The XR90 (XR90-SYS) is a medical display workstation intended for 3D image visualization and image interaction in conjunction with traditional imaging and monitors. The virtual images are generated from tracked Ultrasound, tracked interventional device, and 3D volumetric data acquired from CT sources and stereoscopically projected such that the proximity of the virtual interventional device is displayed relative to live ultrasound and 3D models from previously acquired CT. The device is intended to provide visual information and reference to be used by the health care professionals for analysis of surgical options during pre-operative planning, and the heads-up, intra-operative display of the images during ultrasound-guided needle-based procedures. Virtual images on the heads-up display should always be used in conjunction with traditional monitors.

The XR90 (XR90-SYS) system is intended to be used as an adjunct to the interpretation of images performed using diagnostic imaging systems and is not intended for primary diagnosis.

The XR90 (XR90-SYS) system is intended to be used as a reference display for consultation and guidance to assist the clinician who is responsible for making all final patient management decisions.

During system use, the position and orientation tracking of the interventional instruments should always be available to the clinician on traditional imaging and monitors.

Device Description

The MediView™ XR90 (XR90-SYS) system is an augmented reality-based medical device to be used adjunctively to clinical ultrasound (US) systems, with the ability to stereoscopically project and fuse standard-of-care US with digital anatomical models based on pre-procedural computed tomography (CT) imaging in biopsies and percutaneous ablations to overcome the limitations of two-dimensional image fusion. The XR90 (XR90-SYS) system provides visual information and remote collaboration features.

XR90 (XR90-SYS) and cleared image fusion devices spatially register and project virtual representations of a) tracked interventional instruments and b) imaged patient anatomy in a common coordinate system. Accordingly, the use of XR90 (XR90-SYS) involves the co-registration of virtual objects (tracked device, US, and CT) for visual information and does not involve use of stereoscopic projection to physical (i.e., real-world) anatomy for navigation, consistent with predicate devices. XR90 (XR90-SYS) spatially registers and stereoscopically co-projects three types of virtual objects: (1) Holographic Light Ray (HLR), (2) CT-based virtual anatomy, and (3) live ultrasound b-sector (Flashlight) with the HUD ultrasound display/augmented reality user interface, while maintaining the same principle of operation compared to predicate devices. Accordingly, the paired registration of holographic entities are:

(1) HLR and virtual US-sector (Flashlight),
(2) CT-based virtual anatomy and virtual US-sector (Flashlight), and
(3) HLR and CT-based virtual anatomy.

The system is comprised of a commercial, off-the-shelf augmented reality head-mounted display, wirelessly connected to a streamer which interfaces with a GE Vivid iq ultrasound system and an electromagnetic (EM) field generator. The US signal is transmitted from the streamer to the headmounted display, where a virtual display of the US image is stereoscopically projected into the user's field-of-view in conjunction with pre-acquired CT-based images and tracked instrumentation.

The XR90 (XR90-SYS) system is capable of teleprocedural collaboration through the head-mounted display using Microsoft Dynamics 365 Remote Assist, allowing for other healthcare professionals to securely connect remotely to the head-mounted display, viewing the US signal and communicating (both through voice and needle annotation on the screen) in real-time with the local proceduralist. The remote collaborator may interact with the proceduralist via mobile device, laptop, desktop, or head-mounted display but the collaborator participates as an observer and should not make care decisions. The combination of teleprocedure communication and Holographic Needle Guide features provide workflow and ergonomics to the user for pre-operative planning and intra-operative display of virtual images. XR90 (XR90-SYS) is intended to be used adjunctively to standard of care imaging and provides guidance to the user. Proceduralists must refer to standard of care (conventional monitors) and prioritize clinical experience and/or judgement when using the XR90 (XR90-SYS) system.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study details for the MediView XR90 (XR90-SYS), based on the provided FDA 510(k) summary:

Overview
The MediView XR90 (XR90-SYS) is an augmented reality-based medical visualization system intended to be used as an adjunct to clinical ultrasound systems. It projects and fuses live ultrasound data with 3D volumetric data from CT scans and tracked interventional devices into a stereoscopic heads-up display. It is for visual information and reference during pre-operative planning and intra-operative guidance for ultrasound-guided needle-based procedures. The system is not for primary diagnosis.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document primarily focuses on the safety and performance aspects through non-clinical testing rather than specific "acceptance criteria" against which a statistical hypothesis test was performed in a clinical study. However, we can infer performance metrics that served as benchmarks. The key performance indicators for accuracy are Mean Target Registration Error (TRE) and 95% Upper Bound for TRE, along with Mean Angular Error and 95% Upper Bound for Angular Error. There are no explicit pass/fail thresholds stated, but the results demonstrate the device performs within clinically acceptable ranges for image-guided procedures.

