The Ziehm Vision RFD is intended for use in providing medical imaging for adult and pediatric populations, using pulsed and continuous fluoroscopic digital imaging, as well as digital subtraction and cine image capture during diagnostic interventional and surgical procedures where intra-operative imaging and visualization of complex anatomical structures of both lower and higher contrast density are required. Such procedures may include but are not limited to those of interventional cardiology, heart surgery, hybrid procedures, interventional radiology, interventional angiography, electrophysiology, pediatrics, endoscopic, urological, gastroenterology, orthopedic, maxillofacial surgery, neurology, neurosurgery, critical care, emergency room procedures, and those procedures visualizing structures of the cervical, thoracic, and lumber regions of the spine, and joint fractures of the upper and lower extremities, and where digital image data is required for computer aided surgery procedures and whenever the clinician benefits from the high degree of geometric imaging accuracy, and where such fluoroscopic, cine and DSA imaging is required. The visualization of such anatomical structures assists the clinician in the clinical outcome.

This device does not support direct radiographic film exposures and is not intended for use in performing mammography. The system is not intended for use near MRI systems.

Device Description

The ZIEHM VISION RFD employs X-rays as its imaging technology for visualizing human anatomy. The X-ray tube in the generator produces Xrays, quided toward the patient under control of the user at the direction of a physician who determines the specific clinical procedure. The images from the system assist the physicians in visualizing the patient's anatomy. This visualization helps to localize regions of pathology and for surgical procedures. The device provides both real-time image capture and post capture visualization and of in vivo surgical procedures and post-surgical outcomes.

The Ziehm Vision RFD mobile fluoroscopy system is a flat panel detector (FPD) Computed tomography x-ray system and fluoroscopic X-ray imaging system consisting of two mobile units: a Mobile Stand (C-Arm) and a Monitor Cart/Workstation. The Mobile Stand is comprised of a mono-block high voltage generator, X-ray control, and a C-Profile which is "C" shaped and supports the X-ray generator, and the image receptor Flat Panel Detector (FPD).

Motorization of vertical axis as well as manual or optionally motorized three axes provides the user/operator the option to use manual or motorized linear and rotational movements of the C- Profile for positioning of the imaging components at various angles and distances with respect to the patient using a control interface, Vision Center, Remote Vision Center or remote Position Control Center.

The motorization of the 4 axes provides the user an alternative for visualizing anatomical structures using a variable iso-centric location. The system working with a variable iso-center allows freely selectable positions of patient anatomy. The variable iso-center and distance control ensures that anatomical structures are safely visualized from different angles without re-adjusting the C-arm or moving the patient. The iso-center is not restricted to orbital movements and can hold this iso-center during angulations and vertical travel using the 4 motorized axes.

The Distance Control surface detection integrated around the lower edge of the flat panel detects objects, such as patients. When the flat panel approaches an object, the device reduces speed, slowing the motorized movement. The movement stops immediately before entering a defined safety zone.

The mobile stand supports the optional wireless footswitch for optimum positioning for the surgeon by removing the cable on the floor.

The Monitor Cart is a mobile platform that connects to the Mobile Stand by a cable, and which integrates the LCD flat panel display monitors, image processing, user controls and image recording devices. Interfaces provided for optional peripheral devices such as external monitors, thermal video printers, wireless video display, wireless video server, injector connection and image storage devices (USB, DVD) and DICOM fixed wired and wireless network interfaces.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Ziehm Vision RFD, an image-intensified fluoroscopic x-ray system. The document focuses on demonstrating substantial equivalence to a legally marketed predicate device (K132904), rather than detailing specific acceptance criteria and a standalone human reader study with quantitative metrics for AI performance.

Therefore, many of the requested details about acceptance criteria, specific performance metrics, sample sizes, expert qualifications, and ground truth establishment for an AI-driven device are not explicitly present in this regulatory submission. This document primarily focuses on demonstrating that the modified device (Ziehm Vision RFD) is substantially equivalent to its predicate device (also Ziehm Vision RFD, K132904), which is a conventional fluoroscopic x-ray system, not an AI-assisted one in the typical sense of a diagnostic AI algorithm.

However, I can extract the information provided that is relevant to "device acceptance criteria" in broad terms and the "study" (non-clinical testing) that supports these criteria for this imaging device.

Here's an interpretation based on the provided text:

Device Name: Ziehm Vision RFD (Modified)

Type of Device: Image-intensified fluoroscopic x-ray system (medical imaging device)

Acceptance Criteria (Interpreted from the document's focus on substantial equivalence and safety/performance):

The primary "acceptance criterion" for this 510(k) submission is demonstrating substantial equivalence to the predicate device (Ziehm Vision RFD, K132904) in terms of:

Indications for Use
Technological Characteristics (including x-ray generator, image detector, controls, and software architecture)
Safety and Effectiveness (including radiation safety, electrical safety, electromagnetic compatibility, and image quality).

Given this context, the performance is generally described in relation to the predicate, with a focus on maintaining or improving upon key aspects without introducing new safety or effectiveness concerns.

