(422 days)
No
The summary describes a software device for visualizing medical images as 3D holograms for pre-operative planning. It explicitly states "Mentions AI, DNN, or ML: Not Found" and does not mention any AI/ML-specific features, training data, or performance metrics typically associated with AI/ML devices.
No
The device is described as software for displaying medical images for pre-operative planning and informational purposes, not for treating a disease or condition.
No
The "Intended Use / Indications for Use" and "Device Description" sections explicitly state that the images viewed are "for informational purposes only and not intended for diagnostic use."
Yes
The device description explicitly states "VSI HoloMedicine is a software device". While it mentions accessing the software via hardware like HMDs and PCs, the device itself is defined as the software component for displaying and visualizing medical images.
Based on the provided information, this device is NOT an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The primary intended use is for "displaying digital medical images... to visualize 3D imaging holograms of the patient for pre-operative planning." It explicitly states that images viewed are "for informational purposes only and not intended for diagnostic use."
- IVD Definition: IVDs are defined as devices intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to determine the compatibility with potential recipients, or to monitor therapeutic measures. This device does not perform any in vitro examination of specimens.
- Focus on Visualization and Planning: The device's function is centered around visualizing existing medical images for surgical planning, not on analyzing biological samples or providing diagnostic information based on those samples.
While the device uses medical images (which are often used for diagnosis), its stated purpose and limitations clearly place it outside the scope of an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes
LLZ
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT, Angio CT, MRI, CBCT, PET, and SPECT
Anatomical Site
Not Found
Indicated Patient Age Range
The device is a software which allows for viewing of DICOM data. Therefore, its intended use is without any restrictions regarding patient population.
Intended User / Care Setting
Qualified healthcare professionals including surgeons, radiologists, physicians, and technologists.
The software is intended to be used:
• In operating rooms
• In office environments within hospitals or at any other location with a computer
• For informational only purposes at any location using the head-mounted display (HMD)
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)
Visual quality testing on software using the Microsoft Hololens Headset has been performed.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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).
0
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
1
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
2
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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3
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.
5
| Item
No. | Device
Characteristic | Proposed Device VSI
HoloMedicine® | Primary Predicate Device
SurgicalAR K190764 | Reference Device:
Novarad- OpenSight
K172418 | Comparison
Analysis:
Identical /
Substantially
Equivalent /
Modified /
Cannot Be
Determined /
Not
Applicable | Rationale as
to why
Modification
or
Difference
from
Predicate to
Subject
Device Does
Not Impact
Safety and
Effectiveness
: |
|-------------|--------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1 | 510 (k) Number | K213215 | K190764 | K172418 | N/A | Difference in
510k numbers
do not impact
safety or
efficacy of the
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,
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 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. | SurgicalAR is a software
device for display of medical
images and other healthcare
data. It includes functions for
image
review image manipulation,
basic measurements, and 3D
visualization (MPR
reconstructions and 3D
volume rendering).
Lossy compressed
mammography images and
digitized film screen images
must not be reviewed for
primary image
interpretations.
Mammographic images may
only be interpreted using an
FDA cleared display that
meets technical
specifications reviewed and
accepted by FDA or displays
accepted by the appropriate
regulatory agency for the
country in
which it is used.
Display monitors used for
reading medical images for
diagnostic purposes must
comply with the applicable
regulatory
approvals and quality control
requirements for their use and
maintenance.
SurgicalAR software is | OpenSight is intended to
enable users to display,
manipulate, and evaluate 2D,
3D, and 4D digital images
acquired from
CR, DX, CT, MR, and PT
sources. It is intended to
visualize 3D imaging
holograms of the patient, on
the patient, for pre-
operative localization and
pre-operative planning of
surgical options. OpenSight is
designed for use only with
performance-tested hardware
specified in the user
documentation.
OpenSight is intended to
enable users to segment
previously acquired 3D
datasets, overlay, and register
these 3D
segmented datasets with the
same anatomy of the patient in
order to support pre-operative
analysis.
OpenSight is not intended for
intraoperative use. It is not to
be used for stereotactic
procedures.
OpenSight is intended for use
by trained healthcare | Substantially
Equivalent | N/A |
| | | | healthcare professionals
including, but not restricted to
radiologists,
non-radiology specialists,
physicians and technologists.
