(186 days)
No
The summary describes a standard mobile fluoroscopy system with image processing capabilities, but there is no mention of AI, ML, or related concepts like deep learning, neural networks, or training/test sets for such algorithms.
No
The device is described as providing medical imaging to assist clinical outcomes during diagnostic, interventional, or surgical procedures, not to directly treat a disease or condition.
Yes
The "Intended Use / Indications for Use" section states that the device is used for "diagnostic, interventional and surgical procedures" and that "The visualization of such anatomical structures assists the clinical outcome." This indicates its role in diagnosis.
No
The device description clearly outlines hardware components such as a mobile stand, C-Profile shaped support, mono-block high voltage generator assembly, Flat Panel image receptor, user touch screen, and display monitors. While it includes software functions, it is fundamentally a hardware system with integrated software.
Based on the provided information, the Ziehm Vision FD is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for providing medical imaging using fluoroscopy to visualize anatomical structures during diagnostic, interventional, and surgical procedures. This is an in-vivo imaging function, not an in-vitro test performed on biological samples outside the body.
- Device Description: The description details a mobile fluoroscopy system with an X-ray generator and image receptor, designed to capture images of the patient's anatomy directly. This aligns with in-vivo imaging.
- Input Imaging Modality: The input modality is fluoroscopic X-ray, which is used for imaging within the body.
- Anatomical Site: The device is used to visualize anatomical structures within the human body.
- Lack of IVD Characteristics: There is no mention of the device being used to test biological samples (blood, urine, tissue, etc.) or to detect the presence of specific substances or markers in those samples, which are hallmarks of IVD devices.
Therefore, the Ziehm Vision FD is a medical imaging device used for in-vivo procedures, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Ziehm Vision FD is intended for use in providing medical imaging for adults and pediatric populations, using pulsed and continuous fluoroscopic imaging. The device provides contactless fluoroscopic image capture, temporarily storing, and display of digital subtraction, and acquisition of cine loops during diagnostic, interventional and surgical procedures. Examples of clinical application may include pediatric, cholangiography, endoscopic, urologic, lithotripsy, orthopedic, neurologic, vascular, cardiac, angiographic, critical care, and emergency room fluoroscopy procedures. The visualization of such anatomical structures assists the clinician in the clinical outcome. This device does not support direct radiographic film exposures and is not intended for use in performing mammography. The system is not intended for use near MRI systems.
Product codes
OWB, JAA
Device Description
The Ziehm Vision FD mobile fluoroscopy system is comprised of a mobile stand with a C-Profile shaped support with both a mono-block high voltage generator assembly and Flat Panel image receptor. These attach to either end of a C-Profile providing a fixed SID. The device performs 2D medical imaging using 4 axes of manual movement and one vertical axes of motorized movement. A user touch screen provides for concise user selectable anatomical programs and Xray technique control. Integrated high-resolution flat panel display monitors directly mounted on the monitor cart providing the clinician with a precise angle for visualization of live fluoroscopic images of the patient's anatomy. This visualization helps to localize regions of pathology for surgical procedures. The mobile stand supports both a cable bound and optional wireless fluoroscopic footswitch. The Wireless footswitch operation allows for optimum positioning for the surgeon by removing the cable on the floor. The optional interface panel of the Ziehm Vision FD provides connection of peripheral devices such as external monitors, thermal video printers, and image storage devices (USB, DVD) and DICOM fixed wire and wireless network interfaces.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Fluoroscopic X-ray
Anatomical Site
The system is intended for use with human bodies covering such structures but not limited to the following, e.g. organs, tissue, bones, implants depending on the medical indication.
Indicated Patient Age Range
Adults and pediatric populations, using pulsed and continuous fluoroscopic imaging. 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.
Intended User / Care Setting
Only trained and instructed qualified personnel are allowed to operate the system.
Examples of clinical application may include pediatric, cholangiography, endoscopic, urologic, lithotripsy, orthopedic, neurologic, vascular, cardiac, angiographic, critical care, and emergency room fluoroscopy procedures.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Non-clinical image comparison with sets of images with the modified device and the predicate shows equivalence regarding image quality. Non-clinical image and dose Lab testing, were emploved. Anatomical 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)
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 emploved. Anatomical 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 FD results in a comparable patient care to the reference device Ziehm Vision FD (K193230) and fulfils the requirements as stated by the intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K193230 Ziehm Vision FD
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1650 Image-intensified fluoroscopic x-ray system.
