K Number

Device Name

xvision Spine system (XVS)

Manufacturer

Augmedics Ltd

Date Cleared

2021-07-19

(90 days)

Product Code

OLO

Regulation Number

882.4560

Intended Use

The xvision Spine System, with xvision System Software, is intended as an aid for precisely locating anatomical structures in either open or percutaneous spine procedures. Their use is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the spine or pelvis, can be identified relative to CT imagery of the anatomy. This can include the spinal implant procedures, such as Posterior Pedicle Screw Placement in the thoracic and sacro-lumbar region. The Headset of the xvision Spine System displays 2D stereotaxic screens and a virtual anatomy screen. The stereotaxic screen is indicated for correlating the tracked instrument location to the registered patient imagery. The virtual screen is indicated for displaying the virtual instrument location to the virtual anatomy to assist in percutaneous visualization and traiectory planning. The virtual display should not be relied upon solely for absolute positional information and should always be used in conjunction with the displayed stereotaxic information

Device Description

The xvision Spine (XVS) system is an image-guided navigation system that is designed to assist surgeons in placing pedicle screws accurately, during open or percutaneous computer-assisted spinal surgery. The system consists of a dedicated software, Headset, single use passive reflective markers and reusable components. It uses wireless optical tracking technology and displays to the surgeon the location of the tracked surgical instruments relative to the acquired intraoperative patient's scan, onto the surgical field. The 2D scanned data and 3D reconstructed model, along with tracking information, are projected to the surgeons' retina using a transparent near-eye-display Headset, allowing the surgeon to both look at the patient and the navigation data at the same time.

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

K190929

Reference Devices

VV FLUORO 3D (K070106)

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes an image-guided navigation system using optical tracking and displaying pre-acquired CT data. There is no mention of AI or ML in the intended use, device description, or performance studies. The system relies on registration of tracked instruments to the CT imagery, which is a standard navigation technique, not necessarily involving AI/ML.

Therapeutic

No.
This device is an image-guided navigation system intended to assist surgeons in precisely locating anatomical structures and placing screws during spine procedures, rather than directly treating a medical condition itself.

Diagnostic

The device is described as an image-guided navigation system that aids in precisely locating anatomical structures and assisting in surgical procedures, specifically pedicle screw placement. It does not diagnose medical conditions.

SaMD (Software as a Medical Device)

The device description explicitly states the system consists of dedicated software, a Headset, single-use passive reflective markers, and reusable components, indicating it includes hardware components beyond just 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 medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
Device Function: The xvision Spine System is an image-guided navigation system used during surgical procedures to help surgeons accurately place instruments and implants. It uses imaging data and tracking technology to provide real-time guidance within the surgical field.
Intended Use: The intended use clearly states it's an "aid for precisely locating anatomical structures in either open or percutaneous spine procedures." This is a surgical guidance tool, not a diagnostic test performed on a sample.
No Sample Analysis: The device does not analyze any biological samples from the patient. Its input is imaging data (CT imagery) and its output is visual guidance displayed to the surgeon.

Therefore, the xvision Spine System falls under the category of a surgical navigation or guidance system, not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The xvision Spine System, with xvision Spine System Software, is intended as an aid for precisely locating anatomical structures in either open or percutaneous spine procedures. Their use is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the spine or pelvis, can be identified relative to CT imagery of the anatomy. This can include the spinal implant procedures, such as Posterior Pedicle Screw Placement in the thoracic and sacro-lumbar region.

The Headset of the xvision Spine System displays 2D stereotaxic screens and a virtual anatomy screen. The stereotaxic screen is indicated for correlating the tracked instrument location to the registered patient imagery. The virtual screen is indicated for displaying the virtual instrument location to the virtual anatomy to assist in percutaneous visualization and traiectory planning.

The virtual display should not be relied upon solely for absolute positional information and should always be used in conjunction with the displayed stereotaxic information.

Product codes

OLO

Device Description

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

X-Ray Based Imaging

Anatomical Site

spine or pelvis, spinal implant procedures, Posterior Pedicle Screw Placement in the thoracic and sacro-lumbar region.