Performance Metric	Acceptance Criteria (Implicit)	Reported Device Performance
Target Registration Error (TRE)
Phantom Study	Within acceptable limits for registration/fusion	Mean TRE: 2.543 mm; 95% Upper Bound: 2.726 mm (at 7.1 cm needle depth)
Cadaver Study	Within acceptable limits for registration/fusion	Mean TRE: 2.293 mm; 95% Upper Bound: 2.825 mm (at 8.5 cm needle depth)
Animal Study	Within acceptable limits for registration/fusion	Mean TRE: 2.9 mm; 95% Upper Bound: 3.4 mm (at 7.6 cm needle depth)
Angular Errors (Animal Study)
In-plane angular errors	Within acceptable limits	Mean: 7.08°; 95% Upper Bound: 8.77°
Out-of-plane angular errors	Within acceptable limits	Mean: 4.79°; 95% Upper Bound: 6.50°

2. Sample Size Used for the Test Set and Data Provenance

The document describes non-clinical performance testing in different models:

Phantom Study: Sample size not specified, but typically involves a series of measurements on a physical phantom.
Cadaver Study: Sample size not specified.
Animal Study: Sample size not specified, though it mentions a GLP porcine study. The data is prospective as it was collected specifically for this performance study. The animal study took place in a GLP (Good Laboratory Practice) environment, implying a controlled setting, but the specific country of origin is not stated.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

The document does not specify the number or qualifications of experts involved in establishing ground truth for the non-clinical performance tests. For phantom studies, ground truth is typically established by the known geometric properties of the phantom and precise measurement tools. For cadaver and animal studies, ground truth for accuracy metrics (like TRE) would likely be established by precise physical measurements by trained personnel.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1 consensus) for the non-clinical test sets. For accuracy measurements on phantoms and animal models, the ground truth is established objectively through physical and imaging measurements, so a multi-reader adjudication process as seen in clinical image interpretation studies is typically not applicable.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not reported in this 510(k) summary. The performance studies focused on the device's accuracy in a standalone or augmented setting, not on comparing human reader performance with and without AI assistance. The device is referred to as an "adjunct," implying it assists the clinician, but no quantitative measure of this assistance's effect on human reader performance is provided.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The performance testing (e.g., TRE and angular error measurements) implicitly evaluates the algorithm's accuracy in fusing and displaying images and tracked instruments. While a human operator uses the device, the reported metrics (TRE, angular error) reflect the system's inherent accuracy in aligning virtual objects with the physical world, which is a form of standalone performance for the core algorithmic functionality related to image registration and tracking. The "system accuracy verification" indicates an evaluation of the device's output accuracy independent of user interpretation skills.

7. The Type of Ground Truth Used

The ground truth for the non-clinical performance studies was established through:

Known physical properties/measurements: For the phantom study.
Precise physical measurements: For cadaver and animal models, likely using known target points or tracked instruments on the anatomy to verify the system's displayed position against the true physical position. The term "measurement validation of distances measured in the system against a ground truth" explicitly points to this.

8. The Sample Size for the Training Set

The document does not provide information about the training set size or methodology for any machine learning components. It's possible that the "system" itself relies on traditional image processing and tracking algorithms rather than deep learning that would require a distinct "training set." If there are machine learning components, details are not disclosed in this summary.

9. How the Ground Truth for the Training Set Was Established

As no training set details are provided, the method for establishing its ground truth is also not described.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".

MediView XR, Inc. Adam Cargill Director, QARACA 10000 Cedar Ave Ste# Gcic 2-153 CLEVELAND, OHIO 44106

July 13, 2023

Re: K223125

Trade/Device Name: Xr90 (xr90-sys) Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: LLZ Dated: June 9, 2023 Received: June 12, 2023

Dear Adam Cargill:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's

{1}------------------------------------------------

requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Jessica Lamb

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) K223125

Device Name XR90 (XR90-SYS)

Indications for Use (Describe)

The XR90 (XR90-SYS) is a medical display workstation intended for 3D image visualization and image interaction in conjunction with traditional imaging and monitors. The virtual images are generated from tracked Ultrasound, tracked interventional device, and 3D volumetric data acquired from CT sources and stereoscopically projected such that the proximity of the virtual interventional device is dive to live ultrasound and 3D models from previously acquired CT. The device is intended to provide visual information and reference to be used by the health care professionals for analysis of surgical options during pre-operative planning, and the heads-up, intra-operative display of the images during ultrasound-guided needle-based procedures. Virtual images on the heads-up displays be used in conjunction with traditional monitors.

The XR90 (XR90-SYS) system is intended to be used as an adjunct to the interpretation of images performed using diagnostic imaging systems and is not intended for primary diagnosis.

The XR90 (XR90-SYS) system is intended to be used as a reference display for consultation and guidance to assist the clinician who is responsible for making all final patient management decisions.

During system use, the position and orientation tracking of the interventional instruments should always be available to the clinician on traditional imaging and monitors.

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)
------------------------------------------------------------------------------------------------------	-----------------------------------------------------------------------------------------------------

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image contains the logo for MediView. The logo consists of a circular graphic on the left and the company name on the right. The circular graphic is made up of curved lines in shades of blue, green, and orange. To the right of the graphic is the company name "MediView" in a blue sans-serif font, with the tagline "TRANSFORMATIVE VISION" in smaller, lighter blue letters below it.

