The Next Generation EMG 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 laryngeal musculature when connected to an appropriate EMG monitor.

The EMG Tube is indicated for use when continuous monitoring of the integrity of the nerves supplying the laryngeal musculature is required during surgical procedures.

Device Description

The Next Gen EMG Endotracheal Tube is a standard-size PVC (DEHP-free polyvinyl chloride) endotracheal tube with inflatable high volume, low pressure cuffs. Each tube is imprinted with four (two pairs) conductive silver electrodes. The conductive silver is printed on the PVC of the main shaft of the endotracheal tube and exposed only for a short distance, approximately 40 mm, slightly superior to the cuff, for contacting the vocal cords. The electrodes are designed to make contact with the patient's vocal cords to facilitate electromyographic (EMG) monitoring of the laryngeal musculature during surgery when connected to a multi-channel EMG neuromonitoring device.

AI/ML Overview

The provided document describes the safety and performance testing for the Medtronic Xomed, Inc. Next Gen EMG Endotracheal Tube as part of its 510(k) submission (K112686). This submission focuses on demonstrating substantial equivalence to predicate devices (NuVasive® NeuroVision® EMG Endotracheal Tube K094054 and Xomed EMG Endotracheal Tube K925640) due to a design change from silicone to PVC material for the tube and from stainless steel wire to conductive silver ink for the electrodes.

The device is not an AI/ML device, therefore, many of the questions related to AI/ML will not be applicable.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of numerical acceptance criteria or performance metrics in a pass/fail format common for quantitative performance claims. Instead, it describes compliance with standards and functional equivalence.

Item	Acceptance Criteria (Implicit)	Reported Device Performance
Biocompatibility	Full compliance with ISO 10993-1 requirements	Testing performed, including cytotoxicity (ISO 10993-5:2009), intracutaneous reactivity (ISO 10993-10:2010), and sensitization (ISO 10993-10:2010). Data determined to be scientifically valid.
Mechanical/Physical Compliance	Compliance with ISO 5361:1999 (for endotracheal tubes)	Compliance testing performed.
Electrical Functionality (Electrodes)	Proper electrode impedance for EMG monitoring	Electrode impedance test performed.
Wire Harness Integrity	Reliable connection and signal transmission through the wire harness	Wire harness test performed.
Product Integration	Components function together as intended	Product integration testing performed.
Marking Ink Adhesion	Ink applied to the tube remains adherent and functional	Marking ink adhesion test performed.
In-vivo EMG Monitoring Performance	Substantially equivalent performance to predicate devices in monitoring nerve integrity during surgery	Functional testing performed using an animal model demonstrated substantial equivalence to predicate devices.
Safety and Effectiveness	Device is safe and effective when used as intended, with risks and benefits comparable to predicate devices.	Data supports that the subject device is safe and effective and performs in the same manner as the predicate devices.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not explicitly stated as a number. The document mentions "in house laboratories conducted studies" and "functional testing was performed using an animal model." It does not specify the number of animals or trials.
Data Provenance: The studies were conducted "in house laboratories" by Medtronic Xomed, Inc. The nature of the studies implies prospective testing for the functional and animal model studies, designed specifically to evaluate the new device. The country of origin for the data is implied to be the USA, given the company's location (Jacksonville, Florida) and the 510(k) submission to the FDA.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This section is not applicable as the device is not an AI/ML diagnostic tool that relies on expert interpretation of output for ground truth establishment. The performance is assessed through objective biophysical measurements and functional equivalence. The "ground truth" for the animal study would be the actual nerve integrity, which is monitored by the device's EMG output and compared to the predicate device's output.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where multiple human readers assess subjective findings and discrepancies are resolved. This device's testing involves objective measurements (biocompatibility, electrical, mechanical) and functional comparison in an animal model, not subjective human assessment needing adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. This is not applicable as the device is not an AI/ML algorithm designed for interpretation or assistance to human readers in a diagnostic context. Its function is to facilitate EMG monitoring.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The device itself is a medical instrument (an endotracheal tube with electrodes) that functions to provide EMG signals for monitoring. It is not an algorithm, and therefore the concept of "standalone algorithm performance" is not applicable. Its performance is inherent to its physical and functional properties.

7. The Type of Ground Truth Used

For biocompatibility: Compliance with ISO standards and specific test outcomes (e.g., absence of cytotoxicity, irritation, sensitization).
For functional testing (electrode impedance, wire harness, product integration, ink adhesion, compliance): Engineering specifications and established biophysical principles, and adherence to relevant ISO standards (e.g., ISO 5361:1999 for compliance).
For animal model study: The "ground truth" is the actual nerve integrity and laryngeal muscle activity in the animal model, observed and verified through established physiological methods, with the new device's EMG output compared directly to that of the predicate devices. The goal was to prove substantial equivalence in monitoring capability.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that requires a training set. Its design and manufacturing are based on engineering principles and material science.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this type of medical device.

