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.

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 regions of pathology for surgical procedures. The mobile stand supports both a cable bound and optional wireless floorswitch. 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 video printers, and image storage devices (USB, DVD) and DICOM fixed wire and wireless network interfaces.

AI/ML Overview

There is no information in the provided text regarding acceptance criteria for a device, nor is there a study described that proves the device meets specific acceptance criteria.

The document is an FDA 510(k) clearance letter for a medical device (Ziehm Vision FD) and its accompanying 510(k) summary. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against pre-defined acceptance criteria through a specific study with statistical endpoints.

The document states:

"The key modification refers to an updated release of the software, which incorporates an operating system upgrade from Ubuntu 16.04 to Ubuntu 20.04."
"No new non-clinical image comparison with sets of images with the modified device and the predicate have been performed, the device equivalent regarding image quality."
"Software testing was performed as required by "Content of Premarket Submissions for Device Software Functions". The Cybersecurity of the device has been improved."

This indicates that the focus of the submission was on validating the software upgrade and ensuring that the device's overall safety and effectiveness are maintained and equivalent to the predicate, not on a new clinical study to meet specific performance metrics.

Therefore, I cannot provide the requested information, specifically:

A table of acceptance criteria and reported device performance.
Sample size used for the test set and data provenance.
Number of experts and their qualifications for ground truth establishment.
Adjudication method for the test set.
MRMC comparative effectiveness study results or effect size.
Standalone performance results.
Type of ground truth used.
Sample size for the training set.
How ground truth for the training set was established.

Summary

{0}------------------------------------------------

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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

January 30, 2024

Ziehm Imaging GmbH % Tsvetelina Milanova Specialist Regulatory Affairs Lina-Ammon-Strasse 10 Nuremberg, 90471 GERMANY

Re: K240020

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: January 2, 2024 Received: January 2, 2024

Dear Tsvetelina 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 (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

{1}------------------------------------------------

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Lu Jiang

Lu Jiang, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Radiologic Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

{2}------------------------------------------------

Indications for Use

Submission Number (if known)

K240020

Device Name

Ziehm Vision FD

Indications for Use (Describe)

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

510(k) #:	510(k) Summary		Prepared on: 2024-01-02
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	+4991166067581
Applicant Contact	Ms. Tsvetelina Milanova
Applicant Contact Email	Zie-Regulatory@ziehm.com
Device Name			21 CFR 807.92(a)(2)
Device Trade Name	Ziehm Vision FD
Common Name	Image-intensified fluoroscopic x-ray system
Classification Name	Interventional 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
K231700	Ziehm Vision FD	OWB

The proposed modified Ziehm Vision FD employs the same fundamental control, and substantially equivalent scientific technology as that of our predicate device Ziehm Vision FD (K231700), Software architecture design is substantially equivalent to that ofthe predicate Ziehm Vision FD.

Intended Use/Indications for Use

21 CFR 807.92(a)(5)

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

{4}------------------------------------------------

Indications for Use Comparison

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

Technological Comparison

The predicate and proposed devices have the same technological characteristic. The key modification refers to an updated release of the software, which incorporates an operating system upgrade from Ubuntu 16.04 to Ubuntu 20.04.

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 documentation.

No new tests regarding electrical safety according to ANSI/AAM ES60601-1 and regarding electromagnetic compatibility according to IEC 60601-1-2 were performed. The device is compliant with both standards. No new tests have been done according to Guidance's "Radio Frequency Wireless Technology in Medical Devices" and "Design Considerations and Premarket Submissions Recommendations for Interoperable Medical Devices". Neither the wireless features nor the interfaces of the device affect the safety and effectiveness.

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 60601-2-43, IEC 60601-2-54. No new non-clinical image comparison with sets of images with the modified device and the predicate have been performed, the device equivalent regarding image quality. Software testing was performed as required by "Content of Premarket Submissions for Device Software Functions". The Cybersecurity of the device has been improved.

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.