The O-arm O2 Imaging System is a mobile x-ray system designed for adults and pediatric patients weighing 601bs 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 anatomical structures and objects with high x-ray attenuation such as bony anatomy and metallic objects.

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

Device Description

The O-arm™ O2 Imaging System is a mobile x-ray system that provides 3D and 2D imaging. O-arm O2™ Imaging System was originally cleared for market under the original 510(k) K151000 and subsequently via special 510(k) K173664. The device is classified under primary product code OWB (secondary product codes OXO, JAA) ref 21 CFR 892.1650.

This submission for the O-arm™ O2 Imaging System 4.2.0 software release introduces following features:

. "2D Long Film" Imaging Protocol (Intraoperative Radiographic Scan)
. Gantry Rotor Angle and Tilt Angle Display
User Access Enhancements ●

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 Imaging System 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

The provided text describes a 510(k) premarket notification for the Medtronic O-arm™ O2 Imaging System 4.2.0 software. This submission aims to demonstrate substantial equivalence to a predicate device (O-arm™ O2 Imaging System 4.1.0 software).

The key takeaway is that this submission modifies an existing imaging device, adding new features, rather than being a new AI/ML-driven diagnostic/CADe device that would typically have specific AI-driven acceptance criteria. Therefore, the "acceptance criteria" and "study" described in the document are primarily focused on demonstrating that the modified device remains safe and effective and performs as intended, similar to the predicate device, for its original intended use. There is no mention of AI/ML components in this submission.

Given this context, I will address the questions as they relate to the information provided about the device's modifications and the performance testing conducted to support its substantial equivalence.

1. A table of acceptance criteria and the reported device performance

Based on the provided document, the acceptance criteria are implicitly tied to demonstrating substantial equivalence to the predicate device and showing that the new features function as intended without introducing new risks. The "reported device performance" is described through various testing types.

Acceptance Criteria (Implicit)	Reported Device Performance (as tested)
Maintain Intended Use: The device continues to fulfill its stated Indications for Use.	The Indications for Use for the O-arm™ O2 Imaging System 4.2.0 software are identical to the predicate device, with only a minor phrasing change ("fluoroscopic" removed, as explained due to multiple 2D modes). This indicates the device maintains its core purpose.
Safety Conformity: The device meets relevant electrical, electromagnetic compatibility (EMC), radiation safety, and usability standards.	- AAMI/ANSI ES 60601-1 2005+A1:2012 (Basic Safety & Essential Performance)- IEC 60601-1-2:2014 (EMC)- IEC 60601-1-3:2008 + A1:2013 (Radiation Protection)- IEC 60601-2-28:2010 (X-ray Source Assemblies Safety)- IEC 60601-2-43:2010 + A1:2017 (Specific Safety Requirements)- Software Verification and Validation testing- Hardware verification- Dosimetry Report (measures radiation dose for various modes)
Performance of New Features: New features (2D Long Film, Gantry Rotor/Tilt Angle Display, User Access Enhancements) function as designed.	- "2D Long Film" Imaging Protocol: Added as an "Automatically stitched 2D Radiographic (Long Film)" feature, leveraging gantry motion for sequential image acquisition and stitching. This implies successful implementation and functionality. - Gantry Rotor Angle and Tilt Angle Display: Added feature, providing real-time display on the pendant. This implies successful implementation. - User Access Enhancements (LDAP, etc.): Added feature, implying successful implementation of these cybersecurity and user management functionalities.
Image Quality Equivalence: Image quality of the modified device is comparable to the predicate device, especially for existing imaging protocols.	Image Quality Assessment: "quantitative image quality assessment of the O-arm O2 Imaging System with 4.2.0 in comparison to the predicate O-arm™ O2 Imaging System with 4.1.0." This testing demonstrates comparable image quality.
Clinical Utility (New Features): The new features are clinically useful and do not negatively impact existing clinical utility.	O-arm™ Cadayer Image Pair Study: "evaluated the clinical utility of the images obtained using the O-arm™ O2 Imaging System with 4.2.0 compared to the images obtained using the predicate O-arm™ O2 Imaging System with 4.1.0." This study aimed to confirm clinical utility.
No New Risks: The modifications do not introduce new safety or effectiveness concerns.	The conclusion states: "These aspects, along with the functional testing conducted to the FDA recognized standards, demonstrate that Oarm™ O2 Imaging System with 4.2.0 software does not raise new risks of safety and effectiveness when compared to the predicate."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify exact sample sizes for all tests beyond general statements like "Usability Testing was conducted" or "The Image Quality Assessment... provides a quantitative image quality assessment."

