(28 days)
Not Found
No
The summary describes standard image processing techniques and iterative algorithms for 3D reconstruction, but does not mention AI, ML, or related concepts.
No
The device is an imaging system (X-ray) used for diagnostic purposes, not for providing therapy.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device is for "diagnostic interventional and surgical procedures" and helps to "localize regions of pathology," indicating its role in diagnosing medical conditions.
No
The device description explicitly states it is an X-ray system consisting of mobile units (Mobile Stand and Monitor Cart/Workstation) with hardware components like an X-ray tube, generator, C-Profile, and Flat Panel Detector. 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:
- Intended Use: The intended use clearly states the device is for providing medical imaging (2D and 3D fluoroscopy) during diagnostic, interventional, and surgical procedures. This involves visualizing anatomical structures within the patient (in vivo).
- Device Description: The description details an X-ray system that generates images of the patient's internal anatomy. It describes components like an X-ray tube, flat panel detector, and C-arm, all used for imaging the patient directly.
- Lack of IVD Characteristics: An IVD device is used to examine specimens from the human body (like blood, urine, tissue) outside the body (in vitro) to provide information for diagnosis, monitoring, or treatment. The Ziehm Vision RFD 3D does not perform any analysis on such specimens.
The device is a medical imaging system used for visualizing the patient's internal structures directly, which falls under the category of diagnostic imaging equipment, 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 pulsed and continuous fluoroscopic medical imaging for adult and pediatric populations.
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, 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 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. 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, JAK, JAA, OXO
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 Xray 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 (FPD) 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 (FPD).
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 iso-center 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-ray / Fluoroscopy
Anatomical Site
Complex anatomical structures, interventional cardiology, heart, interventional angiography, electrophysiology, cervical, thoracic, and lumbar regions of the spine, joint fractures of the upper and lower extremities, bones, joints, maxillofacial, pelvis, acetabulum.
Indicated Patient Age Range
Adult and pediatric populations. It is the physician's responsibility to decide whether to use the system with infants, children and adipose patients.
Intended User / Care Setting
Physician / Not explicitly stated, though context suggests diagnostic 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
Non-clinical image comparison with sets of images with the modified device and the predicate. Anthropomorphic (PMMA material) phantoms and anatomical simulation phantoms were employed. Image comparison sets taken were representative of both the adult and pediatric populations. A Radiologist performed an assessment of individual image sets.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: Non-clinical imaging and dose testing (bench testing).
Sample Size: Not explicitly stated, implied from image comparison sets and phantom usage.
Key Results: Device capability to provide both reduced dose while maintaining image quality. Radiologist concluded that the image quality of the Ziehm Vision RFD 3D results in comparable patient care to the Predicate device Ziehm Vision RFD 3D (K142740) and fulfills the requirements as stated by the intended use.
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.
0
September 16, 2020
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size below that.
Ziehm Imaging GmbH % Mr. Steve Seeman Director of Regulatory Affairs and Quality Assurance Ziehm-Orthoscan, Inc. 14555 N. 82nd Street SCOTTSDALE AZ 85260
Re: K202360
Trade/Device Name: Ziehm Vision RFD 3D Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: Class II Product Code: OWB, JAK, JAA, OXO Dated: August 14, 2020 Received: August 19, 2020
Dear Mr. Seeman:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K202360
Device Name Ziehm Vision RFD 3D
Indications for Use (Describe)
The Ziehm Vision RFD 3D system is intended for use in providing both 2D and 3D pulsed and continuous fluoroscopic medical imaging for adult and pediatric populations.
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 angiography, electrophysiology, pediatrics, endoscopic, urological, gastroenterology, orthopedic, maxillofacial surgery, neurology, neurosurgery, critical care, emergency room procedures visualizing structures of the cervical, thoracic, and lumbar regions of the spine and joint fractures of the upper and lower 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. This device does not support direct radiographic film exposures and is not in performing mammography. The system is not intended for use near MRI systems.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image shows the logo for Ziehm Imaging. The logo consists of a circular graphic with intersecting lines, resembling a globe with a human figure inside. To the right of the graphic is the text "ziehmimaging" in a teal sans-serif font. The logo appears to be for a medical imaging company.
