NuVasive LessRay with Enhanced Tracking

K170800 · Nu Vasive, Incorporated · OWB · Aug 18, 2017 · Radiology

Device Facts

• Record ID: K170800
• Device Name: NuVasive LessRay with Enhanced Tracking
• Applicant: Nu Vasive, Incorporated
• Product Code: OWB · Radiology
• Decision Date: Aug 18, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1650
• Device Class: Class 2
• Attributes: Software as a Medical Device

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.

Device Story

LessRay is a software application interfacing with a fluoroscope via video cable to enhance real-time imaging. It captures fluoroscopic video, applies image processing to reduce noise and improve contrast/clarity, and displays the enhanced output on a secondary monitor. The system supports C-arm tracking to guide positioning relative to prior baseline images and includes instrument tracking, where a tracker attached to an instrument allows the system to track its location and aid in positioning relative to baseline x-rays. Used in clinical settings by technicians and physicians to facilitate navigation and instrument placement. By enabling high-quality visualization from low-dose or pulsed fluoroscopy, the device aims to reduce radiation exposure while maintaining diagnostic utility. The system is passive, relying on the fluoroscope's video output without transmitting signals back to the imaging hardware.

Clinical Evidence

No clinical data. Bench testing only. Verification and validation included instrument tracking accuracy, GUI performance, and regression testing for image alignment and registration. Validation confirmed that instrument tracking allows for instrument relocalization with fewer x-ray images, greater accuracy, and less time compared to conventional fluoroscopy.

Technological Characteristics

Software-based image processing system. Interfaces with fluoroscope via video cable and frame grabber. Uses averaging algorithms for contrast/brightness enhancement and random noise reduction. Supports electromagnetic or optical tracking systems for 6 DOF C-arm and instrument tracking. Hardware requirements: Intel Core 2 Duo, NVIDIA Quadro 4000, 8GB RAM, Windows 7/8.1. Passive display system; does not transmit signals to the fluoroscope.

Indications for Use

Indicated for use in any application where a fluoroscope is incorporated to aid in diagnosis and treatment of disease. Applicable to patients requiring fluoroscopic imaging during interventional procedures.

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)

Submission Summary (Full Text)

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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

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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 [phone] or [phone] 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 [phone] or [phone] 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

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# 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: [phone]

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.

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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<br>/<br>Property | Predicate Device<br>LessRay with Tracking (K142243) | Subject Device<br>NuVasive LessRay with Enhanced<br>Tracking | Discuss<br>ion |
|-------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------|
| Intended Use<br>/ Indications<br>for Use | LessRay® with Tracking is intended for<br>use in any application where a<br>fluoroscope is incorporated to aid in<br>diagnosis and treatment of disease. | NuVasive® LessRay® with Enhanced<br>Tracking is intended for use in any<br>application where a fluoroscope is<br>incorporated to aid in diagnosis and<br>treatment of disease. | Same |
| Device Class | II | II | Same |
| Product Code | OWB, JAA, LLZ | OWB, JAA, LLZ | Same |
| Regulation<br>Number<br>(21CFR) | §892.1650 | §892.1650 | Same |
| Device<br>Classification<br>Name | Interventional Fluoroscopic X-Ray<br>System | Interventional Fluoroscopic X-Ray<br>System | Same |
| Specification / Property | Predicate Device<br>LessRay with Tracking (K142243) | Subject Device<br>NuVasive LessRay with Enhanced Tracking | Discussion |
| Device<br>Functionalities (image<br>acquisition, enhancement,<br>and display) | - Software based device used to<br>provide computer display systems<br>interfaced to a fluoroscope through<br>a video cable. The images<br>produced by the fluoroscope are<br>transmitted through a cable to a<br>frame capture board in the<br>computer where the images are<br>enhanced and then displayed on the<br>monitor.<br>- Enhanced images are displayed on<br>a computer monitor at the same<br>time that the corresponding<br>original image is displayed on the<br>fluoroscope monitor(s).<br>- Serves only as an image display<br>which is in addition to the<br>fluoroscope's standard image<br>display device. Device is passive,<br>in that the operation depends only<br>on the video output of the<br>fluoroscope, and it does not<br>transmit any signals or images to<br>the fluoroscope. | - Software based device used to<br>provide computer display systems<br>interfaced to fluoroscope through a<br>video cable. The images produced<br>by the fluoroscope are transmitted<br>through a cable to a frame capture<br>board in the computer where the<br>images are enhanced and then<br>displayed on the monitor.<br>- Enhanced images are displayed on<br>a computer monitor at the same<br>time that the corresponding<br>original image is displayed on the<br>fluoroscope monitor(s).<br>- Serves only as an image display<br>which is in addition to the<br>fluoroscope's standard image<br>display device. Device is passive,<br>in that the operation depends only<br>on the video output of the<br>fluoroscope, and it does not<br>transmit any signals or images to<br>the fluoroscope. | Same |
| Algorithms | - Image quality improvement using<br>averaging algorithm<br>- Contrast and brightness<br>enhancement with simultaneous<br>reduction of random noise | - Image quality improvement using<br>averaging algorithm<br>- Contrast and brightness enhancement<br>with simultaneous reduction of<br>random noise | Same |
| Compatible<br>hardware<br>platforms | Any computer that meets the following<br>minimum specifications:<br>CPU: Intel Core 2 Duo<br>GPU: NVIDIA Quadro 4000<br>RAM: 8 GB<br>HDD: 256 GB<br>Frame Grabber: Aver Media H339 or<br>Elgato<br>Operating System: Windows 7 or 8.1 | Any computer that meets the following<br>minimum specifications:<br>CPU: Intel Core 2 Duo<br>GPU: NVIDIA Quadro 4000<br>RAM: 8 GB<br>HDD: 256 GB<br>Frame Grabber: Aver Media H339 or<br>Elgato<br>Operating System: Windows 7 or 8.1 | Same |
| Specification / Property | Predicate Device<br>LessRay with Tracking (K142243) | Subject Device<br>NuVasive LessRay with Enhanced<br>Tracking | Discussion |
| C-arm<br>Tracking | - When tracking is enabled, will<br>automatically choose the Baseline<br>when the fluoroscope is near the<br>location and orientation that the<br>Baseline was initially taken.<br><br>- When tracking is enabled, requires | - When tracking is enabled, will<br>automatically choose the Baseline<br>when the fluoroscope is near the<br>location and orientation that the<br>Baseline was initially taken.<br><br>- When tracking is enabled, requires | Same |
| | hardware components in order to<br>mount the off-the-shelf tracking<br>hardware to the C-arm and to the<br>operating table. | hardware components in order to<br>mount the off-the-shelf tracking<br>hardware to the C-arm and to the<br>operating table. | |
| | - When tracking is enabled, requires<br>the use of an off-the-shelf tracking<br>system in order to track the 6 DOF<br>location of the C-arm relative to the<br>operating table. | - When tracking is enabled, requires<br>the use of an off-the-shelf tracking<br>system in order to track the 6 DOF<br>location of the C-arm relative to the<br>operating table. | |
| | - When tracking is enabled, visual<br>cues are provided which help guide<br>the user in positioning the C-arm<br>back to where a prior Baseline was<br>taken. | - When tracking is enabled, visual<br>cues are provided which help guide<br>the user in positioning the C-arm<br>back to where a prior Baseline was<br>taken. | |
| Tracking<br>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.