(117 days)
Not Found
No
The document describes standard image processing and motorized positioning features, but there is no mention of AI, ML, or related terms like deep learning or neural networks. The performance studies focus on image quality and dose reduction using phantoms, not on the performance of any AI/ML algorithms.
No
The device is an imaging system designed for visualization and diagnosis, not direct treatment of medical conditions.
Yes
The intended use explicitly states "diagnostic interventional and surgical procedures" and mentions processes like "visualizing structures of the cervical, thoracic, and lumber regions of the spine, and joint fractures of the upper and lower extremities," which are diagnostic in nature. The device "assists the physicians in visualizing the patient's anatomy" and "helps to localize regions of pathology."
No
The device description clearly outlines hardware components such as an X-ray tube, generator, C-Profile, Flat Panel Detector (FPD), mobile stand, and monitor cart/workstation. It is a physical imaging system, not solely software.
Based on the provided information, the Ziehm Vision RFD is not an IVD (In Vitro Diagnostic) 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 about a person's health. This testing is done outside of the body (in vitro).
- Ziehm Vision RFD Function: The Ziehm Vision RFD is an X-ray imaging system used to visualize anatomical structures within the human body (in vivo) during medical procedures. It does not analyze specimens.
The description clearly states its purpose is for "providing medical imaging for 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... are required." This is a description of an in vivo imaging device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Ziehm Vision RFD is intended for use in providing medical imaging for adult and pediations, 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, heart surgery, hybrid procedures, interventional radiology, interventional angiography, electrophysiology, pediatrics, endoscopic, urological, gastroenterology, orthopedic, maxillofacial surgery, neurology, neurosurgery, critical care, emergency room procedures visualizing structures of the cervical, thoracic, and lumber regions of the spine, and joint fractures of the upper extremities, and where digital image data is required for computer aided surgery procedures and whenever the clinician benefits from the high degree of geometric imaging accuracy, and where such fluoroscopic, cine and DSA imaging is required. 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)
JAA, OWB, OXO
Device Description
The ZIEHM VISION RFD employs X-rays as its imaging technology for visualizing human anatomy. The X-ray tube in the generator produces Xrays, 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 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).
Motorization of vertical axis as well as manual or optionally motorized three axes 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.
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, 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
Anatomical Site
complex anatomical structures of both lower and higher contrast density, 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 visualizing structures of the cervical, thoracic, and lumber regions of the spine, and joint fractures of the upper extremities.
Specifically, "human bodies covering such structures but not limited to the following, e.g. organs, tissue, bones, implants".
Indicated Patient Age Range
adult and pediatric populations / human beings of any age. It is the physician's responsibility to decide whether to use the system with infants, children and adipose patients.
Intended User / Care Setting
Physician / 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 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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical image comparison with sets of images with the modified device and the predicate shows equivalence regarding image quality.
Non-clinical imaging and dose testing methods demonstrated the device capability to provide both reduced dose while maintaining image quality.
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 results in a comparable patient care to the Predicate device Ziehm Vision RFD (K132904). and fulfils 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
March 17, 2021
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services - USA. To the right of the symbol, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The word "FDA" is in a larger font size than the rest of the text.
Ziehm Imaging GmbH % Mr. Steve Seeman Director of Regulatory Affairs and Quality Assurance Ziehm-Orthoscan, Inc. 14555 N. 82nd Street SCOTTSDALE AZ 85260
Re: K203428
Trade/Device Name: Ziehm Vision RFD Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: Class II Product Code: JAA, OWB, OXO Dated: February 15, 2020 Received: February 24, 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 (QS) 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 mediation-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) K203428
Device Name Ziehm Vision RFD
Indications for Use (Describe)
The Ziehm Vision RFD is intended for use in providing medical imaging for adult and pediations, 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, heart surgery, hybrid procedures, interventional radiology, interventional angiography, electrophysiology, pediatrics, endoscopic, urological, gastroenterology, orthopedic, maxillofacial surgery, neurology, neurosurgery, critical care, emergency room procedures visualizing structures of the cervical, thoracic, and lumber regions of the spine, and joint fractures of the upper extremities, and where digital image data is required for computer aided surgery procedures and whenever the clinician benefits from the high degree of geometric imaging accuracy, and where such fluoroscopic, cine and DSA imaging is required. 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.
| 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 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 graphic features a stylized representation of a human figure within a circular design, and the text is in a teal color.
