The Ziehm Vision R is designed to provide pulsed and continuous fluoroscopic imaging, and spot film imaging of the patient during diagnostic, Interventional and surgical procedures. The design includes features for diagnostic and interventional cardiac imaging procedures, and is also intended for use in visualizing complex anatomical structures and procedures for vascular, angiographic, cholangiography, endoscopic, urologic, orthopedic, neurologic, and critical care and emergency room procedures. At the physician's discretion the device may be used for other imaging applications.

Radiographic film examinations can be made with an accessory cassette device attached to the Image Intensifier.

Device Description

The Ziehm Vision R has two mobile units: a mobile C-arm stand and a monitor cart/ workstation. The C-arm stand contains the x-ray control, high voltage generator, VisionCenter touch controlusion interface, power subs-systems, and control system. The "C profile" or C-shaped mechanical assembly supports at one end the image intensifier and the other the high voltage generator and lubes hassion assembly. The C-Profile is designed to perform rotational and linear movements that allow the user to position the imaging components at various angles and distances with respect to the prieve

The monitor cart/workstation supports dual flat panel LCD display monitors, integrated Ziehm Vision digital image system, imaging capture, image processing, DICOM 3, and VisionCenter touch vontol user interface. External Video connection is provided with RS-170 video timing for domestic market, CCIR for International markets.

The Ziehm Vision R also provides optional peripheral connections for such devices as video printers, thermal printers, network connections, DICOM 3, and external media storage such as USB, DVD devices. A single auxiliary connection is provided for connection to angiographic injoctor systems with the aim of synchronizing image acquisition of angiographic images during controst media injections.

AI/ML Overview

This 510(k) submission for the Ziehm Vision R Digital Mobile Imaging System is for an X-ray system, not an AI/ML powered device. Typically, 510(k) submissions for such traditional medical devices do not include the detailed performance study information requested for AI/ML devices. Therefore, a direct answer to the prompt's specific requirements (acceptance criteria of an AI model, sample sizes, ground truth establishment, MRMC studies, etc.) cannot be provided from the given text.

The provided text focuses on:

Substantial Equivalence: Comparing the Ziehm Vision R to previously cleared predicate devices (Ziehm Vision K011292, OEC 9800 Plus K021049, OEC 9800 E/CV K024012). This is the primary method of demonstrating safety and effectiveness for traditional devices in 510(k) submissions.
Device Description and Intended Use: Outlining what the device is, how it functions, and for what medical purposes it is intended.
Compliance with Standards: Listing various electrical, radiation safety, and medical device standards the device adheres to.

Therefore, many of the requested fields cannot be filled based on the provided document because they pertain to performance testing protocols specific to AI/ML software, which is not applicable here.

However, to address the prompt as best as possible with the available information, here's a summary of what can be extracted and an explanation of why other requested information is not present:

1. Acceptance Criteria and Reported Device Performance:

For a traditional X-ray system, "acceptance criteria" and "reported device performance" are typically defined by compliance with manufacturing specifications, safety standards, and functional equivalence to predicate devices, rather than AI-specific metrics like AUC or F1 score.

Acceptance Criteria (Implied by Standards & Equivalence)	Reported Device Performance (Implied)
Electrical Safety: Compliance with IEC 60601-1, UL 60601-1.	Meets relevant electrical safety standards.
Radiation Safety: Compliance with 21 CFR 1020.30, 1020.31, 1020.32; IEC 60601-1-3.	Meets U.S. federal and international radiation protection standards for diagnostic X-ray equipment.
Electromagnetic Compatibility (EMC): Compliance with IEC 60601-1-2.	Operates reliably in standard medical environments without harmful electromagnetic interference.
Mechanical Safety & Functionality: Performance similar to predicate mobile C-arms.	Provides pulsed and continuous fluoroscopic imaging and spot film imaging effectively for intended procedures (cardiac, vascular, orthopedic, etc.).
Image Quality: Quality comparable to predicate devices.	Produces diagnostic-quality images suitable for its indicated uses. (Specific quantitative metrics are not provided in this summary but would be part of the full submission).
Software Safety: Compliance with IEC 60601-1-4.	Programmable electrical medical system functions safely and reliably.

2. Sample size used for the test set and the data provenance: Not applicable. This device is not an AI/ML algorithm requiring a distinct test set for performance evaluation in the context of this 510(k) summary. Its "performance" is primarily demonstrated through engineering verification and validation against established standards and comparison to predicate devices, not through a clinical test set for an AI model.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth establishment for an AI model's test set is not relevant for this traditional hardware device 510(k) summary.

4. Adjudication method for the test set: Not applicable.

5. 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: Not applicable. This device is an X-ray imaging system, not an AI-powered diagnostic aid that would be compared for its impact on human reader performance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not a standalone AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.

8. The sample size for the training set: Not applicable. The device does not "learn" from a training set in the way an AI/ML model does.

9. How the ground truth for the training set was established: Not applicable.

Summary of what the document does provide regarding "proof of meeting acceptance criteria":

The document argues for substantial equivalence primarily based on:

Identical Intended Use: The Ziehm Vision R has the same intended use as the predicate devices (K011292, K021049, K024012) for fluoroscopic and spot film imaging during various medical procedures.
Similar Technological Characteristics: It is a mobile C-arm type X-ray system, including a high-voltage generator, X-ray tubes, image intensifier, monitor cart/workstation with digital imaging capabilities, similar to the predicates.
Compliance with Recognized Standards: The device was designed to comply with a comprehensive list of national and international standards for medical electrical equipment, radiation safety, electromagnetic compatibility, and software safety (listed in Section 2). These standards themselves embody a set of "acceptance criteria" for safe and effective operation.

