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.

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 (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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for AD-TECH Depth Electrodes. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a standalone study. Therefore, most of the requested information regarding acceptance criteria, sample sizes, ground truth, experts, and comparative effectiveness studies is not applicable to this type of submission.

Here's a breakdown of the relevant and non-applicable points based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Not Applicable. This submission is for demonstrating substantial equivalence based on technological characteristics and intended use, not for reporting performance against predefined acceptance criteria from a specific study for a novel device. The conclusion states: "The characteristics of the Depth Electrodes are substantially equivalent to the predicate devices. No new questions of safety or effectiveness are raised."

2. Sample Size Used for the Test Set and Data Provenance

Not Applicable. There is no specified "test set" or data from a performance study mentioned in this 510(k) summary. The submission relies on demonstrating similarity to existing, legally marketed predicate devices.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not Applicable. No ground truth establishment for a test set is discussed.

4. Adjudication Method for the Test Set

Not Applicable. No adjudication method for a test set is discussed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

Not Applicable. No MRMC study was conducted or mentioned. The submission is not focused on demonstrating improved human reader performance with or without AI assistance, as it pertains to medical devices (depth electrodes) rather than AI-driven diagnostic tools.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not Applicable. This device is hardware (depth electrodes), not an algorithm or software. Therefore, a standalone algorithm performance study is irrelevant.

7. The Type of Ground Truth Used

Not Applicable. No ground truth is discussed as this is not a diagnostic device requiring comparison to a definitive truth. The "ground truth" in 510(k) submissions for devices like this typically relates to established clinical use and safety of predicate devices.

8. The Sample Size for the Training Set

Not Applicable. There is no "training set" as this is not a machine learning or AI device.

9. How the Ground Truth for the Training Set Was Established

Not Applicable. As there is no training set, this question is not relevant.

Summary of what the submission does present:

The submission focuses on establishing substantial equivalence to predicate depth electrodes by comparing their intended use and technological characteristics.

Intended Use: The AD-TECH Depth Electrodes are intended for temporary (< 30 days) use with recording, monitoring, and stimulation equipment for recording, monitoring, and stimulating electrical signals at the subsurface level of the brain, aiding in defining epileptogenic foci and brain mapping. This intended use is compared to the predicate devices.
Technological Characteristics: The submission explicitly states, "The technical characteristics of the depth electrodes are not affected this submission," implying that the characteristics of the new electrodes are sufficiently similar to the predicate devices and thus do not raise new questions of safety or effectiveness. From the context, this suggests the new electrodes inherit similar design, materials, and function as the specified predicate devices.

The "study" proving the device meets the acceptance criteria (in this context, substantial equivalence criteria) is the 510(k) premarket notification process itself, where the manufacturer provides documentation to the FDA demonstrating that the new device is as safe and effective as a legally marketed predicate device. The FDA's review and subsequent letter of substantial equivalence (K053358) serve as the "proof" that the device meets the regulatory requirements for market entry.

Summary

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053358

510(k) Summary

MAY 2 5 2006

Company Name:	AD-TECH Medical Instrument Corporation1901 William StreetRacine, 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,Marco-Micro Depth Electrodes, Spencer Probe Depth Electrodes, WylerSphenoidal Depth Electrodes)
Common Name:	Depth Electrodes
Classification Name:	21 CFR 882.1330, Depth Electrode
Predicate Device(s):
	510(k) Number:Manufacture:Trade Name:	K891920, K964644AD-TECH Medical Instrument CorporationDepth Electrode
	510(k) Number:Manufacture:Trade Name:	K990788AD-TECH Medical Instrument CorporationForamen Ovale Depth Electrode
	510(k) Number:Manufacture:Trade Name:	K041604AD-TECH Medical Instrument CorporationMacro-Micro Depth Electrode
	510(k) Number:Manufacture:Trade Name:	K861031AD-TECH Medical Instrument CorporationWyler Sphenoidal Depth Electrode
	510(k) Number:Manufacture:Trade Name:	K042384Cyberkinetics, Inc.NeuroPortTM Cortical Microelectrode Array System (NeuroportElectrode)

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1.0 Description of Electrodes

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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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three distinct head profiles, suggesting a sense of community or collaboration. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the bird symbol.

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 (240) 276-0115. 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,
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:

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_

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).