The Anatase Navi Disposable Instrument is designed for use with Anatase Spine Surgery Navigation System and Remex Spine Surgery Navigation System II. 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 quidance system to enable open or percutaneous image guided surgery by means of registering intraoperative 2D fluoroscopic projections to pre-operative 3D CT imagerv. Example procedures include : Posterior-approach spinal implant procedures, such as pedicle screw placement, within the lumbar region.

Device Description

The Anatase Navi Disposable Instrument is designed for use with Anatase Spine Surgery Navigation System and Remex Spine Surgery Navigation System II. The Guiding awl is intended to support the surgeon to create an entry point before implanting the screw. The Spine pin with DRF-D and MIS LOC with DRF are both intended to fix the DRF on the vertebra by boned pins or the clamp. Once the DRF is fixed on the vertebra, the system can track the position of the patient's vertebra and instruments.

AI/ML Overview

This document is a 510(k) summary for the Anatase Navi Disposable Instrument. It primarily focuses on demonstrating substantial equivalence to a predicate device by addressing changes in material, packaging, and sterilization due to a change from repeat-use to single-use. The acceptance criteria and performance data provided are related to these specific changes, rather than clinical performance metrics of an AI/algorithm-based device.

Therefore, many of the requested details regarding AI/algorithm performance (e.g., sample size for the test set, data provenance, number of experts for ground truth, MRMC studies, standalone performance, training set details) are not applicable to this submission as it describes a physical medical instrument, not a software or AI device.

Here's a breakdown of the available information based on your request, highlighting where information is not present in the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria listed here are primarily for the changes related to the device being single-use and sterilized, rather than clinical performance of an AI/algorithm.

Test	Acceptance Criteria (Implicit from "Description" and "Compliance")	Reported Device Performance
Package	Sterile barrier integrity over intended shelf-life (validated per FDA-recognized standards).	"Validation is confirmed by the demonstration of sterile barrier integrity over the intended shelf-life." "all the results are passed."
Sterilization	Effective sterilization process per ISO 11135.	"The sterilization process must be controlled and validated in compliance with ISO 11135 to ensure the effectiveness of the sterilization process." "all the results are passed."
Biocompatibility Evaluation	No rejection, allergic, or adverse reactions when in contact with human tissue, blood, or bone, as per FDA guidance and ISO 10993-1.	"The subject device 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." (Implied acceptance through "all the results are passed.")
Risk Assessment	Effectiveness of all risk control measures, in accordance with ISO 14971:2007.	"The effectiveness of all risk control measures is verified in accordance with ISO 14971:2007." (Implied acceptance through "all the results are passed.")
Design Verification	Design output fulfills all design input requirements.	"The design output fulfills all design input requirements." (Implied acceptance through "all the results are passed.")

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

This document describes a physical instrument and its manufacturing/sterilization validation. It does not involve a clinical "test set" in the context of an AI/algorithm performance study. Therefore, this information is not applicable.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This is not applicable as the submission is for a physical medical instrument, not an AI/algorithm requiring expert ground truth in a clinical context.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This is not applicable as there is no clinical "test set" and no need for expert adjudication.

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

This is not applicable as the device is a physical instrument, not an AI or software device.

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

This is not applicable as the device is a physical instrument, not an AI or software device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the physical and process validation tests (package, sterilization, biocompatibility, risk assessment, design verification), the "ground truth" would be established by relevant scientific and engineering standards and validated laboratory test results, rather than clinical outcomes or expert consensus on medical images.

8. The sample size for the training set

This is not applicable as the device is a physical instrument and does not involve AI model training.

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

This is not applicable as the device is a physical instrument and does not involve AI model training or a "training set" in that context.

Summary

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July 5, 2024

Remex Medical Corp. Wang Cheng-Hsiung Quality Representative 4F, No.9, Jingke Road, Nantun Dist. Taichung, TW 408209 Taiwan

Re: K241625

Trade/Device Name: Anatase Navi Disposable Instrument Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: June 6, 2024 Received: June 6, 2024

Dear Wang Cheng-Hsiung:

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.

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).

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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 OS 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 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-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 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.

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-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 -S

Shumaya Ali, MPH 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

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Indications for Use

Submission Number (if known)

K241625

Device Name

Anatase Navi Disposable Instrument

Indications for Use (Describe)

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)

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

K241625 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
Date Prepared	June 6th, 2024
Device Name	Anatase Navi Disposable Instrument
Classification Name	Stereotaxic instrument
Regulation Number	882.4560
Product Codes	OLO
Device Class	Class II
Predicate Devices Information	K220348, Anatase Spine Surgery Navigation System (Primary Predicate)K180523, ΙΝΤAI Surgery Navigation System (Additional Predicate DeviceK233513, Remex Spine Surgery Navigation System II (Additional Predicate Device)
Device Description	The Anatase Navi Disposable Instrument is designed for use withAnatase Spine Surgery Navigation System and Remex Spine Surgery Navigation System II.The Guiding awl is intended to support the surgeon to create an entry point before implanting the screw.The Spine pin with DRF-D and MIS LOC with DRF are both intended to fix the DRF on the vertebra by boned pins or the clamp. Once the DRF is fixed on the vertebra, the system can track the position of the patient's vertebra and instruments.
Indications for Use	The Anatase Navi Disposable Instrument is designed for use withAnatase Spine Surgery Navigation System and Remex Spine Surgery Navigation System II. 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

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Remex Medical Corporation 4F, No. 9, Jingke Road, Nantun District, Taichung City408209, Taiwan
TechnologicalCharacteristics	The subject device has the same intended use, indications for use, design, fundamental technology, and surgical technique as the instrument in the predicate device, Anatase Spine Surgery Navigation System.The difference between the subject device and the predicate device is the fabricated material, package, and sterilization method. The package and sterilization are changed because the subject device is intended to be single-use instead of repeat-use as the predicate device. However, these modifications are tested accordingly to demonstrate that the subject device is as safe and effective as the predicate device.
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 carried out on the subject device to demonstrate that the subject device performs as safely and effectively as the predicate device.
Test	Description
Package	The package related to the sterile barrier must be validated to confirm the safety and effectiveness of the medical device. Validation is confirmed by the demonstration of sterile barrier integrity over the intended shelf-life.
Sterilization	The subject device is provided EO sterilized. The sterilization process must be controlled and validated in compliance with ISO 11135 to ensure the effectiveness of the sterilization process.
BiocompatibilityEvaluation	The materials that contact with human tissue, blood or bone must be considered for biocompatibility to ensure no rejection, allergic and adverse reactions occur. The subject device 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.
RiskAssessment	The effectiveness of all risk control measures is verified in accordance with ISO 14971:2007
DesignVerification	The design output fulfills all design input requirements.

The design of the device is identical to the predicate device. However, the change from repeat-use to single-use triggers sterilization and package change which require validation to ensure the sterile barrier and sterile parameter can fulfill its intended purpose. The tests in the above

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table are all tested in compliance with FDA-recognized standards, and all the results are passed. Therefore, REMEX believes the testing demonstrated that the subject devices are as safe and effective as the predicate devices.

The subject device has been compared to the predicate device with Conclusion respect to intended use, materials, design features, and performance data. The technological characteristics of the subject device do not raise new types of questions regarding safety and effectiveness. These comparisons demonstrate that the subject device is substantially equivalent to the predicate device.

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).