LESSRAY

K132970 · Saferay Spine, LLC · OWB · Nov 29, 2013 · Radiology

Device Facts

• Record ID: K132970
• Device Name: LESSRAY
• Applicant: Saferay Spine, LLC
• Product Code: OWB · Radiology
• Decision Date: Nov 29, 2013
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1650
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The LessRay® 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-only device designed to enhance low-dose fluoroscopic images. It interfaces with a fluoroscope via a video cable, transmitting images to a frame grabber on a computer. The software processes these images by comparing them to a baseline image taken at a regular dose setting; it then displays the enhanced, reduced-noise images on a computer monitor simultaneously with the original fluoroscopic feed. Used in clinical settings during procedures involving fluoroscopy, the device is operated by healthcare professionals. It does not control the fluoroscope. By improving the quality of low-dose images, the device allows clinicians to maintain diagnostic image quality while potentially reducing radiation exposure for the patient.

Clinical Evidence

No clinical data. Bench testing only. Verification testing was conducted on four distinct computer platforms to ensure the software functions correctly and meets the specifications of the previously cleared device.

Technological Characteristics

Software-only device; runs on standalone computers (Windows 7/8) with specific CPU, GPU, RAM, and frame grabber requirements. Passive device; does not control fluoroscope. Uses summation of prior full-dose images with subsequent low-dose images to reduce noise. Connectivity via video cable input. No specific material standards or sterilization required as it is software-only.

Indications for Use

Indicated for use in any clinical application where a fluoroscope is utilized to assist in the diagnosis and treatment of disease. Intended for prescription use.

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® (K123226)

Submission Summary (Full Text)

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K132970
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# 510(K) SUMMARY

In accordance with 21 CFR 807.87(h) and (21 CFR 807.92) the 510(k) Summary for the LessRay® is provided below.

| Device Common Name: | Interventional Fluoroscope X-Ray System, Accessory | |
|----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Device Proprietary Name: | LessRay® | |
| Submitter: | SafeRay Spine, LLC<br>5012 Chapel Hill Durham Blvd. Suite 203<br>Durham, NC 27707 | |
| Contact: | Calley Herzog<br>Consultant, Medical Devices<br>Biologics Consulting Group, Inc.<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] | NOV 29 2013 |
| Alternate Contact: | Donna-Bea Tillman, Ph.D.<br>Biologics Consulting Group, Inc.<br>Phone: [phone]<br>Email: [e-mail] | |
| Date Prepared: | September 19, 2013 | |
| Classification Regulation: | 21 CFR 892.1650 | |
| Panel: | Radiology | |
| Product Code: | OWB | |
| Predicate Device: | K123226 - Submitter's own previously cleared device | |

## Indication for Use:

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

# Device Description:

I.essRay* is a software only device that is used to enhance the utility of low dose images by comparing them to a baseline image taken at a regular dose setting. A computer running LessRay" is interfaced to a fluoroscope with a video cable. The images produced by the

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fluoroscope are transmitted to a frame grabber in the computer where the images are enhanced and then displayed on the monitor of the computer running LessRay®. Each image is displayed by LessRay at the same time as the corresponding original image is displayed on the fluoroscope monitor(s).

## Performance Data:

The subject of this 510(k) is a modification to the previously cleared LessRay® System. The l.essRay device that was previously cleared in K123226 was provided preloaded on a computer system. The only modification to the device since its previous clearance is that the software will now be provided on a CD for installation by the end user onto a computer that meets the stated specifications. These modifications represent a minor device modification and do not affect the indications for use. To assess the impact of this change a risk analysis was conducted. Based on the risk analysis verification testing was performed to ensure proper functioning of the software on four computer platforms. Each of the four computer platforms tested meet the specifications of the LessRay® System as previously cleared.

# Substantial Equivalence:

The modification of the LessRay System to not provide it on a pre-loaded computer does not change the fundamental technology of the device or the intended use of the device. The algorithm used and the user experience are identical to that of the previously cleared version. Based on technological characteristics and indication for use, the modified device is substantially equivalent to the previously cleared LessRay" System.

| | Proposed Device | Predicate Device |
|---------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K132970 | K123226 |
| Submitter | SafeRay Spine. LLC | SafeRay Spine. LLC |
| Classification Regulation | 892.1650 | 892.1650 |
| Product Code | OWB, LLZ | OWB, LLZ |
| Indication | Indicated for use in any<br>application where a fluoroscope<br>is incorporated to aid in diagnosis<br>and treatment of disease. | Indicated for use in any<br>application where a fluoroscope<br>is incorporated to aid in diagnosis<br>and treatment of disease. |
| | Proposed Device | Predicate Device |
| Compatible Hardware<br>Platforms | 1. ONYX 175z<br>CPU: Intel Core 2 Duo<br>GPU: NVIDIA Quadro 4000<br>RAM: 8 GB<br>HDD: 500 GB<br>Frame Grabber: Aver Media<br>H339<br>Windows 7<br>2. Sony VAIO L Series<br>CPU: Intel Core i7<br>GPU: NVIDIA GeForce 640M<br>RAM: 8 GB<br>HDD: 500 GB<br>Frame Grabber: El Gato<br>Windows 8<br>3. Maxant Mediport 3000<br>CPU: Intel Core i7<br>GPU: NVIDIA GTX660TI<br>RAM: 8 GB<br>HDD: 512 GB<br>Frame Grabber: El Gato<br>Windows 7<br>4. Dell Precision M6700<br>CPU: Intel Core i5<br>GPU: NVIDIA Quadro k3000M<br>RAM: 8 GB<br>HDD: 750 GB<br>Frame Grabber: El Gato<br>Windows 7 | 1. ONYX 175z<br>CPU: Intel Core 2 Duo<br>GPU: NVIDIA Quadro 4000<br>RAM: 8 GB<br>HDD: 500 GB<br>Frame Grabber: Aver Media<br>H339<br>Windows 7 |
| Software is Run on a stand-<br>alone computer and monitor | Yes | Yes |
| Device is passive and doesn't<br>control the fluoroscope | Yes | Yes |
| Displays reduced noise images | Yes | Yes |
| For use during procedures that<br>involve fluoroscopy | Yes | Yes |
| Improves quality of low does<br>images | Yes | Yes |
| Uses data from prior images to<br>improve quality of subsequent<br>images | Yes | Yes |
| Algorithm used to improve<br>image quality | NO CHANGE from K123226 | Summation of prior full dose<br>images with subsequent images |

#### Table 1: Device Comparison Table

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K132970
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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the circumference of the circle.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 29, 2013

SafeRay Spine, LLC % Ms. Calley Herzog, Consultant Biologics Consulting Group, Inc. 400 N. Washington Street, Suite 100 ALEXANDRIA VA 22314

Re: K132970

Trade/Device Name: LessRay® Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OWB, LLZ Dated: November 6, 2013 Received: November 7, 2013

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 (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.

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## Page 2- Ms. Calley Herzog

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] 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

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### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

510(k) Number (if known) K132970

Device Name LessRay(R)

### Indications for Use (Describe)

The LessRay® 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)

## 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) (Signalure)

Robert A Ochs