The Macro-Micro Depth Electrodes are intended for use with recording, monitoring and stimulation equipment for the recording, monitoring and stimulation of electrical signals at the subsurface level of the brain.

Device Description

Depth electrodes described in this application are single patient use, disposable, sterile and non-sterile devices. The electrodes are invasive as they are placed in contact with nerve tissue. The electrodes provide the patient contact device. The electrodes connect to the user's recording, monitoring and stimulation/response equipment. The electrodes are used under the supervision of a physicians in the areas of biopotential recording, monitoring and stimulation/response studies understand the use of depth electrodes. The main components of the depth electrodes are: 1. Contract strip with macro depth electrode contacts and connector contacts; 2. Stylet; Inner lumen: 3. 4. Micro wire electrode(s) for insertion and placement through the macro electrode inner lumen. The lead wires terminate in a safety connector that cannot be connected to an AC power outlet. The materials are the same as used in the predicate devices and/or are common to depth electrodes.

AI/ML Overview

The provided text is a 510(k) premarket notification for a medical device called "Macro-Micro Depth Electrodes." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed clinical study data with specific acceptance criteria and performance metrics typically seen for novel devices.

Therefore, the information you've requested regarding acceptance criteria, study details, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set information is not present in the provided document.

Instead, the document highlights:

Substantial Equivalence: The primary assertion is that the Macro-Micro Depth Electrodes are "substantially equivalent" to predicate devices (K891920, K964644 from AD-TECH Medical Instrument Corporation and K033173 from Fhc, Inc.). This means the device has the same intended use and similar technological characteristics, and "no new questions of safety or effectiveness are raised."
Technological Characteristics: The document lists the components (contact strip, stylet, inner lumen, micro wire electrode) and states that the materials are the "same as used in the predicate devices and/or are common to depth electrodes."
Intended Use: The device is for "recording, monitoring and stimulation of electrical signals at the subsurface level of the brain."

In summary, there is no detailed study or acceptance criteria reported within this 510(k) summary because the approval mechanism relies on demonstrating equivalence to already approved devices, not on proving efficacy through new clinical trials against specific performance benchmarks.

Summary

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K041604

AUG 1 6 2004

Summary of Safety and Effectiveness

Company Name:	AD-TECH Medical Instrument Corporation1901 William StreetRacine, WI 53404 1876
Contact:Phone:Fax:	John Ziobro, Chief Operating Officer262 367-9200, ext. 101262 367-9149
Summary Date:	August 2, 2004
Trade Name:	Macro-Micro Depth Electrodes
Common Name:	Depth Electrodes
Classification Name:	21 CFR 882.1330, Depth Electrode
Predicate Device(s):
	510(k) Number:	K891920, K964644
	Manufacture:	AD-TECH Medical Instrument Corporation
	Trade Name:	Depth Electrode
	Product Code:	GZL
	510(k) Number:	K033173
	Manufacture:	Fhc, Inc.
	Trade Name:	Micro Targeting Electrode
	Product Code:	GZL

1.0 Description of Electrodes

Depth electrodes described in this application are single patient use, disposable, sterile and non-sterile devices. The electrodes are invasive as they are placed in contact with nerve tissue.

The electrodes provide the patient contact device. The electrodes connect to the user's recording, monitoring and stimulation/response equipment. The electrodes are used under the supervision of a physicians in the areas of biopotential recording, monitoring and stimulation/response studies understand the use of depth electrodes.

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K041604

2.0 Intended Use of Electrodes

3.0 Technological Characteristics

The main components of the depth electrodes are:

1. Contract strip with macro depth electrode contacts and connector contacts;
1. Stylet;
Inner lumen: 3.
1. Micro wire electrode(s) for insertion and placement through the macro electrode inner lumen.

The lead wires terminate in a safety connector that cannot be connected to an AC power outlet. The materials are the same as used in the predicate devices and/or are common to depth electrodes.

4.0 Conclusions

The characteristics of the Macro-Micro Depth Electrodes are substantially equivalent to the predicate devices. No new questions of safety or effectiveness are raised.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 stylized eagle or bird-like symbol with three curved lines representing its wings or body. The symbol is enclosed within a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 6 2004

Ad-Tech Medical Instrument Corporation c/o Mr. Gary Syring Quality and Regulatory Associates, LLC 800 Levanger Lane Stoughton, Wisconsin 53589

Re: K041604

Trade/Device Name: Macro-Micro Depth Electrodes Regulation Number: 21 CFR 882.1330 Regulation Name: Depth electrode Regulatory Class: II Product Code: GZL Dated: June 11, 2004 Received: June 15, 2004

Dear Mr. Syring:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bection 9 re(x) presidentially equivalent (for the indications felerenced above and nave dotermined in marketed predicate devices marketed in interstate for use stated in the encreate) to the enactment date of the Medical Device Amendments, or to commence provision to May 20, 1978, the enaordance with the provisions of the Federal Food. Drug, devices that have been recuire approval of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval application (PM You may, therefore, market the device, subject to the general controls provisions of the Act. The 1 ou may, mercrore, market the act include requirements for annual registration, listing of general controls provisions of use tice, 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 If your device is classified (soc aborto) als. Existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations may be subject to suen additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Our cements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not nean I rease oc advised that I Dri 3155aantes over device complies with other requirements of the Act that I Dri has made a determaniations administered by other Federal agencies. You must of any I edical statutes and regaranents ancluding, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFK Fart 807), labeling (21 CFR Part 820); and if applicable, the electronic north in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Gary Syring

This letter will allow you to begin marketing your device as described in your Section 5 10(k) I his letter will anow you to ocgin manceing your artial equivalence of your device to a legally premarket notification. The 127 imaing of sackanner sy.
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 If you desire specific advice for your are not 100 %. 4659. Also, please note the regulation entitled, contact the Office of Complance at (bet notification" (21CFR Part 807.97). You may obtain "Misoranuiling by Icierchee to premailer novilities under the Act from the Division of Small other general information on your responser Assistance at its toll-free number (800) 638-2041 or Manufacturers, International and Soless http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

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

510(k) Number (if known): K041604

Device Name: Macro-Micro Depth Electrodes

Indications for Use:

× 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)

iriam C. Provost

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

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510(k) Number K0 41604

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).