(105 days)
Not Found
Not Found
No
The summary describes a physical fiducial marker system and does not mention any software, algorithms, or AI/ML capabilities.
No
The device is a fiducial marker system used for navigation during stereotactic surgery, not for treating a disease or condition itself.
No
The device provides fixed reference points for stereotactic surgery, which is a treatment procedure, not a diagnostic one.
No
The device is described as a "Fiducial Marker System," which strongly implies a physical component (the fiducial markers themselves) used in conjunction with CT imaging. The summary does not mention any software component or function.
Based on the provided information, the Navigus Unibody Fiducial Marker System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used in patients requiring stereotactic surgery in conjunction with CT imaging. IVDs are used to examine specimens from the human body (like blood, urine, tissue) outside the body to provide information about a person's health.
- Device Description (Not Found): While the description is missing, the intended use is the primary indicator.
- Mentions image processing, AI, DNN, or ML (Not Found): These are often associated with IVDs that analyze images or data from specimens.
- Input Imaging Modality (CT imaging): CT imaging is a diagnostic imaging technique performed on the patient, not on a specimen from the patient.
- Anatomical Site (Not Found): While not explicitly stated, the use in stereotactic surgery implies placement within the patient's body.
- Other sections (Patient Age, User, Training/Test Sets, Performance Studies, Metrics, Predicates, References): The lack of information in these sections doesn't directly confirm or deny IVD status, but the intended use is the most definitive factor.
In summary, the Navigus Unibody Fiducial Marker System is a medical device used in vivo (within the living body) to aid in surgical procedures, not a device used in vitro (outside the living body) to diagnose conditions based on specimens.
N/A
Intended Use / Indications for Use
The Navigus Unibody Fiducial Marker System is intended to provide fixed reference point(s) in patients requiring stereotactic surgery in conjunction with CT imaging.
Product codes
HAW
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT imaging
Anatomical Site
Not Found
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features an eagle-like emblem with three stylized lines representing the bird's body and wings. The emblem is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The text is in all capital letters and is evenly spaced around the emblem.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR - 2 2004
Mr. David M. Lee Director of Regulatory Affairs Image-Guided Neurologics 2290 W. Eau Gallie Boulevard Melbourne, Florida 32935
Re: K033619
Trade/Device Name: Navigus Unibody Fiducial Marker System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW Dated: January 14, 2004 Received: January 15, 2004
Dear Mr. Lec:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave teviewed your bected. 9 retty pe device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate (of use stated in the enclosure) (o regar) the enactment date of the Medical Device Amendments, or to conninered process that have been recordance with the provisions of the Federal Food, Drug, devices that have boon require approval of a premarket approval application (PMA). and Cosmetic Tion (110) that the device, subject to the general controls provisions of the Act. The r ou may, moreloro, mains of the Act include requirements for annual registration, listing of general oonlines provisions practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is clusion of too as controls. Existing major regulations affecting your device can may be subject to sach additional results , 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 1 lease of advised that 1191 bilseanter over device complies with other requirements of the Act that I DX has made a asid regulations administered by other Federal agencies. You must or any I cactar stutures and registeries, including, but not limited to: registration and listing (21 Comply with an the Act 81equirements, and manufacturing practice requirements as set CI K Furt 6075, adoming (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
Page 2 - Mr. David M. Lee
This letter will allow you to begin marketing your device as described in your Section 510(k) I ms reter nation. The FDA finding of substantial equivalence of your device to a legally promanced predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you dosire specific acreoliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Miriam C. Provost
for Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known): K033619
Device Name: Navigus Unibody Fiducial Marker System
Indications For Use: The Navigus Unibody Fiducial Marker System is intended to provide fixed reference point(s) in patients requiring stereotactic surgery in conjunction with CT imaging.
Prescription Use _____________________________________________________________________________________________________________________________________________________________
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE. ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Muriami C. Provost
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
KO33619 510(k) Number_