(265 days)
Not Found
No
The summary describes a standard mobile C-arm fluoroscopy system with basic image processing and storage capabilities. There is no mention of AI, ML, or related concepts in the intended use, device description, or performance studies.
No.
The device is used for medical imaging to support diagnosis and procedures, not to provide therapy.
Yes
The "Intended Use / Indications for Use" section states that the device provides medical imaging for "diagnostic, interventional and surgical procedures." The "intends to support" medical imaging for diagnostic procedures, indicating 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, Image Intensifier, user keyboard, flat panel display monitors, and a footswitch. This indicates it is a hardware device with integrated software, not a software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Ziehm 8000 mobile C-arm is an imaging device that uses X-rays to visualize internal structures of the body 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 for diagnostic, interventional, and surgical procedures requiring X-ray imaging. This is consistent with an imaging device, not an IVD.
Therefore, the Ziehm 8000 mobile C-arm falls under the category of a medical imaging device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Ziehm 8000 mobile C-arm is intended for use in providing medical imaging for general populations. The device provides contactless fluoroscopic image capture, temporarily storing, and display of digital subtraction of cine loops during diagnostic, interventional and surgical procedures requiring X-ray imaging both inside and outside the operating room. Examples of clinical application may include cholangiography, endoscopic, urologic, lithotripsy, cardiac, orthopedic, vascular, pain management, angiographic, critical care, and emergency room fluoroscopy procedures.
This device does not support direct radiographic film exposures and is not intended for use in performing mammography.
Product codes (comma separated list FDA assigned to the subject device)
OWB, JAA, OXO
Device Description
The Ziehm 8000 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 Image Intensifier. 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 keyboard provides for concise user selectable anatomical programs and X-ray technique control. Integrated highresolution 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 a cable bound fluoroscopic footswitch. The optional interface panel of the Ziehm 8000 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
X-ray
Anatomical Site
The system is intended for use with human bodies covering structures such as but not limited to the following, e.g. organs, tissue, bones, implants depending on the medical indication.
Indicated Patient Age Range
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
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 and dose Lab testing, were employed. Anthropomorphic (PMMA material) phantoms and anatomical simulation phantoms were employed, image comparison sets taken were representative of both the adult and pediatric populations. A Radiologist performed an assessment of individual image sets.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: Non-clinical image and dose Lab testing, image comparison study.
Sample Size: Anthropomorphic (PMMA material) phantoms and anatomical simulation phantoms were employed.
Key Results: Radiologist conclusion, the image quality of the Ziehm 8000 results in a comparable patient care to the Predicate device (K051064). and fulfils the requirements as stated by the intended use. His conclusion was the image quality combined with a reduced patient dosage will result in a comparable patient care to the Predicate device Ziehm Quantum (K051064). His comparison of the dose and images provided further evidence in addition to the laboratory performance data that the complete system works as intended and is substantially equivalent to the predicate device.
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.
Ziehm Quantum (K051064)
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.
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Image /page/0/Picture/0 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 is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 20, 2019
Ziehm Imaging GmbH % Steve Seeman Director of Regulatory Affairs and Quality Assurance Ziehm Imaging, Inc. 6280 Hazeltine National Drive ORLANDO, FL 32822
Re: K190497
Trade/Device Name: Ziehm 8000 Regulation Number: 21 CFR 892.1650 Regulation Name: Image-Intensified Fluoroscopic X-Ray System Regulatory Class: Class II Product Code: OWB, JAA, OXO Dated: October 16, 2019 Received: October 18, 2019
Dear Steve Seeman:
We have reviewed vour Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal
1
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 post-marketing 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,
Michael D. O'Hara
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure
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Indications for Use
510(k) Number (if known) K190497
Device Name Ziehm 8000
Indications for Use (Describe)
The Ziehm 8000 mobile C-arm is intended for use in providing medical imaging for general populations. The device provides contactless fluoroscopic image capture, temporarily storing, and display of digital subtraction of cine loops during diagnostic, interventional and surgical procedures requiring X-ray imaging both inside and outside the operating room. Examples of clinical application may include cholangiography, endoscopic, urologic, lithotripsy, cardiac, orthopedic, vascular, pain management, angiographic, critical care, and emergency room fluoroscopy procedures.
