NEUROVISION SE (NERVEANA)

K102862 · Neurovision Medical Products, Inc. · ETN · Dec 21, 2010 · Ear, Nose, Throat

Device Facts

• Record ID: K102862
• Device Name: NEUROVISION SE (NERVEANA)
• Applicant: Neurovision Medical Products, Inc.
• Product Code: ETN · Ear, Nose, Throat
• Decision Date: Dec 21, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.1820
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The Neurovision Nerve Locator/Monitor is an electronic device consisting of a surgical nerve stimulator and an evoked EMG monitor with integrated detecting and warning capability. This device is intended for use in surgical procedures where motor nerves are at risk to assist the surgeon in locating these nerves. This device is intended for use only by qualified, trained medical practitioners who perform operative surgery and who fully understand that this device is only an adjuvant to proper surgical technique and good surgical judgment. The EMGView software is an accessory to the Neurovision Nerve Locator/Monitor. When the dedicated USB output of the EMG unit is connected to a personal computer, the PC installed software provides status monitoring data, troubleshooting data, real-time EMG waveforms, and digital backup of all data obtained during clinical use of the device. The real-time display of EMG waveforms is intended to assist the surgeon with nerve integrity monitoring.

Device Story

EMGView Software is a PC-based accessory for the Neurovision Nerve Locator/Monitor. It receives real-time EMG data from the Nerve Locator/Monitor via a dedicated serial USB connection. The software functions as a read-only display and documentation tool; it does not control or modify the Nerve Locator/Monitor. It provides surgeons with real-time EMG waveform visualization, status monitoring, troubleshooting data, and digital data backup. Used in surgical settings, it assists surgeons in nerve location and integrity monitoring by providing visual feedback and postoperative review capabilities. It serves as an adjuvant to surgical technique and judgment.

Clinical Evidence

Bench testing only. Verification was performed using the Nerveana bench testing performance as a baseline. Validation confirmed that clinical use of the software conforms to user needs.

Technological Characteristics

PC-installed software accessory; connects via dedicated serial USB to the Neurovision Nerve Locator/Monitor. Provides real-time EMG waveform display, threshold audio alarms, and database/playback functionality. Read-only architecture; does not control the primary device.

Indications for Use

Indicated for use by qualified, trained medical practitioners performing operative surgery where motor nerves are at risk, to assist in nerve location and integrity monitoring.

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 Nerve Locator/Monitor (K954601)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows handwritten text on a white background. The text includes the alphanumeric string "K102862" and "P. 1 of 3". The handwriting appears to be in black ink and is slightly slanted.

Image /page/0/Picture/1 description: The image shows the logo for Neurovision Medical. The word "neurovision" is in large, bold, sans-serif font. Below that, the word "medical" is in a smaller, sans-serif font, with two horizontal lines above it.

Traditional 510k - EMGView Software

DEC 2 1 2010

## 510(k) Summarv

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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:

Date: 12/10/10

Submitter: Christine Vergely Neurovision Medical Products, Inc. 2225 Sperry Ave., Suite 1000 Ventura, CA 93003 Telephone: [phone] Fax: [phone]

Trade or Proprietary Name: Common or Usual Name: Classification Name:

EMGView Software EMG software for Windows® PC Surgical nerve stimulator/locator (21 CFR §874.1820)

Predicate Device:

Neurovision Nerve Locator/Monitor (K954601)

Device Description:

The EMGView Software is a Windows PC operating system software dedicated to viewing and documentation of the output of the Neurovision (Nerveäna) Nerve Locator/Monitor. The software is dedicated to the EMG device by a serial USB connection. The EMGView software is a read-only device and is thus incapable of modifying or controlling the Nerveäna Device.

Intended Use:

The EMGView software is an accessory to the Neurovision Nerve Locator/Monitor. When the dedicated USB output of the EMG unit is connected to a personal computer, the PC installed software provides status monitoring data, troubleshooting data, realtime EMG waveforms, and digital backup of all data obtained during clinical use of the device.

Indications for Use:

The Neurovision Nerve Locator/Monitor is an electronic device consisting of a surgical nerve stimulator and an evoked EMG monitor with integrated detecting and warning capability. This device is intended for use in surgical procedures where motor nerves are at risk to assist the surgeon in locating these nerves. This device is intended for

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Image /page/1/Picture/0 description: The image shows handwritten text on a white background. The text includes the alphanumeric string "k102862" and the phrase "p. 2 of 3". The text is slightly rotated, giving it a dynamic appearance.

Image /page/1/Picture/1 description: The image shows the logo for Neurovision Medical. The word "neurovision" is in large, bold, black letters. Below the word "neurovision" are three horizontal lines with a small EKG waveform in the middle. To the right of the horizontal lines is the word "MEDICAL" in bold, black letters.

Traditional 510k - EMGView Software

use only by qualified, trained medical practioners who perform operative surgery and who fully understand that this device is only an adjuvant to proper surgical technique and good surgical judgment.

The EMGView software is an accessory to the Neurovision Nerve Locator/Monitor. When the dedicated USB output of the EMG unit is connected to a personal computer, the PC installed software provides status monitoring data, troubleshooting data, realtime EMG waveforms, and digital backup of all data obtained during clinical use of the device. The real-time display of EMG waveforms is intended to assist the surgeon with nerve integrity monitoring.