The "O-arm™ Cadayer Image Pair Study" is the most relevant test mentioned for clinical utility:

Sample Size: Not explicitly stated in the provided text.
Data Provenance: Not explicitly stated (e.g., country of origin). It's likely a controlled, prospective study given the nature of a "Cadayer Image Pair Study" for comparing device versions. However, the specific type (retrospective vs. prospective) is not detailed.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the excerpt. For the "O-arm™ Cadayer Image Pair Study," it's highly probable that medical professionals (e.g., radiologists, surgeons) were involved in evaluating image utility, but their number and specific qualifications are not mentioned.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

The document does not specify any adjudication methods for the "O-arm™ Cadayer Image Pair Study" or other performance tests.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

MRMC Study: The "O-arm™ Cadayer Image Pair Study" mentioned sounds like it could potentially involve multiple readers evaluating images. However, the document does not explicitly state that it was an MRMC study, nor does it describe its design in detail.
AI Assistance: This device and the listed modifications do not involve AI/ML. The effect size of human readers improving with AI assistance is therefore not applicable and not discussed. The study's purpose was to compare the image utility of the new software version to the predicate software version of the imaging system itself.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Standalone Performance: This question is typically asked for AI/ML algorithms. Since the O-arm™ O2 Imaging System 4.2.0 software does not contain an AI/ML algorithm within the scope of this 510(k) submission, this concept is not applicable. The device is an imaging system, and its performance is evaluated as a system (hardware and software combined), not as a standalone algorithm. The "2D Long Film" feature is described as an automated stitching process which is a traditional image processing function, not an AI/ML algorithm requiring separate "standalone" validation.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the "O-arm™ Cadayer Image Pair Study," the "ground truth" would likely be the clinical utility or perceptual quality of the images as evaluated by medical professionals. This would closer resemble expert opinion/consensus on image quality and usefulness in a clinical context, rather than a definitive "true positive/negative" based on pathology or outcomes data, as it's a comparison of imaging system versions. However, the document doesn't explicitly define what "ground truth" means for this specific study.

8. The sample size for the training set

This device does not appear to utilize AI/ML algorithms that would necessitate a "training set." Therefore, this question is not applicable.

9. How the ground truth for the training set was established

As there is no mention of a "training set" for AI/ML, this question is not applicable.

Summary

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April 24, 2020

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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

Re: K200074

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: Class II Product Code: OWB, JAA, OXO Dated: March 27, 2020 Received: March 30, 2020

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmp/pmn.cfm identifies combination product submissions. 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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see

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https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K200074

Device Name Medtronic O-arm™ O2 Imaging System

Indications for Use (Describe)

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

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

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510(k) Summary

Submitter:	Medtronic Navigation, Inc. (Littleton)300 Foster StreetLittleton, MA 01460
Contact Person:	Dean Honkonen (Primary)Sr. Regulatory Affairs ManagerPhone: (978) 698-6065Fax: (978) 698-6090e-mail: dean.honkonen@medtronic.comTijana Prodanovic (Alternate)Sr. Regulatory Affairs SpecialistPhone: (978) 339-4134Fax: (978) 698-6090e-mail: tijana.prodanovic@medtronic.com
Date Summary Prepared:	January 13, 2020
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, Mobile
Predicate Device:	K173664 – O-arm™ O2 Imaging System 4.1.0 software

Device Description:

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Modified Device:

This submission for the O-arm™ O2 Imaging System 4.2.0 software release introduces following features:

. "2D Long Film" Imaging Protocol (Intraoperative Radiographic Scan)
. Gantry Rotor Angle and Tilt Angle Display
User Access Enhancements ●

These features are described in more detail in the Substantial Equivalence section.

