The AnyPlus Navigated Instrument System is indicated for the preparation and placement of the Poly-Axial Screws of the AnyPlus Spinal Fixation System during a navigated thoracolumbar fusion procedure to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. This system is intended to be used in conjunction with the Medtronic 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 vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.

The use of the AnyPlus Navigated Instrument system is limited to use only with the AnyPlus Spinal Fixation System.

Device Description

The subject device, AnyPlus Navigated Instrument System, includes Taps and a Driver that are compatible with the Medtronic StealthStation® S7 Navigation System. The subject, AnyPlus Navigated Instruments (Taps and Driver), is used to place the GS Medical's AnyPlus Spinal Fixation pedicle screws (Poly-Axial Screws) during a navigated thoracolumbar fusion procedure. These instruments include a regular driver for AnyPlus pedicle screws and multiple taps ranging from 4.5mm to 8.5mm in diameter, increasing by increments of 0.5mm.

These Navigated Instruments are supplied non-sterile, reusable, and fabricated from UNS S45500 Precipitation-Hardened Stainless Steel in accordance with ASTM F899.

AI/ML Overview

This 510(k) summary describes the AnyPlus Navigated Instrument System, a device for spinal surgery. The information provided is sufficient to answer the request.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria / Performance Metric	Reported Device Performance
Recognition and Location with Medtronic StealthStation® Navigation System	Passed: Both the subject device (AnyPlus Navigated Instrument system Driver and Tap) and the additional predicate device (Navigated CD HORIZON® SOLERA® Driver and Tap) passed recognition and location testing with the Medtronic StealthStation® navigation system.
Dimensional Accuracy (Critical Length)	Within Tolerance: Subject device and additional predicate Driver and Tap were compared for dimensional accuracy, and the critical length measurements are within the tolerance limit. The text specifies a "+/-0.15mm difference in tolerance," and states that this "minor difference... does not raise new questions of safety and effectiveness."
Successful Registration and Placement of AnyPlus Pedicle Screws	Successfully Achieved: Performance testing proves that the subject device Taps and driver successfully register and place the AnyPlus pedicle screws with the help of the Medtronic Stealth Station System, performing the same as the additional predicate.
Compatibility with Medtronic StealthStation® System	The subject device includes Taps and a Driver that are explicitly stated to be compatible with the Medtronic StealthStation® S7 Navigation System. The performance testing confirmed this compatibility, as the devices "passed recognition and location testing with the Medtronic StealthStation® navigation system" and "successfully register and place the AnyPlus pedicle screws with the help of the Medtronic Stealth Station System."
Material Identity to Primary Predicate	Identical: The material (UNS S45500 Precipitation-Hardened Stainless Steel in accordance with ASTM F899) and manufacturing process of the subject device (AnyPlus Navigated Instruments) are identical to the primary predicate (Anyplus Spinal Fixation Systems Drivers and taps, K091717).
Technological Characteristics and Principle of Operation to Primary Predicate	Identical: The subject device (AnyPlus Navigated Instrument system) and the Primary Predicate (AnyPlus Spinal Fixation System, K091717) have identical material, the same technological characteristics, and the principle of operation (to implant an AnyPlus Screw).
Indications for Use/Intended Use Equivalence to Additional Predicate	Identical: The subject device (AnyPlus Navigated Instrument) and the additional predicate (Navigated CD Horizon Solera Screwdrivers and Taps, K140454) have identical indications for use/intended use.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample size used for the test set or the specific data provenance (e.g., country of origin, retrospective/prospective). It generally refers to "performance testing" and "recognition and location testing."

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

The document does not provide information regarding the number of experts, their qualifications, or their involvement in establishing ground truth for the test set. The testing appears to be primarily technical and performance-based against a navigation system and a predicate device.

4. Adjudication Method for the Test Set

The document does not mention any adjudication method like 2+1, 3+1, or none. The testing described focuses on device performance and compatibility rather than subjective interpretation by experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This device is a navigated instrument system for spinal surgery, not an AI-assisted diagnostic or imaging interpretation tool that involves human readers. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable to this type of device and was not performed according to the provided information.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

This device is an instrument system used in conjunction with a navigation system (Medtronic StealthStation® System) and operated by a surgeon. It is not an algorithm that performs autonomously or 'standalone' in a diagnostic sense. The testing described is about the standalone performance of the instruments (Taps and Driver) in interacting correctly with the navigation system. The "algorithm" here would be the navigation system's own algorithms, which are not the subject device. The performance data focuses on the navigational instruments' ability to be recognized, located, and successfully used for screw placement.

7. The Type of Ground Truth Used

The ground truth used for this type of device is primarily physical and functional performance metrics. This includes:

Dimensional Accuracy: Comparing the critical lengths of the subject device to the predicate device within specified tolerances.
System Recognition and Location: Confirming that the navigation system correctly identifies and tracks the instruments.
Successful Mechanical Interaction: Verifying that the instruments can successfully prepare and place pedicle screws.
Material and Technological Identity: Confirming that the subject device matches the primary predicate in these fundamental aspects.

It is not based on expert consensus, pathology, or outcomes data in the traditional sense, as these are instruments, not diagnostic tools.

8. The Sample Size for the Training Set

This document describes a medical instrument, not a machine learning or AI algorithm that requires a "training set" in the context of data. Therefore, the concept of a training set sample size is not applicable to this device.

