No
The document mentions "sophisticated algorithms" for image processing and reconstruction, which is common in CT systems, but does not explicitly mention or describe the use of AI or ML technologies.
No.
The device is used for imaging (diagnosis), not for treating conditions.
Yes
Explanation: The "Intended Use / Indications for Use" section states that TRON is "intended to be used for anatomy that can safely fit within the device gantry and positioned within the imaging aperture". This describes a device used to acquire images for the purpose of medical diagnosis.
No
The device description explicitly lists multiple hardware components including an x-ray generator, gantry, x-ray tube assembly, detector panel, and PCs, indicating it is a hardware system with integrated software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The TRON is an X-ray imaging system. It uses X-rays to create images of the internal anatomy of the body. It does not perform tests on biological samples.
- Intended Use: The intended use describes imaging of anatomical structures within the body.
- Device Description: The description details the components of an X-ray imaging system, not a device for analyzing biological samples.
Therefore, the TRON falls under the category of a medical imaging device, not an In Vitro Diagnostic device.
N/A
Intended Use / 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).
Product codes
OWB, OXO, 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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-Ray, fluoroscopy, tomography (cone-beam CT)
Anatomical Site
head, neck, chest, abdomen, and extremities: arm, wrist, hand, leg, knee, ankle, and foot
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Bench Testing, SW Validation, and Product Validation testing.
- 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 Report document
- Identified hazards and risks were tested and successfully mitigated by traceable requirements.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench Testing, SW Validation, and Product Validation testing. TRON meets all the evaluation criteria for these tests. No animal or clinical testing was conducted.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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) | |
|---|---|
| 区 Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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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: 734-418-5125 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:
O-arm 02 Imaging System | Subject Device:
TRON | Discussion |
|-------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------|
| Classification | Class II | Class II | Identical |
| Product Code | OWB | OWB | Identical |
| 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
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. | 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). | Equivalent |
| 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 TRON 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. | Equivalent |
| 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 |
| X-ray Generator
Technology | 32 kW generator | 1.050 kW generator | Equivalent in
functionality |
| | Predicate Device:
O-arm 02 Imaging System | Subject Device:
TRON | Discussion |
| Collimator | Includes collimator
assembly | Xoran designed beam
limiter board 15006 | Functional
Equivalent |
| 2D Imaging | 2D Fluoroscopic | 2D Fluoroscopic | Identical |
| 3D Imaging | 20cm and 40cm FOV | 22cm FOV | Equivalent |
| Annotation | Allows for adding arrows
lines and text to 2D images
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 | While using the MPR
viewer: Allows for
adding arrows lines and
text to 2D images
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 | Equivalent |
| Image Transfer | Automatically transfers
auto-registered navigation
scans. Easy Image Transfer:
Depending upon the clinical
application and workflow
within the procedure, this
will automatically transfer
non-auto-registered (non-
navigated) images to the
navigation system | Easy Image Transfer:
Depending upon the
clinical application and
workflow within the
procedure. Including
being able to manually
or automatically
transfer images to
navigation systems or
PACs as needed. | Equivalent |
| 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
Improved visualization of
images that contain objects
of high-x-ray attenuation
such as metal implants on
the Mobile View Station. | 3D visualization of
CBCT image on the
workstation. It allows
the user to window
level the images as well
as render oblique
views. | Equivalent |
| | Predicate Device:
O-arm 02 Imaging System | Subject Device:
TRON | Discussion |
| Cybersecurity | Industry standard protocols
with error detection for data
transmission and storage.
Authentication that includes
usernames and passcodes
Software integrity check | Industry standard
protocols with error
detection for data
transmission and
storage. Authentication
that includes usernames
and passcodes
Software integrity check | Equivalent |
| Mobility | Moves fluidly in your OR;
Inter-room mobility for
concurrent cases | Can be easily moved
from room to room and
positioned for scanning
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:
xCAT | Subject Device:
TRON | Discussion |
|-------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------|
| Classification | Class II | Class II | Identical |
| Product Codes | JAK | OWB, OXO, JAK | JAK is Identical |
| Indications for
Use | The xCAT is intended to
be used for x-ray
computed tomography
imaging of anatomy that
safely fits into the imaging
gantry (such as the head,
neck, wrist, ankle, hand,
and foot). | 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). | Identical with the
exception that
TRON can also do
fluoroscopy. |
| 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 |
| X-ray Generator
Technology | 1.050 kw generator | 1.050 kw generator | Identical |
| Collimator | Xoran designed beam
limiter board 15006 | Xoran designed beam
limiter board 15006 | Identical |
| 2D Imaging | 2D Radiography | 2D Fluoroscopic | Identical with the
exception that
TRON can also do
fluoroscopy. |
| | Reference Device:
xCAT | Subject Device:
TRON | Discussion |
| 3D Imaging | A series of 360 deg
projection data is
collected and processed
using sophisticated
algorithms to generate a
3D volumetric data
(reconstructed data),
commonly referred to as
computed tomography
(CT). | A series of 360 deg
projection data is
collected and processed
using sophisticated
algorithms to generate a
3D volumetric data
(reconstructed data),
commonly referred to as
computed tomography
(CT). | Identical |
| Annotation | While using the MPR
viewer: Allows for adding
arrows lines and text to
2D images 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 | While using the MPR
viewer: Allows for
adding arrows lines and
text to 2D images
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 | Identical |
| Image Transfer | Easy Image Transfer:
Depending upon the
clinical application and
workflow within the
procedure. Including
being able to manually or
automatically transfer
images to navigation
systems or PACs as
needed. | Easy Image Transfer:
Depending upon the
clinical application and
workflow within the
procedure. Including
being able to manually or
automatically transfer
images to navigation
systems or PACs as
needed. | Identical |
| 3D Visualization
(Enhanced
Dynamic Range) | 3D visualization of CBCT
image on the workstation.
It allows the user to
window level the images
as well as render oblique
views. | 3D visualization of
CBCT image on the
workstation. It allows the
user to window level the
images as well as render
oblique views. | Identical |
| | Reference Device:
xCAT | Subject Device:
TRON | Discussion |
| Cybersecurity | Industry standard
protocols with error
detection for data
transmission and storage.
Authentication that
includes usernames and
passcodes Software
integrity check | Industry standard
protocols with error
detection for data
transmission and storage.
Authentication that
includes usernames and
passcodes Software
integrity check | Identical |
| Mobility | Can be easily moved from
room to room and
positioned for scanning by
one person. | Can be easily moved
from room to room and
positioned for scanning
by one person. | Identical |
9
10
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
11
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