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Intended User: Orthopedic surgeons or neurosurgeons
Care Setting: Operating Room

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

Bench testing was conducted to evaluate:

overall system accuracy
image registration accuracy
tracking accuracy

Studies were performed using phantoms under different conditions simulating clinical conditions:

Headset mounted statically and Headset moving above the markers
different distances between the Headset and the markers
different angles
partial detectability of the radiopaque beads and reflective points in the scan and IR image
different registration methods (Z-link and X-link)

The Z-link method uses a known mechanical position between the registration marker and the rigid reference marker, and the X-link method, calculates this position using the optical tracker. Under all test conditions, the average and standard deviation of the system's positional and angular errors were substantially equivalent to the predicate and met acceptance criteria. Tracking accuracy was verified per ASTM F2554-18.

The System's accuracy was also validated in a cadaver study, in which pedicle screws were positioned percutaneously in thoracic and sacro-lumbar vertebrae, using the Perc Pin as the rigid reference point. Both Z-link and X-link registration methods were used. The positional error was calculated as the difference between the actual screw tip position, derived from the post-op scan, and its virtual tip, as recorded by the xvision-Spine system. The trajectory error was calculated as the difference between the screw orientation and its recorded virtual trajectory. An overall mean positional error of 2.32mm (99% UBL= 2.58mm) and angular error of 1.66º (99% UBL=1.93º) was measured.

The System's clinical accuracy, using the X-link registration method was validated in a prospective, single arm multicenter study. System's accuracy was evaluated using the Gertzbein score by viewing the post-op scans. A total accuracy of 97.7% was demonstrated for seventeen (17) subjects who were scheduled for elective open spinal surgery that required posterior pedicle screw placement in the sacral/lumbar vertebrae. The accuracy of the XVS system was found to be very similar to the literature control rate of 95%.

Key Metrics

Positional error in cadaver study: mean of 2.32mm (99% UBL= 2.58mm)
Angular error in cadaver study: 1.66º (99% UBL=1.93º)
Clinical accuracy (Gertzbein score) in multicenter study: 97.7%

Predicate Device(s)

xvision Spine, manufactured by Augmedics Ltd. Israel (K190929)

Reference Device(s)

VV FLUORO 3D, manufactured by Brainlab AG, Germany (K070106)

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 882.4560 Stereotaxic instrument.

(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).

Summary

July 19, 2021

Image /page/0/Picture/1 description: The image contains the logos of the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA). The HHS logo is on the left and features a stylized human figure. The FDA logo is on the right and includes the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

Augmedics Ltd % Janice Hogan Regulatory Counsel Hogan Lovells US LLP 1735 Market Street. Floor 23 Philadelphia, Pennsylvania 19103

Re: K211188

Trade/Device Name: xvision Spine (XVS) Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: April 20, 2021 Received: April 20, 2021

Dear Janice Hogan:

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

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,

For: Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair, and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use

510(k) Number (if known)

K211188

Device Name

xvision Spine (XVS)

Indications for Use (Describe)

The virtual display should not be relied upon solely for absolute positional information and should always be used in conjunction with the displayed stereotaxic information

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

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K211188

510(k) SUMMARY

Augmedics' xvision Spine system

Submitter

Augmedics Ltd. 1 Ha-Tsmikha St. Yokneam Illit, 2069205 Israel

Phone: +972-4-3730111 Facsimile: +972-4-3730850

Contact Person: Tami Harel Date Prepared: April 20, 2021

Name of Device: xvision Spine

Common or Usual Name: XVS

Classification Name: Orthopedic Stereotaxic Instrument (21 CFR 882.4560)

Regulatory Class: Class II

Product Code: OLO

Predicate Devices: xvision Spine, manufactured by Augmedics Ltd. Israel (K190929)

Reference Device: VV FLUORO 3D, manufactured by Brainlab AG, Germany (K070106)

Intended Use / Indications for Use

The Headset of the xvision Spine System displays 2D stereotaxic screens and a virtual anatomy screen. The stereotaxic screen is indicated for correlating the tracked instrument location to the registered patient imagery. The virtual screen is indicated for displaying the virtual instrument location in relation to the virtual anatomy to assist in percutaneous visualization and trajectory planning.

