(164 days)
Not Found
No
The document mentions "image processing" but does not contain any terms related to AI, ML, deep learning, or neural networks. The performance studies focus on image quality and dose reduction, not AI/ML performance metrics.
No
The device is described as an X-ray imaging system used for providing medical imaging and visualization during diagnostic, interventional, and surgical procedures. It assists clinicians in visualization but does not directly provide therapy.
Yes
The 'Intended Use / Indications for Use' section explicitly states that the device is used "during diagnostic interventional and surgical procedures" and provides "visualization of complex anatomical structures" which "assists the clinician in the clinical outcome." This indicates its role in aiding diagnosis.
No
The device description clearly outlines hardware components such as a Mobile Stand (C-Arm) with an X-ray generator and Flat Panel Detector, and a Monitor Cart/Workstation. This indicates it is a hardware-based medical device with integrated software, not a software-only device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- Device Function: The Ziehm Vision RFD is an imaging system that uses X-rays to visualize internal anatomical structures in vivo (within the living body). It does not analyze samples taken from the body.
- Intended Use: The intended use clearly describes providing medical imaging during diagnostic, interventional, and surgical procedures, which are performed directly on the patient.
N/A
Intended 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 intraoperative imaging and visualization of complex anatomical structures of both lower and higher contrast density are required. Such procedures may include but are not limited to those of interventional cardiology, heart surgery, hybrid procedures, interventional radiology, interventional angiography, electrophysiology, pediatrics, endoscopic, urological, gastroenterology, orthopedic, maxillofacial surgery, neurosurgery, critical care, emergency room procedures, and those procedures visualizing structures of the cervical, thoracic, and 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.
Product codes (comma separated list FDA assigned to the subject device)
JAA, OWB, OXO
Device Description
The Ziehm Vision RFD mobile fluoroscopy system is a flat panel detector (EPD) 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 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
Pulsed and continuous fluoroscopic digital imaging, digital subtraction and cine image capture.
Anatomical Site
Complex anatomical structures of both lower and higher contrast density, structures of the cervical, thoracic, and lumber regions of the spine and joint fractures of the upper and lower extremities, organs, tissue, bones, implants.
Indicated Patient Age Range
Adult and pediatric populations, human beings of any age.
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Non-clinical image comparison with sets of images with the modified device and the predicate shows equivalence regarding image quality.
Non-clinical image and dose Lab testing were employed. 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 image and dose Lab testing.
Sample Size: Not specified.
Key Results: Radiologist conclusion, the image quality of the Ziehm Vision RFD results in a comparable patient care to the Predicate device Ziehm Vision RFD (K203428) 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
November 20, 2023
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, which consists of 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.
Ziehm Imaging GmbH % Stefan Fiedler Director Quality Management & Regulatory Affairs Lina-Ammon-Strasse 10 Nuremberg, Bavaria 90471 GERMANY
Re: K231692
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: October 23, 2023 Received: October 23, 2023
Dear Stefan Fiedler:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
Lu Jiang
Lu Jiang, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Radiologic Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
Indications for Use
Submission Number (if known)
Device Name
Ziehm Vision RFD
Indications for Use (Describe)
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 intraoperative imaging and visualization of complex anatomical structures of both lower and higher contrast density are required. Such procedures may include but are not limited to those of interventional cardiology, heart surgery, hybrid procedures, interventional radiology, interventional angiography, electrophysiology, pediatrics, endoscopic, urological, gastroenterology, orthopedic, maxillofacial surgery, neurosurgery, critical care, emergency room procedures, and those procedures visualizing structures of the cervical, thoracic, and 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.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
ver-The-Counter Use (21 CFR 801 Subpart C)
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3
Image /page/3/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 text is in a teal color, with the "imaging" portion being a darker shade of teal.
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
November 20, 2023
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 66067 0
Fax: +49 911 66067 390 |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------|
| Primary Contact Person
Agent: | Kevin Bridgman
VP Quality Assurance & Requlatory Affairs
Ziehm-Orthoscan, Inc.
