VSI HoloMedicine
Device Facts
| Record ID | K213215 |
|---|---|
| Device Name | VSI HoloMedicine |
| Applicant | Apoqlar GmbH |
| Product Code | LLZ · Radiology |
| Decision Date | Nov 25, 2022 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.2050 |
| Device Class | Class 2 |
| Attributes | Software as a Medical Device |
Indications for Use
VSI HoloMedicine® is a software device for displaying digital medical images acquired from CT, Angio CT, MRI, CBCT, PET, and SPECT sources. It is intended to visualize 3D imaging holograms of the patient for pre-operative planning outside and/or inside the surgical room. When accessing VSI HoloMedicine® from a wireless head-mounted display (HMD) or PC monitor, images viewed are for informational purposes only and not intended for diagnostic use. VSI HoloMedicine® is indicated for use by qualified healthcare professionals including surgeons, radiologists, physicians, and technologists.
Device Story
VSI HoloMedicine is a software-based medical image management and processing system. It ingests digital medical images (CT, Angio CT, MRI, CBCT, PET, SPECT) and transforms them into 3D holographic visualizations. The system operates on a Microsoft HoloLens 2 head-mounted display (HMD) or PC monitor. Used by surgeons, radiologists, and physicians for pre-operative planning in clinical or surgical environments. The software provides tools for image manipulation (rotation, arrangement, level adjustment) and MPR/3D volume rendering. It supports spatial mapping to represent real-world surfaces. Output is viewed by the clinician to assist in understanding patient anatomy and pathology. The device does not provide diagnostic-grade interpretations; it serves as an informational tool for surgical planning. Data transmission between the headset and computer is wireless and encrypted (256-bit).
Clinical Evidence
Bench testing only. Performance data included visual quality testing on software using the Microsoft HoloLens headset and software verification testing to ensure intended performance under specified use conditions.
Technological Characteristics
Software-based medical image management system. Operates on Microsoft HoloLens 2 HMD or PC. Supports DICOM, OBJ, STL, JPEG, PNG, MP4, PDF. Features include MPR, 3D volume rendering, and spatial mapping. Connectivity via encrypted wireless (256-bit). Complies with EN ISO 13485, EN ISO 14971, EN 62304, IEC 62366-1, IEC 82304-1, and ISO/TR 20416.
Indications for Use
Indicated for qualified healthcare professionals (surgeons, radiologists, physicians, technologists) for pre-operative planning using 3D imaging holograms derived from CT, Angio CT, MRI, CBCT, PET, and SPECT data. Intended for use inside or outside the surgical room. Images are for informational purposes only, not for diagnostic use.
Regulatory Classification
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.
Special Controls
*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).
Predicate Devices
- SurgicalAR (K190764)
Reference Devices
- Novarad-OpenSight (K172418)
Submission Summary (Full Text)
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Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services - USA logo. The logo on the right is the FDA U.S. Food & Drug Administration logo. The FDA logo is in blue.
ApoQlar GmbH % Liliana Duarte Chief Regulatory Affairs Officer c/o the-labs.space, Raboisen 32,20095 HAMBURG, GERMANY
November 25, 2022
Re: K213215
Trade/Device Name: VSI HoloMedicine® Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: LLZ Dated: October 18, 2022 Received: October 19, 2022
Dear Liliana Duarte:
We have reviewed vour 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
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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 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,
Jessica Lamb
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) K213215
Device Name VSI HoloMedicine®
### Indications for Use (Describe)
VSI HoloMedicine® is a software device for displaying digital medical images acquired from CT, Angio CT, MRI, CBCT, PET, and SPECT sources. It is intended to visualize 3D imaging holograms of the patient for pre-operative planning outside and/or inside the surgical room.
When accessing VSI HoloMedicine® from a wireless head-mounted display (HMD) or PC monitor, images viewed are for informational purposes only and not intended for diagnostic use. VSI HoloMedicine® is indicated for use by qualified healthcare professionals including surgeons, radiologists, physicians, and technologists.
| 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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#### 5.1 General Information
### Primary Submission Contact
Liliana Duarte
Chief Regulatory Affairs Officer apoQlar GmbH c/o the-labs.space, Raboisen 32,20095 Hamburg, Germany
Mobile: +49 157 337 455 71
Phone: +49 40 241 927 79
Email: liliana.duarte@apoqlar.com
### Manufacturer / Submitter
Liliana Duarte
Chief Regulatory Affairs Officer apoQlar GmbH c/o the-labs.space, Raboisen 32,20095 Hamburg, Germany
Mobile: +49 157 337 455 71
Phone: +49 40 241 927 79 Email: liliana.duarte@apoqlar.com
#### 5.2 Regulatory Information
| Subject Device Name | VSI HoloMedicine® |
|-----------------------|------------------------------------------------|
| Classification Names | Medical Image Management and Processing System |
| Device Classification | II |
| Common Name | VSI HoloMedicine® |
| FDA Product Code | LLZ |
| CFR References | 892.2050 |
| Review Panel | Radiology |
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#### 5.3 Identification of Predicate Device
ApoQlar regards the VSI HoloMedicine® to be substantially equivalent to the predicate K190764 the Medivis-SurgicalAR. A reference device is also used for comparison, K172418 Novarad-OpenSight.
