O-ARM IMAGING SYSTEM

K050996 · Breakaway Imaging, LLC · OXO · May 5, 2005 · Radiology

Device Facts

• Record ID: K050996
• Device Name: O-ARM IMAGING SYSTEM
• Applicant: Breakaway Imaging, LLC
• Product Code: OXO · Radiology
• Decision Date: May 5, 2005
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 892.1650
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The O-Arm™ Imaging System is designed for 2D Fluoroscopic and 3D imaging for intraoperative applications in surgical theaters, particularly for orthopedic applications. The O-Arm™ Imaging System is compatible with certain Image Guided Surgery Systems.

Device Story

O-Arm Imaging System is a mobile X-ray system providing 2D fluoroscopic and 3D volumetric imaging for intraoperative use in surgical theaters. System comprises two interconnected units: an X-ray stand with a power-assisted transport mechanism and a mobile viewing station. The X-ray stand features a C-shaped rotor housed within an enclosed, full-circle 'O' configuration; this rotor utilizes high-precision robotics to orient the X-ray source and flat-panel digital detector to specific trajectories, allowing for automated return to saved positions. The viewing station processes images and provides a user interface for image/patient management. Surgeons use the system to obtain real-time 2D fluoroscopy or 3D reconstructions to assist in orthopedic procedures; the system is compatible with certain Image Guided Surgery Systems. By providing high-precision, automated 3D imaging intraoperatively, the device assists clinicians in surgical navigation and decision-making, potentially improving procedural accuracy.

Clinical Evidence

Bench testing only. A concurrence study compared 31 pairs of 2D fluoroscopic and 3D images of identical cadaveric anatomical structures acquired using the O-Arm and the Siemens ISO-C C-Arm. A radiologist evaluated the images and determined that the O-Arm and predicate device provide equivalent diagnostic capability.

Technological Characteristics

Mobile X-ray system with power-assisted transport. Features a full-circle housing containing a C-shaped rotor for 360-degree imaging. Uses a flat-panel digital X-ray detector. Employs robotic positioning for the internal rotor. System is comprised of an X-ray stand and a separate mobile viewing station. Connectivity includes compatibility with Image Guided Surgery Systems.

Indications for Use

Indicated for 2D fluoroscopic and 3D imaging during intraoperative surgical procedures, specifically orthopedic applications. Intended for use in surgical theaters.

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

• Siemens SIREMOBIL Iso-C30 (K032280, K003266)

Submission Summary (Full Text)

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K050996

### MAY - 5 2005

### 510(k) Summary for the O-Arm™ Imaging System (4/01/05)

### Submittal information:

Wolfgang Krull Breakaway Imaging, LLC 300 Foster Street Littleton, MA 01460

Phone: [phone]

#### Device name and classification

| Proprietary Name: | O-Arm™ Imaging System |
|-----------------------|-----------------------------------------------|
| Classification Names: | Mobile X-ray System, Solid-state X-ray Imager |
| Classification Panel: | Radiology |
| CFR Sections: | 21 CFR 892.1720, 21 CFR 892.1650 |
| Class: | II |
| Product Codes: | OXO |

#### Substantial Equivalence

The O-Arm™ Imaging System is substantially equivalent to the Siemens SIREMOBIL Iso-C30, which was cleared in 510(k)'s K032280 and K003266.

# Device Description

The O-Arm™ Imaging System is a mobile x-ray system which provides 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 monitors).

#### Intended Use

The O-Arm™ Imaging System is designed for 2D Fluoroscopic and 3D imaging for intraoperative applications in surgical theaters, particularly for orthopedic applications. The O-Arm™ Imaging System is compatible with certain Image Guided Surgery Systems.

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### 510(k) Summary for the O-Arm™ Imaging System (4/01/05) continued

### Comparison with the Predicate Device

KOSO996

#### O-Arm™ Imaging System A portable system with separate Physical viewing station. The imaging configuration unit is full circle or "O-arm". 3-D imaging Imaging modes 2-D fluoroscopy Intraoperative imaging Intended use

SIREMOBIL Iso C3D A portable system with separate viewing station. The imaging unit is a 190ºC-arm.