510(k) Number: K202360
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
September 15, 2020
In accordance with 21 CFR §807.92 the following 510(k) summary information is provided:
| Submitter Address: | Ziehm Imaging GmbH
Lina-Ammon-Strasse 10
90471 Nuremberg
Germany
Phone: + 49.911.2172-219
Fax: +49.911.2172-390 |
|------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|
| Primary Contact
Person / Agent: | Steve Seeman
Director of Regulatory Affairs and Quality Assurance
Ziehm-Orthoscan, Inc.
14555 N 82nd St
Scottsdale AZ, 85260 |
| 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(s) | 21CFR 892.1650 |
| Classification
Names: | Image-intensified fluoroscopic x-ray system |
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Image /page/4/Picture/0 description: The image shows the logo for Ziehm Imaging. The logo consists of a stylized globe with a human figure inside, followed by the text "ziehmimaging" in a teal color. The text is written in a sans-serif font and appears to be slightly faded.
Device: Interventional fluoroscopic x-ray system
OWB, JAK, JAA, OXO Product Code:
Predicate Device: K142740 Ziehm Vision RFD 3D
Decision Date: 04/06/2015
21CFR 892.1650 Classification:
Classification Image-intensified fluoroscopic x-ray system Names:
Interventional fluoroscopic x-ray system Device:
Product Code: OWB, JAA, JAK, OXO
General Description: The ZIEHM VISION RFD 3D employs X-rays as its imaging technology for visualizing human anatomy in both 2D and 3D imaging. The Xray 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 (FPD) 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 (FPD).
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
5
Image /page/5/Picture/0 description: The image shows the logo for Ziehm Imaging. The logo consists of a stylized globe with a human figure inside, followed by the text "ziehmimaging" in a teal color. The text is written in a sans-serif font.
positions of patient anatomy. The variable iso-center 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.
Intended Use The Ziehm Vision RFD 3D is a mobile C-arm providing image data by means of a non-invasive x-ray technique during medical procedures and stores them temporarily.
The Ziehm Vision RFD 3D is intended for use in all medical indications requiring fluoroscopy. The Ziehm Vision RFD 3D is intended for use to provide 2D and 3D image data specifically but not limited in the field of orthopedics, traumatology and oral and maxillofacial surgery. Furthermore, it is intended for use specifically but not limited to the imaging of soft tissues. The system is intended for use with human beings of any age. It is the physician's responsibility to decide whether to use the system with infants, children and adipose patients.
The system is intended for use with human bodies covering such as structures but not limited to the following, e.g. organs, tissue, bones, implants depending on the medical indication.
The system is not intended for use near MRI systems or for mammography.
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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 on the left and the text "ziehmimaging" on the right. The text is in a teal color and appears to be a sans-serif font. The circular graphic contains a stylized image of a person inside of a globe.
The Ziehm Vision RFD 3D system is intended for use in providing both 2D and Indications for Use: 3D pulsed and continuous fluoroscopic medical imaging for adult and pediatric populations.
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, 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 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 Carm positioning data is required for Computer-Assisted Surgery procedures.
The visualization of such anatomical structures assists the clinician in the clinical outcome. 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.
- The proposed modified device Ziehm Vision RFD 3D C-arm employs Technology: the same fundamental control, and scientific technology as that of our predicate device Ziehm Vision RFD 3D C-arm (K142740).
The radiation control, X-Ray monoblock generator, power supplies as well as our advanced imaging system are very similar to the predicate device Ziehm Vision RFD 3D C-arm (K142740).
Software architecture design is nearly identical to that of the predicate device Ziehm Vision RFD C-arm (K142740). With modification of the software to support functionality, Imaqe processing applications related to the optional device specific features.
The primary modifications of the C-Arm include a 30 kW generator using the same housing, x-ray tube, and very similar design while keeping the same dimensions as the predicate Ziehm Vision RFD 3D (K142740), new pre-filter and low absorption removable grid, for lower skin entrance dose imaging, improving operator workflow during extended procedures, brachytherapy geometric data, updated NaviPort, enhanced vessel visualization, enhanced screw visualization, surface rendering, measurement function, while keeping
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Image /page/7/Picture/0 description: The image shows the logo for ziehmimaging. The logo consists of a circular graphic with a stylized human figure inside, along with the company name "ziehmimaging" in a teal sans-serif font. The logo appears to be for a medical imaging company.
the same profile of our predicate device Ziehm Vision RFD 3D C-arm (K142740).
