Ziehm Vision RFD 3D

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized representation of an eagle or bird-like figure with three curved lines forming its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The text is in all capital letters and is positioned around the upper half of the logo. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 April 6, 2015 Ziehm Imaging GmbH % Mr. Richard Westrich Director of Regulatory Affairs and Quality Assurance Ziehm Imaging, Inc. 6280 Hazeltine National Drive ORLANDO FL 32822 Re: K142740 Trade/Device Name: Ziehm Vision RFD 3D Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OWB, OXO, JAA, JAK Dated: March 16, 2015 Received: March 16, 2015 Dear Mr. Westrich: 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 (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. {1}------------------------------------------------ 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 (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/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 (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 Robert Ochs. Ph.D. Acting Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows the logo for Ziehm Imaging. The logo consists of a circular graphic on the left and the text "ziehmimaging" on the right. The graphic is a stylized representation of a person inside of a circle with lines around it. The text is in a teal color. # Indications for Use 510(k) Number (if known): K142740 ZIEHM VISION RFD 3D Device Name: ### Indications for Use: The Ziehm Vision RFD 3D system is intended for use in providing both 2D and 3D medical imaging for all adult and pediatric populations, using pulsed and continuous fluoroscopic imaging. The device provides 2D medical imaging for fluoroscopy, digital subtraction, and acquisition of cine loops during diagnostic interventional and surgical procedures where intra-operative imaging and visualization of complex anatomical structures of both lower and higher contrast density are required. Such procedures may include but are not limited to those of interventional cardiology, heart surgery, hybrid procedures, interventional radiology, interventional angiography, electrophysiology, pediatrics, endoscopic, urological, gastroenterology, orthopedic, maxillofacial surgery, neurosurgery, critical care, emergency room procedures, and those procedures visualizing structures of the cervical, thoracic, and lumbar regions of the spine and joint fractures of the upper and lower extremities, and where digital image data is required for Computer-Assisted Surgery procedures. The device is also intended to provide 3D medical imaging of patients during orthopedic, neurological, intra-operative surgical procedures and where the clinician benefits from 3D visualization of complex anatomical structures, such as but not limited to those of high contrast objects, bones, joints, maxillofacial, cervical, thoracic, and lumbar regions of the spine, pelvis, acetabulum and joint fractures of the upper and lower extremities, and where digital image and C-arm positioning data is required for Computer-Assisted Surgery procedures. The visualization of such anatomical structures assists the clinical outcome. At the discretion of a physician, the device may be used for other imaging applications. This device does not support direct radiographic film exposures and is not intended for use in performing mammography. The system is not intended for use near MRI systems. Prescription Use X (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 Center for Devices and Radiological Health (CDRH) {3}------------------------------------------------ Image /page/3/Picture/0 description: The image contains the logo for Ziehm Imaging. The logo consists of a circular emblem on the left and the text "ziehmimaging" on the right. The emblem features a stylized human figure within a globe-like structure. The text is in a teal color and appears to be a sans-serif font. U.S. Food and Drug Administration Center for Devices and Radiological Health Document Mail Center -W066-G609 10903 New Hampshire Avenue Silver Spring, MD 20993-0002 ## 510 (k) Summary March 31, 2015 In accordance with 21 CFR §807.92 the following 510(k) summary information is provided: | Submitter Address: | Ziehm Imaging GmbH<br>Donaustrasse 31<br>90451 Nuremberg<br>Germany<br>Phone: + 49.911.2172-219<br>Fax: +49.911.2172-390 | |-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------| | Primary Contact<br>Person /Agent: | Richard L. Westrich<br>Director of Regulatory Affairs and Quality<br>Assurance<br>Ziehm Imaging, Inc.