The Anatase Spine 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.

Device Description

The Anatase Spine Surgery Navigation System, also known as an Image Guided System, is comprised of a platform, clinical software, surgical instruments, and a referencing system. The system uses optical tracking technology to track the position of instruments in relation to the surgical anatomy and identifies this position on diagnostic or intraoperative images of a patient. The system helps guide surgeons during spine procedures such as spinal fusion. The software functionality in terms of its feature sets is categorized as imaging modalities, registration, planning, interfaces with medical devices, and views.

The modified Anatase Spine Surgery Navigation System, the subject of these 510(k) applications, introduces software, hardware and instruments modifications to the original Surgery Navigation System cleared in 510(k) K180523.

AI/ML Overview

The Anatase Spine Surgery Navigation System, Model number: SNS-Spine2-S and SNS-Spine2-V, is indicated for precise positioning of surgical instruments or spinal implants during general spinal surgery.

Here's a breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance:

Test	Acceptance Criteria/Standard	Reported Device Performance
Sterilization	ISO 17665-1:2006	Moist heat sterilization of reusable accessories validated.
Repeated Reprocessing	ISO 11737-2: 2019	Reliability of reusable instruments validated.
Biocompatibility	FDA guidance for ISO 10993-1 (June 16, 2016), ISO 10993-1:2009	Accessories in contact with patient evaluated.
Software	FDA guidance for software in medical devices (May 11, 2005)	Software verified and validated.
Electrical Safety	ANSI/AAMI ES60601-1:2005/(R)2012, A1:2012, C1:2009/(R)2012, A2:2010/(R)2012	Complied with requirements.
Electromagnetic Compatibility	IEC 60601-1-2:2014	Complied with requirements.
Usability	ANSI/AAMI HE75:2009/(R)2013, IEC 62366-1:2015, IEC 60601-1-6:2010 + A1:2013	System usability validated.
Accuracy	ASTM F2554-18	Positional accuracy evaluated. (Specific results not given in summary)
Risk Assessment	ISO 14971:2007	Effectiveness of risk control measures verified.
Design Verification	Not explicitly stated, but "all design input requirements"	Design output fulfills all design input requirements.

2. Sample size used for the test set and the data provenance:

The provided document does not specify sample sizes for any test sets nor the data provenance (e.g., country of origin, retrospective/prospective). The studies are non-clinical, meaning they did not involve patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided in the document as these were non-clinical tests.

4. Adjudication method for the test set:

This information is not provided in the document as these were non-clinical tests.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No clinical testing, including MRMC studies, was conducted. The document explicitly states: "No clinical testing has been conducted."

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

The provided information focuses on the entire system's performance, which is an image-guided navigation system that would inherently involve human interaction (a surgeon). While software verification and validation were performed, the document does not distinguish between human-in-the-loop and algorithm-only performance for a standalone assessment in a manner that would typically be seen for an AI diagnostic device. The "Accuracy" test implies an assessment of the system's ability to track and display positions, which is a standalone performance metric for the navigation component, but it's not described as an AI-specific algorithm performance.

7. The type of ground truth used:

For the accuracy testing, the ground truth would likely be established through precise physical measurements to determine the true positional accuracy of the system against a known standard. However, the document does not specify the exact methodology for establishing the ground truth beyond referencing ASTM F2554-18. For other tests like electrical safety, EMC, and sterilization, the "ground truth" is defined by compliance with the referenced standards.

8. The sample size for the training set:

As this is a navigation system and not explicitly an AI diagnostic device in the context of machine learning model training, the concept of a "training set" in that sense is not directly applicable or discussed in the document. Software verification and validation were performed, but details on data used for these processes are not provided.

9. How the ground truth for the training set was established:

Same as above, the concept of a "training set" with established ground truth as typically understood in AI/machine learning is not applicable here. Software verification and validation would use various testing methods to ensure the software performs as designed and meets requirements.

Summary

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

August 24, 2022

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 and Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.

Remex Medical Corporation % Sandy Liu Consultant Jin Services Co. 9F-1, No13, Lane41, Zhangrong Rd, Sec. 5, North District Tainan City, 70447 Taiwan

Re: K220348

Trade/Device Name: Anatase Spine Surgery Navigation System, Model number: SNS-Spine2-S and SNS-spine2-V Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Code: OLO

Dear Sandy Liu:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated July 14, 2022. Specifically, FDA is updating this SE Letter for a typo in the company name as an administrative correction.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Shumaya Ali, M.P.H., OHT6: Office of Orthopedic Devices, 301-796-2356, Shumaya.Ali(@fda.hhs.gov.

Sincerely,

Shumaya Ali-S

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

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

July 14, 2022

Image /page/1/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The FDA logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA wordmark on the right. The Department of Health and Human Services logo is a stylized depiction of a human figure embracing a sphere. The FDA wordmark is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Remax Medical Corporation % Sandy Liu Consultant Jin Services Co. 9F-1. No13. Lane41. Zhangrong Rd. Sec. 5. North District Tainan City, 70447 Taiwan

Re: K220348

Trade/Device Name: Anatase Spine Surgery Navigation System, Model number: SNS-Spine2-S and SNS-spine2-V Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: June 13, 2022 Received: June 13, 2022

Dear Sandy Liu:

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.

