(19 days)
Not Found
No
The summary describes a standard digital X-ray system replacing older technology. There is no mention of AI or ML in the intended use, device description, or performance studies.
No
The device is described as an X-ray system for diagnostic and planning procedures, not for direct treatment. While it's used for procedures in urology, gastroenterology, and gynecology, its primary function is imaging.
Yes
The "Intended Use / Indications for Use" section explicitly states that the system is used for "functional x-ray diagnostics" and "diagnostic procedures."
No
The device description clearly states it is a "solid state detector X-ray system" and a "radiographic and fluoroscopy examination table with the X-ray tube over the table and the detector underneath the patient table," indicating it is a hardware system with physical components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the human body. They perform tests in vitro (in a lab setting, outside the body).
- This device is an X-ray system. It uses radiation to create images of the human body in vivo (within the living body).
- The intended use and device description clearly state it's for imaging procedures on patients. It's a diagnostic imaging system, not a device for analyzing biological samples.
Therefore, the Liebel-Flarsheim Direct Digital Imaging System falls under the category of diagnostic imaging devices, not IVDs.
N/A
Intended Use / Indications for Use
The Liebel-Flarsheim Direct Digital Imaging System is a solid state detector X-ray system that facilitates digital radiologic and/or fluoroscopic procedures requiring a beam of diagnostic quality radiation and a flat imaging table primarily for urological applications such as functional x-ray diagnostics, endourology and minimal invasive urology/surgery. The system may be used for urological, gastroenterological, and gynecological treatment, planning and diagnostic procedures. It is intended to replace fluoroscopic images formerly obtained through image intensifier technology. Not intended for mammography applications.
Product codes
MOB
Device Description
The Liebel-Flarsheim Direct Digital Imaging System is a radiographic and fluoroscopy examination' table with the X-ray tube over the table and the detector underneath the patient table. The table top can be moved longitudinally and laterally as well as vertically. The imaging system and table top can be rotated in the Trendelenburg and reverse-Trendelenburg positions. The system is a modified version of the Hydra Vision Urological X-Ray System (marketed as Hydra Vision Plus DR System). The modification features a multipurpose (radiography and fluoroscopy) solid state digital detector in place of the Image Intensifier and CCD camera for image acquisition. The table design remains unchanged.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-Ray
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
Extensive functional testing was performed comparing the Liebel-Flarsheim Direct Digital Imaging System to the Hydra Vision Urological X-Ray System. These tests included evaluations of the contrast resolution, maximum entrance exposure, maximum viewable image, and motion imaging performance. The testing confirms the Liebel-Flarsheim Direct Digital Imaging System meets the required specifications and supports the claim of substantial equivalence. No adverse affects have been detected.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1680 Stationary x-ray system.
(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. 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). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary 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.
0
Mallinckrodt
Section 4: 510(k) Summary
510(k) Owner:
JUL 1 1 2012
Liebel-Flarsheim Company LLC 2111 East Galbraith Rd. Cincinnati, OH 45237 Establishment Number: 1518293
Contact: Title: Telephone: Fax: Date Prepared: Mr. Craig Buehler Regulatory Affairs Specialist (314) 654-3188 (314) 654-3344 26 March 2012
Device:
Trade Name: Common Name: Classification Panel: CFR Section: Device Class: Product Code:
Liebel-Flarsheim Direct Digital Imaging System Solid State X-Ray Imager (Flat Panel/Digital Imager) Classification Name: Image-Intensified Fluoroscopic X-Ray System Radiology 21 CFR 892.1650 Class II MOB
Predicate Devices:
Hydra Vision Urological X-Ray System (K943581) UROSKOP Omnia (K101491) Nexus DRF Digital X-ray Imaging System (K103416)
Device Description:
The Liebel-Flarsheim Direct Digital Imaging System is a radiographic and fluoroscopy examination' table with the X-ray tube over the table and the detector underneath the patient table. The table top can be moved longitudinally and laterally as well as vertically. The imaging system and table top can be rotated in the Trendelenburg and reverse-Trendelenburg positions. The system is a modified version of the Hydra Vision Urological X-Ray System (marketed as Hydra Vision Plus DR System). The modification features a multipurpose (radiography and fluoroscopy) solid state digital detector in place of the Image Intensifier and CCD camera for image acquisition. The table design remains unchanged.