<br>Phone: (407) 615-8560 Ext 140<br>Fax: (470) 615-8561 | | Secondary Contact<br>Person: | Stefan Fiedler<br>Director QM/RA<br>Ziehm Imaging GmbH<br>Phone: + 49.911. 2172-219<br>Fax: +49.911.2172-390 | | Device (Trade Name): | Ziehm Vision RFD 3D | | Common /Usual<br>Names: | Mobile Fluoroscopic C-Arm | | Classification: | 21CFR 892.1650 | {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for Ziehm Imaging. The logo consists of a circular icon with a stylized human figure inside, surrounded by orbital lines. To the right of the icon is the text "ziehmimaging" in a gradient teal color, with the color becoming more saturated from left to right. | Regulation<br>Description: | Image-intensified fluoroscopic x-ray system | |-------------------------------------|--------------------------------------------------------| | Device: | Interventional fluoroscopic x-ray system | | Product Code: | OWB | | Subsequent<br>Classification(s) | 21CFR 892.1650 | | Regulation<br>Description: | Image-intensified fluoroscopic x-ray system | | Device: | Image-intensified fluoroscopic x-ray system,<br>mobile | | Product Code: | OXO | | Subsequent<br>Classification(s) | 21CFR 892.1650 | | Regulation<br>Description: | Image-intensified fluoroscopic x-ray system | | Device: | System, x-ray, fluoroscopic, image intensified | | Classification Product<br>Code: | JAA | | Classification: | 21CFR 892.1750 | | Regulation<br>Description: | Computed tomography x-ray system. | | Device: | System, X-ray, tomography, computed | | Classification Product<br>Code: | JAK | | Predicate Device:<br>Decision Date: | K132904 Ziehm Vision RFD<br>12/05/2013 | | Classification Product<br>Code: | JAA | | Classification: | 21CFR 892.1650 | | Subsequent Product<br>Codes: | OWB, OXO | {5}------------------------------------------------ | Predicate Device: | K073346 Ziehm Vision2 FD Vario 3D | |------------------------------|-----------------------------------| | Decision Date: | 03/12/2008 | | Classification Product Code: | JAA | | Classification: | 21CFR 892.1650 | | Subsequent Product Codes: | OWB, JAK | The ZIEHM VISION RFD 3D employs X-rays as its imaging General Description: technology for visualizing human anatomy in both 2D and 3D imaqing. The X-ray tube in the generator produces X-rays, quided toward the patient under control of the user at the direction of a physician who determines the specific clinical procedure. The images from the system assist the physicians in visualizing the patient's anatomy. This visualization helps to localize regions of pathology and for surgical procedures. The device provides both real-time image capture and post capture visualization and of in vivo surgical procedures and post-surgical outcomes. > The Ziehm Vision RFD 3D mobile fluoroscopy system is a flat panel detector (FD) Computed tomography x-ray system and fluoroscopic X-ray imaging system consisting of two mobile units: a Mobile Stand (C-Arm) and a Monitor Cart/Workstation. The Mobile Stand is comprised of a mono-block high voltage generator, X-ray control, and a C-Profile which is "C" shaped and supports the X-ray generator, and the image receptor Flat Panel Detector (FD). > The device performs both 2D medical imaging and the specialized 4 axes of motorized movement necessary for the 3D imaging. This provides the user/operator the option to use manual or motorized linear and rotational movements of the C- Profile for positioning of the imaging components at various angles and distances with respect to the patient using a control interface, Vision Center, Remote Vision Center or remote Position Control Center. > The motorization of the 4 axes provides the user an alternative for visualizing anatomical structures using a variable iso-centric location. The system working with a variable iso-center allows freely selectable positions of patient anatomy. The variable isocenter and distance control ensures that anatomical structures are safely visualized from different angles without re-adjusting the Carm or moving the patient. The iso-center is not restricted to orbital movements and can hold this iso-center during angulations and vertical travel using the 4 motorized axes. This same motion control provides the bases for 3D views of the patient anatomy. These 3D views are generated by means of an iterative algorithm. {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for Ziehm