The Ziehm Vision RFD 3D system is intended for use in providing both 2D and 3D pulsed and continuous fluoroscopic medical imaging for adult and pediatric populations.

The device provides 2D medical imaging for fluoroscopy, digital subtraction, and acquisition of cine loops 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 angiography, electrophysiology, pediatrics, endoscopic, urological, gastroenterology, orthopedic, maxillofacial surgery, neurology, neurosurgery, critical care, emergency room procedures visualizing structures of the cervical, thoracic, and lumbar regions of the spine and joint fractures of the upper and lower extremities, and where digital image data is required for Computer-Assisted Surgery procedures.

The device is also intended to provide 3D medical imaging of patients during orthopedic, neurological, intra-operative surgical procedures and where the clinician benefits from 3D visualization of complex anatomical structures, such as but not limited to those of high contrast objects, bones, joints, maxillofacial, cervical, thoracic, and lumbar regions of the spine, pelvis, acetabulum and joint fractures of the upper and lower extremities, and where digital image and C-arm positioning data is required for Computer-Assisted Surgery procedures.

The visualization of such anatomical structures assists the clinical outcome. This device does not support direct radiographic film exposures and is not intended for use in performing mammography. The system is not intended for use near MRI systems.

Device Description

The ZIEHM VISION RFD 3D employs X-rays as its imaging technology for visualizing human anatomy in both 2D and 3D imaging. The Xray tube in the generator produces X-rays, 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 3D 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).

The device performs both 2D medical imaging and the specialized 4 axes of motorized movement necessary for the 3D imaging. This 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. This same motion control provides the bases for 3D views of the patient anatomy. These 3D views are generated by means of an iterative algorithm. The system uses the images of a scan captured with relation to a predefined scan center to compute the three-dimensional representation of an object. The 3D views are always displayed on the reference screen of the monitor cart. It is possible to display multiplanar reconstructions, orthogonal or freely selectable sections, and different surface reconstructions.

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, 2D image processing, Optional 3D 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 is a 510(k) Premarket Notification for the Ziehm Vision RFD 3D system. This document is a summary demonstrating substantial equivalence to a predicate device (K142740), rather than a detailed report of a clinical study designed to measure specific performance criteria with acceptance thresholds.

Therefore, the document does not contain the direct acceptance criteria or a detailed study report with quantitative performance metrics for the device's image quality or clinical efficacy in the format requested.

Instead, it relies on demonstrating that the modified device's performance, particularly image quality and dose, is comparable to the predicate device and meets relevant regulatory standards. The "study" mentioned is primarily non-clinical bench testing and image comparison rather than a multi-reader, multi-case (MRMC) clinical efficacy trial or a standalone AI performance study.

Here's an attempt to extract and infer information based on the provided text, while highlighting what is not present:

Acceptance Criteria and Device Performance Study

The provided 510(k) summary does not outline specific, quantitative acceptance criteria in the format of a table with numerical thresholds for performance (e.g., minimum sensitivity, AUC, or Dice scores). Since this is a submission demonstrating substantial equivalence to a predicate device (K142740), the "acceptance criteria" are implicitly met by demonstrating that the modified device performs comparably to the predicate and complies with relevant safety and performance standards.

The "study" conducted for performance evaluation was primarily non-clinical bench testing and image comparison, not a large-scale clinical trial.

1. Table of Acceptance Criteria and Reported Device Performance

As noted, explicit quantitative acceptance criteria for image quality or clinical performance are not stated in this 510(k) summary. The "performance" assessment is based on comparability to the predicate device and compliance with general radiographic performance standards.

