(52 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on visualization and manipulation of pre-acquired 3D models, not on automated analysis or interpretation.
No.
The device is for visualization, planning, and communication of treatment options, and specifically states it is "not intended to guide surgical instrumentation and it is not to be used for stereotactic procedures or surgical navigation," indicating it does not directly perform or facilitate a therapeutic action.
No
The "Intended Use / Indications for Use" section explicitly states, "Digital models viewed through the HMD are for informational purposes only and not intended for diagnostic use."
No
The device description explicitly states that OrionXR includes and is compatible with the Microsoft Hololens 2 head mounted display, which is a hardware component. The performance studies also include testing related to the optical performance of the headset display, further indicating hardware involvement.
Based on the provided information, no, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the digital models viewed through the HMD are for "informational purposes only and not intended for diagnostic use." IVDs are specifically designed to be used in vitro (outside the body) to examine specimens from the human body to provide information for diagnostic purposes.
- Device Description: The device description focuses on displaying and manipulating pre-acquired 3D models of patient anatomy. This is a visualization and planning tool, not a device that analyzes biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any of the typical components or processes associated with IVD devices.
The device is clearly described as a software device for displaying and manipulating 3D anatomical models for visualization, planning, and communication, which falls under the category of medical image management and processing, but not IVD.
N/A
Intended Use / Indications for Use
OrionXR is a software device for display, manipulation, and evaluation of externally-generated 3D models of patient anatomy through an Augmented Reality Head Mounted Display (HMD) to assist in visualization, planning and communication of treatment options.
OrionXR is indicated for use by qualified healthcare professionals including but not restricted to radiologists, nonradiology specialists, physicians, and technologists.
Digital models viewed through the HMD are for informational purposes only and not intended for diagnostic use. OrionXR is not intended to guide surgical instrumentation and it is not to be used for stereotactic procedures or surgical navigation.
OrionXR software is designed for use with performance-tested hardware specified in the User Manual.
Product codes
LLZ
Device Description
OrionXR includes a server for uploading pre-acquired 3D annotations of patient anatomy and the Microsoft Hololens 2 head mounted display for visualizing the models via a Mixed reality platform. The components of the device include:
- Web Server Users can load 3D annotations of anatomy to OrionXR web server which can then be accessed on the Head mounted display.
- Head Mounted Display OrionXR is compatible with the Microsoft Hololens 2. A user is able to access 3D digital models on the headset. User can manipulate the model in three dimensions of translational and rotational space.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient anatomy
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Qualified healthcare professionals including but not restricted to radiologists, non-radiology specialists, physicians, and technologists.
Not for intraoperative use. The software is intended to be used in the following environments:
• Operating rooms
• Office environment within hospitals or any other clinical setting
• Intensive Care unit, Emergency room, or any other location where medical care is provided
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Software verification and validation were successfully conducted and is summarized below.
Design verification and validation was performed to ensure that output specifications meet design input requirements:
- Dimensional Accuracy of 3D Models
- Optical Performance of Headset Display: Contrast ratio, Resolution, Field of View, Luminance Uniformity, Eyebox, Distortion, Frame Rate
- Qualitative Assessment of 3D Anatomic Models.
Human Factors and Usability enqineering testing was also performed to identify use errors that could result in serious harm to the patient or user, as well as to develop relevant risk mitigation measures. This testing included simulated use replicative of both the intended use and the intended environment of use. No additional use-related risks to the safety or effectiveness of the device were identified.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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).
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". To the right of the seal, there is a blue square with the letters "FDA" in white. Next to the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.