Summary

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K112686

JUN 2 7 2012

Medtronic Xomed, Inc. Section 5.0 510(k) Summary

Traditional 510(k) Submission, Next Gen EMG Endotracheal Tube

Section 5.0 510(k) Summary

A. 510(k) Owner

Medtronic Xomed, Inc 6743 Southpoint Drive North Jacksonville, Florida 32216-0980 USA 904-279-7586 904-296-2386 (FAX)

B. Contact Information

Marek Pawlowski Senior Regulatory Affairs Specialist Medtronic Xomed, Inc marek.pawlowski@medtronic.com

Next Gen EMG Endotracheal Tube

C. Date Summary Prepared

D. Proprietary Name

E. Device Name

Trade name:

Common/Usual Name: Classification Name:

Next Gen EMG Endotracheal Tube (final name TBD) EMG ET Tube, EMG Endotracheal Tube Surgical nerve stimulator/locator (21 CFR 874.1820, Product Code ETN, Class II)

F. Predicate Devices:

Trade Name:	NuVasive® NeuroVision® EMG Endotracheal Tube
Common/Usual Name:	EMG ET Tube
Classification Name:	Surgical nerve stimulator/locator(21 CFR 874.1820, Product Code ETN, Class II)
Premarket Notification:	K094054

November 10, 2011

Xomed EMG Endotracheal Tube Trade Name: EMG ET Tube Common/Usual Name: Classification Name: Surgical nerve stimulator/locator (21 CFR 874.1820, Product Code ETN, Class II) K925640 Premarket Notification:

G. Purpose of Submission:

Design change in the material of the tube from silicone in the predicate device Xomed EMG Tube to PVC in the proposed device and design change of electrodes from stainless steel wire in the predicate device to conductive silver ink in the proposed device.

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K112686

Traditional 510(k) Submission, Next Gen EMG Endotracheal Tube Medtronic Xomed, Inc. Section 5.0 510(k) Summary

H. Device Description

I. Intended Use/Indications for Use:

Indications for Use:

The EMG Tube is indicated for use when continuous monitoring of the integrity of the nerves supplying the laryngeal musculature is required during surgical procedures.

Intended Use:

J. Substantial Equivalence

The subject device: Next Gen EMG Endotracheal Tube is substantially equivalent to predicate devices cleared by FDA for commercial distribution in the United States. A comparison of technological characteristics in areas including design, material composition, function, packaging and sterilization is presented in the table below:

	Subject DeviceNext Gen EMGEndotracheal Tube	Predicate Device(s)
		NuVasive®NeuroVision® EMGEndotracheal Tube(K094054)	Xomed EMG EndotrachealTube(K925640)
Laryngeal SurfaceElectrode	Yes	Yes	Yes
EndolaryngealLocation	Yes	Yes	Yes
Number ofElectrodes	4	4	4
Electrode SurfaceMaterial	Conductive Silver Ink	Conductive Silver Ink	Stainless Steel Wire
Tube & CuffMaterial	PVC	PVC	Silicone
Reinforcing Material	None	None	Stainless Steel Wire
Tube Dimensions	Various Dimensions	Various Dimensions	Various Dimensions
Sterilization &Packaging	Sterile, single use only	Sterile, single use only	Sterile, single use only

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-k 112 686

Traditional 510(k) Submission, Next Gen EMG Endotracheal Tube Medtronic Xomed, Inc. Section 5.0 510(k) Summary

K. Conclusion

In house laboratories conducted studies verifying the design of the proposed device. Studies followed scientific protocols. The data were determined to be scientifically valid under 21 CFR 860.7.

Nonclinical testing was performed to demonstrate that the proposed Next Gen EMG Tube is substantially equivalent to the predicate devices.

The following testing was performed:

Biocompatibility testing per ISO 10993-1 requirements, including: .
- cytotoxicity testing (per ISO 10993-5:2009) O
- intracutaneous reactivity testing (per ISO 10993-10:2010) o
- sensitization testing (per ISO 10993-10:2010) o
Functional testing, including:
- o compliance testing per ISO 5361:1999
- electrode impedance test O
- wire harness test o
- product integration testing o
- o marking ink adhesion test.

Functional testing was performed using an animal model. The animal study provided evidence that the proposed device performed substantially equivalent to the predicate devices during monitoring of nerve integrity during surgical procedures.

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).

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.

A direct comparison of key technological characteristics demonstrates that the proposed Next Gen EMG Endotracheal Tube is substantially equivalent to the predicate devices in areas including design, material composition, function, packaging and sterilization.

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

Medtronic Xomed c/o Mr. Marek Pawlowski Senior Regulatory Affairs Specialist 6743 Southpoint Dr. North Jacksonville, FL 32216

JUN 2 7 2012

Re: K112686

Trade/Device Name: Next Generation EMG Endotracheal Tube Regulation Number: 21 CFR 874.1820 Regulation Name: Surgical nerve stimulator/locator Regulatory Class: Class II Product Code: ETN Dated: June 15, 2012 Received: June 18, 2012

Dear Mr. Pawlowski:

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. Marek Pawlowski

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.fdagov/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/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

E.L. Rummell MD

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

Enclosure

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K112 686

Traditional 510(k) Submission, Next Gen EMG Endotracheal Tube Medtronic Xomed, Inc. Section 4.0 Indications for Use Statement

Section 4.0 Indications for Use Statement

Indications for Use

510(k) Number (if known): KIIQ 660

Next Generation EMG Endotracheal Tube (Final name to be Device Name: _ determined).

Intended Use/Indications for Use:

The EMG Tube is indicated for use when continuous monitoring of the integrity of the nerves supplying the laryngeal musculature is required during surgical procedures.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

John Doucett

(Division Sign-Off)
Division of Ophthalmic, Neurological and Ear,
Division of Ophthalmic, Neurologices (Division Sign-Off) Division of Opinal

K112686

510(k) Number.

Image /page/5/Picture/18 description: The image shows the text "Prescription Use (Per 21 CFR 801.109)" in a bold, sans-serif font. The text is oriented diagonally from the bottom left to the upper right of the image. A dark line crosses out the text.

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.