Criterion Type	Implicit Acceptance Criterion (Inferred from Document)	Reported Device Performance
Image Quality	Comparable image quality to predicate device (Ziehm Vision RFD 3D K142740).	"Non-clinical image comparison with sets of images with the modified device and the predicate shows equivalence regarding image quality."
Radiation Dose	Ability to reduce dose for certain applications while maintaining image quality.	"an assessment regarding the low dose functionality of the modified Ziehm Vision RFD 3D shows the ability to reduce dose for certain applications."
	Compliance with 21 CFR 1020.30-32 Federal Performance Standards for X-Ray Fluoroscopic equipment (e.g., leakage radiation, peak tube potential, entrance exposure rates, beam-limiting alignment).	"performance testing confirmed that the modified Ziehm Vision RFD 3D 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."
Electrical Safety & EMC	Compliance with electrical safety and electromagnetic compatibility standards.	"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."
Wireless/Interoperability	Wireless and interoperable features do not affect safety and effectiveness.	"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."
Software	Compliance with software and cybersecurity guidance.	"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'."

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

Test Set Sample Size: Not explicitly stated as a numerical count of cases/patients. "Sets of images" were used for non-clinical image comparison. For the dose and image quality assessment, "Anthropomorphic (PMMA material) phantoms and anatomical simulation phantoms were employed."
Data Provenance: The data appears to come from non-clinical bench testing in a controlled lab environment, likely in Germany (where Ziehm Imaging GmbH is located) or at certified testing facilities. It is retrospective in the sense that it's performed on phantoms and not derived from new clinical patient studies. No mention of country of origin for clinical patient data, as this was not a clinical trial.

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

Number of Experts: "A Radiologist performed an assessment of individual image sets." This implies one radiologist.
Qualifications: "A Radiologist." No specific details on years of experience or sub-specialty are provided in this summary.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable or not specified beyond a single radiologist's assessment. There is no mention of consensus reading, 2+1, or 3+1 methods, typically used in multi-reader studies.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was NOT done. The document explicitly states "Non-clinical image comparison... shows equivalence regarding image quality." The assessment was performed by "A Radiologist." There is no mention of multiple readers or a comparative study measuring how human readers improve with or without AI assistance, as this is an imaging device, not an AI-assisted diagnostic tool.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done

This question is not applicable in the context of this 510(k). The device is an X-ray fluoroscopic system, not an AI algorithm intended for standalone diagnostic performance. The "algorithm" refers to iterative reconstruction for 3D views, which is an intrinsic part of the image generation process, not a separate diagnostic algorithm.

7. The Type of Ground Truth Used

For Image Quality: The ground truth for image quality was established by a Radiologist's assessment of image sets from anthropomorphic phantoms and anatomical simulation phantoms, comparing them to images from the predicate device. This is a form of "expert qualitative assessment" on phantom data simulating real anatomy, rather than ground truth from pathology, outcomes data, or deep consensus of multiple experts on patient cases.

8. The Sample Size for the Training Set

Not applicable / Not explicitly stated. This device is an X-ray imaging system. While it uses digital image processing and potentially iterative reconstruction algorithms for 3D views, the document does not describe it as an AI/ML device in the sense of requiring a "training set" for a learning algorithm that generates diagnostic outputs. The underlying "algorithms" (e.g., for 3D reconstruction) are likely deterministic or model-based, not machine learning algorithms trained on large datasets.

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

Not applicable. As above, no "training set" is described for this device in the context of AI/ML.

Summary

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September 16, 2020

Image /page/0/Picture/1 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, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size below that.

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

Re: K202360

Trade/Device Name: Ziehm Vision RFD 3D Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: Class II Product Code: OWB, JAK, JAA, OXO Dated: August 14, 2020 Received: August 19, 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

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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 (OS) 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 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-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

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Indications for Use

510(k) Number (if known) K202360

Device Name Ziehm Vision RFD 3D

Indications for Use (Describe)

The Ziehm Vision RFD 3D system is intended for use in providing both 2D and 3D pulsed and continuous fluoroscopic medical imaging for adult and pediatric populations.