This device does not support direct radiographic film exposures and is not intended for use in performing mammography.
| 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/1 description: The image shows 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 globe-like structure.
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
Oct 06, 2019
In accordance with 21 CFR §807.92 the following 510(k) summary information is provided:
| Submitter Address: | Ziehm Imaging GmbH
Donaustrasse 31
90451 Nuremberg
Germany |
|------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|
| Primary Contact Person /
Agent: | Steve Seeman
Director of Regulatory Affairs and Quality Assurance
Ziehm Imaging, Inc.
E-Mail: Steve.Seeman@Ziehm.com |
| Secondary Contact Person: | Stefan Fiedler
Director QM/RA
Ziehm Imaging GmbH |
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| Device (Trade Name): | Ziehm 8000 |
|---|---|
| 510(k) Number: | unknown |
| Common /Usual Names: | Mobile Fluoroscopic C-Arm |
| Regulation number: | 21CFR 892.1650 |
| Regulation Description: | Image-intensified fluoroscopic x-ray system |
| Device: | Interventional fluoroscopic x-ray system |
| Product Code: | OWB, JAA, OXO |
| Predicate Device: | Ziehm Quantum (K051064) |
| Regulation number: | 21CFR 892.1650 |
| Regulation Description: | Image-intensified fluoroscopic x-ray system |
| Device: | Interventional fluoroscopic x-ray system |
| Product Code: | OWB, JAA, OXO |
| General Description: | The Ziehm 8000 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 Image Intensifier. 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 keyboard provides for concise user selectable anatomical programs and X-ray technique control. Integrated highresolution 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 a cable bound fluoroscopic footswitch. The optional interface panel of the Ziehm 8000 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.
- The Ziehm 8000 is a mobile C-arm providing image data Intended Use by means of a non-contact noninvasive x-ray technique during medical procedures and stores them
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Image /page/5/Picture/1 description: The image contains the word "imaging" in a stylized font. The word is in a teal color, and it appears to be part of a larger logo or brand name. To the left of the word is a circular graphic with a human figure inside.
temporarily.
The system can be used for all medical indications where fluoroscopy is required.
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 structures such as but not limited to the following, e.g. organs, tissue, bones, implants depending on the medical indication.
Indications for Use: The Ziehm 8000 mobile C-arm is intended for use in providing medical imaging for general populations. 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 or guidance procedures requiring X-ray imaging both inside and outside the operating room. Examples of clinical application may include cholangiography, endoscopic, urologic, lithotripsy, cardiac, orthopedic, neurologic, vascular, pain management, angiographic, critical care, and emergency room fluoroscopy procedures.
This device does not support direct radiographic film exposures and is not intended for use in performing mammography.
- Technology: The proposed modified device Ziehm 8000 C-arm employs the same fundamental control, and scientific technology as that of our predicate device Ziehm Quantum C-arm (K051064).
The radiation control, X-Ray monoblock generator, power supplies as well as our advanced imaging system are very similar to the predicate device Ziehm Quantum C-arm (K051064).
Software architecture design is nearly identical to that of the predicate device Ziehm Quantum C-arm (K051064)
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Image /page/6/Picture/1 description: The image shows the logo for Ziehm Imaging. The logo consists of a circular graphic with a stylized human figure inside, next to the company name "ziehmimaging" in a teal, serif font. The overall design is clean and professional.
with modification of the software to support, lower dose functionality, processing applications related to the optional low dose range, image, Variable beam limiting device, and device specific features.
The primary modifications of the C-Arm include a larger but virtually the same medical grade Image receptor as that of the predicate device Ziehm Quantum C-arm (K051064), virtual beam limiting device for precise collimating to anatomical structures, new pre-filter for lower skin entrance dose imaging, incorporation of mechanical design improvements in the C-Arm and mobile workstation balancing, locks, and maneuverability improving operator workflow during extended procedures while keeping the essential profile of our predicate device Ziehm Quantum C-arm (K051064)
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Image /page/7/Picture/1 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 and graphic are in a teal color.
