Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a standard image-guided navigation system using optical tracking and image registration. There is no mention of AI, ML, or related concepts in the intended use, device description, or performance studies.

Therapeutic

No
The device is a surgical navigation system that provides guidance for precise positioning of instruments and implants during surgery; it does not directly treat a disease or condition.

Diagnostic

No

The device is described as a surgical navigation system, intended for precise positioning of surgical instruments and guidance during spinal surgery. It provides intraoperative guidance to surgeons based on imaging, rather than diagnosing a condition.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is comprised of a "navigation cart, software and its accessories" and uses "wireless optical tracking technology," indicating the presence of hardware components beyond just software.

IVD (In Vitro Diagnostic)

Based on the provided information, the INTAI Surgery Navigation System 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.
INTAI System Function: The INTAI Surgery Navigation System is a surgical guidance system. It uses imaging data (fluoroscopy and CT) and optical tracking to help surgeons precisely position instruments during surgery. It does not analyze biological samples from the patient.
Intended Use: The intended use clearly states its purpose is for "precise positioning of surgical instruments or spinal implants" and "planning and intraoperative guidance system." This is a surgical tool, not a diagnostic test.

Therefore, the INTAI Surgery Navigation System falls under the category of a surgical navigation or image-guided surgery system, not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The INTAI Surgery Navigation System is indicated for precise positioning of surgical instruments or spinal implants during general spinal surgery when reference to a rigid anatomical structure, such as the vertebra, can be identified relative to a patient's fluoroscopic or CT imagery. It is intended as a planning and intraoperative guidance system to enable open or percutaneous image guided surgery by means of registering intraoperative 2D fluoroscopic projections to pre-operative 3D CT imagery.

Example procedures include but are not limited to: Posterior-approach spinal implant procedures, such as pedicle screw placement, within the lumbar region.

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

OLO

Device Description

The INTAI Surgery Navigation System, also known as an image guided system, is comprised of navigation cart, software and its accessories. The system uses wireless optical tracking technology to identify the position of instruments relative to the patient's anatomy and displays such position on preoperative or intraoperative images of the patient. The images can help guide the surgeons during spinal surgical procedures, such as spinal fusion. The software links all system components and provides several application modules for trajectory planning, image registration, instrument auto-identification and real-time navigation. The system is compatible with the following pedicle screw system and C-arm systems.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

fluoroscopic or CT imagery, intraoperative 2D fluoroscopic projections, pre-operative 3D CT imagery, CT

Anatomical Site

rigid anatomical structure, such as the vertebra, spinal, lumbar region

Indicated Patient Age Range

Not Found

Intended User / Care Setting

surgeons, general spinal surgery

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)

System Performance Validation: Clinical accuracy of the system is validated in cadaver against the acceptance criteria of mean positional error

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

0

September 20, 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.

Intai Technology Corporation Shih-Chang Chuang Manager No. 9 Jingke Rd., Nantun Dist., Taichung City, 40852 TW

Re: K180523

Trade/Device Name: INTAI Surgery Navigation System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: August 21, 2019 Received: August 23, 2019

Dear Shih-Chang Chuang:

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,

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

2

Indications for Use

510(k) Number (if known) K180523

Device Name INTAI Surgery Navigation System

Indications for Use (Describe)

The INTAI Surgery Navigation System is indicated for precise positioning of surgical instruments or spinal implants during general spinal surgery when reference to a rigid anatomical structure, such as the vertebra, can be identified relative to a patient's fluoroscopic or CT imagery. It is intended as a planning and intraoperative guidance system to enable open or percutaneous image guided surgery by means of registering intraoperative 2D fluoroscopic projections to pre-operative 3D CT imagery.

Example procedures include but are not limited to:

Posterior-approach spinal implant procedures, such as pedicle screw placement, within the lumbar region.

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)

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

This chapter provides a summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92.

5.1. Submitter's information

Applicant name	INTAI Technology Corporation
Address	No. 9, JingKe Rd., Nantun Dist., Taichung City 40852, Taiwan
(R.O.C.)
Telephone number	+886-4-2359-5336
Contact person	Teng-Kuan Tsai
Date prepared	August 15, 2019

5.2. Device information

Device name	INTAI Surgery Navigation System
Trade name	INTAI Surgery Navigation System
Common name	Surgery Navigation System for Spine
Classification name	Orthopedic Stereotaxic Instrument
Classification	Class II (21 CFR 882.4560)
Product code	OLO
Predicate device	Medtronic StealthStation System (K133444)
Primary product code: HAW
Secondary product code: OLO

5.3. Device description

The INTAI Surgery Navigation System, also known as an image guided system, is comprised of navigation cart, software and its accessories. The system uses wireless optical tracking technology to identify the position of instruments relative to the patient's anatomy and displays such position on preoperative or intraoperative images of the patient. The images can help guide the surgeons during spinal surgical procedures, such as spinal fusion. The software links all system components and provides several application modules for trajectory planning, image registration, instrument auto-identification and real-time navigation. The system is compatible with the following pedicle screw system and C-arm systems.