{2}------------------------------------------------

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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for

combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

For comprehensive regulatory information about medical devices and radiation-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-S

Enclosure

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

Indications for Use

510(k) Number (if known) K220348

Device Name

Anatase Spine Surgery Navigation System, Model number: SNS-Spine2-S and SNS-spine2-V

Indications for Use (Describe)

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)> 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."

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

K220348

510(k) Summary

As required by 21CFR 807.92

Applicant Information

Company Name:	REMEX MEDICAL CORP.
Company Address:	4F., No. 9, Jingke Road, Nantun Dist. Taichung, TW 408224, 408224, Taiwan
Telephone:	+886-4-23595336
Fax:	+886-4-23598875
Contact Person:	Shih-Chang Chuang
Summary Updated Date:	June 9, 2022

Official Correspondent

Company Name:	Jin Services Co.
Company Address:	9F-1, No13, Lane41, Zhangrong Rd, Sec. 5, North Distrit, Tainan City70447 Taiwan
Telephone:	+886-917535026
Email:	contact@fdaclass.com
Contact Person:	Sandy Liu, Consultant

Device Name:

Trade Name:	Anatase Spine Surgery Navigation System, Model number: SNS-Spine2-Sand SNS-spine2-V
Classification Name:	Stereotaxic instrument
Regulation Number:	882.4560
Product Code:	OLO
Device Class:	Class 2
Panel:	Stereotaxic, Trauma and Restorative Devices (DHT6C)

PREDICATE DEVICE:

K180523, INTAI Surgery Navigation System, Intai Technology Corporation

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

REFERENCE DEVICE:

K162309 StealthstationS8 System Platforms K172548 Wiltrom Spinal Fixation System K132884 PATHFINDER NXT MINIMALLY INVASIVE PEDICLE SCREW SYSTEM K113529 CD HORIZON VOYAGER SPINAL SYSTEM K150231 Navigated Disc Prep Instruments

Purpose of Submission: The purpose of this submission is to 1). The Optical Tracker camera "Polaris Spectra" has been discontinued by the supplier, NDI. We add the optional camera "Polaris Vega" to ensure continuous supply of products after clearing the stock of "Polaris Spectra". 2) The calibration process of navigation before surgery become to utilize smoothly via modification of calibration software module and changing the design of calibration instruments. 3) The additional specific screwdrivers are for use with more brands of pedical screws, specifically, Wiltrom™ Spinal Fixation System, PATHFINDER NXT™ Minimally Invasive Pedicle Screw System, and CD HORIZON SOLERA VOYAGER 4.75 SPINAL SYSTEM™. 4) The original trade name "INTAI Surgery Navigation System" was changed after design modification and rename to "Anatase Spine Surgery Navigation System".

Device Description

Intended Use:

The Anatase Spine Surgery Navigation System, Model number: SNS-spine2-S and SNS-spine2-V 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

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

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.

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.

