The NuVasive EMG Endotracheal Tube is intended for use with any compatible monitoring system during surgical procedures for continuous EMG neurological monitoring and status assessment of the nerves supplying the laryngeal musculature as well as for providing an open airway for patient ventilation.

Device Description

The NuVasive® EMG Endotracheal (ET) Tube is an endotracheal tube with integrated electrodes for electromyographic (EMG) monitoring surgery. The ET tube is made of a flexible PVC material with an inflatable low pressure cuff. The EMG ET Tube is provided as a sterile, single use disposable accessory that connects to a compatible EMG monitor to provide an open airway for patient ventilation during EMG neuromonitoring of the Recurrent Laryngeal Nerve (RLN).

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the NuVasive® EMG Endotracheal Tube, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

Test Name	Acceptance Criteria	Reported Device Performance
Biocompatibility Testing
Cytotoxicity testing – MEM Elution	Non-cytotoxic	Discrete intracytoplasmic granules; no cell lysis (Grade 0) - Pass (Non-cytotoxic)
Intracutaneous testing – NS and CSO	No erythema (Score 0) & No edema (Score 0)	No erythema (Score 0) & No edema (Score 0) - Pass (Requirements met)
Sensitization testing – NS and CSO	No sensitization observed (Score 0)	No sensitization observed (Score 0) - Pass (Non-sensitizer)
Systemic toxicity – NS and CSO	No signs or symptoms of systemic toxicity observed	No signs or symptoms of systemic toxicity observed - Pass (Requirements met)
Functional Bench Testing
Functional testing per ISO 5361	Meets specifications of ISO 5361	Meets specifications and criteria
Inflation valve functionality	Functional	Meets specifications and criteria
Leak test	No leaks	Meets specifications and criteria
Electrode resistance test	Appropriate resistance levels	Meets specifications and criteria
System integration test	Compatible with EMG monitor	Meets specifications and criteria
Bending test	Maintains integrity and function after bending	Meets specifications and criteria
Other Testing
Stability Testing	Maintains performance over time	Meets specifications and criteria
Sterilization & Packaging Validations	Sterile/maintains sterility & packaging integrity	Meets specifications and criteria

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

The document does not specify the exact sample sizes for each nonclinical test (biocompatibility, functional bench testing, stability, sterilization & packaging). It generally states that "Nonclinical testing was performed."

The data provenance is from nonclinical laboratory testing conducted by the manufacturer, NuVasive, Incorporated. It is not patient or human subject data, so concepts like "country of origin" for data are not applicable in this context, nor is it a retrospective or prospective study on patient outcomes.

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

This information is not provided in the document. For nonclinical tests like biocompatibility and functional bench testing, ground truth is typically established through adherence to recognized standards (e.g., ISO 10993, ISO 5361) and internal quality control specifications, rather than through expert consensus in the way clinical diagnostic studies might.

4. Adjudication Method for the Test Set

This information is not provided. Given the nature of these nonclinical tests (objective measurements against established standards), formal adjudication methods like 2+1 or 3+1 by human experts are generally not used. The results are typically interpreted against quantitative criteria defined by the test protocols and standards.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done. This study is focused on the substantial equivalence of a medical device (an EMG Endotracheal Tube) based on nonclinical performance data, not on the comparative effectiveness of human readers with or without AI assistance in interpreting medical images or data.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not Applicable. This device is a passive accessory (an endotracheal tube with electrodes) that connects to a separate EMG monitor. It is not an algorithm or an AI-powered system that would have a "standalone" performance without human interaction (e.g., a surgeon using it for monitoring). The document explicitly states, "This device does not contain software."

7. Type of Ground Truth Used

The ground truth used for these nonclinical tests is based on:

Established international standards and guidelines: Such as ISO 10993-1 for biocompatibility and ISO 5361 for functional testing.
Manufacturer's internal specifications and criteria: Derived from engineering design and performance requirements.
Objective measurements and observations: Against predefined pass/fail criteria for each test.

8. Sample Size for the Training Set

There is no training set for this device. This is a physical medical device, not an AI/ML algorithm that requires training data.

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

Not Applicable. As there is no training set for this physical device, there is no ground truth to establish for a training set.

Summary

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510(k) Summary

MAY 0 2 2014

In accordance with Title 21 of the Code of Federal Regulations, Part 807, and in particular 21 CFR §807.92, the following summary of information is provided:

Submitted by: A.