(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized representation of human services. To the right of the symbol is the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
December 15, 2023
Ziehm Imaging GmbH c/o Tsvetelina Milanova Specialist Regulatory Affairs Lina-Ammon-Strasse 10 Nuremberg, Bavaria 90471 GERMANY
Re: K231700
Trade/Device Name: Ziehm Vision FD Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: Class II Product Code: OWB, JAA Dated: November 23, 2023 Received: November 24, 2023
Dear Ms. Milanova:
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.
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 803) for 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,
Lu Jiang
Lu Jiang, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Radiological 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
510(k) Number (if known) K231700
Device Name Ziehm Vision FD
Indications for Use (Describe)
The Ziehm Vision FD is intended for use in providing medical imaging for adults and pediatric populations, using pulsed and continuous fluoroscopic imaging. The device provides contactless fluoroscopic image capture, temporarily storing, and display of digital subtraction, and acquisition of cine loops during diagnostic, interventional and surgical procedures. Examples of clinical application may include pediatric, cholangiography, endoscopic, urologic, lithotripsy, orthopedic, neurologic, vascular, cardiac, angiographic, critical care, and emergency room fluoroscopy procedures.
The visualization of such anatomical structures assists 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) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the logo for Ziehm Imaging. The logo consists of a circular graphic on the left and the text "ziehmimaging" on the right. The graphic is a stylized representation of a person inside a globe. The text is in a teal color and is written in a sans-serif font.
510k Summary K231700 -
November, 23 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 | Tsvetelina Milanova
Specialist Regulatory Affairs
Ziehm Imaging GmbH
Phone: +49 911 66067 219
Fax: +49 172 8651712 |
| Secondary Contact
Person: | Stefan Fiedler
Director QM/RA
Ziehm Imaging GmbH
Phone: +49 911 66067 219
Fax: +49 172 8651712 |
| US Agent | Kevin Bridgman
VP Quality Assurance & Regulatory Affairs
Ziehm-Orthoscan, Inc.
14555 N 82nd St
Scottsdale AZ, 85260 |
| Device (Trade Name): | Ziehm Vision FD |
| Common /Usual
Names: | Mobile Fluoroscopic C-Arm |
| Regulation: | 21CFR 892.1650 |
| Regulation Description: | Image-intensified fluoroscopic x-ray system |
510(k) Summary
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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 company name "ziehmimaging" on the right. The graphic features a stylized human figure within a globe-like structure. The text is in a teal color and appears to be a sans-serif font.
| Product Code: | OWB , JAA |
|---|---|
| Product Class: | II |
| Predicate Device: | K193230 Ziehm Vision FD |
| Decision Date: | 20/12/2019 |
| Regulation: | 21CFR 892.1650 |
| Regulation Description | |
| Name: | Image-intensified fluoroscopic x-ray system |
| Product Code: | JAA; OWB |
| Device Class: | II |
Device Class
Summary of Technological Characteristics The Ziehm Vision FD mobile fluoroscopy system is comprised of a mobile stand with a C-Profile shaped support with both a mono-block high voltage generator assembly and Flat Panel image receptor. These attach to either end of a C-Profile providing a fixed SID. The device performs 2D medical imaging using 4 axes of manual movement and one vertical axes of motorized movement. A user touch screen provides for concise user selectable anatomical programs and Xray technique control. Integrated high-resolution flat panel display monitors directly mounted on the monitor cart providing the clinician with a precise angle for visualization of live fluoroscopic images of the patient's anatomy. This visualization helps to localize regions of pathology for surgical procedures. The mobile stand supports both a cable bound and optional wireless fluoroscopic footswitch. The Wireless footswitch operation allows for optimum positioning for the surgeon by removing the cable on the floor. The optional interface panel of the Ziehm Vision FD provides connection of peripheral devices such as external monitors, thermal video printers, and image storage devices (USB, DVD) and DICOM fixed wire and wireless network interfaces.
modified device Ziehm Vision FD employs The proposed the same fundamental control, and substantially equivalent scientific technology as that of predicate device Ziehm Vision FD (K193230). Software architecture our design is substantially equivalent to that of the predicate Ziehm Vision FD.