Items	Subject Device	Predicate Device	Comparison Result
	Anatase Spine Surgery Navigation System, Model number: SNS-Spine2-S, SNS-Spine2-V	INTAI Surgery Navigation System
Submitter	REMEX MEDICAL CORP.	Intai Technology Corporation	N/A
Trade name	Anatase Spine Surgery Navigation System	INTAI Surgery Navigation System	N/A
Model number	SNS-Spine2-SSNS-Spine2-V	SNS-Spine	Note 1
510(k) Number	N/A	K180523	N/A
Device Regulation number	882.4560	882.4560	same
Classification	2	2	same
FDA Product Code	OLO	OLO	same
Indications for Use	The Anatase Spine Surgery Navigation System, Model number: SNS-Spine2-S, SNS-Spine2-V SNS-spine2-S and SNS-spine2-V 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	The Intai Technology Corporation 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:	Same
Items	Subject Device	Predicate Device	ComparisonResult
	Anatase Spine SurgeryNavigation System, Modelnumber: SNS-Spine2-S,SNS-Spine2-V	INTAI Surgery NavigationSystem
	include but are not limited to:Posterior-approach spinal implantprocedures, such as pedicle screwplacement, within the lumbarregion.	Posterior-approach spinalimplant procedures, such aspedicle screw placement, withinthe lumbar region.
Operatingprinciple	The subject device creates arelative position between thepatient and 2D C-arm images bymeans of capturing intra-operative2D C-arm images of the patient.The relative position between thepatient and 3D CT images isestablished through the registrationof intra-operative 2D C-armimages to pre-operative 3D CTimages. Subsequently, the subjectdevice can continuously displaythe relative position of a trackedinstrument to a representation ofthe patient's anatomy. The surgeoncan utilize this information as aguide to perform either open orpercutaneous spine surgery.	The subject device creates arelative position between thepatient and 2D C-arm images bymeans of capturing intra-operative 2D C-arm images ofthe patient. The relative positionbetween the patient and 3D CTimages is established throughthe registration of intra-operative 2D C-arm images topre-operative 3D CT images.Subsequently, the subject devicecan continuously display therelative position of a trackedinstrument to a representation ofthe patient's anatomy. Thesurgeon can utilize thisinformation as a guide toperform either open orpercutaneous spine surgery.	Same
Supportedimage format	DICOM	DICOM	Same
Prescriptionfor use	Yes	Yes	Same
Over theCounter	No	No	Same
Contain anydrugs orbiologics	No	No	Same
ContainLATEX	Yes	Yes	Same
REUSE	Yes	Yes	Same
Non-Steriledevicesprovided	Yes	Yes	Same
Operatingtemperature	10°C - 40°C	10°C - 40°C	Same
Operatinghumidity	30-75% (RH)	30-75% (RH)	Same
Operatingpressure	700hPa-1060 hPa	700hPa-1060 hPa	same
Storage	-10°C - 50°C	-10°C - 50°C	same
Items	Subject Device	Predicate Device	Comparison Result
	Anatase Spine SurgeryNavigation System, Modelnumber: SNS-Spine2-S,SNS-Spine2-V	INTAI Surgery NavigationSystem
temperature
Storagehumidity	10-90% (RH)	10-90% (RH)	same
Storagepressure	700 hPa-1060 hPa	700 hPa-1060 hPa	same
Transporttemperature	-10°C - 50°C	-10°C - 50°C	same
Transporthumidity	10-90% (RH)	10-90% (RH)	same
Transportpressure	700 hPa-1060 hPa	700 hPa-1060 hPa	same
Main systemcomponents	● Navigation cart, includingoptical tracker, No touchreader, medical panel PC andarticulating arms● Image Calibrator withAssembly Kit● Instrument kits● Navigation softwareinstallation Disc● User Manual and SoftwareInstallation Manual	● Navigation cart, includingoptical tracker, No touchreader, medical panel PCand articulating arms● Image Calibrator withAssembly Kit● Instrument kits● Navigation softwareinstallation Disc● User Manual andSoftware InstallationManual	same

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

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

*Note 1: The Optical Tracker camera "Polaris Spectra" has been discontinued by the supplier, NDI. We add the optional Tracker camera "Polaris Vega" to ensure continuous supply of products after clearing the stock of "Polaris Spectra". To identify the different Optical Tracker camera for use in same navigation system, two (2) model numbers are created in the subject devices. "Polaris Vega" is current popular use in similar navigation system, such as reference device "K162309 StealthstationS8 System Platforms".

Therefore, it is concluded that the subject device (modified from predicate devices) is substantially equivalent to the predicate device with respect to its indications for use and technological characteristics.

Summary of 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.

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

Test	Description
Sterilization	Moist heat sterilization of those reusable accessories is validatedin accordance with ISO 17665-1:2006.
RepeatedReprocessing	Reliability of those reusable instruments after repeatedreprocessing is validated throughout their use-life, for referenceof ISO 11737-2: 2019
Biocompatibility	Biocompatibility of those accessories that come into contactwith patient is evaluated in accordance with FDA guidance forthe use of international standard ISO 10993-1, "Biologicalevaluation of medical devices – Part 1: Evaluation and testingwithin a risk management process" issued on June 16, 2016 andISO 10993-1:2009.
Software	Software is verified and validated in accordance with FDAguidance for the content of premarket submissions for softwarecontained in medical devices issued on May 11, 2005,
Electrical Safety	Electrical safety of the system is complied with the requirementsof ANSI/AAMI ES60601-1:2005/(R)2012 and A1:2012,C1:2009/(R)2012 and A2:2010/(R)2012.
ElectromagneticCompatibility	Electromagnetic compatibility of the system is complied withthe requirements of IEC 60601-1-2:2014.
Usability	Usability of the system is validated in accordance withANSI/AAMI HE75:2009/(R)2013, IEC 62366-1:2015 and IEC60601-1-6:2010 + A1:2013.
Accuracy	Positional accuracy of the system is evaluated in accordancewith ASTM F2554-18.
Risk Assessment	The effectiveness of all risk control measures is verified inaccordance with ISO 14971:2007.
DesignVerification	The design output fulfills all design input requirements.

Clinical testing:

No clinical testing has been conducted.

Conclusions:

The conclusion drawn from the non-clinical tests demonstrates that the subject device, the Anatase Spine Surgery Navigation System, Model number: SNS-Spine2-S, SNS-Spine2-V, is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K180523. Thus, Anatase Spine Surgery Navigation System, Model number: SNS-Spine2-S, SNS-Spine2-V is substantially equivalent to the predicate devices with respect to its intended use, technological characteristics and performance characteristics.

Page 6 of 6

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).