MACRO-MICRO DEPTH ELECTRODE

K041604 · Ad-Tech Medical Instrument Corp · GZL · Aug 16, 2004 · Neurology

Device Facts

• Record ID: K041604
• Device Name: MACRO-MICRO DEPTH ELECTRODE
• Applicant: Ad-Tech Medical Instrument Corp
• Product Code: GZL · Neurology
• Decision Date: Aug 16, 2004
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 882.1330
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 Story

Macro-Micro Depth Electrodes are invasive, single-patient-use, sterile/non-sterile devices; designed for placement in contact with nerve tissue. Device consists of contact strip with macro depth electrode contacts, stylet, inner lumen, and micro wire electrodes for insertion through macro electrode lumen. Connects to external recording, monitoring, and stimulation equipment. Used by physicians for biopotential recording and stimulation studies. Provides subsurface brain signal access; enables clinical monitoring and stimulation; facilitates neurological assessment.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and design similarity to predicate devices.

Technological Characteristics

Components: contact strip with macro contacts, stylet, inner lumen, micro wire electrodes. Safety connector prevents AC power outlet connection. Materials are standard for depth electrodes. Invasive form factor for subsurface brain placement.

Indications for Use

Indicated for use with recording, monitoring, and stimulation equipment for subsurface brain electrical signal recording, monitoring, and stimulation. Intended for prescription use only.

Regulatory Classification

Identification

A depth electrode is an electrode used for temporary stimulation of, or recording electrical signals at, subsurface levels of the brain.

Predicate Devices

• Depth Electrode (K891920)
• Depth Electrode (K964644)
• Micro Targeting Electrode (K033173)

Submission Summary (Full Text)

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K041604

## AUG 1 6 2004

### Summary of Safety and Effectiveness

| Company Name: | AD-TECH Medical Instrument Corporation<br>1901 William Street<br>Racine, WI 53404 1876 | |
|----------------------------|----------------------------------------------------------------------------------------|----------------------------------------|
| Contact:<br>Phone:<br>Fax: | John Ziobro, Chief Operating Officer<br>262 367-9200, ext. 101<br>262 367-9149 | |
| 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

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.

#### 3.0 Technological Characteristics

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.

#### 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 [phone] 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:

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.

× 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