PMT SUBDURAL CORTICAL ELECTRODES

K082474 · Pmt Corp. · GYC · May 8, 2009 · Neurology

Device Facts

• Record ID: K082474
• Device Name: PMT SUBDURAL CORTICAL ELECTRODES
• Applicant: Pmt Corp.
• Product Code: GYC · Neurology
• Decision Date: May 8, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1310
• Device Class: Class 2

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 Elcctrodes, 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 Story

Invasive subdural cortical electrodes; used intraoperatively or during monitoring for epilepsy; placed directly on surgically exposed brain surface. Device consists of platinum-iridium (90:10) alloy contacts molded into silicone rubber matrix; insulated wires extend to external EEG recording/stimulation equipment. Macro electrodes (2-4.5mm discs) capture general activity; micro electrodes (exposed wire tips) provide precise definition of epileptic activity. Used by neurosurgeons/neurologists to localize seizure foci; enables high-confidence mapping of electrical activity; guides clinical decision-making for surgical intervention. Benefits include improved localization of small or deep seizure foci compared to scalp EEG.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Materials: 90:10 platinum-iridium alloy contacts, silicone rubber matrix. Form factor: Grids and strips with macro (2mm, 3mm, 4.5mm discs) and micro (wire tip) electrodes. Connectivity: Wired connection to external EEG monitoring/stimulation equipment. Sterilization: Not specified. Software: None.

Indications for Use

Indicated for patients requiring temporary (<30 day) intracranial, subdural recording, monitoring, and stimulation of electrical brain activity, specifically for localizing seizure foci, determining seizure frequency, severity, and electro-clinical characteristics when foci are too small or deep for standard EEG.

Regulatory Classification

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.

Predicate Devices

• Cortac Cortical Electrode (k964224)
• AD-TECH Subdural Electrode (k053363)

Submission Summary (Full Text)

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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 (<30 day) use with recording, monitoring, and stimulation equipment for the recording, monitoring and stimulation of electrical signals on the surface of the brain.

#### 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.

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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

### Technological Characteristics and Performance

The technological characteristics of the product are not affected in this submission.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is black and white and appears to be a simple, graphic representation of the department.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

PMT Corporation % Mr. Eric Caille 1500 Park Road Chanhassen, Minnesota 55317

Re: K082474

Trade Name: PMT Subdural Cortical Electrodes Regulation Number: 21 CFR 882.1310 Regulation Name: Cortical Electrode Regulatory Class: II Product Code: GYC Dated: April 22, 2009 Received: April 23, 2009

Dear Mr. Caille:

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.

MAY - 8 2009

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2- Mr. Eric Caille

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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/industry/support/index.html.

Sincerely yours,

Daniel Krane

- Mark N. Melkerson Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## EXHIBIT 3

## Indications for Use Statement

K082474

### 510(k) Number (if known)

Device Name

PMT Subdural Cortical Electrodes LL-

#### 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 Elcctrodes, 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. .

## (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

## Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X (Per 21 CFR 801.109 OR

Over the Counter Use

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K082474

(Optimal Format 1-2-96)

PMT Corporation

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