Category	Acceptance Criteria (Implicitly based on predicate equivalence and standards)	Reported Device Performance and Discussion
Indications for Use	Substantially equivalent to predicate, maintaining the same scope of intended medical imaging procedures for adult and pediatric populations, including pulsed/continuous fluoroscopic digital imaging, DSA, and cine image capture for diagnostic, interventional, and surgical procedures requiring visualization of complex anatomical structures. Not for direct radiographic film exposures, mammography, or near MRI systems.	"Substantially Equivalent" to predicate. Slight modification in wording for "joint fractures of the upper and lower extremities" (predicate had only "upper") and removal of "in and around high magnetic fields" for the predicate. However, the overall scope remains consistent.
Technological Characteristics	Maintenance of fundamental control, scientific technology, image processing applications, and core components similar to the predicate. Minor enhancements should not alter the fundamental principles.	X-ray Generator: Higher maximum power output (e.g., new 30 kW variant vs. predicate's 25 kW max.), but design and housing are identical. The general system exposure control technology and operational functionality remain identical. Image Detector, Collimator, Laser, Electrical, Mechanics, Monitors, User Interface, Radiation Switches: Identical to predicate.Digital Image Processing:* Enhanced Vessel Visualization (Option): New function not present in predicate. No specific performance criterion mentioned, but deemed to not raise new questions of safety/effectiveness.* 2D Measurement Function (within AMT Option): New function not present in predicate (predicate only had "Mark anatomical structures"). Deemed similar to predicate's general functionality and not raising new safety/effectiveness questions.Data Organization (Radiation Dose): New features for "Calculated Dose Area Product (DAP) value tagged to stored image" and "Air Kerma dose display/value tagged to stored image". These features "improve the clinician's ability to obtain more information as to the dose for each image" and are therefore an improvement over the predicate, supporting substantial equivalence. Software: Architecture "`nearly identical`" with modifications to support new features (Enhanced Vessel Visualization, 2D measurement).
Safety and Performance	Compliance with relevant FDA regulations, recognized consensus standards (e.g., IEC 60601 series, ANSI/AAMI ES60601-1, ISO 14971), and FDA guidance documents. Risk analysis and verification/validation testing should confirm designed performance and not raise new safety/effectiveness concerns. Image quality should be "comparable" to the predicate.	Demonstrated compliance with: • 21 CFR 1020.30-32 (Federal Performance Standard for Diagnostic X-ray Systems) • ANSI/AAMI ES60601-1 (Electrical Safety) • IEC 60601-1-2 (EMC) • IEC 60601-1-3 (Radiation Protection) • IEC 60601-1-6 (Usability) • IEC 60601-2-43 (X-ray for interventional procedures) • IEC 60601-2-54 (X-ray for radiography and radioscopy) • IEC 60825-1 (Laser Safety) • ISO 14971 (Risk Management) • FDA guidance documents for diagnostic X-ray systems, wireless technology, interoperable devices, solid-state X-ray imaging devices, pediatric medical devices, and software in medical devices. Image Quality: "Non-clinical image comparison with sets of images with the modified device and the predicate shows equivalence regarding image quality." Dose: "An assessment regarding the low dose functionality of the modified Ziehm Vision RFD shows the ability to reduce dose for certain applications." "Non-clinical imaging and dose testing methods demonstrated the device capability to provide both reduced dose while maintaining image quality."

Study Proving Device Meets Acceptance Criteria (Non-Clinical Testing):

The document explicitly states: "Summary of Non-Ziehm Vision RFD is based on direct modifications to cleared predicate device Clinical Test Data: Ziehm Vision RFD (K132904)." This means they did not perform new clinical studies but relied on bench testing and comparisons to the predicate.

Sample sizes used for the test set and the data provenance:
- Test Set Description: "Non-clinical image and dose Lab testing, were employed."
- Data Provenance: Not explicitly stated (e.g., country of origin), but implies lab-based, phantom testing.
- Sample Size:
  - "Anthropomorphic (PMMA material) phantoms and anatomical simulation phantoms were employed."
  - "image comparison sets taken were representative of both the adult and pediatric populations."
  - Specific number of phantoms or images is NOT provided.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: "A Radiologist performed an assessment of individual image sets." (Implies one radiologist)
- Qualifications of Experts: "A Radiologist" - no further details provided regarding experience, subspecialty, or board certification.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- "A Radiologist performed an assessment of individual image sets." This suggests no formal adjudication among multiple readers was performed for the non-clinical image comparison. It was a single-reader assessment.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- NO. An MRMC study was not performed as this is a traditional imaging device, not an AI-assisted diagnostic algorithm in the sense of comparing human performance with and without AI. The comparison was for image quality equivalence between the modified device and its predicate.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- N/A. This is a hardware/software imaging system, not a standalone AI algorithm that performs a diagnostic task. Its "performance" is in generating images and enabling certain features, not in making a call by itself. The "Enhanced Vessel Visualization" is an imaging feature, not a standalone diagnostic AI.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For image quality comparison: Radiologist assessment of images acquired from anthropomorphic and anatomical simulation phantoms. This is a form of expert assessment of image quality based on known phantom characteristics, rather than true clinical ground truth (like a biopsy or outcome).
The sample size for the training set:
- N/A. This approval is for an imaging system, not a machine learning model that requires a "training set" in the typical ML sense. The software modifications are described as supporting "functionality, image processing applications related to the optional device specific features," implying traditional software development and image processing rather than deep learning.
How the ground truth for the training set was established:
- N/A. As above, no training set for a machine learning model is mentioned or implied.