The primary modification of the C-Arm includes an 8 inch IGZO (Indium gallium zinc oxide) flat panel detector (FPD). The new 8 inch IGZO FPD is an addition to already introduced CMOS and a-Si FPD. 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) 8 inch CMOS, 12 inch a-Si and the only difference to the predicate Ziehm Vision FD is the additional 8 inch IGZO panel.
The comparison of the predicate device and the modified devices shows that the scientific and technical characteristics of the Ziehm Vision FD are
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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, surrounded by orbital lines. To the right of the graphic is the company name, "ziehmimaging," written in a teal-colored, sans-serif font.
substantially equivalent as those of the Ziehm Vision FD predicate device (K193230).
The Ziehm Vision FD is a mobile C-arm providing image data by means of a Intended Use non-contact noninvasive x-ray technique during medical procedures and stores them temporarily. The Ziehm Vision FD is intended for use in all medical indications requiring fluoroscopy.
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. organs, tissue, bones, implants depending on the medical indication.
- Indications for Use: The Ziehm Vision FD is intended for use in providing medical imaging for adults and pediatric populations, using pulsed and continuous fluoroscopic imaging. The device provides contactless fluoroscopic image capture, temporarily storing, and display of digital subtraction, and acquisition of cine loops during diagnostic, interventional and surgical procedures. Examples of clinical application may include pediatric, cholangiography, endoscopic, urologic, lithotripsy, orthopedic, neurologic, vascular, cardiac, angiographic, critical care, and emergency room fluoroscopy procedures. The visualization of such anatomical structures assists the clinician in the clinical outcome. This device does not support direct radiographic film exposures and is not intended for use in performing mammography. The
system is not intended for use near MRI systems.
Device Comparison Table
The table below summarizes the substantive feature/technological differences between the predicate device and the proposed device:
| Model | Modified
Ziehm Vision FD | Predicate
Ziehm Vision FD (K193230) | Comparable Properties
Substantial Equivalence
Discussion |
|---------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k)
Number | K231700 | K193230 | - |
| Product
Codes | OWB (interventional
fluoroscopic x-ray system)
Subsequent:
JAA (system, x-ray,
fluoroscopic, image-
intensified) | OWB (interventional
fluoroscopic x-ray system)
Subsequent:
JAA (system, x-ray,
fluoroscopic, image-intensified) | Identical |
| Model | Modified
Ziehm Vision FD | Predicate
Ziehm Vision FD (K193230) | Comparable Properties
Substantial Equivalence
Discussion |
| Device
Image/
General
Overview | Image: Ziehm Vision FD 8"x 8"
Image: Ziehm Vision FD 12"x 12" | Image: Ziehm Vision FD 8"x 8"
Image: Ziehm Vision FD 12"x 12" | The modified Ziehm Vision FD
and the predicate Ziehm Vision
FD (K193230) share the same
outer design.
The flat panel detectors are
identical in the design of the
housing, both devices use
safety shielding for radiation
suppression and use solid state
x-ray image receptors (SSXI /
FPD) 12 inch aSi, 8 inch CMOS
and the difference to the
predicate Ziehm Vision FD is the
new 8 inch IGZO FPD.
The 8 inch and 12 inch a-Si
Varex FPD's have been
discontinued. |
| X-ray Generator | | | |
| Maximum
Output | Variant A0: 2.0 kW
Variant A1: 2.4 kW | Variant A0: 2.0 kW
Variant A1: 2.4 kW | Identical. |
| Pulsed
Fluoroscopy:
Pulse and
Duration | • pulse width:
7 - 23 ms (12" FPD)
10 - 40 ms (8" FPD)
• pulse rate:
1, 2, 4, 8, 12.5, 25
pulse/s (8" and 12"
FPD)
1, 2, 5, 10, 15, 30
pulse/s (8" FPD) | • pulse width:
7 - 23 ms (12" FPD
Fujifilm aSi)
10 - 40 ms (12" FPD
Varex, 8" FPD Varex
aSi/CMOS)
• pulse rate:
1, 2, 4, 8, 12.5, 25 pulse/s
1, 2, 5, 10, 15, 30 pulse/s | Substantial equivalence.