9. How the Ground Truth for the Training Set was Established

As the concept of a "training set" is not applicable, this question is also not relevant to the information provided for this device.

Summary

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December 6, 2024

GS Medical Co. Ltd. Barry Sands 90, Osongsaengmyeong 4-ro, Osong-eup, Heungdeok-gu. Cheongju-si, Chungcheongbuk-do Korea. South

Re: K243073

Trade/Device Name: AnyPlus Navigated Instruments System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: September 27, 2024 Received: September 27, 2024

Dear Barry Sands:

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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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 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.

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-device-advicecomprehensive-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-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-regulatory

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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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Indications for Use

510(k) Number (if known) K243073

Device Name AnyPlus Navigated Instruments System

Indications for Use (Describe)

The use of the AnyPlus Navigated Instrument system is limited to use only with the AnyPlus Spinal Fixation System.

Type of Use (Select one or both, as applicable)
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X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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510(K) SUMMARY

SUBJECT DEVICE: GS MEDICAL'S ANYPLUS® NAVIGATED INSTRUMENT SYSTEM

1. SUBMITTER'S CONTACT INFORMATION

Submitter	Kimberley FountainEngineerGS Medical Co. Ltd.90 Osongsaengmyong 4-roOsong-eup, Heungdeok-gu,Gheongju-si, Chungcheongbuk-do 28161 KoreaTel.: +1 949 380-6385Email: kfountain@gsmedicalusa.com
Author	Arunkumar PrabhakaranUS RA Submission ManagerPhone: 978-358-7307Email: regulatorysubmissions@rqmis.com
PrimaryContact	Barry E. SandsRQMIS Inc.110 Haverhill Road, Suite 524Amesbury, MA 01913Phone: (978) 358-7307Email: regulatorysubmissions@rqmis.com
Date Prepared	September 26, 2024

2. SUBJECT DEVICE

Trade/Proprietary Nameof Device:	Anyplus Navigated Instruments System
Common Or Usual Name:	Stereotaxic Instrument, Navigated Screwdriver, Tap
Classification Name:	Stereotaxic Instrument
Regulation Number:	21 CFR 882.4560
Classification:	Class II
Product Code:	OLO

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3. PREDICATE DEVICE

Trade/ProprietaryName of Device:	Anyplus Spinal Fixation System
510(k) number:	K091717
Common Or Usual Name:	Pedicle Screw System
Classification Name:	Thoracolumbosacral Pedicle Screw System
Regulation Number:	21 CFR 888.3070
Classification:	Class II
Product Code:	NKB, KWP, KWQ, MNH, MNI

4. ADDITIONAL PREDICATE

Trade/Proprietary Name ofDevice:	Navigated CD Horizon Solera Screwdrivers and Taps
510(k) number	K140454
Common Or Usual Name:	Stereotaxic Instrument
Classification Name:	Stereotaxic Instrument
Regulation Number:	21 CFR 882.4560
Classification:	Class II
Product Code:	OLO

5. INDICATIONS FOR USE

The use of the AnyPlus Navigated Instrument system is limited to use only with the AnyPlus Spinal Fixation System.

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6. DEVICE DESCRIPTION

These Navigated Instruments are supplied non-sterile, reusable, and fabricated from UNS S45500 Precipitation-Hardened Stainless Steel in accordance with ASTM F899. The material and manufacturing process of the subject device, AnyPlus Navigated Instruments, are identical to the primary predicate (Anyplus Spinal Fixation Systems Drivers and taps, K091717).

7. Technological Characteristics comparison:

The Subject Device: AnyPlus Navigated Instrument system and the Primary Predicate: AnyPlus Spinal Fixation System (K091717), have identical material, the same technological characteristics, and the principle of operation (to implant an AnyPlus Screw).The Subject Device: AnyPlus Navigated Instruments, and the Additional Predicate: Navigated CD Horizon® Screwdrivers and Taps (K140454), have identical indications for use/intended use.

Both the subject device and additional predicate's Taps and driver are intended to place the pedicle screws during the spinal surgery with the help of the Medtronic StealthStation® system. Both the subject device and additional predicate Taps and driver have equivalent critical lengths with a +/-0.15mm difference in tolerance. This minor difference between the subject device and the additional predicate instruments' critical length does not raise new questions of safety and effectiveness since the performance testing proves that the subject device Taps and driver successfully register and place the AnyPlus pedicle screws with the help of Medtronic Stealth Station System as same as the additional predicate.

8. PERFORMANCE DATA

Both the subject device AnyPlus Navigated Instrument system (Driver and Tap) and the additional predicate device Navigated CD HORIZON® SOLERA® (Driver and Tap) passed recognition and location testing with the Medtronic StealthStation® navigation system. Subject device and additional predicate Driver and Tap were compared for dimensional accuracy, and the critical length are within the tolerance limit. The subject device is equivalent to the predicate device in use and performance.

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9. CONCLUSION

The subject device, AnyPlus Navigated Instrument, and the additional predicate, the Navigated CD Horizon Solera Screwdrivers and Taps (K140454), have identical indications for use/intended use.
. The subject device and the primary predicate instruments (i.e., Driver and Taps) have identical material, the same technological characteristics, and the principle of operation.
. The performance of the subject device (i.e., dimensional accuracy, verification, and compatibility of the subject Taps and Drivers to the Medtronic Stealth Station) was equivalent to the additional predicate. Acceptable performance test results demonstrate that the subject device is as safe and effective as its primary and additional predicate.

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).