NEUROVISION NERVE LOCATOR MONITOR

K110140 · Neurovision Medical Products, Inc. · GWF · Sep 30, 2011 · Neurology

Device Facts

• Record ID: K110140
• Device Name: NEUROVISION NERVE LOCATOR MONITOR
• Applicant: Neurovision Medical Products, Inc.
• Product Code: GWF · Neurology
• Decision Date: Sep 30, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1870
• Device Class: Class 2

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 or warning capability. The device is intended to assist the surgeon in locating motor nerves that are at risk in surgical procedures.

Device Story

Single-channel evoked EMG device for intraoperative nerve location and monitoring. Inputs: electrical stimulation pulses delivered to tissue via probe; EMG signals detected via electrodes. Operation: device delivers pulsed nerve stimulation (0.1-5.0 mA standard; 3.0-12 mA high-level via dedicated cable); detects resulting muscle activity. Output: visual EMG data, electrode impedance readings, and audio alerts (tic-tic). Used in surgical settings by surgeons. Healthcare providers use real-time audio/visual feedback to identify nerve proximity, helping avoid nerve damage during surgery. Features digital display, serial USB data output, and improved isolation compared to predecessor. Includes self-test and calibration features.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by preclinical bench testing verifying design requirements, stimulation accuracy (within 5% of delivered current), and compliance with ISO 60601-2-40 standards.

Technological Characteristics

Evoked response electrical stimulator; 150 microsecond square pulse; 0.1-5.0 mA (low) and 3.0-12 mA (high) output; 10-step intensity control. Features digital display for impedance, serial USB connectivity, and improved physical isolation via opto-isolators. Construction includes through-hole and surface-mount components. Powered by 12V DC certified supply. Sterilization: disposable sterile stimulating lead wires.

Indications for Use

Indicated for use by qualified, trained medical practitioners performing operative surgery to assist in locating motor nerves at risk during surgical procedures, including spinal procedures.

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

• Neurovision Nerve Locator/Monitor System Modification NV004 (K954601)
• NuVasive INS-1 Intraoperative Nerve Surveillance System (K002677)

Reference Devices

• EMGView oscilloscope software (K102861)
• Laryngeal Surface electrode (K003745)
• Stimulating Hemostat (K895676)
• Hydrogel Ground (K092744)
• Hydrogel Ground (K110138)
• Needle Ground Electrode (K091056)

Submission Summary (Full Text)

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K110140

Image /page/0/Picture/1 description: The image shows the logo for Neurovision Medical. The word "neurovision" is written in bold, black letters on the top line. Below that, there is a black line with a heartbeat symbol in the middle, and the word "MEDICAL" is written in bold, black letters to the right of the heartbeat symbol.

30
2011

## Traditional 510k - Neurovision Nerve Locator/Monitor Model NV006

#### 510K 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:

### 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]

Date of Summary: 5/02/11

#### Device Identification:

Trade Name: Neurovision Nerve Locator Monitor NV006 (tbd) Common Name: Nerve Monitor/Locator System Regulation Number: 21 CFR 882.1870 Regulation Name: Evoked Response Electrical Stimulator Regulatory Class: Class II Product Code: GWF, ETN

#### Predicate Devices

Neurovision, Nerve Locator/Monitor System Modification NV004 model (K954601) NuVasive, INS-1 Intraoperative Nerve Surveillance System (K002677)

#### Device Description

The Neurovision Nerve Locator Monitor Model NV006 is a single channel evoked EMG device for surgical nerve location and monitoring. The device operates exactly as the predicate model NV004. The stimulation range for the predicate device (Model NV004) as a proactive nerve locator is up to 5.0 mA of pulsed nerve stimulation. An accessory cable adds optional "high level" stimulation (Model NV006) ranging from 3.0 to 12 mA.

#### 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 or warning capability. The device is intended to assist the surgeon in locating motor nerves that are at risk in surgical procedures.

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

The Neurovision High-Stim Nerve Locator/Monitor modification uses a dedicated stimulation cable assembly, the CSTI-HS, to activate an embedded capability to deliver nerve stimulation at higher levels (to 12 mA pulsed stimulation) as sometimes required for spinal screw testing purposes. The "HighStim" Cable Assembly, which activates higher level stimulation, is provided to the user as an accessory with the NV006 model in addition to the standard Stimulating Cable Assembly (CSTI).