Imaging. The logo consists of a circular graphic with a stylized human figure inside, next to the text "ziehmimaging". The text is in a teal color and appears to be a sans-serif font. The system uses the images of a scan captured with relation to a predefined scan center to compute the three-dimensional representation of an object. The 3D views are always displayed on the reference screen of the monitor cart. It is possible to display multiplanar reconstructions, orthogonal or freely selectable sections, and different surface reconstructions. The Distance Control surface detection integrated around the lower edge of the flat panel detects objects, such as patients. When the flat panel approaches an object, the device reduces speed, slowing the motorized movement. The movement stops immediately before entering a defined safety zone. The mobile stand supports the optional wireless footswitch for optimum positioning for the surgeon by removing the cable on the floor. The Monitor Cart is a mobile platform that connects to the Mobile Stand by a cable, and which integrates the LCD flat panel display monitors, 2D image processing, Optional 3D image processing, user controls and image recording devices. Interfaces provided for optional peripheral devices such as external monitors, thermal video printers, wireless video display, wireless video server, injector connection and image storage devices (USB, DVD) and DICOM fixed wired and wireless network interfaces. - The Ziehm Vision RFD 3D system is intended for use in providing Indications for Use: both 2D and 3D medical imaging for all adult and pediatric populations, using pulsed and continuous fluoroscopic imaging. The device provides 2D medical imaging for fluoroscopy, digital subtraction, and acquisition of cine loops during diagnostic interventional and surgical procedures where intra-operative imaging and visualization of complex anatomical structures of both lower and higher contrast density are required. Such procedures may include but are not limited to those of interventional cardiology, heart surgery, hybrid procedures, interventional radiology, pediatrics, endoscopic, urological, gastroenterology, orthopedic, maxillofacial surgery, neurology, neurosurgery, critical care, emergency room procedures, and those procedures visualizing structures of the cervical, thoracic, and lumbar regions of the spine and joint fractures of the upper and lower extremities, and where digital image data is required for Computer-Assisted Surgery procedures. The device is also intended to provide 3D medical imaging of patients during orthopedic, neurological, intra-operative surgical procedures and where the clinician benefits from 3D visualization {7}------------------------------------------------ Image /page/7/Picture/0 description: The image contains the logo for ziehmimaging. The logo consists of a circular graphic on the left and the company name "ziehmimaging" on the right. The text is in a teal color and appears to be a sans-serif font. of complex anatomical structures, such as but not limited to those of high contrast objects, bones, joints, maxillofacial, cervical, thoracic, and lumbar regions of the spine, pelvis, acetabulum and joint fractures of the upper and lower extremities, and where digital image and C-arm positioning data is required for Computer-Assisted Surgery procedures. The visualization of such anatomical structures assists the clinician in the clinical outcome. At the discretion of a physician, the device may be used for other imaging applications. This device does not support direct radiographic film exposures and is not intended for use in performing mammography. The system is not intended for use near MRI systems. Summary of The Ziehm Vision RFD 3D is based on the Ziehm Vision RFD Technological K132904 including the major system control, x-ray generator, Characteristics: Pulsed fluoroscopy, image detector, 4 Axes motorization, software, with imaging workstation upgraded to integrate the 3D image capture and control functions from our Ziehm Vision2 FD Vario 3D K073346. The subject device employs the same fundamental scientific technologies, as the predicate devices for system controls, full DICOM compatibility, and intuitive graphical user interface. The technological comparison chart in Section 12, of this premarket submission reveals that the proposed device shares the technological characteristics performed by the predicate devices. > The following table compares the dominant