Summary

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

March 17, 2021

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services - USA. To the right of the symbol, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The word "FDA" is in a larger font size than the rest of the text.

Ziehm Imaging GmbH % Mr. Steve Seeman Director of Regulatory Affairs and Quality Assurance Ziehm-Orthoscan, Inc. 14555 N. 82nd Street SCOTTSDALE AZ 85260

Re: K203428

Trade/Device Name: Ziehm Vision RFD Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: Class II Product Code: JAA, OWB, OXO Dated: February 15, 2020 Received: February 24, 2020

Dear Mr. Seeman:

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.

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

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

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.

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

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

Indications for Use

510(k) Number (if known) K203428

Device Name Ziehm Vision RFD

Indications for Use (Describe)

The Ziehm Vision RFD is intended for use in providing medical imaging for adult and pediations, using pulsed and continuous fluoroscopic digital imaging, as well as digital subtraction and cine image capture during diagnostic interventional and surgical procedures where intra-operative imaging and visualization of complex anatomical structures of both lower and higher contrast density are required. Such procedures may include but are not limited to those of interventional cardiology, heart surgery, hybrid procedures, interventional radiology, interventional angiography, electrophysiology, pediatrics, endoscopic, urological, gastroenterology, orthopedic, maxillofacial surgery, neurology, neurosurgery, critical care, emergency room procedures visualizing structures of the cervical, thoracic, and lumber regions of the spine, and joint fractures of the upper extremities, and where digital image data is required for computer aided surgery procedures and whenever the clinician benefits from the high degree of geometric imaging accuracy, and where such fluoroscopic, cine and DSA imaging is required. The visualization of such anatomical structures assists the clinician in the clinical outcome.

This device does not support direct radiographic film exposures and is not intended for use in performing mammography. The system is not intended for use near MRI systems.

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	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}------------------------------------------------

Image /page/3/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 representation of a human figure within a circular design, and the text is in a teal color.

K203428

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

March 11, 2020

In accordance with 21 CFR §807.92 the following 510(k) summary information is provided:

Submitter Address:	Ziehm Imaging GmbHLina-Ammon-Strasse 1090471 NurembergGermanyPhone: + 49.911.2172-219Fax: +49.911.2172-390
Primary Contact PersonAgent:	Steve SeemanDirector of Requlatory Affairs and Quality AssuranceZiehm-Orthoscan, Inc.14555 N 82nd StScottsdale AZ, 85260
Secondary ContactPerson:	Stefan FiedlerDirector QM/RAZiehm Imaging GmbHPhone: + 49.911. 2172-219Fax: +49.911.2172-390
Device (Trade Name):	Ziehm Vision RFD
Common /UsualNames:	Mobile Fluoroscopic C-Arm
Regulation:	21CFR 892.1650
Requlation Description:	Image-intensified fluoroscopic x-ray system
Product Code:	JAA; OWB; OXO
Classification:	II

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

Image /page/4/Picture/0 description: The image shows the logo for ziehmimaging. The logo consists of a circular graphic on the left and the company name "ziehmimaging" on the right. The graphic features a stylized representation of a person inside a sphere with orbital lines around it. The text is in a teal color.

Predicate Device:	K132904 - Ziehm Vision RFD
Decision Date:	12/05/2013
Regulation:	21CFR 892.1650
Regulation DescriptionName:	Image-intensified fluoroscopic x-ray system
Product Code:	JAA; OWB; OXO

General Description: The ZIEHM VISION RFD employs X-rays as its imaging technology for visualizing human anatomy. The X-ray tube in the generator produces Xrays, quided toward the patient under control of the user at the direction of a physician who determines the specific clinical procedure. The images from the system assist the physicians in visualizing the patient's anatomy. This visualization helps to localize regions of pathology and for surgical procedures. The device provides both real-time image capture and post capture visualization and of in vivo surgical procedures and post-surgical outcomes.

The Ziehm Vision RFD mobile fluoroscopy system is a flat panel detector (FPD) Computed tomography x-ray system and fluoroscopic X-ray imaging system consisting of two mobile units: a Mobile Stand (C-Arm) and a Monitor Cart/Workstation. The Mobile Stand is comprised of a mono-block high voltage generator, X-ray control, and a C-Profile which is "C" shaped and supports the X-ray generator, and the image receptor Flat Panel Detector (FPD).

Motorization of vertical axis as well as manual or optionally motorized three axes provides the user/operator the option to use manual or motorized linear and rotational movements of the C- Profile for positioning of the imaging components at various angles and distances with respect to the patient using a control interface, Vision Center, Remote Vision Center or remote Position Control Center.

