Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a standard EMG endotracheal tube for nerve monitoring, with no mention of AI or ML in the intended use, device description, or specific sections for AI/ML mentions.

Therapeutic

No.
The device is used for monitoring EMG activity during surgical procedures and maintaining an open airway, not for treating a disease or condition. Its purpose is diagnostic/monitoring, not therapeutic.

Diagnostic

No

The device is an endotracheal tube designed for continuous monitoring of EMG activity during surgical procedures, not for diagnosing a condition. It provides real-time data for monitoring, which is distinct from diagnostic assessment of a disease state.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a physical endotracheal tube made of silicone elastomer with embedded stainless steel wires and electrodes, indicating it is a hardware device, not software-only.

IVD (In Vitro Diagnostic)

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

Here's why:

IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
Device Function: The CONTACT™ EMG Rotatable Endotracheal Tube is a device that is inserted into the body (endotracheal) to maintain an airway and directly measure electrical activity (EMG) of the laryngeal muscles. It is used for intraoperative monitoring during surgery.
Lack of Sample Analysis: The device does not analyze a sample taken from the body. It is a direct measurement tool used within the body.

Therefore, the device's function and intended use fall outside the scope of in vitro diagnostics. It is a medical device used for physiological monitoring during a surgical procedure.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

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 nerves supplying the laryngeal musculature is required during surgical procedures.

Product codes (comma separated list FDA assigned to the subject device)

ETN

Device Description

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

intrinsic laryngeal musculature / vocal cords

Indicated Patient Age Range

Not Found

Intended User / Care Setting

licensed physician / surgical procedures

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

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

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 874.1820 Surgical nerve stimulator/locator.

(a)
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.(b)
Classification. Class II.

Summary

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.

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