The device provides 2D medical imaging for fluoroscopy, digital subtraction, and acquisition of cine loops 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 angiography, electrophysiology, pediatrics, endoscopic, urological, gastroenterology, orthopedic, maxillofacial surgery, neurology, neurosurgery, critical care, emergency room procedures visualizing structures of the cervical, thoracic, and lumbar regions of the spine and joint fractures of the upper and lower digital image data is required for Computer-Assisted Surgery procedures.

The visualization of such anatomical structures assists the clinical outcome. 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.

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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Image /page/3/Picture/0 description: The image shows the logo for Ziehm Imaging. The logo consists of a circular graphic with intersecting lines, resembling a globe with a human figure inside. To the right of the graphic is the text "ziehmimaging" in a teal sans-serif font. The logo appears to be for a medical imaging company.

510(k) Number: K202360

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

September 15, 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 ContactPerson / Agent:	Steve SeemanDirector of Regulatory 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 (TradeName):	Ziehm Vision RFD 3D
Common /UsualNames:	Mobile Fluoroscopic C-Arm
Classification(s)	21CFR 892.1650
ClassificationNames:	Image-intensified fluoroscopic x-ray system

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Image /page/4/Picture/0 description: The image shows the logo for Ziehm Imaging. The logo consists of a stylized globe with a human figure inside, followed by the text "ziehmimaging" in a teal color. The text is written in a sans-serif font and appears to be slightly faded.

Device: Interventional fluoroscopic x-ray system

OWB, JAK, JAA, OXO Product Code:

Predicate Device: K142740 Ziehm Vision RFD 3D

Decision Date: 04/06/2015

21CFR 892.1650 Classification:

Classification Image-intensified fluoroscopic x-ray system Names:

Interventional fluoroscopic x-ray system Device:

Product Code: OWB, JAA, JAK, OXO

General Description: The ZIEHM VISION RFD 3D employs X-rays as its imaging technology for visualizing human anatomy in both 2D and 3D imaging. The Xray tube in the generator produces X-rays, 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 3D 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).

The device performs both 2D medical imaging and the specialized 4 axes of motorized movement necessary for the 3D imaging. This 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

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Image /page/5/Picture/0 description: The image shows the logo for Ziehm Imaging. The logo consists of a stylized globe with a human figure inside, followed by the text "ziehmimaging" in a teal color. The text is written in a sans-serif font.

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. This same motion control provides the bases for 3D views of the patient anatomy. These 3D views are generated by means of an iterative algorithm. The system uses the images of a scan captured with relation to a predefined scan center to compute the three-dimensional representation of an object. The 3D views are always displayed on the reference screen of the monitor cart. It is possible to display multiplanar reconstructions, orthogonal or freely selectable sections, and different surface reconstructions.

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

Intended Use The Ziehm Vision RFD 3D 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 3D is intended for use in all medical indications requiring fluoroscopy. The Ziehm Vision RFD 3D is intended for use to provide 2D and 3D image data specifically but not limited in the field of orthopedics, traumatology and oral and maxillofacial surgery. Furthermore, it is intended for use specifically but not limited to the imaging of soft tissues. 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 as structures but not limited to the following, e.g. organs, tissue, bones, implants depending on the medical indication.

The system is not intended for use near MRI systems or for mammography.

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

The Ziehm Vision RFD 3D system is intended for use in providing both 2D and Indications for Use: 3D pulsed and continuous fluoroscopic medical imaging for adult and pediatric populations.

The device provides 2D medical imaging for fluoroscopy, digital subtraction, and acquisition of cine loops 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 lumbar regions of the spine and joint fractures of the upper and lower extremities, and where digital image data is required for Computer-Assisted Surgery procedures.

The device is also intended to provide 3D medical imaging of patients during orthopedic, neurological, intra-operative surgical procedures and where the clinician benefits from 3D visualization of complex anatomical structures, such as but not limited to those of high contrast objects, bones, joints, maxillofacial, cervical, thoracic, and lumbar regions of the spine, pelvis, acetabulum and joint fractures of the upper and lower extremities, and where digital image and Carm positioning data is required for Computer-Assisted Surgery procedures.