LIEBEL-FLARSHEIM COMPANY LLC 2111 E. GALBRAITH ROAD CINCINNATI. OH 45237
513-761-2700 (T)
WW.COVIDIEN.COM
1
Indication for Use:
The Liebel-Flarsheim Direct Digital Imaging System is a solid state detector X-ray system that facilitates digital radiologic and/or fluoroscopic procedures requiring a beam of diagnostic quality radiation and a flat imaging table primarily for urological applications such as functional x-ray diagnostics, endourology and minimal invasive urology/surgery. The system may be used for urological, gastroenterological, and gynecological treatment, planning and diagnostic procedures. It is intended to replace fluoroscopic images formerly obtained through image intensifier technology. Not intended for mammography applications.
Technological Characteristics:
The Liebel-Flarsheim Direct Digital Imaging System is a modified version of the Hydra Vision Urological X-Ray System. The Liebel-Flarsheim Direct Digital Imaging System incorporates a solid state detector instead of an x-ray image intensifier like the predicate Hydra Vision Urological X-Ray System. The Liebel-Flarsheim Direct Digital Imaging System utilizes the same solid state detector as found in the UROSKOP Omnia (K101491) and the Nexus DRF Digital X-ray Imaging System (K103416). The imaging chain is the same as found on the Nexus DRF Digital X-rav Imaging System (K103416). Many of the same components found on the Liebel-Flarsheim Direct Digital Imaging System are used on the Hydra Vision Urological X-Ray System or include minor modifications to existing components.
General Safety and Effectiveness Testing and Conformance
Electrical, mechanical safety and performance testing according to standards IEC 60601-1 (1988 + A1:1991 + A2:1995), IEC 60601-1-1 (2000), IEC 60601-1-3, and IEC 60601-2-32 (1994). The device was also tested in accordance with standard IEC 60601-1-2 3- edition 2007 - 03 for Electromagnetic Compatibility. All tests were satisfactory.
Performance Data:
Extensive functional testing was performed comparing the Liebel-Flarsheim Direct Digital Imaging System to the Hydra Vision Urological X-Ray System. These tests included evaluations of the contrast resolution, maximum entrance exposure, maximum viewable image, and motion imaging performance. The testing confirms the Liebel-Flarsheim Direct Digital Imaging System meets the required specifications and supports the claim of substantial equivalence. No adverse affects have been detected.
Conclusion:
The Liebel-Flarsheim Direct Digital Imaging System has the same intended use as its predicates. The imaging chain has been modified to include a flat panel detector and the Nexus DRF Digital Xray Imaging System.
The results of all testing contained in this submission demonstrates the Liebel-Flarsheim Direct Digital Imaging System does not raise any new significant issues of safety, effectiveness or
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performance when compared to the existing predicate devices. Liebel-Flarsheim Company LLC believes the Liebel-Flarsheim Direct Digital Imaging System is substantially equivalent to its and the country of the country of the county of the county of the country of the county of the county of the country of the country of the country of the country of the count predicates. · .
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Image /page/3/Picture/0 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 a stylized symbol that resembles an abstract human figure or a caduceus, with three wavy lines representing the branches of government or the flow of services.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Liebel-Flarsheim Company LLC % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313
JUL 1 1 2012
Re: K121838
Trade/Device Name: Liebel-Flarsheim Direct Digital Imaging System Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: MQB Dated: June 21, 2012 Received: June 22, 2012
Dear Mr. Job:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed 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.
If your device is classified (see above) into class II (Special Controls), it may be subject to such If your device is classified (bee aos regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 or any 1 vith all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of
4
medical device-related adverse events) (21 CFR 803); and good manufacturing practice medical device-related ad reibe evelity systems (QS) regulation (21 CFR Part 820). This letter requirements as set form in the quality, elevice as described in your Section 510(k) premarket wifi anow you to ogainmalized for a substantial equivalence of your device to a legally marketed nonification. The I Driving sification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 11 you desire specific davice of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket 9 150. Thous processions of the regarding the reporting 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 Tou may 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/cdrh/industry/support/index.html.
Sincerely Yours,
Janine M. Morris
Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Section 3: Indications For Use Statement
510(k) Number (if known): K121838
Device Name: Liebel-Flarsheim Direct Digital Imaging System Model Numbers: 700559 and 700560
Indications for Use:
The Liebel-Flarsheim Direct Digital Imaging System is a solid state detector X-ray system that facilitates digital radiologic and/or fluoroscopic procedures requiring a beam of diagnostic quality radiation and a flat imaging table primarily for urological applications such as functional x-ray diagnostics, endourology and minimal invasive urology/surgery. The system may be used for urological, gastroenterological, and gynecological treatment, planning and diagnostic procedures. It is intended to replace fluoroscopic images formerly obtained through image intensifier technology. Not intended for mammography applications.
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 OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
K121838
510K