(50 days)
Not Found
No Reference Device(s) were found in the provided text.
No
The summary does not mention AI, ML, deep learning, or any related terms, nor does it describe functionalities typically associated with AI/ML in medical devices like automated image analysis or predictive modeling. The description focuses on stereotactic guidance based on imaging.
No.
The document states that "The Trajectory Guide is intended to provide stereotactic guidance for the placement and operation of instruments or devices during planning and operation of neurological procedures," indicating it is a guidance system for other devices, not a therapeutic device itself.
No
Explanation: The device is intended for stereotactic guidance and placement of instruments during neurological procedures, not for identifying a disease or condition. It is a surgical aid rather than a diagnostic tool.
Unknown
The provided 510(k) summary lacks a "Device Description" section, which is crucial for determining if the device is software-only or includes hardware components. The "Intended Use" describes a function that could be implemented with or without dedicated hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used for stereotactic guidance during neurological procedures within the MRI/CT environment. This involves guiding instruments or devices within the body for procedures like biopsies, catheter and electrode introduction.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are performed outside the body (in vitro).
The Trajectory Guide's function is to assist in procedures performed on the patient's body, not to analyze samples taken from the patient's body.
N/A
Intended Use / Indications for Use
The Trajectory Guide is intended to provide stereotactic guidance for the placement and operation of instruments or devices during planning and operation of neurological procedures within the MRI/CT environment and in conjunction with MR/CT imaging. The Trajectory Guide is intended as an integral part of procedures that have traditionally used stereotactic methodology. These procedures include biopsies, catheter and electrode introduction. The device will provide accurate delivery of devices or instruments to target sites 3mm and larger.
Product codes
HAW
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MRI/CT
Anatomical Site
neurological
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)
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 & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 27 1999
Mr. Michael J. Renner Vice President, Operations Image-Guided Neurologics, Inc. 2290 W. Eau Gallie Boulevard Melbourne, Florida 32935
K992304 Re: Trade Name: Navigus Traiectory Guide Regulatory Class: II Product Code: HAW Dated: July 7, 1999 Received: July 8, 1999
Dear Mr. Renner:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Michael J. Renner
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely vours.
Mark N Melkerson
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(K) NUMBER (IF, KNOWN): 99230 4 DEVICE NAME: NAN JUNS TRASECTORy by INDICATIONS FOR USE:
The Trajectory Guide is intended to provide stereotactic guidance for the placement and operation of instruments or devices during planning and operation of neurological procedures within the MRI/CT environment and in conjunction with MR/CT imaging. The Trajectory Guide is intended as an integral part of procedures that have traditionally used stereotactic methodology. These procedures include biopsies, catheter and electrode introduction. The device will provide accurate delivery of devices or instruments to target sites 3mm and larger.
Mark M Mellemson
Division Sign-O (Division Sign-Om)
Division of General Restorative Devices 510(k) Number
(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