The "study" that "proves" the device meets acceptance criteria, in this context, is the demonstration of adherence to these standards and the comparison of its technical specifications and performance to the legally marketed predicate devices, which the FDA found acceptable in their previous clearances. This is the standard pathway for traditional medical device 510(k) clearance, rather than a clinical trial or performance study on an algorithm's output.

Summary

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Ziehm Imaging, Inc.

KD61203

JUN 19 2006

510(k) Summary

In accordance with the requirements of 21 CFR §807.92 the following summary of 510(k) safety and effectiveness information for the Zichm Vision FD is being submitted.

Date:

April 26, 2006

Name of Submitter:

Ziehm Imaging, Inc. 4181 Latham Street Riverside, CA 92501 (951) 718-2020

Corresponding Official:

Richard Westrich. V.P. Product Development, Regulatory Affairs

Device Proprietary Name:

Ziehm Vision R Digital Mobile Imaging System

Classification Name:

System, X-ray, Fluoroscopic, Image-Intensified -or

System, X-ray, Mobile

Common/Usual Names:

Mobile C-arm, Fluoroscopic Imaging System

Substantial Equivalence:

The ZIEHM VISION R is substantially equivalent to the following devices that are currently marketed:

-Ziehm Imaging, Inc. ZIEHM VISION Digital Mobile Imaging System 510(k) K011292
-OEC 9800 Plus Digital Mobile Imaging System 510(k) K021049
-OEC 9800 E/CV Digital Mobile Imaging System 510(k) K024012

These devices are mobile C-arm type x-ray systems intended for fluoroscopic imaging. The systems include high-voltage x-ray generator, and control, rotating and fixed anode x-ray tubes, image intensifier, and monitor cart/workstations with video image displays, digital image processing and image storage capability, as well as conventional spot-film capability.

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Device Description:

Indications for Use

The Ziehm Vision R is designed to provide pulsed and continuous fluoroscopic imaging, and spot film imaging of the patient during diagnostic, Interventional and surgical procedures. The design includes features for diagnostic and interventional cardiac imaging procedures, and is also intended for use in visualizing complex anatomical structures and procedures for vascular, angiographic, cholangiography, endoscopic, urologic, orthopedic, neurologic, and critical care and emergency room procedures. At the discretion of physician the device may be used for other imaging applications,

Radiographic film examinations can be made with an accessory cassette device attached to the Image Intensifier.

User Characteristics

The device is intended for use by health care professionals such as physicians, surgeous, cardiologists, radiologists and technologists in hospitals, out-patient clinics and other clinical environments. Itelian Imaging anticipates the device will be used on a nearly daily basis. Ziehm Imaging applications: specialists and/or qualified site personnel provide on site operator training in the proper use of the device.

General Description

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Standards:

The ZIEHM VISION R series mobile x-ray systems were designed to comply with applicable portions of the following standards and regulations for product safety requirements:

-Federal Performance Standard for Diagnostic X-ray Systems 21 CFR 1020.30, 21 CFR 1020.31 and 21 CFR 1020.30
UL 60601-1 Medical Electrical Equipment -
ー IEC 6060'1-1, Medical Electrical Equipment, General Requirements for Safety
IEC 60601-1-2. Medical Electrical Equipment, General Requirements for Safety, ー Electromagnetic Compatibility
-IEC 60601-1-3, Medical Electrical Equipment, Radiation Protection in Diagnostic X-ray Equipment
IEC 60601-1-4, General requirements for safety, Programmable electrical medical l systems.
-IEC 60601-2-7, Medical Electrical Equipment, Safety of HV/X-ray Generators
IEC 60601-2-28, Medical Electronic, Particular Requirements for l Safety of X-ray Source Assemblies, and X-ray Tube Assemblies.
। IEC 60601-2-32, Medical Electrical Equipment, Safety of Associated X-ray Equipment
IEC 60825-1. Safety of Laser Products, Equipment Safety l . Requirements, and User Guide
l 93/42/EEC - Annex 1 Essential Requirements of the Medical Devices Directive
ー DIN ISO 14971

Conclusion:

The ZIEHM VISION R does not raise new questions of safety or effectiveness and is substantially equivalent to the current model Zichm Vision K011292, and OEC 9800 Mobile C-arm K021049 and OEC 9800 E/CV K024012

End of 5 10(k) Summary

Abby Flinto

Richard Vice President Product Development and Regulatory Affairs Ziebm Imaging, Inc.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The logo is rendered in black and white.

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

MAY 2 3 2012

Mr. Richard Westrich Vice President of Product Development and Regulatory Affairs Ziehm Imaging, Inc. 4181 Latham Street RIVERSIDE CA 92501

Re: K061203 Trade/Device Name: Ziehm Vision R Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OWB, JAA and OXO Dated: April 27, 2006 Received: May 1, 2006

Dear Mr. Westrich:

This letter corrects our substantially equivalent letter of November 14, 2011.

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. 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.

If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industrv/support/index.html.

Sincerely Yours,

Janine M. Morris

Janine M. Morri Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications For Use Statement

Applicant:

Ziehm Imaging, Inc.

KO61203 510(k) Number (if known):

Device Name:

Ziehm Vision R

Indications for Use:

Radiographic film examinations can be made with an accessory cassette device attached to the Image Intensifier.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Lyman

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K061203

Company Confidential

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.