Who is the manufacturer of CONTACT EMG ROTATABLE ENDOTRACHEAL TUBE?

Medtronic Xomed, Inc. filed the 510(k) submission for CONTACT EMG ROTATABLE ENDOTRACHEAL TUBE (K050162).

What is the FDA product code for CONTACT EMG ROTATABLE ENDOTRACHEAL TUBE?

ETN. It is classified under 21 CFR 874.1820 as a Class 2 device in the Ear, Nose, Throat panel.

What is the regulatory pathway for CONTACT EMG ROTATABLE ENDOTRACHEAL TUBE?

510(k) clearance (submission type: Traditional).

What are the predicate devices for CONTACT EMG ROTATABLE ENDOTRACHEAL TUBE?

Xomed EMG Endotracheal Tubes (K925640); RLN Systems Inc., Laryngeal Surface Electrode-Endotracheal Tube (LSE-ET) (K003745).

Who can help prepare an FDA 510(k) submission like CONTACT EMG ROTATABLE ENDOTRACHEAL TUBE?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

CONTACT EMG ROTATABLE ENDOTRACHEAL TUBE

K050162 · Medtronic Xomed, Inc. · ETN · Mar 3, 2005 · Ear, Nose, Throat

Device Facts

Record ID	K050162
Device Name	CONTACT EMG ROTATABLE ENDOTRACHEAL TUBE
Applicant	Medtronic Xomed, Inc.
Product Code	ETN · Ear, Nose, Throat
Decision Date	Mar 3, 2005
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 874.1820
Device Class	Class 2

Intended Use

The CONTACT™ EMG Rotatable Endotracheal Tube is intended for use as a means of providing both an open airway for patient ventilation and for intraoperative monitoring of EMG activity of the intrinsic laryngeal musculature when connected to an appropriate EMG monitor.

Device Story

Flexible, cuffed endotracheal tube; silicone elastomer construction; reinforced with embedded stainless steel spiral. Four stainless steel wires embedded longitudinally; exposed sections serve as sensing/recording electrodes. Device provides airway for ventilation; simultaneously interfaces with external electromyographic (EMG) monitor to detect EMG activity of intrinsic laryngeal musculature. Used intraoperatively by physicians; enables continuous monitoring of recurrent laryngeal nerve integrity during neck surgeries. Output displayed on external EMG monitor; assists surgeon in nerve mapping/locating. Benefits include real-time nerve integrity assessment, reducing risk of nerve damage during procedures.

Clinical Evidence

Bench testing only. In-house laboratory studies verified device design and performance against scientific protocols. No clinical data presented.

Technological Characteristics

Silicone elastomer tube; stainless steel wire reinforcement; four stainless steel sensing electrodes. Dimensions: 5.0-8.0 mm ID, approx. 12.8 inches length. Connectivity: wired interface to external EMG monitor. Sterilization: not specified. Software: none.

Indications for Use

Indicated for patients requiring continuous monitoring of the integrity of the nerves supplying the laryngeal musculature during surgical procedures.

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

Xomed EMG Endotracheal Tubes (K925640)
RLN Systems Inc., Laryngeal Surface Electrode-Endotracheal Tube (LSE-ET) (K003745)

Related Devices

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K230320 — NIM Standard Reinforced EMG Endotracheal Tube; CONTACT Reinforced EMG Endotracheal Tube · Medtronic Xomed, Inc. · Oct 26, 2023
K130806 — NEUROVISION INK PRINTED ENDOTRACHEAL TUBE ELECTRODE · Neurovision Medical Products, Inc. · Jul 12, 2013
K251672 — NIM Essence EMG Endotracheal Tube (NIMEID060); NIM Essence EMG Endotracheal Tube (NIMEID065); NIM Essence EMG Endotracheal Tube (NIMEID070); NIM Essence EMG Endotracheal Tube (NIMEID075); NIM Essence EMG Endotracheal Tube (NIMEID080) · Medtronic Xomed, Inc. · Feb 10, 2026
K112686 — NEXT GEN EMG ENDOTRACHEAL TUBE · Medtronic Xomed, Inc. · Jun 27, 2012