#### 5.4 Subject Device Description
VSI HoloMedicine is a software device for displaying digital medical images acquired from CT, Angio CT, MRI, CBCT, PET, and SPECT sources. It is intended to visualize 3D imaging holograms of the patient for pre-operative planning outside and/or inside the surgical room.
When accessing VSI HoloMedicine from a wireless head-mounted display (HMD) or PC monitor, images viewed are for informational purposes only and not intended for diagnostic use. VSI HoloMedicine is indicated for use by qualified healthcare professionals including surgeons, radiologists, physicians, and technologists.
## Indications for Use
VSI HoloMedicine is a software device for displaying digital medical images acquired from CT, Angio CT, MRI, CBCT, PET, and SPECT sources. It is intended to visualize 3D imaging holograms of the patient for pre-operative planning outside and/or inside the surgical room.
When accessing VSI HoloMedicine from a wireless head-mounted display (HMD) or PC monitor, images viewed are for informational purposes only and not intended for diagnostic use. VSI HoloMedicine is indicated for use by qualified healthcare professionals including surgeons, radiologists, physicians, and technologists.
#### ર્સ્ડ Substantial Equivalence Discussion
Any modifications between the predicate device and the subject device are provided in while the table below. The review of the indications for use and comparison characteristics provided in Table 1 demonstrate that VSI HoloMedicine® is substantially equivalent to the predicate device. A reference device was also included.
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| Item<br>No. | Device<br>Characteristic | Proposed Device VSI<br>HoloMedicine® | Primary Predicate Device<br>SurgicalAR K190764 | Reference Device:<br>Novarad- OpenSight<br>K172418 | Comparison<br>Analysis:<br>Identical /<br>Substantially<br>Equivalent /<br>Modified /<br>Cannot Be<br>Determined /<br>Not<br>Applicable | Rationale as<br>to why<br>Modification<br>or<br>Difference<br>from<br>Predicate to<br>Subject<br>Device Does<br>Not Impact<br>Safety and<br>Effectiveness<br>: |
|-------------|--------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1 | 510 (k) Number | K213215 | K190764 | K172418 | N/A | Difference in<br>510k numbers<br>do not impact<br>safety or<br>efficacy of the<br>product. |
| 2 | Device Name, Model | VSI HoloMedicine® | SurgicalAR | OpenSight | N/A | N/A |
| 3 | Manufacturer | apoQlar GmbH | Medivis | Novarad | N/A | N/A |
| 4 | CFR Reference | 21 CFR 892.2050 | 21 CFR 892.2050 | 21 CFR 892.2050 | Identical | N/A |
| 5 | FDA Review Panel | Radiology | Radiology | Radiology | Identical | N/A |
| 6 | FDA Device Name | System, Image Processing,<br>Radiological | System, Image Processing,<br>Radiological | System, Image Processing,<br>Radiological | Identical | N/A |
| 7 | FDA Product Code | LLZ | LLZ | LLZ | Identical | N/A |
| 8 | Class | II | II | II | Identical | N/A |
| 9 | Indications for use | VSI HoloMedicine is a<br>software device for<br>displaying digital medical<br>images acquired from CT,<br>Angio CT, MRI, CBCT,<br>PET, and SPECT sources.<br>It is intended to visualize<br>3D imaging holograms of<br>the patient for pre-operative<br>planning outside and/or<br>inside the surgical room.<br><br>When accessing VSI<br>HoloMedicine from a<br>wireless head-mounted<br>display (HMD) or PC<br>monitor, images viewed are<br>for informational purposes<br>only and not intended for<br>diagnostic use. VSI<br>HoloMedicine is indicated<br>for use by qualified<br>healthcare professionals<br>including surgeons,<br>radiologists, physicians,<br>and technologists. | SurgicalAR is a software<br>device for display of medical<br>images and other healthcare<br>data. It includes functions for<br>image<br>review image manipulation,<br>basic measurements, and 3D<br>visualization (MPR<br>reconstructions and 3D<br>volume rendering).<br><br>Lossy compressed<br>mammography images and<br>digitized film screen images<br>must not be reviewed for<br>primary image<br>interpretations.<br>Mammographic images may<br>only be interpreted using an<br>FDA cleared display that<br>meets technical<br>specifications reviewed and<br>accepted by FDA or displays<br>accepted by the appropriate<br>regulatory agency for the<br>country in<br>which it is used.<br>Display monitors used for<br>reading medical images for<br>diagnostic purposes must<br>comply with the applicable<br>regulatory<br>approvals and quality control<br>requirements for their use and<br>maintenance.<br>SurgicalAR software is | OpenSight is intended to<br>enable users to display,<br>manipulate, and evaluate 2D,<br>3D, and 4D digital images<br>acquired from<br>CR, DX, CT, MR, and PT<br>sources. It is intended to<br>visualize 3D imaging<br>holograms of the patient, on<br>the patient, for pre-<br>operative localization and<br>pre-operative planning of<br>surgical options. OpenSight is<br>designed for use only with<br>performance-tested hardware<br>specified in the user<br>documentation.<br><br>OpenSight is intended to<br>enable users to segment<br>previously acquired 3D<br>datasets, overlay, and register<br>these 3D<br>segmented datasets with the<br>same anatomy of the patient in<br>order to support pre-operative<br>analysis.<br><br>OpenSight is not intended for<br>intraoperative use. It is not to<br>be used for stereotactic<br>procedures.<br><br>OpenSight is intended for use<br>by trained healthcare | Substantially<br>Equivalent | N/A |
