(194 days)
Not Found
No
The summary describes image processing and an iterative algorithm for 3D reconstruction, but does not mention AI, ML, or related terms like neural networks or deep learning. The focus is on the mechanical movement and image processing techniques, not on learning from data.
No
The device is an imaging system that assists in diagnosis and surgical procedures by providing visualization of anatomical structures, rather than directly treating a condition.
Yes
Explanation: The device is intended for providing both 2D and 3D medical imaging, which is used for intra-operative imaging and visualization of complex anatomical structures, and to assist physicians in localizing regions of pathology. These activities are diagnostic in nature as they involve identifying or visualizing diseases or conditions. The "Intended Use" section explicitly states "diagnostic interventional and surgical procedures."
No
The device description clearly outlines hardware components such as an X-ray tube, generator, C-Profile, Flat Panel Detector (FD), Mobile Stand, and Monitor Cart. While it includes software for image processing and control, it is fundamentally a hardware-based imaging system.
Based on the provided text, the Ziehm Vision RFD 3D system is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Ziehm Vision RFD 3D Function: The description clearly states that the Ziehm Vision RFD 3D system uses X-rays to visualize human anatomy in vivo (within the living body). It is used during diagnostic, interventional, and surgical procedures to provide real-time and post-capture imaging of internal structures.
The device's function is based on imaging the patient directly, not on analyzing samples taken from the patient. Therefore, it falls under the category of medical imaging devices, not In Vitro Diagnostics.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
OWB, OXO, JAA, JAK
Device Description
The ZIEHM VISION RFD 3D employs X-rays as its imaging technology for visualizing human anatomy in both 2D and 3D imaging. The X-ray tube in the generator produces X-rays, guided 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 C-arm 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.
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-rays, Fluoroscopic
Anatomical Site
Complex anatomical structures of both lower and higher contrast density, including but not limited to 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. For 3D imaging: 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.
Indicated Patient Age Range
Adult and pediatric populations.
Intended User / Care Setting
Physician, user, operator in interventional and surgical procedures.
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)
Non-Clinical Test Data: Verification and Validation testing were successfully conducted in accordance with Ziehm Imaging GmbH Quality Management System Design Controls and Engineering, standards compliance. Tests performed on the Ziehm Vision RFD 3D demonstrated that the device is safe and effective, performs comparably to the 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.
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.
K132904 Ziehm Vision RFD, K073346 Ziehm Vision2 FD Vario 3D
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.
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
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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)
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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
Donaustrasse 31
90451 Nuremberg
Germany
Phone: + 49.911.2172-219
Fax: +49.911.2172-390 |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Primary Contact
Person /Agent: | Richard L. Westrich
Director of Regulatory Affairs and Quality
Assurance
Ziehm Imaging, Inc.
Phone: (407) 615-8560 Ext 140
Fax: (470) 615-8561 |
| Secondary Contact
Person: | Stefan Fiedler
Director QM/RA
Ziehm Imaging GmbH
Phone: + 49.911. 2172-219
Fax: +49.911.2172-390 |
| Device (Trade Name): | Ziehm Vision RFD 3D |
| Common /Usual
Names: | Mobile Fluoroscopic C-Arm |
| Classification: | 21CFR 892.1650 |
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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
| Description: | Image-intensified fluoroscopic x-ray system |
|---|---|
| Device: | Interventional fluoroscopic x-ray system |
| Product Code: | OWB |
| Subsequent | |
| Classification(s) | 21CFR 892.1650 |
| Regulation | |
| Description: | Image-intensified fluoroscopic x-ray system |
| Device: | Image-intensified fluoroscopic x-ray system, |
| mobile | |
| Product Code: | OXO |
| Subsequent | |
| Classification(s) | 21CFR 892.1650 |
| Regulation | |
| Description: | Image-intensified fluoroscopic x-ray system |
| Device: | System, x-ray, fluoroscopic, image intensified |
| Classification Product | |
| Code: | JAA |
| Classification: | 21CFR 892.1750 |
| Regulation | |
| Description: | Computed tomography x-ray system. |
| Device: | System, X-ray, tomography, computed |
| Classification Product | |
| Code: | JAK |
| Predicate Device: | |
| Decision Date: | K132904 Ziehm Vision RFD |
| 12/05/2013 | |
| Classification Product | |
| Code: | JAA |
| Classification: | 21CFR 892.1650 |
| Subsequent Product | |
| Codes: | OWB, OXO |
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| 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.
