K Number
K210257
Device Name
Xoran Workstation, Model 10050
Date Cleared
2021-05-20

(108 days)

Product Code
Regulation Number
892.2050
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
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
More Information

Reference Device(s): Not Found

No
The document describes standard image processing and viewing software without mentioning AI or ML capabilities.

No
The device is described as image processing and viewing software for analysis and interpretation, not for direct therapeutic intervention.

Yes

The software provides tools for viewing, interpretation, clinical review, and analysis of patient image data by healthcare professionals, which are all activities involved in forming a diagnosis.

Yes

The device is explicitly described as "image processing and viewing software" and runs on a standard Windows PC. While it processes data from hardware devices (Xoran MiniCAT, etc.), the device itself, as described in the summary, is solely the software component.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is focused on processing and viewing medical images (specifically CT scans from Xoran devices) for interpretation, clinical review, analysis, etc., by healthcare professionals. This is a function related to medical imaging and diagnosis based on visual information, not on analyzing biological samples.
  • Device Description: The device is described as image processing and viewing software.
  • Lack of Biological Sample Analysis: IVD devices are designed to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. There is no mention of this device interacting with or analyzing any biological samples.
  • Input: The input is image data, not biological samples.

Therefore, the Xoran Workstation falls under the category of medical imaging software, not an In Vitro Diagnostic device.

N/A

Intended Use / 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, clinical review, analysis, distribution, archival, printing, and administrative reporting by healthcare professionals.

Product codes

OAS

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
  • o Windows 10 64-bit Professional or Enterprise
  • 4GB of RAM or more O
  • Intel i5 or better O
  • USB Type A port O

Mentions image processing

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.

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.

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

MiniCAT IQ, MiniCAT 2020, xCAT XL, and xCAT IQ patient image data.

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

healthcare professionals.
ENT, Allergy, and dental Offices

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

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.

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K113421

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 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).

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)

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.

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)

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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:

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
    • 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.

| Comparable
Properties | Predicate Device:
MiniCAT | Xoran Workstation | Comparison
Result |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The MiniCAT is an X-ray
imaging device that
constructs a three-
dimensional model of the
head and neck from images
taken during a rotational X-
ray sequence. The MiniCAT
is optimized for the imaging
of the maxillofacial complex,
temporal bone, sinuses and
for neuro-angiography. | 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. | Software:
Functionally
Equivalent
Hardware:
There is no
scanning
hardware for
Xoran
Workstation |
| 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 | Equivalent |
| | 3D reconstruction of images
taken by the MiniCAT | Xoran Workstation can
import raw 2D images
acquired with MiniCAT or
xCAT devices for 3D
reconstruction and viewing.
It can also import 3D
images from any MiniCAT | Equivalent |
| Comparable
Properties | Predicate Device:
MiniCAT | Xoran Workstation | Comparison
Result |
| | | or xCAT device for viewing | |
| | Annotation tools: distance,
circle, rectangle, text, label | Annotation tools: distance,
circle, rectangle, text, label | Equivalent |
| | Annotations are
automatically saved with
image planning file | Annotations are
automatically saved with
image 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 and
pan | 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, slice
thickness | Viewing tools: zoom, slice
thickness | Equivalent |
| Administration | 3D Reconstruction of
acquired images | Xoran Workstation can
import raw 2D images
acquired with MiniCAT or
xCAT devices for 3D
reconstruction | Equivalent |
| | User login | User login | Equivalent |
| | User New/Edit/Delete/Active | User
New/Edit/Delete/Active | Equivalent |
| | Service mode for
administration | Service mode for
administration | 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.