DEPTH ELECTRODE, FORAMEN OVALE DEPTH ELECTRODES, WYLER SPHENOIDAL DEPTH ELECTRODES

K053358 · Ad-Tech Medical Instrument Corp · GZL · May 25, 2006 · Neurology

Device Facts

• Record ID: K053358
• Device Name: DEPTH ELECTRODE, FORAMEN OVALE DEPTH ELECTRODES, WYLER SPHENOIDAL DEPTH ELECTRODES
• Applicant: Ad-Tech Medical Instrument Corp
• Product Code: GZL · Neurology
• Decision Date: May 25, 2006
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 882.1330
• Device Class: Class 2

Intended Use

The AD-TECH Depth Electrodes (Depth Electrode, Foramen Ovale Depth Electrode, Macro Micro Depth Electrode, Spencer Probe Depth Electrode, Wyler Sphenoidal Depth Electrode) are intended for temporary (< 30 days) use with recording, monitoring and stimulation equipment for the recording, monitoring and stimulation of electrical signals at the subsurface level of the brain. The recording of electrical activity supports definition of the location of epileptogenic foci and brain mapping.

Device Story

Depth electrodes are invasive, single-patient-use, sterile/non-sterile devices designed for temporary (< 30 days) placement in brain tissue. Electrodes serve as the patient-contact interface, connecting to external recording, monitoring, and stimulation equipment. Operated by physicians specializing in biopotential recording and brain mapping, the device captures subsurface electrical signals. Output is displayed on external monitoring equipment, allowing clinicians to identify epileptogenic foci and perform brain mapping. This information guides clinical decision-making regarding surgical or therapeutic interventions for epilepsy and neurological mapping, potentially improving patient outcomes by providing precise localization of brain activity.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Invasive depth electrodes for subsurface brain contact. Single-patient use, disposable. Connects to external recording/stimulation equipment. Technical characteristics are unchanged from previously cleared predicate devices.

Indications for Use

Indicated for patients requiring temporary (< 30 days) intracranial recording, monitoring, and stimulation of electrical signals at the subsurface level of the brain to assist in the localization of epileptogenic foci and brain mapping.

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)
• Foramen Ovale Depth Electrode (K990788)
• Macro-Micro Depth Electrode (K041604)
• Wyler Sphenoidal Depth Electrode (K861031)
• NeuroPortTM Cortical Microelectrode Array System (Neuroport Electrode) (K042384)

Submission Summary (Full Text)

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# 053358

## 510(k) Summary

## MAY 2 5 2006

| Company Name: | AD-TECH Medical Instrument Corporation<br>1901 William Street<br>Racine, WI 53404 1876 | |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|
| Contact: | John Ziobro, Chief Operating Officer | |
| Phone: | 262 367-9200, ext. 101 | |
| Fax: | 262 367-9149 | |
| Summary Date: | November 22, 2005 | |
| Trade Name: | Depth Electrodes (Depth Electrodes, Foramen Ovale Depth Electrodes,<br>Marco-Micro Depth Electrodes, Spencer Probe Depth Electrodes, Wyler<br>Sphenoidal Depth Electrodes) | |
| Common Name: | Depth Electrodes | |
| Classification Name: | 21 CFR 882.1330, Depth Electrode | |
| Predicate Device(s): | | |
| | 510(k) Number:<br>Manufacture:<br>Trade Name: | K891920, K964644<br>AD-TECH Medical Instrument Corporation<br>Depth Electrode |
| | 510(k) Number:<br>Manufacture:<br>Trade Name: | K990788<br>AD-TECH Medical Instrument Corporation<br>Foramen Ovale Depth Electrode |
| | 510(k) Number:<br>Manufacture:<br>Trade Name: | K041604<br>AD-TECH Medical Instrument Corporation<br>Macro-Micro Depth Electrode |
| | 510(k) Number:<br>Manufacture:<br>Trade Name: | K861031<br>AD-TECH Medical Instrument Corporation<br>Wyler Sphenoidal Depth Electrode |
| | 510(k) Number:<br>Manufacture:<br>Trade Name: | K042384<br>Cyberkinetics, Inc.<br>NeuroPortTM Cortical Microelectrode Array System (Neuroport<br>Electrode) |

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#### 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 (brain).

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 physician. Physicians in the areas of biopotential recording, monitoring and stimulation/response studies understand the use of depth electrodes.

#### 2.0 Intended Use of Electrodes

The AD-TECH Depth Electrodes (Depth Electrode, Foramen Ovale Depth Electrode, Macro Micro Depth Electrode, Spencer Probe Depth Electrode, Wyler Sphenoidal Depth Electrode) are intended for temporary (< 30 days) use with recording, monitoring and stimulation equipment for the recording, monitoring and stimulation of electrical signals at the subsurface level of the brain. The recording of electrical activity supports definition of the location of epileptogenic foci and brain mapping.

#### 3.0 Technological Characteristics

The technical characteristics of the depth electrodes are not affected this submission.

#### 4.0 Conclusions

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

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 5 2006

AdTech Medical Instrument Corporation % Quality & Regulatory Associates, LLC Mr. Gary Syring Principal Consultant 800 Levanger Lane Stoughton. Wisconsin 53589

Re: K053358

Trade/Device Name: Depth Eletrodes Regulation Number: 21 CFR 882.1330 Regulation Name: Depth electrode Regulatory Class: II Product Code: GZL Dated: March 24, 2006 Received: March 27, 2006

Dear Mr. Syring:

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

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### Page 2 - Mr. Gary Syring

forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,
el.mll.

Mark N. Melkerson 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): ____________________________________________________________________________________________________________________________________________________

## Device Name: Depth Electrodes

Indications for Use:

The AD-TECH Depth Electrodes (Depth Electrodes, Foramen Ovale Depth Electrodes, Maero Micro Depth Electrodes, Spencer Probe Depth Electrodes, Wyler Sphenoidal Depth Electrodes) are intended for temporary (< 30 days) use with recording, monitoring and stimulation equipment for the recording, monitoring and stimulation of electrical signals at the subsurface level of the brain. The recording of electrical activity supports definition of the location of epileptogenic foci and brain mapping.

Prescription Use X (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)

ellmell.

Division of General, Restorative, and Neurological Devices

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K053358 510(k) Number_