K Number

Device Name

SurgicalAR

Manufacturer

MEDIVIS, Inc.

Date Cleared

2019-05-13

(49 days)

Product Code

LLZ

Regulation Number

892.2050

Intended Use

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 visualizations 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 indicated for use by qualified 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.

Device Description

SurgicalAR is a software platform to be used by clinicians for the visualization of medical images in 3D to allow for surgical planning activities. The device takes pre-acquired 2D medical images and reconstructs 3D models that a clinician can then view on a stereoscopic, holographic display. The software application is used to: • Load patient CT/MR DICOM data • View DICOM data using a traditional computer monitor or in Augmented Reality (AR) using a head-mounted display, HMD.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K163232

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes basic image processing, 3D reconstruction, and visualization software. There is no mention of AI, ML, or related concepts like training/test sets, performance metrics associated with AI/ML, or specific AI/ML algorithms.

Therapeutic

No.
The device is a software for visualization and manipulation of medical images for surgical planning, not for therapy delivery or direct treatment of a disease or condition.

Diagnostic

The device description explicitly states that "images viewed are for informational purposes only and not intended for diagnostic use" when accessed from a wireless stereoscopic head-mounted display (HMD) or mobile device. While it handles medical images and can be used in settings like operating rooms for visualization and surgical planning, it is not primarily advertised or indicated for diagnostic interpretation.

SaMD (Software as a Medical Device)

Yes

The device description explicitly states "SurgicalAR is a software platform" and "The software application is used to...". The intended use also refers to it as a "software device". While it utilizes external hardware (computer monitors, HMDs), the device itself, as described, is the software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
SurgicalAR's Function: SurgicalAR is a software device that processes and displays pre-acquired medical images (CT/MR DICOM data) for visualization and surgical planning. It does not involve the analysis of biological samples from the patient.
Intended Use: The intended use is for display of medical images and other healthcare data for review, manipulation, visualization, and surgical planning. While it supports diagnostic review in some contexts (with appropriate displays), its primary function is image processing and visualization, not the analysis of in vitro samples.
Device Description: The description explicitly states it takes "pre-acquired 2D medical images" and reconstructs 3D models for viewing. This confirms it works with existing image data, not biological samples.

Therefore, SurgicalAR falls under the category of medical image processing and visualization software, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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 indicated for use by qualified 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.

Product codes (comma separated list FDA assigned to the subject device)

LLZ

Device Description

The software application is used to:

• Load patient CT/MR DICOM data

• View DICOM data using a traditional computer monitor or in Augmented Reality (AR) using a head-mounted display, HMD.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

CT/MR DICOM data

Anatomical Site

The device is software only which allows for the viewing of DICOM data. Therefore, it does not interact with any body and/or tissue part and the viewing is also not limited to any body and/or tissue part.

Indicated Patient Age Range

The device is software which allows for viewing of DICOM data. Therefore, there is no specific patient population.

Intended User / Care Setting

Qualified healthcare professionals, including but not restricted to surgeons, radiologists, nonradiology specialists, 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)

Both design verification and design validation were successfully conducted. Design verification activity ensured design output specifications met design input requirements; deviations did not negatively impact the device, its intended use, or introduce additional risks. Design validation, including human factors and usability engineering (simulated use testing), was performed to assess user interactions, identify use errors, and assess risk management effectiveness. Testing met all predetermined acceptance criteria, and no additional risks to safety or efficacy were identified.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

VitreaView (K163232)

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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).

Summary

May 13, 2019

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

MEDIVIS, Inc. % Ms. Amy Lynn Regulatory Affairs Consultant 20 Jay Street, Suite 312 BROOKLYN NY 11201

Re: K190764

Trade/Device Name: SurgicalAR Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: March 15, 2019 Received: March 25, 2019

Dear Ms. Lynn:

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/cfpmp/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

Indications for Use

510(k) Number (if known) K190764

Device Name SurgicalAR

Indications for Use (Describe)

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 indicated for use by qualified 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.