510(k) Summary

This summary of safety and effectiveness information is submitted in accordance with 21 CFR $807.92.

Sponsor:	MediView XR, Inc.10000 Cedar AveSTE GCIC 2-153Cleveland, OH 44106Establishment Registration Number: 9102640Phone: (661) 917-9775
Contact:	Adam CargillDirector, QARACA
Date Prepared:	July 12, 2023
Subject Device:	Trade Name: XR90 (XR90-SYS)Submission Number: K223125Regulation Number: 21 CFR 892.2050Regulation Name: Medical Image Management and Processing SystemRegulatory Class: Class IIProduct Code: LLZCommon Name: System, Image Processing, Radiological
Predicate Device:	Trade Name: HOLOSCOPE-iPremarket Notification: K210072Regulation Number: 21 CFR 892.2050Regulation Name: Medical Image Management and Processing SystemRegulatory Class: Class IIProduct Code: LLZCommon Name: System, Image Processing, Radiological
Reference Device:	Trade Name: PercuNav Image Fusion and Interventional NavigationPremarket Notification: K170716Regulation Number: 21 CFR 892.1750Regulation Name: Computed Tomography X-Ray SystemRegulatory Class: Class IIProduct Code: JAKCommon Name: System, X-Ray, Tomography, ComputedAssociated Product Code: IYO, LLZCommon Name: System, Imaging, Pulsed Echo, Ultrasonic

Device Description

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image contains the logo for MediView. On the left side of the logo is a circular graphic with three curved lines in the colors orange, blue, and green. To the right of the graphic is the company name "MediView" in blue, with the words "TRANSFORMATIVE VISION" in smaller green font underneath.

(1) HLR and virtual US-sector (Flashlight),
(2) CT-based virtual anatomy and virtual US-sector (Flashlight), and
(3) HLR and CT-based virtual anatomy.

Intended Use

The XR90 (XR90-SYS) is a medical display workstation intended for 3D image visualization and image interaction in conjunction with traditional imaging and monitors. The virtual images are generated from tracked Ultrasound, tracked interventional device, and 3D volumetric data acquired from CT sources and stereoscopically projected such that the proximity of the virtual interventional device is displayed relative to live ultrasound and 3D models from previously acquired CT. The device is intended to provide visual information and reference to be used by the health care professionals for analysis of surgical options during pre-operative planning, and the heads-up, intra-operative display of the images during ultrasoundguided needle-based procedures. Virtual images on the heads-up display should always be used in conjunction with traditional monitors.

The XR90 (XR90-SYS) system is intended to be used as an adjunct to the interpretation of images performed using diagnostic imaging systems and is not intended for primary diagnosis.

{5}------------------------------------------------

Image /page/5/Picture/0 description: The image contains the logo for MediView. The logo consists of a circular graphic on the left and the company name on the right. The circular graphic is made up of curved lines in the colors blue, orange, and green. To the right of the graphic, the company name "MediView" is written in blue, with the words "TRANSFORMATIVE VISION" written in a smaller font size below the company name.

The XR90 (XR90-SYS) system is intended to be used as a reference display for consultation and guidance to assist the clinician who is responsible for making all final patient management decisions.

During system use, the position and orientation tracking of the interventional instruments should always be available to the clinician on traditional imaging and monitors.

The intended use and indications for use are similar to the predicate Real View Imaging Ltd. HOLOSCOPE-i (K210072, referred to as HOLOSCOPE-i throughout this document).

Summary of Technological Characteristics

The XR90 (XR90-SYS) system has a similar intended use and indications for use, principles of operation. and technological characteristics as the legally marketed predicate device, HOLOSCOPE-i (K210072) and the legally marketed reference device, PercuNav Image Fusion and Navigation System (K170716).

Intended Use: Like HOLOSCOPE-i, the proposed XR90 (XR90-SYS) is a medical display . workstation intended for 3D image visualization and image interaction. Additionally, both devices are intended to be used as a reference display as an adjunct to the interpretation of images performed using legally marketed diagnostic imaging systems and are not intended for primary diagnosis.
. Intended Users: Like HOLOSCOPE-i, the proposed XR90 (XR90-SYS) is intended to be used by health care professionals who are responsible for making all final patient decisions.
. Principles of Operation: Like HOLOSCOPE-i, the proposed XR90 (XR90-SYS) receives medical imaging data from standard imaging modalities and generates 3D models to enable the health care professional to visualize the patient's anatomy. Like PercuNav, the proposed XR90 (XR90-SYS) provides image-guided diagnostic and intervention that enables fusion of diagnostic images and pre-procedural reference of tracked instruments to physician-defined targets.
. Visualization and Navigation: Like the HOLOSCOPE-i, the proposed XR90 (XR90-SYS) provides three-dimensional visualization and image interaction by acquiring data from CT and ultrasound sources to intraoperatively display the images to provide visual information to be used by the health care professional. Similar to the reference device, the proposed XR90 (XR90-SYS) provides real-time, three-dimensional visualization and reference tools for all stages of intervention, including pre-procedure planning and intra-procedural virtual display of images. The system uses transformed two-dimensional patient images into representations that can be fused with live ultrasound.
Tool Tracking: Both the reference device and XR90 (XR90-SYS) utilize EM tracking to track an ● ultrasound probe and interventional instrument (eTRAX - K092619). Similar hardware is utilized for the EM field generator, cable connection interface, tracked interventional instrument, and micro-EM sensors.
Registration: Similar to the reference device, the proposed XR90 (XR90-SYS) performs spatial mapping from one image space to another image space (registration), allowing the physician to correlate scan sets with each other and to the tracked instrument.
- o Automatic Registration: The reference device, PercuNav, contains an automatic registration method, in which the ultrasound probe is swept across anatomical landmarks, and then the ultrasound image is registered with the CT images. Similarly, XR90-SYS) contains an automatic registration feature in which a user gazes at each Registration Marker in a sweeping motion, and the system automatically performs the registration of CT-based Holographic Anatomy, ultrasound Flashlight, and tracked interventional instrument using the registration method described in the Device Description and Principles of Operation document.

