Oryx Cloud Imaging

{0}------------------------------------------------ April 29, 2022 Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left side of the logo is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. Oryx Dental Software INC % Ms. Mary Vater Regulatory Consultant Medical Device Academy, Inc. 345 Lincoln Hill Road SHREWSBURY VT 05738 Re: K220684 Trade/Device Name: Oryx Cloud Imaging Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: LLZ Dated: March 7, 2022 Received: March 8, 2022 Dear Ms. Vater: 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 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) K220684 Device Name Oryx Cloud Imaging ### Indications for Use (Describe) Oryx Cloud Imaging is an internet-based, image management software (PACS) that enables dental offices to keep records of hard and soft tissue charts in a form of digital images. The system uses a Web-based interface and includes acquisition, editing and storage of digital images. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations. Images can be acquired from standard dental imaging devices, or can be uploaded directly from the user's computer. Images can be edited (e.g., zoomed, contrast, rotated, etc.), as well as exported. The system is designed to provide images for diagnostic use. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------| | <div> <span> <span style="font-size:16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> <span style="font-size:16px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> | ### 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}------------------------------------------------ # 510(k) SUMMARY K220684 This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR §807.92: - l. SUBMITTER Oryx Dental Software INC 1001 Fairview Avenue North Seattle, WA 98109 Tel: 202-758-4111 | Contact Person: | Meritxell Martinez | |-----------------|--------------------| | Date Prepared: | March 25th, 2022 | | II. DEVICE | | |------------------------------|------------------------------------------------| | Device Trade Name: | Oryx Cloud Imaging | | Device 510(k): | K220684 | | Classification Name: | Medical Image Management and Processing System | | Regulation: | 21 CFR §892.2050 | | Regulatory Class: | Class II | | Device Panel: | Radiology | | Product Classification Code: | LLZ | | III. PREDICATE DEVICE | | | Predicate Manufacturer: | Curve Dental, Inc. | | Predicate Trade Name: | Curve Image 2.0 | | Predicate 510(k): | K112974 | | Classification Name: | Medical Image Management and Processing System | | Regulation: | 21 CFR §892.2050 | | Regulatory Class: | Class II | | Device Panel: | Radiology | | Product Classification Code: | LLZ | No reference devices were used in this submission. #### DEVICE DESCRIPTION IV. Oryx Cloud Imaging is a cloud-based dental imaging software that allows access to diagnostic images on any Mac or PC with an active internet connection. Oryx Cloud Imaging is feature rich, including full feature parity with traditional client-server based dental imaging software. {4}------------------------------------------------ Oryx Cloud Imaging is a Class II dental imaging software that includes the ability to acquire, view, annotate, and organize dental radiographs and color images. Oryx Cloud Imaging integrates with most major client-server and web-based practice management software. Images stored using Oryx Cloud Imaging are saved using lossless compression, and can be exported as DICOM, PNG, JPEG, or PDF files. Oryx Cloud Imaging is a software-only dental image device which allows the user to acquire images using standard dental imaging devices, such as intraoral X-ray sensors, intraoral cameras, and scanners. Orvx Cloud Imaging is imaging software designed for use in dentistry. The main Oryx Cloud Imaging software functionality includes image acquisition, organization. Oryx Cloud Imaging is used by dental professionals for the visualization of patient images retrieved from a dental imaging device or scanner, for assisting in case diagnosis, review, and treatment planning. Dentists and other qualified individuals can display and review images, apply annotations, and manipulate images. Oryx Cloud Imaging is a standalone product but is designed to work cooperatively with dental practice management software that is used for scheduling, clinical note taking, and billing. The software operates upon standard PC hardware and displays images on the PC's connected display/monitor. The subject device is the Oryx PACS software; the computer or the monitor are not part of the submission. Oryx Cloud Imaging neither contacts the patient nor controls any life sustaining devices. Diagnosis is not performed by this software but by doctors and other qualified individuals. A physician, providing ample opportunity for competent human intervention, interprets images and information being displayed and printed. Oryx Cloud Imaging is intended for use on adult and pediatric patients. Oryx Cloud Imaging Software has a Moderate Level of Concern. #### > INDICATIONS FOR USE Oryx Cloud Imaging is an internet-based, image management software (PACS) that enables dental offices to keep records of hard and soft tissue charts in a form of digital images. The system uses a Web-based interface and includes acquisition, editing and storage of digital images. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations. Images can be acquired from standard dental imaging devices, or can be uploaded directly from the user's computer. Images can be edited (e.g., zoomed, contrast, rotated, etc.), as well as exported. The system is designed to provide images for diagnostic use. {5}------------------------------------------------ ## VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVCE The following characteristics were compared between the subject device and the predicate device in order to demonstrate substantial equivalence: | | Oryx Cloud Imaging | Curve Image 2.0 –<br>K112974 | Substantial<br>Equivalence<br>Comparison | |---------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Product Code<br>Regulation<br>Class | LLZ<br>21 C.F.R. 892.2050<br>II | LLZ<br>21 C.F.R. 892.2050<br>II | Same.<br>Same.<br>Same. | | Intended Use | Oryx Cloud Imaging is an internet- based,<br>image management software (PACS) that<br>enables dental offices to keep records of<br>hard and soft tissue charts in a form of<br>digital images. The system uses a Web-<br>based interface and includes acquisition,<br>editing and storage of digital images.<br>Images and data can be stored,<br>communicated, processed and displayed<br>within the system or across computer<br>networks at distributed locations.<br><br>Images can be acquired from standard<br>dental imaging devices, or can be uploaded<br>directly from the user's computer. Images<br>can be edited (e.g., zoomed, contrast,<br>rotated, etc.), as well as exported.<br><br>The system is designed to provide images<br>for diagnostic use. | CURVE IMAGE is an internet- based,<br>image management software (PACS) that<br>enables dental offices to keep records of<br>hard and soft tissue charts in a form of<br>digital images. The system uses a Web-<br>based interface and includes acquisition,<br>editing and storage of digital images.<br>Images and data can be stored,<br>communicated, processed and displayed<br>within the system or across computer<br>networks at distributed locations.<br><br>Images can be acquired from standard<br>dental imaging devices, or can be uploaded<br>directly from the user's computer. Images<br>can be edited ( e.g., zoomed, contrast,<br>rotated, etc.), as well as exported.<br><br>The system is designed to provide images<br>for diagnostic use. | Same. | | Indications for<br>Use | Oryx Cloud Imaging is an internet-based,<br>image management software (PACS) that<br>enables dental offices to keep records of<br>hard and soft tissue charts in a form of<br>digital images. The system uses a Web- | CURVE IMAGE is an internet-based,<br>image management software (PACS) that<br>enables dental offices to keep records of<br>hard and soft tissue charts in a form of<br>digital images. The system uses a Web- | Same. | | | editing and storage of digital images.<br>Images and data can be stored,<br>communicated, processed and displayed<br>within the system or across computer<br>networks at distributed locations. Images<br>can be acquired from standard dental<br>imaging devices, or can be uploaded<br>directly from the user's computer. Images<br>can be edited (e.g., zoomed, contrast,<br>rotated, etc.), as well as exported. The<br>system is designed to provide images for | editing and storage of digital images.<br>Images and data can be stored,<br>communicated, processed and displayed<br>within the system or across computer<br>networks at distributed locations. Images<br>can be acquired from standard dental<br>imaging devices, or can be uploaded<br>directly from the<br>user's computer. Images can be edited (e.g.,<br>zoomed, contrast, rotated, etc.), as well as<br>exported. The system is designed to provide | | | | diagnostic use. | images for diagnostic use. | | | Environment of<br>Use | Dental offices. | Dental offices. | Same. | | Performance<br>Characteristics<br>& Principle of<br>Operation | <b>Basic Technology:</b><br>Web-based, software application<br><br><b>Features:</b><br>Browsing Images by Date and/or Source Viewing an Image Uploading and Image file Acquiring an Image from Web camera Acquiring an Image from a TWAIN Device Acquiring an image from standard dental imaging devices Copying an Image to the Local Computer Saving a Modified Image Annotating an Image Zooming In on an Image Cropping an Image Inverting Colors on an Image Rotating an Image (increments of 90 degrees) | <b>Basic Technology:</b><br>Web-based, software