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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Section 5 - 510(k) Summary

Company:	MEDIVIS, Inc.
Address:	20 Jay Street, Suite 312
Brooklyn, New York, 11201
Contact:	Amy Lynn
	Regulatory Affairs Consultant
Telephone Number:	954.600.8299
Email:	amylynncicatello@gmail.com
Preparation Date:	March 15, 2019
Trade Name:	SurgicalAR
Device Common Name:	System, Image Processing, Radiological
Classification Regulation:	21 CFR 892.2050
Classification Name:	Picture archiving and communications system
Class:	II
Panel:	Radiology
Product Code:	LLZ
Predicate Device:	VitreaView (K163232)

5.1 Device Description

The software application is used to:

• Load patient CT/MR DICOM data

• View DICOM data using a traditional computer monitor or in Augmented Reality (AR) using a head-mounted display, HMD.

5.2 Intended Use

K190764

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 indicated for use by qualified 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.

5.3 Operator profile

Qualified healthcare professionals, including but not restricted to surgeons, radiologists, nonradiology specialists, physicians, and technologists.

5.4 Patient population

The device is software which allows for viewing of DICOM data. Therefore, there is no specific patient population.

5.5 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 purposes at any location using the head-mounted display (HMD)

5.6 Operating principle

There are different operating principles such as viewing:

On desktop PCs with a traditional monitor the interaction with the software is performed with a mouse and/or keyboard;
On PCs with a touchscreen monitor the interaction with the software is performed with a touchscreen interface; or
On a head-mounted display the interaction with the software is performed using hand ● gestures.

5.7 Part of the body or type of tissue applied or interacted with

5.8 Comparison to predicate device

The SurgicalAR proposed device is substantially equivalent to the predicate device. K163232. as both devices have the same intended use and technological characteristics. While both devices do not have the exact same software features, the difference does not pose any safety and/or effectiveness questions. A full substantial equivalent discussion is provided in Section 12. The exact feature differences and omissions are detailed in the tables contained within Section 12.

The proposed device slightly differs from the predicate device in two ways as listed below:

First, the proposed device is not available for use through internet browsers like the predicate device. The predicate device allows access via an internet browser in addition to traditional installation on a PC's hard drive. This design difference does not create new or additional safety risks regarding the use of the device but rather limits the scope of accessibility of SurgicalAR.

Secondly, the proposed device does not contain all of the same features as the predicate device. The lack of features are not key features nor do they impact the function or intended use of the device.

The table below demonstrates the similarities in technology and features between SurgicalAR and the predicate device.

