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 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.

AI/ML Overview

The provided text does not contain detailed performance data or acceptance criteria for the VSI HoloMedicine® device beyond a general statement that "Visual quality testing on software using the Microsoft Hololens Headset has been performed." and that "software verification demonstrate that the VSI Holomedicine should perform as intended in the specified use conditions."

The document focuses on establishing substantial equivalence to a predicate device (Medivis-SurgicalAR K190764) and a reference device (Novarad-OpenSight K172418) based on their design, indications for use, and technology. It lists applicable standards, but does not provide the results of specific performance tests against measurable acceptance criteria.

Therefore, I cannot fulfill your request for:

A table of acceptance criteria and the reported device performance: This information is not present in the provided text.
Sample sizes used for the test set and the data provenance: This information is not present.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not present.
Adjudication method for the test set: This information is not present.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: This information is not present.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: This information is not present.
The type of ground truth used: This information is not present.
The sample size for the training set: This information is not present.
How the ground truth for the training set was established: This information is not present.

The document primarily provides regulatory information for a 510(k) submission, confirming the device's substantial equivalence and general safety/effectiveness, rather than detailed performance study results.

Summary

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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)

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

Indications for Use

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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ItemNo.	DeviceCharacteristic	Proposed Device VSIHoloMedicine®	Primary Predicate DeviceSurgicalAR K190764	Reference Device:Novarad- OpenSightK172418	ComparisonAnalysis:Identical /SubstantiallyEquivalent /Modified /Cannot BeDetermined /NotApplicable	Rationale asto whyModificationorDifferencefromPredicate toSubjectDevice DoesNot ImpactSafety andEffectiveness:
1	510 (k) Number	K213215	K190764	K172418	N/A	Difference in510k numbersdo not impactsafety orefficacy of theproduct.
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,Radiological	System, Image Processing,Radiological	System, Image Processing,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 asoftware device fordisplaying digital medicalimages acquired from CT,Angio CT, MRI, CBCT,PET, and SPECT sources.It is intended to visualize3D imaging holograms ofthe patient for pre-operativeplanning outside and/orinside the surgical room.When accessing VSIHoloMedicine from awireless head-mounteddisplay (HMD) or PCmonitor, images viewed arefor informational purposesonly and not intended fordiagnostic use. VSIHoloMedicine is indicatedfor use by qualifiedhealthcare professionalsincluding surgeons,radiologists, physicians,and technologists.	SurgicalAR is a softwaredevice for display of medicalimages and other healthcaredata. It includes functions forimagereview image manipulation,basic measurements, and 3Dvisualization (MPRreconstructions and 3Dvolume rendering).Lossy compressedmammography images anddigitized film screen imagesmust not be reviewed forprimary imageinterpretations.Mammographic images mayonly be interpreted using anFDA cleared display thatmeets technicalspecifications reviewed andaccepted by FDA or displaysaccepted by the appropriateregulatory agency for thecountry inwhich it is used.Display monitors used forreading medical images fordiagnostic purposes mustcomply with the applicableregulatoryapprovals and quality controlrequirements for their use andmaintenance.SurgicalAR software is	OpenSight is intended toenable users to display,manipulate, and evaluate 2D,3D, and 4D digital imagesacquired fromCR, DX, CT, MR, and PTsources. It is intended tovisualize 3D imagingholograms of the patient, onthe patient, for pre-operative localization andpre-operative planning ofsurgical options. OpenSight isdesigned for use only withperformance-tested hardwarespecified in the userdocumentation.OpenSight is intended toenable users to segmentpreviously acquired 3Ddatasets, overlay, and registerthese 3Dsegmented datasets with thesame anatomy of the patient inorder to support pre-operativeanalysis.OpenSight is not intended forintraoperative use. It is not tobe used for stereotacticprocedures.OpenSight is intended for useby trained healthcare	SubstantiallyEquivalent	N/A
			healthcare professionalsincluding, but not restricted toradiologists,non-radiology specialists,physicians and technologists.When accessing SurgicalARsoftware from a wirelessstereoscopic head-mounteddisplay (HMD) or mobiledevice,images viewed are forinformational purposes onlyand not intended fordiagnostic use.	surgeons, radiologists,chiropractors,physicians, cardiologists,technologists, and medicaleducators. The device assistsdoctors to better understandanatomyand pathology of patient.
10	Intended UseEnvironment	The software is intended to beused:• In operating rooms• In office environmentswithin hospitals or at anyother location with a computer• For informational only	The software is intended to beused:• In operating rooms• In office environments withinhospitals or at any otherlocation with a computer• For informational only	Healthcare settings, such ashospitals and clinics	Identical	N/A
		purposes at any location usingthe head-mounted display(HMD)	purposes at any location usingthe head-mounted display(HMD)
11	Intended Users	Qualified healthcareprofessionals includingsurgeons, radiologists,physicians.	Qualified healthcareprofessionals, including butnot restricted to surgeons,radiologists, nonradiologyspecialists, physicians, andtechnologists.	Qualified healthcareprofessionals, includingsurgeons, radiologists,chiropractors, physicians,cardiologists, technologists,and medical educators.	Identical	N/A
12	Patient Population	The device is a softwarewhich allows for viewing ofDICOM data. Therefore, itsintended use is without anyrestrictions regarding patientpopulation.	The device is software whichallows for viewing of DICOMdata. Therefore, there is nospecific patient population.	OpenSight is a medical imageviewer software. Therefore,specific information on theintended disease, condition,and patient population is notapplicable.	Identical	N/A