The 8 inch and 12 inch a-Si
Varex FPD's have been
discontinued.. |
| Model | Modified
Ziehm Vision FD | Predicate
Ziehm Vision FD (K193230) | Comparable Properties
Substantial Equivalence
Discussion |
| Digital
Radiography
(Snapshot) /
Operating
Values | • Variant A0:
kV range: 40 - 110 kV
mA range: up to 20 mA
• Variant A1:
kV range: 40 - 120 kV
mA range: up to 24 mA
(8" and 12" FPD) | • Variant A0:
kV range: 40 -110 kV
mA range: up to 20 mA
• Variant A1:
kV range: 40 - 120 kV
mA range: up to 20 mA (8"
FPD Varex aSi)
mA range: up to 24 mA (8"
FPD Varex
CMOS, 12" FPD Varex aSi,
12" FPD Fujifilm aSi) | Substantial equivalence.
The 8 inch and 12 inch a-Si
Varex FPD's have been
discontinued. |
| Image Detector | | | |
| Image
Detector | Flat Panel Detector
Image: Flat panel detector | Flat Panel Detector
Image: Flat panel detector | Substantial equivalence.
They are identical in the outer
product design of the housing,
both devices use safety
shielding for radiation
suppression and use solid state
x-ray image receptor (SSXI /
FPD) The modified Ziehm Vision
FD has additionally new 8 inch
IGZO (Indium gallium zinc
oxide) flat panel detector.
The 8 inch and 12 inch a-Si
Varex FPD's have been
discontinued. |
| Detector
Technology | Variant aSi FPD:
• Type: Amorphous Silicon
Flat Panel Detector (aSi)
• Scintillator: Cesium-
Iodide (CsI)
Variant CMOS FPD:
• Type: Complementary
Metal Semi-conductor)
• Scintillator: Cesium-
Iodide (CsI)
Variant IGZO FDP:
• Type: Indium gallium
zinc oxide
• Scintillator: Cesium-
Iodide (CsI) | Variant aSi FPD:
• Type: Amorphous Silicon
Flat Panel Detector (aSi)
• Scintillator: Cesium-Iodide
(CsI)
Variant CMOS FPD:
• Type: Complementary Metal
Semi-conductor)
• Scintillator: Cesium-Iodide
(CsI) | Substantial equivalence.
IGZO based detectors are
manufactured using processes
that are similar to aSi
detectors. The slight differences
in used sensor glass technology
does not have influence on
safety and effectiveness of the
C-arm product. |
| Model | Modified
Ziehm Vision FD | Predicate
Ziehm Vision FD (K193230) | Comparable Properties
Substantial Equivalence
Discussion |
| Detector
Sizes | Variant 21cm x 21cm
(8"x8") CMOS:
• Size: 21 cm x 21 cm
• Detector matrix:
2,053 x 2,051 pixels
• Magnifier 1:
1,536 x 1,536 pixels
• Magnifier 2:
1,024 x 1,024 pixels
• Dynamic Range:
– 1 x 1 binning: 84 dB
– 1 x 2 binning: 95 dB
• System resolution
(Nyquist):
5 lp/mm
Variant 31cm x 31cm
(12"x12") aSi:
• Size: 31 cm x 31 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
• Dynamic Range: ≥86 dB
• System resolution
(Nyquist):
3.3 lp/mm
Variant 21cm x 21cm
(8"x8") IGZO:
• Size: 21 cm x 21 cm
• Detector matrix:
1,536 x 1,536 pixels
• Magnifier 1:
1,024 x 1,024 pixels
• Magnifier 2:
768 x 768 pixels
• System resolution
(Nyquist):
3.7 lp/mm | Variant 20.5cm x 20.5cm
(8"x8") CMOS:
• Size: 20.5 cm x 20.5 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
• Dynamic Range:
– 1 x 1 binning: 84 dB
– 1 x 2 binning: 95 dB
• System resolution
(Nyquist):
5 lp/mm
Variant 20cm x 20cm (8"x8")
aSi:
• 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
• Dynamic Range: 94 dB
• System resolution:
2.6 lp/mm
Variant 30cm x 30cm
(12"x12") aSi:
• 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
• Dynamic Range: 94 dB
• System resolution
(Nyquist):
2.6 lp/mm
Variant 30,7 cm x 30.7 cm
(12"x12") aSi:
• Size: 31 cm x 31 cm
• Detector matrix:
2,048 x 2,048 pixels
• Magnifier 1:
1,536 x 1,536 pixels | Substantial equivalence.