The visualization of such anatomical structures assists the clinician in the clinical outcome. This device does not support direct radiographic film exposures and is not intended for use in performing mammography. The system is not intended for use near MRI systems.

The proposed modified device Ziehm Vision RFD 3D C-arm employs Technology: the same fundamental control, and scientific technology as that of our predicate device Ziehm Vision RFD 3D C-arm (K142740).
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 3D C-arm (K142740).

Software architecture design is nearly identical to that of the predicate device Ziehm Vision RFD C-arm (K142740). With modification of the software to support functionality, Imaqe processing applications related to the optional device specific features.

The primary modifications of the C-Arm include a 30 kW generator using the same housing, x-ray tube, and very similar design while keeping the same dimensions as the predicate Ziehm Vision RFD 3D (K142740), new pre-filter and low absorption removable grid, for lower skin entrance dose imaging, improving operator workflow during extended procedures, brachytherapy geometric data, updated NaviPort, enhanced vessel visualization, enhanced screw visualization, surface rendering, measurement function, while keeping

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Image /page/7/Picture/0 description: The image shows the logo for ziehmimaging. The logo consists of a circular graphic with a stylized human figure inside, along with the company name "ziehmimaging" in a teal sans-serif font. The logo appears to be for a medical imaging company.

the same profile of our predicate device Ziehm Vision RFD 3D C-arm (K142740).

Summary of The comparisons of the predicate devices show the scientific and Technological technology characteristics of the Ziehm Vision RFD 3D are substantial equivalence to that of the predicate device Ziehm Vision Characteristics: RFD 3D (K142740).