The virtual display should not be relied upon solely for absolute positional information and should always be used in conjunction with the displayed stereotaxic information.

Device Description

The xvision Spine (XVS) system is an image-guided navigation system that is designed to assist surgeons in placing pedicle screws accurately, during open or percutaneous computer-assisted

spinal surgery. The system consists of a dedicated software, Headset, single use passive reflective markers and reusable components. It uses wireless optical tracking technology and displays to the surgeon the location of the tracked surgical instruments relative to the acquired intraoperative patient's scan, onto the surgical field. The 2D scanned data and 3D reconstructed model, along with tracking information, are projected to the surgeons' retina using a transparent near-eye-display Headset, allowing the surgeon to both look at the patient and the navigation data at the same time.

The principal technological differences between the XVS and its predicate include the addition of another registration method (X-link) compared to the single registration method for the predicate (Zlink); an additional option of a rigid reference point on the pelvis, in addition to the rigid reference point on the spine included in the predicate device; and improvements to the registration and tracking algorithms enabling successful registration and continuous tracking even when not all radiopaque beads and reflective points are detected.

Summary of Technological Characteristics

The modified xvision Spine System is similar in its technological features to its predicate device, the cleared xvision Spine systems include very similar hardware and software components, with the following basic components: software, Headset with optical tracking camera, single use passive reflective markers, rigid reference point, and reusable tool adaptors. The Headset in both systems is positioned on the surgeon's head and is designed to provide 2D and stereoscopic 3D augmented reality (AR) display with overlaid navigation information, onto patient's anatomy. The software in both systems is designed for real time calculation and display of the spatial position of the tip of the surgical instruments relative to patient's anatomy. Both systems share the same safety features and are compatible with the same intraoperative scanners. Both systems follow similar fundamental principles of operation.

