(51 days)
Not Found
No
The description mentions image enhancement but does not use terms like AI, ML, deep learning, or neural networks, which are typically associated with AI/ML image processing. The predicate device also appears to be a standard image enhancement system.
No.
The LessRay™ is a display system that enhances fluoroscopic images for diagnosis and treatment; it does not directly provide therapy itself.
No.
The "Intended Use" states that it aids in diagnosis and treatment but the device itself is a display system that enhances fluoroscopic images, it does not perform the diagnosis. The fluoroscope is the diagnostic device.
No
The device description explicitly states it is a "stand-alone computer display system interfaced to a fluoroscope with a video cable" and includes a "frame grabber in the computer" and a "LessRay™ monitor." These are hardware components, not just software.
Based on the provided information, the LessRay™ is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- LessRay™ Function: The LessRay™ processes and enhances fluoroscopic X-ray images of the human body in vivo (within the living body). It does not analyze biological specimens.
- Intended Use: The intended use clearly states it's used "where a fluoroscope is incorporated to aid in diagnosis and treatment of disease," which involves imaging the patient directly.
Therefore, the LessRay™ falls under the category of a medical imaging device, not an IVD.
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
The LessRay™ is a stand-alone computer display system 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 LessRay™ monitor. Each image is displayed on the LessRay™ monitor 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
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 LessRay™ device the following performance tests were performed:
- Validation Test 1 Low Dose/Pulse Image Improvement
- Validation Test 2 Blocked Anatomy
- Validation Test 3 Parallax Test
- Validation Test 4 Pig Study
The LessRay™ system meets the following Electrical Safety and EMC standards:
- IEC 60601-1, Medical Electrical Equipment Part 1: General Requirements for Safety, 1988
- IEC 60601-1-2, Medical Electrical Equipment Part 1-2: General Requirements for Safety - Collateral standard: Electromagnetic Compatibility - Requirements and Tests
Results: The results of validation testing demonstrate that the LessRay™ provides accurate and clinically relevant images. Therefore performance testing demonstrates that the LessRay™ is as safe and effective as the 3DFIS.
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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5.0 510(k) Summary be
DEC 05 2012
| Device Common Name: | Interventional Fluoroscopic X-Ray System, Accessory |
|---|---|
| Device Proprietary Name: | LessRay™ |
| Submitter: | SafeRay Spine, LLC 5103 Brookstone Dr. Durham, NC 27713 |
| Contact: | Calley Herzog, Consultant to SafeRay Spine Biologics Consulting Group, Inc. Phone: 720-883-3633 Fax: 720-293-0014 Email: cherzog@bcg-usa.com |
| Date Prepared: | November 30, 2012 |
| Classification Regulation: | 892.1650 |
| Panel: | Radiology |
| Product Codes: | Primary: OWB - Interventional Fluoroscopic X-Ray System, Accessory |
| Additional Product Code: LLZ - System, Image Processing, Radiological | |
| Predicate Device: | K013841 3D Sharp Fluoroscope Image System (3DFIS – Model IES-FL-101) |
| 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:
::
. :
The LessRay™ is a stand-alone computer display system 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 LessRay™ monitor. Each image is displayed on the LessRay™ monitor at the same time as the corresponding original image is displayed on the fluoroscope monitor(s).
: :
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Performance Data:
To establish the substantial equivalence of the LessRay™ device the following performance tests were performed: .::.:..
- Validation Test 1 Low Dose/Pulse Image Improvement
- Validation Test 2 Blocked Anatomy
- Validation Test 3 Parallax Test
- Validation Test 4 Pig Study
The LessRay™ system meets the following Electrical Safety and EMC standards:
- IEC 60601-1, Medical Electrical Equipment Part 1: General Requirements for Safety, 1988
- IEC 60601-1-2, Medical Electrical Equipment Part 1-2: General Requirements for Safety - Collateral standard: Electromagnetic Compatibility - Requirements and Tests
Substantial Equivalence Discussion:
The LessRay™ System is substantially equivalent to the 3DSharp Fluoroscope Image System (3DFIS) K013841. The 3DFIS is also designed to capture multiple images, manipulate the images arithmetically, and display the generated reduced noise images.
The differences between the LessRay™ System and the 3DFIS are that the LessRay™ System, the LessRay™ System can merge sequential and non-sequential images of the same anatomy to enhance image quality, while the 3DFIS merges only sequential images to enhance image quality. An additional difference is that the 3DFIS uses an algorithm similar to a Fourier transform to enhance image quality, while the LessRayTM System uses an averaging algorithm to use full-dose images to enhance image quality. Although the LessRay™ and 3DFIS use different mathematical methods to improve image quality, the results of validation testing demonstrate that the LessRay™ provides accurate and clinically relevant images. Therefore performance testing demonstrates that the LessRay™ is as safe and effective as the 3DFIS.
Substantial Equivalence Conclusion:
Based on the identical indication, similar technological characteristics, and results of performance testing, the LessRay™ is substantially equivalent to the 3D Sharp Fluoroscope Image System (3DFIS - Model IES-FL-101) as it was cleared in K0138413DFIS as it was cleared in K013841.
| Device Characteristic | Predicate Device | Subject Device |
|---|---|---|
| 510(k) Number | K013841 | - |
| Device Name | 3DFIS, MODEL IES-FL-101 | LessRay™ |
| Manufacturer | 3DSHARP, INC. | SafeRay Spine, LLC |
| Computer | Dual G4 Power Mac | Intel Core 2 Duo Processor, |
| 8GB | ||
| Frame Grabber | Scion Corp, Model CG7 | Hybrid ATSC/QAM/Analog F2 |
| Type Minicard w/10-pin AV-Input | ||
| Monitor | Apple 15" Flat Screen | 17" LCD Touch Screen |
| Device Characteristic | Predicate Device | Subject Device |
| Operation System | MacOS 9.1 | Windows 7 |
| Image Processing Speed | 30 frame/sec | 10.6 frame/sec |
| Delay between frame acquisition | 33msec | 33msec |
| 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. |
| Stand-alone computer and monitor | Yes | Yes |
| Displays unaltered image from fluoroscope | Yes | Yes |
| Displays reduced noise images | Yes | Yes |
| For use during procedures that involve fluoroscopy | Yes | Yes |
A detailed comparison is provided in the Table below:
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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - (USA)" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure with stylized wings.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
December 5. 2012
SafeRay Spine, LLC % Ms. Calley Herzog Consultant Biologics Consulting Group, Inc. 13417 Quivas St. WESTMINSTER CO 80234
Re: K123226
Trade/Device Name: LessRayTM Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OWB and LLZ Dated: October 15, 2012 Received: October 24, 2012
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 vour 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.
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Page 2-Ms. Herzog
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.
Michael D. O'Hara
Janine M. Morris, M.S. Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
5
Indications for Use Statement 4.0
510(k) Number (if known):
Device Name: LessRay™
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.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OlR)
Michael D. O'Hara
(Division Sign Off)
Division of Radiological Health
Office of In Vitro Diagnostic and Radiological Health
510(k) K 123226
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