The EMG tube is indicated for use where continuous monitoring of the laryngeal musculature is required during surgical procedures. The EMG tube is not intended for postoperative use.

Device Description

Medtronic Xomed, Inc.'s NIM™ Standard Reinforced and NIM CONTACT™ Reinforced Endotracheal Tubes are flexible, reinforced endotracheal tubes with inflatable cuffs. The NIM EMG ET Tubes are made from silicone elastomer. Each tube is fitted with electrodes on the main shaft, which are exposed only for a short distance, slightly superior to the cuff. The electrodes are designed to make contact with the laryngeal muscles around the patient's vocal cords to facilitate electromyographic (EMG) monitoring of the laryngeal musculature during surgery when connected to an EMG monitoring device. Both the tube and cuff are manufactured from material that allows the tube to conform readily to the shape of the patient's trachea with minimal trauma to tissues.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Medtronic Xomed, Inc. NIM Standard Reinforced EMG Endotracheal Tube and NIM CONTACT Reinforced EMG Endotracheal Tube. This type of submission aims to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving a de novo device meets specific performance criteria through extensive clinical studies.

Therefore, the document does not contain the kind of detailed information about acceptance criteria and a study proving a device meets them that one would find for a novel device or an AI/ML-based device seeking de novo authorization or PMA. Specifically, it lacks:

A table of acceptance criteria and reported device performance: This document focuses on demonstrating equivalence to predicate devices, not on meeting predefined performance metrics for a novel technology.
Sample sizes for test sets, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance, or type of ground truth for a test set. These elements are typically found in studies designed to validate the performance of a diagnostic or therapeutic device against a gold standard, especially for AI/ML products.
Sample size for the training set or how ground truth for the training set was established: This information is pertinent to machine learning models, which are not the subject of this 510(k) submission.

What the document does describe regarding "performance data" is limited to nonclinical testing for usability and labeling design validation to support substantial equivalence.

Here's an analysis of the "Performance Data" section based on the provided text:

1. Acceptance Criteria and Reported Device Performance:

The document does not present quantitative acceptance criteria for the device's technical or diagnostic performance in the way one would see for a novel medical device like an AI algorithm. Instead, the "acceptance" is tied to proving substantial equivalence to predicate devices. The performance data presented relates to usability and labeling effectiveness, which are indirectly linked to safety and effectiveness.

Usability Goal: "The Anesthesiologist/Nurse Anesthetist shall be able to intubate the patient and maintain the airway without introducing any unrealized use errors or critical tasks."
Critical Tasks: "Confirm the Critical tasks were completed without any unacceptable Use Error that may have resulted in unmitigated potential hazards."
Risk Mitigations: "To show the risk mitigations were effective in regard to labeling and training."
Labeling Design Validation User Need: "The product labeling was to be understandable and provide needed information for proper safe and effective use of the device."

Reported Performance:
"The results of these validations with the modified proposed labeling demonstrated that the usability goal was achieved, all critical tasks were completed without introducing any additional unmitigated hazards, the user need and risk control measures were met and the training mitigations proposed were effective."

2. Sample Sizes and Data Provenance:

The document mentions "Summative Usability Validation" and "Labeling Design Validation" but does not specify the sample size (e.g., number of users, number of simulated scenarios) used for these nonclinical tests.
The data provenance is implied to be from internal testing conducted by the manufacturer, Medtronic Xomed, Inc., as part of their 510(k) submission process. It is not retrospective or prospective clinical data in the typical sense. The country of origin of the data is not explicitly stated but is implied to be in the US, given the FDA submission.

3. Number of Experts and Qualifications:

The document refers to "Anesthesiologist/Nurse Anesthetist" as the target users for the usability testing. However, it does not specify the number of experts used in the usability or labeling validation studies, nor their specific qualifications (e.g., years of experience). These individuals would have served as the "test subjects" or "evaluators" for the usability study, not necessarily as "experts establishing ground truth" in a diagnostic context.

4. Adjudication Method:

The document does not mention any adjudication method. This is not relevant for the type of usability and labeling validation studies described. Adjudication is typically used in studies where multiple human readers or algorithms produce interpretations that need to be reconciled to establish a ground truth (e.g., for diagnostic accuracy studies).

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

No MRMC study was conducted or reported. The device is not an AI/ML diagnostic aid that assists human readers. It is an endotracheal tube with EMG monitoring capabilities. The "performance data" is purely for usability and labeling effectiveness, not comparative diagnostic accuracy for human readers with or without an AI.

6. Standalone Performance (Algorithm Only):

This section is not applicable. The device is a physical medical device (an endotracheal tube), not a software algorithm. Therefore, there is no "standalone performance" in the context of an algorithm's output.

