PMT SUBDURAL CORTICAL ELECTRODES

• K Number: K082474
• Device Name: PMT SUBDURAL CORTICAL ELECTRODES
• Manufacturer: PMT CORP.
• Date Cleared: 2009-05-08 ( 253 days)
• Product Code: GYC
• Regulation Number: 882.1310

Intended Use

Catalog Numbers 2110-XXX: The Subdural Cortical Electrodes (Dual Side Macro Electrodes, Dual Side Micro Electrodes, Dual Side Macro-Micro Electrodes, Dual Sided Hemispherical Macro Electrodes, Dual Sided Hemispherical Micro Electrodes, Dual Side Hemispherical Macro-Micro Electrodes, Macro Grids, Macro Strip, Macro-Micro Grids, Macro-Micro Strips, Micro Grids, and Micro Strips.) are intended for temporary (<30 day) use with recording, monitoring, and stimulation equipment for the recording, monitoring and stimulation of electrical signals on the surface of the brain. This device is restricted to the sale by or on the order of a physician.

Device Description

PMT Subdural Cortical Electrodes (Dual Side Macro Electrodes, Dual Side Micro Electrodes, Dual Side Macro-Micro Electrodes, Dual Sided Hemispherical Macro Electrodes, Dual Sided Hemispherical Micro Electrodes, Dual Side Hemispherical Macro-Micro Electrodes, Macro Strip, Macro-Micro Grids, Macro-Micro Strips, Micro Grids, and Micro Strips.) The Subdural Cortical Electrode is used intraoperatively for monitoring recordable electrical brain activity. This invasive intracranial, subdural electrode recording is performed directly on the surgically exposed brain. This method is necessary when the seizure focus is too small and or too deep within the brain to produce a recordable EEG seizure. The Subdural Cortical Electrode strip and grid electrode are used in cases where it is necessary to establish a high degree of confidence in the electrical localization (foci), seizure frequency, severity type and other electro-clinical characteristics. Macro Electrodes use 2mm, 3mm or 4.5mm diameter platinum circular recording discs. Micro Electrodes are single wires with the distal tip exposed and flush with the surface of the silicone. They are made of the same material used in the assembly of the Electrode. The Micro electrode allow for more precise definition of the Epileptic activity. They can be used solo or in combination with Macro recording discs. The PMT device consists of one or more electrically contacts. The model number 2110 indicates a platinum alloy wire and platinum alloy electrode contacts. The electrodes' contacts are molded into a silicone rubber matrix in a fixed pattern. Insulated wires extend from each electrode through a flexible silicone tube to connector for EEG monitoring. The electrode material for the 2110-XXX is 90:10 platinum iridium

Predicate Devices

K964224, K053363

Reference Devices

K964224,K053363

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on the physical characteristics and intended use of subdural cortical electrodes for recording and stimulating electrical signals on the brain's surface. There is no mention of any computational analysis, algorithms, or learning processes that would indicate the use of AI or ML.

Therapeutic

No.
The device is intended for recording, monitoring, and stimulation of electrical signals on the surface of the brain, not for treating a condition.

Diagnostic

Yes

Explanation: The device is intended for "recording, monitoring, and stimulation of electrical signals on the surface of the brain" and is used to "establish a high degree of confidence in the electrical localization (foci), seizure frequency, severity type and other electro-clinical characteristics." This focuses on gathering information to understand a patient's condition, which is a diagnostic purpose.

SaMD (Software as a Medical Device)

No

The device description clearly details physical components such as electrodes, wires, silicone matrix, and connectors, indicating it is a hardware device.

IVD (In Vitro Diagnostic)

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
• Device Function: The description clearly states that this device is used for "recording, monitoring and stimulation of electrical signals on the surface of the brain." This is an in vivo (within the living body) procedure, not an in vitro (outside the living body) test on a specimen.
• Intended Use: The intended use is for temporary use with recording, monitoring, and stimulation equipment for direct interaction with the brain's electrical activity.
• Anatomical Site: The device is applied directly to the "surface of the brain."

Therefore, the PMT Subdural Cortical Electrodes are medical devices used for neurological monitoring and stimulation within the body, not for testing specimens outside the body.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Catalog Numbers 2110-XXX: The Subdural Cortical Electrodes (Dual Side Macro Electrodes, Dual Side Micro Electrodes, Dual Side Macro-Micro Electrodes, Dual Sided Hemispherical Macro Electrodes, Dual Sided Hemispherical Micro Electrodes, Dual Side Hemispherical Macro-Micro Electrodes, Macro Grids, Macro Strip, Macro-Micro Grids, Macro-Micro Strips, Micro Grids, and Micro Strips.) are intended for temporary (

Regulation Number and Section

§ 882.1310 Cortical electrode.

(a)
Identification. A cortical electrode is an electrode which is temporarily placed on the surface of the brain for stimulating the brain or recording the brain's electrical activity.(b)
Classification. Class II (performance standards).

Summary

0

K082474

EXHIBIT 5

MAY - 8 2009

PMT Corporation 510(k) Summary

Submitter's Name, Address, and Date of Submission

Eric Caillé General Manager PMT Corporation . 1500 Park Road Chanhassen, MN

Phone: [phone] Fax: [phone]

Submitted:

Device Name

Trade Name:

PMT Subdural Cortical Electrodes

PMT Subdural Cortical Electrodes (Dual Side Macro Electrodes, Dual Side Micro Electrodes, Dual Side Macro-Micro Electrodes, Dual Sided Hemispherical Macro Electrodes, Dual Sided Hemispherical Micro Electrodes, Dual Side Hemispherical Macro-Micro Electrodes, Macro Grids, Macro Strip, Macro-Micro Grids, Macro-Micro Strips, Micro Grids, and Micro Strips.)

Classification Name: Common/Usual Name: GYC, 21CFR882.1310 Electrode, Cortical

Predicate Device

Cortac Cortical Electrode (K964224) AD-TECH Subdural Electrode (K053363)

Indication for Use

Catalog Numbers 2110-XXX: The Subdural Cortical Electrodes (Dual Side Macro Electrodes, Dual Side Micro Electrodes, Dual Side Macro-Micro Electrodes, Dual Sided Hemispherical Macro Electrodes, Dual Sided Hemispherical Micro Electrodes, Dual Side Hemispherical Macro-Micro Electrodes, Macro Grids, Macro Strip, Macro-Micro Grids, Macro-Micro Strips, Micro Grids, and Micro Strips.) are intended for temporary (