| | | | healthcare professionals<br>including, but not restricted to<br>radiologists,<br>non-radiology specialists,<br>physicians and technologists.<br>When accessing SurgicalAR<br>software from a wireless<br>stereoscopic head-mounted<br>display (HMD) or mobile<br>device,<br>images viewed are for<br>informational purposes only<br>and not intended for<br>diagnostic use. | surgeons, radiologists,<br>chiropractors,<br>physicians, cardiologists,<br>technologists, and medical<br>educators. The device assists<br>doctors to better understand<br>anatomy<br>and pathology of patient. | | |
| 10 | Intended Use<br>Environment | The software is intended to be<br>used:<br>• In operating rooms<br>• In office environments<br>within hospitals or at any<br>other location with a computer<br>• For informational only | The software is intended to be<br>used:<br>• In operating rooms<br>• In office environments within<br>hospitals or at any other<br>location with a computer<br>• For informational only | Healthcare settings, such as<br>hospitals and clinics | Identical | N/A |
| | | purposes at any location using<br>the head-mounted display<br>(HMD) | purposes at any location using<br>the head-mounted display<br>(HMD) | | | |
| 11 | Intended Users | Qualified healthcare<br>professionals including<br>surgeons, radiologists,<br>physicians. | Qualified healthcare<br>professionals, including but<br>not restricted to surgeons,<br>radiologists, nonradiology<br>specialists, physicians, and<br>technologists. | Qualified healthcare<br>professionals, including<br>surgeons, radiologists,<br>chiropractors, physicians,<br>cardiologists, technologists,<br>and medical educators. | Identical | N/A |
| 12 | Patient Population | The device is a software<br>which allows for viewing of<br>DICOM data. Therefore, its<br>intended use is without any<br>restrictions regarding patient<br>population. | The device is software which<br>allows for viewing of DICOM<br>data. Therefore, there is no<br>specific patient population. | OpenSight is a medical image<br>viewer software. Therefore,<br>specific information on the<br>intended disease, condition,<br>and patient population is not<br>applicable. | Identical | N/A |
| 13 | Prescription or OTC | Prescription | Prescription | Prescription | Identical | N/A |
| 14 | Main System<br>components | VSI HoloMedicine® software,<br>and Headset (Microsoft<br>HoloLens 2) | SurgicalAR software<br>Headset((Microsoft HoloLens<br>2) | Novarad PACS Viewer<br>software.<br>OpenSight headset (Microsoft<br>HoloLens)<br>Box (23.6 cm width by 18.8<br>cm height by 29.6 cm long)<br>with copper BB's | Substantially<br>Equivalent | N/A |
| 15 | Spatial Mapping | Spatial mapping provides a<br>representation of real-world<br>surfaces around the device | Spatial mapping provides a<br>representation of real-world<br>surfaces around the device | Spatial mapping provides a<br>representation of real-world<br>surfaces around the device | Substantially<br>Equivalent | N/A |
| 16 | Imaging Modality | CT, Angio CT, MRI, CBCT,<br>PET CT and SPECT CT | CT/MR | CR, DX, CT, MR, and PET | Substantially<br>Equivalent | N/A |
| 17 | Data Type Supported | • DICOM<br>• OBJ<br>• STL<br>• JPEG<br>• PNG<br>• MP4<br>• PDF | • DICOM<br>• Non-DICOM | OpenSight is Radiological<br>Image Processing System,<br>which retrieves, stores, and<br>displays images from DICOM<br>compliant medical imaging<br>modalities and/or systems. | Substantially<br>Equivalent | N/A |
| 18 | Image<br>View/Manipulation | • Level<br>• Reset<br>• Image Rotate<br>• Manually arranging object<br>dimensions | • Image Zoom<br>• Pan<br>• Window Level<br>• AutoWindow<br>• Level<br>• Reset<br>• Scout Lines<br>• Image Rotate<br>• Image Flip<br>• Magnify | • Image Zoom<br>• Level<br>• Reset<br>• Image Rotate<br>• Manually arranging object<br>dimensions | Substantially<br>Equivalent | N/A |
| 19 | Communication<br>between Headset and<br>computer | Wireless, encrypted | Wireless, encrypted | Wireless, encrypted | Identical | N/A |
| 20 | Data Encryption | • HTTPS<br>• SSL | • HTTPS<br>• SSL | 256 encryption | Identical | N/A |
| 21 | Patient Demographic<br>Display | Only the external ID that is<br>provided to the patient after<br>signing the patient agreement<br>is displayed | Capable of displaying<br>patient demographic<br>information | Not Listed…