performance data of the subject device with the predicate devices to substantiate equivalence of the subject device and predicate devices. | Features/Technology | Subject Device<br>Ziehm Vision RFD<br>3D (K142740) | Predicate Device<br>Ziehm Vision RFD<br>(K132904) | Predicate Device<br>Ziehm Vision2 FD<br>Vario 3D (K073346) | |----------------------------------------------------------------------|----------------------------------------------------|---------------------------------------------------|------------------------------------------------------------| | Mobile fluoroscopic c-arm | Yes | Yes | Yes | | Product Codes | OWB, OXO, JAA,<br>JAK | OWB, JAA, OXO | JAA, OWB, JAK | | User interface touch<br>control panel | Yes, same design | Yes, same design | Yes, same design | | X-ray generator and tube<br>housing assembly<br>monoblock technology | Yes, same<br>monoblock design<br>rotating anode | Yes, same<br>monoblock design<br>rotating anode | monoblock design<br>Fixed anode tube | | KV Range 40-120 kV | Yes | Yes | 40-110 kV<br>Opt 120 kV | | Max power output | 25 kW<br>Optional 20 kW or<br>7.5 kW | 25 kW<br>Optional 20 kW or<br>7.5 kW | 2.02 kW | | Pulsed fluoroscopy | 7.5 kW 1.5-75mA | 7.5 kW 1.5-75mA | 1.5-20mA | {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the logo for Ziehm Imaging. The logo consists of a circular icon with a stylized human figure inside, surrounded by orbiting lines. To the right of the icon is the company name, "ziehmimaging", written in a teal-colored, sans-serif font. | | 20 kW 1.5-200mA<br>25 kW 1.5-250mA | 20 kW 1.5-200mA<br>25 kW 1.5-250mA | | |----------------------------------------------------------|--------------------------------------------------------------------------------|--------------------------------------------------------------------------------|------------------------------------------------------------| | X-ray tube | Rotating anode<br>0.3, 0.6 focal spot | Rotating anode<br>0.3, 0.6 focal spot | Stationary anode<br>0.6 focal spot | | Collimator/beam limiter<br>asymmetrical shutters | Yes, same design | Yes, same design | Yes, same design | | Virtual collimation | Yes, same design | Yes, same design | Yes, same design | | X-ray detector (FPD) | Yes, same design | Yes, same design | Yes, same design | | Amorphous silicon | 20 cm x 20 cm or<br>30 cm x 30 cm | 20 cm x 20 cm or<br>30 cm x 30 cm | 20 cm x 20 cm | | FPD Matrix size | 20 cm x 20 cm<br>1024x1024 pixels<br>or<br>30 cm x 30 cm<br>1536 x 1536 pixels | 20 cm x 20 cm<br>1024x1024 pixels<br>or<br>30 cm x 30 cm<br>1536 x 1536 pixels | 20 cm x 20 cm<br>1024x1024 pixels | | FPD's same panel<br>technology. | Yes, same design | Yes, same design | Yes, same design | | AERC Dose control system | Yes, same design<br>kV/mA curve types<br>Use of all three | Yes, same design<br>kV/mA curve types<br>Use of only two | Yes, same design<br>kV/mA curve types<br>Use of only two | | Image data port for<br>navigation system | Yes, same design<br>Export of image<br>data and<br>parameters | Yes, same design<br>Export of image<br>data and<br>parameters | Yes, same design<br>Export of image data<br>and parameters | | Manual and motorized<br>axes of movement | Yes, both manual<br>and motorized 4<br>axes of movement | Yes, both manual<br>and motorized 4<br>axes of movement | Yes both manual and<br>motorized 3 axes of<br>movement | | Image Post Processing 2D | Yes, same design | Yes, same design | Yes, same design | | 3D Imaging Workstation<br>With Post Processing | Yes, uses same 3D<br>Image Workstation | No 3D Image<br>Capture | Yes, uses same 3D<br>Image Workstation | | 3D Reconstruction<br>Algorithm | Yes | No 3D Workstation | Yes | | DICOM functionality<br>including RSDR | Yes, same design | Yes, same design | Yes, same design | | Monitors Dual 19" TFT<br>Flat Screen Displays | Yes, same design | Yes, same design | Yes, same design | | Vision Center<br>Graphical user<br>interface touch panel | Yes, same design | Yes, same design | Yes, same design | #### Summary of Non-Clinical Test Data: Ziehm Vision RFD 3D is based on the direct modifications to a cleared predicate device Ziehm Vision RFD (K132904); The Ziehm Vision RFD 3D design changes were completed in accordance with Ziehm Imaging GmbH Quality Management System Design Controls and Engineering, standards compliance, and Verification and Validation testing were successfully conducted. Tests were performed on the Ziehm Vision RFD 3D which demonstrated that the device is safe and effective, performs