NUVASIVE EMG ENDOTRACHEAL TUBE

K133530 · Nu Vasive, Incorporated · PDQ · May 2, 2014 · Ear, Nose, Throat

Device Facts

• Record ID: K133530
• Device Name: NUVASIVE EMG ENDOTRACHEAL TUBE
• Applicant: Nu Vasive, Incorporated
• Product Code: PDQ · Ear, Nose, Throat
• Decision Date: May 2, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.1820
• Device Class: Class 2

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

Device Story

Device is a sterile, single-use, flexible PVC endotracheal tube with integrated bipolar electrodes; used during surgery to provide an open airway for ventilation while simultaneously enabling continuous EMG monitoring of the recurrent laryngeal nerve (RLN). The tube is inserted by a clinician; electrodes connect to a compatible external EMG monitoring system. The system detects electrical signals from laryngeal muscles; these signals are processed by the external monitor to provide real-time status assessment of nerve function. This allows surgeons to monitor nerve integrity during procedures, potentially reducing the risk of nerve injury. The device is used in clinical/surgical settings.

Clinical Evidence

Bench testing only. Biocompatibility testing (cytotoxicity, intracutaneous, sensitization, systemic toxicity) per ISO 10993-1 passed. Functional bench testing per ISO 5361 included inflation valve functionality, leak testing, electrode resistance, system integration, and bending tests. All results met specifications.

Technological Characteristics

Flexible non-DEHP PVC endotracheal tube with inflatable low-pressure cuff. Features 2 integrated bipolar electrodes using conductive silver ink with a PVC base. Dimensions vary. Sterile, single-use. No software. Complies with ISO 5361 for tracheal tubes and ISO 10993-1 for biocompatibility.

Indications for Use

Indicated for patients undergoing surgical procedures requiring continuous EMG neurological monitoring of laryngeal musculature nerves and airway ventilation.

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

• NuVasive NV EMG Endotracheal Tube (K094054)

Submission Summary (Full Text)

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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: [phone]

Date Prepared: April 25, 2014

#### B. Device Name

| Trade or Proprietary Name: | NuVasive® EMG Endotracheal Tube |
|----------------------------|--------------------------------------------------------------------------------------------------------|
| Common or Usual Name: | Neurosurgical Nerve Locator;<br>Endotracheal Tube with Electromyography (EMG)<br>monitoring Electrodes |
| Classification Name: | Surgical nerve stimulator/locator;<br>Tracheal Tube;<br>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.

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).

#### 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 Endotracheal<br>Tube (K094054) | NuVasive EMG Endotracheal<br>Tube |
| Laryngeal Surface<br>Electrode | YES | YES |
| Endolaryngeal<br>Location | YES | YES |
| Number of<br>Electrodes | 2 bipolar | 2 bipolar |
| Electrode<br>Surface Material | Conductive<br>Silver Ink | Conductive<br>Silver Ink with PVC Base |
| Tube & Cuff<br>Materials | PVC | PVC (Non-DEHP) |
| Reinforcing<br>Material | None | None |
| Tube Dimensions | Various Dimensions | Various Dimensions |
| Sterilization &<br>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 –<br>MEM Elution | Discrete intracytoplasmic granules;<br>no cell lysis (Grade 0) | Pass<br>Non-cytotoxic |
| Intracutaneous testing –<br>NS and CSO | No erythema (Score 0)<br>No edema (Score 0) | Pass<br>Requirements met |
| Sensitization testing –<br>NS and CSO | No sensitization observed<br>(Score 0) | Pass<br>Non-sensitizer |
| Systemic toxicity –<br>NS and CSO | No signs or symptoms of systemic<br>toxicity observed | Pass<br>Requirements 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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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus symbol. The logo is black and white.

## 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 [phone] or [phone] 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 [phone] or [phone] 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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