O-Arm O2 Imaging System

K151000 · Medtronic, Inc. · OWB · Aug 6, 2015 · Radiology

Device Facts

• Record ID: K151000
• Device Name: O-Arm O2 Imaging System
• Applicant: Medtronic, Inc.
• Product Code: OWB · Radiology
• Decision Date: Aug 6, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1650
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The O-arm® O2 Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging for adult and pediatric patients weighing 60 lbs or greater and having an abdominal thickness greater than 16cm, and is intended to be used where a 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® O2 Imaging System is compatible with certain image guided surgery systems.

Device Story

Mobile x-ray system providing 2D fluoroscopic and 3D cone-beam CT imaging; utilizes 360-degree gantry rotation for 3D reconstruction. System comprises Image Acquisition System (IAS) with x-ray generator/detector and Mobile View Station (MVS) for image processing/viewing. Adds extended field-of-view (40cm) mode via half-fan scan acquisition. Used in clinical settings (e.g., OR) by physicians to visualize anatomic structures and metallic objects; compatible with image-guided surgery systems. Output assists clinicians in surgical planning and navigation; benefits include improved visualization of larger anatomic regions.

Clinical Evidence

Bench testing only. Includes AAMI/ANSI ES 60601-1, IEC 60601-1-2, 1-3, 2-28, and 2-43 compliance. Software/hardware verification and validation performed. Dosimetry report and image quality assessment conducted. Usability testing performed per FDA human factors guidance. Cadaver image pair study compared O-arm® O2 images against predicate O-arm® 1000 and reference Artis Zeego to evaluate clinical utility.

Technological Characteristics

Mobile cone-beam CT; 32kW RoHS-compliant generator; 40x30cm CsI flat-panel detector. Isocentric gantry motion. 2D fluoroscopy and 3D imaging (20cm full-fan, 40cm half-fan). Connectivity via cable between IAS and MVS. Power: 100/120/240 VAC, 50/60Hz. Internal battery for transport/gantry; UPS for MVS. Software-controlled imaging protocols.

Indications for Use

Indicated for adult and pediatric patients weighing ≥60 lbs with abdominal thickness >16cm requiring 2D fluoroscopic or 3D imaging of bony anatomy or metallic objects.

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

• Medtronic O-arm® Imaging System (K092564)

Reference Devices

• Artis Zeego

Submission Summary (Full Text)

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

August 6, 2015

Medtronic, Inc. Medtronic Navigation, Inc. (Littleton) % Mr. Rishi Sinha Prinicipal Regulatory Affairs Specialist 300 Foster Street LITTLETON MA 01460

Re: K151000

Trade/Device Name: O-arm® O2 Imaging System Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OWB, OXO and JAA Dated: June 30, 2015 Received: July 2, 2015

Dear Mr. Sinha:

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. Please note: CDRH does not evaluate information related to contract 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 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.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education 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'Hara

For

Robert Ochs, Ph.D. Acting Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) NA K151000

Device Name O-arm® O2 Imaging System

#### Indications for Use (Describe)

The O-arm® O2 Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging for adult and pediatric patients weighing 60 lbs or greater and having an abdominal thickness greater than 16cm, and is intended to be used where a 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® O2 Imaging System is compatible with certain image guided surgery systems.

| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------|----------------------------------------------------------------------|
| <input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) | <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) |