{6}------------------------------------------------

Image /page/6/Picture/0 description: The image shows the logo for MediView. The logo consists of a circular graphic on the left and the word "MediView" on the right. The circular graphic is made up of three curved lines in different colors: orange, blue, and green. Below the word "MediView" is the phrase "TRANSFORMATIVE VISION" in a smaller font.

Manual Registration: The reference device, PercuNav, contains a manual registration O method in which corresponding points on different imaging modalities are used to translate the images. Similarly, XR90 (XR90-SYS) contains an "Adjustment" feature, in which corresponding points on the CT-based Holographic Anatomy and ultrasound Flashlight are used to translate the CT-based Holographic Anatomy to the real-time ultrasound.
Proiected Path of Interventional Instrument: The reference device contains a "biopsy" line ● that is aligned with the user-specified target prior to insertion. This is similar to the Holographic Needle Guide and alignment of the Holographic Light Ray with the user-specified target on the Flashlight to be used for pre-operative planning.
. Targeting Feedback Indicators: The reference device contains an "Ultrasound Guidance Bar" on the right side of the screen that helps detect whether the target is in the ultrasound scanning plane after a target is set. Similarly, the XR90 (XR90-SYS) system contains visual and auditory feedback indicators on in-plane or out-of-plane targeting while aligning the Holographic Light Ray with the Ultrasound Flashlight.

Based on the above comparison, the XR90 (XR90-SYS) has a similar intended use and similar technological and functional features as the predicate device in providing tools and workflows designed to support users with 3D visualization and image interaction with medical device images. Similar to the cited predicate device, XR90 (XR90-SYS) is used for image viewing and interaction both prior to and during procedures.

The XR90 (XR90-SYS) system is substantially equivalent to the predicate device with regards to intended use and technological characteristics and any differences between the XR90 (XR90-SYS) system and the predicate do not introduce new questions of safety or efficacy. Performance testing demonstrates the device performs as intended.

Summary of Performance Data

Verification and validation testing data summarized below were provided in support of the substantial equivalence documentation.

Non-Clinical Performance Testing:

Non-clinical bench testing on the XR90 (XR90-SYS) system was performed to demonstrate the system meets the performance specifications per the device's intended use. The testing concluded that XR90 (XR90-SYS) does not raise any new questions of safety and effectiveness. This included the System Accuracy Verification, Cadaver Study which concluded that the registration and fusion of virtual images was within acceptable limits in a phantom and cadaver model. Additionally, the system performance was evaluated in an animal model. System accuracy performance testing is summarized below:

{7}------------------------------------------------

Image /page/7/Picture/0 description: The image shows the logo for MediView. The logo consists of a circular design on the left and the word "MediView" on the right. The circular design is made up of curved lines in different colors, including blue, green, and orange. Below the word "MediView" is the phrase "TRANSFORMATIVE VISION" in a smaller font.

Test	Mean TRE (mm)	95% Upper Bound forTRE (mm)	TRE Measured at MeanNeedle Depth of (cm):
Phantom	2.543 mm	2.726 mm	7.1 cm
Cadaver	2.293 mm	2.825 mm	8.5 cm
Animal	2.9 mm	3.4 mm	7.6 cm

The angular errors, including in-plane and out-of-plane error between the tip of the needle and target was measured in an animal model, and is summarized below:

Test	Mean Angular Error(degrees)	95% Upper Bound(degrees)
In-plane angular errors	7.08°	8.77°
Out-of-plane angular errors	4.79°	6.50°

The following non-clinical testing was conducted to evaluate the device:

