(90 days)
Not Found
Not Found
No
The provided 510(k) summary does not contain any keywords or descriptions related to AI or ML technology. The device description and intended use focus on mechanical positioning and guidance.
No
The device is used for the precise positioning of instruments in the brain or nervous system, but it does not directly treat a disease or condition. It is an accessory for surgical procedures.
No
The device is used for precise positioning of instruments in the brain or nervous system, which is an interventional or therapeutic function, not a diagnostic one.
No
The device description explicitly mentions "Disposable Micro-drive" and "Drive System Display and Power Assist Accessories," which are hardware components. The intended use also describes the positioning of physical instruments.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the "precise positioning of microelectrodes, stimulating electrodes, implantable electrodes, or other instruments in the brain or nervous system." This describes a surgical or interventional procedure performed directly on the patient's body.
- IVD Definition: In Vitro Diagnostics (IVDs) 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. This device does not involve the examination of specimens in vitro (outside the body).
- Anatomical Site: The anatomical site is the "brain or nervous system," which is an in vivo (within the body) location.
The description points to a device used for guiding instruments during neurosurgical procedures, which is a different category of medical device than an IVD.
N/A
Intended Use / Indications for Use
The NeXdrive Disposable Micro-drive for use the with FHC microTargeting® Drive System Display and Power Assist Accessories is intended to be used in conjunction with the Navigus™ family of Trajectory Guides for the precise positioning of microelectrodes, stimulating electrodes, implantable electrodes, or other instruments in the brain or nervous system.
Product codes
HAW
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
brain or nervous system
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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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 Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an image of an eagle.
Public Health Service
FEB - 7 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. David M. Lee Director of Regulatory Affairs Image Guided Neurologics, Inc. 2290 W. Eau Gallie Boulevard Melbourne, Florida 32935
Re: K043091
Trade/Device Name: NeXdrive Disposable Microdrive Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW Dated: January 13, 2005 Received: January 14, 2005
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 (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 clectronic 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) 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 (240) 276-0115. 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/industry/support/index.html.
Sincerely yours.
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): KO43091
Device Name: NeXdrive Disposable Microdrive
Indications For Use: The NeXdrive Disposable Micro-drive for use the with FHC microTargeting® Drive System Display and Power Assist Accessories is intended to be used in conjunction with the Navigus™ family of Trajectory Guides for the precise positioning of microelectrodes, stimulating electrodes, implantable electrodes, or other instruments in the brain or nervous system.
Prescription Use X
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)
Mark H. Miller
Division Sign-Off
eral, Reserative, al Devices
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