PMT Platinum Depthalon Depth Electrode

K151790 · Pmt Corporation · GZL · Jul 14, 2016 · Neurology

Device Facts

• Record ID: K151790
• Device Name: PMT Platinum Depthalon Depth Electrode
• Applicant: Pmt Corporation
• Product Code: GZL · Neurology
• Decision Date: Jul 14, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1330
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Platinum Depthalon® Depth Electrodes are intended for temporary (<30 day) use with recording, monitoring, and stimulation equipment for the recording, monitoring and stimulation of electrical signals in the subsurface of the brain.

Device Story

PMT Platinum Depthalon Depth Electrodes are invasive medical devices designed for temporary intracranial use. The electrodes function as conduits for electrical signals, enabling the recording, monitoring, and stimulation of subsurface brain activity when connected to external neurophysiological equipment. Used in clinical settings by neurosurgeons or neurologists, these devices facilitate the localization of neurological activity, aiding in diagnostic or therapeutic decision-making for patients with conditions requiring intracranial monitoring. The device provides a direct interface between brain tissue and external monitoring systems, allowing healthcare providers to observe electrical patterns and deliver stimulation as part of a clinical procedure. Benefits include precise intracranial signal acquisition for diagnostic evaluation.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Depth electrode for intracranial use; temporary implantation (<30 days). Designed for signal recording, monitoring, and stimulation. Compatible with standard neurophysiological recording and stimulation equipment. Class II device (21 CFR 882.1330).

Indications for Use

Indicated for temporary (<30 days) use in patients requiring recording, monitoring, and stimulation of electrical signals in the subsurface of the brain via compatible equipment.

Regulatory Classification

Identification

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

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of three faces in profile, stacked on top of each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 29, 2016

PMT Corporation Kim Schmelzer Quality Manager 1500 Park Road Chanhassen, MN 55317

Re: K151790

Trade/Device Name: PMT Platinum Depthalon Depth Electrodes Regulation Number: 21 CFR 882.1330 Regulation Name: Depth Electrode Regulatory Class: Class II Product Code: GZL Dated: June 9, 2016 Received: October 9, 2015

Dear Kim Schmelzer:

This letter corrects our substantially equivalent letter of July 14, 2016.

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

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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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

William J.

Heetderks -A

Digitally signed by William J. Heetderks -A
DN: c=US, o=U.S. Government, ou=HHS,
ou=NIH, ou=People,
0.9.2342.19200300.100.1.1=0010149848,
cn=William J. Heetderks -A
Date: 2016.07.29 11:32:59 -04'00'

for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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1500 Park Road • Chanhassen, MN 55317 USA • Phone [phone] • Fax [phone] • www.pmtcorp.com

## Indications for Use Statement

510(k) Number (if known): _____K151790_

## Device Name

PMT® Platinum Depthalon® Depth Electrodes

## Indications for Use

The Platinum Depthalon® Depth Electrodes are intended for temporary (<30 day) use with recording, monitoring, and stimulation equipment for the recording, monitoring and stimulation of electrical signals in the subsurface of the brain.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X (Per 21 CFR 801.109

OR

Over the Counter Use _________________________________________________________________________________________________________________________________________________________

(Optimal Format 1-2-96)

CONFIDENTIAL

PMT® Corporation

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