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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
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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
Ziehm Vision RFD
3D (K142740) | Predicate Device
Ziehm Vision RFD
(K132904) | Predicate Device
Ziehm Vision2 FD
Vario 3D (K073346) |
|----------------------------------------------------------------------|----------------------------------------------------|---------------------------------------------------|------------------------------------------------------------|
| Mobile fluoroscopic c-arm | Yes | Yes | Yes |
| Product Codes | OWB, OXO, JAA,
JAK | OWB, JAA, OXO | JAA, OWB, JAK |
| User interface touch
control panel | Yes, same design | Yes, same design | Yes, same design |
| X-ray generator and tube
housing assembly
monoblock technology | Yes, same
monoblock design
rotating anode | Yes, same
monoblock design
rotating anode | monoblock design
Fixed anode tube |
| KV Range 40-120 kV | Yes | Yes | 40-110 kV
Opt 120 kV |
| Max power output | 25 kW
Optional 20 kW or
7.5 kW | 25 kW
Optional 20 kW or
7.5 kW | 2.02 kW |
| Pulsed fluoroscopy | 7.5 kW 1.5-75mA | 7.5 kW 1.5-75mA | 1.5-20mA |
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| | 20 kW 1.5-200mA
25 kW 1.5-250mA | 20 kW 1.5-200mA
25 kW 1.5-250mA | |
|----------------------------------------------------------|--------------------------------------------------------------------------------|--------------------------------------------------------------------------------|------------------------------------------------------------|
| X-ray tube | Rotating anode
0.3, 0.6 focal spot | Rotating anode
0.3, 0.6 focal spot | Stationary anode
0.6 focal spot |
| Collimator/beam limiter
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
30 cm x 30 cm | 20 cm x 20 cm or
30 cm x 30 cm | 20 cm x 20 cm |
| FPD Matrix size | 20 cm x 20 cm
1024x1024 pixels
or
30 cm x 30 cm
1536 x 1536 pixels | 20 cm x 20 cm
1024x1024 pixels
or
30 cm x 30 cm
1536 x 1536 pixels | 20 cm x 20 cm
1024x1024 pixels |
| FPD's same panel
technology. | Yes, same design | Yes, same design | Yes, same design |
| AERC Dose control system | Yes, same design
kV/mA curve types
Use of all three | Yes, same design
kV/mA curve types
Use of only two | Yes, same design
kV/mA curve types
Use of only two |
| Image data port for
navigation system | Yes, same design
Export of image
data and
parameters | Yes, same design
Export of image
data and
parameters | Yes, same design
Export of image data
and parameters |
| Manual and motorized
axes of movement | Yes, both manual
and motorized 4
axes of movement | Yes, both manual
and motorized 4
axes of movement | Yes both manual and
motorized 3 axes of
movement |
| Image Post Processing 2D | Yes, same design | Yes, same design | Yes, same design |
| 3D Imaging Workstation
With Post Processing | Yes, uses same 3D
Image Workstation | No 3D Image
Capture | Yes, uses same 3D
Image Workstation |
| 3D Reconstruction
Algorithm | Yes | No 3D Workstation | Yes |
| DICOM functionality
including RSDR | Yes, same design | Yes, same design | Yes, same design |
| Monitors Dual 19" TFT
Flat Screen Displays | Yes, same design | Yes, same design | Yes, same design |
| Vision Center
Graphical user
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
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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
(5/11) | A Guide for the Submission of Initial Reports on Diagnostic X-Ray
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
Basic Safety and Essential Performance (IEC 60601-1:2005, mod),
Date: 2010, Conformance Standard #19-5 |
| IEC 60601-1:2005 | Medical Electrical Equipment, General Requirements for Safety.
Edition 3.0, Date: 2005-12-15.
No Recognized Conformance Standard but general basis of
AAMI/ANSI ES60601-1. |
| IEC 60601-1-2: 2007 | Medical Electrical Equipment, General Requirements for Safety,
Electromagnetic Compatibility. Edition 3.0, Date: 2007-03-30,
Conformance Standard #19-1 |
10
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- 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
- 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
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