The motorization of the 4 axes provides the user an alternative for visualizing anatomical structures using a variable iso-centric location. The system working with a variable iso-center allows freely selectable positions of patient anatomy. The variable iso-center and distance control ensures that anatomical structures are safely visualized from different angles without re-adjusting the C-arm or moving the patient. The iso-center is not restricted to orbital movements and can hold this iso-center during angulations and vertical travel using the 4 motorized axes.

The Distance Control surface detection integrated around the lower edge of the flat panel detects objects, such as patients. When the flat panel approaches an object, the device reduces speed, slowing the motorized movement. The movement stops immediately before entering a defined safety zone.

The mobile stand supports the optional wireless footswitch for optimum positioning for the surgeon by removing the cable on the floor.

{5}------------------------------------------------

Image /page/5/Picture/0 description: The image contains the logo for ziehmimaging. The logo consists of a circular graphic on the left and the company name "ziehmimaging" on the right. The text is in a teal color.

Intended Use The Ziehm Vision RFD is a mobile C-arm providing image data by means of a non-invasive x-ray technique during medical procedures and stores them temporarily. The Ziehm Vision RFD is intended for use in all medical indications requiring fluoroscopy. The Ziehm Vision RFD is intended for use to provide image data specifically but not limited in the field of interventional radiology and cardiology as well as in cardiac surgery and in hybrid applications. The system is intended for use with human beings of any age. It is the physician's responsibility to decide whether to use the system with infants, children and adipose patients. The system is intended for use with human bodies covering such structures but not limited to the following, e.g. orqans, tissue, bones, implants depending on the medical indication. These devices are not intended for use in performing mammographic exposures. The systems are not intended for use near MRI systems.
The Ziehm Vision RFD is intended for use in providing medical imaging for Indications for Use: adult and pediatric populations, using pulsed and continuous fluoroscopic digital imaging, as well as digital subtraction and cine image capture during diagnostic interventional and surgical procedures where intra-operative imaging and visualization of complex anatomical structures of both lower and higher contrast density are required. Such procedures may include but are not limited to those of interventional cardiology, heart surgery, hybrid procedures, interventional radiology, interventional angiography, electrophysiology, pediatrics, endoscopic, urological, gastroenterology, orthopedic, maxillofacial surgery, neurology, neurosurgery, critical care, emergency room procedures, and those procedures visualizing structures of the cervical, thoracic, and lumber regions of the spine, and joint fractures of the upper and lower extremities, and where digital image data is required for computer aided surgery procedures and whenever the clinician benefits from the high degree of geometric imaging accuracy, and where such fluoroscopic, cine and DSA imaging is required. The visualization of such anatomical structures assists the clinician in the clinical outcome.

This device does not support direct radiographic film exposures and is not intended for use in performing mammography. The system is not intended for use near MRI systems.

The proposed modified device Ziehm Vision RFD C-arm employs the same Technology: fundamental control, and scientific technology as that of our predicate device Ziehm Vision RFD C-arm (K132904).

The radiation control, X-Ray monoblock generator, power supplies as well as our advanced imaging system are very similar to the predicate device Ziehm Vision RFD C-arm (K132904).

Software architecture design is nearly identical to that of the predicate

{6}------------------------------------------------

Image /page/6/Picture/0 description: The image shows the logo for Ziehm Imaging. The logo consists of a circular graphic on the left and the text "ziehmimaging" on the right. The graphic is a stylized representation of a globe with a human figure inside. The text is in a teal color and appears to be a sans-serif font.

device Ziehm Vision RFD C-arm (K132904). With modification of the software to support functionality, image processing applications related to the optional device specific features.

The primary modifications of the C-Arm include a 30 kW generator using the same housinq, x-ray tube, and very similar design while keeping the same dimensions as the predicate Ziehm Vision RFD (K132904), new pre-filter and low absorption removable grid, for lower skin entrance dose imaging, improving operator workflow during extended procedures, , Enhanced Vessel Visualization, measurement function, while keeping the same profile of our predicate device Ziehm Vision RFD C-arm (K132904).

Summary of Technological Characteristics:

The comparisons of the predicate devices show the scientific and technology characteristics of the Ziehm Vision RFD are substantial equivalence to that of the predicate device Ziehm Vision RFD (K132904).

Device Comparison Table

The table below summarizes the substantive feature/technological differences between the predicate device and the proposed device:

Model	ModifiedZiehm Vision RFD	PredicateZiehm Vision RFD(K132904)	Comparable PropertiesSubstantialEquivalence Discussion
510(k) Number	Unknown at this time	K132904	-
Classification	Class II	Class II	Identical
Product Code	JAA (system, x-ray,fluoroscopic, image-intensified)	JAA (system, x-ray,fluoroscopic, image-intensified)	Identical
Application / Indications for Use
Indications forUse	The Ziehm Vision RFD isintended for use inproviding medical imagingfor adult and pediatricpopulations, using pulsedand continuousfluoroscopic digitalimaging, as well as digitalsubtraction and cineimage capture duringdiagnostic interventionaland surgical procedureswhere intra-operativeimaging and visualizationof complex anatomicalstructures of both lowerand higher contrast	The Ziehm Vision RFD isintended for use inproviding medical imaging,using pulsed andcontinuous fluoroscopicdigital imaging, as well asdigital subtraction and cineimage capture duringdiagnostic interventionaland surgical procedureswhere intraoperativeimaging and visualizationof complex anatomicalstructures of both lowerand higher contrastdensity are required. Suchprocedures may include	Substantially Equivalent
Model	ModifiedZiehm Vision RFD	PredicateZiehm Vision RFD(K132904)	Comparable PropertiesSubstantialEquivalence Discussion
	density are required. Suchprocedures may includebut are not limited tothose of interventionalcardiology, heart surgery,hybrid procedures,interventional radiology,interventionalangiography,electrophysiology,pediatrics, endoscopic,urological,gastroenterology,orthopedic, maxillofacialsurgery, neurology,neurosurgery, criticalcare, emergency roomprocedures, and thoseprocedures visualizingstructures of the cervical,thoracic, and lumberregions of the spine, andjoint fractures of theupper and lowerextremities, and wheredigital image data isrequired for computeraided surgery proceduresand whenever theclinician benefits from thehigh degree of geometricimaging accuracy, andwhere such fluoroscopic,cine and DSA imaging isrequired. The visualizationof such anatomicalstructures assists theclinician in the clinicaloutcome.	but are not limited tothose of interventionalcardiology, heart surgery,hybrid procedures,interventional radiology,interventionalangiography,electrophysiology,pediatrics, endoscopic,urological,gastroenterology,orthopedic, maxillofacialsurgery, neurology,neurosurgery, critical care,emergency roomprocedures, and thoseprocedures visualizingstructures of the cervical,thoracic, and lumberregions of the spine andjoint fractures of the upperand lower extremities, andwhere digital image data isrequired for computeraided surgery procedures,and whenever the clinicianbenefits from the highdegree of geometricimaging accuracy, andwhere such fluoroscopic,cine and DSA imaging isrequired in and aroundhigh magnetic fields. Thevisualization of suchanatomical structuresassists the clinician in theclinical outcome. At thediscretion of a physician,the device may be used forother imaging applications.
	This device does notsupport directradiographic filmexposures and is notintended for use inperformingmammography. Thesystem is not intended foruse near MRI systems.	This device does notsupport direct radiographicfilm exposures and is notintended for use inperformingmammography. Thesystem is not intended foruse near MRI systems.
Model	ModifiedZiehm Vision RFD	PredicateZiehm Vision RFD(K132904)	Comparable PropertiesSubstantialEquivalence Discussion
X-ray Generator
MaximumParameter	• Variant 20 kW:max. 20 kW,max. 120 kV,max. 200 mA	• Variant 7.5 kW:max. 7.5 kW,max. 120 kV,max. 75 mA	The new proposed devicegenerator (variant 30 kW)has a higher maximumpower output.
	• Variant 25 kW:max. 25 kW,max. 120 kV,max. 250 mA	• Variant 20 kW:max. 20 kW,max. 120 kV,max. 200 mA	100 kV @ 300 mA.
	• Variant 30 kW:max. 30 kW @nominal 100kVmax. 120 kV,max. 300 mA	• Variant 25 kW:max. 25 kW,max. 120 kV,max. 250 mA
PulsedFluoroscopy:Operating values	• Variant 20 kWkV range: 40 - 120 kVmA range: 1.5 - 200mA_	• Variant 7.5 kWkV range: 40 - 120 kVmA range: 1.5 - 75 mA_	The new generator 30 kWof the new modifiedproposed device has a
	• Variant 25 kWkV range: 40 - 120 kVmA range: 1.5 - 250mA	• Variant 20 kWkV range: 40 - 120 kVmA range: 1.5 - 200mA	higher maximum poweroutput as compared tothe Predicate. However,the design and housingare identical.
	• Variant 30 kWkV range: 40 - 120 kVmA range: 1.5 – 300mA	• Variant 25 kWkV range: 40 - 120 kVmA range: 1.5 - 250mA_
PulsedFluoroscopy:Pulse andDuration	• pulse width:- 20 kW generator: 7 -40 ms	• pulse width:- 7.5 kW generator: 7 -40 ms
	- 25 kW generator: 7 -40 ms	- 20 kW generator: 7 -40 ms
	- 30 kW generator:4 - 40 ms	- 25 kW generator: 7 -40 ms
	pulse rate:50/60 Hz: 1, 2, 4, 8,12.5, 25 pulse/s	pulse rate:50/60 Hz: 1, 2, 4, 8,12.5, 25 pulse/s
DigitalRadiography(Snapshot) /Operating Values	• Variant 20kWkV range: 40 - 120 kVmA range: up to 200mA_	• Variant 7.5 kWkV range: 40 - 120 kVmA range: up to 75 mA_	Although the modifieddevice Ziehm Vision RFDis not identical to thepredicate K132904 thegeneral system exposure
	• Variant 25kW	• Variant 20 kW	control technology and
Model	ModifiedZiehm Vision RFD	PredicateZiehm Vision RFD(K132904)	Comparable PropertiesSubstantialEquivalence Discussion
	kV range: 40 - 120 kVmA range: up to 250 mA	kV range: 40 - 120 kVmA range: up to 200 mA	operational functionalityare identical in regards tothe predicate K132904
	Variant 30 kWkV range: 40 - 120 kVmA range: up to 300 mA	Variant 25kWkV range: 40 - 120 kVmA range: up to 250 mA
ThermalManagement	Active cooling	Active cooling	Identical
X-ray Tube
Tube Type	Rotating anode	Rotating anode	Identical
Beam Limiter/ Collimator
CollimatorSystem	Asymmetrical Collimator	Asymmetrical Collimator	Identical
Image Detector
DetectorTechnology	Variant aSi FPD (8inch;12inch):• Type: AmorphousSilicon Flat PanelDetector (aSi)• Scintillator: Cesium-Iodide (CsI)Variant CMOS FPD(8inch;12inch):• Type: CMOS Flat PanelDetector• Scintillator: Cesium-Iodide (CsI)	Variant aSi FPD (8inch;12inch):• Type: AmorphousSilicon Flat PanelDetector (aSi)• Scintillator: Cesium-Iodide (CsI)Variant CMOS FPD(8inch;12inch):• Type: CMOS Flat PanelDetector• Scintillator: Cesium-Iodide (CsI)	Identical
Anti-Scatter Grids
Fixed anti-scatter grid	fixed anti-scatter grid:Pb 8/70	fixed anti-scatter grid:Pb 8/70	Identical
optionalremovable anti-scatter grid	Removable Grid: Pb 8:1 /70lines	Removable Grid: Pb 8:1 /70lines	Identical
Laser Positioning Device