Device Comparison Table

Model	ModifiedZiehm Vision RFD 3D	PredicateZiehm Vision RFD3D(K142740)	Comparable PropertiesSubstantialEquivalence Discussion
510(k) Number	Unknown at this time	K142740	-
Classification	Class II	Class II	Identical
Product Code	OWB (interventionalfluoroscopic x-ray system)	OWB (interventionalfluoroscopic x-ray system)	Identical
Application / Indications for Use
Indications forUse	The Ziehm Vision RFD 3Dsystem is intended for usein providing both 2D and3D pulsed and continuousfluoroscopic medicalimaging for adult andpediatric populations.The device provides 2Dmedical imaging forfluoroscopy, digitalsubtraction, andacquisition of cine loopsduring diagnosticinterventional and surgicalprocedures where intra-operative imaging andvisualization of complexanatomical structures ofboth lower and highercontrast density arerequired. Such proceduresmay include but are notlimited to those of	The ZIEHM VISION RFD 3Dis intended for use inproviding both 2D and 3Dmedical imaging for alladult and pediatricpopulations, using pulsedand continuousfluoroscopic digitalimaging, as well as digitalsubtraction and cine imagecapture during diagnosticinterventional and surgicalprocedures where intra-operative imaging andvisualization of complexanatomical structures ofboth lower and highercontrast density arerequired. Such proceduresmay include but are notlimited to those ofinterventional cardiology,	Removed the followingstatement from theproposed device in the IFU(At the discretion of aphysician the device maybe used for other imagingapplications).
Model	ModifiedZiehm Vision RFD 3D	PredicateZiehm Vision RFD3D(K142740)	Comparable PropertiesSubstantialEquivalence Discussion
	interventional cardiology,heart surgery, hybridprocedures, interventionalradiology, interventionalangiography,electrophysiology,pediatrics, endoscopic,urological,gastroenterology,orthopedic, maxillofacialsurgery, neurology,neurosurgery, critical care,emergency roomprocedures, and thoseprocedures visualizingstructures of the cervical,thoracic, and lumbarregions of the spine andjoint fractures of the upperand lower extremities, andwhere digital image data isrequired for Computer-Assisted Surgeryprocedures.The device is also intendedto provide 3D medicalimaging of patients duringorthopedic, neurological,intra-operative surgicalprocedures and where theclinician benefits from 3Dvisualization of complexanatomical structures,such as but not limited tothose of high contrastobjects, bones, joints,maxillofacial, cervical,thoracic, and lumbarregions of the spine,pelvis, acetabulum andjoint fractures of the upperand lower extremities, andwhere digital image and C-arm positioning data is	heart surgery, hybridprocedures, interventionalradiology, interventionalangiography,electrophysiology,pediatrics, endoscopic,urological,gastroenterology,orthopedic, maxillofacialsurgery, neurology,neurosurgery, critical care,emergency roomprocedures, and thoseprocedures visualizingstructures of the cervical,thoracic, and lumbarregions of the spine andjoint fractures of the upperand lower extremities, andwhere digital image data isrequired for computeraided surgery procedures,and whenever the clinicianbenefits from variable iso-centric positioning and/orintraoperatively generated3D imaging of high contrastobjects (bones and joints),complex anatomicalstructures and a highdegree of geometricimaging accuracy, andwhere such fluoroscopic,cine and DSA imaging isrequired in and around highmagnetic fields. Thevisualization of suchanatomical structuresassists the clinician in theclinical outcome. At thediscretion of a physician,the device may be usedfor other imagingapplications.
Model	ModifiedZiehm Vision RFD 3D	PredicateZiehm Vision RFD3D(K142740)	Comparable PropertiesSubstantialEquivalence Discussion
	required for Computer-Assisted Surgeryprocedures.The visualization of suchanatomical structuresassists the clinician in theclinical outcome. Thisdevice does not supportdirect radiographic 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 inperforming mammography.The system is not intendedfor use near MRI systems.
X-ray Generator
MaximumParameter	• Variant A0:max. 25 kW,max. 120 kV,max. 250 mAVariant A1:max. 30 kW @nominal 100kVmax. 120 kV,max. 300 mA	Variant A2:max. 25 kW, @ nominal100kVmax. 120 kV,max. 250 mA	PredicateThe new proposed devicegenerator (variant 30 kW)has a higher maximumpower output.100 kV @ 300 mA.
PulsedFluoroscopy:Operating values	• Variant A0:25 kWkV range: 40 - 120 kVmA range: 0.2 - 250mAVariant A1: 30 kWkV range: 40 - 120 kVmA range: 0.2 - 300mA	• Variant A2:25 kWkV range: 40 - 120 kVmA range: 0.2 - 250mA	The new generator(variant A1) of the newmodified proposed devicehas a higher maximumpower output as comparedto the Predicate. however,the design and housingare identical.
Model	ModifiedZiehm Vision RFD 3D	PredicateZiehm Vision RFD3D(K142740)	Comparable PropertiesSubstantialEquivalence Discussion
PulsedFluoroscopy:Pulse andDuration	• pulse width:4 - 40 ms (30cm and31 cm" FPDaSi/CMOS)pulse rate:50/60 Hz: 1, 2, 4, 8,12.5, 25 pulse/s	• pulse width:4 - 40 ms (30cm and31 cm" FPD aSi/CMOS)pulse rate:50/60 Hz: 1, 2, 4, 8,12.5, 25 pulse/s	Identical.