Summary of The comparisons of the predicate devices show the scientific and Technological technology characteristics of the Ziehm Vision RFD 3D are substantial equivalence to that of the predicate device Ziehm Vision Characteristics: RFD 3D (K142740).
Device Comparison Table
| Model | Modified
Ziehm Vision RFD 3D | Predicate
Ziehm Vision RFD3D
(K142740) | Comparable Properties
Substantial
Equivalence Discussion |
|----------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | Unknown at this time | K142740 | - |
| Classification | Class II | Class II | Identical |
| Product Code | OWB (interventional
fluoroscopic x-ray system) | OWB (interventional
fluoroscopic x-ray system) | Identical |
| Application / Indications for Use | | | |
| Indications for
Use | The Ziehm Vision RFD 3D
system is intended for use
in providing both 2D and
3D pulsed and continuous
fluoroscopic medical
imaging for adult and
pediatric populations.
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 | The ZIEHM VISION RFD 3D
is intended for use in
providing both 2D and 3D
medical imaging for all
adult and pediatric
populations, using pulsed
and continuous
fluoroscopic digital
imaging, as well as digital
subtraction and cine image
capture 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, | Removed the following
statement from the
proposed device in the IFU
(At the discretion of a
physician the device may
be used for other imaging
applications). |
| Model | Modified
Ziehm Vision RFD 3D | Predicate
Ziehm Vision RFD3D
(K142740) | Comparable Properties
Substantial
Equivalence Discussion |
| | interventional cardiology,
heart surgery, hybrid
procedures, interventional
radiology, interventional
angiography,
electrophysiology,
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 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 | heart surgery, hybrid
procedures, interventional
radiology, interventional
angiography,
electrophysiology,
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
aided surgery procedures,
and whenever the clinician
benefits from variable iso-
centric positioning and/or
intraoperatively generated
3D imaging of high contrast
objects (bones and joints),
complex anatomical
structures and a high
degree of geometric
imaging accuracy, and
where such fluoroscopic,
cine and DSA imaging is
required in and around high
magnetic fields. 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. | |
| Model | Modified
Ziehm Vision RFD 3D | Predicate
Ziehm Vision RFD3D
(K142740) | Comparable Properties
Substantial
Equivalence Discussion |
| | required for Computer-
Assisted Surgery
procedures.
The visualization of such
anatomical structures
assists the clinician in the
clinical outcome. 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. | 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. | |
| X-ray Generator | | | |
| Maximum
Parameter | • Variant A0:
max. 25 kW,
max. 120 kV,
max. 250 mA
Variant A1:
max. 30 kW @
nominal 100kV
max. 120 kV,
max. 300 mA | Variant A2:
max. 25 kW, @ nominal
100kV
max. 120 kV,
max. 250 mA | Predicate
The new proposed device
generator (variant 30 kW)
has a higher maximum
power output.
100 kV @ 300 mA. |
| Pulsed
Fluoroscopy:
Operating values | • Variant A0:25 kW
kV range: 40 - 120 kV
mA range: 0.2 - 250
mA
Variant A1: 30 kW
kV range: 40 - 120 kV
mA range: 0.2 - 300
mA | • Variant A2:25 kW
kV range: 40 - 120 kV
mA range: 0.2 - 250
mA | The new generator
(variant A1) of the new
modified proposed device
has a higher maximum
power output as compared
to the Predicate. however,
the design and housing
are identical. |
| Model | Modified
Ziehm Vision RFD 3D | Predicate
Ziehm Vision RFD3D
(K142740) | Comparable Properties
Substantial
Equivalence Discussion |
| Pulsed
Fluoroscopy:
Pulse and
Duration | • pulse width:
4 - 40 ms (30cm and
31 cm" FPD
aSi/CMOS)
pulse rate:
50/60 Hz: 1, 2, 4, 8,
12.5, 25 pulse/s | • pulse width:
4 - 40 ms (30cm and
31 cm" FPD aSi/CMOS)
pulse rate:
50/60 Hz: 1, 2, 4, 8,
12.5, 25 pulse/s | Identical. |
| Digital
Radiography
(Snapshot) /
Operating Values | • Variant A0: 25kW
kV range: 40 - 120 kV
mA range: up to 250
mA
• Variant A1: 30 kW
kV range: 40 -120 kV
mA range: up to 300
mA with Varex 31
cm CMOS FPD, and
Varex 30 cm aSi
FPD) | • Variant A2: 25kW
kV range: 40 - 120 kV
mA range: up to 250
mA | Although the modified
device Ziehm Vision RFD
3D is not identical to the
predicate K142740 the
general system exposure
control technology and
operational functionality
are identical in regards to
the predicate K142740 |
| Thermal
Management | Active cooling: | Active cooling: | Identical |
| X-ray Tube | | | |
| Tube Type | Rotating anode: | Rotating anode: | Identical |
| Beam Limiter/ Collimator | | | |
| Collimator
System | Digital Collimator: | Asymmetrical Collimator: | Identical in operation.
