ZIEHM VISION RFD

K083545 · Ziehm Imaging, Inc. · OWB · May 15, 2009 · Radiology

Device Facts

• Record ID: K083545
• Device Name: ZIEHM VISION RFD
• Applicant: Ziehm Imaging, Inc.
• Product Code: OWB · Radiology
• Decision Date: May 15, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1650
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The ZIEHM VISION RFD is intended for use in providing medical imaging, 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 included but are not limited to those of interventional cardiology, heart surgery, hybrid procedures, interventional radiology, interventional electrophysiology, angiography, 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 in and around high magnetic fields. The visualization of such anatomical structures assists the clinician in the clinical outcome. At the discretion of a physician the device may be used for other imaging applications. This device does not support direct radiographic film exposures and is not intended for use in performing mammography.

Device Story

Mobile C-arm x-ray system for intra-operative fluoroscopic, cine, and digital subtraction angiography (DSA) imaging. System comprises high-frequency generator (7.5kW or 20kW), dual-focus rotating anode x-ray tube, and flat-panel detector (SSXI). Operated by physicians and technologists in hospitals, ORs, and clinics. Provides real-time visualization of anatomical structures on dual high-resolution LCD monitors via VisionCenter touch-screen interface. Supports computer-aided surgery and imaging in high magnetic fields. Clinicians use output for intra-operative guidance, anatomical visualization, and procedural decision-making. Benefits include high geometric imaging accuracy and compact design for easier patient positioning.

Clinical Evidence

Bench testing only. No clinical data provided. Device performance verified through compliance with federal performance standards for diagnostic x-ray systems (21 CFR 1020.30-32) and international safety/EMC standards (IEC 60601-1, 60601-1-2, 60601-1-3, 60601-1-4, 60601-2-7, 60601-2-28, 60601-2-32, 60601-2-43, 60825-1).

Technological Characteristics

Mobile C-arm with high-frequency generator (7.5kW or 20kW) and dual-focus rotating anode x-ray tube. Imaging via flat-panel detector (SSXI). Features motorized vertical movement and manual rotation. Workstation includes dual high-resolution LCD monitors, digital image processing, and storage (USB/DVD). Connectivity via peripheral interfaces. Complies with IEC 60601-1 (safety), IEC 60601-1-2 (EMC), and 21 CFR 1020.30-32.

Indications for Use

Indicated for intra-operative imaging and visualization of complex anatomical structures (high/low contrast) during diagnostic, interventional, and surgical procedures including cardiology, heart surgery, radiology, angiography, electrophysiology, pediatrics, endoscopy, urology, gastroenterology, orthopedics, maxillofacial surgery, neurology, neurosurgery, critical care, and emergency procedures. Includes visualization of spine (cervical, thoracic, lumbar) and joint fractures. Not for mammography or direct radiographic film exposure.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• ZIEHM VISION R (K061203)
• ZIEHM VISION2 FD (K073346)

Submission Summary (Full Text)

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K083545

#### Section 7 - 510(k) Summary

The following information is being submitted in accordance with the requirements of 21 CFR §807.92

Date: April 30, 2009

#### Name of Submitter:

Ziehm Imaging, Inc. 4181 Latham Street Riverside, CA 92501 [phone]

### Contact Person:

Richard L. Westrich Vice President of Regulatory Affairs and Quality Assurance 4181 Latham Street Riverside, CA 92501 Office phone: [phone] ext 140 Fux: [phone]

#### Device Proprietary Name:

Zichm Vision RFD

## Clussification Name:

Regulation Description: System, X-Ray, Fluoroscopic, Image Intensifier, Product Code: JAA Regulation number: 892.1650 Subsequent Product Code: MOB Regulation number: 892.1650

## Common/Usual Names:

Digital Mobile C-Arm Mobile Surgical C-Arm Mobile C-Arm

# Substantial Equivalence:

The ZIEHM VISION RFD mobile c-arm has been found to be subsumially equivalent to the following current legally marketed devises.

- Zichmi Imaging, ZIEHM VISION R K061203 Product Code JAA & IZL .
- ZIEHM VISION2 FD K073346 Product Code JAA, MQB & IZL Zichm Imaging,

These devices are mobile C-arm type x-ray systems intended for fluoroscopic imaging. The systems include high-voltage x-ray generator, and can control, fixed anode and rotating x-ray tubes, Flat-panel Detector SSXI, or Image Intensifier, and monitor cart/workstations with video image displays, digital image processing and image storage capability, as well as image export functionality.

Section 7 - 510(k) Summary

Page 1 of 3-SUM

MAY 15 2009

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## Device Description:

Indications for Use

The ZIEHM VISION RFD is intended for use in providing medical imaging, using pulsed and continuous fluoroscopic digital inaging, as well as digital subtraction and cine image caplure during diagnostic interventional, and surgical procedures where intra-operative imaging and visualization of complex anatomical structures of both lower and higher contrast density arc required, such procedures may included 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 carc, emergency room procedures, and those procedures visualizing structures of the cervical, thoracic, and lumber regions of the spine und 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 in and around high magnetic fields. The visualization of such anatomical structures assists the clinical outcome. At the discrction of a plysiciun the device may be used for other imaging applications.

This device does not support direct radiographic film exposures and is not intended for use in performing mammography.

