The Medyssey Navigation System is indicated for use during the preparation and placement of Medyssey screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The Medyssey Navigation System is reusable and is specifically designed for use with the Medtronic Navigation StealthStation System which 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 a vertebra can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks for the anatomy. Use of the Medyssey Navigation System is limited to use only with ILIAD™ Spinal Fixation System and Zenius™ Spinal Fixation System (including Hedjet and ARTeMIS pedicle screw systems).

Device Description

Medyssey Navigation System is comprised of reusable instruments intended to be used in conjunction with the Medtronic StealthStation® Navigation System and its associated NavLock arrays to assist surgeons in precisely locating anatomical structures in either open, minimally invasive, or percutaneous procedures for preparation and placement of pedicle screw system implants. The Medyssey Navigation System is comprised of Bone Taps and Screw Drivers. These instruments are made of medical grade stainless steel. The Medyssey Navigation System is supplied clean and non-sterile, to be sterilized by the end user.

AI/ML Overview

Here's an analysis of the provided FDA 510(k) clearance letter for the Medyssey Navigation System, focusing on the acceptance criteria and the study that proves the device meets those criteria.

Note: This document is a 510(k) clearance letter, which primarily focuses on demonstrating substantial equivalence to a predicate device. It does not contain the detailed study protocols, results, and statistical analyses typically found in a full submission. Therefore, some information, especially regarding specific numerical performance metrics, sample sizes for test sets, and detailed adjudication methods, is not explicitly stated in this high-level summary.

Acceptance Criteria and Device Performance

The provided document defines the acceptance criteria implicitly through "Performance Testing" which aims to demonstrate "substantial equivalence to the predicate instruments" and suitability for intended use.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (Implicit from document)	Reported Device Performance (as per document)
Functionality & Accuracy	Appropriate for intended use with Medtronic StealthStation® System using NavLock Tracker	Demonstrated functionality and accuracy
Compatibility	Compatible with Medtronic StealthStation® System using NavLock Tracker	Demonstrated compatibility
Substantial Equivalence	Similar technological characteristics (design, dimensions, materials, technology) and similar function to predicate devices	Performance testing demonstrates substantial equivalence
Reprocessing	Ability to be reprocessed (cleaned and sterilized) according to recognized standards	Reprocessing (cleaning and sterilization) validations conducted per ANSI/AAMI ST98 and ISO 17665
Biocompatibility	Biocompatible for patient contact	Biocompatibility data leveraged from K181978 and K232218 (reference devices)

Study Details

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

Sample Size: Not explicitly stated. The document mentions "comparative dimensional analysis" and "performance testing" of the Medyssey Navigation System instruments. The specific number of instruments tested, or cases/measurements included in the accuracy and functionality testing, is not provided.
Data Provenance: Not explicitly stated. The nature of the testing ("comparative dimensional analysis," "functionality, accuracy and compatibility with the Medtronic StealthStation® System") suggests laboratory and/or bench testing. There is no indication of clinical data from patients or a specific country of origin for the data beyond Medyssey Co, Ltd. being based in Korea. It appears to be a prospective test conducted for the purpose of this submission, based on physical and functional evaluation of the device.

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. The type of testing described (dimensional analysis, compatibility, reprocessing validations) typically relies on engineering and quality control measurements rather than expert human interpretation in the same way an AI diagnostic device would. If any expert evaluation was involved in assessing functionality or accuracy, it is not detailed.

4. Adjudication method for the test set

This information is not provided in the document. Given the nature of the testing (dimensional analysis, compatibility, reprocessing), a formal adjudication method by multiple experts (like 2+1 or 3+1) is unlikely to be applicable in the same way it would for a clinical study involving subjective interpretations. The results would likely be based on objective measurement comparisons against specifications or predicate device data.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No, an MRMC comparative effectiveness study was not done. The provided document describes engineering and performance testing to demonstrate substantial equivalence, not a clinical study involving multiple human readers assessing performance with or without AI assistance. The Medyssey Navigation System is an instrument; it's not an AI/software device that assists human interpretation of medical images or data.