13	Prescription or OTC	Prescription	Prescription	Prescription	Identical	N/A
14	Main Systemcomponents	VSI HoloMedicine® software,and Headset (MicrosoftHoloLens 2)	SurgicalAR softwareHeadset((Microsoft HoloLens2)	Novarad PACS Viewersoftware.OpenSight headset (MicrosoftHoloLens)Box (23.6 cm width by 18.8cm height by 29.6 cm long)with copper BB's	SubstantiallyEquivalent	N/A
15	Spatial Mapping	Spatial mapping provides arepresentation of real-worldsurfaces around the device	Spatial mapping provides arepresentation of real-worldsurfaces around the device	Spatial mapping provides arepresentation of real-worldsurfaces around the device	SubstantiallyEquivalent	N/A
16	Imaging Modality	CT, Angio CT, MRI, CBCT,PET CT and SPECT CT	CT/MR	CR, DX, CT, MR, and PET	SubstantiallyEquivalent	N/A
17	Data Type Supported	• DICOM• OBJ• STL• JPEG• PNG• MP4• PDF	• DICOM• Non-DICOM	OpenSight is RadiologicalImage Processing System,which retrieves, stores, anddisplays images from DICOMcompliant medical imagingmodalities and/or systems.	SubstantiallyEquivalent	N/A
18	ImageView/Manipulation	• Level• Reset• Image Rotate• Manually arranging objectdimensions	• Image Zoom• Pan• Window Level• AutoWindow• Level• Reset• Scout Lines• Image Rotate• Image Flip• Magnify	• Image Zoom• Level• Reset• Image Rotate• Manually arranging objectdimensions	SubstantiallyEquivalent	N/A
19	Communicationbetween Headset andcomputer	Wireless, encrypted	Wireless, encrypted	Wireless, encrypted	Identical	N/A
20	Data Encryption	• HTTPS• SSL	• HTTPS• SSL	256 encryption	Identical	N/A
21	Patient DemographicDisplay	Only the external ID that isprovided to the patient aftersigning the patient agreementis displayed	Capable of displayingpatient demographicinformation	Not Listed	SubstantiallyEquivalent	N/A
22	User and PasswordControl	Users have own credentialinformation to access. Userscan be managed via aninternal database and activedirectory	Users can be managed via aninternal database, activedirectory, or parentapplication	Not Listed	SubstantiallyEquivalent	N/A
23	Data Security	Stored on server	Stored on server	Stored on server	Identical	N/A
24	MPR Viewing	This viewing feature enablesthe display of CT, MRI,CBCT, Angio CT, PET CTand SPECT CT images intoaxial, coronal and sagittalorientations	This viewing feature enablesthe display of reformatted CTand MR images into axial,coronal and sagittalorientations	This viewing feature enablesthe display of reformatted CR,DX, CT, MR, and PETimages into axial, coronal andsagittal orientations	Identical	N/A
25	3D VolumeRendered Viewing	This viewing feature enablesthe display of 3D perspectiveviews of CT, MRI, CBCT,angio CT, PET CT andSPECT CT images sets thathave been transformed intovolumes. It also providespresets to enable users to alterthe visualization parametersof the 3D views to highlightfeatures	This viewing feature enablesthe display of 3D perspectiveviews of CT and MR imagesets that have beentransformed into volumes. Italsoprovides presets toenable users to alterthe visualizationparametersof the 3D views tohighlight features.	This viewing feature enablesthe display of 3D perspectiveviews of CR, DX, CT, MR,and PET image sets that havebeen transformed intovolumes. It alsoprovides presets toenable users to alterthe visualizationparametersof the 3D views tohighlight features.	Identical	N/A
26	Diagnostic QualityMedical imagereview	Ability to provide diagnosticquality medical image reviewfor multi-dimensional digitalimages acquired from avariety of imaging devices	Ability to provide diagnosticquality medical image reviewfor multi-dimensional digitalimages acquired from avariety of imaging devices	Ability to provide diagnosticquality medical image reviewfor multi-dimensional digitalimages acquired from avariety of imaging devices	Identical	N/A
27	Surgical planning	Saving and loadingconfigurations of medicalimages, marks, and 3D modelson HMDAbility to save and loadcombinations and arrangementof objects displayed in the 3Dspace on HoloLens forplanning purposes. In case it isused during surgicalinterventions, must not replacethe role of traditional medicalimaging screens.	SurgicalAR is a softwareplatform to be used byclinicians for the visualizationof medical images in 3D toallow for surgical planningactivities.	Pre-operative planning ofsurgical option.	SubstantiallyEquivalent	N/A
28	Creatingdocumentation	Ability to create and viewdocumentation on theHoloLens device, includingpictures, videos and speech totext notes.	Not Reported	Not Reported	Cannot bedetermined	Thisfunctionalitydoes notimpact safetyor efficacy ofthe product.
29	View of 2D pictures	Ability to view 2D pictures onHoloLens. Interact with it bydragging, scaling and rotation.	Not Reported	The patient's anatomy can bedisplayed in 2D mode. Thesurgeons can rotate andmagnify the anatomy free ofthe patient to get a bettervisual picture	SubstantiallyEquivalent	N/A
30	Help tips	It has not a feature to educateusers on certain functionalitythat may not be obvious to anew user	It has not a feature to educateusers on certain functionalitythat may not be obvious to anew user.	It has not a feature to educateusers on certain functionalitythat may not be obvious to anew user.	Identical	N/A
31	Transmission Modes	Via web with Internetbrowsers and wirelessVSI HoloMedicine® containswireless technology and thewireless information transferis encrypted with 256encryption for data security	SurgicalAR is not availablefor use through internetbrowsers	OpenSight contains wirelesstechnology using Wi-Fi802.11ac networkingstandard. The wirelesstechnology is used to streamimages in a 2D format from aNovarad server onto theOpenSight headset. Thewireless information transferis encrypted with 256encryption for data security	SubstantiallyEquivalent	N/A
32	Support for TIF Files	VSI HoloMedicine® cannotdisplay TIF files.	SurgicalAR can display TIFfiles.	OpenSight cannot display TIFfiles.	Identical	N/A
33	Crosshair Navigationand Synchronization	VSI HoloMedicine® has notthe feature that provides afacility to synchronize andscroll through multiple viewsat the same time.	This viewing feature providesa facility to synchronize andscroll through multiple viewsat the same time.	Not Reported	Identical	N/A
33	HoloNetwork	The HoloLens part of thesystem should contain aninteractive hologram of theEarth that would displayinformation on locations ofthe HoloMedicine® ExpertGroup members along withtheir title, first name, lastname and country ofresidence.	Not Reported	Not Reported	Cannot bedetermined	Thisfunctionalitydoes notimpact safetyor efficacy ofthe product.

