The SPINEART Navigation System reusable instruments are intended to be used during the preparation and placement of SPINEART screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The SPINEART Navigation reusable instruments are specifically designed for use with the Medtronic® StealthStation® System or the Brainlab® Spine & Trauma Navigation System which are 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 long bone, or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks for the anatomy.

Device Description

The Spineart® Navigation reusable instruments are surgical instruments to be used with a Navigation System to assist surgeons in precisely locating anatomical structures in either open, minimally invasive, or percutaneous procedures for preparation and placement of pedicle screw system instruments. Current cleared Spineart® Navigation reusable instruments (K241644, K210472 & K183630) feature a connecting area for the tracker compatible with the Navlock Tracker to be navigated with the Medtronic® StealthStation® Navigation System. The purpose of this submission is to get clearance to include Spineart's Brainlab® Navigation Adapter (subject device) designed to enable navigation of Spineart Navigation Instruments with the Brainlab® Spine & Trauma Navigation System to the cleared range of SPINEART® Navigation Instrument System.

AI/ML Overview

The provided FDA 510(k) clearance letter describes the "SPINEART Navigation Instrument System." This document is a clearance letter and a 510(k) summary, which may not always detail the full extent of the testing that would typically be found in a full submission. However, based on the information provided, here's a breakdown of the acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance

The document states: "Performance data showed the addition of the SPINEART Brainlab® Navigation Adaptor (Subject device) on the SPINEART Navigation reusable instruments for a use with the Brainlab® Spine & Trauma System, provides an accuracy at least equivalent to the initial intended use defined for Brainlab® and provides results in simulated use more accurate than the acceptance criteria."

However, specific numerical acceptance criteria for accuracy are not explicitly stated in the provided text. The performance is reported as meeting or exceeding unspecified acceptance criteria.

Acceptance Criterion	Reported Device Performance
Accuracy (Specific numerical values for linear and angular accuracy are not provided in the document.)	"provides an accuracy at least equivalent to the initial intended use defined for Brainlab®" and "provides results in simulated use more accurate than the acceptance criteria."

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

The document does not specify the sample size used for the test set. It mentions "Comparison of accuracy between the Brainlab® tracker and clamps directly attached on the SPINEART Navigation Reusable Instruments and the Brainlab® tracker and clamps attached on the SPINEART Navigation Reusable Instrument using the SPINEART Brainlab® Navigation Adaptor (subject device)" and "Accuracy in simulated use (protocol adapted from ASTM F2554-22)."

The data provenance is not explicitly stated as originating from a specific country or as retrospective/prospective. The testing appears to be non-clinical performance bench testing conducted by the manufacturer, Spineart SA, located in Switzerland.

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

The document does not mention the use of experts or their qualifications for establishing ground truth in the non-clinical testing. The ground truth (or reference standard) in this type of accuracy testing is typically established through precise metrological instruments and methods.

4. Adjudication method for the test set

Not applicable. The described testing is non-clinical performance testing (bench testing for accuracy), not a study involving human interpretation that would typically require an adjudication method.

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

Not applicable. The device is a "Navigation Instrument System" intended to assist surgeons in precisely locating anatomical structures. It is not an AI-assisted diagnostic device that would typically involve human readers interpreting images, therefore, an MRMC study is not relevant to this device.

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

This device appears to be an instrument system and not an algorithm in the traditional sense of AI. The "standalone" performance tested was the accuracy of the navigation system components (specifically the new adapter with the instruments and Brainlab system), which is essentially the performance of the technical system without direct human variability in judgment as the primary outcome. The testing performed was a "Comparison of accuracy" and "Accuracy in simulated use," which are standalone technical evaluations.

7. The type of ground truth used

The ground truth for the accuracy testing would typically be established by highly precise measurement systems (e.g., coordinate measuring machines, optical tracking systems) that can determine the true position and orientation of instruments with sub-millimeter accuracy in a controlled testing environment. The document mentions "dimensional analysis" as also confirming accuracy.

8. The sample size for the training set

Not applicable. This device is not described as an AI/ML device that requires a training set. It is a navigation instrument system, and its performance is evaluated based on its mechanical and optical tracking accuracy.

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

Not applicable, as no training set for an AI/ML algorithm is mentioned.