Name change |
| Image Detector | | | |
| Detector
Technology | Variant A0: 30 cm aSi
FPD: | Variant A0: 30 cm aSi
FPD: | Identical |
| Model | Modified
Ziehm Vision RFD 3D | Predicate
Ziehm Vision RFD3D
(K142740) | Comparable Properties
Substantial Equivalence Discussion |
| | • Type: Amorphous Silicon Flat Panel Detector (aSi)
Variant A1: 31 cm CMOS FPD:
• Type: CMOS Flat Panel Detector | • Type: Amorphous Silicon Flat Panel Detector (aSi)
Variant A1: 31 cm CMOS FPD:
• Type: CMOS Flat Panel Detector | |
| Anti-Scatter Grids | | | |
| Fixed anti-
scatter grid | fixed anti-scatter grid:
Pb 8/70 | fixed anti-scatter grid:
Pb 8/70 | Identical |
| optional
removable anti-
scatter grid | Removable Grid: Pb 8:1 /
70 lines | Removable Grid: Pb 8:1 /
70 lines | Identical |
| Laser Positioning Device | | | |
| Laser Positioning
Device on
Generator
(optional) | Class 2M (IEC 60825-1),
635 nm | Class 2M (IEC 60825-1),
635 nm | Identical |
| Laser Positioning
Device on Image
Detector
(optional) | Class 2M (IEC 60825-1),
635 nm | Class 2M (IEC 60825-1),
635 nm | Identical |
| Electrical Requirements | | | |
| Electrical
Requirements | • Power supply:
100-240 VAC (± 10%),
50/60 Hz | • Power supply:
100-240 VAC (± 10%),
50/60 Hz | Identical. |
| Mechanics | | | |
| Mechanical Size
weight | Weight and dimensions | Weight and dimensions | Identical |
| Monitors | | | |
| Display Monitor | • 19" Duo flat screen
monitors or | • 18" Duo flat screen
monitors or | Identical in performance
and use. |
| Model | Modified
Ziehm Vision RFD 3D | Predicate
Ziehm Vision RFD3D
(K142740) | Comparable Properties
Substantial
Equivalence Discussion |
| | • 32" UDH single flat
screen monitor | • 20" UDH Duo flat screen
monitor | |
| Monitor Arm | Monitor Cart with fix or
articulating monitor arm
(option) | Monitor Cart with fix or
articulating monitor arm
(option ) | Identical |
| Endoscopy
Display Option | N/A | Color flat screen monitor | The new modified Ziehm
Vision RFD 3D does not
have the option for an
Endoscopy display when
compared to the Predicate
device K142740 |
| User Interface | | | |
| Control Elements
Touch Panel | Vision Center
Remote Vision Center | Vision Center
Remote Vision Center | Identical |
| Radiation Switches | | | |
| X-Ray hand
switch | • cable bound hand
switch on Mobile Stand | • cable bound hand
switch on Mobile Stand | Identical |
| X-Ray foot
switch | • Cable bound footswitch
• optional: Wireless
footswitch | • Cable bound footswitch
• optional: Wireless
footswitch | Identical, |
| Further
X-ray switches | • Radiation button at
"Vision Center" | • Radiation button at
"Vision Center" | Identical |
| | • Radiation button at
"Remote Vision Center" | • Radiation button at
"Remote Vision Center" | |
| Digital Image Processing | | | |
| 2D imaging | 2D Fluorscopic Imaging | 2D Fluorscopic Imaging | Identical: |
| 3D image
acquisition | • 180° motor-driven scan
165° orbital rotation
15° shift scan | • 180° motor-driven scan
165° orbital rotation
15° shift scan | Identical |
| | • Standard scan scan
time: 48 s
up to 400 images | • Standard scan scan time:
48 s
up to 400 images | |
| 3D Visualization | • Multiplanar
Reconstruction (MPR)
• Volume Rendering | • Multiplanar
Reconstruction (MPR)
• Volume Rendering | Change of 3D Features for
proposed device.