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
March 11, 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 Requlatory 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 |
| Common /Usual
Names: | Mobile Fluoroscopic C-Arm |
| Regulation: | 21CFR 892.1650 |
| Requlation Description: | Image-intensified fluoroscopic x-ray system |
| Product Code: | JAA; OWB; OXO |
| Classification: | II |
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Image /page/4/Picture/0 description: The image shows the logo for ziehmimaging. 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 person inside a sphere with orbital lines around it. The text is in a teal color.
| Predicate Device: | K132904 - Ziehm Vision RFD |
|---|---|
| Decision Date: | 12/05/2013 |
| Regulation: | 21CFR 892.1650 |
| Regulation Description | |
| Name: | Image-intensified fluoroscopic x-ray system |
| Product Code: | JAA; OWB; OXO |
General Description: The ZIEHM VISION RFD employs X-rays as its imaging technology for visualizing human anatomy. The X-ray tube in the generator produces Xrays, 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 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).
Motorization of vertical axis as well as manual or optionally motorized three axes 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.
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.
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Image /page/5/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.
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, 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 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 is intended for use in all medical indications requiring fluoroscopy. The Ziehm Vision RFD is intended for use to provide image data specifically but not limited in the field of interventional radiology and cardiology as well as in cardiac surgery and in hybrid applications. 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 structures but not limited to the following, e.g. orqans, tissue, bones, implants depending on the medical indication. These devices are not intended for use in performing mammographic exposures. The systems are not intended for use near MRI systems.
- The Ziehm Vision RFD is intended for use in providing medical imaging for Indications for Use: 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, 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 lumber 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 the high degree of geometric imaging accuracy, and where such fluoroscopic, cine and DSA imaging is required. 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 C-arm employs the same Technology: fundamental control, and scientific technology as that of our predicate device Ziehm Vision RFD C-arm (K132904).
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 C-arm (K132904).
Software architecture design is nearly identical to that of the predicate
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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 graphic is a stylized representation of a globe with a human figure inside. The text is in a teal color and appears to be a sans-serif font.
device Ziehm Vision RFD C-arm (K132904). With modification of the software to support functionality, image processing applications related to the optional device specific features.
The primary modifications of the C-Arm include a 30 kW generator using the same housinq, x-ray tube, and very similar design while keeping the same dimensions as the predicate Ziehm Vision RFD (K132904), new pre-filter and low absorption removable grid, for lower skin entrance dose imaging, improving operator workflow during extended procedures, , Enhanced Vessel Visualization, measurement function, while keeping the same profile of our predicate device Ziehm Vision RFD C-arm (K132904).
Summary of Technological Characteristics:
The comparisons of the predicate devices show the scientific and technology characteristics of the Ziehm Vision RFD are substantial equivalence to that of the predicate device Ziehm Vision RFD (K132904).
