MOBILE C-ARM

K121303 · Canon Inc. -Medical Equipment Group · OXO · Jul 26, 2012 · Radiology

Device Facts

• Record ID: K121303
• Device Name: MOBILE C-ARM
• Applicant: Canon Inc. -Medical Equipment Group
• Product Code: OXO · Radiology
• Decision Date: Jul 26, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1650
• Device Class: Class 2

Intended Use

The XEPHILIO MC-1100 mobile fluoroscopy system is designed to provide fluoroscopic and spot-film radiographic images of the patient during diagnostic, surgical and interventional procedures. Examples of clinical application may include cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures. The system may be used for other imaging applications at the physician's discretion.

Device Story

Mobile C-arm fluoroscopy system consisting of mainframe (C-arm) and workstation. Mainframe includes high-voltage generator, X-ray control, X-ray tube, and flat panel detector. System performs linear and rotational motions for patient positioning. Acquires still and moving X-ray images. Used in clinical settings (OR, ER, etc.) by physicians/technicians. Workstation supports image display and processing; provides interfaces for recording/printing. Output used by clinicians for real-time visualization during diagnostic, surgical, and interventional procedures to guide clinical decision-making and improve patient outcomes.

Clinical Evidence

Bench testing only. Verification and validation testing performed to internal functional specifications, including software. Non-clinical image comparisons conducted between the subject device and predicate devices. Compliance with U.S. Performance Standards for radiographic equipment and relevant IEC safety standards (60601-1, 60601-1-1, 60601-1-2, 60601-1-3, 60601-1-4, 60601-2-7, 60601-2-28, 60601-2-32, 60601-2-43) confirmed.

Technological Characteristics

Mobile C-arm fluoroscopy system; flat panel detector (Canon CSX-10); high-voltage X-ray generator. Complies with IEC 60601 series for electrical safety and electromagnetic compatibility. Software-controlled image processing and display. System supports linear and rotational positioning.

Indications for Use

Indicated for patients undergoing diagnostic, surgical, or interventional procedures requiring fluoroscopic or spot-film radiographic imaging, including cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac, critical care, and emergency room applications.

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

• MQB Veradius, Philips (K090590)
• JAA/OXO OEC 9800 Plus, GE Healthcare (K021049)
• MQB URS-50RF, Virtual Imaging (K093688)
• MQB CSX-10, Canon, Inc. (K111824)

Submission Summary (Full Text)

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

K121303

Image /page/0/Picture/1 description: The image shows the word "Canon" in a bold, sans-serif font. The letters are black, and the background is white. The word is slightly tilted to the right.

.

:

# 5. 510(k) SUMMARY

ົງ ເປັນ

| Submitter: | Canon, Inc. - Medical Equipment Group<br>30-2 Shimomaruko, 3-chrome<br>Ohta-ku, Tokyo 146-8501 Japan |
|-------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Mr. Naoyasu Asaka<br>Staff Manager<br>TEL: [phone]<br>FAX: [phone]<br>[e-mail] |
| Date Prepared: | April 24, 2012 revised June 27, 2012 |
| Trade Name: | XEPHILIO MC-1100 |
| Common Name: | Mobile C-Arm |
| Classification Name: | OWB 892.1650 Solid State X-Ray Imager (Flat Panel/Digital Imager).<br>OXO 892.1650 Mobile Image-Intensified Fluoroscopic X-Ray System |
| Predicate Devices: | K090590 MQB Veradius, Philips<br>K021049 JAA/OXO OEC 9800 Plus, GE Healthcare<br>K093688 MQB URS-50RF, Virtual Imaging (A Canon USA Company)<br>K111824 MQB CSX-10, Canon, Inc. |
| Device Description: | The XEPHILIO MC-1100 mobile fluoroscopy system consists of two mobile units:<br>a Mainframe (C-Arm) and a Workstation. The Mainframe (C-Arm) is comprised of<br>a high voltage generator, x-ray control, and a "C" shaped apparatus, which supports<br>an X-ray tube and a flat panel detector [Canon CSX-10].<br>The Mainframe is designed to perform linear and rotational motions that allow the<br>user to position the x-ray imaging components at various angles and distances with<br>respect to the patient. The Mainframe can be used to acquire both still and moving<br>images.<br>The Workstation is a mobile platform that supports image display monitors and<br>image processing. Interfaces are provided for optional peripherals such as recording<br>and printing devices. |
| Statement of<br>Intended Use: | The XEPHILIO MC-1100 mobile fluoroscopy system is designed to provide<br>fluoroscopic and spot-film radiographic images of the patient during diagnostic,<br>surgical and interventional procedures. Examples of clinical application may<br>include cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular,<br>cardiac, critical care and emergency room procedures. The system may be used for<br>other imaging applications at the physician's discretion. |
| Summary of<br>Technological<br>Characteristics: | Comparisons with the predicate devices show the technological characteristics of<br>the XEPHILIO MC-1100 are substantially equivalent to the predicate devices. |