7. Type of Ground Truth Used:

For the usability and labeling studies, the "ground truth" was essentially defined by the successful completion of critical tasks without unacceptable use errors and the understandability of the labeling, as determined by the study design and its evaluators. This is not "expert consensus," "pathology," or "outcomes data" in the clinical diagnostic sense. It's about demonstrating safe and effective interaction with the device.

8. Sample Size for the Training Set:

This is not applicable. The device is a physical product, not an AI/ML model that requires a training set.

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

This is not applicable for the same reason as above.

In summary, the provided FDA 510(k) summary focuses on demonstrating substantial equivalence to predicate devices, with performance data limited to nonclinical usability and labeling validation. It does not provide the details typically found in studies for novel diagnostic or AI/ML devices that aim to prove specific performance metrics against a clinical ground truth.

Summary

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October 26, 2023

Medtronic Xomed, Inc. Emily Davis Principal Regulatory Affairs Specialist 6743 Southpoint Drive North Jacksonville, Florida 32216

Re: K230320

Trade/Device Name: NIM Standard Reinforced EMG Endotracheal Tube; CONTACT Reinforced EMG Endotracheal Tube Regulation Number: 21 CFR 874.1820 Regulation Name: Surgical nerve stimulator/locator Regulatory Class: Class II Product Code: ETN Dated: August 29, 2023 Received: August 30, 2023

Dear Emily Davis:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies.combination product submissions. 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100. Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrl-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Shuchen Peng -S

Shu-Chen Peng, Ph.D. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known) K230320

Device Name

NIM™ Standard Reinforced EMG Endotracheal Tube and NIM CONTACT™ Reinforced EMG Endotracheal Tube

Indications for Use (Describe)

The EMG tube is indicated for use where continuous monitoring of the laryngeal musculature is required during surgical procedures. The EMG tube is not intended for postoperative use.

Type of Use (Select one or both, as applicable)
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X Prescription Use (Part 21 CFR 801 Subpart D)

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

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Medtronic

Medtronic Xomed, Inc. 6743 Southpoint Drive N. Jacksonville, FL 32216 United States of America www.medtronic.com Tel. 904-296-9600

510(k) Summary

This 510(k) Summary was prepared in accordance with 21 CFR 807.92.

Submitted By:	Medtronic Xomed, Inc.6743 Southpoint Drive NorthJacksonville, Florida 32216 USATelephone Number: (904) 296-9600
510(k) Number:	K230320
Date Prepared:	10/26/2023
Official Correspondent:	Alexandra OliverRegulatory Affairs ManagerTelephone: (904) 332-8936Email Address:Alexandra.j.oliver@medtronic.com
Alternate Contact:	Emily DavisPrincipal Regulatory Affairs SpecialistTelephone: (949) 636-4621Email Address:emily.r.davis@medtronic.com
I. DEVICE
Proprietary (Trade) Names:	NIMTM Standard Reinforced EMG Endotracheal Tube,NIM CONTACTTM Reinforced EMG Endotracheal TubeStimulator
Common Name:	Surgical nerve stimulator/locator
Regulation Name:	21 CFR 874.1820
Regulation Number:	ETN
Product Code:	II
Device Classification:	Ear, Nose, & Throat (ENT)
Review Panel:

II. PREDICATE DEVICE(S)

The NIM™ Standard Reinforced EMG Endotracheal Tube and NIM CONTACT™ EMG Reinforced Endotracheal Tube are substantially equivalent in intended use and technological characteristics to the following predicate device(s):

510(k) Number	510(k) Device Name	ProductCode	RegulationNumber	510(k)Clearance Date
K925640	Xomed-Treace EMGEndotracheal Tube	ETN	21 CFR 874.1820	August 17, 1993
K050162	CONTACT™ EMGRotatable Endotracheal Tube	ETN	21 CFR 874.1820	March 3, 2005

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Medtronic

III. DEVICE DESCRIPTION

Device Description

Intended Use

The 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 intrinsic laryngeal musculature when connected to an appropriate EMG monitor.

IV. INDICATIONS FOR USE

Indications for Use

The EMG tube is indicated for use where continuous monitoring of the nerves supplying the laryngeal musculature is required during surgical procedures. The EMG tube is not intended for postoperative use.

V. TECHNOLOGICAL COMPARISON TO THE PREDICATE DEVICE(S)

The EMG Endotracheal tube is substantially equivalent to the predicate devices based on comparison of indications for use and technological characteristics where additions to the subject devices instructions for use were made being the only difference. Technological Characteristics of our device compared to each predicate is shown in the following table and in the Substantial Equivalence section of this submission.