	xvision Spine	xvision Spine (K190929)	Conclusion
	(subject device)	(predicate device)
Intended Use /
Indication for
Use	The xvision Spine System, with
xvision Spine System Software,
is intended as an aid for
precisely locating anatomical
structures in either open or
percutaneous spine procedures.
Their use is indicated for any
medical condition in which the
use of stereotactic surgery may
be appropriate, and where
reference to a rigid anatomical
structure, such as the spine or
pelvis, can be identified relative
to CT imagery of the anatomy.
This can include the spinal	The xvision Spine System, with
xvision Spine System Software, is
intended as an aid for precisely
locating anatomical structures in
either open or percutaneous
spine procedures. Their use is
indicated for any medical
condition in which the use of
stereotactic surgery may be
appropriate, and where reference
to a rigid anatomical structure,
such as the spine, can be
identified relative to CT imagery
of the anatomy. This can include
the spinal implant procedures,	Similar.
The pelvis was
added as an
additional rigid
anatomical
structure to
support the
addition of the
XVS Perc Pin.
This change
does not alter the
intended use of
the device and
does not change
	implant procedures, such as
Posterior Pedicle Screw	such as Posterior Pedicle Screw
Placement in the thoracic and	its fundamental
technology or
	xvision Spine
(subject device)	xvision Spine (K190929)
(predicate device)	Conclusion
	Placement in the thoracic and
sacro-lumbar region.
The Headset of the xvision
Spine System displays 2D
stereotaxic screens and a virtual
anatomy screen. The
stereotaxic screen is indicated
for correlating the tracked
instrument location to the
registered patient imagery. The
virtual screen is indicated for
displaying the virtual instrument
location in relation to the virtual
anatomy to assist in
percutaneous visualization and
trajectory planning.
The virtual display should not be
relied upon solely for absolute
positional information and
should always be used in
conjunction with the displayed
stereotaxic information	sacro-lumbar region.
The Headset of the xvision Spine
System displays 2D stereotaxic
screens and a virtual anatomy
screen. The stereotaxic screen is
indicated for correlating the
tracked instrument location to the
registered patient imagery. The
virtual screen is indicated for
displaying the virtual instrument
location in relation to the virtual
anatomy to assist in
percutaneous visualization and
trajectory planning.
The virtual display should not be
relied upon solely for absolute
positional information and should
always be used in conjunction
with the displayed stereotaxic
information	principles of
operation.
User Population	Orthopedic surgeons or
neurosurgeons	Orthopedic surgeons or
neurosurgeons	Identical
Intended Use
Environment	Operating Room	Operating Room	Identical
Main system
components	• Headset with near eye see-
through display and tracking
camera
• Software application
• Flat reflective markers
• Tool adaptors
• Reference point
• Accessories: Panel PC, Roll
Stand, 8" Tablet (Remote UI),
VESA docking station for 8"
Tablet	• Headset with near eye see-
through display and tracking
camera
• Software application
• Flat reflective markers
• Tool adaptors
• Reference point	Similar.
Providing
accessories as
opposed to
requiring the
user to purchase
them separately
does not raise
any new
questions of
safety and
effectiveness.
Modes of
Operation	• Patient Preparation
• System Set-up
• Intraoperative scan
• Scan Import
• Patient Registration
• Navigation	• Patient Preparation
• System Set-up
• Intraoperative scan
• Scan Import
• Patient Registration
• Navigation	Identical
Registration
Methods	• Z link - registration
transformation matrix is
calculated based on the
known mechanical position of	Z link - registration transformation
matrix is calculated based on the
known mechanical position of the
registration marker from the	Similar.
Both registration
methods are
	xvision Spine
(subject device)	xvision Spine (K190929)
(predicate device)	Conclusion
	the registration marker from the reference frame
• X link – registration transformation matrix is calculated based on the calculated relative position of an optical registration marker positioned near the reference frame	reference frame	based on the same fundamental technology and principles of operation. No new questions of safety or effectiveness are raised based on the difference between the Z-link and X-link methods, and the use of the Automatic Registration of the reference device further supports the substantial equivalence of this additional feature
Rigid reference
point	• Patient Clamp attached to the spinous process
• Perc Pin inserted into the PSIS
• Off-the-shelf Schantz screws	• Patient Clamp attached to the spinous process	Similar. Additional options for a rigid reference point do not alter the intended use of the device or raise new safety or performance questions. The questions of stability, biocompatibility and sterility are common to all configurations of a rigid reference point.
Instrument
(Tool) Adaptors	• Reusable
• universal (connects to various tools, not system-specific)
• VP & Ergonomic (system specific adaptors)	• Reusable
• universal (connects to various tools, not system-specific)	Similar. All configurations of Tool Adaptors share the same risk of improper fixation of the reflective marker to the surgical
	xvision Spine
(subject device)	xvision Spine (K190929)
(predicate device)	Conclusion
Localization
Technology	Optical	Optical	system. The
design mitigation
for this risk is
identical for all
configurations.
Thus, no new
questions of
safety and
performance are
raised
Identical
Reflective
Markers	• Flat
• Single use, provided sterile
• Sterilized by Gamma
Radiation	• Flat
• Single use, provided sterile
• Sterilized by Gamma Radiation	Identical
Optical Tracker	Single infrared camera,
positioned 0.5m above tracked
objects	Single infrared camera,
positioned 0.5m above tracked
objects	Identical
Tracking	6 DOF	6 DOF	Identical
System
Accuracy
Requirement	System Level Accuracy with a
mean 3D positional error of
2.0mm and mean trajectory
error of 2°	System Level Accuracy with a
mean 3D positional error of
2.0mm and mean trajectory error
of 2°	Identical
Imaging
Modality	X-Ray Based Imaging	X-Ray Based Imaging	Identical
Medical Device
Interfaces	O-arm Imaging System
Ziehm Vision FD Vario 3D C-Arm and RFD 3D
Siemens CIOS SPin
Airo system by Brainlab	O-arm Imaging System
Ziehm Vision FD Vario 3D C-Arm
and RFD 3D
Siemens CIOS SPin
Airo system by Brainlab	Identical
Communication
between
Scanner and
platform/compu
ter	USB & LAN connectivity using
DICOM	USB & LAN connectivity using
DICOM	Identical
Display and
Optics
Technology	Augmented Reality using near
eye see-through display; data
displayed on patient's anatomy	Augmented Reality using near
eye see-through display; data
displayed on patient's anatomy	Identical
Communication
between
Headset and
computer	Wireless, encrypted	Wireless, encrypted	Identical
Supported	2.4GHZ & 5 GHz:	2.4GHz:	Similar.
	xvision Spine
(subject device)	xvision Spine (K190929)
(predicate device)	Conclusion
Frequencies &
Transmission
protocols	802.11g/n/ac	802.11g	Support
additional
transmission
frequency and
protocol
increases
communication
rate. No new
safety or efficacy
questions are
raised due to this
modification
Frame rate of
displayed
images	60 fps	60 fps	Identical
Pixel resolution	1280x720 per eye	1280x720 per eye	Identical
Headset power
source	Li-ion rechargeable battery	Li-ion rechargeable battery	Identical
Number of
supported
Headsets	Two	Two	Identical