14555 N 82nd St
Scottsdale AZ, 85260 |
| Secondary Contact
Person: | Stefan Fiedler
Director QM/RA
Ziehm Imaging GmbH
Phone: +49 911 66067 219
Fax: +49 172 8651712 |
| Device (Trade Name): | Ziehm Vision RFD |
| Common /Usual
Names: | Mobile Fluoroscopic C-Arm |
| Regulation: | 21CFR 892.1650 |
| Regulation 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 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.
| Predicate Device: | K203428 - Ziehm Vision RFD |
|---|---|
| Decision Date: | 03/17/2021 |
| Regulation: | 21CFR 892.1650 |
| Regulation Description | |
| Name: | Image-intensified fluoroscopic x-ray system |
| Product Code: | JAA; OWB; OXO |
| Summary of | |
| Technological | |
| Characteristics | The Ziehm Vision RFD employs X-rays as its imaging technology for visualizing human anatomy. The X-ray tube in the generator produces X- rays, guided toward the patient under control of the user at the direction of a physician who determines the specific clinical procedure. The images from the system assist the physicians in visualizing the patient's anatomy. This visualization helps to localize regions of pathology and for surgical procedures. The device provides both real-time image capture and post capture visualization and of in vivo surgical procedures and post-surgical outcomes. The Ziehm Vision RFD mobile fluoroscopy system is a flat panel detector (EPD) and fluoroscopic X-ray imaging system consisting of two mobile units. |
at panel detector (FPD) 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 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.
The proposed modified device Ziehm Vision RFD C-arm employs the same fundamental control, and substantially equivalent scientific technology as that of our predicate device Ziehm Vision RFD C-arm (K203428).
The radiation control, X-Ray monoblock generator, power supplies as well as our advanced imaging system are the same as the predicate device Ziehm Vision RFD C-arm (K203428).
Software architecture design is substantially equivalent to that of the predicate device Ziehm Vision RFD C-arm (K203428).
5
Image /page/5/Picture/0 description: The image shows 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, with the letters gradually becoming darker from left to right.
The primary modification of the C-Arm includes a 12 inch IGZO (Indium gallium zinc oxide) flat panel detector (FPD) which have substantially equivalent technology characteristics as our predicate device Ziehm Vision RFD C-arm (K203428). The new 12 inch IGZO FPD is an addition to already introduced a-Si and CMOS FPD's. The flat panel detectors have the same outer product design of the housing, both devices use safety shielding for radiation suppression and use solid state x-ray image receptors (SSXI / FPD) 8inch and 12 inch aSi, 8 inch and 12 inch CMOS and the only difference to the predicate Ziehm Vision RFD is the new 12 inch IGZO panel.
The comparison of the predicate device and the modified devices shows that the scientific and technical characteristics of the Ziehm Vision RFD are substantially equivalent as those of the Ziehm Vision RFD predicate device (K203428).
- 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.q. organs, 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.
- 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 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 in all MRI environments.
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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.
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
(K203428) | Comparable Properties
Substantial
Equivalence Discussion |
|--------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K231692 | K203428 | - |
| 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 density are
required. Such
procedures may include
but are not limited to
those of interventional
cardiology, heart
surgery, hybrid
procedures,