Modes of operation are |
| Model | Modified
Ziehm Vision RFD 3D | Predicate
Ziehm Vision RFD3D
(K142740) | Comparable Properties
Substantial
Equivalence Discussion |
| | • Enhanced Screw
Visualization (Option)
• Surface Rendering | | described in the
Instructions for Use. |
| 3D Volume size: | • 3D Volume size
(standard): 16.0 cm x
16.0 cm x 16.0 cm
• (option Zoom in
function and Cochlea
Package): 10.0 cm x
10.0 cm x 10.0 cm
• (option larger field of
view): 19.8 cm x 19.6
cm x 18.0 cm
• Resolution: 3203 voxels
and 5123 voxels | • 3D Volume size
(standard): 16.0 cm x
16.0 cm x 16.0 cm
• (option Zoom in function
and Cochlea Package):
10.0 cm x 10.0 cm x
10.0 cm
• (option larger field of
view): 19.8 cm x 19.6
cm x 18.0 cm
• Resolution: 3203 voxels
and 5123 voxels | Identical |
| Application-
Oriented
Anatomical
Programs
(AOAP) | 2D and 3 D imaging | 2D and 3D imaging | Identical: |
| Additional
Functions | • Metal
• 2D Measurement
w/anatomical marking
• Reposition
• High Quality
• Low Dose
• Obese Patient | • Metal
• Reposition
• High Quality
• Low Dose
• Obese Patient
• Motion | The Modified Device
ZVRFD 3D has additional
measurement and Obese
feature to that of the
Predicate ZVRFD 3D
(K142740) |
| Image
Acquisition | • Auto save
• Cine loop | • Auto save
• Cine loop | Identical |
| Post-Processing
Functions | • Zoom: 3 levels | • Zoom: 7 levels | The predicate K142740
has 7 levels of zoom. The
proposed device has 3
levels. |
| DSA Functions
(option) | DSA real-time subtraction | DSA real-time subtraction | Identical |
| Model | Modified
Ziehm Vision RFD 3D | Predicate
Ziehm Vision RFD3D
(K142740) | Comparable Properties
Substantial
Equivalence Discussion |
| Anatomical
Marking Tool -
AMT (Option) | • Mark anatomical
structures | • Mark anatomical
structures | Identical |
| Digital Memory | • Storage capacity: | • Storage capacity: | Identical |
| Data
Organization | Radiation Dose Structured
Report (RDSR)
• Calculated Dose Area
Product (DAP)
• DAP value tagged to
stored image
• Air Kerma dose
display
• Air Kerma value
tagged to stored
image | Radiation Dose Structured
Report (RDSR)
• Calculated Dose Area
Product (DAP) | Although not identical.
The new features improve
the clinician's ability to
obtain more information
as to the dose for each
image in the radiation
structed dose report. |
| HIPAA | option for HIPAA Security | option for HIPAA Security | Identical |
| Cybersecurity | Software integrity check | Software integrity check | Identical |
| DICOM | DICOM 3 | DICOM 3 | Identical |
| Inter-operability
(options) | • Ziehm NaviPort 2D
• Ziehm NaviPort 3D
Extended operation | • Ziehm NaviPort 2D
• Ziehm NaviPort 3D | Although both devices
have 2D and 3D NaviPort.
The proposed device has
additional 3D geometrical
data and connection for
external navigation |
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Image /page/8/Picture/0 description: The image shows the logo for Ziehm Imaging. The logo consists of a circular graphic on the left and the company name "ziehmimaging" on the right. The graphic features a stylized representation of a human figure within a globe-like structure. The text is in a teal color and appears to be a sans-serif font.
