(49 days)
No
The summary describes a mechanical drive system for positioning instruments and mentions "power assist and position display capabilities," but there is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The description focuses on accurate positioning and adaptability to existing stereotactic systems.
No.
The device is described as a system for accurately positioning instruments in the brain or nervous system during neurosurgical procedures, rather than directly treating a disease or condition. It is a tool for precise placement, not a therapeutic agent itself.
No
Explanation: The device is intended for the accurate positioning of instruments (electrodes, probes) in the brain or nervous system during neurosurgical procedures, rather than for diagnosing medical conditions.
No
The device description explicitly mentions a "Drive System" which implies a physical, mechanical component used for positioning instruments. This is not a software-only device.
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 "neurosurgical procedures which require the accurate positioning of microelectrodes, stimulation electrodes, or other instruments in the brain or nervous system." This describes a surgical tool used directly on a patient's body.
- Device Description: The description reinforces this by detailing its use in positioning instruments within the "brain and nervous system."
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) outside the body to provide information about a person's health. The provided information does not mention any interaction with biological specimens or diagnostic testing.
Therefore, the FHC microTargeting® Drive System is a surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The FHC microTargeting® Drive System is intended to be used with commercially available stereotactic systems for neurosurgical procedures which require the accurate positioning of microelectrodes, stimulation electrodes, or other instruments in the brain or nervous system.
Product codes
HAW
Device Description
The microTargeting® Drive System with permits the accurate positioning of microelectrodes, stimulation electrodes, lesion electrodes, biopsy probes and other instruments in the brain and nervous system and is adaptable to all major stereotactic systems. The current microTargeting® Drive System allows the user to add position display capability or add power assist and position display capabilities.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
brain or nervous system
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)
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
KO11992
AUG 1 4 2001
510(k) SUMMARY of SAFETY and EFFECTIVENESS
FHC, Inc.
9 Main Street
207-666-8190
Frederick Haer
June 6, 2001
1226598
Bowdoinham, ME 04008
A. General Information
-
- Submitter's Name:
-
Address:
-
Telephone Number:
-
Contact Person:
-
Date Prepared:
-
Registration Number:
- B. Device
-
- Name:
- Trade Name:
-
- Common Name:
-
Classification Name:
-
Product Code:
-
Class:
-
Regulation Number:
microTargeting® Drive System microTargeting® Drive System Stereotactic microdrive system Stereotactic Instrument HAW ll
11
882.4560
1
C. Identification of Legally Marketed Devices
| Name | K Number | Date Cleared |
|---|---|---|
| 1. FHC, Inc microTargeting® Drive System | K003776 | Feb. 23, 2001 |
D. Description of Device
The microTargeting® Drive System with permits the accurate positioning of microelectrodes, stimulation electrodes, lesion electrodes, biopsy probes and other instruments in the brain and nervous system and is adaptable to all major stereotactic systems. The current microTargeting® Drive System allows the user to add position display capability or add power assist and position display capabilities.
E. Intended Use Statement
The FHC microTargeting® Drive System is intended to be used with commercially available stereotactic systems for neurosurgical procedures which require the accurate positioning of microelectrodes, stimulation electrodes, or other instruments in the brain or nervous system.
F. Technological Characteristics Summary
The FHC microTargeting® Drive System is substantially equivalent to the previously marketed FHC microTargeting® Drive System (K003776).
Differences that exist between these devices, relating to technical specifications, physical appearance, and design do not affect the relative safety and effectiveness of the microTargeting® Drive System.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & 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 an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
AUG 1 4 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Frederick Haer President and Chief Executive Officer FHC, Inc. 9 Main Street Bowdoinham, Maine 04008
Re: K011992
Trade/Device Name: microTargeting® Drive System Regulation Number: 882.4560 Regulatory Class: II Product Code: HAW Dated: July 25, 2001 Received: July 26, 2001
Dear Mr. Haer:
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 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 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.
3
Page 2 - Mr. Frederick Haer
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 If you desire specific daires diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, (301) 594-1639. Tracklessf Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small monifacturers 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,
Sincerely yours,
Ro. Mark A. Mellikson
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
4
510(k) Number (if known): Kc) / 992
Device Name: microTargeting® Drive System
Indications For Use: The FHC microTargeting® Drive System is intended to be used with commercially available stereotactic systems for neurosurgical procedures which require the accurate ncaroourg.our provelectrodes, stimulating electrodes, or other pooltioning in the brain or nervous system.
(Please Do NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark N Melkener
General, Restorative and Neurological Devices
K 011992 510(k) Number _
(Optional Format 3-10-98)