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 such as vascular cardiac, angiographic, cholangiography, endoscopic, urologic, orthopedic, neurologic, critical care, enom procedures, and where higher accuracy in Image geometry is required. This device does not support direct radiographic film exposures and is not in performing mammography. The system is not intended for use near MRI systems.

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. Tehse 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 X-ray technique control. Integrated high-resolution flat panel display monitors directly mounted on the clinican with a precise angle for visualization of live fluoroscopy images of the patient's anatomy. This visualization helps to localize reqions of pathology for surgical procedures. The mobile stand supports both a cable bound and optional wireless fluoroscopic 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 Dice and wireless network interfaces.

The proposed modified Ziehm Vision FD employs the same fundamental control, and substantially equivalent scientific technology as that of our predicate device Ziehn Vision FD (K240020). Software architecture design is substantially equivalent to that of the predicate Ziehm Vision FD.

AI/ML Overview

The provided FDA 510(k) summary does not contain detailed information regarding acceptance criteria or a specific study proving the device meets those criteria in the typical format of a clinical trial or performance evaluation with specific metrics. Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (Ziehm Vision FD K240020) by highlighting updates in software and detector technology.

However, based on the text, we can infer some general acceptance criteria and the types of studies/testing performed to support the device's performance.

Here's an attempt to structure the information based on your request, acknowledging the limitations of the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Reported Device Performance (Summary from provided text)
Image Quality Performance	- Image comparison between optimized system settings (including 2k imaging chain) of the modified device shows that the image quality is better or at least all images show more detectability and are sharper than corresponding reference images.
	- "From a radiological point of view, the image quality of the presented images that were acquired fulfill the requirements as stated by the intended use."
	- For pediatric dose settings: "image quality may be reduced due to physical factors, but sufficient image quality is still provided to support the physician during the whole clinical procedure."
Compliance with Federal Performance Standards	- Complies with 21 CFR 1020.30-32 Federal Performance Standards for X-Ray Fluoroscopic equipment.
Compliance with Safety Standards	- Complies with ANSI AAMI ES60601-1-2:2020, IEC 60601-1-3:2021, IEC 60601-2-43:2022, and IEC 60601-2-54:2022.
System and Imaging Performance (Non-Clinical)	- Performance bench testing demonstrated system and imaging performance, including physical characteristics, operational and exposure characteristics, and safety features.
Software Performance	- Verification and Validation testing successfully conducted.
Cybersecurity Posture	- Vulnerability scanning (SBOMs, Tenable Nessus) findings assessed and found acceptable.
	- Two separate penetration tests displayed a "good cybersecurity posture."
	- Static code analysis indicated some code locations that might benefit from adaptation but no stability nor any security issue could be identified that would require immediate action.
Substantial Equivalence	- Risk control assessment, verification activities, and system functionality are consistent with user needs and intended use, and performs as designed, raising no new questions regarding safety or effectiveness. - Device is considered substantially equivalent to the predicate device (Ziehm Vision FD K240020) based on shared design, technology, functionality, and indications for use.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The document does not specify a numerical sample size for the test set of images or patients. It mentions "anthropomorphic as well as motion-induced phantoms" for image quality testing and "anthropomorphic phantoms" for pediatric dose testing. This suggests the tests were performed on a set of phantom images, not human patient data in the context of specific image count.
Data Provenance: The testing was performed using phantoms, which are simulated patient data. The origin of the phantoms (e.g., specific manufacturer or dataset) is not explicitly stated. The tests are non-clinical, implying they were conducted in a controlled environment, likely at the manufacturer's facility in Germany.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

The document implies an expert evaluation for image quality: "From a radiological point of view the image quality of the presented images that were acquired fulfill the requirements as stated by the intended use."
However, it does not specify the number of experts used, nor their specific qualifications (e.g., X years of experience, specific board certifications).

4. Adjudication Method for the Test Set

The document does not specify an adjudication method (e.g., 2+1, 3+1). The statement regarding image quality being acceptable "from a radiological point of view" suggests a qualitative assessment, but the process is not detailed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

The document does not mention or describe a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. The device is an image-intensified fluoroscopic X-Ray system, and the submission focuses on hardware and software updates related to image acquisition and processing ("QuantumStream" and "Image Insights" overlay), not an AI-assisted diagnostic tool that would typically involve human reader improvement metrics.
The text does not refer to "AI assistance" in the context of improving human reader performance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This evaluation is on an X-ray imaging system, not a standalone algorithm. The device's performance is inherently tied to the images it produces. The image quality tests described ("better or at least all images show more detectability and are sharper") are a form of standalone performance evaluation of the system's output, comparing it to a reference.

7. The Type of Ground Truth Used

For image quality testing, the "ground truth" was established by comparing the images produced by the modified device to "corresponding reference images" from the predicate system, and evaluating them against general "radiological requirements" and criteria like "detectability" and "sharpness." Phantoms were used to generate these images.
For compliance, the ground truth was regulatory standards (21 CFR 1020.30-32 to 21 CFR 892.1650, ANSI/IEC safety standards) and specific guidance documents (e.g., "Guidance for submission of 510(k)s for Solid State X-Ray Imaging Devices").
For cybersecurity, ground truth involved identifying vulnerabilities and assessing the security posture through established security testing methodologies.

8. The Sample Size for the Training Set

The document does not mention a traditional "training set" in the context of machine learning, as the update primarily involves a software update to an imaging chain and a new display overlay ("QuantumStream" and "Image Insights") rather than a new AI algorithm that would typically require a large training dataset for development. The "optimized system settings" likely refer to engineering adjustments and calibration rather than algorithm training.