Device Comparison Table
The table below summarizes the substantive feature/technological differences between the predicate device and the proposed device:
| Model | Modified
Ziehm Vision RFD | Predicate
Ziehm Vision RFD
(K132904) | Comparable Properties
Substantial
Equivalence Discussion |
|------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | Unknown at this time | K132904 | - |
| Classification | Class II | Class II | Identical |
| Product Code | JAA (system, x-ray,
fluoroscopic, image-
intensified) | JAA (system, x-ray,
fluoroscopic, image-
intensified) | Identical |
| Application / Indications for Use | | | |
| Indications for
Use | The Ziehm Vision RFD is
intended for use in
providing medical imaging
for 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 | The Ziehm Vision RFD is
intended for use in
providing medical imaging,
using pulsed and
continuous fluoroscopic
digital imaging, as well as
digital subtraction and cine
image capture during
diagnostic interventional
and surgical procedures
where intraoperative
imaging and visualization
of complex anatomical
structures of both lower
and higher contrast
density are required. Such
procedures may include | Substantially Equivalent |
| Model | Modified
Ziehm Vision RFD | Predicate
Ziehm Vision RFD
(K132904) | Comparable Properties
Substantial
Equivalence Discussion |
| | 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 lumber
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 the
high degree of geometric
imaging accuracy, and
where such fluoroscopic,
cine and DSA imaging is
required. The visualization
of such anatomical
structures assists the
clinician in the clinical
outcome. | 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 lumber
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 the 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. | |
| | 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. | |
| Model | Modified
Ziehm Vision RFD | Predicate
Ziehm Vision RFD
(K132904) | Comparable Properties
Substantial
Equivalence Discussion |
| X-ray Generator | | | |
| Maximum
Parameter | • Variant 20 kW:
max. 20 kW,
max. 120 kV,
max. 200 mA | • Variant 7.5 kW:
max. 7.5 kW,
max. 120 kV,
max. 75 mA | The new proposed device
generator (variant 30 kW)
has a higher maximum
power output. |
| | • Variant 25 kW:
max. 25 kW,
max. 120 kV,
max. 250 mA | • Variant 20 kW:
max. 20 kW,
max. 120 kV,
max. 200 mA | 100 kV @ 300 mA. |
| | • Variant 30 kW:
max. 30 kW @
nominal 100kV
max. 120 kV,
max. 300 mA | • Variant 25 kW:
max. 25 kW,
max. 120 kV,
max. 250 mA | |
| Pulsed
Fluoroscopy:
Operating values | • Variant 20 kW
kV range: 40 - 120 kV
mA range: 1.5 - 200
mA_ | • Variant 7.5 kW
kV range: 40 - 120 kV
mA range: 1.5 - 75 mA_ | The new generator 30 kW
of the new modified
proposed device has a |
| | • Variant 25 kW
kV range: 40 - 120 kV
mA range: 1.5 - 250
mA | • Variant 20 kW
kV range: 40 - 120 kV
mA range: 1.5 - 200
mA | higher maximum power
output as compared to
the Predicate. However,
the design and housing
are identical. |
| | • Variant 30 kW
kV range: 40 - 120 kV
mA range: 1.5 – 300
mA | • Variant 25 kW
kV range: 40 - 120 kV
mA range: 1.5 - 250
mA_ | |
| Pulsed
Fluoroscopy:
Pulse and
Duration | • pulse width:
- 20 kW generator: 7 -
40 ms | • pulse width: - 7.5 kW generator: 7 -
40 ms | |
| | - 25 kW generator: 7 -
40 ms | - 20 kW generator: 7 -
40 ms | |
| | - 30 kW generator:
4 - 40 ms | - 25 kW generator: 7 -
40 ms | |
| | pulse rate:
50/60 Hz: 1, 2, 4, 8,
12.5, 25 pulse/s | pulse rate:
50/60 Hz: 1, 2, 4, 8,
12.5, 25 pulse/s | |
| Digital
Radiography
(Snapshot) /
Operating Values | • Variant 20kW
kV range: 40 - 120 kV
mA range: up to 200
mA_ | • Variant 7.5 kW
kV range: 40 - 120 kV
mA range: up to 75 mA_ | Although the modified
device Ziehm Vision RFD
is not identical to the
predicate K132904 the
general system exposure |
| | • Variant 25kW | • Variant 20 kW | control technology and |
| Model | Modified
Ziehm Vision RFD | Predicate
Ziehm Vision RFD
(K132904) | Comparable Properties
Substantial
Equivalence Discussion |
| | kV range: 40 - 120 kV
mA range: up to 250 mA | kV range: 40 - 120 kV
mA range: up to 200 mA | operational functionality
are identical in regards to
the predicate K132904 |
| | Variant 30 kW
kV range: 40 - 120 kV
mA range: up to 300 mA | Variant 25kW
kV range: 40 - 120 kV
mA range: up to 250 mA | |
| Thermal
Management | Active cooling | Active cooling | Identical |
| X-ray Tube | | | |
| Tube Type | Rotating anode | Rotating anode | Identical |
| Beam Limiter/ Collimator | | | |
| Collimator
System | Asymmetrical Collimator | Asymmetrical Collimator | Identical |
| Image Detector | | | |
| Detector
Technology | Variant aSi FPD (8inch;
12inch):
• Type: Amorphous
Silicon Flat Panel
Detector (aSi)
• Scintillator: Cesium-
Iodide (CsI)
Variant CMOS FPD(8inch;
12inch):
• Type: CMOS Flat Panel
Detector
• Scintillator: Cesium-
Iodide (CsI) | Variant aSi FPD (8inch;
12inch):
• Type: Amorphous
Silicon Flat Panel
Detector (aSi)
• Scintillator: Cesium-
Iodide (CsI)
Variant CMOS FPD(8inch;
12inch):
• Type: CMOS Flat Panel
Detector
• Scintillator: Cesium-
Iodide (CsI) | Identical |
| 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 | | | |
7
Image /page/7/Picture/0 description: The image shows the logo for Ziehm Imaging. The logo consists of a circular icon on the left and the company name "ziehmimaging" on the right. The icon features a stylized human figure within a globe-like structure, and the text is in a teal color.
