NEUROVISION INK PRINTED ENDOTRACHEAL TUBE ELECTRODE

K130806 · Neurovision Medical Products, Inc. · PDQ · Jul 12, 2013 · Ear, Nose, Throat

Device Facts

• Record ID: K130806
• Device Name: NEUROVISION INK PRINTED ENDOTRACHEAL TUBE ELECTRODE
• Applicant: Neurovision Medical Products, Inc.
• Product Code: PDQ · Ear, Nose, Throat
• Decision Date: Jul 12, 2013
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 874.1820
• Device Class: Class 2

Intended Use

The Neurovision Ink Printed Endotracheal Tube Electrode is intended for use during surgery and parasurgical care only, with any compatible monitoring system, for continuous EMG monitoring and status assessment of the nerves supplying the laryngeal musculature as well as providing an open airway for patient ventilation.

Device Story

Endotracheal tube with integrated conductive silver ink electrodes; used during surgery/parasurgical care for airway ventilation and continuous EMG monitoring of recurrent laryngeal nerve (RLN). Device connects to compatible external EMG monitoring systems; electrodes detect electrical activity from laryngeal musculature. Clinicians use output to assess nerve status during procedures. Benefits include simultaneous airway maintenance and real-time nerve monitoring to prevent injury.

Clinical Evidence

No clinical data. Bench testing only, including valve functionality, electrode impedance, bend tests, and biocompatibility testing (ISO 10993-11 Systemic Toxicity, ISO 10993-10 Intracutaneous Sensitivity, and ISO 10993-10 Irritation and Skin Sensitization).

Technological Characteristics

Flexible PVC endotracheal tube with inflatable low-pressure cuff; 2 or 4 conductive silver ink electrodes; dielectric coating attached via non-phthalate PVC adhesive. Sterile, single-use. Connects to external EMG monitoring systems.

Indications for Use

Indicated for patients undergoing surgery requiring continuous EMG monitoring of nerves supplying laryngeal musculature and airway management. No specific age or gender contraindications stated.

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

• Neurovision Ink Printed Endotracheal Tube Electrode (K110989)

Submission Summary (Full Text)

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K130806

Image /page/0/Picture/1 description: The image shows the logo for Neurovision Medical. The word "neurovision" is in large, outlined letters on the top line. Below that, the word "MEDICAL" is in smaller, outlined letters with three lines above it.

Special 510k - Ink Printed Endotracheal Tube Electrode Modification

JUL 1 2 2013

#### 510K Summary

#### Date: 5/1/2013

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

#### Applicant Information

Christine Vergely Regulatory Affairs Manager Neurovision Medical Products, Inc. 2225 Sperry Ave., Suite 1000 Ventura, CA 93003 PH 805-866-6999 Fax: [phone] [e-mail]

#### Device Identification:

Trade or Proprietary Name: Common or Usual Name:

Neurovision Ink Printed Endotracheal Tube Electrode. Endotracheal Tube with Electromyography (EMG) monitoring Electrodes. Class II

Device Class: Product Code:

#### Predicate Device

The subject Neurovision Ink Printed Endotracheal Tube Electrode is substantially equivalent to the following predicate devices concurrently distributed commercially in the U.S.:

- . K110989 Neurovision Ink Printed Endotracheal Tube Electrode
ETN

#### Device Description

The Neurovision Ink Printed Endotracheal Tube Electrode 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 Ink Printed Endotracheal Tube Electrode 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 Laryngel Nerve (RLN).

#### Intended Use

The Neurovision Ink Printed Endotracheal Tube Electrode is intended for use during surgery and parasurgical care only, with any compatible monitoring system, for continuous EMG monitoring and status assessment of the nerves supplying the laryngeal musculature as well as providing an open airway for patient ventilation.

#### Technological Characteristics of Device in Relation to Predicate Devices

The Neurovision Ink Printed Endotracheal Tube Electrode is substantially equivalent to the predicated device in intended use and technological characteristics including design,

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Image /page/1/Picture/0 description: The image shows the logo for Neurovision Medical. The word "neurovision" is written in large, outlined letters. Below that, the word "MEDICAL" is written in smaller, block letters, underlined by three horizontal lines that are connected by a small, jagged line in the middle.

Special 510k - Ink Printed Endotracheal Tube Electrode Modification

material composition, function, packaging, and sterilization.

### Comparison with the Predicate Device

| | Predicate Device | Subject Device |
|----------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------|
| Device Name | Neurovision Ink Printed<br>Endotracheal Tube Electrode | No Change |
| Indicated Use | The Neurovision Ink Printed<br>Endotracheal Tube Electrode is<br>intended for use during surgery<br>and parasurgical care only,<br>with any compatible monitoring<br>system, for continuous EMG<br>monitoring and status<br>assessment of the nerves<br>supplying the laryngeal<br>musculature as well as<br>providing an open airway for<br>patient ventilation. | No Change |
| Operating Principle | Receives EMG signal | No Change |
| Shelf Life | 3 years | No Change |
| Laryngeal<br>Surface<br>Electrode | YES | No Change |
| Endotracheal<br>Location | YES | No Change |
| Number<br>of<br>Electrodes | 2 or 4 | No Change |
| Electrode<br>Surface<br>Material | Conductive Silver Ink | No Change |
| Tube<br>&<br>Cuff<br>Materials | PVC | No Change |
| Reinforcing Material | Dielectric coating | Dielectric coating attached<br>to tube by non-phthalate<br>PVC adhesive. |
| Tube Dimensions | Various Dimensions | No Change |
| Sterilization<br>and<br>Packaging | Sterile, Single Use Only | No Change |
| Labeling,<br>Instructions for Use,<br>Intended Use | See attachments 1 and 2 | No Change |

Nonclinical testing, including valve functionality, electrode impedance and bend tests demonstrated that the subject Neurovision Ink Printed Endotracheal Tube Electrode is substantially equivalent to the predicate.

Biocompatibility testing included ISO 10993-11 Systemic Toxicity, ISO 10993-10 Intracutaneous Sensitivity and ISO 10993-10 Irritation and Skin Sensitization.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol of medicine, with three lines representing the branches of government. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the caduceus.

#### 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

#### July 12, 2013

Neurovision Medical Product, Inc. Ms. Christine Vergely Regulatory Affairs Manager 2225 Sperry Avenue, Suite 1000 Ventura, CA 93003

Re: K130806

Trade/Device Name: Neurovision Ink Printed Endotracheal Tube Electrode Regulation Number: 21 CFR 874.1820 Regulation Name: Neurosurgical Nerve Locator Regulatory Class: Class II Product Code: PDO, ETN, BTR, GWF Dated: June 12, 2013 Received: June 13, 2013

Dear Ms. Vergely:

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 }] (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

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Page 2 - Ms. Christine Vergely

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.fdagov/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 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,

# Victor Krauthamer -S

Victor Krauthamer, Ph.D. Acting Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): K130806

Device Name: Neurovision Ink Printed Endotracheal Tube Electrode

Indications For Use:

The Neurovision Ink Printed Endotracheal Tube Electrode is intended for use during surgery and parasurgical care only, with any compatible monitoring system, for continuous EMG 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 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Victor Krauthamer: -S 2013.07.12 16:49:43 -04'00'

Division Sign Off) Division of Neurological and Physical Medicine Devices (DNPMD)

510(k) Number

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