(39 days)
Not Found
No
The summary does not mention AI, ML, deep learning, or any related terms, nor does it describe features typically associated with AI/ML in medical imaging (e.g., automated detection, segmentation, or analysis beyond basic stereotactic guidance).
No
The device is a trajectory guide for needle placement, providing guidance rather than directly treating a condition.
No
The device provides stereotactic guidance for needle placement in brain biopsies, which is an interventional procedure, not a diagnostic one. It assists in the biopsy, which may lead to diagnosis, but the device itself does not perform diagnosis.
No
The summary describes a "Biopsy Kit" and "brain biopsy needle," which are hardware components. The software component is described as providing "stereotactic guidance," implying it works in conjunction with physical instruments.
Based on the provided information, the Navigus Trajectory Guide Biopsy Kit 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 of a brain biopsy needle". This describes a surgical or interventional procedure performed on the patient, not a test performed on a sample taken from the patient.
- 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 for diagnostic purposes, but their absence doesn't definitively rule out an IVD. However, in this case, the intended use is the key factor.
- Input Imaging Modality (MRI and/or CT imaging): While imaging is used, it's for guiding the procedure, not for analyzing the images themselves to diagnose a condition from a sample.
- Anatomical Site (brain): This refers to the location of the procedure on the patient.
- Indicated Patient Age Range, Intended User / Care Setting, Training/Test Set Descriptions, Performance Studies, Key Metrics, Predicate/Reference Devices (Not Found): The absence of this information doesn't change the fundamental nature of the device based on its intended use.
In summary, the Navigus Trajectory Guide Biopsy Kit is a surgical guidance device used during a procedure on a patient, not a device used to perform tests on samples taken from a patient. This aligns with the definition of a medical device used in vivo, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Navigus Trajectory Guide Biopsy Kit is intended to provide stereotactic guidance for the placement of a brain biopsy needle in conjunction with the use of a MB and/or CT imaging Workstation System in a given procedure. This is a single time use.
Product codes
HAW
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MB and/or CT imaging
Anatomical Site
Brain
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 logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 3 2001
Mr. David M. Lee Director of Regulatory Affairs Image-Guided Neurologics, Inc. 2290 W. Eau Gallie Boulevard Melbourne, Florida 32935
Re: K011971
Trade/Device Name: Navigus Trajectory Guide Biopsy Kit Regulation Number: 882.4560 Regulatory Class: II Product Code: HAW Dated: June 21, 2001 Received: June 25, 2001
Dear Mr. Lee:
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 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). 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 provision, 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 requirements, 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. David M. Lee
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 nothleation. THCT D71 midning of saction 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 11 you desire specific dayse for your actic devices), please contact the Office of Compliance at additionally 607.10 for in viao alagliestions on the promotion and advertising of your device, (201) 594-4639. Radhionally, 2011 - 12:4639. Also, please note the regulation prease connect the ories ceference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small miorination on your responsibilities and more (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
R. Mark N. Wilkerson
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
Page of
510 (k) NUMBER (IF KNOWN) : 1 ( c) // 9/ |
DEVICE NAME:
INDICATIONS FOR USE:
Intended Use: The Navigus Trajectory Guide Biopsy Kit is intended ntended Use: The Navigus Trajector Starement of a brain biopsy
to provide stereotactic guidance for the placement of a brain biopsy Cuided to provide stereotactic guidante 10- a Frameless Image Guided
needle in conjunction with the use of a MB and/or CT imaging needle in confunction with the about will and/or CT imaging. Workstation Bystem in a goten in a got 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 1-2-96)
Koll 971
for Mark N. Mulhessen
Division Sign Off
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number_
23