{7}------------------------------------------------

Image /page/7/Picture/0 description: The image shows the logo for Ziehm Imaging. The logo consists of a circular icon on the left and the company name "ziehmimaging" on the right. The icon features a stylized human figure within a globe-like structure, and the text is in a teal color.

{8}------------------------------------------------

Image /page/8/Picture/0 description: The image shows the logo for Ziehm Imaging. The logo consists of a circular icon on the left and the text "ziehmimaging" on the right. The icon 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.

{9}------------------------------------------------

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 word "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.

{10}------------------------------------------------

Image /page/10/Picture/0 description: The image features the logo of Ziehm Imaging. On the left is a circular emblem with a stylized human figure inside, surrounded by orbital lines. To the right of the emblem is the company name, "ziehmimaging," written in a teal sans-serif font. The overall design is clean and professional, suggesting a focus on medical imaging technology.

Model	ModifiedZiehm Vision RFD	PredicateZiehm Vision RFD(K132904)	Comparable PropertiesSubstantialEquivalence Discussion
Laser PositioningDevice onGenerator(optional)	Class 2M (IEC 60825-1),635 nm	Class 2M (IEC 60825-1),635 nm	Identical
Laser PositioningDevice on ImageDetector	Class 2M (IEC 60825-1),635 nm	Class 2M (IEC 60825-1),635 nm	Identical
Electrical Requirements
ElectricalRequirements	• Power supply:100-240 VAC (± 10%),50/60 Hz	• Power supply:100-240 VAC (± 10%),50/60 Hz	Identical.
Mechanics
Mechanical Sizeweight	Weight and dimensions	Weight and dimensions	Identical
Monitors
Display Monitor	• 19" Duo flat screenmonitors or• 26" color flat screenmonitor• 32" UDH single flatscreen monitor	• 18" Duo flat screenmonitors or• 19" Duo flat screenmonitors or• 26" color flat screenmonitor	Identical in performanceand use.
Monitor Arm	Monitor Cart with fix orarticulating monitor arm(option)	Monitor Cart with fix orarticulating monitor arm(option)	Identical
EndoscopyDisplay Option	26" color flat screenmonitor	26" color flat screenmonitor	Identical
User Interface
Control ElementsTouch Panel	Vision CenterRemote Vision Center	Vision CenterRemote Vision Center	Identical
Radiation Switches				X-Ray handswitch	• cable bound handswitch on Mobile Stand	• cable bound handswitch on Mobile Stand	Identical	X-Ray footswitch	• Cable bound footswitch• optional: Wirelessfootswitch	• Cable bound footswitch• optional: Wirelessfootswitch	Identical	FurtherX-ray switches	• Radiation button at"Vision Center"• Radiation button at"Remote VisionCenter"	• Radiation button at"Vision Center"• Radiation button at"Remote Vision Center"	Identical
Radiation Switches
X-Ray handswitch	• cable bound handswitch on Mobile Stand	• cable bound handswitch on Mobile Stand	Identical
X-Ray footswitch	• Cable bound footswitch• optional: Wirelessfootswitch	• Cable bound footswitch• optional: Wirelessfootswitch	Identical
FurtherX-ray switches	• Radiation button at"Vision Center"• Radiation button at"Remote VisionCenter"	• Radiation button at"Vision Center"• Radiation button at"Remote Vision Center"	Identical

{11}------------------------------------------------

Image /page/11/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 inside a globe-like structure, and the text is in a teal color.

