TRON

K221230 · Xoran Technologies, LLC · OWB · Jul 28, 2022 · Radiology

Device Facts

• Record ID: K221230
• Device Name: TRON
• Applicant: Xoran Technologies, LLC
• Product Code: OWB · Radiology
• Decision Date: Jul 28, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1650
• Device Class: Class 2

Intended Use

TRON is a mobile X-Ray imaging system with fluoroscopy and tomography capability that is intended to be used for anatomy that can safely fit within the device gantry and positioned within the imaging aperture (such as the head, neck, chest, abdomen, and extremities: arm, wrist, hand, leg, knee, ankle, and foot).

Device Story

Mobile point-of-care (POC) X-ray system; features 360-degree rotational open-bore gantry, X-ray generator, tube, and flat-panel detector. Operates by collecting 360-degree projection data; processes data via algorithms to reconstruct 3D volumetric (CBCT) images. Used in clinical settings (e.g., OR) by healthcare professionals. Provides 2D fluoroscopic and 3D tomographic images on an operator workstation. Supports image annotation (arrows, text, angular measurements like Cobb angles) and window-leveling. Facilitates clinical decision-making by providing real-time anatomical visualization; images can be transferred to navigation systems or PACS. Benefits include portable, intraoperative imaging capability for bony anatomy and metallic objects.

Clinical Evidence

No clinical testing was conducted for the TRON. Evidence consists of bench testing, software validation, and product validation performed on production-equivalent units to demonstrate conformance to design requirements and standards (IEC 60601 series).

Technological Characteristics

Mobile, wheeled gantry; 360-degree rotation; 40x30cm CsI flat-panel detector; 1.050 kW X-ray generator; onboard PC/operator workstation; RoHS compliant components; laser-guided patient positioning; connectivity via standard protocols for image transfer to PACS/navigation systems.

Indications for Use

Indicated for mobile X-ray imaging, including fluoroscopy and tomography, for anatomy fitting within the gantry aperture (head, neck, chest, abdomen, extremities) in patients requiring 2D/3D imaging.

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™ 02 Imaging System (K200074)

Reference Devices

• xCAT; xCAT for Neuro (K061834)

Submission Summary (Full Text)

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July 28, 2022

Image /page/0/Picture/1 description: The image shows 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.

Xoran Technologies LLC % Mark McGarrow VP of Quality and Operations 5210 S. State Rd. Ann Arbor MI 48108

Re: K221230

Trade/Device Name: TRON Regulation Number: 21 CFR 892.1650 Regulation Name: Image-Intensified Fluoroscopic X-Ray System Regulatory Class: Class II Product Code: OWB, OXO, JAK Dated: April 28, 2022 Received: April 29, 2022

Dear Mark Mcgarrow:

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/cfpmn/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

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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 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 mediation-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Laurel Burk, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of 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) K221230

Device Name

TRON

Indications for Use (Describe)

TRON is a mobile X-Ray imaging system with fluoroscopy and tomography capability that is intended to be used for anatomy that can safely fit within the device gantry and positioned within the imaging aperture (such as the head, neck, chest, abdomen, and extremities: arm, wrist, hand, leg, knee, ankle, and foot).

| Type of Use (Select one or both, as applicable) | |
|-----------------------------------------------------------------------------------|------------------------------------------------------------------------------------|
| <div> <span> 区 Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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510(k) Number: K221230

This 510(k) summary of the Safety and Effectiveness information is submitted in accordance with the requirements of 21 CFR 807.92.