Technological Characteristics:

The EMGView software is a PC installed software accessory to the Neurovision Nerve Locator/Monitor.

| | Subject Device | Predicate device (after approved modification |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Neurovision (Nerveäna) with<br>EMGView Software | Nerveäna (post 2006) K954601 |
| Surgical Nerve<br>Locator/Monitor | Yes | Yes |
| Device data<br>output | Dedicated serial USB to PC | Dedicated serial USB to PC |
| Indications for<br>Use | The Neurovision Nerve Locator/Monitor is an<br>electronic device consisting of a surgical nerve<br>stimulator and an evoked EMG monitor with<br>integrated detecting and warning capability.<br>This device is intended for use in surgical<br>procedures where motor nerves are at risk to<br>assist the surgeon in locating these nerves.<br>This device is intended for use only by qualified,<br>trained medical practioners who perform<br>operative surgery and who fully understand that<br>this device is only an adjuvant to proper<br>surgical technique and good surgical judgment.<br>The EMGView software is an accessory to the<br>Neurovision Nerve Locator/Monitor. When the<br>dedicated USB output of the EMG unit is<br>connected to a personal computer, the PC | The Neurovision Nerve Locator/Monitor is an<br>electronic device consisting of a surgical nerve<br>stimulator and an evoked EMG monitor with<br>integrated detecting and warning capability. This<br>device is intended for use in surgical procedures<br>where motor nerves are at risk to assist the<br>surgeon in locating these nerves. This device is<br>intended for use only by qualified, trained medical<br>practioners who perform operative surgery and who fully understand that this device is only an<br>adjuvant to proper surgical technique and good surgical judgment. |

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Image /page/2/Picture/1 description: The image shows the logo for Neurovision Medical. The word "neurovision" is in large, bold, black letters. Underneath the word is a black line with a small EKG-like waveform in the middle, followed by the word "MEDICAL" in smaller, bold, black letters.

## Traditional 510k - EMGView Software

| | installed software provides status monitoring<br>data, troubleshooting data, real-time EMG<br>waveforms, and digital backup of all data<br>obtained during clinical use of the device. The<br>real-time display of EMG waveforms is intended<br>to assist the surgeon with nerve integrity<br>monitoring. | |
|----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----|
| Software | Dedicated <i>EMGView</i> Program | N/A |
| EMG Waveform<br>Display | PC Based Accessory | N/A |
| PC based<br>threshold audio<br>alarm | PC Based Accessory | N/A |
| Database and<br>Playback<br>capability | PC Based Accessory | N/A |

## Safety and Efficacy

The EMGView Software (v4.31, current version) requirements were verified using the Nerveana bench testing performance as a baseline. The software was validated by confirming that its clinical use conforms to user needs.

The Nerveäna device with EMGView software is as safe and effective as the Nerveäna device alone in locating and monitoring motor nerves during surgery:

- The EMGView software, being a read-only device accessory, does not affect the . performance of the Nerveäna device.
- · No surgeon input is required for operation of the Nerveäna accessory.
- · The EMGView software provides additional troubleshooting tools for the surgeon to verify proper Nerveäna operation and electrode position.
- · The Database Feature of the Nerveäna provides focus by the surgeon on the issue of proper nerve location and preservation as well as providing postoperative review data that would otherwise be unobtainable in answering any questions about the relationship of nerve monitoring to the surgical outcome.

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Neurovision Medical Products, Inc. c/o Ms. Christine Vergely Regulatory Manager 2225 Sperry Avenue, Suite 1000 Ventura, CA 93003

DEC212010

Re: K102862

Trade/Device Name: EMGView Software (v4.31) Regulation Number: 21 CFR 874.1820 Regulation Name: Surgical nerve stimulator/locator Regulatory Class: Class II Product Code: ETN Dated: December 10, 2010 Received: December 13, 2010

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.

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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.

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/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,

R. A. Rosenbaum Jr.

Malvina B. Eydelman, 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): K102862

DEC 2 1 2010

Device Name: EMGView Software

Indications for Use:

The Neurovision Nerve Locator/Monitor is an electronic device consisting of a surgical nerve stimulator and an evoked EMG monitor with integrated detecting and warning capability. This device is intended for use in surqical procedures where motor nerves are at risk to assist the surgeon in locating these nerves. This device is intended for use only by qualified, trained medical practitioners who perform operative surgery and who fully understand that this device is only an adjuvant to proper surgical technique and good surgical judgment.

The EMGView software is an accessory to the Neurovision Nerve Locator/Monitor. When the dedicated USB output of the EMG unit is connected to a personal computer, the PC installed software provides status monitoring data, troubleshooting data, real-time EMG waveforms, and digital backup of all data obtained during clinical use of the device. The real-time display of EMG waveforms is intended to assist the surgeon with nerve integrity monitoring.

Prescription Use X (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 OF NEEDED)

| Prescription Use | X |
|----------------------|---|
| (Per 21 CFR 801.109) | |

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

| 510(k) Number | K102862 |
|---------------|---------|
|---------------|---------|