Bench testing performance tests demonstrated the system meets its performance requirements by ● verifying the following elements:
- Measurement of Positional Accuracy of the EM Tracking Subsystem in accordance with O ASTM F2554-22
- Accuracy of the system registration, including Target Registration Error and Image O Fusion Registration Error, in a benchtop phantom study and in a cadaver model, as well as measurement validation of distances measured in the system against a ground truth.
- Latency and data communication on the benchtop O
- Registration/image target tracking on the benchtop O
. Electrical safety was tested in accordance with ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.
Electromagnetic Compatibility (EMC) was tested in accordance with IEC 60601-1- 2:2014 -● Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests.
. System cleaning and disinfection validation was performed according to AAMI TIR 30:2011/(R)2016, AAMI TIR 12:2010, and FDA guidance:" Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Guidance for Industry and Food and Drug Administration Staff" (March 17, 2015).
. Sterilization validation according to ISO 11135:2014
The biocompatibility of all user contact materials was tested according to ISO 10993-1:2018 and ● FDA guidance on the use of ISO 10993-1.
. Software verification and validation testing was conducted as required by IEC 62304 and FDA guidance on general principles of software validation, January 11, 2002.

{8}------------------------------------------------

Image /page/8/Picture/0 description: The image contains the logo for MediView. The logo consists of a circular graphic on the left and the company name on the right. The circular graphic is made up of four curved segments in different colors: blue, light blue, orange, and green. To the right of the graphic is the word "MediView" in a blue, sans-serif font. Below "MediView" is the phrase "TRANSFORMATIVE VISION" in a smaller, green, sans-serif font.

Usability evaluation the system was validated with intended users in simulated use conditions to ● ensure tasks, including critical tasks, were met and no new issues of safety or effectiveness were raised.
The following performance testing was also conducted to evaluate the device:
The XR90 (XR90-SYS) system was verified and validated in a GLP porcine study that evaluated ● the safety, efficacy, and accuracy (including Target Registration Error and angular errors) of the system when used in adjunct to standard-of-care imaging during ultrasound-guided needle-based procedures in porcine models. Secondary endpoints of the study included evaluating overall procedure time, complications, and overall clinical usability.

Substantial Equivalence Conclusion

MediView XR maintains that the subject device is substantially equivalent to the legally marketed predicate based on the comparison information provided above and further extrapolated in the substantial equivalence comparison table below. Verification testing, including system level tests, and safety tests established the performance, functionality, and reliability characteristics of the system. It is concluded that the XR90 (XR90-SYS) system is substantially equivalent to the legally marketed predicate device (K210072).

{9}------------------------------------------------

Image /page/9/Picture/0 description: The image contains the logo for MediView. The logo consists of a circular design with overlapping segments in shades of blue, green, and orange on the left. To the right of the circular design is the word "MediView" in a teal sans-serif font, with the words "TRANSFORMATIVE VISION" in a smaller teal font below it.

Substantial Equivalence Table

The table below outlines the similarities and differences between the subject XR90 (XR90-SYS) system and the predicate Real View Inaging Ltd. HOLOSCOPE-i system, in addition to the Philips PercuNav Image Fusion and Interventional Navigation as a reference device.