application<br><br><b>Features:</b><br>Browsing Images by Date and/or Source Viewing an Image Uploading an Image File Acquiring an Image from a Web Camera Acquiring an Image from a TWAIN Device Acquiring image from standard dental imaging devices Copying an Image to the Local Computer Saving a Modified Image Annotating an Image Zooming In on an Image Cropping an Image Inverting Colors of an Image | Same. | | | | | | | | Flipping an Image Horizontally or Vertically Increasing/Decreasing Image Brightness Increasing/Decreasing Image Contrast Adjusting Gamma Function Lossless Image Compression Zoom depth: absolute 1x, Fit and Relative | Rotating an Image (increments of 90 degrees) Flipping an Image Horizontally or Vertically Increasing/Decreasing Image Brightness Increasing/Decreasing Image Contrast Adjusting Gamma Function Lossless image compression Zoom dept: absolute 1x, Fit and relative | | | Technical<br>Characteristics | Web-based application and interface Secure data transmission (HTTPS) Database Management and Storage Secure server and Infrastructure | Web-based application and interface Secure data transmission (HTTPS) Database Management and Storage Secure server and Infrastructure | Same. | | Administration | User login Account management Security administration privileges for Administrator, Basic User, Clinical User and Practice Management User | User login Account management Security administration privileges for Administrator, Basic User, Clinical User and Practice Management User | | | Patient<br>Management | Patient profile and data management | Patient profile and data management | Same. | | Scheduling | Appointment managements functions with calendar | Appointment managements functions with calendar | Same. | | Billing | Setting up billing and insurance information | Setting up billing and insurance information | Same. | | Insurance<br>Management | Retrieve Insurance payments | Retrieve Insurance payments | Same. | | Claims<br>Management | Create and manage Insurance claims | Create and manage Insurance claims | Same. | | Dental<br>Charting | Dental Chart layout and treatment plans management | Dental Chart layout and treatment plans management | Same. | | Perio Charting | Perio Chart, perio exam and perio graph management | Perio Chart, perio exam and perio graph management | Same. | | Patient notes<br>and History | Patient text notes, note history | Patient text notes, note history | Same. | | Prescriptions | Prescription notepad writer | Prescription notepad writer | Same. | | Patient<br>Education | Patient education reports, documents, video links and interface | Patient education movies and interface | Same. | | Summary of<br>Non-Clinical<br>Testing | Product Risk Assessment Software Modules Verification Tests Software Validation Test | Product Risk Assessment Software Modules Verification Tests Software Validation Test | Same. | | Differences<br>Between Two<br>Softwares | Features:<br>Spyglass Tool Two-Factor Authentication Calibration to auto-correct orientation<br>UI Differences: Minor differences in UI in terms of terminology. Eg: Uses "Templates" as opposed to "Mounts”, Imaging acquisition and viewing are on two seperate windows. | Features:<br>N/A<br>UI Differences: Minor differences in UI in terms of terminology and flow. Eg: Uses "Mounts" as opposed to "Templates", Imaging acquisition and viewing are from the same window. | Differences highlighted are mostly minor between the two softwares in the form of negligible UI and flow differences and features that improve on the user's experience that are available on Oryx Cloud Imaging, but not on the predicate software. None of the mentioned differences in features and UI changes any of the safety, effectiveness, or indications for use of Oryx Cloud Imaging as compared to the Curve Image predicate. | {6}------------------------------------------------ {7}------------------------------------------------ {8}------------------------------------------------ {9}------------------------------------------------ ## VII. SUMMARY OF NON-CLINICAL TESTING Oryx Dental Software INC, has conducted extensive non-clinical and validation testing of the Oryx Cloud Imaging, as a PACS system that is capable of providing reliable post-processing and display of images for dental applications. All of the different components of the Oryx Cloud Imaging software have been tested to ensure that the system as a whole provides all the capabilities necessary to operate in a manner substantially equivalent to the predicate device. The tests performed included: - . Software Risk Assessment - Software verification and validation testing ● - . Clinical Expert Evaluation ### VIII. CONCLUSIONS Based on the comparison of intended use, indications for use and technological characteristics, the Oryx Cloud Imaging software is substantially equivalent to the predicate device.