Date Prepared: April 22, 2022

## Submitter:

Xoran Technologies LLC 5210 S. State Road Ann Arbor, MI 48108

## Contact Person:

Mark McGarrow Vice President of Quality and Operations Phone: [phone] Email: mark.mcgarrow(@xorantech.com

## Device Name and Classification:

| Trade Name: | TRON |
|----------------------------|---------------------------------------------|
| Classification Name: | Interventional Fluoroscopic X-Ray System |
| Classification Panel: | Radiology |
| Classification Regulation: | 21 CFR 892.1650 |
| Regulation Name: | Image-intensified fluoroscopic x-ray system |
| Device Class: | Class II |
| Product Code: | OWB |
| Secondary Product Codes: | OXO, JAK |

## Predicate Device:

| Trade Name: | Medtronic O-arm™ 02 Imaging System |
|----------------------------|---------------------------------------------|
| 510(k) number: | K200074 cleared 04/24/2020 |
| Manufacturer: | Medtronic, Inc. |
| Classification Name: | Interventional Fluoroscopic X-Ray System |
| Classification Panel: | Radiology |
| Classification Regulation: | 21 CFR 892.1650 |
| Regulation Name: | Image-intensified fluoroscopic x-ray system |
| Device Class: | Class II |
| Product Code: | OWB |
| Secondary Product Codes: | JAA, OXO |

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| Reference Device: | |
|----------------------------|-------------------------------------|
| Trade Name: | xCAT; xCAT for Neuro |
| 510(k) number: | K061834 cleared 08/07/2006 |
| Manufacturer: | Xoran Technologies LLC |
| Classification Name: | System, X-Ray, Tomography, Computed |
| Classification Panel: | Radiology |
| Classification Regulation: | 21 CFR 892.1750 |
| Regulation Name: | Computed tomography x-ray system |
| Device Class: | Class II |
| Product Code: | JAK |

## Device Description:

The TRON is a mobile fluoroscopy and cone-beam CT x-ray system for point-of-care (POC) imaging. The TRON system consists of a high voltage x-ray generator, 360-degree rotational open-bore gantry, x-ray tube assembly, x-ray controller, detector panel, and x-ray controls containing a power distribution unit, onboard PC and operator PC (user interface).

## Indications for Use:

TRON is a mobile X-Ray imaging system with fluoroscopy and tomography capability that is intended to be used for anatomy that can safely fit within the device gantry and positioned within the imaging aperture (such as the head, neck, chest, abdomen, and extremities: arm, wrist, hand, leg, knee, ankle, and foot).

## Substantial Equivalence:

TRON is substantially equivalent to the Medtronic O-arm™ 02 Imaging System in Indications for Use, hardware and technology. TRON is also substantially equivalent to the Xoran Technologies xCAT in technology, including both hardware and software. See comparison Table 1 and Table 2 below