8
Image /page/8/Picture/0 description: The image shows the logo for Ziehm Imaging. The logo consists of a circular icon on the left and the text "ziehmimaging" on the right. The icon 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.
9
Image /page/9/Picture/0 description: The image contains the logo for Ziehm Imaging. The logo consists of a circular graphic on the left and the word "ziehmimaging" on the right. The circular 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.
10
Image /page/10/Picture/0 description: The image features the logo of Ziehm Imaging. On the left is a circular emblem with a stylized human figure inside, surrounded by orbital lines. To the right of the emblem is the company name, "ziehmimaging," written in a teal sans-serif font. The overall design is clean and professional, suggesting a focus on medical imaging technology.
| Model | Modified
Ziehm Vision RFD | Predicate
Ziehm Vision RFD
(K132904) | Comparable Properties
Substantial
Equivalence Discussion | | | | | | | | | | | | |
|-----------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------|----------------------|----------------------------------------------|----------------------------------------------|-----------|----------------------|----------------------------------------------------------------|----------------------------------------------------------------|-----------|---------------------------|------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|-----------|
| 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 | 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
• 26" color flat screen
monitor
• 32" UDH single flat
screen monitor | • 18" Duo flat screen
monitors or
• 19" Duo flat screen
monitors or
• 26" color flat screen
monitor | Identical in performance
and use. | | | | | | | | | | | | |
| Monitor Arm | Monitor Cart with fix or
articulating monitor arm
(option) | Monitor Cart with fix or
articulating monitor arm
(option) | Identical | | | | | | | | | | | | |
| Endoscopy
Display Option | 26" color flat screen
monitor | 26" color flat screen
monitor | Identical | | | | | | | | | | | | |
| 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
"Remote Vision
Center" | • Radiation button at
"Vision Center"
• Radiation button at
"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
"Remote Vision
Center" | • Radiation button at
"Vision Center"
• Radiation button at
"Remote Vision Center" | Identical | | | | | | | | | | | | |
11
Image /page/11/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 graphic features a stylized human figure inside a globe-like structure, and the text is in a teal color.
| Model | Modified
Ziehm Vision RFD | Predicate
Ziehm Vision RFD
(K132904) | Comparable Properties
Substantial
Equivalence Discussion |
|--------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Digital Image Processing | | | |
| 2D imaging | 2D Fluorscopic Imaging | 2D Fluorscopic Imaging | Identical: |
| Application-
Oriented
Anatomical
Programs
(AOAP) | • Bone: Extremities,
Trunk
• Heart, Abdomen, Soft
• Vascular (option):
Extremities, Trunk,
Bolus
• Urology (option)
• Endo (option) | • Bone: Extremities,
Trunk
• Heart, Abdomen, Soft
• Vascular (option):
Extremities, Trunk,
Bolus
• Urology (option)
• Endo (option) | Identical |
| Additional
Functions | • Metal
• Enhanced Vessel
Visualization
(option)
• Reposition
• High Quality
• Low Dose
• Obese Patient | • Metal
• Reposition
• High Quality
• Low Dose
• Obese Patient
• Motion | The Modified Device
Ziehm Vision RFD has
additional Enhanced
Vessel Detection function
to that of the Predicate
Ziehm Vision RFD
(K132904) |
| Image
Acquisition | • Auto save
• Cine loop | • Auto save
• Cine loop | Identical |
| Post-Processing
Functions | • Zoom: 3 levels | • Zoom: 3 levels | Identical |
| DSA Functions
(option) | • DSA real-time
subtraction with re-
masking capability
• MSA max.