	Subject Device:MediView XR90 (XR90-SYS) System (K223125)	Predicate Device: Real ViewImaging Ltd.HOLOSCOPE-i (K210072)	Reference Device:Philips PercuNav ImageFusion and InterventionalNavigation System(K170716)	Explanation ofDifferences
Submission Number	K223125	K210072	K170716	N/A
Product Code(s)	LLZ	LLZ	JAK/IYO/LLZ	Equivalent to predicate device.
Regulation	Medical Image Management andProcessing System (21 CFR892.2050)	Medical Image Management andProcessing System (21 CFR892.2050)	Computed Tomography X-RaySystem (21 CFR 892.1750)
Intended Use	The XR90 (XR90-SYS) is amedical display workstationintended for 3D imagevisualization and imageinteraction in conjunction withtraditional imaging and monitors.The virtual images are generatedfrom tracked Ultrasound, trackedinterventional device, and 3Dvolumetric data acquired fromCT sources and stereoscopicallyprojected such that the proximityof the virtual interventionaldevice is displayed relative tolive ultrasound and 3D modelsfrom previously acquired CT.The device is intended to providevisual information and referenceto be used by the health care	The HOLOSCOPE-i is a medicaldisplay workstation intended for3D image visualization and imageinteraction. The holograms aregenerated from 3D volumetricdata acquired from CT andUltrasound sources. The device isintended to provide visualinformation to be used by thehealth care professional foranalysis of surgical options, andthe intraoperative display of theimages. The HOLOSCOPE-i isintended to be used as an adjunctto the interpretation of imagesperformed using diagnosticimaging systems and is notintended for primary diagnosis.The HOLOSCOPE-i is intended	The PercuNav system is astereotaxic accessory forcomputed tomography (CT),magnetic resonance (MR),ultrasound (US), and positronemission tomography (PET). CT,Ultrasound, PET, and MR maybe fused in variouscombinations, such as CT withMR, MR with ultrasound, and soon. It may includeinstrumentation to display thesimulated image of a trackedinsertion tool such as a biopsyneedle or probe on a computermonitor screen that showsimages of the target organs andthe current and the projectedfuture path of the interventional	There are no fundamentaldifferences in the intended useof the XR90 (XR90-SYS)system compared to thepredicate device.• The XR90 (XR90-SYS)system is not an accessory toimaging modalities, but rather,indicated to be usedadjunctively to ultrasound.Ultrasound images may befused with previously acquiredCT imaging, whereas thereference allows for fusion invarious combinations.
Subject Device:MediView XR90 (XR90-SYS) System (K223125)	Predicate Device: Real ViewImaging Ltd.HOLOSCOPE-i (K210072)	Reference Device:Philips PercuNav ImageFusion and InterventionalNavigation System(K170716)	Explanation ofDifferences
professionals for analysis ofsurgical options during pre-operative planning, and theheads-up intra-operative displayof the images during ultrasound-guided needle-based procedures.Virtual images on the heads-updisplay should always be used inconjunction with traditionalmonitors.The XR90 (XR90-SYS) systemis intended to be used as anadjunct to the interpretation ofimages performed usingdiagnostic imaging systems andis not intended for primarydiagnosis.The XR90 (XR90-SYS) systemis intended to be used as areference display for consultationand guidance to assist theclinician who is responsible formaking all final patientmanagement decisions.During system use, the positionand orientation tracking of theinterventional instruments shouldalways be available to theclinician on traditional imagingand monitors.	to be used as a reference displayfor consultation to assist theclinician who is responsible formaking all final patientmanagement decisions.	instrument. The PercuNavsystem is intended for treatmentplanning and guidance forclinical, interventional, ordiagnostic procedures.The PercuNav system alsosupports an image-free mode inwhich the proximity of theinterventional device isdisplayed relative to anotherdevice. The PercuNav system isintended to be used ininterventional and diagnosticprocedures in a clinical setting.The PercuNav system is alsointended for use in clinicalinterventions to determine theproximity of one device relativeto another.Example procedures include, butare not limited to, the following:• Image fusion for diagnosticclinical examinations andprocedures• Soft tissue biopsies (liver, lung,kidney, breast, pancreas, bladder,adrenal glands, lymph node,mesentery, and so on.)• Soft tissue ablation (liver,kidney, breast, pancreas, lung,and so on)• Bone ablations• Bone biopsies	• The XR90 (XR90-SYS)system utilizes a head-mounted display for viewingimaging in augmented reality(AR), as opposed to thepredicate, which uses anoptical unit attached to aboom.• XR90 (XR90-SYS) is asupplement to live imaging inclinical interventions and isnot meant to replace standardof care imaging.• Similar to the reference,XR90 (XR90-SYS) is notintended to be the soleguidance for any procedure.Philips also included thisstatement in a more recent510(k) submission for theirPercuNav device (K201053),so this is similar in bothdevices.The differences in intendeduse between the predicate andXR90 (XR90-SYS) do notaffect the safety or efficacy ofthe device, as each havesimilar underlying technologyand basic components.
	Subject Device:MediView XR90 (XR90-SYS) System (K223125)	Predicate Device: Real ViewImaging Ltd.HOLOSCOPE-i (K210072)	Reference Device:Philips PercuNav ImageFusion and InterventionalNavigation System(K170716)	Explanation ofDifferences
			• Nerve blocks and painmanagement• Drainage placements• Tumor resections
Intended UseEnvironment	Hospital operating rooms andprocedure rooms	Interventional suites, hybridoperating rooms, and diagnosticclinics	Hospital operating rooms,outpatient surgery centers andprocedure rooms	Similar to the predicate. XR90(XR90-SYS) is not intended tobe used in diagnostic clinics,as the EM field generator isdesigned to be compatiblewith tables found in operatingor procedure rooms.
Main SystemComponents	• EM Field Generator• Tool Connection Unit(SCU/SIU)• Computing Hardware(Server/Router)• Microsoft HoloLens 2 head-mounted display configured withXR90 (XR90-SYS) Software• Instrumentation [see 'Tracking'below]	• Optical Unit• Computing Hardware• Cart and boom mechanicalfixture to mechanically connectthe Optical Unit and systemcomputer• 3D Control Device	• EM Field Generator• Tool Connection Unit (TCU)• Computing Hardware• Monitor to display PercuNavSoftware• Instrumentation [see 'Tracking'below]	XR90 (XR90-SYS) uses aMicrosoft HoloLens 2 todisplay imaging and trackedinstrumentation for pre-operative planning and intra-operative display of virtualimages, as opposed to thepredicate device, whichutilizes an optical unitconnected to a boommechanical fixture.Predicate device uses a 3DControl Device for interaction,while XR90 (XR90-SYS) is"hands-free," using voice andhand gestures.
	Subject Device:MediView XR90 (XR90-SYS) System (K223125)	Predicate Device: Real ViewImaging Ltd.HOLOSCOPE-i (K210072)	Reference Device:Philips PercuNav ImageFusion and InterventionalNavigation System(K170716)	Explanation ofDifferences
Modes of Operation	• On a head-mounted display, theinteraction with the software isperformed using hand gestures.Voice commands are optional forfurther interaction with thesoftware.• Ultrasound parameters may bechanged on the local US system,not in the XR90 (XR90-SYS)software.There are different viewingoptions for the US imaging,including:• Heads-Up Display (HUD)• Registered Holograms (In-situFlashlight Mode registered withCT-based models and trackedinstrumentation)	• 3D Control Device is used forinterfacing with the hologram.• 3D volumetric data is receivedfrom CT or US and generates ahologram in the holographicdisplay.• Spatial Light Modulator (SLM)is used to generate holograms andguided to the desired projectionarea via the optical systemadjacent to the SLM.	• The viewing of imaging andtracked instrumentation isdisplayed on a computer monitorscreen.• CT, Ultrasound, PET, and MRmay be fused in variouscombinations, such as CT withMR, MR with ultrasound, and soon.	The principles of operationbetween the subject andpredicate device are similar atthe core: A proceduralist isviewing fused imaging on acomputer screen, whether viaa traditional monitor or head-mounted display. Each systemhas different modes ofviewing information.XR90 (XR90-SYS) uses handgestures and voice commandsfor interaction rather thaninteraction with a 3D controldevice.