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| | Predicate Device:<br>O-arm 02 Imaging System | Subject Device:<br>TRON | Discussion |
|-------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------|
| Classification | Class II | Class II | Identical |
| Product Code | OWB | OWB | Identical |
| Indications for<br>Use | The O-arm O2 Imaging<br>System is a mobile x-ray<br>system designed for 2D and<br>3D imaging for adult and<br>pediatric patients weighing<br>60lbs or greater and having<br>an abdominal thickness<br>greater than 16cm and is<br>intended to be used where a<br>physician benefits from 2D<br>and 3D information of<br>anatomic structures and<br>objects with high x-ray<br>attenuation such as bony<br>anatomy and metallic<br>objects.<br>The O-arm O2 Imaging<br>System is compatible with<br>certain image guided<br>surgery systems. | TRON is a mobile X-<br>Ray imaging system<br>with fluoroscopy and<br>tomography capability<br>that is intended to be<br>used for anatomy that<br>can safely fit within the<br>device gantry and<br>positioned within the<br>imaging aperture (such<br>as the head, neck,<br>chest, abdomen, and<br>extremities: arm, wrist,<br>hand, leg, knee, ankle,<br>and foot). | Equivalent |
| Cone Beam CT | The O-arm O2 Imaging<br>System is a mobile cone-<br>beam x-ray system with<br>isocentric motion options. It<br>allows 3D image<br>reconstruction using a 360-<br>degree rotation of the x-ray<br>source and detector within<br>closed gantry. | The TRON is a mobile<br>cone-beam x-ray<br>system with isocentric<br>motion options. It<br>allows 3D image<br>reconstruction using a<br>360-degree rotation of<br>the x-ray source and<br>detector. | Equivalent |
| Detector<br>Technology | 40 x 30 cm (RoHS<br>compliant, Flat-Panel<br>Detector using a CsI<br>scintillation) | 40 x 30 cm (RoHS<br>compliant, Flat-Panel<br>Detector using a CsI<br>scintillation) | Identical |
| X-ray Generator<br>Technology | 32 kW generator | 1.050 kW generator | Equivalent in<br>functionality |
| | Predicate Device:<br>O-arm 02 Imaging System | Subject Device:<br>TRON | Discussion |
| Collimator | Includes collimator<br>assembly | Xoran designed beam<br>limiter board 15006 | Functional<br>Equivalent |
| 2D Imaging | 2D Fluoroscopic | 2D Fluoroscopic | Identical |
| 3D Imaging | 20cm and 40cm FOV | 22cm FOV | Equivalent |
| Annotation | Allows for adding arrows<br>lines and text to 2D images<br>Additional annotation<br>capability to perform<br>angular measurements onto<br>a 2D images. These<br>measurements include<br>closed, open and Cobb<br>angles. It also provides the<br>ability to place a right angle<br>on the image | While using the MPR<br>viewer: Allows for<br>adding arrows lines and<br>text to 2D images<br>Additional annotation<br>capability to perform<br>angular measurements<br>onto a 2D images.<br>These measurements<br>include closed, open<br>and Cobb angles. It<br>also provides the ability<br>to place a right angle<br>on the image | Equivalent |
| Image Transfer | Automatically transfers<br>auto-registered navigation<br>scans. Easy Image Transfer:<br>Depending upon the clinical<br>application and workflow<br>within the procedure, this<br>will automatically transfer<br>non-auto-registered (non-<br>navigated) images to the<br>navigation system | Easy Image Transfer:<br>Depending upon the<br>clinical application and<br>workflow within the<br>procedure. Including<br>being able to manually<br>or automatically<br>transfer images to<br>navigation systems or<br>PACs as needed. | Equivalent |
| 3D Visualization<br>(Enhanced<br>Dynamic Range) | 3D visualization of CBCT<br>image on the MVS. It<br>allows the user to window<br>level the images as well as<br>render oblique views<br>Improved visualization of<br>images that contain objects<br>of high-x-ray attenuation<br>such as metal implants on<br>the Mobile View Station. | 3D visualization of<br>CBCT image on the<br>workstation. It allows<br>the user to window<br>level the images as well<br>as render oblique<br>views. | Equivalent |
| | Predicate Device:<br>O-arm 02 Imaging System | Subject Device:<br>TRON | Discussion |
| Cybersecurity | Industry standard protocols<br>with error detection for data<br>transmission and storage.<br>Authentication that includes<br>usernames and passcodes<br>Software integrity check | Industry standard<br>protocols with error<br>detection for data<br>transmission and<br>storage. Authentication<br>that includes usernames<br>and passcodes<br>Software integrity check | Equivalent |
| Mobility | Moves fluidly in your OR;<br>Inter-room mobility for<br>concurrent cases | Can be easily moved<br>from room to room and<br>positioned for scanning<br>by one person. | Equivalent |

## Table 1 – Predicate Comparison

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Image /page/8/Picture/0 description: The image contains the logo for Xoran Technologies. The logo features a stylized letter X in a light blue color, partially overlaid by a square. To the right of the X, the word "ORAN" is written in the same light blue color, with the word "TECHNOLOGIES" appearing in smaller font beneath it. A trademark symbol is present to the upper right of the word "ORAN".