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

This question is not applicable as the Medyssey Navigation System is a surgical instrument. It is designed to be used with a human surgeon and the Medtronic StealthStation® Navigation System (which itself is a navigation tool, not an autonomous algorithm for diagnosis or treatment decision-making). The "algorithm only" concept does not apply here.

7. The type of ground truth used

The "ground truth" for the performance testing appears to be based on:
- Engineering Specifications/Standards: For dimensional analysis and compatibility with the Medtronic StealthStation.
- Recognized Standards: For reprocessing validations (ANSI/AAMI ST98 and ISO 17665).
- Predicate Device Data/Characteristics: For comparison to demonstrate substantial equivalence in terms of design, dimensions, materials, technology, and function.

8. The sample size for the training set

This information is not applicable/not provided. The Medyssey Navigation System is a physical instrument, not a machine learning or AI model that requires a training set. The term "training set" is relevant for AI/ML algorithms.

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

This information is not applicable/not provided for the same reasons as point 8.

Summary

FDA 510(k) Clearance Letter - Medyssey Navigation System

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

Doc ID # 04017.07.05

April 16, 2025

Medyssey Co, Ltd.
℅ Christine Scifert
Partner
MRC Global
9085 East Mineral Circle
Suite 110
Centennial, Colorado 80112

Re: K242806
Trade/Device Name: Medyssey Navigation System
Regulation Number: 21 CFR 882.4560
Regulation Name: Stereotaxic Instrument
Regulatory Class: Class II
Product Code: OLO
Dated: September 17, 2024
Received: March 17, 2025

Dear Ms. Scifert:

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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K242806 - Christine Scifert
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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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K242806 - Christine Scifert
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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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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

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

Indications for Use

Submission Number (if known)
K242806

Device Name
Medyssey Navigation System

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)

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:

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"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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K242806
Page 1 of 2

510(k) Summary

Medyssey Navigation System

15 April 2025

Company: Medyssey Co, Ltd.
129 Hanbang expo-ro, Jecheon-si
Chungcheongbuk-do, Korea 27116
(484) 427-7060

Company Contact: Taehyun Park
RA Part, R&D Dept.
Taehyun.park@medyssey.com
+82-43-716-1014

Official Correspondent: Christine Scifert – MRC Global, LLC
Christine.scifert@askmrcglobal.com
901-831-8053

Trade Name: Medyssey Navigation System

Common Name: Orthopedic Stereotaxic Instrument

Classification: Class II

Regulation Number: 21 CFR 882.4560 (Stereotaxic Instrument)

Panel: Orthopedic

Product Code: OLO

Device Description:

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K242806
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Indications for Use:

Substantial Equivalence:

The subject Medyssey Navigation System is substantially equivalent to the following predicate device:

Primary Predicate:

Medtronic Navigation, Inc – NAVIGATED CD HORIZON SOLERA SCREWDRIVERS, TAPS, ILIAC TAPS, LEGACY TAPS (K124004)

Reference Devices:

Medyssey ILIAD™ Spinal Fixation System (K181978)
Medyssey Zenius Spinal Fixation System, including Hedjet™ Spinal Fixation System and ARTeMIS™ Percutaneous MIS Spinal Fixation (K232218)

Similar to the predicate navigated instruments, Medyssey Navigation System instruments are intended to be used with the Medtronic's StealthStation® System to assist the surgeon in locating anatomical structures. Additionally, the Medyssey Navigation System instruments and their predicate devices have similar technological characteristics, including design, dimensions, materials and technology, and they function in the same manner. Performance testing demonstrates that the Medyssey Navigation System instruments are substantially equivalent to the predicate devices. Thus, it can be concluded that the subject device does not raise new questions about safety and effectiveness.

Performance Testing:

A comparative dimensional analysis was conducted to verify that the Medyssey Navigation System instruments are appropriate for their intended use, to ensure functionality, accuracy and compatibility with the Medtronic StealthStation® System using the NavLock Tracker, and to demonstrate substantial equivalence to the predicate instruments. The reprocessing (cleaning and sterilization) validations were conducted per ANSI/AAMI ST98 and ISO 17665. Additionally, biocompatibility data was leveraged from K181978 and K232218.

Conclusion:

Based on the comparative dimensional analysis results, the subject device is determined to be 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).