The active pixel area of the
detector types are not identical
but are very similar in image
area of approx. 8 inch x 8 inch.
The modified device Ziehm
Vision FD with IGZO has a
higher resolution size in
comparison to predicate device
with 8 inch a-Si FPD, which
leads to better image quality.
All other differences with regard
to the used technology have no
influence on safety and
effectiveness of the C arm.
Variant 20cm x 20cm (8"x8")
aSi and Variant 30cm x 30cm
(12"x12") aSi were
discontinued. |
| Model | Modified
Ziehm Vision FD | Predicate
Ziehm Vision FD (K193230) | Comparable Properties
Substantial Equivalence
Discussion |
| Anti-Scatter Grids | | Magnifier 2:
1,024 x 1,024 pixels System resolution
(Nyquist):
3.3 lp/mm | |
| Fixed anti-
scatter grid | fixed anti-scatter grid:
CMOS (8inch) Pb 8:1/70 lines/cm IGZO (8inch) Pb 8:1/70 lines/cm | fixed anti-scatter grid:
CMOS (8inch) Pb 8/70 | Substantial equivalence.
The grids for the CMOS and the
IGZO FPD are identical for the
predicate and the modified
Ziehm Vision FD. |
| optional
removable
anti-scatter
grid | Removable Grid:
CMOS (8inch) Pb 8:1/70 lines/cm a-Si (12inch) Pb 6:1 /80 lines/cm IGZO (8inch) Pb 8:1/70 lines/cm Image: [removable anti-scatter grid] | Removable Grid:
CMOS (8inch) Pb 8:1/70 lines/cm a-Si (8inch) Pb 8:1/70 lines/cm a-Si (12inch) Pb 6:1 /80 lines/cm | Substantial equivalence.
The grids for the CMOS and the
IGZO FPD are identical for the
predicate and the modified
Ziehm Vision FD. The grid of the
a-Si (12 inch) FPD has a slightly
different value compared to the
anti-scatter grids for the other
two FPD's. The 8 inch and 12
inch a-Si Varex FPD's have been
discontinued. |
| Mechanics | | | |
| Model | Modified
Ziehm Vision FD | Predicate
Ziehm Vision FD (K193230) | Comparable Properties
Substantial Equivalence
Discussion |
| Length of
Mobile Stand | IGZO & CMOS (8"):
174 cm/196 cm aSi (12"): 176 cm /
198 cm | 160 / 182 cm (20/20 135° orbital) CMOS (8"): 180 / 202 cm(orbital with lifting column expansion) aSi (12"): 176 / 198 cm | Substantial equivalence.
Ziehm Vision FD 8" a-Si , the length of 160 / 182 cm (20/20 135° orbital) for Ziehm Vision FD a-Si 8" and the optional orbital length with lifting column expansion were discontinued.
The length of Mobile Stand for Ziehm Vision FD 8" CMOS has been optimized and does not have influence on the safety and effectiveness of the C-arm. |
| Height of
Mobile Stand | IGZO, CMOS and a-Si:
155 / 197 cm | a-Si (8"): 155 / 200 cm CMOS (8") and a-Si (12"):
155 / 197 cm CMOS (8") (optional): 158 / 220 cm (20/20 165° orbital with lifting column expansion) | Substantial equivalence.
a-Si (8"): 155 / 200 cm and the option for CMOS (8"): 158 / 220 cm (20/20 165° orbital with lifting column expansion) were discontinued. |
| Weight | Mobile Stand:
max. 321 ± 5% kg (FD 8") max. 326 ± 3% kg (FD 12") Monitor Cart: 156 kg ± 10% | Mobile Stand: max. 321 ± 5% kg (FD 8") max. 326 ± 3% kg (FD 12") Monitor Cart: max 233 kg | Identical.
The weight of the monitor cart of the predicate and the modified Ziehm Vision FD is identical. The value given before was a typing error. |
| Digital Image Processing | | | |
| Real-Time
processing
functions | Recursive filter: 4 levels 'Last Image Hold' Edge enhancement filter:
5 levels Windowing and step
windowing Digital image rotation and reversal without radiation Grayscale inversion Virtual collimators Ziehm Adaptive Image
Processing (ZAIP) | Recursive filter: 4 levels Stack filter ('Last Image Hold'): 5 levels 'Last Image Hold' Edge enhancement filter: 5 levels Windowing and step windowing Digital image rotation and reversal without radiation Grayscale inversion Virtual collimators Ziehm Adaptive Image Processing (ZAIP) | Substantial equivalence.