.....

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

**Canon**

### 5. 510(k) SUMMARY (continued)

Summary of Non-Clinical / . Test Data:

Conclusion:

Tests were performed on the XEPHILIO MC-1100 which demonstrated that the device is safe and effective, performs comparably to the predicate device(s), and is substantially equivalent to the predicate device(s). Tests included verification/validation testing to internal functional specifications (including software) and non-clinical image comparisons involving flat panel display images taken with the new device and the predicate device(s). Documentation was provided demonstrating compliance of the XEPHILIO MC-1100 to all FDA requirements stated in Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, including results of verification/validation plus traceability of verification/validation tests to software requirements and software risk hazards.

Testing confirmed that the XEPHILIO MC-1100 complies with the U.S. Performance Standard for radiographic equipment and with relevant voluntary safety standards for Electrical safety and Electromagnetic Compatibility testing, specifically IEC standards 60601-1, 60601-1-1, 60601-1-2, 60601-1-3, 60601-1-4, 60601-2-7, 60601-2-28; 60601-2-32, and 60601-2-43.

Together, these verification/validation activities successfully demonstrated that the XEPHILIO MC-1100 correctly performs as designed, has been validated for its intended use, and raises no new questions regarding either safety or effectiveness when compared to the predicate device(s). Therefore, the verification/validation testing conducted supports a determination of substantial equivalence for the XEPHILIO MC-1100 device.

Canon, Inc. - Medical Equipment Group considers the Mobile C-Arm XEPHILIO MC-1100 to be substantially equivalent to the predicate devices listed above. This conclusion is based on the similarities in primary intended use, principles of operation, functional design, and established medical use.

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

Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized graphic of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the graphic.

# DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

JUL 26 2012

Canon, Inc. - Medical Equipment Group % Ms. Diane Rutherford Regulatory Engineer Ken Block Consulting 1201 Richardson Drive, Suite 280 RICHARDSON TX 75080

Re: K121303

Trade/Device Name: XEPHILIO MC-1100 Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OXO and OWB Dated: April 24, 2012 Received: May 1, 2012

#### Dear Ms. Rutherford:

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 10 mmerce 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 r reaso or a now a 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

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

#### Page 2

medical device-related adverse events) (21 CFR 803); and good manufacturing pactice medical device-related adverse of really (21 cr r (QS) regulation (21 CFR Part 820). This letter requirences as bet for in are quandy - device as described in your Section 510(k) premarket will anow you to oogin mailioning your antial equivalence of your device to a legally marketed nothication. The I D71 midnig of succiantian vour 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 11 you desire specific at riot for your con Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket s 150. Theo, promotions at 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/ReportalProblem/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 I ou may 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

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

## INDICATIONS FOR USE

### 510(k) Number:

Device Name: XEPHILIO MC-1100

Indications for Use:

The XEPHILIO MC-1100 mobile fluoroscopy system is designed to provide fluoroscopic and spot-film radiographic images of the patient during diagnostic, surgical and interventional procedures. Examples of clinical application may include cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures. The system may be used for other imaging applications at the physician's discretion.

Prescription Use · X (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 IF NEEDED)

Concurrence of CDHR, Office of Device Evaluation (ODE)

***(Division Sign-Off)***

Division of Reciological Device other of In ફાઉદ્ય

Page 1 of 1