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Image /page/10/Picture/0 description: The image shows the logo for Ziehm Imaging. The logo consists of a circular graphic to the left of the company name. The graphic contains a stylized image of a person inside of a globe. The company name is written in a teal sans-serif font.
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Image /page/11/Picture/0 description: The image shows the logo for Ziehm Imaging. The logo consists of a circular graphic to the left of the company name. The graphic contains a stylized image of a person inside of a globe. The company name is written in a teal sans-serif font.
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Image /page/12/Picture/0 description: The image contains the logo for Ziehm Imaging. The logo consists of a circular graphic on the left and the company name "ziehmimaging" on the right. The circular graphic features a stylized representation of a person inside of a globe. The text is in a teal color.
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Image /page/13/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 features a stylized human figure inside a globe-like structure. The text is in a teal color and appears to be a sans-serif font.
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The table below summarizes the substantive feature/technological differences between the predicate device and the proposed device:
Conclusion of Table The changes of the proposed modified device Ziehm Vision RFD 3D C-arm above: described in the table do not change the fundamental control mechanism, operating principle, energy type, or intended use found on predicate device and supports substantially equivalents to the predicate device Ziehm Vision RFD 3D (K142740) in accordance with its labeling. Adverse Effects on The proposed Ziehm Vision RFD 3D C-arm's potential radiatical, Health: and electrical hazards are identified and analyzed as part of risk management, and controlled by meeting the applicable CDRH 21CFR
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subchapter J performance requirements, recognized and general consensus standards, designing and manufacturing under Ziehm Imaging GmbH Quality System, and system verification and validation testing ensure the device performs to the product specifications and its intended use. The adherence to these applicable requlations and certification to Recognized Consensus Standards that apply to this product provides the assurance of device safety and effectiveness.
Summary of Non-Clinical Test Data:
Ziehm Vision RFD 3D is based on direct modifications to cleared predicate device Ziehm Vision RFD 3D (K142740).
The design of the modified Ziehm Vision RFD 3D was completed in accordance with Ziehm Imaging GmbH Quality Management System Design Controls, 21 CFR 820 and applicable standards. Verification and Validation testing were successfully conducted on the device in compliance with FDA requirements as stated in the following documentation.
Testing regarding electrical safety according to ANSI/AAMI ES60601-1 and regarding electromagnetic compatibility according to IEC 60601-1-2 was performed. The test results show compliance with both standards.
Testing according to Guidance's "Radio Frequency Wireless Technology in Medical Devices" and "Design Considerations and Premarket Submissions Recommendations for Interoperable Medical Devices" show, neither the wireless features nor the interoperable interfaces of the device affect the safety and effectiveness.
Documentation provided demonstrates compliance of the modified device Ziehm Vision RFD 3D to FDA requirements stated in "A Guide for the Submission of Initial Reports on Diagnostic X-Ray Systems and Their Major Components" as applicable. This includes but is not limited to leakage radiation of diagnostic source assembly, peak tube potential (kV), tube current mA, fluoroscopic entrance exposure rates, and beam-limiting alignment to device image receptor. Further, this performance testing confirmed that the modified Ziehm Vision RFD 3D complies with 21 CFR 1020.30-32 Federal Performance Standards for X-Ray Fluoroscopic equipment and with relevant safety standards such as IEC 60601-1-3, IEC 60601-2-43, IEC 60601-2-54.
Non-clinical image comparison with sets of images with the modified device and the predicate shows equivalence regarding image quality.
With reqard to the flat panel detector (SSXI), documentation provided in this submission demonstrates compliance of the modified device Ziehm Vision RFD 3D (K142470) to "Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices".
Furthermore, an assessment regarding the low dose functionality of the modified Ziehm Vision RFD 3D shows the ability to reduce dose for certain applications.
Software testing was performed as required by "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" and
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"Content of Premarket Submissions for Management of Cybersecurity in Medical Devices".
Determination of The verification/validation activities successfully confirmed device requirements have been fulfilled, system functionality is consistent with the Substantial user needs, intended uses, and performs as designed, and raises no new Equivalence: questions regarding either safety or effectiveness.
