(101 days)
Not Found
No
The summary describes a passive marker system used with image-guided surgery systems for localization and registration. There is no mention of AI, ML, or any computational analysis of images or data that would suggest the use of these technologies. The system relies on a camera tracking the physical markers.
No
This device is an accessory to an image-guided surgery system, used for auto-registration and localization. It does not directly treat or diagnose a medical condition.
No
The device is described as an accessory for image-guided surgery systems, used to define specific locations on instruments and reference geometries for orientation and localization during surgical procedures. It aids in the execution of surgery rather than in diagnosing a medical condition.
No
The device description explicitly states that the markers are used as accessories with image-guided surgery systems and define specific locations on instruments and reference geometries. This implies physical markers, which are hardware components, not solely software.
Based on the provided information, the ILUMARK Navigation Markers are not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the examination of specimens derived from the human body in order to provide information for diagnostic, monitoring, or compatibility purposes. This typically involves tests performed on blood, urine, tissue samples, etc., outside of the living body.
- ILUMARK Function: The ILUMARK Navigation Markers are described as accessories for image-guided surgery systems. Their purpose is to aid in the localization and tracking of anatomical structures and instruments during surgical procedures on a living patient. They do not analyze biological specimens.
- Intended Use: The intended use clearly states their role in image-guided surgery for various procedures, all of which are performed in vivo (within the living body).
Therefore, the ILUMARK Navigation Markers fall under the category of surgical accessories or instruments used in conjunction with image-guided surgery systems, not as devices for analyzing biological samples in vitro.
N/A
Intended Use / Indications for Use
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 .
Product codes
HAW, OLO
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
rigid patient anatomical structure, brain, sinus, pedicle (for screw placement), orthopedic (for reconstructive orthopedic surgery), soft tissue.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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
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.
5. Intended Use
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 .
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 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
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
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