Xoran Workstation is an image processing and viewing software. The Xoran Workstation software provides tools for patient data management, image processing, viewing, interpretation, clinical review, analysis, distribution, archival, printing, and administrative reporting by healthcare professionals.

Device Description

Xoran Workstation is an image processing and viewing software for use with imported Xoran MiniCAT IQ, MiniCAT 2020, xCAT XL, and xCAT IQ patient image data. The Xoran Workstation runs on a Windows OS based PC with the following Minimum requirements:

Laptop or desktop computer
Windows 10 64-bit Professional or Enterprise
4GB of RAM or more
Intel i5 or better
USB Type A port

AI/ML Overview

This document describes the Xoran Workstation, Model 10050, an image processing and viewing software. This submission focuses on its substantial equivalence to the predicate device, the MiniCAT. The provided text, however, does not describe specific acceptance criteria and detailed study results to prove that the device meets those criteria.

Based on the provided text, here is a summary of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that the Xoran Workstation underwent "Verification. Software Validation and Product Validation testing to demonstrate its safety, effectiveness, and conformance to its user needs intended use, as required by 21 CFR 820.30 Design controls - (f) Design Verification, and (g) Design Validation." It also states, "Xoran Workstation meets all the evaluation criteria for Verification, Software Validation and Product Validation tests."

However, specific numerical acceptance criteria (e.g., minimum accuracy, sensitivity, specificity, or image quality metrics) and the reported device performance against these criteria are not provided in the document. The document refers to these details being laid out in "Test Protocol and Test Cases" documents and results captured in "Test Results" documents, which are not included in the provided text.

The closest to "performance" comparison is the "Comparable Properties" table which outlines functional equivalence to the predicate device:

Comparable Properties	Predicate Device: MiniCAT (Software Features)	Xoran Workstation (Software Features)	Comparison Result
Intended Use	X-ray imaging device constructs 3D model of head/neck from rotational X-ray sequence.	Image processing and viewing software. Provides tools for patient data management, image processing, viewing, interpretation, annotation, clinical review, analysis, distribution, archival, printing, and administrative reporting.	Software: Functionally Equivalent
Environment of Use	ENT, Allergy, and dental Offices	ENT, Allergy and dental Offices	Functionally Equivalent
Basic Technology	PC Based SW	PC Based SW	Functionally Equivalent
Principles of Operations	Browsing images by Patient, Date, Ordering physician, Protocol	Browsing images by Patient, Date, Ordering physician, Protocol	Equivalent
Viewing Images	Viewing Images	Viewing Images	Equivalent
3D Reconstruction	3D reconstruction of images taken by the MiniCAT	Can import raw 2D images acquired with MiniCAT or xCAT devices for 3D reconstruction and viewing. Can also import 3D images from any MiniCAT or xCAT device for viewing.	Equivalent
Annotation Tools	distance, circle, rectangle, text, label. Automatically saved with image planning file.	distance, circle, rectangle, text, label. Automatically saved with image planning file.	Equivalent
Viewing Tools	zoom and pan; continuous rotation up to +/- 45 degrees; Window/Level adjustment; slice thickness.	zoom and pan; continuous rotation up to +/- 45 degrees; Window/Level adjustment; slice thickness.	Equivalent
Administration	3D Reconstruction of acquired images; User login (New/Edit/Delete/Active); Service mode for administration.	Can import raw 2D images acquired with MiniCAT or xCAT devices for 3D reconstruction; User login (New/Edit/Delete/Active); Service mode for administration.	Equivalent

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

The document states that "test sample sizes" were "established" in the Test Protocol and Test Cases documents. However, the specific sample size used for the test set is not provided in the given text.

The data provenance (e.g., country of origin, retrospective or prospective) for any clinical data used in validation is not specified. The Xoran Workstation is intended to import data from Xoran MiniCAT IQ, MiniCAT 2020, xCAT XL, and xCAT IQ devices.

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

The document states that "Product validation evaluations were performed by qualified physicians, who have anatomical and/or surgical expertise related to Xoran Workstation's intended use."

However, the exact number of experts used to establish ground truth or for product validation, and their specific qualifications (e.g., years of experience, specialty) are not provided.

4. Adjudication Method

The adjudication method used for the test set is not specified in the document.

Summary

{0}------------------------------------------------

May 20, 2021

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is the Department of Health & Human Services logo, which features a stylized eagle. To the right of the eagle is the FDA logo, with the letters "FDA" in a blue box, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

Xoran Technologies LLC % Mr. Mark Mcgarrow VP of Quality and Operations 5210 South State Road ANN ARBOR MI 48108

Re: K210257

Trade/Device Name: Xoran Workstation, Model 10050 Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: OAS Dated: April 23, 2021 Received: April 26, 2021

Dear Mr. 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/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

{1}------------------------------------------------

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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K210257

Device Name Xoran Workstation, Model 10050

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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

"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}------------------------------------------------

K210257

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 19, 2021

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:	Xoran Workstation, Model 10050
Classification Name:	Computed Tomography X-Ray System
Classification Panel:	Radiology
Classification Regulation:	21 CFR 892.1750
Device Class:	Class II
Product Code:	OAS

Predicate Devices:

Trade Name:	MiniCAT
510(k) number:	K113421 cleared 07/11/2012
Manufacturer:	Xoran Technologies, LLC
Classification Name:	Computed Tomography X-Ray System
Classification Panel:	Radiology
Classification Regulation:	21 CFR 892.1750
Device Class:	Class II
Product Code:	JAK

Device Description:

. Laptop or desktop computer
- o Windows 10 64-bit Professional or Enterprise

{4}------------------------------------------------

4GB of RAM or more O
Intel i5 or better O
USB Type A port O

Indications for Use:

Xoran Workstation is an image processing and viewing software. The Xoran Workstation software provides tools for patient data management, image processing, viewing, interpretation, annotation, clinical review, analysis, distribution, archival, printing, and administrative reporting by healthcare professionals.