# 510(k) Summary

# Table 2 – Reference Device

| | Reference Device:<br>xCAT | Subject Device:<br>TRON | Discussion |
|-------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------|
| Classification | Class II | Class II | Identical |
| Product Codes | JAK | OWB, OXO, JAK | JAK is Identical |
| Indications for<br>Use | The xCAT is intended to<br>be used for x-ray<br>computed tomography<br>imaging of anatomy that<br>safely fits into the imaging<br>gantry (such as the head,<br>neck, wrist, ankle, hand,<br>and foot). | TRON is a mobile X-Ray<br>imaging system with<br>fluoroscopy and<br>tomography capability<br>that is intended to be<br>used for anatomy that can<br>safely fit within the<br>device gantry and<br>positioned within the<br>imaging aperture (such as<br>the head, neck, chest,<br>abdomen, and<br>extremities: arm, wrist,<br>hand, leg, knee, ankle,<br>and foot). | Identical with the<br>exception that<br>TRON can also do<br>fluoroscopy. |
| Detector<br>Technology | 40 x 30 cm (RoHS<br>compliant, Flat-Panel<br>Detector using a CsI<br>scintillation) | 40 x 30 cm (RoHS<br>compliant, Flat-Panel<br>Detector using a CsI<br>scintillation) | Identical |
| X-ray Generator<br>Technology | 1.050 kw generator | 1.050 kw generator | Identical |
| Collimator | Xoran designed beam<br>limiter board 15006 | Xoran designed beam<br>limiter board 15006 | Identical |
| 2D Imaging | 2D Radiography | 2D Fluoroscopic | Identical with the<br>exception that<br>TRON can also do<br>fluoroscopy. |
| | Reference Device:<br>xCAT | Subject Device:<br>TRON | Discussion |
| 3D Imaging | A series of 360 deg<br>projection data is<br>collected and processed<br>using sophisticated<br>algorithms to generate a<br>3D volumetric data<br>(reconstructed data),<br>commonly referred to as<br>computed tomography<br>(CT). | A series of 360 deg<br>projection data is<br>collected and processed<br>using sophisticated<br>algorithms to generate a<br>3D volumetric data<br>(reconstructed data),<br>commonly referred to as<br>computed tomography<br>(CT). | Identical |
| Annotation | While using the MPR<br>viewer: Allows for adding<br>arrows lines and text to<br>2D images Additional<br>annotation capability to<br>perform angular<br>measurements onto a 2D<br>images. These<br>measurements include<br>closed, open and Cobb<br>angles. It also provides the<br>ability to place a right<br>angle on the image | While using the MPR<br>viewer: Allows for<br>adding arrows lines and<br>text to 2D images<br>Additional annotation<br>capability to perform<br>angular measurements<br>onto a 2D images. These<br>measurements include<br>closed, open and Cobb<br>angles. It also provides<br>the ability to place a right<br>angle on the image | Identical |
| Image Transfer | Easy Image Transfer:<br>Depending upon the<br>clinical application and<br>workflow within the<br>procedure. Including<br>being able to manually or<br>automatically transfer<br>images to navigation<br>systems or PACs as<br>needed. | Easy Image Transfer:<br>Depending upon the<br>clinical application and<br>workflow within the<br>procedure. Including<br>being able to manually or<br>automatically transfer<br>images to navigation<br>systems or PACs as<br>needed. | Identical |
| 3D Visualization<br>(Enhanced<br>Dynamic Range) | 3D visualization of CBCT<br>image on the workstation.<br>It allows the user to<br>window level the images<br>as well as render oblique<br>views. | 3D visualization of<br>CBCT image on the<br>workstation. It allows the<br>user to window level the<br>images as well as render<br>oblique views. | Identical |
| | Reference Device:<br>xCAT | Subject Device:<br>TRON | Discussion |
| Cybersecurity | Industry standard<br>protocols with error<br>detection for data<br>transmission and storage.<br>Authentication that<br>includes usernames and<br>passcodes Software<br>integrity check | Industry standard<br>protocols with error<br>detection for data<br>transmission and storage.<br>Authentication that<br>includes usernames and<br>passcodes Software<br>integrity check | Identical |
| Mobility | Can be easily moved from<br>room to room and<br>positioned for scanning by<br>one person. | Can be easily moved<br>from room to room and<br>positioned for scanning<br>by one person. | Identical |

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## Comparison of Technological Characteristics:

The substantial equivalence of TRON with the predicate and reference devices are presented in the chart above and have the following overall shared technological characteristics:

Mobile Imaging: Wheeled configuration for point-of-care (POC) x-ray imaging.