opacification sequence
• Single frame,
Multiframe RSA (road-
mapping)
• Pixel shift /
landmarking | • DSA real-time
subtraction with re-
masking capability
• MSA max. opacification
sequence
• Single frame,
Multiframe RSA (road-
mapping)
• Pixel shift / landmarking | Identical |
| Anatomical
Marking Tool -
AMT (option) | • Mark anatomical
structures
• 2D measurement
function | • Mark anatomical
structures | The Modified Device
Ziehm Vision RFD has
additional 2D
measurement function
within the Anatomical
Marking Tool that is
similar to that of the
Predicate Ziehm Vision
RFD |
| Digital Memory | • Storage capacity | • Storage capacity | Identical |
| Data | • Radiation Dose | • Radiation Dose | Although not identical. |
| Model | Modified
Ziehm Vision RFD | Predicate
Ziehm Vision RFD
(K132904) | Comparable Properties
Substantial
Equivalence Discussion |
| Organization | 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 | Structured Report
(RDSR)
• Calculated Dose Area
Product (DAP) | The new features improve
the clinician's ability to
obtain more information
as to the dose for each
image in the radiation
structured 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 NetPort (DICOM
3.0 interface)
• Generic interface to
injector
• Video transmission
(video connector or
wireless video)
• Interface for external
separate X-ray
indication lamp | • Ziehm NaviPort 2D
• Ziehm NetPort (DICOM
3.0 interface)
• Generic interface to
injector
• Video transmission
(video connector or
wireless video)
• Interface for external
separate X-ray
indication lamp | Identical |
12
Image /page/12/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 in a serif font.
- Conclusion of Table The changes of the proposed modified device Ziehm Vision RFD 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 (K132904) in accordance with its labeling.
- Safety and Performance: The proposed Ziehm Vision RFD C-arm's potential radiation, mechanical, and electrical hazards are identified and analyzed as part of risk management, and controlled by meeting the applicable CDRH 21CFR 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 regulations and certification to Recognized Consensus Standards that apply to this product provides the assurance of device safety and effectiveness.
- Summary of Non-Ziehm Vision RFD is based on direct modifications to cleared predicate device Clinical Test Data: Ziehm Vision RFD (K132904).
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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 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 design of the modified Ziehm Vision RFD 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 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 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 (K132904) 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 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 "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices".
Determination of The verification/validation activities successfully confirmed device Substantial Equivalence: requirements have been fulfilled, system functionality is consistent with the user needs, intended uses, and performs as designed, and raises no new questions regarding either safety or effectiveness.
Therefore, Ziehm Imaging GmbH believes the modified device Ziehm Vision RFD C-arm image quality, safety and effectiveness supports a determination of substantial equivalence to the predicate device Ziehm Vision RFD (K132904).
14
Image /page/14/Picture/0 description: The image contains the logo for Ziehm Imaging. The logo consists of a circular graphic with a stylized human figure inside, accompanied by the text "ziehmimaging" in a teal color. The text is written in a sans-serif font and is positioned to the right of the circular graphic.
Compliance to FDA Guidance and Standards
FDA/CDRH From 3626 A Guide for the Submission of Initial Reports on Diagnostic X-Ray Systems and Their Major Components. (5/11)
- 21 CFR 1020.30-32 Federal Performance Standard for Diagnostic X-ray Systems.
General Standards / Regulations
MDSAP Medical Device Single Audit Program (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
- 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
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Image /page/15/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 circle with curved lines. The text is in a teal color and appears to be in a sans-serif font.
- 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:
01 Summary Bench Testing
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 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:
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 results in a comparable patient care to the Predicate device Ziehm Vision RFD (K132904). and fulfils the requirements as stated by the intended use. Therefore, Ziehm Imaging GmbH believes the Ziehm Vision RFD C-arm image quality, safety and effectiveness to be substantially equivalent to that of the predicate device Ziehm Vision RFD (K132904).
- Conclusion Ziehm Imaging GmbH considers the Ziehm Vision RFD to be as safe, as effective, and performs substantially equivalent to the predicate device Ziehm Vision RFD (K132904) in accordance with its labeling.