4

Compatible Systems	Device Name	510(k) Number
Pedicle screw	Wiltrom spinal fixation system	K172548
C-arm	Siemens Arcadis Varic	K040066
C-arm	GE OEC Fluorostar	K043076
C-arm	Ziehm Imaging Ziehm Solo	K092438

5.4. Intended use/Indications for use

The INTAI Surgery Navigation System is indicated for precise positioning of surgical instruments or spinal implants during general spinal surgery when reference to a rigid anatomical structure, such as the vertebra, can be identified relative to a patient's fluoroscopic or CT imagery. It is intended as a planning and intraoperative guidance system to enable open or percutaneous image guided surgery by means of registering intraoperative 2D fluoroscopic projections to pre-operative 3D CT imagery.

Example procedures include but are not limited to:

Posterior-approach spinal implant procedures, such as pedicle screw placement, within the lumbar region.

5.5. Substantial equivalence comparison
The subject device has the same intended use and technological characteristics as the predicate device. Below is a comparison of the indications for use and technological characteristics of subject device to the predicate device and an assessment of the equivalence of each characteristic. It is shown that technological differences in the subject device do not raise different questions of safety and effectiveness than the predicate device. Therefore, it is concluded that the subject device is substantially equivalent to the predicate device with respect to its indications for use and technological characteristics.

	Subject Device	Predicate Device	Equivalence Assessment
Device name	INTAI Surgery Navigation System	Medtronic StealthStation System	N/A
Submitter	INTAI Technology Co.	Medtronic Navigation, Inc.	N/A
510(k) number	TBD	K133444	N/A
Primary
product code	OLO	HAW	N/A
Secondary
product code	N/A	OLO	N/A
	Subject Device	Predicate Device	Equivalence Assessment
Indications for
use	The INTAI Surgery Navigation
System is indicated for precise
positioning of surgical
instruments or spinal implants
during general spinal surgery
when reference to a rigid
anatomical structure, such as the
vertebra, can be identified
relative to a patient's
fluoroscopic or CT imagery. It is
intended as a planning and
intraoperative guidance system
to enable open or percutaneous
image guided surgery by means
of registering intraoperative 2D
fluoroscopic projections to
pre-operative 3D CT imagery.
Example procedures include but
are not limited to:
Posterior-approach spinal
implant procedures, such as
pedicle screw placement, within
the lumbar region.	The StealthStation System is
intended as an aid for precisely
locating anatomical structures in
either open or percutaneous
procedures, The StealthStation
System 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 skull, a
long bone, or vertebra, can be
identified relative to a CT or MR
based model, fluoroscopy
images, or digitized landmarks of
the anatomy.	Equivalent
The scope of indications for use
of subject device is entirely
contained within that of
predicate device. The subject
device does not have any new
indications for use.
Operating
principle	The subject device creates a
relative position between the
patient and 2D C-arm images by
means of capturing
intra-operative 2D C-arm images
of the patient. The relative
position between the patient and
3D CT images is established
through the registration of
intra-operative 2D C-arm images
to pre-operative 3D CT images.
Subsequently, the subject device
can continuously display the
relative position of a tracked
instrument to a representation of
the patient's anatomy. The
surgeon can utilize this
information as a guide to
perform either open or
percutaneous spine surgery.	The navigation system creates a
translation map between points
in the patient anatomy and the
corresponding points on
radiologic images of the patient.
Once this map is established
through a process called
registration), the software can
display the relative position of a
tracked instrument to a
representation of the patient's
anatomy.
During surgery, the system tracks
the position of specialized
surgical instruments in or on the
patient anatomy and
continuously updates the
instrument position on these
images either by optical tracking
or electromagnetic tracking.	Equivalent
Both subject device and
predicate device are intended to
establish the relative position
between the tracked instrument
and patient's anatomy. The
subject device utilizes the same
optical tracking system as the
predicate device.
Main system
components	Optical tracker
Navigation cart, including optical
tracker, medical panel PC and
articulating arms	Optical and electromagnetic
(AXIEM)
localization system
Staff cart (optical system),
including camera and articulating
arms, and surgeon cart, including
surgeon monitor and articulating
arms	Equivalent
The function of optical tracker,
i.e. optical tracking, is equivalent
to that of optical localization
system. The subject device does
not have electromagnetic
localization system.
Equivalent
The subject device integrates
optical tracker and medical panel
PC into a cart. The function of
navigation cart is equivalent to
that of staff cart and surgeon
cart.
	N/A	Keyboard and mouse	Equivalent