Submission Summary (Full Text)

{0}------------------------------------------------ Koś016 2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . MAR 3 - 2005 Image /page/0/Picture/2 description: The image shows the Medtronic XOMED logo. The logo consists of a circular graphic on the left, with the Medtronic name in bold, sans-serif font to the right. Below the Medtronic name is the word XOMED, in a smaller, less bold font. ## Summary of 510(k) Submission: CONTACT™ EMG Rotatable Endotracheal Tube | Name and address of submitter | Medtronic Xomed Inc. 6743 Southpoint Drive North Jacksonville, Florida 32216 Contact: David S. Dodd Phone: (904) 332-8746 Date Prepared: January 24, 2005 | |-------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Identification of Devices | Trade name: CONTACT™ EMG Rotatable Endotracheal Tube (name not finalized and may change at a later date) Common or usual name: Endotracheal Tube with EMG Detection electrodes, EMG ET Tube Classification Name(s): Surgical Nerve Stimulator/locator (per 21 CFR §874.1820) Tracheal Tube, Inflatable Cuff (per 21 CFR §868.5730 and 868.5750) FDA Classification: Class II | | Predicate Device(s) | Xomed EMG Endotracheal Tubes (K925640)., and RLN Systems Inc., Laryngeal Surface Electrode-Endotracheal Tube (LSE-ET) (K003745) | | Description of Device | The CONTACT™ EMG Rotatable Endotracheal Tube is a flexible, cuffed, Endotracheal tube manufactured from silicone elastomer, reinforced with an embedded stainless steel spiral. Four stainless steel wires are longitudinally embedded in the tube and serve, over an exposed length, as a pair of sensing/recording electrodes designed to interface with an electromyographic monitor. | | | Continued on next page | {1}------------------------------------------------ KOS-0162 | Summary of 510(k) Submission: | |-----------------------------------------------------| | CONTACT™ EMG Rotatable Endotracheal Tube, Continued | The CONTACT™ EMG Rotatable Endotracheal Tube is intended for use as Intended Use a means of providing both an open airway for patient ventilation and for intraoperative monitoring of EMG activity of the intrinsic laryngeal musculature when connected to an appropriate EMG monitor. > The EMG Tube is indicated for use where continuous monitoring of the integrity of the nerves supplying the laryngeal musculature is required during surgical procedures. | Conclusions drawn from studies | Validity of Scientific Data | In-house laboratories conducted studies verifying the design of this device; all followed scientific protocols. The data were determined to be scientifically valid under 21 CFR 860.7. | |--------------------------------------|--------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Substantial Equivalence | The data presented in this Premarket Notification support that the subject device is safe and effective and performs in the same manner as the predicate devices when used in accordance with the labeled directions for use and for the specified indication(s). | | | Risk and Benefits | The risks of the subject device, as well as the benefits to the patient, are the same as those attributed to the use of the predicate devices. | {2}------------------------------------------------ K050162 ## COMPARISON OF SUBJECT DEVICE TO PREDICATE DEVICES | | Predicate Device: (K003745) | Predicate Device: (K925640) | Subject Device: | |--------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | RLN Systems Inc. Laryngeal Surface Electrode-ET (LSE-ET) | Xomed EMG Endotracheal Tube | New Xomed EMG Endotracheal Tube | | Laryngeal Surface Electrode | Yes | Yes | Yes | | Endolaryngeal location | Yes | Yes | Yes | | Functions with commercial EMG units? | Yes | Yes | Yes | | Number of discrete electrodes? | 2 | 4 | 4 | | Number of channels? | 1 | 2 | 1 | | Electrode Surface | Carbon w/Ag | Stainless Steel Wire | Stainless Steel Wire | | Intended Use | Intended to be used as a disposable, self- adhesive electrode attached to an endotracheal tube and positioned for continuous EMG monitoring of the larynx during surgical procedures. It is intended for use only by a licensed physician and in conjunction with a commercially available, medical grade electromyographic monitor. | Intended for use as a