When accessing SurgicalAR
software from a wireless
stereoscopic head-mounted
display (HMD) or mobile
device,
images viewed are for
informational purposes only
and not intended for
diagnostic use. | surgeons, radiologists,
chiropractors,
physicians, cardiologists,
technologists, and medical
educators. The device assists
doctors to better understand
anatomy
and pathology of patient. | | |
| 10 | Intended Use
Environment | The software is intended to be
used:
• In operating rooms
• In office environments
within hospitals or at any
other location with a computer
• For informational only | The software is intended to be
used:
• In operating rooms
• In office environments within
hospitals or at any other
location with a computer
• For informational only | Healthcare settings, such as
hospitals and clinics | Identical | N/A |
| | | purposes at any location using
the head-mounted display
(HMD) | purposes at any location using
the head-mounted display
(HMD) | | | |
| 11 | Intended Users | Qualified healthcare
professionals including
surgeons, radiologists,
physicians. | Qualified healthcare
professionals, including but
not restricted to surgeons,
radiologists, nonradiology
specialists, physicians, and
technologists. | Qualified healthcare
professionals, including
surgeons, radiologists,
chiropractors, physicians,
cardiologists, technologists,
and medical educators. | Identical | N/A |
| 12 | Patient Population | The device is a software
which allows for viewing of
DICOM data. Therefore, its
intended use is without any
restrictions regarding patient
population. | The device is software which
allows for viewing of DICOM
data. Therefore, there is no
specific patient population. | OpenSight is a medical image
viewer software. Therefore,
specific information on the
intended disease, condition,
and patient population is not
applicable. | Identical | N/A |
| 13 | Prescription or OTC | Prescription | Prescription | Prescription | Identical | N/A |
| 14 | Main System
components | VSI HoloMedicine® software,
and Headset (Microsoft
HoloLens 2) | SurgicalAR software
Headset((Microsoft HoloLens
2) | Novarad PACS Viewer
software.
OpenSight headset (Microsoft
HoloLens)
Box (23.6 cm width by 18.8
cm height by 29.6 cm long)
with copper BB's | Substantially
Equivalent | N/A |
| 15 | Spatial Mapping | Spatial mapping provides a
representation of real-world
surfaces around the device | Spatial mapping provides a
representation of real-world
surfaces around the device | Spatial mapping provides a
representation of real-world
surfaces around the device | Substantially
Equivalent | N/A |
| 16 | Imaging Modality | CT, Angio CT, MRI, CBCT,
PET CT and SPECT CT | CT/MR | CR, DX, CT, MR, and PET | Substantially
Equivalent | N/A |
| 17 | Data Type Supported | • DICOM
• OBJ
• STL
• JPEG
• PNG
• MP4
• PDF | • DICOM
• Non-DICOM | OpenSight is Radiological
Image Processing System,
which retrieves, stores, and
displays images from DICOM
compliant medical imaging
modalities and/or systems. | Substantially
Equivalent | N/A |
| 18 | Image
View/Manipulation | • Level
• Reset
• Image Rotate
• Manually arranging object
dimensions | • Image Zoom
• Pan
• Window Level
• AutoWindow
• Level
• Reset
• Scout Lines
• Image Rotate
• Image Flip
• Magnify | • Image Zoom
• Level
• Reset
• Image Rotate
• Manually arranging object
dimensions | Substantially
Equivalent | N/A |
| 19 | Communication
between Headset and
computer | Wireless, encrypted | Wireless, encrypted | Wireless, encrypted | Identical | N/A |
| 20 | Data Encryption | • HTTPS
• SSL | • HTTPS
• SSL | 256 encryption | Identical | N/A |
| 21 | Patient Demographic
Display | Only the external ID that is
provided to the patient after
signing the patient agreement
is displayed | Capable of displaying
patient demographic
information | Not Listed | Substantially
Equivalent | N/A |
| 22 | User and Password
Control | Users have own credential
information to access. Users
can be managed via an
internal database and active
directory | Users can be managed via an
internal database, active
directory, or parent
application | Not Listed | Substantially
Equivalent | N/A |
| 23 | Data Security | Stored on server | Stored on server | Stored on server | Identical | N/A |
| 24 | MPR Viewing | This viewing feature enables
the display of CT, MRI,
CBCT, Angio CT, PET CT
and SPECT CT images into
axial, coronal and sagittal
orientations | This viewing feature enables
the display of reformatted CT
and MR images into axial,
coronal and sagittal
orientations | This viewing feature enables
the display of reformatted CR,
DX, CT, MR, and PET