comparably to the {9}------------------------------------------------ Image /page/9/Picture/0 description: The image shows the logo for Ziehm Imaging. The logo consists of a circular emblem on the left and the company name "ziehmimaging" on the right. The text is in a teal color and appears to be a sans-serif font. predicate devices, and is substantially equivalent to the predicate devices. Tests included verification/validation testing to internal functional specifications (including software) and non-clinical image comparisons involving flat panel display images taken with the new device and the predicate devices Ziehm Vision RFD K132904 and Ziehm Vision2 FD Vario 3D K073346. Documentation provided demonstrates compliance of the modified device Ziehm Vision RFD 3D to all FDA requirements stated in Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, including results of verification/validation tests to software requirements and software risk hazards. Performance testing confirmed that the Ziehm Vision RFD 3D complies with 21 CFR 1020.30-32 Federal Performance Standards for X-Ray Fluoroscopic equipment and with relevant voluntary safety standards for Electrical Safety and Electromagnetic Compatibility testing, specifically IEC standards listed in the table below. Together, the verification/validation activities successfully confirmed device requirements has been fulfilled, and that system functionality is consistent with the user needs, intended uses, and the Ziehm Vision RFD 3D device correctly performs as designed, and raises no new questions reqarding either safety or effectiveness. Therefore, when compared to the predicate devices the Ziehm Vision RFD 3D supports a determination of substantial equivalence to the predicate devices. Compliance Standards: | FDA/CDRH From 3626<br>(5/11) | A Guide for the Submission of Initial Reports on Diagnostic X-Ray<br>Systems and Their Major Components. | |------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 21 CFR 1020.30-32 | Federal Performance Standard for Diagnostic X-ray Systems. | | MDD 93/42/EEC | Annex II of the Medical Devices Directive (MDD) 93/42/EEC | | AAMI/ANSI ES60601-1 | Medical Electrical Equipment -- Part 1: General Requirements for<br>Basic Safety and Essential Performance (IEC 60601-1:2005, mod),<br>Date: 2010, Conformance Standard #19-5 | | IEC 60601-1:2005 | Medical Electrical Equipment, General Requirements for Safety.<br>Edition 3.0, Date: 2005-12-15.<br>No Recognized Conformance Standard but general basis of<br>AAMI/ANSI ES60601-1. | | IEC 60601-1-2: 2007 | Medical Electrical Equipment, General Requirements for Safety,<br>Electromagnetic Compatibility. Edition 3.0, Date: 2007-03-30,<br>Conformance Standard #19-1 | {10}------------------------------------------------ Image /page/10/Picture/0 description: The image shows the logo for ziehmimaging. The logo consists of a circular graphic with a stylized human figure inside, surrounded by orbital lines. To the right of the graphic is the text "ziehmimaging" in a teal, sans-serif font. The text appears to be slightly gradient, with the left side being lighter than the right. - IEC 60601-1-3: 2008 Medical Electrical Equipment, Radiation Protection in Diagnostic Xray Equipment. Edition 2.0, Date: 2008-01-22, Conformance Standard #12-210 - Medical electrical equipment, Part 2-43: Particular requirements IEC 60601-2-43: 2010 for basic safety and essential performance of X-ray equipment for interventional procedures. Edition 2.0, Date: 2010-03-25, Conformance Standard #12-202 - Medical electrical equipment, Part 2-54: Particular requirements IEC 60601-2-54: 2009 for the basic safety and essential performance of X-ray equipment for radiography and radioscopy. Edition 1.0, Date: 2009-06-29, Conformance Standard #12-274 - Safety of laser products, Equipment Safety, requirements, and IEC 60825-1: 2007 user quide Edition 2.0, Date: 2007-03-30 Conformance Standard #12-273 - ISO 14971: 2007 Application of risk management to medical devices. Edition 2.0, Date: 2007-03-01, Conformance Standard #5-40 - Ziehm Imaging GmbH considers the Ziehm Vision RFD 3D to be as Conclusion: safe, as effective, and performs substantially equivalent to the predicate device Ziehm Vision RFD (K132904) and Ziehm Vision2 FD Vario 3D (K073346) in accordance with its labeling. ### End of 510(k) Summary Richard L. Westrich Official Agent and Correspondent for Ziehm Imaging GmbH. Ziehm Imaging Inc, 6280 Hazeltine National Drive Orlando, FI. 32822