A table comparing the key features of the subject and the predicate devices is provided below:

Performance Data:

The following testing was conducted to evaluate the device:

. Bench testing was conducted in order to demonstrate that the xvision-Spine system performs according to its requirements and specifications. In particular, overall system accuracy, image registration accuracy and tracking accuracy were tested using phantoms, under different conditions simulating clinical conditions such as: Headset mounted statically and Headset moving above the markers, different distances between the Headset and the markers, different angles, partial detectability of the radiopaque beads and reflective points in the scan and IR image, and different registration methods (Z-link and X-link). The Z-link method uses a known mechanical position between the registration marker and the rigid reference marker, and the X-link method, calculates this position using the optical tracker. Under all test conditions, the average and standard deviation of the system's positional and angular errors were substantially equivalent to the predicate and met acceptance criteria.
Additionally, tracking accuracy was verified per ASTM F2554-18.
. The System's accuracy was also validated in a cadaver study, in which pedicle screws were positioned percutaneously in thoracic and sacro-lumbar vertebrae, using the Perc Pin as the rigid reference point. Both Z-link and X-link registration methods were used. The positional

error was calculated as the difference between the actual screw tip position, derived from the post-op scan, and its virtual tip, as recorded by the xvision-Spine system. The trajectory error was calculated as the difference between the screw orientation and its recorded virtual trajectory. An overall mean positional error of 2.32mm (99% UBL*= 2.58mm) and angular error of 1.66º (99% UBL*=1.93º) was measured. Thus, the system has demonstrated performance in 3D positional accuracy with a mean error statistically significantly lower than 3mm and in trajectory angle accuracy with a mean error statistically significantly lower than 3 degrees, both in phantom and cadaver studies.

. The System's clinical accuracy, using the X-link registration method was validated in a prospective, single arm multicenter study. System's accuracy was evaluated using the Gertzbein score by viewing the post-op scans. A total accuracy of 97.7% was demonstrated for seventeen (17) subjects who were scheduled for elective open spinal surgery that required posterior pedicle screw placement in the sacral/lumbar vertebrae. The accuracy of the XVS system was found to be very similar to the literature control rate of 95%.
. 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.
. Sterilization validation for the single use components was conducted in accordance with the ANSI AAMI ISO 11137-1:2006/(R)2015. Additionally, shelf life and packaging testing were performed to support the labeled shelf life. All tests were successfully completed.
. Reusable components were validated for cleaning, in accordance with the AAMI TIR30:2011 guidance, and for steam sterilization, in compliance with the partial cycle validation approach outlined in ANSI/AAMI/ISO 17665-1:2006/(R)2013 and the validation approach outlined in ANSI/AAMI/ISO 14937:2009/(R)2013
. The biocompatibility of all patient contact materials was verified according to ISO 10993-1:2018 and FDA guidance on the use of ISO 10993-1, June 16, 2016. All tests were successfully completed.
Software verification and validation testing was conducted as required by IEC 62304 and . FDA guidance on general principles of software validation, January 11, 2002.

All performance testing demonstrates that the xvision System performs according to specifications and functions as intended.

Conclusions

The xvision Spine System is substantially equivalent to its predicate, the cleared xvision Spine System. Both systems have the same intended use and similar indications, technological characteristics, and principles of operation. The minor differences in indications do not alter the intended surgical use of the device and do not affect its safety and effectiveness when used as labeled. None of the minor differences raise new types of safety or effectiveness questions. Performance data demonstrated that the xvision Spine system functions as intended.