The Anatase Spine Surgery Navigation System and Remex Spine Surgery Navigation System II are indicated for precise positioning of surgical instruments or spinal implants during general spine 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: Posterior-approach spinal implant procedures, such as pedicle screw placement, with the lumbar region.

Device Description

The subject devices, Image calibrator-21F and Image calibrator-31F are designed for use with Anatase Spine Surgery Navigation System (K230783) and Remex Spine Surgery Navigation System II (K233513). The subject devices are modified from previously cleared devices to be compatible with the 21 cm/ 31 cm flat panel C-arm for CT image position and calibration.

The software upgrade is due to these newly added Image calibrators and one added function of auto-labeling for CT/C-arm image registration.

AI/ML Overview

This 510(k) clearance letter and summary discuss the Anatase Spine Surgery Navigation System and Remex Spine Surgery Navigation System II. However, the provided document does not contain the detailed acceptance criteria and the specific study data proving the device meets these criteria in the format requested.

The document states:

"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."
"The test methods are the same as the previously cleared 510(k), K233513."
"All the results are passed."

This indicates that performance testing was conducted and passed, but the specific metrics, criteria, and the results themselves are not enumerated in this public summary. This level of detail is typically found in the full 510(k) submission, which is not publicly released in its entirety.

Therefore, I cannot extract the information needed to fill out the requested table and answer the specific questions about the study design, sample sizes, expert qualifications, and ground truth establishment from the provided text.

Based on the provided text, here's what can be inferred or explicitly stated regarding performance testing, but not the detailed acceptance criteria or results:

Type of device: Spine Surgery Navigation System. These systems are typically evaluated based on their accuracy in guiding surgical instruments or implants relative to anatomical structures.
Performance Data Section: The document mentions "Verification and validation activities have been completed" for the subject device.
Test Descriptions mentioned:
- Software: Verified and validated in accordance with FDA guidance for software in medical devices and IEC 62304.
- Risk Assessment: Effectiveness of risk control measures verified in accordance with ISO 14971.
- Design Verification: Design output fulfills design input requirements.
Comparison to Predicate: "The intended use and fundamental technology of the subject device are identical to the predicate devices and could share the same testing methods as the predicate devices. All the results are passed." This implies that the performance was at least as good as the predicate device (K233513).
Nature of changes: The current 510(k) is for a modification to the device, including compatibility with new Image Calibrators (21F and 31F for flat panel C-arm CT imaging) and an auto-labeling function for CT/C-arm image registration. Performance testing would have focused on verifying these changes do not adversely affect safety and effectiveness, and that the existing fundamental performance (e.g., accuracy of navigation) is maintained.

Conclusion: The provided text confirms that performance testing was conducted and passed, but does not provide the specific acceptance criteria or the reported performance data in a quantifiable manner. The document acts as a summary and approval letter, not a detailed study report.

Summary

FDA 510(k) Clearance Letter - K251315

Page 1

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

Doc ID # 04017.07.05

May 29, 2025

Remex Medical Corp.
Cheng-Hsiung Wang
Official Correspondent
4F, No.9, Jingke Road, Nantun District
Taichung, 408209
Taiwan

Re: K251315
Trade/Device Name: Anatase Spine Surgery Navigation System and Remex Spine Surgery Navigation System II
Regulation Number: 21 CFR 882.4560
Regulation Name: Stereotaxic Instrument
Regulatory Class: Class II
Product Code: OLO
Dated: April 29, 2025
Received: April 29, 2025

Dear Cheng-Hsiung Wang:

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 (the 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 available 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.

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K251315 - Cheng-Hsiung Wang Page 2

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-

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K251315 - Cheng-Hsiung Wang Page 3

assistance/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

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

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FORM FDA 3881 (8/23) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.

510(k) Number (if known)
K251315

Device Name
Anatase Spine Surgery Navigation System and Remex Spine Surgery Navigation System II

Indications for Use (Describe)
The Anatase Spine Surgery Navigation System and Remex Spine Surgery Navigation System II are indicated for precise positioning of surgical instruments or spinal implants during general spine 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: Posterior-approach spinal implant procedures, such as pedicle screw placement, with 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."

