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 Description

The O-arm O2 Imaging System is a mobile x-ray system that provides 3D imaging as well as 2D fluoroscopic imaging. It was originally cleared for market under 510(k) K151000. The device is classified under primary product code OWB (secondary product codes OXO, JAA) ref 21 CFR 892.1650.

This is a special submission for the addition of the following software features:

Angular Annotation
Easy Image Transfer
Enhance Dynamic Range
Cybersecurity Enhancements

These changes are only changes in software. There are no changes related to radiation performance. There are no changes to the device hardware required for these software changes. These features are described in more detail below and in the Device Description. This software also includes defect corrections.

The O-arm O2 Imaging System consists of two main assemblies that are used together:

The Image Acquisition System (IAS)
. The Mobile View Station (MVS)

The two units are interconnected by a single cable that provides power and signal data. The IAS has an internal battery pack that provides power for motorized transportation and gantry positioning. In addition the battery pack is used to power the X-ray tank. The MVS has an internal UPS to support its function when mains power is disconnected.

The O-arm O2 operates off standard line voltage within the following voltages:

VAC 100, 120 or 240
Frequency 60Hz or 50Hz
. Power Requirements 1440 VA

AI/ML Overview

This FDA 510(k) summary focuses on a software update (revision 4.1) for the Medtronic O-arm O2 Imaging System. The submission claims substantial equivalence to the previously cleared device and therefore does not include detailed clinical performance studies to establish new acceptance criteria. Instead, it relies on performance testing to demonstrate that the updated software does not negatively impact the device's intended performance.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly define new acceptance criteria directly related to clinical performance metrics (like sensitivity, specificity, accuracy) for the new software features. Because this is a special 510(k) for software changes, the acceptance criteria are primarily focused on maintaining the safety and effectiveness of the previously cleared device. The "reported device performance" in this context refers to the successful completion of testing according to recognized standards, indicating that the device continues to perform as intended and its safety and effectiveness are not compromised by the software changes.

The performance testing conducted was against these standards to demonstrate that the product "will perform as intended according to the outlined design requirements."

Acceptance Criteria (Implied)	Reported Device Performance
Device performs as intended according to outlined design requirements (including new software features) and applicable recognized standards.	Performance testing was conducted in accordance with: - AAMI/ANSI ES 60601-1:2012 (Basic Safety & Essential Performance) - IEC 60601-1-2:2007 (Electromagnetic Compatibility) - IEC 60601-1-3:2008 (Radiation Protection) - IEC 60601-2-28:2010 (X-ray Source Assemblies & Tube Assemblies Safety) - IEC 60601-2-43:2010 (X-ray Equipment for Interventional Procedures) - Risk / Hazard Analysis performed. - Verification and/or validation activities performed based on Risk/Hazard Analysis with appropriate methods/tests and pass/fail criteria. Conclusion: "The O-arm O2 Imaging 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 0-arm 02 Imaging System with 4.1 software does not raise new risks of safety and effectiveness when compared to the predicates."
Cybersecurity enhancements effectively address identified risks.	Cybersecurity Enhancements (removal of hardcoded passwords, added user authentication, software integrity check) performed within a Risk / Hazard Analysis framework.
New software features maintain the safety and effectiveness of the device as compared to the predicate.	Functional testing conducted to FDA recognized standards demonstrates no new risks of safety and effectiveness.

2. Sample Size Used for the Test Set and Data Provenance

This document does not describe a clinical study with a "test set" in the traditional sense of evaluating diagnostic or clinical performance of the device's new software features on patient data. The "testing" mentioned refers to engineering and quality assurance tests against recognized standards. Therefore, specific details about sample size (e.g., number of patients/cases) for a clinical test set or data provenance (country, retrospective/prospective) are not provided as they are not relevant to this type of 510(k) submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not applicable. As noted above, there was no clinical "test set" or ground truth established by experts for the performance evaluation described in this document. The evaluation focuses on engineering performance, safety, and functionality.

4. Adjudication Method for the Test Set

Not applicable. There was no clinical "test set" requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study would typically be conducted to evaluate the impact of a device on human reader performance, which is not the focus of this software update notification.