interventional radiology,
interventional | 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 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 | Identical |
| Model | Modified
Ziehm Vision RFD | Predicate
Ziehm Vision RFD
(K203428) | Comparable Properties
Substantial
Equivalence Discussion |
| | 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 in all MRI
environments. | 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. | |
| Model | Modified
Ziehm Vision RFD | Predicate
Ziehm Vision RFD
(K203428) | Comparable Properties
Substantial
Equivalence Discussion |
| Digital
Radiography
(Snapshot) /
Operating Values | • Variant 20kW
kV range: 40 - 120 kV
mA range: up to 200
mA
• Variant 25kW
kV range: 40 - 120 kV
mA range: up to 250
mA
• Variant 30 kW
kV range: 40 - 120 kV
mA range: up to 300
mA | • Variant 20kW
kV range: 40 - 120 kV
mA range: up to 200
mA
• Variant 25kW
kV range: 40 - 120 kV
mA range: up to 250
mA
• Variant 30 kW
kV range: 40 - 120 kV
mA range: up to 300 mA | Identical |
| Beam Limiter/ Collimator | | | |
| Collimator
System | Asymmetrical Collimator:
• Devices with 12inch
and 8inch cm Flat Panel
Detectors:
• Dedicated pre-
collimator for FPD
• Collimator Rotation:
+/- 90°
• Iris and Asymmetric
SlotCollimator:
- 50 - 307 mm
diameter (12 inch FPD
CMOS & IGZO)
-50 - 298 mm
diameter (12 inch FPD
aSi) - 50-205 mm diameter
(8inch FPD CMOS)
• Virtual Collimation
without radiation | Asymmetrical Collimator:
• Devices with 12inch and
8inch cm Flat Panel
Detectors:
• Dedicated pre-
collimator for FPD
• Collimator Rotation:
+/- 90°
• Iris and Asymmetric
SlotCollimator: - 50 - 307 mm
diameter (12 inch FPD
CMOS)
-50 - 289 mm diameter
(12 inch FPD aSi) - 50-205 mm diameter
(8inch FPD CMOS) - 50-198 mm diameter
(8inch FPD aSi)
• Virtual Collimation
without radiation | The collimator system of
the IGZO is the same as
the already introduced
CMOS FPD. |
| Image Detector | | | |
| Detector
Technology | Variant aSi FPD:
• Type:
Amorphous
Silicon
Flat Panel
Detector (aSi)
• Scintillator:
Cesium-
Iodide (CsI)
Variant CMOS FPD: | Variant aSi FPD:
• Type: Amorphous Silicon
Flat Panel Detector (aSi)
• Scintillator:
Cesium-
Iodide (CsI)
Variant CMOS FPD:
• Type: CMOS Flat Panel | The new 12 inch IGZO
(FPD) is an additional flat
panel type beside the
already established FPDs
based on aSi (amorphous
Silicon) and CMOS
(Complementary Metal
Semi-conductor) |
| Model | Modified
Ziehm Vision RFD | Predicate
Ziehm Vision RFD
(K203428) | Comparable Properties
Substantial
Equivalence Discussion |
| | • Type: CMOS Flat Panel
Detector
• Scintillator: Cesium-
Iodide (CsI)
Variant IGZO FPD:
• Type: IGZO Flat Panel
Detector
• Scintillator: Cesium-
Iodide (CsI) | • Scintillator: Cesium_ | technology. IGZO FPDs
are using the aSi/IGZO
sensor technology |
| Detector Sizes | 30cm x 30cm (12inch) aSi
(amorphous silicon TFT
technology)
• Size: 29.8 cm x 29.8
cm
• Detector matrix:
1,536 x 1,536 pixels
• Magnifier 1:
1,024 x 1,024 pixels
• Magnifier 2:
768 x 768 pixels
• Scintillator cesium
iodide
• Dynamic Range: 94 dB
• DQE: 77%
• MTF>50%@1lp/mm
• Pixel size 194µm
• Garyscale 65,536 gray
scale values (16bit)
• System resolution
(Nyquist):
2.6 lp/mm | 30cm x 30cm (12inch) aSi
(amorphous silicon TFT
technology)
• Size: 29.8 cm x 29.8
cm
• Detector matrix:
1,536 x 1,536 pixels
• Magnifier 1:
1,024 x 1,024 pixels
• Magnifier 2:
768 x 768 pixels
• Scintillator cesium
iodide
• Dynamic Range: 94 dB
• DQE: 77%
• MTF>50%@1lp/mm
• Pixel size 194µm
• Garyscale 65,536 gray
scale values (16bit)
• System resolution
(Nyquist):
2.6 lp/mm | The active pixel area of
the detector types are not
identical but are very
similar in image area of
approx. 12 inch x 12 inch.
IGZO detector has higher
number of pixel and
smaller pixel pitch
accordingly; therefor the
IGZO detector has better
resolution compared to
aSi detectors. This shows
the technical advantage
over the established aSi
systems.