9. How the Ground Truth for the Training Set Was Established

As no "training set" (in the machine learning sense) is explicitly mentioned, the establishment of ground truth for such a set is not described. The improvements are described as arising from an updated 2k imaging chain.

Summary

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March 13, 2025

Ziehm Imaging GmbH % Cornelia Schildbach Specialist Regulatory Affairs Lina-Ammon-Strasse 10 NUREMBERG, 90471 GERMANY

Re: K243735

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: December 19, 2024 Received: December 19, 2024

Dear Cornelia Schildbach:

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.

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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).

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.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

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 medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatory

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assistance/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

Enclosure

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Indications for Use

Submission Number (if known)

K243735

Device Name

Ziehm Vision FD

Indications for Use (Describe)

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.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) #: K243735	510(k) Summary	Prepared on: 2025-02-24
-------------------	----------------	-------------------------

Contact Details	21 CFR 807.92(a)(1)
Applicant Name	Ziehm Imaging GmbH
Applicant Address	Lina-Ammon-Strasse 10 Nuremberg 90471 Germany
Applicant Contact Telephone	49 (91166) 067-258
Applicant Contact	Mrs. Cornelia Schildbach
Applicant Contact Email	Zie-Regulatory@ziehm.com

Device Name	21 CFR 807.92(a)(2)
Device Trade Name	Ziehm Vision FD
Common Name	Interventional Fluoroscopic X-Ray System
Classification Name	Image-intensified fluoroscopic x-ray system
Regulation Number	892.1650
Product Code(s)	OWB, JAA

Legally Marketed Predicate Devices	21 CFR 807.92(a)(3)
------------------------------------	---------------------

Predicate #	Predicate Trade Name (Primary Predicate is listed first)	Product Code
K240020	Ziehm Vision FD	OWB

Device Description Summary	21 CFR 807.92(a)(4)
----------------------------	---------------------

Intended Use/Indications for Use

21 CFR 807 92(a)(5)

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Indications for Use Comparison

The indications for use of the predicate and modified device are equivalent.

Technological Comparison

The key modification refers to an software update to software version 7.10.0, which incorporates the 2k imaging chain "QuantumStream", along with the corresponding new "Image Insights" overlay. In addition to the already introduced 8 inch IGZO flat panel detector (K231700), the modified Ziehm Vision FD offers an additional IGZO panel. The manufacturing technology (IGZO, Indium-Gallium-Zinc-Oxide) of both detectors, the detector size as well as the image quality are equivalent.

The predicate Ziehm Vision FD (K240020) and the modified Ziehm Vision FD share substantially equivalent design, technology, functionality and have substantially equivalent Indications for Use.

Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)

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 text.

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 ANSI AAM E560601-1-2:2020, IEC 60601-1-3:2021, IEC 60601-243:2022 and IEC 60601-2-54:2022.

Performance bench testing included non-clinical testing methods specific to "Guidance for submission of 510(k)s for Solid State X-Ray lmaging Devices (Guidance for Industry and Drug Administration Staff, September 2016)", demonstrating system, and imaging performance. In particular physical characteristics as well as operational and exposure characteristics and safety features were taken into consideration. All requirements related to labelling and quality assurance were addressed.

The image quality testing was performed with anthropomorphic as well as motion-induced phantoms for the analysis and comparison of image quality with the predicate system. Furthernore Ziehm Imaging GmbH performed pediatic dose testing as required by FDA Guidance "Pediatric Information for X-ray Imaging Device Premarket Notifications (Guidance for Industry and Food and Druq Administration Staff, November 2017". Anthropomorphic phantoms were used and are constructed with a natural human skeleton cast inside a proprietary urethane material that has the same number as the body's soft tissue. The image comparison between the system settings of the optimized system settings (including 2k inaging chain) of the modified device shows that the image quality acquired with the test device is better or at least all images generated by the test device show more detectability and are sharper than the corresponding reference inages. From a radiological point of view the image quality of the presented images that were acquired fulfil the requirements as stated by the intended use. Regarding imaging with pediatric dose settings the image quality may be reduced due to physical factors, but sufficient image quality is still provided to support the physician during the whole clinical procedure.

Software and cybersecurity testing was performed as required by "Content of Premarket Submissions for Device Software Functions (Guidance for Industry and Food and Drug Administration Staff, June 2023)" and "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions (Guidance for Industry and Food and Drug Administration Staff, September 2023)".

Cybersecurity testing comprises vylnerability scanning, penetration testing an static code analysis. Vulnerability scanning has been performed on the devices SBOMs and additionally using Tenable Nessus. The findings have been assessed and found acceptable. Two separate penetration tests have been conducted and displayed a qood cybersecurity posture of the results from the static code analysis indicate some code locations that might benefit from a code adaption, but no stability nor any security issue could be identified that would require immediate action. The points for insequent software releases. Overall the testing activities demonstrate a good level of cybersecurity for the device, complying with the FDA requirements.

After review of the modified device Ziehn Vision FD risk control assessment, the verification activities which successfully confirmed device requirements have been fulfilled, system functionality is consistent with the user needs, intended use, and performs as designed and raises no new questions regarding either safety or effectiveness. Ziehm Imaging GmbH therefore believes the modified device Ziehm Vision FD to be substantial equivalent to the predicate device Ziehm Vision FD (K240020).

21 CFR 807 92(a)(5)

21 CFR 807.92(a)(6)

Regulation Number and Section

§ 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.