## User Characteristics

The ZIEHM VISION RFD docs not require nor is it intended to be used in contact with patients. In some circumstances however, as part of its use in clinical environments the patient may come in contact with the device when operator moves or positions the device is intended for use by health care professionals such as but not limited to physicians, orthopedic surgeons, vascular surgeons, neuro-vascular surgeous, cardiologists, or other clinical physicians and technologists in hospitals, emergency rooms, out-patient clinics, and other clinical environments. Ziehm 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

The ZIEIIM VISION RFD Mobile Stand incorporates a small compact design making the positioning of the c-arm in relation to the patient easier for the operator. The C-profile provides fixed distance mounting of the generator and Flat-panel Detector (SSXI) and manual rotation around a non iso-centric location. The mobile stand allows manual rotational and linear movements with a motorized vertical movement for positioning the c-arm at various angles and distances for visualization of pation's anatomical structures. The high frequency generator with dual focus rotating anode x-ray lube, advanced active cooling, x-ray control, are assembled in one housing in a single mono-block generator tube housing assembly, with the virtual collimator mounting to the housing assemble. The Zichm Vision RFD can have one of the following two generators 7.5 kW or optional 20 kW. They both provide pulsed and continuous fluoroscopy operations including a special digital radiography (snapshot) mode. The VisionCenter is a ccuralized touch screen panel providing the uscr/operator with a clear graphicul user Interface including the xray control panel. The ZIEHM VISION RFD Monitor Cart workstation consists of a mechanical cart assembly, supporting dual high-resolution flat panel LCD display monitors and interfaces are provided for preinherial devices such as external monitors, video printers, injectors and storage devices (USB, DVD).

Section 7 - 510(k) Summary

Page 2 of 3-SUM

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#### Standards:

The ZIEHM VISION RFD mobile x-ray devices shall be tested and be shown to mcct the appropriate requirements of the following standards prior to being marketed.

| 21 CFR 1020.30-32 | Federal Performance Standard for Diagnostic X-ray Systems |
|-------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 93/42/EEC - | Annex II of EC directive of the Medical Devices<br>Directive (MDD) |
| IEC 60601-1, | Medical Electrical Equipment, General Requirements for Safety |
| IEC 60601-1-2 | Medical Electrical Equipment, General Requirements for Safety,<br>Electromagnetic Compatibility |
| IEC 60601-1-3, | Medical Electrical Equipment, Radiation Protection in Diagnostic<br>X-ray Equipment |
| IEC 60601-1-4, | General requirements for safety, Programmable electrical<br>medical systems. |
| IEC 60601-2-7, | Medical Electrical Equipment, Safety of HV/X-ray<br>Generators |
| IEC 60601-2-28 | Medical Electrical Equipment Part 2: Particular<br>Requirements for the Safety of X-Ray Source Assemblies<br>and X-Ray Tube Assemblies for Medical Diagnosis |
| IEC 60601-2-32, | Medical Electrical Equipment, Safety of Associated X-ray<br>Equipment |
| IEC60601-2-43, | Particular requirements for the safety of X-Ray<br>equipment for interventional procedures. |
| IEC 60825-1, | Safety of laser products, Equipment Safety, requirements, and<br>user guide |
| IEC 14971 | Risk Management |

# Conclusion:

The ZIEHM VISION RFD does not raise new questions of safety or effectiveness and is substantially equivalent to the currently marketed devices Zichm Vision2 FD (K073346) and Ziehm Vision R (K061203)

End of 510(k) Summary

Section 7 - 510(k) Summary

Page 3 of 3-SUM

Richard L. Westrich Vice President Regulatory Affairs and Quality Assurance Zichm Imaging, Inc.

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Public Health Service

JUL 30 2012

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

Mr. Richard Westrich V. P. Regulatory Affairs and Quality Assurance Ziehm Imagine, Inc. 4181 Latham Street RIVERSIDE CA 92501

Re: K083545 Trade/Device Name: ZIEHM VISION RFD Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OWB and JAA Dated: March 25, 2009 Received: April 6, 2009

Dear Mr. Westrich:

This letter corrects our substantially equivalent letter of May 15, 2009.

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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely Yours,

Janine M. Morris

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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Image /page/5/Picture/0 description: The image contains the logo and name of a company called "ziehm imaging". The logo is a circular design with a stylized figure inside. The text "ziehm imaging" is written in a simple, sans-serif font to the right of the logo.

# Indications for Use Statement

Applicant:

Zichm Imaging, Inc.

510(k) Number (if known):

K083545

Device Name:

# ZIEHM VISION RFD

Indications for Use:

The ZIEHM VISION RFD is intended for use in providing medical imaging, using pulsed and continuous fluoroscopic digital imuging, 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 included but are not limited to those of interventional cardiology, heart surgery, hybrid procedures, interventional radiology, interventional electrophysiology, angiography, 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 in and around high magnetic ficids. The visualization of such unatomical structures assists the clinician in the clinical outcome. At the discretion of a physician the device may be used for other imaging applications.

This device does not support direct radiographic film exposures and is not intended for use in performing mammography.

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)

loam mwham
(Division Sign-Off)

Division of Reproductive, Abdominal and Radiological Device 510(k) Number

April 29, 2009

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