Therefore, Ziehm Imaging GmbH believes the modified device Ziehm Vision RFD 3D C-arm image quality, safety and effectiveness supports a determination of substantial equivalence to the predicate device Ziehm Vision RFD 3D (K142740).
Compliance to FDA Guidance and Standards
FDA/CDRH From 3626 A Guide for the Submission of Initial Reports on Diagnostic X-Ray (5/11) Systems and Their Major Components.
- 21 CFR 1020.30-32 Federal Performance Standard for Diagnostic X-ray Systems.
General Standards / Requlations
- Medical Device Single Audit Program (MDSAP) MDSAP
- MDD 93/42/EEC Annex II of the Medical Devices Directive (MDD) 93/42/EEC
EN ISO 13485 Medical devices - Quality management systems - Requirements for regulatory purposes Date: 2016
Recognized Consensuses Standards
- ANSI/AAMI ES60601-1: Medical Electrical Equipment, Part 1: General Requirements for Basic Safety and Essential Performance (IEC 60601-1:2005, mod) Date: 2012 Conformance Standard #19-4
- IEC 60601-1-2: Medical Electrical Equipment, Part 1-2: General Requirements for Safety, Electromagnetic Compatibility Edition 4.0, Date: 2014-02 Conformance Standard #19-8
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- IEC 60601-1-3: Medical Electrical Equipment, Part 1-3: Radiation Protection in Diagnostic X-ray Equipment Edition 2.1, Date: 2013-04 Conformance Standard #12-269
- IEC 60601-1-6: Medical Electrical Equipment, Part 1-6: Usability Edition 3.1, Date: 2013-10 Conformance Standard #5-89
- IEC 60601-2-43: Medical electrical equipment, Part 2-43: Particular requirements for basic safety and essential performance of X-ray equipment for interventional procedures Edition 2.0, Date: 2010-03 Conformance Standard #12-202
- IEC 60601-2-54: Medical electrical equipment, Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy Edition 1.1, Date: 2015 Conformance Standard #12-296
- IEC 60825-1: Safety of laser products, Equipment Safety, requirements, and user guide Edition 2.0, Date: 2007 Conformance Standard #12-273
- ISO 14971: Medical devices Application of risk management to medical devices Edition 2.0, Date: 2007 Conformance Standard #5-40
Determination of Summary Bench Testing
Substantial Equivalence:
Verification and Validation including hazard mitigations executed resulted in demonstrated system met Design Input and user needs.
The device was tested by the notified test laboratory resulting in device being certified compliant with ANSI/AAMI ES6060-1-1 series, including IEC 60601-2-54. Further device met all applicable sections of 21 CFR Subchapter J performance standards.
The modified Ziehm Vision RFD 3D development occurred under our design control processes, software development processes, and overall quality management system. They included but are not limited to,
- Risk Analysis .
- . Required reviews
- Design reviews ●
- Component testing ●
- Integration testing
- Performance testing
- Safety testing .
- Product use testing ●
Performance bench testing included:
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Image /page/18/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 features a stylized human figure inside a globe-like structure. The text is in a teal color and appears to be a sans-serif font.
Non-clinical imaging and dose testing methods demonstrated the device capability to provide both reduced dose while maintaining image quality. Further in line with UCM089742- Premarket Assessment of Pediatric Medical Devices May 24, 2014 and UCM 302938- Pediatric Information for X-ray Imaging Device Premarket Notifications Nov 28, 2017. Non-clinical image and dose Lab testing, were employed. Anthropomorphic (PMMA material) phantoms and anatomical simulation phantoms were employed, image comparison sets taken were representative of both the adult and pediatric populations. A Radiologist performed an assessment of individual image sets. Radiologist conclusion, the image quality of the Ziehm Vision RFD 3D results in a comparable patient care to the Predicate device Ziehm Vision RFD 3D (K142740). and fulfils the requirements as stated by the intended use. Therefore, Ziehm Imaging GmbH believes the Ziehm Vision RFD 3D C-arm image quality, safety and effectiveness to be substantially equivalent to that of the predicate device Ziehm Vision RFD 3D (K142740).
- Conclusion Ziehm Imaging GmbH considers the Ziehm Vision RFD 3D to be as safe, as effective, and performs substantially equivalent to the predicate device Ziehm Vision RFD 3D (K142740) in accordance with its labeling.
End of 510(k) Summary