Jeremy Markovich Associate Manager, Regulatory Affairs NuVasive, Incorporated 7475 Lusk Blvd. San Diego, California 92121 Telephone: (858) 909-1800

Date Prepared: April 25, 2014

B. Device Name

Trade or Proprietary Name:	NuVasive® EMG Endotracheal Tube
Common or Usual Name:	Neurosurgical Nerve Locator;Endotracheal Tube with Electromyography (EMG)monitoring Electrodes
Classification Name:	Surgical nerve stimulator/locator;Tracheal Tube;Inflatable Cuff:
Device Class:	Class II
Classification:	§874.1820, §882.1820, §868.5730 and §868.5750
Product Code:	PDQ, ETN, GWX, BSK and BTR

Predicate Devices C.

The subject NuVasive EMG Endotracheal Tube is substantially equivalent to the following predicate devices currently distributed commercially in the U.S .:

. K094054 - NuVasive NV EMG Endotracheal Tube

Device Description D.

E. Intended Use

The NuVasive EMG Endotracheal Tube is intended for use with any compatible monitoring system during surgical procedures for continuous EMG neurological monitoring and status

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assessment of the nerves supplying the laryngeal musculature as well as for providing an open airway for patient ventilation.

F. Technological Characteristics

As was established in this submission, the subject NuVasive EMG Endotracheal Tube is substantially equivalent to other predicate devices cleared by the FDA for commercial distribution in the United States. The subject device was shown to be substantially equivalent and have the same technological characteristics to its predicate devices through comparison in areas including design, intended use, material composition, function, packaging, and sterilization. This device does not contain software. See the table below for a detailed comparison:

	Predicate Devices	Subject Device
	NuVasive NV EMG EndotrachealTube (K094054)	NuVasive EMG EndotrachealTube
Laryngeal SurfaceElectrode	YES	YES
EndolaryngealLocation	YES	YES
Number ofElectrodes	2 bipolar	2 bipolar
ElectrodeSurface Material	ConductiveSilver Ink	ConductiveSilver Ink with PVC Base
Tube & CuffMaterials	PVC	PVC (Non-DEHP)
ReinforcingMaterial	None	None
Tube Dimensions	Various Dimensions	Various Dimensions
Sterilization &Packaging	Sterile, single use only	Sterile, single use only

G. Performance Data

Nonclinical testing was performed to demonstrate that the subject NuVasive EMG Endotracheal Tube is substantially equivalent to other predicate devices. The following testing was performed:

Biocompatibility testing per ISO 10993-1 requirements, including: .

Test Name	Results	Conclusion
Cytotoxicity testing –MEM Elution	Discrete intracytoplasmic granules;no cell lysis (Grade 0)	PassNon-cytotoxic
Intracutaneous testing –NS and CSO	No erythema (Score 0)No edema (Score 0)	PassRequirements met
Sensitization testing –NS and CSO	No sensitization observed(Score 0)	PassNon-sensitizer
Systemic toxicity –NS and CSO	No signs or symptoms of systemictoxicity observed	PassRequirements met

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Functional bench testing, including: .
- Functional testing per ISO 5361
- inflation valve functionality
- leak test
- electrode resistance test
- system integration test
- bending test
Stability Testing .
Sterilization & Packaging Validations .

The results of these studies showed that the modified device meets the same specifications and criteria as the predecessor predicate device, and the device was therefore found to be substantially equivalent.

H. Conclusions

Based on the indications for use, technological characteristics, performance testing, and comparison to predicate devices, the subject NuVasive EMG Endotracheal Tube has been shown to be substantially equivalent to legally marketed predicate devices for its intended use.

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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 20993-0002

May 2, 2014

NuVasive, Incorporated Mr. Jeremy Markovich Associate Manager, Regulatory Affairs 7475 Lusk Blvd. San Diego, California 92121

Re: K133530

Trade/Device Name: NuVasive® EMG Endotracheal Tube Regulation Number: 21 CFR 874.1820 Regulation Name: Neurosurgical Nerve Locator Regulatory Class: Class II Product Code: PDQ, BSK and BTR Dated: March 31, 2014 Received: April 1, 2014

Dear Mr. Markovich:

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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical

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Page 2 - Mr. Jeremy Markovich

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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Felipe Aquel -S

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

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K133530

Device Name Nu Vasive EMG Endotracheal Tube

Indications for Use (Describe)

The NuVasive EMG Endoracheal Tube is intended for use with any compatible monitoring surgical procedures for continuous EMG neurological monitoring and status assessment of the laryngeal musculature as well as for providing an open airway for patient ventilation.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

... .

er for Devices and Radiological Health (CDRH) (Signature)

Date: 2014.05.02 11:22:42 -04'00'

FORM FDA 3881 (1/14)

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

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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.