Summary

FDA 510(k) Clearance Letter - SPINEART Navigation Instrument System

Page 1

U.S. Food & Drug Administration
10903 New Hampshire Avenue Doc ID # 04017.07.05
Silver Spring, MD 20993
www.fda.gov

June 18, 2025

Spineart SA
Estelle Lefeuvre
Regulatory & Market Access Manager
3 chemin du Pré-Fleuri
Plan Les Ouates, 1228
Switzerland

Re: K242933
Trade/Device Name: SPINEART Navigation Instrument System
Regulation Number: 21 CFR 882.4560
Regulation Name: Stereotaxic Instrument
Regulatory Class: Class II
Product Code: OLO
Dated: September 25, 2024
Received: September 25, 2024

Dear Estelle Lefeuvre:

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"

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June 18, 2025

Spineart SA
Estelle Lefeuvre
Regulatory & Market Access Manager
3 chemin du Pré-Fleuri
Plan Les Ouates, 1228
Switzerland

Dear Estelle Lefeuvre:

K242933 - Estelle Lefeuvre Page 2

(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-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE

Page 3

K242933 - Estelle Lefeuvre Page 3

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

Page 4

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)
K242933

Device Name
SPINEART Navigation Instrument 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.

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510(k) Summary

510(k)#: K242933 Prepared on: 2025-06-18

Contact Details 21 CFR 807.92(a)(1)

Applicant Name	SPINEART SA
Applicant Address	3 chemin du Pré-Fleuri PLAN LES OUATES 1228 Switzerland
Applicant Contact Telephone	+41 22 570 1203
Applicant Contact	Ms. ESTELLE LEFEUVRE
Applicant Contact Email	elefeuvre@spineart.com

Device Name 21 CFR 807.92(a)(2)

Device Trade Name	SPINEART Navigation Instrument System
Common Name	Orthopedic Naviagated instruments
Classification Name	Orthopedic Stereotaxic Instrument
Regulation Number	882.4560
Product Code(s)	OLO

Legally Marketed Predicate Devices 21 CFR 807.92(a)(3)

Predicate #	Predicate Trade Name (Primary Predicate is listed first)	Product Code
K241644	SPINEART Navigation Instrument System	OLO
K210472	SPINEART Navigation Instrument System	OLO
K183630	SPINEART Navigation Instrument System	OLO
K212245	Spine and Trauma Navigation System	OLO
K242890	SPINEART Navigation Instrument System	OLO

Device Description Summary 21 CFR 807.92(a)(4)

Intended Use/Indications for Use 21 CFR 807.92(a)(5)

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The SPINEART Navigation reusable instruments are specifically designed for use with the Medtronic® StealthStation® System or the Brainlab® Spine & Trauma Navigation System which are 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 long bone, or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks for the anatomy.

Indications for Use Comparison 21 CFR 807.92(a)(5)

Compared to predicate devices (K241644, K210472, K183630) the only modification to the indications for use is to add the option of using the SPINEART Navigation Reusable Instrument system with the Brainlab® Navigation System through the introduction of a SPINEART Brainlab® Navigation Adaptor. The added SPINEART Brainlab® Navigation Adaptor does not alter the intended use of the SPINEART Navigation Reusable Instrument system.

Technological Comparison 21 CFR 807.92(a)(6)

The intended use, design features, technological characteristics, feature comparisons and performance assessment of the subject SPINEART Navigation Reusable Instrument system remain the same as predicate devices (SPINEART Navigation Reusable Instrument system K241644, K210472, K183630). It has been established that the addition of the SPINEART Brainlab® Tracker Adaptor on the SPINEART Navigation reusable instruments for a use with the Brainlab® Spine & Trauma System does not raise accuracy issues, and has very similar design and operation to the adapter cleared in K242890. The added SPINEART Brainlab® Navigation Adaptor does not affect the safety and effectiveness of the device relative to the predicate (SPINEART Navigation Reusable Instrument system K241644, K210472, K183630). Based on the comparison to the predicate devices and the performance testing conducted, the subject device is considered substantially equivalent to the predicate devices (K241644, K210472, K183630).

Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)

The following testing were conducted on the SPINEART Brainlab® Navigation Adaptor (subject device) to establish substantial equivalence with the predicate devices:

Comparison of accuracy between the Brainlab® tracker and clamps directly attached on the SPINEART Navigation Reusable Instruments and the Brainlab® tracker and clamps attached on the SPINEART Navigation Reusable Instrument using the SPINEART Brainlab® Navigation Adaptor (subject device).
Accuracy in simulated use (protocol adapted from ASTM F2554-22): Verification of the Navigation adaptor with SPINEART Navigation reusable instruments and the full Brainlab® chain of the Brainlab Spine & Trauma system.
A dimensional analysis further confirmed that adequate navigation accuracy will be maintained with the subject instruments. Performance data showed the addition of the SPINEART Brainlab® Navigation Adaptor (Subject device) on the SPINEART Navigation reusable instruments for a use with the Brainlab® Spine & Trauma System, provides an accuracy at least equivalent to the initial intended use defined for Brainlab® and provides results in simulated use more accurate than the acceptance criteria.

No clinical testing was required for the subject device.

It has been demonstrated that the addition of the SPINEART Brainlab® Navigation Adaptor (subject device) on the SPINEART Navigation reusable instruments (predicate device) for a use with the Brainlab® Spine & Trauma System does not raise accuracy issues.

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).