6. Standalone Performance Study

The document does not describe a "standalone" performance study in the sense of evaluating the algorithm's performance on its own against a ground truth. The performance testing conducted was to verify that the upgraded system (hardware + new software) meets safety and performance standards for an imaging device.

7. Type of Ground Truth Used

Not applicable. For this special 510(k) submission focused on software updates, the "ground truth" refers to compliance with engineering standards and predefined design requirements, rather than clinical ground truth (e.g., pathology, expert consensus on images).

8. Sample Size for the Training Set

Not applicable. This document is a 510(k) submission for a software update to an existing medical imaging system. It does not describe the development of a new AI/machine learning algorithm that would require a dedicated training set. The software features added (Angular Annotation, Easy Image Transfer, Enhance Dynamic Range, Cybersecurity Enhancements) are functional improvements, not machine learning algorithms that are "trained" on data.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there was no training set for a new AI/ML algorithm.

Summary

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Medtronic Inc. % Mr. Dean Honkonen Regulatory Affairs Manager 300 Foster Street LITTLETON MA 01460

December 29, 2017

Re: K173664

Trade/Device Name: Medtronic 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, JAA, Dated: November 28, 2017 Received: November 29, 2017

Dear Mr. Honkonen:

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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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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Page 2 - Mr. Dean Honkonen

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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn

(http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Michael D. O'Hara For

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

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known)

K173664

Device Name Medtronic O-arm O2 Imaging System

Indications for Use (Describe)

The O-arm O2 Imaging System is compatible with certain image guided surgery systems.

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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information unless it displays a currently valid OMB number."

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510(k) Summary

Submitter:	Medtronic Navigation, Inc. (Littleton)300 Foster StreetLittleton, MA 01460
Contact Person:	Dean HonkonenRegulatory Affairs ManagerPhone: (978)698-6065(978)698-6090Fax:E-mail: dean.honkonen@medtronic.com
Date Summary Prepared:	October 11, 2017
Device Trade Name:	Medtronic O-arm O2 Imaging System
Common Name:	Interventional Fluoroscopic X-ray System
Device Classification:	Class II
Product Code:	Primary OWBSecondary OXO, JAA
Classification Name:	892.1650 - Image Intensified Fluoroscopic X-ray System
Predicate Device:	K151000 – Medtronic O-arm O2 Imaging System

Device Description:

Modified Device:

This is a special submission for the addition of the following software features:

Angular Annotation
Easy Image Transfer ●
Enhance Dynamic Range ●
Cybersecurity Enhancements ●

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The O-arm O2 Imaging System consists of two main assemblies that are used together:

The Image Acquisition System (IAS) ●
. The Mobile View Station (MVS)

The O-arm O2 operates off standard line voltage within the following voltages:

VAC 100, 120 or 240
Frequency 60Hz or 50Hz
. Power Requirements 1440 VA

Indications for 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 60lbs 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.

Substantial Equivalence:

O-arm O2 with revision 4.1.0 software is viewed as substantially equivalent to the unmodified device as there are no changes that impact indications for use or fundamental technology. We have compared the unmodified device (predicate) and the modified device in Table 5-1 below:

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Table 5-1: Device Comparison Table
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	Predicate	Modified Device	Discussion
	O-arm O2 Imaging System	O-arm O2 Imaging System
		With revision 4.1 Software
Classification	Class 2	Class 2	Identical
Product Code	OWB; 892.1650	OWB; 892.1650	Identical
Indications forUse	The O-arm O2 Imaging System is amobile x-ray system designed for2D fluoroscopic and 3D imaging foradult and pediatric patients weighing60lbs or greater and having anabdominal thickness greater than16cm and is intended to be usedwhere a physician benefits from 2Dand 3D information of anatomicstructures and objects with high x-ray attenuation such as bonyanatomy and metallic objects.The O-arm O2 Imaging System iscompatible with certain imageguided surgery systems.	The O-arm O2 Imaging System is amobile x-ray system designed for2D fluoroscopic and 3D imaging foradult and pediatric patients weighing60lbs or greater and having anabdominal thickness greater than16cm and is intended to be usedwhere a physician benefits from 2Dand 3D information of anatomicstructures and objects with high x-ray attenuation such as bonyanatomy and metallic objects.The O-arm O2 Imaging System iscompatible with certain imageguided surgery systems.	Identical
	Predicate	Modified Device	Discussion
	O-arm O2 Imaging System	O-arm O2 Imaging SystemWith revision 4.1 Software
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 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.	Identical
Detector Technology	40 x 30 cm (RoHS compliant, Flat-Panel Detector using a CsI scintillation)	40 x 30 cm (RoHS compliant, Flat-Panel Detector using a CsI scintillation)	Identical
Generator Technology	32 kW, RoHS compliant generator with improved electrical interface.	32 kW, RoHS compliant generator with improved electrical interface.	Identical
2D Imaging	2D Fluoroscopic	2D Fluoroscopic	Identical
3D Imaging(20 cm FOV)	Full Fan (20cm FOV) scan acquisition	Full Fan (20cm FOV) scan acquisition	Identical
3D ImagingProtocols (20 cm FOV)	Available presets:1. Standard 3D2. HD3D (High Definition)3. Enhanced Cranial4. Low Dose 3D	Available presets:5. Standard 3D6. HD3D (High Definition)7. Enhanced Cranial8. Low Dose 3D	Identical
3D Imaging(40 cm FOV)	Half-fan single scan acquisition	Half-fan single scan acquisition	Identical
	Predicate	Modified Device	Discussion
	O-arm O2 Imaging System	O-arm O2 Imaging System
		With revision 4.1 Software
3D ImagingProtocols (40cm FOV)	Available presets:HD3D (high definition)equivalent to 750 projections	Available presets:HD3D (high definition)equivalent to 750 projections	Identical
Annotation	Stereotaxy protocolsAllows for adding arrows, lines andtext to 2D images	Stereotaxy protocolsAllows for adding arrows lines andtext to 2D imagesAdded:Additional annotation capability toperform angular measurements ontoa 2D images. These measurementsinclude closed, open and Cobbangles. It also provides the ability toplace a right angle on the image.	Additional functionality
ImageTransfer	Allows for transfer of data toexternal devices.	Automatically transfers auto-registered navigation scans.Added:Depending upon the clinicalapplication and workflow within theprocedure, this will automaticallytransfer non-auto-registered (non-navigated) images to the navigationsystem	Improves workflowThe capability to transfernon-auto-registered (non-navigated) images to thenavigation system existed in510(k) K15000 but requiredseveral manual steps
	Predicate	Modified Device	Discussion
	O-arm O2 Imaging System	O-arm O2 Imaging System
		With revision 4.1 Software
3DVisualization(EnhancedDynamicRange)	3D visualization of CBCT image onthe MVS. It allows the user towindow level the images as well asrender oblique views	3D visualization of CBCT image onthe MVS. It allows the user towindow level the images as well asrender oblique viewsAdded:Improved visualization of imagesthat contain objects of high-x-rayattenuation such as metal implantson the Mobile View Station.	Improved visualizationcapability
Cybersecurity	Hardcoded passcodes for systemaccessIndustry standard protocols witherror detection for data transmissionand storage.	Industry standard protocols witherror detection for datatransmission and storage.Removed hardcoded passwordsAdded:Authentication that includes usernames and passcodesSoftware integrity check	Increased cybersecurityprotection.

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Performance Testing:

Testing conducted demonstrates the product will perform as intended according to the outlined design requirements. The following testing was conducted in accordance to the following FDA recognized standards:

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)
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)

As required in Special 510(k) submissions Medtronic Navigation Inc. (Littleton) performed a Risk / Hazard Analysis in accordance to company procedures which was used to assess the impact of the modifications listed above.

Based on the Risk / Hazard Analysis an identification of the verification and / or, validation activities required was made and appropriate methods or tests and the applicable pass / fail criteria applied were performed.

The following guidance documents used in the development of 0-arm O2 Imaging System:

Content of Premarket Submissions for Management of Cybersecurity in Medical Devices .
Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices
. Off-The-Shelf Software Use in Medical Devices

Conclusion:

The O-arm O2 Imaging 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 0-arm 02 Imaging System with 4.1 software does not raise new risks of safety and effectiveness when compared to the predicates.

Regulation Number and Section

§ 892.1650 Image-intensified fluoroscopic x-ray system.

(a)
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.(b)
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.