ILUMARK Navigation Markers are intended to be used as image guided surgery system accessory to aid in auto-registration and localization of rigid patient anatomical structure in either open or percutaneous image guided surgery procedures. It is indicated for any medical condition in which the use of an image guided surgery system may be considered to be appropriate.

ILUMARK Navigation Markers can be used in following procedures:

Stereotactic brain surgery .
Endoscopic Sinus Surgery .
. Pedicle Screw Placement
Reconstructive orthopedic surgery .
Soft tissue treatment .

Device Description

ILUMARK Navigation Markers are used as accessories with image quided surgery systems. The Navigation Markers define specific locations on instruments and reference geometries. A camera system, as part of an image guided surgery system uses the location information to determine the orientation and location of an instrument relative to other instruments or reference geometries. A computer system visualizes the orientation and location of the instrument based on pre-operative data or a computer calculated model of the patients anatomy.

AI/ML Overview

This 510(k) premarket notification for ILUMARK Navigation Markers does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria. The document focuses on demonstrating substantial equivalence to already legally marketed devices, rather than providing new performance data where acceptance criteria would typically be established and tested.

Here's a breakdown of why this information is missing and what the document does provide:

No Acceptance Criteria or Performance Study: The purpose of a 510(k) submission for this type of device (accessories to image-guided surgery systems) is often to establish that it is "substantially equivalent" to predicate devices already on the market. This means the manufacturer claims their device has the same intended use, fundamental technological characteristics, and safety and effectiveness as the predicate. They typically don't need to conduct a new clinical or performance study that sets and meets novel acceptance criteria.

Therefore, I cannot populate the requested table or answer the specific questions related to acceptance criteria, device performance, sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, or ground truth establishment for a performance study because such a study is not part of this 510(k) submission.

What the document does state regarding equivalence:

The document explicitly states:

Section 3. Substantial Equivalence: "ILUMARK's navigation Markers are substantial equivalent based upon their intended use, design, dimensional and materials characterization to other legally marketed devices from different manufacturers, e.g. NDI passive Spheres from Northern Digital Inc., #K033621 and Disposable Reflective Marker Spheres from BrainLAB Ag #K100038."
Section 7. Conclusion: "Based on the available 510(k) summaries and 510(k) statements (21 CFR 807) and the information provided herein, we conclude that ILUMARK's Navigation Markers are substantially equivalent to the existing legally marketed devices under Federal Food, Drug and Cosmetic Act."

In summary, for the provided document:

A table of acceptance criteria and the reported device performance: Not provided. The submission focuses on substantial equivalence rather than new performance data against specific criteria.
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable, as no performance study data is presented.
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): Not applicable.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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. This device is a physical navigation marker, not an AI or imaging diagnostic tool that would involve human "readers."
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

Summary

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ILUMARK GmbH Navigation Markers 510(k) Premarket Notification

°ILUMARK

K/03/92

510(K) SUMMARY OF SAFETY AND EFFECTIVENESS IN ACCORDANCE WITH SMDA OF 1990

DATE OF APPLICATION: 2010-10-22

Submitted by:

ILUMARK GmbH Bodmerstrasse 11 85622 Feldkirchen Germany Phone: +49 89 41139 990 +49 89 710404 771 Fax:

Holger-Claus Rossner Contact Person:

1. Device Name

Trade Name: ILUMARK Navigation Marker Snap; ILUMARK Navigation Marker Twist Common Name: Navigation Marker Classification Name: Neurological Stereotaxic Instrument

2. Classification

Device:	neurological stereotaxic instrument	Orthopedic stereotaxic instrument
Medical Specialty:	Part 882, Neurological Devices	Part 882, Neurological Devices
Product Code:	84 HAW	84 OLO
Regulation Number:	882.4560	2
Device Class:	2	882.4560

3. Substantial Equivalence

ILUMARK's navigation Markers are substantial equivalent based upon their intended use, design, dimensional and materials characterization to other legally marketed devices from different manufacturers, e.g. NDI passive Spheres from Northern Digital Inc., #K033621 and Disposable Reflective Marker Spheres from BrainLAB Ag #K100038.

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4. Description of the Device

5. Intended Use

ILUMARK Navigation Markers can be used in following procedures:

Stereotactic brain surgery .
Endoscopic Sinus Surgery .
. Pedicle Screw Placement
Reconstructive orthopedic surgery .
Soft tissue treatment .

6. Sterilization

ILUMARK Navigation Markers are sterilized with Ethylene oxide vacuum cycle, using 100% EtO. The sterilization process has been validated under consideration of an SAL 10 according to the requirements based on ISO 11135-1 Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (in accordance with ISO 13060 / ISO 17665) in consideration of the respective national requirements.

7. Conclusion

Based on the available 510(k) summaries and 510(k) statements (21 CFR 807) and the information provided herein, we conclude that ILUMARK's Navigation Markers are substantially equivalent to the existing legally marketed devices under Federal Food, Drug and Cosmetic Act.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room ~WO66-G609 Silver Spring, MD 20993-0002

Ilumark GmbH % Medagent GmbH Mr. Andre Weingerl Griesweg 47 Muhlheim, Germany 78570

FEB - 7 2011

Re: K103192

Trade/Device Name: Navigation Marker Snap; Navigation Marker Twist Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Code: HAW, OLO Dated: December 20, 2010 Received: December 27, 2010

Dear Mr. Weingerl:

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 (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. 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.

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

. .

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Page 2 - Mr. Andre Weingerl

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 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.html for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address > http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

AK VS. Reta
for

Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number: K_103192

Device Name: Navigation Markers Snap, Twist

Indications for Use:

ILUMARK Navigation Markers can be used in following procedures:

Stereotactic brain surgery .
Endoscopic Sinus Surgery .
Pedicle Screw Placement .
Reconstructive orthopedic surgery
Soft tissue treatment

Prescription Use YES (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use _NO (21 SFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

M.K.Redl Concurrence of CDRH, Office of Device Evaluation (ODE)

Division Sigh-Off Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K103192

Page 1 of 1

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).