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 Imaging System 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 and 3D imaging for adult and pediatric patients weighing 601bs 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 Imaging System with 4.2.0 software is substantially equivalent to the following device:

K173664 - O-arm™ O2 Imaging System 4.1.0 software The unmodified device (predicate - K173664) and the modified device are compared in table below:

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Device Comparison Table

	Predicate Device	Modified Device
	O-arm O2 Imaging SystemK173664	With revision 4.2.0 software	Discussion
Classification	Class II	Class II	Identical
Product Code	OWB; 892.1650	OWB; 892.1650	Identical
Indications for Use	The O-arm O2 Imaging System is amobile x-ray system designed for 2Dfluoroscopic and 3D imaging for adultand pediatric patients weighing 60lbs orgreater and having an abdominalthickness greater than 16cm and isintended to be used where a physicianbenefits from 2D and 3D information ofanatomic structures and objects with highx-ray attenuation such as bony anatomyand metallic objects.The O-arm O2 Imaging System iscompatible with certain image guidedsurgery systems.	The O-arm O2 Imaging System is amobile x-ray system designed for 2D and3D imaging for adult and pediatricpatients weighing 60lbs or greater andhaving an abdominal thickness greaterthan 16cm and is intended to be usedwhere a physician benefits from 2D and3D information of anatomic structures andobjects with high x-ray attenuation suchas bony anatomy and metallic objects.The O-arm O2 Imaging System iscompatible with certain image guidedsurgery systems.	Changed to remove the word"fluoroscopic".O-arm O2 Imaging System 4.2.0software uses more than one 2Dmode. Modes of operation aredescribed in the Instructions for Use.
Cone Beam CT	The O-arm O2 Imaging System is amobile cone-beam x-ray system withisocentric motion options. It allows 3Dimage reconstruction using a 360 degreerotation of the x-ray source and detectorwithin closed gantry.	The O-arm O2 Imaging System is amobile cone-beam x-ray system withisocentric motion options. It allows 3Dimage reconstruction using a 360 degreerotation of the x-ray source and detectorwithin closed gantry.	Identical
	Predicate Device	Modified Device
	O-arm O2 Imaging System K173664	With revision 4.2.0 software	Discussion
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	32 kW, RoHS compliant generator	Identical
2D Imaging	2D Fluoroscopic	2D Fluoroscopic	Identical
2D Imaging	Manually stitched fluoroscopy	Added Feature:Automatically stitched 2D Radiographic(Long Film)	Added Feature:The O-arm O2 2D Long Film featureleverages the motion capability ofthe O-arm to provide an imagingmode, whereby 2D narrowlycollimated projection images wouldbe automatically acquired while thegantry is moving from twopreprogramed gantry locations.These projections would then beautomatically stitched together usingknowledge of the motion profile toform a single 2D Long Film.
3D Imaging(20 cm FOV)	Full Fan (20cm FOV) scan acquisition	Full Fan (20cm FOV) scan acquisition	Identical

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	Predicate Device	Modified Device	Discussion
	O-arm O2 Imaging SystemK173664	With revision 4.2.0 software
3D Imaging Protocols(20 cm FOV)	Available presets:Standard 3DHD3D (High Definition)Enhanced CranialLow Dose 3D	Available presets:Standard 3DHD3D (High Definition)Enhanced CranialLow Dose 3D	Identical
3D Imaging(40 cm FOV)	Half-fan single scan acquisition	Half-fan single scan acquisition	Identical
3D Imaging Protocols(40 cm FOV)	Available presets:HD3D (high definition) equivalent to750 projectionsStereotaxy protocols	Available presets:HD3D (high definition) equivalent to750 projectionsStereotaxy protocols	Identical
Annotation	Allows for adding arrows lines and text to2D imagesAdditional annotation capability toperform angular measurements onto a 2Dimages. These measurements includeclosed, open and Cobb angles. It alsoprovides the ability to place a right angleon the image.	Allows for adding arrows lines and text to2D imagesAdditional annotation capability toperform angular measurements onto a 2Dimages. These measurements includeclosed, open and Cobb angles. It alsoprovides the ability to place a right angleon the image.	Changed to accommodate the largerimage size of 2D Radiographic(Long Film).