5

6

	Subject Device	Predicate Device	Equivalence Assessment
Main system
components	No touch reader	N/A	Equivalent
No touch reader is used to
automatically identify the
instruments. User shall manually
identify the instrument when
using the predicate device.
Patient
tracking	Dynamic reference frame (DRF)	Dynamic referencing	Identical
Operating
system	Windows 7	Debian Linux	Equivalent
The function of navigation
software is successfully verified
on Windows' platform, which
does not affect its operation.
Modes of
operation	Planning & Navigation Module

Procedure approach (next/last
buttons) software for guiding
surgical navigation
Display of 3D image and
multi-planar reconstruction
image
Localization of patient's
position by DRF
Anatomical images
"Instrument view" at different
depths from the viewpoint of
instrument tip
"Instrument navigation panel"
for trajectory planning | Planning & Navigation Module
Procedure guided software
(next/back buttons) with voice
prompt, instruction window
and task visualization
Advanced 3-D modeling
capabilities for multiple
models or plans
PatienTrak dynamic
referencing
User definable "Look-Ahead"
views and display setup
Display of the 3D accuracy
"Zone"
Linear measurement tools in
all planes for anatomical sizing
3D guidance view with depth
display
Screen export as PC
compatible JPEG file on
CD-ROM | Equivalent
The subject device does not have
those modules incorporated in
the predicate device, i.e. module
5, 6 and 8. These modules
provide optional functions and
do not affect the overall
navigation procedure. |
| Registration
C-arm/CT image registration
Minimally invasive surgery for
lumbar spine | | Advanced Contour Registration
Registration is achieved by
dragging probe across
vertebral body
For use in cervical, thoracic
and lumbar spine
Enabling technology for
minimal access spine surgery | Equivalent
Both subject device and
predicate device need
registration to establish spatial
coordinate transformation. |
| Supported
image
modalities | CT | CT or MR | Equivalent
The subject device uses the same
CT image modality as the
predicate device. |

5.6. Non-clinical testing

Verification and validation activities have been completed to provide sufficient assurance that the subject device meets the performance requirements under its indications for use conditions. Below is a summary of all performance tests carried out on the subject device. It is demonstrated that the subject device performs as safely and effectively as the predicate device.

7

Test	Description
Cleaning	Cleaning of those reusable accessories is validated in
accordance with AAMI TIR30:2011/(R)2016, ASTM F3293-18
and FDA guidance for the “Reprocessing medical devices in
health care settings: Validation methods and labeling” issued on
March 17, 2015.
Sterilization	Moist heat sterilization of those reusable accessories is
validated in accordance with ISO 17665-1:2006.
Repeated
Reprocessing	Reliability of those reusable instruments after repeated
reprocessing is validated throughout their use-life.
Biocompatibility	Biocompatibility of those accessories that come into contact
with patient is evaluated in accordance with FDA guidance for
the use of international standard ISO 10993-1, “Biological
evaluation of medical devices – Part 1: Evaluation and testing
within a risk management process” issued on June 16, 2016 and
ISO 10993-1:2009.
Software	Software is verified and validated in accordance with FDA
guidance for the content of premarket submissions for software
contained in medical devices issued on May 11, 2005 and IEC
62304:2006 + A1:2015.
Electrical Safety	Electrical safety of the system is complied with the
requirements of ANSI/AAMI ES60601-1:2005/(R)2012 and
A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012.
Electromagnetic
Compatibility	Electromagnetic compatibility of the system is complied with
the requirements of IEC 60601-1-2:2014.
Usability	Usability of the system is validated in accordance with
ANSI/AAMI HE75:2009/(R)2013, IEC 62366-1:2015 and IEC
60601-1-6:2010 + A1:2013.
Accuracy	Positional accuracy of the system is evaluated in accordance
with ASTM F2554-10.
System
Performance
Validation	Clinical accuracy of the system is validated in cadaver against
the acceptance criteria of mean positional error $≤$ 3.0 mm and
mean trajectory angle error $≤$ 3.0 degrees.
Risk Assessment	The effectiveness of all risk control measures is verified in
accordance with ISO 14971:2007

8

Test	Description
Design
Verification	The design output fulfills all design input requirements.
User Needs	The system meets the needs of the end user under simulated use conditions.

5.7. Clinical testing

No clinical testing has been conducted.

5.8. Conclusions

The results of all non-clinical tests demonstrate that the INTAI Surgery Navigation System performs as safely and effectively as the legally marketed predicate device. According to the comparison based on the requirements of 21 CFR 807.87 and the information provided herein, it is concluded that the subject device is substantially equivalent to the predicate device with respect to its indications for use and technological characteristics.