images into axial, coronal and
sagittal orientations | Identical | N/A |
| 25 | 3D Volume
Rendered Viewing | This viewing feature enables
the display of 3D perspective
views of CT, MRI, CBCT,
angio CT, PET CT and
SPECT CT images sets that
have been transformed into
volumes. It also provides
presets to enable users to alter
the visualization parameters
of the 3D views to highlight
features | This viewing feature enables
the display of 3D perspective
views of CT and MR image
sets that have been
transformed into volumes. It
also
provides presets to
enable users to alter
the visualization
parameters
of the 3D views to
highlight features. | This viewing feature enables
the display of 3D perspective
views of CR, DX, CT, MR,
and PET image sets that have
been transformed into
volumes. It also
provides presets to
enable users to alter
the visualization
parameters
of the 3D views to
highlight features. | Identical | N/A |
| 26 | Diagnostic Quality
Medical image
review | Ability to provide diagnostic
quality medical image review
for multi-dimensional digital
images acquired from a
variety of imaging devices | Ability to provide diagnostic
quality medical image review
for multi-dimensional digital
images acquired from a
variety of imaging devices | Ability to provide diagnostic
quality medical image review
for multi-dimensional digital
images acquired from a
variety of imaging devices | Identical | N/A |
| 27 | Surgical planning | Saving and loading
configurations of medical
images, marks, and 3D models
on HMD
Ability to save and load
combinations and arrangement
of objects displayed in the 3D
space on HoloLens for
planning purposes. In case it is
used during surgical
interventions, must not replace
the role of traditional medical
imaging screens. | SurgicalAR is a software
platform to be used by
clinicians for the visualization
of medical images in 3D to
allow for surgical planning
activities. | Pre-operative planning of
surgical option. | Substantially
Equivalent | N/A |
| 28 | Creating
documentation | Ability to create and view
documentation on the
HoloLens device, including
pictures, videos and speech to
text notes. | Not Reported | Not Reported | Cannot be
determined | This
functionality
does not
impact safety
or efficacy of
the product. |
| 29 | View of 2D pictures | Ability to view 2D pictures on
HoloLens. Interact with it by
dragging, scaling and rotation. | Not Reported | The patient's anatomy can be
displayed in 2D mode. The
surgeons can rotate and
magnify the anatomy free of
the patient to get a better
visual picture | Substantially
Equivalent | N/A |
| 30 | Help tips | It has not a feature to educate
users on certain functionality
that may not be obvious to a
new user | It has not a feature to educate
users on certain functionality
that may not be obvious to a
new user. | It has not a feature to educate
users on certain functionality
that may not be obvious to a
new user. | Identical | N/A |
| 31 | Transmission Modes | Via web with Internet
browsers and wireless
VSI HoloMedicine® contains
wireless technology and the
wireless information transfer
is encrypted with 256
encryption for data security | SurgicalAR is not available
for use through internet
browsers | OpenSight contains wireless
technology using Wi-Fi
802.11ac networking
standard. The wireless
technology is used to stream
images in a 2D format from a
Novarad server onto the
OpenSight headset. The
wireless information transfer
is encrypted with 256
encryption for data security | Substantially
Equivalent | N/A |
| 32 | Support for TIF Files | VSI HoloMedicine® cannot
display TIF files. | SurgicalAR can display TIF
files. | OpenSight cannot display TIF
files. | Identical | N/A |
| 33 | Crosshair Navigation
and Synchronization | VSI HoloMedicine® has not
the feature that provides a
facility to synchronize and
scroll through multiple views
at the same time. | This viewing feature provides
a facility to synchronize and
scroll through multiple views
at the same time. | Not Reported | Identical | N/A |
| 33 | HoloNetwork | The HoloLens part of the
system should contain an
interactive hologram of the
Earth that would display
information on locations of
the HoloMedicine® Expert
Group members along with
their title, first name, last
name and country of
residence. | Not Reported | Not Reported | Cannot be
determined | This
functionality
does not
impact safety
or efficacy of
the product. |
Table 1. Substantial Equivalence Discussion
6
7
8
9
10
11
12
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.
13
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.