Model	ModifiedZiehm Vision RFD	PredicateZiehm Vision RFD(K132904)	Comparable PropertiesSubstantialEquivalence Discussion
Digital Image Processing
2D imaging	2D Fluorscopic Imaging	2D Fluorscopic Imaging	Identical:
Application-OrientedAnatomicalPrograms(AOAP)	• Bone: Extremities,Trunk• Heart, Abdomen, Soft• Vascular (option):Extremities, Trunk,Bolus• Urology (option)• Endo (option)	• Bone: Extremities,Trunk• Heart, Abdomen, Soft• Vascular (option):Extremities, Trunk,Bolus• Urology (option)• Endo (option)	Identical
AdditionalFunctions	• Metal• Enhanced VesselVisualization(option)• Reposition• High Quality• Low Dose• Obese Patient	• Metal• Reposition• High Quality• Low Dose• Obese Patient• Motion	The Modified DeviceZiehm Vision RFD hasadditional EnhancedVessel Detection functionto that of the PredicateZiehm Vision RFD(K132904)
ImageAcquisition	• Auto save• Cine loop	• Auto save• Cine loop	Identical
Post-ProcessingFunctions	• Zoom: 3 levels	• Zoom: 3 levels	Identical
DSA Functions(option)	• DSA real-timesubtraction with re-masking capability• MSA max.opacification sequence• Single frame,Multiframe RSA (road-mapping)• Pixel shift /landmarking	• DSA real-timesubtraction with re-masking capability• MSA max. opacificationsequence• Single frame,Multiframe RSA (road-mapping)• Pixel shift / landmarking	Identical
AnatomicalMarking Tool -AMT (option)	• Mark anatomicalstructures• 2D measurementfunction	• Mark anatomicalstructures	The Modified DeviceZiehm Vision RFD hasadditional 2Dmeasurement functionwithin the AnatomicalMarking Tool that issimilar to that of thePredicate Ziehm VisionRFD
Digital Memory	• Storage capacity	• Storage capacity	Identical
Data	• Radiation Dose	• Radiation Dose	Although not identical.
Model	ModifiedZiehm Vision RFD	PredicateZiehm Vision RFD(K132904)	Comparable PropertiesSubstantialEquivalence Discussion
Organization	Structured Report(RDSR)• Calculated Dose AreaProduct (DAP)• DAP value tagged tostored image• Air Kerma dosedisplay• Air Kerma valuetagged to storedimage	Structured Report(RDSR)• Calculated Dose AreaProduct (DAP)	The new features improvethe clinician's ability toobtain more informationas to the dose for eachimage in the radiationstructured dose report.
HIPAA	option for HIPAA Security	option for HIPAA Security	Identical
Cybersecurity	Software integrity check	Software integrity check	Identical
DICOM	DICOM 3	DICOM 3	Identical
Inter-operability(options)	• Ziehm NaviPort 2D• Ziehm NetPort (DICOM3.0 interface)• Generic interface toinjector• Video transmission(video connector orwireless video)• Interface for externalseparate X-rayindication lamp	• Ziehm NaviPort 2D• Ziehm NetPort (DICOM3.0 interface)• Generic interface toinjector• Video transmission(video connector orwireless video)• Interface for externalseparate X-rayindication lamp	Identical

{12}------------------------------------------------

Image /page/12/Picture/0 description: The image shows the logo for Ziehm Imaging. The logo consists of a circular graphic on the left and the text "ziehmimaging" on the right. The graphic features a stylized human figure inside a globe-like structure. The text is in a teal color and appears to be in a serif font.

Conclusion of Table The changes of the proposed modified device Ziehm Vision RFD C-arm above: described in the table do not change the fundamental control mechanism, operating principle, energy type, or intended use found on predicate device and supports substantially equivalents to the predicate device Ziehm Vision RFD (K132904) in accordance with its labeling.
Safety and Performance: The proposed Ziehm Vision RFD C-arm's potential radiation, mechanical, and electrical hazards are identified and analyzed as part of risk management, and controlled by meeting the applicable CDRH 21CFR subchapter J performance 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 regulations and certification to Recognized Consensus Standards that apply to this product provides the assurance of device safety and effectiveness.
- Summary of Non-Ziehm Vision RFD is based on direct modifications to cleared predicate device Clinical Test Data: Ziehm Vision RFD (K132904).

{13}------------------------------------------------

Image /page/13/Picture/0 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 text "ziehmimaging". The text is in a teal color and appears to be a sans-serif font.

The design of the modified Ziehm Vision RFD was completed in accordance with Ziehm Imaging GmbH Quality Management System Design Controls, 21 CFR 820 and applicable standards. Verification and Validation testing were successfully conducted on the device in compliance with FDA requirements as stated in the following documentation.

Testing regarding electrical safety according to ANSI/AAMI ES60601-1 and 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.

Documentation provided demonstrates compliance of the modified device Ziehm Vision RFD to FDA requirements stated in "A Guide for the Submission of Initial Reports on Diagnostic X-Ray Systems and Their Major Components" as applicable. This includes but is not limited to leakage radiation of diagnostic source assembly, peak tube potential (kV), tube current mA, fluoroscopic entrance exposure rates, and beam-limiting alignment to device image receptor. Further, this performance testing confirmed that the modified Ziehm Vision RFD complies with 21 CFR 1020.30-32 Federal Performance Standards for X-Ray Fluoroscopic equipment and with relevant safety standards such as IEC 60601-1-3, IEC 60601-2-43, IEC 60601-2-54.