Stack filter ('Last Image Hold'): 5 levels has been discontinued. |
| Model | Modified
Ziehm Vision FD | Predicate
Ziehm Vision FD (K193230) | Comparable Properties
Substantial Equivalence
Discussion |
| Anatomical
Marking Tool
- AMT
(Option) | • Mark anatomical
structures
• Indicate side of body
• Line and connected
line | • Mark anatomical structures
• Indicate side of body | Substantial equivalence.
An optimization of the tool has
been made and has no
influence on the safety and
effectiveness of the device. |
| Data
Organization | • Patient-based data
management with 16-
image mosaic display
• Pre-registration via
DICOM Worklist
• Manual input or
emergency registration
• Calculated Dose Area
Product (DAP)
• Optional: measured Dose
Area Product (DAP)
• DAP value tagged to
stored image
• Air Kerma dose display
• Air Kerma value tagged
to stored image
• HIPAA security package
(option)
• Video output - Full HD SDI
(split display) - 1920 x 1080p
- 60Hz
• Radiation Dose
Structured Report
(RDSR) | • Patient-based data
management with 16-image
mosaic display
• Pre-registration via DICOM
Worklist
• Manual input or emergency
registration
• Calculated Dose Area
Product (DAP)
• Optional: measured Dose
Area Product (DAP)
• DAP value tagged to stored
image
• Air Kerma dose display
• Air Kerma value tagged to
stored image
• HIPAA security package
(option)
• Radiation Dose Structured
Report (RDSR) | Substantial equivalent.
As required by the IEC 60601-
2-43 the modified device Ziehm
Vision FD displays dose area
product (DAP), air kerma rate
and cumulative air kerma at the
same time.
An optimization have been
made through the Video output,
which have no influence on the
device safety and effectiveness. |
| Device Options List | | | |
| Summary of
Options | • Removable anti-scatter
grid
• Footswitch with
customer-specific switch
assignment: cable bound
or wireless, with or
without protective
bracket
• Laser positioning device
on the generator and/or
detector
• Different sizes of display
monitor | • Removable anti-scatter grid
• Footswitch with customer-
specific switch assignment:
cable bound or wireless,
with or without protective
bracket
• Laser positioning device on
the generator and/or
detector
• Different sizes of display
monitor
• Monitor Arm: articulating
monitor arm | Substantial equivalence.
The option Z-Conference for
video streaming and film for
printing was discontinued.
The option No 3.5" floppy disk
drive and vertical 63 cm has
been discontinued. |
| Model | Modified
Ziehm Vision FD | Predicate
Ziehm Vision FD (K193230) | Comparable Properties
Substantial Equivalence
Discussion |
| | • Monitor Arm: articulating
monitor arm • Additional handrails on C
for orbital rotation
support • Vertical lift: 42 cm • Dose Area Product (DAP)
and Air Kerma:
measured or calculated • Key switch Power on/off
or X-ray on/off • Emergency stop button
on the Monitor Cart • Printer: paper • USB port • DVD drive • Ziehm NetPort (DICOM
3.0 interface for digital
network integration) • Ziehm NaviPort 2D
(Interface for transfer of
2D image information to
a navigation system;
only in combination with
DICOM 3.0 interface) • WLAN (interface for
wireless data transfer) • Wireless Video
(transmission of wireless
video signal from the
device to local display
monitors) • Video connector(s):
analog or digital signal • Application-Oriented
Anatomical Programs • Measurement functions • Anatomical Marking Tool
(AMT) • Vascular package • Cine loop: up to 25
frames per second • CO2 package (provides
the option to use CO2 as
contrast media for | • Additional handrails on C for
orbital rotation support • Vertical lift: 42 cm or 63 cm • Dose Area Product (DAP)
and Air Kerma: measured or
calculated • Key switch Power on/off or
X-ray on/off • Emergency stop button on
the Monitor Cart • Printer: paper or paper/film • USB port • DVD drive • No 3.5" floppy disk drive • Ziehm NetPort (DICOM 3.0
interface for digital network
integration) • Ziehm NaviPort 2D
(Interface for transfer of 2D
image information to a
navigation system; only in
combination with DICOM 3.0
interface) • WLAN (interface for wireless
