NUVASIVE NEURO VISION SYSTEM

K090298 · Nuvasive, Inc. · GWF · Jun 8, 2009 · Neurology

Device Facts

• Record ID: K090298
• Device Name: NUVASIVE NEURO VISION SYSTEM
• Applicant: Nuvasive, Inc.
• Product Code: GWF · Neurology
• Decision Date: Jun 8, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1870
• Device Class: Class 2
• Attributes: Therapeutic

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

NeuroVision EMG Endotracheal Tube is a low-pressure cuff endotracheal tube with integrated electrodes. Used during surgery to provide an open airway for patient ventilation while simultaneously enabling continuous electromyographic (EMG) monitoring of nerves supplying laryngeal musculature. Device connects to compatible external monitoring systems to capture EMG signals. Healthcare providers use the output to assess nerve status during procedures. Benefits include integrated nerve monitoring and airway management in a single device.

Clinical Evidence

No clinical data provided; substantial equivalence established through engineering specifications and labeling comparisons.

Technological Characteristics

Low-pressure cuff endotracheal tube with integrated EMG electrodes. Functions as an airway management device and an interface for nerve monitoring systems. No software or active electronic components contained within the tube itself; relies on external compatible monitoring systems.

Indications for Use

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

• Xomed EMG Endotracheal Tube
• Arcadia Medical Tube

Submission Summary (Full Text)

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# VII. 510(k) Summary

K090298

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

#### Submitted by: A.

Ms. Han Fan Regulatory Affairs Associate NuVasive, Incorporated 7475 Lusk Blvd. San Diego, California 92121 Telephone: [phone] Fax: [phone]

JUN - 8 2009

#### B. Device Name

| Trade or Proprietary Name: | NuVasive® NeuroVision® EMG Endotracheal Tube |
|----------------------------|-----------------------------------------------------------------------|
| Common or Usual Name: | Endotracheal Tube with Electromyography (EMG) 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 Xomed EMG Endotracheal Tube and the Arcadia Medical Tube currently distributed commercially in the U.S ..

#### D. Device Description

The NeuroVision® EMG Endotracheal (ET) Tube is a low pressure cuff endotracheal tube with integrated electrodes for electromyographic (EMG) monitoring during surgery.

#### Intended Use E.

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.

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#### Substantial Equivalence F.

As was established in this submission, the subject device is substantially equivalent to other devices cleared by the agency for commercial distribution in the United States.

Engineering specifications and labeling have demonstrated that the subject device is substantially equivalent, if not identical, to its predicate devices in terms of design, materials of composition, indications for use, and such other characteristics as may be associated with the manufacture of any medical device.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The background is white.

### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NuVasive, Inc. c/o Han Fan Regulatory Affairs Associate 7475 Lusk Blvd. San Diego, CA 92121

JUN - 8 2009

Re: K090298

Trade/Device Name: NuVasive® NeuroVision® EMG Endotracheal Tube Regulation Numbers: 21 CFR 882.1870 Regulation Name: Evoked Response Electrical Stimulator Regulatory Class: II Product Code: GWF Dated: May 21, 2009 Received: May 22, 2009

Dear Ms. Fan:

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.

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 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.

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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/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/cdrh/mdr/ 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/cdrh/industry/support/index.html.

Sincerely yours,

Malvina B. Eydelman, M.D.

Director Division of Ophthalmic 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): K090298

Device Name: NuVasive NeuroVision EMG Endotracheal Tube

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 (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)

CG

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510(k) Number K090298

K090298