Non-clinical image comparison with sets of images with the modified device and the predicate shows equivalence regarding image quality.

With reqard to the flat panel detector (SSXI), documentation provided in this submission demonstrates compliance of the modified device Ziehm Vision RFD (K132904) to "Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices".

Furthermore, an assessment regarding the low dose functionality of the modified Ziehm Vision RFD shows the ability to reduce dose for certain applications.

Software testing was performed as required by "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" and "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices".

Determination of The verification/validation activities successfully confirmed device Substantial Equivalence: requirements have been fulfilled, system functionality is consistent with the user needs, intended uses, and performs as designed, and raises no new questions regarding either safety or effectiveness.

Therefore, Ziehm Imaging GmbH believes the modified device Ziehm Vision RFD C-arm image quality, safety and effectiveness supports a determination of substantial equivalence to the predicate device Ziehm Vision RFD (K132904).

{14}------------------------------------------------

Image /page/14/Picture/0 description: The image contains the logo for Ziehm Imaging. The logo consists of a circular graphic with a stylized human figure inside, accompanied by the text "ziehmimaging" in a teal color. The text is written in a sans-serif font and is positioned to the right of the circular graphic.

Compliance to FDA Guidance and Standards

FDA/CDRH From 3626 A Guide for the Submission of Initial Reports on Diagnostic X-Ray Systems and Their Major Components. (5/11)

21 CFR 1020.30-32 Federal Performance Standard for Diagnostic X-ray Systems.

General Standards / Regulations

MDSAP Medical Device Single Audit Program (MDSAP) MDD 93/42/EEC Annex II of the Medical Devices Directive (MDD) 93/42/EEC EN ISO 13485 Medical devices - Quality management systems - Requirements for regulatory purposes Date: 2016

Recognized Consensuses Standards

ANSI/AAMI ES60601-1: Medical Electrical Equipment, Part 1: General Requirements for Basic Safety and Essential Performance (IEC 60601-1:2005, mod) Date: 2012 Conformance Standard #19-4

IEC 60601-1-2: Medical Electrical Equipment, Part 1-2: General Requirements for Safety, Electromagnetic Compatibility Edition 4.0, Date: 2014-02 Conformance Standard #19-8
IEC 60601-1-3: Medical Electrical Equipment, Part 1-3: Radiation Protection in Diagnostic X-ray Equipment Edition 2.1, Date: 2013-04 Conformance Standard #12-269
IEC 60601-1-6: Medical Electrical Equipment, Part 1-6: Usability Edition 3.1, Date: 2013-10 Conformance Standard #5-89
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 2.0, Date: 2010-03 Conformance Standard #12-202
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 1.1, Date: 2015 Conformance Standard #12-296

{15}------------------------------------------------

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 text "ziehmimaging" on the right. The graphic features a stylized human figure inside a circle with curved lines. The text is in a teal color and appears to be in a sans-serif font.

IEC 60825-1: Safety of laser products, Equipment Safety, requirements, and user guide Edition 2.0, Date: 2007 Conformance Standard #12-273
- ISO 14971: Medical devices Application of risk management to medical devices Edition 2.0, Date: 2007 Conformance Standard #5-40

Determination of Summary Bench Testing Substantial Equivalence:

01 Summary Bench Testing

Verification and Validation including hazard mitigations executed resulted in demonstrated system met Design Input and user needs.

The device was tested by the notified test laboratory resulting in device being certified compliant with ANSI/AAMI ES6060-1-1 series, including IEC 60601-2-54. Further device met all applicable sections of 21 CFR Subchapter J performance standards.

The modified Ziehm Vision RFD development occurred under our design control processes, software development processes, and overall quality management system. They included but are not limited to,

Risk Analysis
Required reviews .
Design reviews ●
Component testing
Integration testing ●
Performance testing .
. Safety testing
Product use testing ●

Performance bench testing included:

Non-clinical imaging and dose testing methods demonstrated the device capability to provide both reduced dose while maintaining image quality. Further in line with UCM089742- Premarket Assessment of Pediatric Medical Devices May 24, 2014 and UCM 302938- Pediatric Information for X-ray Imaging Device Premarket Notifications Nov 28, 2017. Non-clinical image and dose Lab testing, were employed. 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. Radiologist conclusion, the image quality of the Ziehm Vision RFD results in a comparable patient care to the Predicate device Ziehm Vision RFD (K132904). and fulfils the requirements as stated by the intended use. Therefore, Ziehm Imaging GmbH believes the Ziehm Vision RFD C-arm image quality, safety and effectiveness to be substantially equivalent to that of the predicate device Ziehm Vision RFD (K132904).

Conclusion Ziehm Imaging GmbH considers the Ziehm Vision RFD to be as safe, as effective, and performs substantially equivalent to the predicate device Ziehm Vision RFD (K132904) in accordance with its labeling.

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.