INVOTEC LARYNGEAL ELECTRODE

K122040 · Invotec International, Inc. · ETN · Oct 31, 2013 · Ear, Nose, Throat

Device Facts

• Record ID: K122040
• Device Name: INVOTEC LARYNGEAL ELECTRODE
• Applicant: Invotec International, Inc.
• Product Code: ETN · Ear, Nose, Throat
• Decision Date: Oct 31, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.1820
• Device Class: Class 2

Intended Use

The Invotec Laryngeal Electrodes are intended to be used as a sterile, single use, selfadhesive electrode attached to an endotracheal tube and positioned for continuous EMG monitoring of larynx during surgical procedure. This electrode is not to be adhesively attached to silicone endotracheal tubes.

Device Story

Invotec Laryngeal Electrode is a sterile, single-use, self-adhesive electrode; designed for attachment to an endotracheal tube. Device functions as a sensor for continuous EMG monitoring of the larynx during surgery. Operated by surgical staff in an OR setting. Provides electrical signal input to external nerve monitoring equipment; enabling real-time laryngeal muscle activity tracking. Benefits patient by facilitating nerve integrity monitoring during procedures involving the neck or airway. Not compatible with silicone endotracheal tubes.

Clinical Evidence

Bench testing only.

Technological Characteristics

Self-adhesive electrode for endotracheal tube mounting. Single-use. Sterile. Conductive material interface for EMG signal acquisition. Non-compatible with silicone substrates.

Indications for Use

Indicated for continuous EMG monitoring of the larynx during surgical procedures in patients requiring endotracheal intubation. Contraindicated for use with silicone endotracheal tubes.

Regulatory Classification

Identification

A surgical nerve stimulator/locator is a device that is intended to provide electrical stimulation to the body to locate and identify nerves and to test their excitability.

Predicate Devices

• Medtronic Xomed Nerve Integrity Monitor (NIM) EMG Endotracheal Tube (K003536)

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

October 31, 2013

Invotec International, Inc. c/o Mr. Jeffrey L. Aull President 6833 Phillips Industrial Blvd. Jacksonville, FL 32256

Re: K122040

Trade/Device Name: Invotec laryngeal electrode Regulation Number: 21 CFR 874.1820 Regulation Name: Surgical Nerve Stimulator Regulatory Class: Class II Product Code: ETN Dated: October 4, 2013 Received: October 9, 2013

Dear Mr. Aull:

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.

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Page 2 - Mr. Jeffrey L. Aull

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 (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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

## Eric A. Mann -S

for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): K122040

Device Name: Invotec Laryngeal Electrode

Indications For Use:

The Invotec Laryngeal Electrodes are intended to be used as a sterile, single use, selfadhesive electrode attached to an endotracheal tube and positioned for continuous ` EMG monitoring of larynx during surgical procedure.

This electrode is not to be adhesively attached to silicone endotracheal tubes.

Prescription Use × (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 Center for Devices and Radiological Health (CDRH)

Sunny Park

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