Xoran Workstation, Model 10050

{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*) | <span> <span style="font-size: 14px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> | |--------------------------------------------------------------------------------------------------------| | <span> <span style="font-size: 14px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> | #### 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: 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<br>Properties | Predicate Device:<br>MiniCAT | Xoran Workstation | Comparison<br>Result | |-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------| | Intended Use | The MiniCAT is an X-ray<br>imaging device that<br>constructs a three-<br>dimensional model of the<br>head and neck from images<br>taken during a rotational X-<br>ray sequence. The MiniCAT<br>is optimized for the imaging<br>of the maxillofacial complex,<br>temporal bone, sinuses and<br>for neuro-angiography. | Xoran Workstation is an<br>image processing and<br>viewing software. The<br>Xoran Workstation software<br>provides tools for patient<br>data management, image<br>processing, viewing,<br>interpretation, annotation,<br>clinical review, analysis,<br>distribution, archival,<br>printing, and administrative<br>reporting by healthcare<br>professionals. | Software:<br>Functionally<br>Equivalent<br>Hardware:<br>There is no<br>scanning<br>hardware for<br>Xoran<br>Workstation | | Environment of<br>Use | ENT, Allergy, and dental<br>Offices | ENT, Allergy and dental<br>Offices | Functionally<br>Equivalent | | Basic<br>Technology | PC Based SW | PC Based SW | Functionally<br>Equivalent | | Principles of<br>Operations | Browsing images by Patient,<br>Date, Ordering physician,<br>Protocol | Browsing images by<br>Patient, Date, Ordering<br>physician, Protocol | Equivalent | | | Viewing Images | Viewing Images | Equivalent | | | 3D reconstruction of images<br>taken by the MiniCAT | Xoran Workstation can<br>import raw 2D images<br>acquired with MiniCAT or<br>xCAT devices for 3D<br>reconstruction and viewing.<br>It can also import 3D<br>images from any MiniCAT | Equivalent | | Comparable<br>Properties | Predicate Device:<br>MiniCAT | Xoran Workstation | Comparison<br>Result | | | | or xCAT device for viewing | | | | Annotation tools: distance,<br>circle, rectangle, text, label | Annotation tools: distance,<br>circle, rectangle, text, label | Equivalent | | | Annotations are<br>automatically saved with<br>image planning file | Annotations are<br>automatically saved with<br>image planning file | Equivalent | | | Annotation tools: distance,<br>circle, rectangle, text, label | Annotation tools: distance,<br>circle, rectangle, text, label | Equivalent | | | Viewing tools: zoom and pan | Viewing tools: zoom and<br>pan | Equivalent | | | Continuous rotation up to +/-<br>45 degrees | Continuous rotation up to<br>+/- 45 degrees | Equivalent | | | Viewing tools:<br>Window/Level adjustment | Viewing tools:<br>Window/Level adjustment | Equivalent | | | Viewing tools:<br>Window/Level adjustment | Viewing tools:<br>Window/Level adjustment | Equivalent | | | Annotation tools: distance | Annotation tools: distance | Equivalent | | | Viewing tools: zoom, slice<br>thickness | Viewing tools: zoom, slice<br>thickness | Equivalent | | Administration | 3D Reconstruction of<br>acquired images | Xoran Workstation can<br>import raw 2D images<br>acquired with MiniCAT or<br>xCAT devices for 3D<br>reconstruction | Equivalent | | | User login | User login | Equivalent | | | User New/Edit/Delete/Active | User<br>New/Edit/Delete/Active | Equivalent | | | Service mode for<br>administration | Service mode for<br>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.