Hoth Intelligence Inc. % Kelliann Payne Partner Hogan Lovells US LLP 1735 Market Street, Suite 2300 PHILADELPHIA, PENNSYLVANIA 19103
September 14, 2023
Re: K232189
Trade/Device Name: OrionXR Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: LLZ Dated: July 24, 2023 Received: July 24, 2023
Dear Kelliann Payne:
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
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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 https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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,
Jessica Lamb. Assistant Director Imaging Software 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) K232189
Device Name
OrionXR
Indications for Use (Describe)
OrionXR is a software device for display, manipulation, and evaluation of externally-generated 3D models of patient anatomy through an Augmented Reality Head Mounted Display (HMD) to assist in visualization, planning and communication of treatment options.
OrionXR is indicated for use by qualified healthcare professionals including but not restricted to radiologists, nonradiology specialists, physicians, and technologists.
Digital models viewed through the HMD are for informational purposes only and not intended for diagnostic use. OrionXR is not intended to guide surgical instrumentation and it is not to be used for stereotactic procedures or surgical navigation.
OrionXR software is designed for use with performance-tested hardware specified in the User Manual.
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) SUMMARY Hoth Intelligence, Inc.'s OrionXR K232189
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared:
Hoth Intelligence Inc. 1700 Market Street Unit 1005, Philadelphia, PA 19103
Contact Person: Kelliann Pavne, Hogan Lovells US LLP Phone: (267) 675-4600 Date Prepared: September 14, 2023
Name of Device: OrionXR
Common or Usual Name: Medical image management and processing system
Classification and Product Code: 21 CFR 892.2050; LLZ
Predicate Device: Xironetic, LLC's IntraOpVSP Software Device (K213128)
Intended Use / Indications for Use
OrionXR is a software device for display, manipulation of externally-generated 3D models of patient anatomy through an Augmented Reality Head Mounted Display (HMD) to assist in visualization, planning and communication of treatment options.
OrionXR is indicated for use by qualified healthcare professionals including but not restricted to radiologists, non-radiology specialists, physicians, and technologists.
Digital models viewed through the HMD are for informational purposes only and not intended for diagnostic use. OrionXR is not intended to guide surgical instrumentation and it is not to be used for stereotactic procedures or surgical navigation.
OrionXR software is designed for use with performance-tested hardware specified in the User Manual.
Technological Characteristics
OrionXR includes a server for uploading pre-acquired 3D annotations of patient anatomy and the Microsoft Hololens 2 head mounted display for visualizing the models via a Mixed reality platform. The components of the device include:
-
- Web Server Users can load 3D annotations of anatomy to OrionXR web server which can then be accessed on the Head mounted display.
-
- Head Mounted Display OrionXR is compatible with the Microsoft Hololens 2. A user is able to access 3D digital models on the headset. User can manipulate the model in three dimensions of translational and rotational space.
Performance Data
Software verification and validation were successfully conducted and is summarized below.
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Design verification and validation was performed to ensure that output specifications meet design input requirements:
- Dimensional Accuracy of 3D Models ●
- Optical Performance of Headset Display: Contrast ratio, Resolution, Field of View, ● Luminance Uniformity, Eyebox, Distortion, Frame Rate
- Qualitative Assessment of 3D Anatomic Models.
Human Factors and Usability enqineering testing was also performed to identify use errors that could result in serious harm to the patient or user, as well as to develop relevant risk mitigation measures. This testing included simulated use replicative of both the intended use and the intended environment of use. No additional use-related risks to the safety or effectiveness of the device were identified.
Substantial Equivalence
The OrionXR is as safe and effective as the IntraOpVSP (K213128). The OrionXR has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate devices. The minor technological differences between the OrionXR and its predicate device raise no new issues of safety or effectiveness. Performance data demonstrate that the OrionXR is as safe and effective as IntraOpVSP (K213128). Thus, the OrionXR is substantially equivalent.