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Remex Medical Corporation 4F, No. 9, Jingke Road, Nantun District, Taichung City408209, Taiwan

510(k) Summary

Submitted By	REMEX MEDICAL CORP.4F., No.9 Jingke Rd., Nantun District, Taichung, TW 408209Tel. +886-4-23595336Fax.+886-4-23598875
Contact Person	Chegn-Hsiung WangKevin816@mail.intai.com.tw
Prepared by	Jessie Wangjessiewang@mail.intai.com.tw
Date Prepared	April 29th, 2025
Device Name	Anatase Spine Surgery Navigation System and Remex Spine Surgery Navigation System II
Classification Name	Stereotaxic instrument
Regulation Number	882.4560
Product Codes	OLO
Device Class	Class II
Predicate Devices Information	K233513, Remex Spine Surgery Navigation System II (primary)
Device Description	The subject devices, Image calibrator-21F and Image calibrator-31F are designed for use with Anatase Spine Surgery Navigation System (K230783) and Remex Spine Surgery Navigation System II (K233513). The subject devices are modified from previously cleared devices to be compatible with the 21 cm/ 31 cm flat panel C-arm for CT image position and calibration.The software upgrade is due to these newly added Image calibrators and one added function of auto-labeling for CT/C-arm image registration.
Indications for Use	The Anatase Spine Surgery Navigation System and Remex Spine Surgery Navigation System II, are 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:Posterior-approach spinal implant procedures, such as pedicle screw placement, within the lumbar region.
Technological Characteristics	The subject devices have the same intended use, same indications for use, same fundamental technology, and similar design as the predicate devices, Anatase Spine Surgery Navigation System (K230783) and Remex Spine Surgery Navigation System II (K233513).The difference between the subject devices and the predicate devices is the upgrade of the system software version, and new Image calibrator for

K251315 - Page 1 of 2

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Remex Medical Corporation 4F, No. 9, Jingke Road, Nantun District, Taichung City408209, Taiwan

	corresponding compatible devices. However, these modifications share the same function and fundamental technology with the predicate devices.
Performance Data	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 which should carried out on the subject device to demonstrated that the subject device performs as safely and effectively as the predicate device.Test DescriptionSoftware - Software is verified and validated in accordance with FDA guidance for the content of premarket submissions for software contained in medical devices and IEC 62304.Risk Assessment - The effectiveness of all risk control measures is verified in accordance with ISO 14971.Design Verification - The design output fulfills all design input requirements. The test methods are the same as the previously cleared 510(k), K233513.The intended use and fundamental technology of the subject device are identical to the predicate devices and could share the same testing methods as the predicate devices. All the results are passed. Therefore, REMEX believes the testing demonstrated that the subject devices are as safe and effective as the predicate devices.
Conclusion	The Anatase Spine Surgery Navigation System and Remex Spine Surgery Navigation System II and the predicate devices have the same intended use and have the same or similar technological characteristics. Moreover, the information contained in this submission demonstrates that any differences in their technological characteristics do not raise new issues of safety or effectiveness. Hence, The Anatase Spine Surgery Navigation System and Remex Spine Surgery Navigation System II is substantially equivalent to the predicate devices.

corresponding compatible devices. However, these modifications share the same function and fundamental technology with the predicate devices.

Performance Data

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 which should carried out on the subject device to demonstrated that the subject device performs as safely and effectively as the predicate device.Test DescriptionSoftware - Software is verified and validated in accordance with FDA guidance for the content of premarket submissions for software contained in medical devices and IEC 62304.Risk Assessment - The effectiveness of all risk control measures is verified in accordance with ISO 14971.Design Verification - The design output fulfills all design input requirements. The test methods are the same as the previously cleared 510(k), K233513.The intended use and fundamental technology of the subject device are identical to the predicate devices and could share the same testing methods as the predicate devices. All the results are passed. Therefore, REMEX believes the testing demonstrated that the subject devices are as safe and effective as the predicate devices.

Conclusion

The Anatase Spine Surgery Navigation System and Remex Spine Surgery Navigation System II and the predicate devices have the same intended use and have the same or similar technological characteristics. Moreover, the information contained in this submission demonstrates that any differences in their technological characteristics do not raise new issues of safety or effectiveness. Hence, The Anatase Spine Surgery Navigation System and Remex Spine Surgery Navigation System II is substantially equivalent to the predicate devices.

K251315 - Page 2 of 2

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).