3-D imaging 2-D fluoroscopy Intra-operative imaging.

### Similarities and Differences

Both devices perform both 2-D fluoroscopy and 3-D volumetric imaging.

The mechanical configuration of both devices allows a lateral approach to the patient. The predicate device has a c-arm configuration, mounting the source and detector on distal ends of the 'C'. The O-Arm™ mounts the imaging components on a c-shaped rotor inside of an enclosed, full circle housing. The O-Arm™ housing is opened to approach the patient.

For 2-D imaging with the predicate device, the user manually orients the source and detector for the needed image trajectory. The O-arm™ utilizes high-precision robotics to orient the internal rotor to the proper trajectory. To return to a position, the Siemens user manually repositions the 'C'. With its robotic positioning, the O-arm™ automatically returns to positions "saved" by the user.

For 3-D imaging, the predicate device drives the 'C' in a circumferential movement through a 190° arc. The O-Arm™ drives the internal C-shaped rotor through a 360° arc inside the enclosed housing.

Both systems have two mobile, interconnected units: an X-ray stand and a mobile viewing station. Both units of the predicate device are moved manually. The O-Arm™ X-ray Stand has a power-assisted transport mechanism.

Both systems are configured with opposing x-ray source and x-ray detector. The sources are similar. The predicate device uses a circular image intensifier tube as the detector, while the O-Arm™ uses a rectangular flat panel digital detector. As a result, the images are displayed differently. In 2-D, the image intensifier displays a circular image, and the flat panel displays a rectangular image. In 3-D, the image intensifier reconstructs to a volumetric sphere, while the O-arm™ reconstructs to a volumetric cylinder. X-ray beam collimation, available in both systems, allow the user to select the area or volume to best fit the application.

Breakaway Imaging, LLC - - -

Q-Arm™ Imaging System 510(k)

Page 5

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## 510(k) Summary for the O-Arm™ Imaging System (4/01/05) continued

Koso996

### Assessment of Performance Data

A concurrence study was performed comparing images of the same anatomical structure made with a Siemens ISO-C C-Arm Imaging System and with the O-Arm™ Imaging System. The imaged subject was a cadaver allowing virtually identical sites to be imaged by both systems. Sites were selected to include common orthopedic procedure locations. Thirty one pairs of images, including 3-D and fluoroscopic images, were evaluated. The fluoroscopic images were evaluated "live". Both the O-Arm and the predicate device have a feature that freezes the last image of a fluoroscopic series. The 3-D images and the "frozen" last images last images were submitted with the 510(k).

A radiologist evaluated the images during the study. He determined that for all image pairs, the images from the O-Arm™ and the predicate device are of equivalent diagnostic capability.

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

Breakaway Imaging, LLC % Mr. Jeff Rongero Senior Project Engineer/Program Reviewer Conformity Assessment Services Underwriters Laboratories, Inc. 1285 Walt Whitman Road MELVILLE NY 11747-3081

NOV 1 7 2011

Re: K050996

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: OXO Dated: April 18, 2005 Received: April 20, 2005

Dear Mr. Rongero:

This letter corrects our substantially equivalent letter of May 5, 2005.

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 comply with all the Act's requirements, including, but not limited to: registration and listing (21

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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/ResourcesforYou/Industry/default.htm.

Sincerely Yours,

Michael D O'Hern for

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): __N/A_______________________________________________________________________________________________________________________________________________

Device Name: ____ O-Arm™ Imaging System_______________________________________________________________________________________________________________________________________

Indications for Use:

The O-Arm™ Imaging System is designed for 2D Fluoroscopic and 3D imaging for The O-Atin - Intagring of Stein is in surgical theaters, particularly for orthopedic mirations. The O-Arm™ Imaging System is compatible with certain Image Guided Surgical Systems.

ﯩﻴ

X Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 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. Syverson

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