(175 days)
Not Found
No
The summary does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices. The device description focuses on the physical electrodes and their intended use for recording and stimulation.
No.
The device is intended for recording and stimulation for diagnostic purposes during neurosurgery, not for treating a condition.
No
The device is used for intra-operative recording and stimulation, which are interventional procedures rather than diagnostic ones. While recording neuronal activity might provide information about the brain, its primary intended use is within the context of surgical intervention (functional neurosurgery), not standalone diagnosis.
No
The device description explicitly states it is an "electrode," which is a hardware component used for recording and stimulation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "intra-operative recording of single unit neuronal activity or intra-operative stimulation of neural elements in the brain." This involves direct interaction with the patient's living tissue (in vivo) during surgery.
- IVD Definition: In Vitro Diagnostics (IVDs) are devices used to examine specimens (like blood, urine, tissue samples) taken from the human body to provide information about a person's health. This is done outside of the body (in vitro).
The FHC microTargeting® Electrodes are used within the body during a surgical procedure, which is the opposite of an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The FHC microTargeting® Electrode is intended for use in intra-operative recording of single unit neuronal activity or intra-operative stimulation of neural elements in the brain.
Product codes
84 GZL
Device Description
The FHC microTargeting® Electrode is for intra-operative single unit recording and stimulation during functional neurosurgery.
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
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
§ 882.1330 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
Ko 33/13
510(k) SUMMARY of SAFETY and EFFECTIVENESS
A. General Information
| 1. Submitter's Name: | FHC, Inc. |
|---|---|
| 2. Address: | 9 Main Street |
| Bowdoinham, ME 04008 | |
| 3. Telephone Number: | 207-666-8190 |
| 4. Contact Person: | Frederick Haer |
| 5. Date Prepared: | September 15, 2003 |
| 6. Registration Number: | 1226598 |
| B. Device | |
| 1. Name: | microTargeting® Electrode |
| 2. Trade Name: | microTargeting® Electrode |
| 3. Common Name: | Depth Electrode |
| 4. Classification Name: | Depth Electrode |
| 5. Product Code: | 84 GZL |
| 6. Class: | II |
| 7. Regulation Number: | 882.1330 |
1
K033/73
C. Identification of Leqally Marketed Devices
| Name | K Number | Date Cleared |
|---|---|---|
| FHC microTargeting® Electrodes | K991522 | Aug. 4, 2000 |
| Radionics Semi-Microelectrode (SME) Kit | K961858 | Aug. 7, 1996 |
| Microrecording Systems Consultants | µEEG Pro System 5000 |
D. Description of Device
The FHC microTargeting® Electrode is for intra-operative single unit recording and stimulation during functional neurosurgery.
microTargeting® Electrode Components
- . Electrodes
- Protective Tube .
microTargeting® Electrode Accessories
- Sterilization Tray .
E. Intended Use Statement
The FHC microTargeting® Electrode is intended for use in intra-operative recording of single unit neuronal activity or intra-operative stimulation of neural elements in the brain.
F. Technological Characteristics Summary
The FHC microTargeting® Electrodes are substantially equivalent to the legally marketed FHC microTargeting® Electrodes (K991522), Radionics Semi-Microelectrode (SME) Kit (K961858), and Microrecording Systems Consultants uEEG Pro System 5000 (K991077).
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.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and 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 a stylized eagle or bird with three curved lines representing its wings or feathers.
Public Health Service
MAR 2 4 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Frederick Haer President/CEO FHC, Inc. 9 Main Street Bowdoinham, Maine 04008
Re: K033173
:
Trade/Device Name: microTargeting® Electrode Regulation Number: 21 CFR 882.1330 Regulation Name: Depth electrode Regulatory Class: II Product Code: GZL Dated: March 2, 2004 Received: March 3, 2004
Dear Mr. Haer:
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 electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 - Mr. Frederick Haer
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 (301) 594-4659. 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/dsma/dsmamain.html
Sincerely yours.
Miriam C. Provost
Ld.
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
Indications for Use {PRIVATE }
510(k) Number (if known): K033173
Device Name: microTargeting® Electrodes
Indications For Use:
The FHC microTargeting® Electrodes are intended for use in intraoperative recording of single unit neuronal activity or intra-operative stimulation of neural elements in the brain.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (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)
Muriam C. Parrest
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
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510(k) Number_________________________________________________________________________________________________________________________________________________________________