Patient ContactingComponents	Registration Markers	None	Patient Tracker	Equivalent to referencedevice. Both use skin-contacting components thatare EM-sensor equipped.
Tracking	• EM Tracking• Registration Markers• Ultrasound Tracker• Tracked InterventionalInstrument (Biopsy and RFAIntroducers, including eTrax,which has been cleared and		• EM Tracking• Patient Tracker• Ultrasound Tracker• Coaxial Needle Tracker (CNT)• Adaptive Needle Tracker(ANT)• Button Probes	Both the reference andproposed systems have sensor-equipped instrumentation totrack the ultrasound andinterventional instrumentwithin the trackingenvironment.
	Subject Device:MediView XR90 (XR90-SYS) System (K223125)	Predicate Device: Real ViewImaging Ltd.HOLOSCOPE-i (K210072)	Reference Device:Philips PercuNav ImageFusion and InterventionalNavigation System(K170716)	Explanation ofDifferences
	marketed by CIVCO Medical[K092619])Registration Markers contain anoptical image for registrationonly.		• Biopsy and RFA Introducers(including eTrax, which has beencleared and marketed by CIVCOMedical [K092619])	The Registration Markers donot track the patient in real-time—they are intended toassist in the registration ofCT-based images withultrasound and trackedinterventional instrument. ThePercuNav Patient Trackertracks the patient movement.
Imaging Modality	Ultrasound, historical segmentedCT images	CT and Ultrasound sources	Ultrasound, CT, MR, PET	None.
Registration Method	• Automatic Registration• Manual registration		• Automatic Registration• Manual Registration	Equivalent to referencedevice.
Medical DeviceInterfaces	• GE Vivid iq PremiumEdition Ultrasound system• Compatible ultrasound probes• CIVCO eTRAX [K092619]• GE Omega V Angio table	• Compatible 3D ultrasoundsystem	• Compatible ultrasound system• Compatible ultrasound probes• CIVCO eTRAX [K092619]	The XR90 (XR90-SYS)system and the predicate bothinterface with a compatibleultrasound system via directconnection. The XR90 (XR90-SYS) system has similarmedical device interfaces tothe reference device. The EMField Generator is attached tocompatible procedure tablesusing custom table brackets,whereas the EM FieldGenerator for PercuNav ismounted on an arm that isplaced above the patient.
Display Features	• 3D models of segmentedimages	• Two optical channels, consistingof a Spatial Light Modulator, an	• 3D view of segmented images	Core technology is equivalentto the predicate device, in
	Subject Device:MediView XR90 (XR90-SYS) System (K223125)	Predicate Device: Real ViewImaging Ltd.HOLOSCOPE-i (K210072)	Reference Device:Philips PercuNav ImageFusion and InterventionalNavigation System(K170716)	Explanation ofDifferences
	• 2D images: Ultrasound(Flashlight and Heads-upDisplay)• Trajectories (Holographic LightRay)• Trajectory Guidance(Holographic Needle Guide)• Virtual instrument's tip view(Light Ray)• 3D transparent (semi-translucence of 3D models)• 3D Off (only 2D)• 3D follow instrumentmovement (Light Ray)	RGB coherent light source, a setof lenses and mirrors to directlight to the see-through eyepieces.	• 2D images: Ultrasound, CT(axial, sagittal, coronal), PET,and MR• Trajectories (projected futurepath of interventionalinstrument)• Trajectory Guidance	which virtual images areoverlaid within the user'sphysical environment. Thesubject device usesstereoscopic projection viasee-through diffractive planarwaveguides, while thepredicate uses interference-based Spatial LightModulators.Reference device and subjectdevice are equivalent.Reference device supportsPET and PER/CT, as well asfusion of two-dimensionalpatient images with previouslyacquired images. XR90(XR90-SYS) only supportsfusion of live ultrasound withpreviously acquired CT. XR90(XR90-SYS) does not supportor claim diagnostic review ofimages.
Software Interface(GUI)	• Visualization control(show/hide virtual anatomy &Flashlight mode)• Patient Selection/Data Import• Buttons for registration• Adjust fusion via Adjustmentmethod (point-to-point method)• Software controls for images• Target selection and plannedtrajectory management	• Interactions with system• Selection of tools• Drive workflowThis includes the ability to:• Visualize• Rotate• Slice• Mark• Measureimages displayed holographically.	• Patient selection/data import• Select registration method• Buttons for registration• Adjust fusion (including point-to-point method)• Save registration button• Software controls for images• Target selection• Feedback on target/ultrasoundalignment (Ultrasound GuidanceBar)	Software interface is similar tothe predicate and referencedevice. XR90 (XR90-SYS)enables a user to visualizeimaging and customize theirdisplay via voice and handgestures, similar to thepredicate. Users can marklocations in the CT-basedHolographic Anatomy andultrasound HUD/Flashlight to
	Subject Device:MediView XR90 (XR90-SYS) System (K223125)	Predicate Device: Real ViewImaging Ltd.HOLOSCOPE-i (K210072)	Reference Device:Philips PercuNav ImageFusion and InterventionalNavigation System(K170716)	Explanation ofDifferences
	• Feedback on target/ultrasoundalignment (Light Ray auditoryand visual indicators)		• Color / MFI / CEUS	perform a CT adjustment.XR90 (XR90-SYS) registersimages with one another,whereas the predicate does notperform registration.Therefore, image rotation isnot a capability of XR90(XR90-SYS).
Communication BetweenImaging and ComputingHardware	• DICOM images imported forsegmentation through hospital-approved USB, CD, or DVD.• Real-time ultrasound connectedvia Ethernet cable to router.	• PACS, USB, or direct fromconnected compatible 3Dultrasound acquisition modality.	• CT, MR, PET images importedusing USB, CD, DVD, or PACS.• Real-time US connected toPercuNav.	Similar. XR90 (XR90-SYS)does not integrate with aPACS system due to thesegmentation process thatDICOM images must undergoprior to a procedure with thedevice.
Communication BetweenHeadset and ComputingHardware	WirelessStreaming hardware (MediViewStreamer and MediView Router)transmits US imaging from thescanner to the headset over LAN	Embedded PC supporting system	No Headset	Subject device uses a localarea network (LAN) totransmit streamed US data toheadset, whereas the predicatedevice has a PC supportingsystem embedded into thesystem, which connects to theoptical unit.Reference device uses acomputer monitor screenrather than a head-mounteddisplay for imaging.
	Subject Device:MediView XR90 (XR90-SYS) System (K223125)	Predicate Device: Real ViewImaging Ltd.HOLOSCOPE-i (K210072)	Reference Device:Philips PercuNav ImageFusion and InterventionalNavigation System(K170716)	Explanation ofDifferences
Display and OpticsTechnology	Stereoscopic HolographicDisplay using near eye see-through holographiclenses/waveguides (MicrosoftHoloLens 2)	Stereoscopic Holographic Displayusing a near eye see-throughdisplay (Custom Optical Unit)	Data displayed on a monitor	Equivalent.Reference device uses acomputer monitor screenrather than a head-mounteddisplay for imaging. TheHoloLens 2 head-mounteddisplay is like a computermonitor, as it is a see-throughcomputer display that runs onWindows 10 HolographicOperating System.
DICOM Compatible	Yes	Yes	Yes	None
Original 2D/3D imageremains visible(acquisition data source)	Yes (ultrasound)	Yes	Yes	None

