(90 days)
Not Found
Not Found
No
The summary describes a mechanical trajectory guide used in conjunction with an image-guided workstation, with no mention of AI or ML in the intended use, device description, or specific sections for AI/ML mentions.
No
The device is a "Trajectory Guide" that provides "stereotactic guidance for the placement and operation of instruments or devices during planning and operation of neurological procedures," which indicates it is a surgical navigation tool, not a therapeutic device. It assists in procedures like biopsies and catheter placements, but does not itself provide a therapeutic effect.
No
A diagnostic device is used to diagnose a disease or condition. This device, the Navigus II Trajectory Guide, is intended to provide stereotactic guidance for the placement and operation of instruments or devices during neurological procedures, which is a therapeutic or interventional function, not a diagnostic one.
No
The device description is not available, but the intended use explicitly states "The Navigus II Trajectory Guide with Verification Reticules is intended to provide stereotactic guidance for the placement and operation of instruments or devices...". This strongly suggests a physical guide or instrument, not purely software. Furthermore, it mentions being "ETO sterilized and for one time use," which is characteristic of a physical medical device.
Based on the provided information, the Navigus II Trajectory Guide with Verification Reticules is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "stereotactic guidance for the placement and operation of instruments or devices during planning and operation of neurological procedures." This describes a surgical guidance tool used in vivo (within the body) during a medical procedure.
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. The Navigus II does not perform this function.
- Anatomical Site: The device is used for "neurological procedures," which are performed directly on the patient's nervous system.
- Input Imaging Modality: The use of "preoperative MR and/or CT imaging" is for planning and guidance during the procedure, not for analyzing a specimen in vitro.
Therefore, the Navigus II Trajectory Guide is a surgical guidance device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Navigus II Trajectory Guide with Verification Reticules is intended to provide stereotactic guidance for the placement and operation of instruments or devices during planning and operation of neurological procedures performed in conjunction with the use of an Image Guided Workstation System using preoperative MR and/or CT imaging. These procedures include biopsies, catheter placement and electrode introduction. The device is ETO sterilized and for one time use.
Product codes
HAW
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MR and/or CT imaging
Anatomical Site
neurological procedures
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or movement. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 5 2003
Image-Guided Neurologics, Inc. David M. Lee Director, Regulatory Affairs 2290 W. Eau Gallie Boulevard Melbourne, Florida 32935
Re: K023949
Trade/Device Name: Navigus II Trajectory Guide with Verification Reticules Regulation Number: 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Code: HAW Dated: November 22, 2002 Received: November 27, 2002
Dear Mr. Lee:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 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
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Page 2 - Mr. David M. Lee
(21 CFR Part 807); labeling (21 CFR Part 801); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed 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 contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,
for Mark A. Milkenon
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
| 510(k) NUMBER (IF KNOWN) : | K023949 |
|---|---|
| DEVICE NAME: | |
| INDICATIONS FOR USE: |
Intended Use: The Navigus II Trajectory Guide with Verification Reticules is intended to provide stereotactic guidance for the placement and operation of instruments or devices during planning and operation of neurological procedures performed in conjunction with the use of an Image Guided Workstation System using preoperative MR and/or CT imaging. These procedures include biopsies, catheter placement and electrode introduction. The device is ETO sterilized and for one time use.
(PLEASE DO NOT WRITE-BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter-Use (Optional Format 1-2-9
Mark N. Mellersen
(Division Sign-Off) Division of General, Restorative and Neurological Devices 510(k) Number_
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