| Subject Device | Predicate Device | |
|---|---|---|
| OrionXR | IntraOpVSP (K213128) | |
| Indication of Use | OrionXR is a software device for | |
| display, manipulation, and | ||
| evaluation of externally-generated | ||
| 3D models of patient anatomy | ||
| through an Augmented Reality | ||
| Head Mounted Display (HMD) to | ||
| assist in visualization, planning | ||
| and communication of treatment | ||
| options. | IntraOpVSP is a software device | |
| that is indicated for use with an | ||
| augmented reality head-mounted | ||
| display which allows for | ||
| visualization and orientation of | ||
| 3D digital models of selected | ||
| structures of a patient's anatomy. | ||
| OrionXR is indicated for use by | ||
| qualified healthcare professionals | ||
| including but not restricted to | ||
| radiologists, non-radiology | ||
| specialists, physicians, and | ||
| technologists. | IntraOpVSP is intended to | |
| supplement conventional Virtual | ||
| Surgical Planning (VSP) by | ||
| facilitating perception of the | ||
| shape and scale of a patient's | ||
| anatomical targets for use in | ||
| preoperative planning and heads- | ||
| up 3D visualization during | ||
| surgery. | ||
| Digital models viewed through the | ||
| HMD are for informational | ||
| purposes only and not intended | ||
| for diagnostic use. OrionXR is not | ||
| intended to guide surgical | ||
| instrumentation and it is not to be | ||
| used for stereotactic procedures | ||
| or surgical navigation. | IntraOpVSP is not intended to | |
| provide diagnosis or to guide | ||
| surgical instrumentation. It is not | ||
| to be used for stereotactic | ||
| procedures or surgical | ||
| navigation. | ||
| IntraOpVSP is intended for use | ||
| by surgeons who have been | ||
| OrionXR software is designed for | ||
| use with performance-tested | ||
| hardware specified in the User | ||
| Manual. | trained to operate IntraOpVSP. | |
| IntraOpVSP software is designed | ||
| for use with performance-tested | ||
| hardware specified in the User | ||
| Manual. | ||
| Intended Use | ||
| Environment | Not for intraoperative use. The | |
| software is intended to be used in | ||
| the following environments: | ||
| • Operating rooms | ||
| • Office environment within | ||
| hospitals or any other | ||
| clinical setting | ||
| • Intensive Care unit, | ||
| Emergency room, or any | ||
| other location where | ||
| medical care is provided | Not for intraoperative use. For | |
| use in healthcare settings, such | ||
| as hospitals, clinics and | ||
| operating rooms | ||
| Intended users | Qualified healthcare professionals | |
| including but not restricted to | ||
| radiologists, non-radiology | ||
| specialists, physicians, and | ||
| technologists. | IntraOpVSP is intended for use | |
| by surgeons who have been | ||
| trained to operate IntraOpVSP. | ||
| System | ||
| Components | • Microsoft Hololens 2 Headset | |
| with near eye see-through display | ||
| • OrionXR Software application | • Microsoft Hololens 2 Headset | |
| with near eye see-through | ||
| display | ||
| • Software application | ||
| Display Frame | ||
| Rate | 60 fps | 60 fps |
| Medical Device | ||
| Interfaces | Pre-operative planning | |
| workstation OrionXR server | Pre-operative planning | |
| workstation Virtual Surgery | ||
| Planning server | ||
| Communication | ||
| between | ||
| Headset and | ||
| Computer | Wireless—WiFi communication | |
| with OrionXR server, encrypted | Wireless, encrypted | |
| HMD Power | ||
| Source | Lithium Batteries + 18W charger | Lithium Batteries + 18W charger |
| Biocompatibility | N/A | N/A |
| Sterilization | Sterilization not required | Sterilization not required |
| Data Type | ||
| Supported | • STL | |
| • OBJ | • STL | |
| • OBJ |
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Conclusions
OrionXR is substantially equivalent to the predicate device, IntraOpVSP. OrionXR has the same intended use, similar indications for use, technological characteristics and principles of operation as its predicate device. Testing demonstrates that OrionXR is capable of accurately uploading and visualizing 3D anatomic models on a HMD. Thus, OrionXR does not raise different questions of safety and effectiveness and is substantially equivalent to the predicate device.