data transfer) • Wireless Video
(transmission of wireless
video signal from the device
to local display monitors) • Z-Conference (Video-server
for streaming the live image
of the left monitor within
the hospital network) • Video connector(s): analog
or digital signal • Application-Oriented
Anatomical Programs • Measurement functions • Anatomical Marking Tool
(AMT) • Subtraction modes DSA,
MSA, RSA • Pixel shift and landmarking • Cine loop: up to 25 frames
per second | |
| | displaying vessels)
• Generic interface to
power injector | • CO2 package (provides the
option to use CO2 as
contrast media for
displaying vessels) | |
| Model | Modified
Ziehm Vision FD | Predicate
Ziehm Vision FD (K193230) | Comparable Properties
Substantial Equivalence
Discussion |
| | • User administration
(HIPAA)
• Interface for external
separate X-ray indication
lamp
• DICOM viewer software
• External display monitor
• Interface for Remote
Vision Center
• Remote Vision Center
• Mounting bracket for
Remote Vision Center
• Mobile Cart for Remote
Vision Center | • Generic interface to power
injector
• User administration (HIPAA)
• Interface for external
separate X-ray indication
lamp
• DICOM viewer software
• External display monitor
• Interface for Remote Vision
Center
• Remote Vision Center
• Mounting bracket for
Remote Vision Center
• Mobile Cart for Remote
Vision Center | |
| Optional
Accessories | • Sterile disposable covers
• Skin protection | • Sterile disposable covers
• Hand surgery table
• Skin protection | Substantial equivalent
The optional Hand surgery table
is no longer available.
Note: Ziehm Imaging GmbH is
not the manufacturer of the
optional accessories |
| Software | | | |
| Level of
Concern | Enhanced | Moderate | Identical
The term of level of concern has
changed according to the
Guidance "Content of
Premarket Submissions for
Device Software Functions", but
there have been no additional
changes to the device that have
increased the level of concern. |
| Software | • Version 7.06.11
• Linux based OS Ubuntu | • Version 7.06 SP2
• Linux based OS Ubuntu | Substantial equivalence.
Updates and optimization of
software features, which does
not have influence on safety
and effectiveness of the device.
For details please refer to
Device Description_Ziehm
Vision FD_revised. |
| | Application / Indications for Use | | |
| Model | Modified
Ziehm Vision FD | Predicate
Ziehm Vision FD (K193230) | Comparable Properties
Substantial Equivalence
Discussion |
| Indications
for Use | The Ziehm Vision FD is
intended for use in
providing medical imaging
for general populations.
The device provides
pulsed and continuous
fluoroscopic imaging of
patients during diagnostic,
interventional and surgical
procedures. It is intended
for use in visualizing
complex anatomical
structures and procedures
such as vascular, cardiac,
angiographic,
cholangiography,
endoscopic, urologic,
orthopedic, neurologic,
critical care, emergency
room procedures, and
where higher accuracy in
Image geometry is
required. 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 Ziehm Vision FD is
intended for use in providing
medical imaging for general
populations. The device
provides pulsed and continuous
fluoroscopic imaging of patients
during diagnostic,
interventional and surgical
procedures. It is intended for
use in visualizing complex
anatomical structures and
procedures such as vascular,
cardiac, angiographic,
cholangiography, endoscopic,
urologic, orthopedic,
neurologic, critical care,
emergency room procedures,
and where higher accuracy in
Image geometry is required.
This device does not support
direct radiographic film
exposures and is not intended
for use in performing
mammography. | Substantial equivalent
The wording of the indications
for use were updated. These
changes do not raise new safety
or effectiveness concerns with
regard to the predicate device. |
| Human
Factors | Only trained and instructed
qualified personnel are
allowed to operate the
system. | Device labeling defines that
only trained and instructed
qualified personnel are allowed
to operate the system. | Substantial equivalence.