DigitalRadiography(Snapshot) /Operating Values	• Variant A0: 25kWkV range: 40 - 120 kVmA range: up to 250mA• Variant A1: 30 kWkV range: 40 -120 kVmA range: up to 300mA with Varex 31cm CMOS FPD, andVarex 30 cm aSiFPD)	• Variant A2: 25kWkV range: 40 - 120 kVmA range: up to 250mA	Although the modifieddevice Ziehm Vision RFD3D is not identical to thepredicate K142740 thegeneral system exposurecontrol technology andoperational functionalityare identical in regards tothe predicate K142740
ThermalManagement	Active cooling:	Active cooling:	Identical
X-ray Tube
Tube Type	Rotating anode:	Rotating anode:	Identical
Beam Limiter/ Collimator
CollimatorSystem	Digital Collimator:	Asymmetrical Collimator:	Identical in operation.Name change
Image Detector
DetectorTechnology	Variant A0: 30 cm aSiFPD:	Variant A0: 30 cm aSiFPD:	Identical
Model	ModifiedZiehm Vision RFD 3D	PredicateZiehm Vision RFD3D(K142740)	Comparable PropertiesSubstantial Equivalence Discussion
	• Type: Amorphous Silicon Flat Panel Detector (aSi)Variant A1: 31 cm CMOS FPD:• Type: CMOS Flat Panel Detector	• Type: Amorphous Silicon Flat Panel Detector (aSi)Variant A1: 31 cm CMOS FPD:• Type: CMOS Flat Panel Detector
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 /70 lines	Removable Grid: Pb 8:1 /70 lines	Identical
Laser Positioning Device
Laser PositioningDevice onGenerator(optional)	Class 2M (IEC 60825-1),635 nm	Class 2M (IEC 60825-1),635 nm	Identical
Laser PositioningDevice on ImageDetector(optional)	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	• 18" Duo flat screenmonitors or	Identical in performanceand use.
Model	ModifiedZiehm Vision RFD 3D	PredicateZiehm Vision RFD3D(K142740)	Comparable PropertiesSubstantialEquivalence Discussion
	• 32" UDH single flatscreen monitor	• 20" UDH Duo flat screenmonitor
Monitor Arm	Monitor Cart with fix orarticulating monitor arm(option)	Monitor Cart with fix orarticulating monitor arm(option )	Identical
EndoscopyDisplay Option	N/A	Color flat screen monitor	The new modified ZiehmVision RFD 3D does nothave the option for anEndoscopy display whencompared to the Predicatedevice K142740
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"Vision Center"	Identical
	• Radiation button at"Remote Vision Center"	• Radiation button at"Remote Vision Center"
Digital Image Processing
2D imaging	2D Fluorscopic Imaging	2D Fluorscopic Imaging	Identical:
3D imageacquisition	• 180° motor-driven scan165° orbital rotation15° shift scan	• 180° motor-driven scan165° orbital rotation15° shift scan	Identical
	• Standard scan scantime: 48 sup to 400 images	• Standard scan scan time:48 sup to 400 images
3D Visualization	• MultiplanarReconstruction (MPR)• Volume Rendering	• MultiplanarReconstruction (MPR)• Volume Rendering	Change of 3D Features forproposed device.Modes of operation are
Model	ModifiedZiehm Vision RFD 3D	PredicateZiehm Vision RFD3D(K142740)	Comparable PropertiesSubstantialEquivalence Discussion
	• Enhanced ScrewVisualization (Option)• Surface Rendering		described in theInstructions for Use.
3D Volume size:	• 3D Volume size(standard): 16.0 cm x16.0 cm x 16.0 cm• (option Zoom infunction and CochleaPackage): 10.0 cm x10.0 cm x 10.0 cm• (option larger field ofview): 19.8 cm x 19.6cm x 18.0 cm• Resolution: 3203 voxelsand 5123 voxels	• 3D Volume size(standard): 16.0 cm x16.0 cm x 16.0 cm• (option Zoom in functionand Cochlea Package):10.0 cm x 10.0 cm x10.0 cm• (option larger field ofview): 19.8 cm x 19.6cm x 18.0 cm• Resolution: 3203 voxelsand 5123 voxels	Identical
Application-OrientedAnatomicalPrograms(AOAP)	2D and 3 D imaging	2D and 3D imaging	Identical:
AdditionalFunctions	• Metal• 2D Measurementw/anatomical marking• Reposition• High Quality• Low Dose• Obese Patient	• Metal• Reposition• High Quality• Low Dose• Obese Patient• Motion	The Modified DeviceZVRFD 3D has additionalmeasurement and Obesefeature to that of thePredicate ZVRFD 3D(K142740)
ImageAcquisition	• Auto save• Cine loop	• Auto save• Cine loop	Identical
Post-ProcessingFunctions	• Zoom: 3 levels	• Zoom: 7 levels	The predicate K142740has 7 levels of zoom. Theproposed device has 3levels.
DSA Functions(option)	DSA real-time subtraction	DSA real-time subtraction	Identical
Model	ModifiedZiehm Vision RFD 3D	PredicateZiehm Vision RFD3D(K142740)	Comparable PropertiesSubstantialEquivalence Discussion
AnatomicalMarking Tool -AMT (Option)	• Mark anatomicalstructures	• Mark anatomicalstructures	Identical
Digital Memory	• Storage capacity:	• Storage capacity:	Identical
DataOrganization	Radiation Dose StructuredReport (RDSR)• Calculated Dose AreaProduct (DAP)• DAP value tagged tostored image• Air Kerma dosedisplay• Air Kerma valuetagged to storedimage	Radiation Dose StructuredReport (RDSR)• Calculated Dose AreaProduct (DAP)	Although not identical.The new features improvethe clinician's ability toobtain more informationas to the dose for eachimage in the radiationstructed 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 NaviPort 3DExtended operation	• Ziehm NaviPort 2D• Ziehm NaviPort 3D	Although both deviceshave 2D and 3D NaviPort.The proposed device hasadditional 3D geometricaldata and connection forexternal navigation

