(459 days)
No
The summary describes electrodes for recording neuronal activity and does not mention any AI/ML components or functions.
No.
The device is used for intra-operative recording of neuronal activity, which is diagnostic in nature, not therapeutic.
Yes
The device is described as being used for "intra-operative recording of single unit neuronal activity in the brain," which directly relates to diagnosing conditions or guiding treatment based on brain activity data.
No
The device description explicitly lists physical components like "Electrodes" and "Protective Tube (Shielded)", indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "intra-operative recording of single unit neuronal activity in the brain." This describes a procedure performed on a living patient, not a test performed on a sample taken from a patient.
- Device Description: The device is an electrode designed for direct insertion into the brain during surgery. This is a surgical tool, not a diagnostic reagent or instrument used to analyze biological samples.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples (like blood, urine, tissue, etc.) or the use of reagents.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to record electrical activity directly from the brain during surgery.
N/A
Intended Use / Indications for Use
The microTargeting™ Electrodes are intended for use in intra-operative recording of single unit neuronal activity in the brain.
Product codes
GZL
Device Description
The microTargeting™ Electrodes (K991522) are for intra-operative single-unit recording during functional neurosurgery.
microTargeting™ Electrodes Components
- Electrodes
- Protective Tube (Shielded) .
microTargeting™ Electrodes Accessories
- . Sterilizable Case (E5-75)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
brain
Indicated Patient Age Range
Not Found
Intended User / Care Setting
intra-operative
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
§ 882.1330 Depth electrode.
(a)
Identification. A depth electrode is an electrode used for temporary stimulation of, or recording electrical signals at, subsurface levels of the brain.(b)
Classification. Class II (performance standards).
0
Main Street, Bowdoinham, ME 04008 US
Phone: 207-666-8190 • Fax: 207-666-8292
Email: fhcinc@fh-co.com • Website: www.fh-co.com
AUG 4 2000
K991522
f.1d2
510(k) SUMMARY of SAFETY and EFFECTIVENESS
A. General Information
-
- Submitter's Name:
- Address:
FHC, Inc
207-666-8190
Frederick Haer
July 12, 2000
Not yet applied for
9 Main Street Bowdoinham, ME 04008
-
- Telephone:
-
Contact Person:
-
Date Prepared:
-
Registration Number:
B. Device
-
- Name:
-
- Trade Name:
-
- Common Name:
Classification Name: 4.
-
- Product Code:
-
- Class:
- 7 Regulation Number:
microTargeting™ Electrodes
microTargeting™ Electrodes
Depth Electrode
Depth Electrode
84 GZL
- II
Not yet applied for
1
C. Identification of Legally Marketed Devices
| 1. Name: | uEEG ProSystem
5000 Depth Electrode | Pali-Trode | Radionics SME |
|-------------------|----------------------------------------|---------------|----------------|
| 2. K Number: | K991077 | K981015 | K961858 |
| 3. Date Cleared: | June 9, 1999 | June 16, 1998 | August 7, 1996 |
D. Description of the Device
The microTargeting™ Electrodes (K991522) are for intra-operative single-unit recording during functional neurosurgery.
microTargeting™ Electrodes Components
- Electrodes
- Protective Tube (Shielded) .
microTargeting™ Electrodes Accessories
- . Sterilizable Case (E5-75)
E. Intended Use Statement
The microTargeting™ Electrodes are intended for use in intra-operative recording of single unit neuronal activity in the brain.
F. Technological Characteristics Summary
The microTargeting™ Electrodes are substantially equivalent to the Microrecording Systems Consultants µEEG ProSystem (K991077) Depth Electrode, Preferred Instruments Pali-Trode (K981015) and the Radionics SME (K961858).
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™ Electrodes.
p.24/2
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.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
4 2000 AUG
Mr. Frederick Haer President/CEO FHC, Inc. 9 Main Street Bowdoinham, Maine 04008
Re: K991522/S2
Trade Name: microTargeting™ Electrodes Regulatory Class: II Product Code: GZL Dated: July 17, 2000 Received: July 18, 2000
Dear Mr. Hare:
We have reviewed your Section 510(k) notification of intent to market the device referenced we have leviewed your bocuon 310(x) hear substantially equivalent (for the indications for use above and we have determined the covices 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 enactment date of the Medical Dories Thisean Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general therefore, market the device, subject to the genirements for annual registration, listing of devices, Controls provisions of the rict metals ready and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III If your device is classified (600 above) and additional controls. Existing major regulations (Fremarks) it hay over device of Federal Regulations, Title 21, Parts 800 to 895. allecting your device can or reamination assumes compliance with the current Good A substantially equivalent acceminates 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 inspections, the Food and Drag Hamilies result in regulatory action. In addition, FDA may publish Comply with the GHT regarater a your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have Itsponse to your premarket nearces of cor devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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 nonitication. The I Drivinant of veation for your device and thus, permits your device to proceed to the market.
3
Page 2 - Mr. Frederick Haer
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in witro diagnostic devices), please contact the Office of Compliance at additionally 607.10 for in Hug angliestions on the promotion and advertising of your device, (2017 594 4639. picase contact the Orifice or Somphanes (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Information on your responsibility of the number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
uma R. lochner.
Celia M. Witten, Ph.D., M.D. 8 Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Page 1 of 1
K991522 510(k) Number (if known):
Device Name: microTargeting™ Electrode
Indications For Use:
The microTargeting™ Electrodes are intended for use in intra-operative recording of single unit neuronal activity in the brain.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
ume R. Vochmes.
(Division Sign-Off) (Division Sign-On) Restors: Devices Division of General Restores Division of General Reston 22
(Optional Format 3-10-98)