MODIFCATION TO: NUVASIVE NEUROVISION EMG ENDOTRACHEAL TUBE

K094054 · Nuvasive, Inc. · GWF · May 14, 2010 · Neurology

Device Facts

• Record ID: K094054
• Device Name: MODIFCATION TO: NUVASIVE NEUROVISION EMG ENDOTRACHEAL TUBE
• Applicant: Nuvasive, Inc.
• Product Code: GWF · Neurology
• Decision Date: May 14, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.1870
• Device Class: Class 2

Intended Use

The NeuroVision® 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

Endotracheal tube with integrated electrodes for electromyographic (EMG) monitoring; used during surgery to monitor recurrent laryngeal nerve (RLN) function. Device features 4 laryngeal surface electrodes (conductive silver ink) on a flexible PVC tube with an inflatable low-pressure cuff. Connects to compatible external EMG monitoring systems. Operated by clinicians in surgical settings to provide airway management and real-time nerve status assessment. Output displayed on external monitor; assists surgeons in identifying and protecting nerves during procedures. Benefits include continuous nerve monitoring and patient ventilation.

Clinical Evidence

Bench testing only. Testing included biocompatibility (cytotoxicity, intracutaneous, sensitization per ISO 10993), functional bench testing (ISO 5361, inflation valve functionality, leak test, electrode resistance, system integration, bending test), stability testing, and sterilization/packaging validation. Results demonstrate the device meets established specifications.

Technological Characteristics

Flexible PVC endotracheal tube with inflatable low-pressure cuff; 4 laryngeal surface electrodes using conductive silver ink. Dimensions vary. Sterile, single-use. Connectivity via integration with external EMG monitoring systems. No reinforcing material.

Indications for Use

Indicated for patients undergoing surgical procedures requiring continuous EMG neurological monitoring and status assessment of nerves supplying laryngeal musculature, while simultaneously providing an open airway for ventilation.

Regulatory Classification

Identification

An evoked response electrical stimulator is a device used to apply an electrical stimulus to a patient by means of skin electrodes for the purpose of measuring the evoked response.

Predicate Devices

• NuVasive NeuroVision EMG Endotracheal Tube (K090298)
• ECOM™ CV4 Endotracheal Cardiac Output Monitor (K032491)
• Contact™ EMG Rotatable Endotracheal Tube (K050162)

Submission Summary (Full Text)

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# 510(k) Summary

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:

#### A. Submitted by:

Sheila Bruschi Senior Regulatory Affairs Associate NuVasive, Incorporated 7475 Lusk Blvd. San Diego, California 92121 Telephone: [phone] Fax: [phone] Date Prepared: May 13, 2010

MAY 1 4 2010

#### B. Device Name

| Trade or Proprietary Name: | NuVasive® NeuroVision® EMG Endotracheal Tube |
|----------------------------|-------------------------------------------------------------------------|
| Common or Usual Name: | Endotracheal Tube with Electromyography (EMG)<br>monitoring Electrodes. |
| Classification Name: | Tracheal Tube<br>Inflatable Cuff<br>Surgical nerve stimulator/locator |
| Device Class: | Class II |
| Classification: | §874.1820, §882.1870, §868.5730 and §868.5750 |
| Product Code: | ETN, GWF |

#### C. Predicate Devices

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

- . K090298 - NuVasive NeuroVision EMG Endotracheal Tube
- K032491 ECOM™ CV4 Endotracheal Cardiac Output Monitor .
- K050162 Contact™ EMG Rotatable Endotracheal Tube .

#### D. Device Description

The NuVasive® NeuroVision® EMG Endotracheal (ET) Tube is an endotracheal tube with integrated electrodes for electromyographic (EMG) monitoring during surgery. The ET tube is made of a flexible PVC material with an inflatable low pressure cuff. The NeuroVision 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).

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Image /page/1/Picture/0 description: The image shows the logo for NUVASIVE. The logo consists of the word "NUVASIVE" in a bold, sans-serif font. Below the word "NUVASIVE" is the phrase "Creative Spine Technology" in a smaller, italicized font. To the left of the word "NUVASIVE" is a stylized graphic.

#### E. Intended Use

The NeuroVision® 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.

#### F. Technological Characteristics

As was established in this submission, the subject NeuroVision® 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. See the table below for a detailed comparison:

| | Subject Device | Predicate Devices | | |
|--------------------------------|--------------------------------------------|---------------------------------------------------|-----------------------------------------------------------------|-------------------------------------------------------------|
| | NeuroVision<br>EMG<br>Endotracheal<br>Tube | NeuroVision EMG<br>Endotracheal Tube<br>(K090298) | ECOM CV4<br>Endotracheal<br>Cardiac Output<br>Monitor (K032491) | Contact™ EMG<br>Rotatable<br>Endotracheal Tube<br>(K050162) |
| Laryngeal Surface<br>Electrode | YES | YES | YES | YES |
| Endolaryngeal<br>Location | YES | YES | YES | YES |
| Number of<br>Electrodes | 4 | 4 | unknown | 4 |
| Electrode<br>Surface Material | Conductive<br>Silver Ink | Stainless Steel Wire | Conductive<br>Silver Ink | Stainless Steel Wire |
| Tube & Cuff<br>Materials | PVC | Silicone | PVC | Silicone |
| Reinforcing<br>Material | None | Stainless Steel Wire | None | Stainless Steel Wire |
| Tube Dimensions | Various<br>Dimensions | Various Dimensions | unknown | Various Dimensions |
| Sterilization &<br>Packaging | Sterile, single use<br>only | Sterile, single use<br>only | Sterile, single use<br>only | Sterile, single use<br>only |

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#### G. Performance Data

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

- . Biocompatibility testing per ISO 10993-1 requirements, including:
- · cytotoxicity testing (per ISO 10993-5)
- · intracutaneous testing (per ISO 10993-10)
- · sensitization testing (per ISO 10993-10)
- 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 NeuroVision® EMG Endotracheal Tube has been shown to be substantially equivalent to legally marketed predicate devices, and safe and effective for its intended use.

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Image /page/3/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is in a serif font. The text is centered on the image and is the only element present.

Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling an emblem. The emblem is a stylized representation of a bird or abstract design, possibly symbolizing health and well-being.

### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

NuVasive, Inc. c/o Ms. Sheila Bruschi Senior Regulatory Affairs Associate 7475 Lusk Blvd. San Diego, CA 92121

MAY. 1 4, 2010

Re: K094054

Trade/Device Name: NuVasive® NeuroVision EMG Endotracheal Tube Regulation Number: 21 CFR 882.1870 Regulation Name: Evoked Response Electrical Stimulator Regulatory Class: Class II Product Code: GWF, ETN Dated: April 12, 2010 Received: April 13, 2010

Dear Ms. Bruschi:

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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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 (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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm11.5809.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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Qula. Kumm, wo fr

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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## Indications for Use

| 510(k) Number (if known): | K |
|---------------------------|---|
|---------------------------|---|

Device Name:

Indications For Use:

The NeuroVision 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.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number K094054