Table 1. Substantial Equivalence Discussion

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The modifications between the VSI HoloMedivis- Surgical AR predicate are examined in detail above. ApoQlar determined that each difference between the devices resulted in no impact to the performance, safety, or efficacy of VSI HoloMedicine® when onlyins-SurgicalAR.

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5.6 Application of Standards

The following standards are applicable to the VSI HoloMedicine®.

Table 2: Applied Standards

STANDARD

EN ISO 13485:2016/A11:2021 Medical devices - Quality management systems

EN ISO 14971:2019/A11:2021 Medical devices - Application of risk management to medical devices

EN 62304:2006+A1:2015 Medical Device software- Software Life-Cycle Processes

IEC 62366-1:2015/AMD 1:2020 Medical devices - Part 1: Application of usability engineering to medical devices -Amendment 1

IEC 82304-1:2016 Health software - Part 1: General requirements for product safety

ISO/TR 20416:2020 Medical devices - Post market surveillance for manufacturers

5.7 Performance Data

Visual quality testing on software using the Microsoft Hololens Headset has been performed.

5.8 Conclusion

The subject device VSI HoloMedicine® is substantially equivalent to the predicate device. VSI HoloMedicine® shares a substantially equivalent design, indications for use and technology (i.e. features, materials, and principles of operation) with the predicate device and no new elements pertaining to change in safety or effectiveness have been identified.

The non-clinical and clinical data demonstrate that VSI HoloMedicine is as safe, as effective, and performs as well as the legally marketed device predicate. Moreover, software verification demonstrate that the VSI Holomedicine should perform as intended in the specified use conditions.

Regulation Number and Section

§ 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).