Who is the manufacturer of LessRay System?

Nu Vasive, Incorporated filed the 510(k) submission for LessRay System (K173314).

What is the FDA product code for LessRay System?

OWB. It is classified under 21 CFR 892.1650 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for LessRay System?

510(k) clearance (submission type: Traditional).

What are the predicate devices for LessRay System?

LessRay with Tracking (K142243); NuVasive LessRay with Enhanced Tracking (K170800).

Who can help prepare an FDA 510(k) submission like LessRay System?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

LessRay System

K173314 · Nu Vasive, Incorporated · OWB · Nov 16, 2017 · Radiology

Device Facts

Record ID	K173314
Device Name	LessRay System
Applicant	Nu Vasive, Incorporated
Product Code	OWB · Radiology
Decision Date	Nov 16, 2017
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.1650
Device Class	Class 2
Attributes	Software as a Medical Device

Intended Use

LessRay® System is intended for use in any application where a fluoroscope is incorporated to aid in diagnosis and treatment of disease.

Device Story

LessRay is a software application interfacing with a fluoroscope via video cable. It captures, enhances, and displays fluoroscopic images on a computer monitor to improve clarity, contrast, and noise reduction, particularly for low-dose/pulsed imaging. The system includes C-arm tracking and instrument tracking capabilities. A tracker attached to an instrument allows the system to track its location relative to prior baseline x-rays, aiding the user in instrument positioning. The system provides visual cues to guide C-arm positioning. It is used in clinical settings by physicians and technicians. The device is passive, relying on the fluoroscope's video output without transmitting signals back to the fluoroscope. It serves as an auxiliary display to assist in surgical interventions, potentially allowing for lower radiation dose usage while maintaining diagnostic image quality.

Clinical Evidence

Bench testing only. Performance was demonstrated through verification of instrument tracking, alignment accuracy, image registration, and software validation. Electrical safety and EMC testing were performed per IEC 60601-1 and IEC 60601-1-2. No clinical data was provided.

Technological Characteristics

Software-based image processing system. Interfaces with fluoroscope via video cable. Hardware includes computer (Intel Core 2 Duo, NVIDIA Quadro 4000, 8GB RAM, 256GB HDD), frame grabber (Aver Media H339 or Elgato), and optical tracking hardware. Operates on Windows 8.1. Passive device; no signal transmission to fluoroscope. Image processing uses averaging algorithms for noise reduction and contrast/brightness enhancement.

Indications for Use

Indicated for use in any application where a fluoroscope is incorporated to aid in diagnosis and treatment of disease. No specific patient population, age, or gender restrictions are defined.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

LessRay with Tracking (K142243)
NuVasive LessRay with Enhanced Tracking (K170800)

Related Devices

K170800 — NuVasive LessRay with Enhanced Tracking · Nu Vasive, Incorporated · Aug 18, 2017
K142243 — LessRay with Tracking · Saferay Spine, LLC · Nov 18, 2014
K123226 — LESSRAY · Saferay Spine, LLC · Dec 5, 2012
K132970 — LESSRAY · Saferay Spine, LLC · Nov 29, 2013
K200360 — TrackX · Track X Technology, LLC · Mar 5, 2020

Submission Summary (Full Text)

{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) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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}------------------------------------------------ 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 | {5}------------------------------------------------ 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 {7}------------------------------------------------ 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. {8}------------------------------------------------ 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.