ComparableProperties	Predicate Device:MiniCAT	Xoran Workstation	ComparisonResult
Intended Use	The MiniCAT is an X-rayimaging device thatconstructs a three-dimensional model of thehead and neck from imagestaken during a rotational X-ray sequence. The MiniCATis optimized for the imagingof the maxillofacial complex,temporal bone, sinuses andfor neuro-angiography.	Xoran Workstation is animage processing andviewing software. TheXoran Workstation softwareprovides tools for patientdata management, imageprocessing, viewing,interpretation, annotation,clinical review, analysis,distribution, archival,printing, and administrativereporting by healthcareprofessionals.	Software:FunctionallyEquivalentHardware:There is noscanninghardware forXoranWorkstation
Environment ofUse	ENT, Allergy, and dentalOffices	ENT, Allergy and dentalOffices	FunctionallyEquivalent
BasicTechnology	PC Based SW	PC Based SW	FunctionallyEquivalent
Principles ofOperations	Browsing images by Patient,Date, Ordering physician,Protocol	Browsing images byPatient, Date, Orderingphysician, Protocol	Equivalent
	Viewing Images	Viewing Images	Equivalent
	3D reconstruction of imagestaken by the MiniCAT	Xoran Workstation canimport raw 2D imagesacquired with MiniCAT orxCAT devices for 3Dreconstruction and viewing.It can also import 3Dimages from any MiniCAT	Equivalent
ComparableProperties	Predicate Device:MiniCAT	Xoran Workstation	ComparisonResult
		or xCAT device for viewing
	Annotation tools: distance,circle, rectangle, text, label	Annotation tools: distance,circle, rectangle, text, label	Equivalent
	Annotations areautomatically saved withimage planning file	Annotations areautomatically saved withimage planning file	Equivalent
	Annotation tools: distance,circle, rectangle, text, label	Annotation tools: distance,circle, rectangle, text, label	Equivalent
	Viewing tools: zoom and pan	Viewing tools: zoom andpan	Equivalent
	Continuous rotation up to +/-45 degrees	Continuous rotation up to+/- 45 degrees	Equivalent
	Viewing tools:Window/Level adjustment	Viewing tools:Window/Level adjustment	Equivalent
	Viewing tools:Window/Level adjustment	Viewing tools:Window/Level adjustment	Equivalent
	Annotation tools: distance	Annotation tools: distance	Equivalent
	Viewing tools: zoom, slicethickness	Viewing tools: zoom, slicethickness	Equivalent
Administration	3D Reconstruction ofacquired images	Xoran Workstation canimport raw 2D imagesacquired with MiniCAT orxCAT devices for 3Dreconstruction	Equivalent
	User login	User login	Equivalent
	User New/Edit/Delete/Active	UserNew/Edit/Delete/Active	Equivalent
	Service mode foradministration	Service mode foradministration	Equivalent

Substantial Equivalence:

{5}------------------------------------------------

Comparison Summary:

The differences between the subject device and the predicate device, the reason they do not impact the indications of use, or the safe and effective use of the Xoran Workstation are listed below:

{6}------------------------------------------------

· Predicate device has both Hardware (for X-ray scanning and imaging) and Software for reconstructing those images.
· Subject device is Software Based on a PC that meets minimum Hardware requirements equivalent to those of the predicate device. While the Hardware components are for xray scanning are not included with Xoran Workstation, the Software reconstruction algorithms and viewing functionality are the equivalent to the Predicate device. Therefore, both are functionally equivalent and do not raise any Safety and Effectiveness questions.

Performance Testing:

Xoran Workstation has undergone Verification. Software Validation and Product Validation testing to demonstrate its safety, effectiveness, and conformance to its user needs intended use, as required by 21 CFR 820.30 Design controls - (f) Design Verification, and (g) Design Validation.

During the design process. risk analysis tools were used to identify hazards and risks, which have been mitigated by traceable requirements, tested during verification and validation.

Each Verification or Validation has followed the same process and it has been documented in the manner listed below:

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 captured in the Test Results document.
The testing was performed on production equivalent units. Verification and Software ● validation tests were performed by qualified personnel, familiar with the function and use of Xoran Workstation, but not directly responsible for its design. Product validation evaluations were performed by qualified physicians, who have anatomical and/or surgical expertise related to Xoran Workstation's intended use.
The evaluation of the results and of the overall verification or validation result was discussed in the Test Report document.

Xoran Workstation meets all the evaluation criteria for Verification, Software Validation and Product Validation tests.

Refer to section 018 Performance Testing Bench for more details.

Conclusion:

The Xoran Workstation is intended for the same use as the predicate device with the exception that it is not an imaging device. It uses the same reconstruction software algorithms and viewing functionality as the MiniCAT. It is Xoran Technologies LLC's opinion that the Xoran Workstation is substantially equivalent to the cleared predicate device, the MiniCAT.

Regulation Number and Section

§ 892.2050 Medical image management and processing system.

(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).