tracheal tube for the administration of anesthesia gases and to maintain an open airway for the patient during surgery. The EMG electrodes are intended to serve as contact electrodes with the vocal cords of the patient and when connected to an EMG monitor, the wire electrodes facilitate the intra-operative monitoring of the vocal cords for locating and mapping the Recurrent Laryngeal Nerve and its branches during surgery of the neck. | Intended for use as a means of providing both an open airway for patient ventilation and for intra-operative monitoring of EMG activity of the intrinsic laryngeal musculature when connected to an appropriate EMG monitor. The EMG Tube is indicated for use where continuous monitoring of the integrity of the nerves supplying the laryngeal musculature is required during surgical procedures. | | Tube Lengths | N/A | Approx. 12.8 inches | Approx. 12.8 inches | | Tube Inside Diameter | N/A | 4.0 – 8.0 mm | 5.0 - 8.0 mm | | Tube material | N/A | Silicone | Silicone | | Cuff material | N/A | Silicone | Silicone | | Reinforcing material | N/A | N/A | Stainless steel wire | {3}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines. MAR 3 - 2005 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Medtronic Xomed c/o David Dodd Manager, Regulatory Affairs 6743 Southpointe Drive N. Jacksonville, Florida 32216-0980 Re: K050162 K030102 Trade/Device Name: CONTACT™ EMG Rotatable Endotracheal Tube Regulation Number: 21 CFR 874.1820 Regulation Name: Surgical Nerve Stimulator/Locator Regulatory Class: Class II Product Code: ETN Dated: January 25, 2005 Received: January 25, 2005 Dear Mr. Dodd: We have reviewed your Scction 510(k) premarket notification of intent to market the device we nave reviewed your boother is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce the stated in the encrosure) to logally has of the Medical Device Amendments, or to devices that production in way 26, 1770, the characterial with the provisions of the Federal Food, Drug, and Cosmetic have bech reclassified in accordance with a proval application (PMA). You may, Act (Act) that do not require apprect to the general controls provisions of the Act. The general therefore, matice the detect active as an assimments for annual registration, listing of devices, good Controls provisions of the of the many of the misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device to such additional controls. Existing major regulations affecting your device can be may of subject to sach adon Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register Please be adviscd that FDA's issuance of a substantial equivalence determination does not mean 1 tease be act bod that 7 27 vination that your device complies with other requirements of the Act or that 117A has made a decemination and inistered by other Federal agencies. You must comply with ally 1 ederal shatates and regulared to: registration and listing (21 CFR Part an the Act 3 requirements medial good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product quality of control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {4}------------------------------------------------ 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 (301) 827-8910. 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/industry/support/index.html. Sincerely vours. A. Ralph Rosenthal A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ 510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________ Device Name: CONTACTTM EMG Rotatable Endotracheal Tube ## Intended Use/Indications For Use The CONTACT™ EMG Rotatable Endotracheal Tube is intended for use as a means of providing both an open airway for patient ventilation and for intraoperative monitoring of EMG activity of the intrinsic laryngeal musculature when connected to an appropriate EMG monitor. The EMG Tube is indicated for use where continuous monitoring of the integrity of the The INTS Tues is in the laryngeal musculature is required during surgical procedures. Prescription Use (Part 21 CFR Subpart D) AND/OR Over-the-Counter Use (Part 21 CFR Subpart C) (Please do not write below this line - continue on another page if needed) Concurrence of CDRH, Office of Device Evaluation (ODE) Kaurt H. Baker 510(k) Number K050162 103/158