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## 510(k) Summary

| Submitter: | Medtronic Navigation, Inc. (Littleton)<br>300 Foster Street<br>Littleton, MA 01460 |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Rishi Sinha (Primary)<br>Principal Regulatory Affairs Specialist<br>Phone: [phone]<br>Fax: [phone]<br>E-mail: [e-mail]<br><br>Paul Smolenski (Alternate)<br>Senior Regulatory Affairs Manager<br>Phone: [phone]<br>Fax: [phone]<br>E-mail: [e-mail] |
| Date Summary Prepared: | June 30th, 2015 |
| Device Trade Name: | Medtronic O-arm® O2 Imaging System |
| Common Name: | Interventional Fluoroscopic X-ray System |
| Device Classification: | Class II |
| Product Code: | Primary: OWB<br>Secondary: OXO, JAA |
| Classification Name: | 892.1650 - Image Intensified Fluoroscopic X-ray System, Mobile |
| Predicate Device: | K092564 - Medtronic O-arm® Imaging System |
| Device Description: | The O-arm® O2 Imaging System is a mobile x-ray system that provides<br>3D imaging as well as 2D fluoroscopic imaging. It was originally cleared<br>for market in 2005 via K050996. Additional submissions were made in<br>2006 (K060344) and 2009 (K092564). The device is classified under<br>primary product code OWB (secondary OXO, JAA) , ref 21 CFR<br>892.1650.<br><br>O-arm® O2 Imaging System, also referred to as “O-arm® O2”, adds an<br>extended field of view imaging mode that offers twice the lateral field of<br>view as the prior design to provide clinicians further visualization options<br>in larger anatomic regions and anatomical structures. It accomplishes<br>this task with essentially the same hardware design as described within.<br><br>The system consists of two parts: the O-arm® Image Acquisition System<br>(IAS), comprising of a x-ray generator, amorphous silicon flat panel x-ray<br>detector and the x-ray control user interface and the Mobile View Station<br>(MVS), comprising of the image processors, a user interface for image<br>and patient handling and viewing monitor.<br><br>The O-arm® O2 Imaging System consists of two main assemblies that<br>are used together during fluoroscopic imaging: |
| | • The Mobile View Station (MVS) |
| | The two units are interconnected by a single cable that provides power<br>and signal data. The O-arm® IAS has an internal battery pack that<br>provides power for motorized transportation and gantry positioning. In<br>addition the battery pack is used to power the X-ray tank. The MVS has<br>an internal UPS to support its function when mains power is<br>disconnected. |
| | The O-arm® operates off standard line voltage within the following<br>voltages:<br>• VAC 100, 120 or 240<br>• Frequency 60Hz; 50Hz<br>• Power Requirements 1440 VA |
| Indications for Use: | The O-arm® O2 Imaging System is a mobile x-ray system designed for<br>2D fluoroscopic and 3D imaging for adult and pediatric patients weighing<br>60lbs or greater and having an abdominal thickness greater than 16cm,<br>and is intended to be used where a physician benefits from 2D and 3D<br>information of anatomic structures and objects with high x-ray<br>attenuation such as bony anatomy and metallic objects. |
| | The O-arm® O2 Imaging System is compatible with certain image guided<br>surgery systems. |

- The Image Acquisition System (IAS) •

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| Substantial Equivalence: | O-arm® O2 is substantially equivalent to the following device: | |
|--------------------------|----------------------------------------------------------------|--|
| | · K092564 – O-arm® Imaging System | |

| | Subject Device | Predicate |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | O-arm® O2 Imaging System | O-Arm® 1000 Imaging System<br>(K092564) |
| Classification | Class 2 | Class 2 |
| Product Code | OXO; 892.1650 | OXO; 892.1650 |
| Indications for Use | The O-arm® O2 Imaging System is<br>a mobile x-ray system designed for<br>2D fluoroscopic and 3D imaging and<br>is intended to be used where a<br>physician benefits from 2D and 3D<br>information of anatomic structures<br>and objects with high x-ray<br>attenuation such as bony anatomy<br>and metallic objects.<br>The O-arm® Imaging System is<br>compatible with certain Image<br>Guided Surgery Systems. | The O-arm® Imaging System is a<br>mobile x-ray system designed for<br>2D fluoroscopic and 3D imaging<br>and is intended to be used where<br>a physician benefits from 2D and<br>3D information of anatomic<br>structures and objects with high<br>x-ray attenuation such as bony<br>anatomy and metallic objects.<br>The O-arm® Imaging System is<br>compatible with certain Image<br>Guided Surgery systems. |