The slight differences in
detector and pixel size
does not have influence on
safety and effectiveness of
the C-arm. |
| | Variant 31 cm x 31 cm
(12inch) CMOS
Technology:
• Size: 30.7 cm x 30.7
cm
• Detector matrix:
3,072 x 3,072 pixels
• Magnifier 1:
2,048x 2,048 pixels
• Magnifier 2:
1,536 x 1,536 pixels
• Dynamic Range:
- 1x1 binning:84 dB
- 2x2 binning: 95 dB | Variant 31 cm x 31 cm
(12inch) CMOS
Technology:
• Size: 30.7 cm x 30.7
cm
• Detector matrix:
3,072 x 3,072 pixels
• Magnifier 1:
2,048x 2,048 pixels
• Magnifier 2:
1,536 x 1,536 pixels
• Dynamic Range: - 1x1 binning:84 dB
- 2x2 binning: 95 dB | |
| Model | Modified
Ziehm Vision RFD | Predicate
Ziehm Vision RFD
(K203428) | Comparable Properties
Substantial
Equivalence Discussion |
| | • Scintillator: cesium
iodide
• DQE: 75%
• MTF: - 1 lp/mm: 55 %
- 2 lp/mm: 23 %
- 3 lp/mm: 10 %
- 4 lp/mm: 5 %
• Pixel size 100 µm
• Garyscale 65,536 gray
scale values (16bit)
System resolution
(Nyquist):
5 lp/mm | • Scintillator: cesium
iodide
• DQE: 75%
• MTF: - 1 lp/mm: 55 %
- 2 lp/mm: 23 %
- 3 lp/mm: 10 %
- 4 lp/mm: 5 %
• Pixel size 100 µm
• Garyscale 65,536 gray
scale values (16bit)
System resolution
(Nyquist):
5 lp/mm | |
| | 20 cm x 20 cm (8inch) aSi
(amorphous silicon TFT
technology)
• Size: 19.9 cm x 19.9
cm
• Detector matrix:
1,024 x 1,024 pixels
• Magnifier 1:
768 x 768 pixels
• Magnifier 2:
512 x 512 pixels
• Scintillator cesium
iodide
• Dynamic Range: 94 dB
• DQE: 77%
• MTF>50%@1lp/mm
• Pixel size 194µm
• Garyscale 65,536 gray
scale values (16bit)
• System resolution
(Nyquist):
2.6 lp/mm | 20 cm x 20 cm (8inch) aSi
(amorphous silicon TFT
technology)
• Size: 19.9 cm x 19.9
cm
• Detector matrix:
1,024 x 1,024 pixels
• Magnifier 1:
768 x 768 pixels
• Magnifier 2:
512 x 512 pixels
• Scintillator cesium
iodide
• Dynamic Range: 94 dB
• DQE: 77%
• MTF>50%@1lp/mm
• Pixel size 194µm
• Garyscale 65,536 gray
scale values (16bit)
• System resolution
(Nyquist):
2.6 lp/mm | |
| | Variant 21 cm x 21 cm
(8inch) CMOS
Technology:
• Size: 20.5 cm x 20.5
cm
• Detector matrix:
2,053x 2,053 pixels
• Magnifier 1:
1,536 x 1,536 pixels | Variant 20.5 cm x 20.5 cm
(8inch) CMOS Technology:
• Size: 20.5 cm x 20.5
cm
• Detector matrix:
2,048x 2,048 pixels
• Magnifier 1:
1,536 x 1,536 pixels
• Magnifier 2: | |
| Model | Modified
Ziehm Vision RFD | Predicate
Ziehm Vision RFD
(K203428) | Comparable Properties
Substantial
Equivalence Discussion |
| | Magnifier 2:
1,024 x 1,024 pixels Dynamic Range: - 1x1 binning:84 dB
- 2x2 binning: 95 dB Scintillator: cesium iodide DQE: 75% MTF:
- 1 lp/mm: 55 %
- 2 lp/mm: 23 %
- 3 lp/mm: 10 %
- 4 lp/mm: 5 % Pixel size 100 μm Garyscale 65,536 gray scale values (16bit) System resolution (Nyquist):
5 lp/mm 31 cm x 31 cm (12inch)
IGZO (IGZO technology) Size: 30.7 cm x 30.7 cm Detector matrix:
2,048 x 2,048 pixels Magnifier 1:
1,536 x 1,536 pixels Magnifier 2:
1,024 x 1,024 pixels Scintillator cesium iodide DQE: - 80% @ 0 lp/mm
- 67% @ 0.5 lp/mm
- 59% @ 1 lp/mm
- 46% @ 2 lp/mm MTF
- 0.5 lp/mm: 82%
- 1 lp/mm: 60%
- 2 lp/mm: 30% Pixel size 150μm Garyscale 65,536 gray scale values (16bit) | Dynamic Range:
- 1x1 binning:84 dB
- 2x2 binning: 95 dB Scintillator: cesium iodide DQE: 75% MTF:
- 1 lp/mm: 55 %
- 2 lp/mm: 23 %
- 3 lp/mm: 10 %
- 4 lp/mm: 5 % Pixel size 100 μm Garyscale 65,536 gray scale values (16bit) System resolution (Nyquist):
5 lp/mm | |
| Model | Modified
Ziehm Vision RFD | Predicate
Ziehm Vision RFD
(K203428) | Comparable Properties
Substantial
Equivalence Discussion |
| | • System resolution
(Nyquist):
3.3 lp/mm | | |
| Anti-Scatter Grid | | | |
| Anti-scatter grid | fixed anti-scatter grid:
a-Si (8inch & 12inch)
• Pb 8/70
CMOS (8inch & 12inch)
• Pb 8/70
IGZO (12inch)
Pb 6/80 | fixed anti-scatter grid:
a-Si (8inch & 12inch)
• Pb 8/70
CMOS (8inch & 12inch)
• Pb 8/70 | The grids for the a-Si and
CMOS FPD are identical
for the predicate Ziehm
Vision RFD (K203428) and
modified Ziehm Vision
RFD. The grid of the new
IGZO has slightly different
values compared to the
anti-scatter grids for the
other two FPD's. |
| Digital Image Processing | | | |
| Application-
Oriented
Anatomical
Programs
(AOAP) | • Bone: Extremities,
Trunk
• Heart, Abdomen, Soft
• Cardio (option):
Heart Coro , Heart EP
• Vascular (option):
Extremities, Trunk,
Bolus, DSA, MSA, RSA
• Urology (option)
• Endo (option) | • Bone: Extremities,
Trunk
• Heart, Abdomen, Soft
• Vascular (option):
Extremities, Trunk,
Bolus, DSA, MSA, RSA
• Urology (option)
• Endo (option) | Cardio application was