All three devices are meant to be rolled to the patient location to perform x-ray imaging techniques for immediate image viewing at the POC.

Image Acquisition: Cone-beam x-ray configuration with flat panel detector.

All three devices use equivalent/identical components for x-ray imaging.

Imaging Bore: Gantry configuration with 360deg rotation.

All three device are configured to enable alignment for full rotation of the x-ray source and detector panel around the patient targeted anatomy.

Patient Support/Positioning: Used with standard patient supports.

All three devices are meant to be used with x-ray imaging compatible patient support tables/surfaces typically found in the hospital operating room setting. All three devices use on-board lasers to guide patient positioning of the targeted anatomy.

The detailed properties of the subject device (TRON) presented in the comparison tables above (see Table 1 and Table 2), and described throughout this submission, do not differ significantly from the legally marketed predicate device with regards to fundamental scientific technology, nor do they reflect a significant change in the indications for use. The differences between the subject device and the legally marketed predicate device have been assessed using Risk Management. The results of these efforts demonstrate that the device is as safe and effective as

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the predicate device and does not raise different questions of safety and effectiveness than the predicate.

## Performance Testing:

TRON has undergone Bench Testing, SW Validation, and Product Validation testing to demonstrate its safety, effectiveness, and conformance to its user needs, indications for use, as required by 21 CFR 820.30 Design controls - (f) Design Verification, and (g) Design Validation.

The device testing has followed the same process and it has been documented in the manner listed below:

- o The test plan and test instructions were laid out in the Test Protocol and Test Cases documents, where information such as test configurations, test sample sizes, and test result evaluation criteria, is established.
- The testing was performed, and the results were captured in the Test Results document. ●
- The testing was performed on production equivalent units. Tests were performed by ● qualified Xoran personnel, familiar with the function and use of TRON, but not directly responsible for its design.
- The evaluation of the results and of the overall test result was discussed in the Test 0 Report document
- Identified hazards and risks were tested and successfully mitigated by traceable 0 requirements.

TRON meets all the evaluation criteria for Bench Testing, SW Validation, and Product Validation tests

## Performance Testing - Animal

N/A - No animal testing was conducted for the TRON

## Performance Testing - Clinical

N/A - No clinical testing was conducted for the TRON

## Conformance with IEC Standards

TRON has been designed to comply with the following standards:

- 0 EN 60601-1:2005
- EN 60601-1-2:2015
- EN 60601-1-3:2008 ●

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- IEC 60601-2-44:2009 .
## Guidance Documents and Resources

TRON has been designed utilizing the following FDA Guidance Documents:

- Medical X-Ray Imaging Devices Conformance with IEC Standards ●
- o Pediatric Information for X-ray Imaging Device Premarket Notifications
- Guidance for Submission of 510(k)s for Solids State X-ray Imaging Devices ●
- Information to Support a claim of Electromagnetic Compatibility (EMC) of Electricallyo Powered Medical Devices
- The Image Gently Alliance Link: http://www.imagegently.org ●
- FDA Pediatric X-ray Imaging Link: https://www.fda.gov/radiation-emitting-. products/medical-imaging/pediatric-x-ray-imaging

## Conclusion

The TRON is intended for the same indications for use as the Medtronic O-arm™ 02 Imaging System. It uses components similar to those in the Medtronic O-arm™ 02 Imaging System (e.g. x-ray tube, collimator, x-ray generator, operator console). It is Xoran Technologies, LLC's opinion that the TRON is substantially equivalent to the cleared predicate device, the Medtronic O-arm™ 02 Imaging System