optical Tracking System ●
- Tracking Accuracy with the Patriot M Electromagnetic Tracking System
- Tracking Accuracy with the Patriot M Electromagnetic Tracking System and Dynamic Metal Distortion
- . Collar Assembly Vertical Pull-Off Safety Test
- Validation of Fluoroscope Navigation
Substantial Equivalence:
Based on the identical indication, similar technological characteristics, and results of performance testing, LessRay with Tracking is substantially equivalent to the previously cleared LessRay® device (K123226).
| Proposed Device | Predicate Device | |
|---|---|---|
| 510(k) Number | K142243 | K132970 |
| Device Name | LessRay® with Tracking | LessRay® |
| Submitter | SafeRay Spine, LLC | SafeRay Spine, LLC |
| Classification Regulation | 892.1650 | 892.1650 |
| Product Code | OWB, LLZ | OWB, LLZ |
Table 1: Device Comparison Table
5
| Proposed Device | Predicate Device | |
|---|---|---|
| Indication | Indicated for use in any | |
| application where a fluoroscope | ||
| is incorporated to aid in diagnosis | ||
| and treatment of disease. | Indicated for use in any | |
| application where a fluoroscope | ||
| is incorporated to aid in diagnosis | ||
| and treatment of disease. | ||
| 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 | ||
| Software is run on a stand- | ||
| alone computer and monitor | Yes | Yes |
| Device is passive and doesn't | ||
| control the fluoroscope | Yes | Yes |
| Displays reduced noise images | Yes | Yes |
| For use during procedures that | ||
| involve fluoroscopy | Yes | Yes |
| Improves quality of low dose | ||
| images | Yes | Yes |
| Uses data from prior images to | ||
| improve the quality of | ||
| subsequent images | Yes | Yes |
| Algorithm used to improve | ||
| image quality | Summation of prior full dose | |
| images with subsequent images | Summation of prior full dose | |
| images with subsequent images | ||
| Provides visual cues which help | ||
| guide the user in positioning | ||
| the C-arm back to where a | ||
| prior Baseline was taken. | Yes | No |
| Automatically selects the | ||
| nearest Baseline as the C-arm | ||
| is being moved. | Yes | No |
| Requires a 6 DOF tracking | ||
| system in some configurations. | Yes | No |
6
| Proposed Device | Predicate Device | |
|---|---|---|
| Requires mounting hardware | ||
| used to mount the 6 DOF | ||
| tracking system to the C-arm | ||
| and the operating table. | Yes | No |
Substantial Equivalence Summary
The addition of the optional tracking feature does not change the intended use of the device as a software application that enhances images from a fluoroscope. LessRay with Tracking provides the additional capability of aiding the user in acquiring fluoroscopic images by ensuring that the fluoroscope is centered over the correct anatomy prior to taking any additional x-ray images. The performance testing demonstrated substantial equivalence of LessRay with Tracking to the previously cleared LessRay device. Therefore, based on the identical indication, similar technological characteristics, and results of performance testing, LessRay® with Tracking is substantially equivalent to LessRay® as it was cleared in K123226 and K132970.
' As evaluated by a human observer in a side by side visual comparison of 30 image pairs with and without LessRay processing.
4 In clinical practice, the amount of image quality 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.