## Table 1: O-arm® O2 Predicate Device Comparison Table

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| | Subject Device | Predicate |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | O-arm® O2 Imaging System | O-Arm® 1000 Imaging System (K092564) |
| Cone Beam CT | The O-arm® O2 Imaging System is a mobile cone-beam x-ray system with isocentric motion options. It allows 3D image reconstruction using a 360 degree rotation of the x-ray source and detector within closed gantry. | The O-arm® Imaging System is a mobile cone-beam x-ray system with isocentric motion options. It allows 3D image reconstruction using a 360 degree rotation of the x-ray source and detector within closed gantry. |
| Detector Technology | 40 x 30 cm (RoHS compliant, Flat-Panel Detector using a Csl scintillation) | 40 x 30 cm (Flat-Panel Detector using a CsI scintillation) |
| Generator Technology | 32 kW, RoHS compliant generator with improved electrical interface. | 32kW Generator |
| 2D Imaging | 2D Fluoroscopic | 2D Fluoroscopic |
| 3D Imaging (20 cm FOV) | Full Fan (20cm FOV) scan acquisition | Full Fan (20cm FOV) scan acquisition |
| 3D Imaging Protocols (20 cm FOV) | Available presets:<br>1. Standard 3D<br>2. HD3D (High Definition)<br>3. Enhanced Cranial<br>4. Low Dose 3D | Available presets:<br>1. Standard 3D<br>2. HD3D (High Definition)<br>3. Enhanced Cranial |
| 3D Imaging (40 cm FOV) | Half-fan single scan acquisition | No 3D Imaging at 40cm FOV |
| 3D Imaging Protocols (40 cm FOV) | Available presets:<br>1. HD3D (high definition) equivalent to 750 projections | No 3D Imaging at 40cm FOV |

Performance Testing: Testing conducted demonstrates the product will perform as intended according to the outlined design requirements. The following testing was conducted on the O-arm O2 Imaging System device to establish substantial equivalence of the O-arm O2 Imaging System and verify that device will perform as intended meeting all of the design inputs.

- AAMI/ANSI ES 60601-1:2012 Medical Electrical Equipment -● Part 1: General Requirements For Basic Safety And Essential Performance (IEC 60601-1:2005, MOD)
- IEC 60601-1-2:2007 Medical Electrical Equipment Part 1-2: . General requirements for safety; Electromagnetic Compatibility -Requirements and Tests (2/2014)
- IEC 60601-1-3:2008 - Medical Electrical Equipment - Part 1-3:General Requirements for Basic Safety and Essential Performance – Collateral Standard: Radiation Protection in Diagnostic X-ray Equipment (1/2014)
- IEC 60601-2-28:2010 Medical electrical equipment part 2: . Particular requirements for the safety of X-ray source assemblies and X-ray tube assemblies for medical diagnosis (8/2013)

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- . IEC 60601-2-43:2010 – Medical electrical equipment Part 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures (3/2010)
- Software Verification and Validation testing verifying the software requirements perform as intended
- . Hardware verification ensuring the hardware requirements identified for the system perform as intended.
- The Dose Setting Guidance for Extra-small Patient Size determines ● recommended dose settings (kVp/mA pairs) for an extra-small patient population to help the end user when imaging such patients.
- . The Image Quality Assessment of the O-arm® O2 System provides a quantitative image quality assessment of the O-arm® O2 system in comparison to the predicate O-arm® 1000 device.
- . The Dosimetry Report documents the dosimetry measurements for the various modes of the O-arm O2 System.
- . The Usability Testing was conducted according to the FDA quidance Applying Human Factors and Usability to Optimize Medical Device Design. Users conducted a series of imaging functions under simulated use conditions.
- The O-arm® Cadaver Image Pair Study evaluates the clinical utility ● of the images obtained using the O-arm® O2 Imaging System compared to the images obtained using the predicate O-arm® 1000 and the reference Artis Zeego device.

All performance testing was conducted to ensure the product meets all prescribed design inputs.

Conclusion: The O-arm® O2 system is similar in technological characteristics, imaging performance and indications for use as the predicate devices listed. These aspects, along with the functional testing conducted to the FDA recognized standards, demonstrate that O-arm® O2 does not raise new risks of safety and effectiveness when compared to the predicates.