Criteria	Description	Subject Device	Predicate Device	Comparison
Annotation and
Measurement Tools	• Line
• Angle
• Ruler
• Arrow	Yes	Yes	Same
User Installation
Requirements	• Runs within browser
using HTML and
JavaScript only
• No installation is
required on user's machine	No	Yes	Different.
Predicate allows
for access via Internet.
Data Type
Supported	• DICOM
• Non-DICOM	Yes	Yes	Same
Image
View/Manipulation	• Image Zoom
• Pan
• Window Level
• AutoWindow
• Level
• Reset
• Scout Lines
• Image Rotate
• Image Flip
• Magnify
• Image Invert
• Image Cine	No	Yes	Different.
Predicate has
"image invert"
and "image cine" features.
Data Encryption	• HTTPS
• SSL	Yes	Yes	Same
	Description	Subject Device	Predicate
Device	Comparison
Criteria	SurgicalAR	Vitrea View
(K163232)
Patient
Demographic
Display	Capable of displaying
patient demographic
information	Yes	Yes	Same
Linking	Co-planar linking:
• Autolink
• Manual	Yes	Yes	Same
User and Password
Control	Users can be managed
via an internal
database, active
directory, or parent
application	Yes	Yes	Same
Data Security	Stored on server	Yes	Yes	Same
Audit Trail	Audit trail logged	Yes	Yes	Same
User Management	Database structure
allows mapping users
to groups internally or
mapping external
groups (AD, parent
application) to internal
groups and role
Transmission
Modes	Via the web with
Internet browsers	No	Yes	Different.
Predicate allows
for access via
Internet.
File Type Used	• JPEG for
Lossy
data
• PNG for
Lossless data	Yes	Yes	Same
MPR Viewing	This viewing feature
enables the display of
reformatted CT and
MR images into axial,
coronal and sagittal
orientations	Yes	Yes	Same
3D Volume
Rendered Viewing	This viewing feature
enables the display of
3D perspective views
of CT and MR image
sets that have been
transformed into	Yes	Yes	Same
Criteria	Description	Subject Device	Predicate Device	Comparison
	volumes. It also
provides presets to
enable users to alter
the visualization
parameters
of the 3D views to
highlight features.	SurgicalAR	Vitrea View
(K163232)
Active Target Tool	This viewing feature
provides a facility to
view a single target
location within
multiple images.	Yes	Yes	Same
Crosshair
Navigation and
Synchronization	This viewing feature
provides a facility to
synchronize and scroll
through multiple
views at the same
time.	Yes	Yes	Same
Ability to clone
images side by side	Ability to clone
images side by side.	No	Yes	Different.
Predicate
contains a
"clone"
copy/paste
feature.
Ability to close an
image by clicking
an "X" in the
upper-left portion
of the view port	Ability to close an
image by clicking an
"X" in the upper-left
portion of the
viewport.	Yes	Yes	Same
Ability to select
locale and language
settings on the
login screen	Ability to select locale
and language settings
on the login screen.	No	Yes	Different.
Predicate has
support for
multiple
languages.
Ability to
customize the
columns in the
study directory by
selecting the
dropdown arrow on	Ability to customize
the columns in the
study directory by
selecting the
dropdown arrow on
the right side of each
column.	No	Yes	Different.
Predicate has
feature to
customize the
view of the
directory.
Criteria	Description	Subject Device	Predicate
Device	Comparison
the right side of
each column.
Help Tips	Proactive help tips
appear for 10-15
seconds to educate
users on certain
functionality that may
not be obvious to a
new user.	No	Yes	Different.
Predicate has
feature to view
"help tips".
Support for TIF
Files	Vitrea View can
display TIF files.	Yes	Yes	Same
Tablet
support for
information
purpose
only
(Not for diagnostic
use)	This viewing feature
provides access of
Vitrea View software
on various iOS and
Android tablet
devices through the
default internet
browser. Key
features are:
• Two-finger
pinch to
zoom and
pan
• Touch and
drag to
scroll
• Double-tap to
access
Gesture
menu
• Tap
Carousel
thumbnail,
then tap
Image Pane
to swap
images
• Ambient
Lighting
Check	No	Yes	Different.
Predicate has
support for iOS
and Android for
non-diagnostic
viewing.
HMD support for
information	This viewing feature
provides access of
SurgicalAR software	No	Yes	Different.
Proposed device
has support for
Criteria	Description	Subject Device	Predicate Device	Comparison
purpose only (not
for diagnostic use)	on consumer, off-the-
shelf-wireless, Wi-Fi
enabled, stereoscopic
head-mounted display
with minimum of 2GB
RAM	SurgicalAR	Vitrea View
(K163232)	HMDs for non-
diagnostic
viewing.
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	Yes	Yes	Same

5.9 Tests conducted

Both design verification and design validation were successfully conducted as part of the testing for the SurgicalAR device.

The purpose of the design verification activity was to ensure that the design output specifications met the design input requirements. Deviations associated with the written protocol were captured within the design verification report. These deviations did not negatively impact the device, it's intended use, nor did they introduce additional risks. Therefore, it is concluded at the design verification was successful in that the design output specifications satisfactorily met the design input requirements.

Design validation, including human factors and usability engineering, was conducted. Human factors and usability engineering testing was performed to assess user interactions with the device's user interface. The purpose is to identify use errors that would or could result in serious harm to the patient or user. Human factors validation testing is also used to assess the effectiveness of risk management measures. The testing performed was simulated use. The design validation was successfully completed, and testing met all predetermined acceptance criteria. Furthermore, no additional risks to the safety or efficacy of the device were identified.

5.10 Essential performance characteristics

SurgicalAR is software for medical image visualization. A hardware shutdown, power failure or other hardware issue that makes the software inoperable does not cause harm. Therefore, no unacceptable risk arises if the hardware loses performance. The hardware does not have any essential performance characteristics. The software risks were analyzed to find risks in the intolerable range. No risks have been identified in the intolerable range. As such, no measures are considered essential performance characteristics. In summary, the SurgicalAR software does not have any essential performance characteristics.