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	Predicate Device	Modified Device
	O-arm O2 Imaging SystemK173664	With revision 4.2.0 software	Discussion
Image Transfer	Automatically transfers auto-registerednavigation scans.Easy Image Transfer:Depending upon the clinical applicationand workflow within the procedure, thiswill automatically transfer non-auto-registered (non-navigated) images to thenavigation system	Automatically transfers auto-registerednavigation scans.Easy Image Transfer:Depending upon the clinical applicationand workflow within the procedure, thiswill automatically transfer non-auto-registered (non-navigated) images to thenavigation system	Identical
3D Visualization(Enhanced DynamicRange)	3D visualization of CBCT image on theMVS. It allows the user to window levelthe images as well as render obliqueviewsImproved visualization of images thatcontain objects of high-x-ray attenuationsuch as metal implants on the MobileView Station.	3D visualization of CBCT image on theMVS. It allows the user to window levelthe images as well as render obliqueviewsImproved visualization of images thatcontain objects of high-x-ray attenuationsuch as metal implants on the MobileView Station.	Identical

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Cybersecurity		Added Feature:	Added Feature
	Industry standard protocols with errordetection for data transmission andstorage.Authentication that includes usernames and passcodesSoftware integrity check	Enhanced user access	• The ability to have a user log in tothe O-arm system through theLightweight Directory AccessProtocol (LDAP) by using hospitaldomain credentials set up by hospitalIT.• The ability for the hospital IT teamto configure group policies on theirhospital IT systems and assign theproper user group to individuals withO-arm user and/or O-arm hospitaladministrator privileges.• The ability to maintain legacy O-arm O2 4.1.0 local authenticationmethods if customers prefer thismethod over LDAP.• The ability for Medtronic Serviceor Manufacturing to configure theauthentication feature based oncustomer requests.• The ability for Authorizedpersonnel to audit changes madewithin the system related toProtected Health Information (PHI),User Management and SystemConfiguration.• Encryption of PHI informationstored on MVS computer for easierintegration of the improved UserAccess Enhancements into variousHospital IT systems.

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	Predicate Device	Modified Device
	O-arm O2 Imaging SystemK173664	With revision 4.2.0 software	Discussion
Hardware – CollimatorAssembly	No slot filter present in CollimatorAssembly	Changed hardwareCollimator Assembly includes a slot filterfor 2D Long Film Imaging	Changed hardwareCollimator Assembly includes a slotfilter for 2D Long Film Imagingcapability. New filter ladderassembly designed for 2D Long Filmallows for higher repeatability offilter positioning than the currentdesign.
Software - Gantry Tilt& Rotor Angle Display	Not present	Added FeatureDisplay of the Gantry Rotor Angle andGantry Tilt Angle on the Pendant	Added feature:Gantry Tilt & Rotor Angle Displaywill provide following capability:• Will enable users to view the tiltangles of the gantry from the O-arm pendant.• Will enable users to view therelative angle/location of X-raysource & detector.

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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 on the O-arm™ O2 Imaging System device to establish substantial equivalence with the predicate device and verify that device will perform as intended in meeting all the design inputs:

AAMI/ANSI ES 60601-1 2005+A1:2012 Medical Electrical Equipment Part 1: General Requirements For Basic Safety And Essential Performance
· IEC 60601-1-2:2014 Medical Electrical Equipment Part 1-2: General requirements for safety; Electromagnetic Compatibility - Requirements and Tests
IEC 60601-1-3:2008 + A1:2013 Medical Electrical Equipment Part 1-3: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Radiation Protection in Diagnostic X-ray Equipment
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
IEC 60601-2-43:2010 + A1:2017 Medical electrical equipment Part 2-43: Particular requirements for the basic safety and essential
IEC60601-1-6:2010 + A1:2013 Medical electrical equipment Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
· 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 Dosimetry Report documents the dosimetry measurements for the various modes of the O-arm™ O2 Imaging System with 4.2.0 software.
· Usability Testing was conducted according to the FDA guidance Applying Human Factors and Usability to Optimize Medical Device Design. Users conducted a series of imaging functions under simulated use conditions.
· The Image Quality Assessment of the O-arm™ O2 Imaging System provides a quantitative image quality assessment of the O-arm O2 Imaging System with 4.2.0 in comparison to the predicate O-arm™ O2 Imaging System with 4.1.0.
· The O-arm™ Cadayer Image Pair Study evaluated the clinical utility of the images obtained using the O-arm™ O2 Imaging System with 4.2.0 compared to the images obtained using the predicate O-arm™ O2 Imaging System with 4.1.0.

Conclusion:

The O-arm™ O2 Imaging System with 4.2.0 software is similar in technological characteristics, imaging performance and indications for use as the predicate device listed. These aspects, along with the functional testing conducted to the FDA recognized standards, demonstrate that Oarm™ O2 Imaging System with 4.2.0 software does not raise new risks of safety and effectiveness when compared to the predicate.

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.