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Medtronic

Feature/Attribute	NIM™ StandardReinforced EMGEndotracheal Tube& NIMCONTACT™Reinforced EMGEndotracheal Tube(Subject Device(s))	Xomed-Treace EMGEndotracheal Tube /K925640(Predicate Device)	CONTACT TM EMGRotatable ET Tube / K050162(Predicate Device)
Product Code	ETN	ETN	ETN
Regulation Number	21 CFR 874.1820	21 CFR 874.1820	21 CFR 874.1820
RegulationDescription	Surgical nervestimulator/locator	Surgical nervestimulator/locator	Surgical nerve stimulator/locator
Classification	Class II	Class II	Class II
Common Name	Nerve Stimulator	Nerve Stimulator	Nerve Stimulator
Indications for Use	The EMG tube isindicated for use wherecontinuous monitoringof the nerves supplyingthe laryngealmusculature is requiredduring surgicalprocedures. The EMGtube is not intended orpostoperative use.	Intraoperativeelectromyographicmonitoring of the vocalcords to facilitate locatingand mapping of therecurrent laryngeal nervein surgical proceduresinvolving the laryngealregion of the throat.	The CONTACTTM EMGRotatable Endotracheal Tube isintended for use as a means ofproviding both an open airway forpatient ventilation and forintraoperative monitoring of EMGactivity of the intrinsic laryngealmusculature when connected to anappropriate EMG monitor.The EMG Tube is indicatedfor use where continuousmonitoring of the integrityof the nerves supplying thelaryngeal musculature isrequired during surgicalprocedures.
Tube Lengths	Approximately 12.8inches	Approximately 12.8inches	Approximately 12.8 inches
Tube InnerDiameter (ID)	6mm-8mm	4mm-8mm	6mm-8mm
Number ofLaryngeal SurfaceElectrodes	4	4	4
Electrode Surface	Stainless steel wire	Stainless steel wire	Stainless steel wire
Tube Material	Silicone	Silicone	Silicone
Cuff Material	Silicone	Silicone	Silicone
ReinforcingMaterial	Stainless Steel	Stainless Steel	Stainless Steel
Sterilization Method	EtO	EtO	EtO

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Substantial Equivalence Discussion

The purpose of this submission is to gain clearance for proposed modifications to the labeling (Instructions for Use (IFU) and product labels) for the NIM™ Standard Reinforced and NIM CONTACT™ Reinforced Endotracheal Tubes. The NIM™ EMG ET Tubes are 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. As the intended use remains the differences in labeling between the subject and predicate devices are additional warnings and precautions in the IFU for actions to be taken if airway obstruction is encountered, with additional symbols on product labeling for clarification on EMG ET Tube material and recommended tool for cuff inflation. These modified labeling differences are critical to the intended surgical use of the device when used as labeled and have been evaluated by Human Factors Testing and a Labeling Design Validation study which were found to improve the safety and efficacy. Both the subject device(s) and the predicate device(s) share similar characteristics (design, materials, operating principle, energy source, and performance).

VI. PERFORMANCE DATA

Performance Testing Discussion

The following nonclinical testing was performed to establish substantial equivalence to the predicates: Summative Usability Validation and Labeling Design Validation. The Objective of this Summative Usability Validation testing was to accomplish:

1. Achieve the Usability Goal: The Anesthesiologist/Nurse Anesthetist shall be able to intubate the patient and maintain the airway without introducing any unrealized use errors or critical tasks;
1. Confirm the Critical tasks were completed without any unacceptable Use Error that may have resulted in unmitigated potential hazards; and
1. To show the risk mitigations were effective in regard to labeling and training.

Additionally, the objective of the Labeling Design Validation was to validate that the NIM EMG Tube IFU and product labels met the User Need which was that the product labeling was to be understandable and provide needed information for proper safe and effective use of the device.

The results of these validations with the modified proposed labeling demonstrated that the usability goal was achieved, all critical tasks were completed without introducing any additional unmitigated hazards, the user need and risk control measures were met and the training mitigations proposed were effective. This nonclinical testing demonstrated that the subject device is substantially equivalent to the predicate device.

Clinical Testing

No clinical test data is required of the proposed device.

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VII. CONCLUSION

The NIM™ Standard Reinforced and NIM CONTACT™ Reinforced Endotracheal Tubes is concluded to be substantially equivalent to the predicates as the identified differences do not raise new or different concerns or questions of safety and effectiveness relative to the predicate device(s). Therefore, it is the opinion of the submitter that the NIM™ Standard Reinforced and NIM CONTACT™ Reinforced Endotracheal Tubes are as safe, as effective and performs as well as the legally marketed predicated devices.

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.