The wording has changed, but
does not have influence on the
safety and effectiveness of the
C-arm product. |
| Standards | | | |
| Model | Modified
Ziehm Vision FD | Predicate
Ziehm Vision FD (K193230) | Comparable Properties
Substantial Equivalence
Discussion |
| Standards | • IEC 60601-1:
2006/AMD1:2013
• IEC 60601-1-2:2014
• IEC 60601-1-
3:2008/AMD1:2013
• IEC 60601-1-
6:2010/AMD2:2021
• IEC 60601-2-
43:2010/AMD2:2020
• IEC 60601-2-54
:2009/AMD2:2019
• IEC 60825-1:2007
• ISO 14971:2019 | • ANSI/AAMI ES60601-
1:2012
• IEC 60601-1-2:2014
• IEC 60601-1-3:2008 +
A1:2013
• IEC 60601-1-6:2013
• IEC 60601-2-43:2010
• IEC 60601-2-54:2009 +
A1:2015
• IEC 60825-1:2007
• ISO 14971:2007 | Applicable standards for the
modified Ziehm Vision FD and
the predicate Ziehm Vision FD
(K193230) remain as before.
Newer versions of the
standards have been applied. |
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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 to the left of the company name. The graphic contains a stylized human figure inside of a globe.
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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 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/8/Picture/0 description: The image contains the logo for ziehmimaging. 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. The company name is written in a teal sans-serif font.
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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 company name "ziehmimaging" on the right. The graphic features a stylized human figure within a circular frame, and the text is rendered in a teal color.
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Image /page/10/Picture/0 description: The image shows the logo for Ziehm Imaging. The logo consists of a circular graphic to the left of the company name. The graphic contains a stylized human figure inside of a globe.
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Image /page/11/Picture/0 description: The image shows the logo for Ziehm Imaging. The logo consists of a circular graphic to the left of the company name. The graphic contains a stylized human figure inside of a globe.
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Image /page/12/Picture/0 description: The image shows the logo for Ziehm Imaging. The logo consists of a globe-like symbol 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.
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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 to the left of the company name. The graphic contains a stylized human figure inside of a globe.
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Image /page/14/Picture/0 description: The image contains 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 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/15/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, with the "imaging" portion being a darker shade of teal.
Conclusion of Table The changes of the proposed modified device Ziehm Vision FD described in the above: table do not change the fundamental control mechanism, operating principle or intended use found on predicate device and supports substantially equivalents to the predicate device Ziehm Vision FD (K193230) in accordance with its labeling.
- Safety and Performance: The proposed Ziehm Vision FD 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 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 FD is based on direct modifications to cleared predicate device Clinical Test Data: Ziehm Vision FD (K193230).
The design of the modified Ziehm Vision FD 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.
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Image /page/16/Picture/0 description: The image shows the logo for Ziehm Imaging. The logo consists of a stylized globe with a human figure inside, followed by the text "ziehmimaging" in a teal color. The text is written in a sans-serif font and is slightly faded.
The performance testing confirmed that the modified Ziehm Vision FD 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 FD 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 FD 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 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 Imaqing GmbH believes the modified device Ziehm Vision FD C-arm image quality, safety and effectiveness supports a determination of substantial equivalence to the predicate device Ziehm Vision FD (K193230).
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) |
|---|---|
| Regulation (EU) | |
| 2017/745 | Annex IX Chapter I, Section2 and 3 and Chapter III |
| EN ISO 13485 | Medical devices - Quality management systems - Requirements for |
| regulatory purposes | |
| Date: 2016 |
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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 |
| 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
Determination of Summary Bench Testing Substantial Equivalence: Verification and Validation including hazard mitigations executed resulted in demonstrated system met Design Input and user needs. The device was tested by the notified test laboratory resulting in device
being certified compliant with ANSI/AAMI ES6060-1-1 series, including IEC
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60601-2-54. Further device met all applicable sections of 21 CFR Subchapter J performance standards.
The modified Ziehm Vision FD 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 emploved. Anatomical 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 FD results in a comparable patient care to the reference device Ziehm Vision FD (K193230) and fulfils the requirements as stated by the intended use. Therefore, Ziehm Imaging GmbH believes the Ziehm Vision FD C-arm image quality, safety and effectiveness to be substantially equivalent to that of the predicate device Ziehm Vision FD (K193230).
- Conclusion Ziehm Imaging GmbH considers the Ziehm Vision FD to be as safe, as effective, and performs substantially equivalent to the predicate device Ziehm Vision FD (K193230) in accordance with its labeling.