{10}------------------------------------------------

Image /page/10/Picture/0 description: The image contains the logo for MediView. The logo consists of a circular graphic on the left and the company name on the right. The circular graphic is made up of three curved lines in the colors blue, orange, and green. The company name, "MediView," is written in blue, and below it, the words "TRANSFORMATIVE VISION" are written in a smaller, lighter blue font.

{11}------------------------------------------------

Image /page/11/Picture/1 description: The image contains the logo for MediView. The logo consists of a circular graphic on the left and the text "MediView" on the right. Below "MediView" is the text "TRANSFORMATIVE VISION" in a smaller font. The circular graphic is made up of curved lines in different colors, including blue, orange, and green.

{12}------------------------------------------------

Image /page/12/Picture/1 description: The image shows the logo for MediView. The logo consists of a circular graphic on the left, made up of curved segments in blue, orange, and green. To the right of the graphic is the word "MediView" in a blue, sans-serif font. Below "MediView" are the words "TRANSFORMATIVE VISION" in a smaller, sans-serif font.

{13}------------------------------------------------

Image /page/13/Picture/1 description: The image shows the logo for MediView. The logo consists of a circular graphic on the left and the company name on the right. The circular graphic is made up of four curved lines in different colors: blue, orange, teal, and green. To the right of the graphic, the word "MediView" is written in blue, and below that, the words "TRANSFORMATIVE VISION" are written in a smaller font.

{14}------------------------------------------------

Medi

TRANSFORMATIVE VISION

{15}------------------------------------------------

TRANSFORMATIVE VISION

{16}------------------------------------------------

TRANSFORMATIVE VISION

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).