reorder of anatomical
program and an
optimization of already
existing heart APR. |
| Anatomical
Marking Tool -
AMT (Option) | • Mark anatomical
structures
• Indicate side of body
• 2D measurement
function
Enhanced Vessel
Visualization(EVV) | • Mark anatomical
structures
• Indicate side of body
• 2D measurement
function | Identical, EVV was
already part of K203428. |
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Image /page/7/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 text is in a teal color and appears to be a sans-serif font.
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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 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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Image /page/9/Picture/0 description: The image shows the logo for Ziehm Imaging. The logo consists of a circular graphic with a stylized human figure inside, surrounded by orbital lines. To the right of the graphic, the text "ziehmimaging" is written in a teal sans-serif font, with the color gradually transitioning from a lighter to a darker shade of teal.
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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 on the left and the text "ziehmimaging" on the right. The circular graphic contains a stylized image of a person inside of a circle. The text is in a teal color and appears to be a 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 on the left and the company name "ziehmimaging" on the right. The text is in a teal color and appears to be a sans-serif font.
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Image /page/12/Picture/0 description: The image shows the logo for Ziehm Imaging. The logo consists of a circular graphic with a stylized human figure inside, along with 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.
- 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 (K203428) 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
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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-Ziehm Vision RFD is based on direct modifications to cleared predicate device Clinical Test Data: Ziehm Vision RFD (K203428).
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 reqarding 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.
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 (K203428) 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 "Content of Premarket Submissions for Device Software Functions". Cybersecurity remains exactly the same as in the predicate device.
Determination of
Substantial Equivalence:
Determination of The verification/validation activities successfully confirmed device requirements Substantial Equivalence: 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 (K203428).
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Compliance to FDA Guidance and Standards
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 3.2, Date: 2020-07 Conformance Standard #5-132
- 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 2.2, Date: 2019-10 Conformance Standard #12-239
- 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 1.2, Date: 2018-06 Conformance Standard #12-317
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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 to the left of the company name. The graphic contains a stylized human figure inside of a circle with intersecting lines. The company name, "ziehmimaging", is written in a teal sans-serif font.
- IEC 61304: Medical device software Software life cycle processes Edition 1.1, Date 2015-06 Conformance Standard #13-79
- IEC 60825-1: Safety of laser products, Equipment Safety, requirements, and user guide Edition 2.0, Date: 2007-03 Conformance Standard #12-273
- ISO 14971: Medical devices Application of risk management to medical devices Edition 3.0, Date: 2019-12 Conformance Standard #5-40
Substantial Equivalence:
Determination of 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. Anatomical simulation phantoms were employed, imaqe 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 (K203428) 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 (K203428).
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Image /page/16/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 human figure inside a circle with intersecting lines, and the text is in a teal color.
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 (K203428) in accordance with its labeling.