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Image /page/12/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 circular graphic features a stylized representation of a person inside of a globe. The text is in a teal color.

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

Conclusion of Table The changes of the proposed modified device Ziehm Vision RFD 3D 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 3D (K142740) in accordance with its labeling. Adverse Effects on The proposed Ziehm Vision RFD 3D C-arm's potential radiatical, Health: and electrical hazards are identified and analyzed as part of risk management, and controlled by meeting the applicable CDRH 21CFR

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subchapter J performance requirements, recognized and general consensus standards, designing and manufacturing under Ziehm Imaging GmbH Quality System, and system verification and validation testing ensure the device performs to the product specifications and its intended use. The adherence to these applicable requlations and certification to Recognized Consensus Standards that apply to this product provides the assurance of device safety and effectiveness.

Summary of Non-Clinical Test Data:

Ziehm Vision RFD 3D is based on direct modifications to cleared predicate device Ziehm Vision RFD 3D (K142740).

The design of the modified Ziehm Vision RFD 3D 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 3D 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 3D 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 3D (K142470) 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 3D 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

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"Content of Premarket Submissions for Management of Cybersecurity in Medical Devices".

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

Therefore, Ziehm Imaging GmbH believes the modified device Ziehm Vision RFD 3D C-arm image quality, safety and effectiveness supports a determination of substantial equivalence to the predicate device Ziehm Vision RFD 3D (K142740).

Compliance to FDA Guidance and Standards

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

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

General Standards / Requlations

Medical Device Single Audit Program (MDSAP) 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

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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
- 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:

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 3D 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:

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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 3D results in a comparable patient care to the Predicate device Ziehm Vision RFD 3D (K142740). and fulfils the requirements as stated by the intended use. Therefore, Ziehm Imaging GmbH believes the Ziehm Vision RFD 3D C-arm image quality, safety and effectiveness to be substantially equivalent to that of the predicate device Ziehm Vision RFD 3D (K142740).

Conclusion Ziehm Imaging GmbH considers the Ziehm Vision RFD 3D to be as safe, as effective, and performs substantially equivalent to the predicate device Ziehm Vision RFD 3D (K142740) in accordance with its labeling.
End of 510(k) Summary

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.