O-ARM IMAGING SYSTEM

K092564 · Medtronic Navigation, Inc. (Littleton) · OXO · Jun 17, 2010 · Radiology

Device Facts

• Record ID: K092564
• Device Name: O-ARM IMAGING SYSTEM
• Applicant: Medtronic Navigation, Inc. (Littleton)
• Product Code: OXO · Radiology
• Decision Date: Jun 17, 2010
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 892.1650
• Device Class: Class 2

Intended Use

The O-arm® Imaging System is a portable x-ray system designed for 2D fluoroscopic and 3D imaging for high contrast objects and anatomic structures. The O-arm® Imaging System is compatible with certain Image Guided Surgery Systems. The O-arm® Imaging System may be used with medical charged particle radiation therapy systems for verification of correct patient position in relation to isocenter and verification of the treatment fields in relation to anatomical and/or fiducial landmarks.

Device Story

Mobile x-ray system providing 2D fluoroscopic and 3D imaging; consists of O-arm® stand (x-ray generator, flat dynamic detector, control interface) and mobile view station (image processors, viewing monitor). Used in surgical theaters by physicians to visualize bony anatomy and metallic objects. System performs 360° sweep of x-ray source and detector within closed gantry to enable 3D image reconstruction. Output displayed on monitor for intraoperative guidance; assists in surgical navigation and radiation therapy positioning. Benefits include improved visualization of anatomy and objects during procedures.

Clinical Evidence

Bench testing only. No clinical data provided. Substantial equivalence based on design characteristics and imaging performance comparisons to predicate devices.

Technological Characteristics

Mobile cone-beam x-ray system; isocentric motion; closed gantry design. Components: x-ray generator, flat dynamic x-ray detector, image processors, viewing monitor. Connectivity: compatible with Image Guided Surgery Systems. Imaging: 2D fluoroscopy and 3D reconstruction.

Indications for Use

Indicated for 2D fluoroscopic and 3D imaging of anatomic structures and high-attenuation objects (e.g., bone, metal) in patients requiring intraoperative imaging. Compatible with Image Guided Surgery Systems and charged particle radiation therapy systems for patient positioning and treatment field verification.

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

• O-arm® Imaging System (K050996)
• O-arm® Imaging System (K060344)

Submission Summary (Full Text)

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**JUN 17 2010**

792564

# Attachment E - 510(k) Summary

Date prepared June 10, 2010

510(k) Owner Medtronic Navigation, Inc. (Littleton)

> Phone: [phone] Fax: [phone]

Contact Seth Kuzdzal, RA/QA Manager

Trade name O-Arm Imaging System

Common name Mobile x-ray system

Classification Name: System, X-ray, mobile name Regulation: 21 CFR 892.1720 Product codes LINE OXD

- O-arm® Imaging System, which was cleared to market in 510(k)s Predicate device K050996 and K060344.
Device The O-arm® Imaging System is a mobile x-ray system which provides description 3D imaging as well as 2D fluoroscopic imaging.

> The system consists of two parts: the x-ray O-arm® Stand (comprising x-ray generator, flat dynamic x-ray detector, and the x-ray control user interface) and the mobile view station (comprising the image processors, a user interface for image and patient handling, and viewing monitor).

Indications for The O-arm® Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging and is intended to be used where a use physician benefits from 2D and 3D information of anatomic structures and objects with high x-ray attenuation such as bony anatomy and metallic objects. The O-arm® Imaging System is compatible with certain Image Guided Surgery Systems.

P. I ನ

K092564 Medtronic Navigation O-arm Imaging System Medironic O-am Imaging System

page 30 of 31

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## Comparison to the predicate

device

| | Modified<br>O-arm® | Predicate<br>O-arm® |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for<br>use | Mobile x-ray imaging<br>designed for 2D<br>fluoroscopic and 3D<br>imaging and is intended<br>to be used where a<br>physician benefits from<br>2D and 3D information of<br>anatomic structures and<br>objects with high x-ray<br>attenuation such as bony<br>anatomy and metallic<br>objects.<br>Compatible with certain<br>Image Guided Surgery<br>Systems. | The O-Arm™ Imaging<br>System is designed for<br>2D Fluoroscopic and 3D<br>imaging for<br>intraoperative<br>applications in surgical<br>theaters, particularly for<br>orthopedic applications.<br>The O-Arm™ Imaging<br>System is compatible<br>with certain Image<br>Guided Surgery Systems. |
| Technology | Same as predicate O-<br>arm®. | Mobile cone-beam x-ray<br>system with isocentric<br>motion options.<br><br>O-arm® allows 3D image<br>reconstruction from 360°<br>sweep of x-ray source<br>and detector within<br>closed gantry. |
| Imaging | Same as predicate O-<br>arm® with image quality<br>improvement. | 2D Fluoroscopy and 3D<br>Imaging. |
| Other<br>characteristics | Same as predicate O-<br>arm®. | Sterile accessories,<br>wireless mouse, etc. |

#### Conclusion

.

Based on design characteristics and imaging performance, the modified O-arm® Imaging System is substantially equivalent to the predicate Oarm® Imaging.

K092584 Medtronic Navigation O-arm Imaging System Medtronic O-arm Imaging System

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized human figure with three heads in profile, connected by a flowing ribbon-like shape. The figure is enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the upper portion of the circle.

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

Mr. Seth Kuzdzal RA/QA Manager Medtronic Navigation, Inc., Littleton 300 Foster Street LITTLETON MA 01460

NOV 1 4 2011

Re: K092564

Trade/Device Name: O-arm® Imaging System Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system, mobile Regulatory Class: II Product Code: LHN and OXO Dated: June 10, 2010 Received: June 11, 2010

Dear Mr. Kuzdzal:

This letter corrects our substantially equivalent letter of June 17, 2010.

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 (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. Please Note: CDRH does not evaluate information related to contact 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

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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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely Yours,

Muthal POThm far

Mary S. Pastel. Sc.D. 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

510(k) Number (if known): K892564

.

ﻤﺎﺷ

Device Name: O-arm® Imaging System

Indications for Use

The O-arm® Imaging System is a portable x-ray system designed for 2D fluoroscopic and 3D imaging for high contrast objects and anatomic structures.

The O-arm® Imaging System is compatible with certain Image Guided Surgery Systems. The O-arm® Imaging System may be used with medical charged particle radiation therapy systems for verification of correct patient position in relation to isocenter and verification of the treatment fields in relation to anatomical and/or fiducial landmarks.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

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

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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