Summary of Technological Characteristics:
The comparisons of the technological characteristics of the proposed device Ziehm 8000 C-Arm to that of the predicate device demonstrates that the scientific and technology characteristics are substantial equivalence to the predicate device Ziehm Quantum C-arm (K051064)
| Differences
Features/Technology | Subject Device
Ziehm 8000 | Predicate Device
Quantum (K051064) | Comparison to
Predicate, Comments
to Differences |
|------------------------------------|------------------------------|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | | The new Ziehm 8000
and the predicate
Ziehm Quantum
(K051064) share the
same general design of
the Mobile Stand.
The new Ziehm 8000 in
comparison to the
predicate has a monitor
cart (workstation)
which supports the
imaging and display
system. Functionality is
essentially the same for
imaging and display.
They also share a
substantial equivalence
with regard to but not
limited to the intended
use, operational
functionality of imaging,
use of a mono block
generator, radiation dos
control, user interface
control keyboards, 2D
imaging acquisition,
general dimensional
features, scientific
technologies, safety, and
effectiveness.
These changes do not
raise new safety or
effectiveness concerns. |
| Mobile fluoroscopic c-arm | Yes | Yes | Identical |
| Product Codes | OWB, OXO, JAA | OWB, OXO, JAA | Identical |
| Classification | 21CFR 892.1650 | 21CFR 892.1650 | Identical |
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Image /page/8/Picture/1 description: The image contains the logo for Ziehm Imaging. The logo consists of a circular emblem on the left and the text "ziehmimaging" on the right. The emblem features a stylized human figure inside a circle with orbital lines, and the text is in a teal color.
| Mobile stand |
|---|
| Control Elements |
| Touch Panel |
Control Panel on Mobile Stand:
Image /page/8/Picture/4 description: The image shows a close-up of the top portion of a medical device, likely an anesthesia machine or similar equipment. The control panel is visible, featuring a digital display with numerical readouts and various buttons with iconographic labels. An emergency stop button is located on the left side of the panel, and handles are attached on both sides for easy maneuverability. The device appears to be well-maintained and designed for precision control in a medical setting.
Control Panel on Monitor Cart:
Image /page/8/Picture/6 description: The image shows a control panel with a variety of buttons and symbols. The panel is light blue and has a grid of small, square buttons at the top, each with a different symbol. There are also larger buttons on the right side of the panel, some of which are green and orange. In the center of the panel, there is a logo that says "Ziehm Imaging".
Electrical Requirements
| • Power supply: |
|---|
| 100-240 VAC (± 10%) |
| 50/60 Hz |
| • Current consumption: |
Current consumption: 100-120 V: 14 A continuous, 22 A shorttime 200-240 V: 10 A continuous, 16 A shorttime
- Max. impedance: 100-120 V: ≤ 0.3 Ω 200-240 V: ≤ 0.6 Ω
- · Class I equipment, Type B
| X-ray generator and tube Yes,
housing assembly
| monoblock technology | Yes | |
|---|---|---|
| KV Range 40-110 kV | Yes | Yes |
| Max power output | 2.2 kW | 2.2 kW |
| Fluoroscopy: | ||
| Output | up to 605 W | up to 660 W |
| Collimator/beam limiter | ||
| shutters | Yes | Yes |
| • Collimator Rotation, | ||
| +/- 90° and Iris | ||
| Collimator | ||
| Virtual collimation | Yes | No |
Control Panel on Mobile Stand:
Image /page/8/Picture/14 description: The image shows a control panel with various buttons and digital displays. The left display reads "75 37 0.1", while the right display reads "88 0.1 0.00". The panel also features an array of buttons with different symbols and functions, arranged in a grid-like pattern on both sides of the displays. The panel is light blue and has a white handle in the center.
Touch control panel "DeskView" on Mobile Stand:
Image /page/8/Picture/16 description: The image shows a close-up of a medical imaging device, likely a C-arm X-ray system. The focus is on the control panel and display screen, which shows a grayscale image, possibly an X-ray or fluoroscopic image. The device has a white and light blue color scheme, and the image is well-lit, highlighting the details of the equipment.
- · Power supply: 120/240 Vac (± 10%), 50/60 Hz Current consumption: . 12 A continuous, 30 A
- short-time • Max. impedance: