(67 days)
Not Found
No
The description focuses on image enhancement through comparison to a baseline image and does not mention AI or ML techniques. The modification is solely about software distribution method.
No.
LessRay® is a software that enhances fluoroscope images to aid in diagnosis and treatment; it does not directly treat disease.
No
The Device Description states that LessRay enhances images produced by a fluoroscope for display, but it does not perform any analysis or interpretation of those images to aid in diagnosis. Its intended use is to aid in "diagnosis and treatment of disease" by enhancing images, which is a tool for diagnosis, not the diagnostic device itself.
Yes
The device description explicitly states "LessRay* is a software only device". While it interfaces with a fluoroscope and uses a frame grabber within a computer, the submission focuses on the software itself and its installation method as the modification. The performance studies also focus on the software's functionality on different computer platforms, not on the hardware components.
Based on the provided information, the LessRay® device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The LessRay® device processes images from a fluoroscope, which is an imaging modality used to visualize structures within the body in real-time. It does not analyze biological samples like blood, urine, or tissue.
- The intended use is related to aiding in diagnosis and treatment using fluoroscopic images. This aligns with the use of medical imaging devices, not IVDs.
- The device description focuses on image processing and display. This is characteristic of medical imaging software, not IVD devices.
Therefore, the LessRay® device falls under the category of a medical imaging software device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The LessRay® 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, LLZ
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 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).
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Fluoroscope X-Ray System
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)
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.
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.
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K132970
Page 1 of 3
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 | |
| 5012 Chapel Hill Durham Blvd. Suite 203 | ||
| Durham, NC 27707 | ||
| Contact: | Calley Herzog | |
| Consultant, Medical Devices | ||
| Biologics Consulting Group, Inc. | ||
| Phone: 720-883-3633 | ||
| Fax: 720-293-0014 | ||
| Email: cherzog@bcg-usa.com | NOV 29 2013 | |
| Alternate Contact: | Donna-Bea Tillman, Ph.D. | |
| Biologics Consulting Group, Inc. | ||
| Phone: 410-531-6542 | ||
| Email: dtillman@bcg-usa.com | ||
| 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
1
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 | |
| 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. | ||
| Proposed Device | Predicate Device | |
| Compatible Hardware | ||
| Platforms | 1. ONYX 175z | |
| CPU: Intel Core 2 Duo | ||
| GPU: NVIDIA Quadro 4000 | ||
| RAM: 8 GB | ||
| HDD: 500 GB | ||
| Frame Grabber: Aver Media | ||
| H339 | ||
| Windows 7 |
- Sony VAIO L Series
CPU: Intel Core i7
GPU: NVIDIA GeForce 640M
RAM: 8 GB
HDD: 500 GB
Frame Grabber: El Gato
Windows 8 - Maxant Mediport 3000
CPU: Intel Core i7
GPU: NVIDIA GTX660TI
RAM: 8 GB
HDD: 512 GB
Frame Grabber: El Gato
Windows 7 - Dell Precision M6700
CPU: Intel Core i5
GPU: NVIDIA Quadro k3000M
RAM: 8 GB
HDD: 750 GB
Frame Grabber: El Gato
Windows 7 | 1. ONYX 175z
CPU: Intel Core 2 Duo
GPU: NVIDIA Quadro 4000
RAM: 8 GB
HDD: 500 GB
Frame Grabber: Aver Media
H339
Windows 7 |
| 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 does
images | Yes | Yes |
| Uses data from prior images to
improve quality of subsequent
images | Yes | Yes |
| Algorithm used to improve
image quality | NO CHANGE from K123226 | Summation of prior full dose
images with subsequent images |
Table 1: Device Comparison Table
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K132970
page 3 of 3
. . . .
3
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.
4
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 (800) 638-2041 or (301) 796-7100 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 (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
5
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