The FHC microTargeting® Electrodes are intended for use in intra-operative recording of single unit neuronal activity or intra-operative stimulation of neural elements in the brain.

Device Description

The FHC microTargeting® Electrode is for intra-operative single unit recording and stimulation during functional neurosurgery.

AI/ML Overview

This document (K033173) is a 510(k) summary for a medical device called the microTargeting® Electrode. It's a premarket notification to the FDA to demonstrate substantial equivalence to legally marketed predicate devices, not a study proving the device meets specific acceptance criteria as you'd find in clinical trials for complex AI/machine learning devices.

Therefore, many of the requested categories (such as acceptance criteria, reported performance, sample size for test set, expert qualifications, adjudication method, MRMC study, standalone performance, ground truth types, training set size, and ground truth establishment for training set) are not applicable in this context.

This document describes a traditional medical device (an electrode) seeking clearance based on technological characteristics and intended use similar to existing products, rather than a device with an algorithm that requires performance metrics against a defined ground truth.

Here's what can be extracted from the provided text based on your request, with the understanding that the nature of the device and submission type means many fields will be "N/A":

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria Category	Acceptance Criteria	Reported Device Performance
Substantial Equivalence	Demonstrating that the device is as safe and effective as legally marketed predicate devices.	The FDA determined the device is substantially equivalent (K033173).
Intended Use	The device is intended for intra-operative recording of single unit neuronal activity or intra-operative stimulation of neural elements in the brain.	The FHC microTargeting® Electrodes are intended for use in intra-operative recording of single unit neuronal activity or intra-operative stimulation of neural elements in the brain. (Matches)
Technological Characteristics	Differences from predicate devices do not affect relative safety and effectiveness.	"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." (Statement of claim)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

N/A: This 510(k) submission does not present data from a clinical test set in the way an AI/ML device would. It relies on demonstrating substantial equivalence to predicate devices based on design, materials, manufacturing, and intended use, rather than specific performance metrics from a clinical study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

N/A: No ground truth establishment by experts for a test set is described or required for this type of 510(k) submission for a non-AI/ML device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

N/A: No adjudication method is described as there is no test set for performance evaluation in this context.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

N/A: This is not an AI-assisted device. No MRMC study was performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

N/A: This is not an algorithm-based device. No standalone performance study was performed.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

N/A: No explicit "ground truth" as a reference standard for performance evaluation is mentioned or required for this device. The regulatory submission focuses on substantial equivalence to existing devices.

8. The sample size for the training set

N/A: The device is a physical electrode. There is no concept of a "training set" as would be used for an AI/ML algorithm.

9. How the ground truth for the training set was established

N/A: As there is no training set, this is not applicable.

Summary

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Ko 33/13

510(k) SUMMARY of SAFETY and EFFECTIVENESS

A. General Information

1. Submitter's Name:	FHC, Inc.
2. Address:	9 Main StreetBowdoinham, 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

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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.

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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.

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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

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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_________________________________________________________________________________________________________________________________________________________________

Regulation Number and Section

§ 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).