Who is the manufacturer of Medtronic O-arm O2 Imaging System?

Medtronic, Inc. filed the 510(k) submission for Medtronic O-arm O2 Imaging System (K173664).

What is the FDA product code for Medtronic O-arm O2 Imaging System?

OWB. It is classified under 21 CFR 892.1650 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for Medtronic O-arm O2 Imaging System?

510(k) clearance (submission type: Special).

What are the predicate devices for Medtronic O-arm O2 Imaging System?

Medtronic O-arm O2 Imaging System (K151000).

Who can help prepare an FDA 510(k) submission like Medtronic O-arm O2 Imaging System?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Medtronic O-arm O2 Imaging System

K173664 · Medtronic, Inc. · OWB · Dec 29, 2017 · Radiology

Device Facts

Record ID	K173664
Device Name	Medtronic O-arm O2 Imaging System
Applicant	Medtronic, Inc.
Product Code	OWB · Radiology
Decision Date	Dec 29, 2017
Decision	SESE
Submission Type	Special
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 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.

Device Story

Mobile cone-beam x-ray system; provides 2D fluoroscopic and 3D imaging. Consists of Image Acquisition System (IAS) and Mobile View Station (MVS). IAS performs 360-degree gantry rotation for 3D reconstruction; MVS provides visualization, window leveling, and oblique view rendering. Used in clinical settings by physicians for intraoperative guidance. Software revision 4.1 adds angular annotation (closed, open, Cobb angles), automated image transfer to navigation systems, and enhanced dynamic range for metal implant visualization. Cybersecurity updates include user authentication and software integrity checks. Output assists surgeons in visualizing anatomy and metallic implants during procedures, potentially improving surgical accuracy and workflow efficiency.

Clinical Evidence

Bench testing only. Verification and validation activities performed per risk/hazard analysis. Compliance with AAMI/ANSI ES 60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-2-28, and IEC 60601-2-43 standards confirmed.

Technological Characteristics

Mobile cone-beam CT; 40x30cm CsI flat-panel detector; 32kW generator. Isocentric motion; 360-degree gantry rotation. Connectivity via cable between IAS and MVS. Software revision 4.1.0. Cybersecurity: user authentication, integrity checks. Standards: AAMI/ANSI ES 60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-2-28, IEC 60601-2-43.

Indications for Use

Indicated for adult and pediatric patients weighing 60 lbs or greater with abdominal thickness >16cm requiring 2D fluoroscopic or 3D imaging of anatomic structures and high-attenuation objects (e.g., bone, metal). Compatible with image-guided surgery systems.

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 O2 Imaging System (K151000)

Related Devices

K200074 — O-arm O2 Imaging System · Medtronic, Inc. · Apr 24, 2020
K151000 — O-Arm O2 Imaging System · Medtronic, Inc. · Aug 6, 2015
K240465 — O-arm O2 Imaging System · Medtronic Navigation, Inc. · Jun 21, 2024
K220946 — SURGIVISIO Device · Ecential Robotics · Apr 15, 2022
K202547 — Surgivisio system · Surgivisio · Mar 26, 2021

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG' in bold blue letters, and the word 'ADMINISTRATION' in smaller blue letters below. 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. {1}------------------------------------------------ ## 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 {2}------------------------------------------------ #### 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 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) | | |---------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------| | <div> ☑ Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </div> | CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ***DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*** The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [PRAStaff@fda.hhs.gov](mailto:PRAStaff@fda.hhs.gov) *"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."* {3}------------------------------------------------ #### 510(k) Summary | Submitter: | Medtronic Navigation, Inc. (Littleton) 300 Foster Street Littleton, MA 01460 | |------------------------|-------------------------------------------------------------------------------------------------------------------------------------| | Contact Person: | Dean Honkonen Regulatory Affairs Manager Phone: (978)698-6065 (978)698-6090 Fax: 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 OWB Secondary OXO, JAA | | Classification Name: | 892.1650 - Image Intensified Fluoroscopic X-ray System | | Predicate Device: | K151000 – Medtronic O-arm O2 Imaging System | ### 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. ### 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 ● 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. {4}------------------------------------------------ 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 # 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: {5}------------------------------------------------ | Table 5-1: Device Comparison Table | |------------------------------------| |------------------------------------| | | 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 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. | 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. | Identical | | | Predicate | Modified Device | Discussion | | | O-arm O2 Imaging System | O-arm O2 Imaging System With 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 Imaging Protocols (20 cm FOV) | Available presets: 1. Standard 3D 2. HD3D (High Definition) 3. Enhanced Cranial 4. Low Dose 3D | Available presets: 5. Standard 3D 6. HD3D (High Definition) 7. Enhanced Cranial 8. 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 Imaging Protocols (40 cm FOV) | Available presets: HD3D (high definition) equivalent to 750 projections | Available presets: HD3D (high definition) equivalent to 750 projections | Identical | | Annotation | Stereotaxy protocols Allows for adding arrows, lines and text to 2D images | Stereotaxy protocols Allows for adding arrows lines and text to 2D images Added: Additional annotation capability to perform angular measurements onto a 2D images. These measurements include closed, open and Cobb angles. It also provides the ability to place a right angle on the image. | Additional functionality | | Image Transfer | Allows for transfer of data to external devices. | Automatically transfers auto- registered navigation scans. Added: Depending upon the clinical application and workflow within the procedure, this will automatically transfer non-auto-registered (non- navigated) images to the navigation system | Improves workflow The capability to transfer non-auto-registered (non- navigated) images to the navigation system existed in 510(k) K15000 but required several manual steps | | | Predicate | Modified Device | Discussion | | | O-arm O2 Imaging System | O-arm O2 Imaging System | | | | | With revision 4.1 Software | | | 3D Visualization (Enhanced Dynamic Range) | 3D visualization of CBCT image on the MVS. It allows the user to window level the images as well as render oblique views | 3D visualization of CBCT image on the MVS. It allows the user to window level the images as well as render oblique views Added: Improved visualization of images that contain objects of high-x-ray attenuation such as metal implants on the Mobile View Station. | Improved visualization capability | | Cybersecurity | Hardcoded passcodes for system access Industry standard protocols with error detection for data transmission and storage. | Industry standard protocols with error detection for data transmission and storage. Removed hardcoded passwords Added: Authentication that includes user names and passcodes Software integrity check | Increased cybersecurity protection. | {6}------------------------------------------------ {7}------------------------------------------------ {8}------------------------------------------------ {9}------------------------------------------------ # 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.