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Image /page/1/Picture/0 description: The image shows the logo for Neurovision Medical. The word "neurovision" is in large, bold, sans-serif font. Below the word "neurovision" is a horizontal line with a small upward spike in the middle. To the right of the line is the word "MEDICAL" in a smaller, sans-serif font.

# Traditional 510k – Neurovision Nerve Locator/Monitor Model NV006

| Table 1: NV004 to NV006 Modification Comparison | | | |
|-------------------------------------------------|----------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|--|
| Feature | NV004 (K954601) | NV006 (High-Stim version) | |
| Indications for Use | Per 510(k) | Same plus addition of spinal<br>procedures | |
| Digital Display | N/A | Provides electrode<br>impedance readings | |
| Firmware | Assembly Language | Same | |
| Logical Algorithm | Neurovision proactive nerve<br>location algorithm | Same | |
| Stim voltage limit | 38 v | Same | |
| Stimulation output | Max 5mA, 5 steps, constant<br>current | Max 5mA/12 mA, 10 steps,<br>high range by separate cable.<br>Lowest setting 0.1mA<br>conforms to ISO 60601-2-40 | |
| Stim delivered audio | "Tic-tic" audio alert | Same | |
| Stimulation calibration | None | Accurate within 5% of<br>delivered current | |
| EMG | Variable gain | Same | |
| Channels | One | Same | |
| Electrode off | 4 beep alarm | Same | |
| Impedance measure | >15 k fixed alert | Actual measurement with<br>digital display | |
| Audio out | Sounder | Speaker | |
| Audio mode | Fixed alarms only | Alarms only, raw EMG only,<br>or both, user select | |
| Audio alarm tone | Beep | Same | |
| Volume | Variable, no zero | Same | |
| Self-test feature | Analog CAP internal | Same | |
| Event LED | Present | Same | |
| Battery LED | Present | Same | |
| Data out | Analog raw EMG out | Serial USB out; raw EMG and<br>status data | |
| Data collection | Digital PC oscilloscope | Dedicated digital EMGView<br>oscilloscope software<br>(K102861) | |
| Cable Assembly | EMG and Stimulation (low) | Same plus additional High-<br>Stimulation cable | |
| Stimulating Lead Wire | Reusable / user sterilizable<br>wire, disposable sterile | Disposable sterile wire | |
| Circuitry | Analog/digital | Same | |
| Layout | Thru-hole components | Same plus surface mount | |
| Isolation | Per design | Improved physical isolation;<br>shielding by Opto Isolators | |
| High Stim LED | N/A | Activated when High Stim<br>cable in use | |
| Power | 20 v AC Power<br>Supply/Charger; not<br>certified | 12 V DC Power<br>Supply/Charger; certified | |
| Nerve Location Indication | Detection circuitry always<br>active | Detection circuitry active only<br>during stimulation. Helps<br>prevent false alarms | |
| Laryngeal Surface electrode-<br>accessory | Accessory sold separately | Cleared through K003745 | |
| Stimulating Hemostat-<br>accessory | Accessory included with<br>System | Cleared through K895676 | |
| Hydrogel Ground-accessory | Accessory sold separately | Cleared through K092744<br>and K110138 | |
| Needle Ground Electrode -<br>accessory | Accessory sold separately | Cleared through K091056 | |

. .

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Image /page/2/Picture/0 description: The image shows the logo for Neurovision Medical. The word "neurovision" is in large, bold, black letters. Underneath the word "neurovision" is a black line with a heartbeat symbol in the middle, followed by the word "MEDICAL" in bold, black letters.

# Traditional 510k – Neurovision Nerve Locator/Monitor Model NV006

| Table 2: Substantial Equivalence Comparison | | | |
|---------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Predicate | Subject Device | |
| Feature | Neurovision Nerve<br>Locator/Monitor<br>System Modification<br>NV004 (K954601) | NuVasive INS-1<br>(K002677) | Neurovision Nerve<br>Locator Monitor<br>Model NV006 |
| Description | Evoked EMG nerve<br>locator/monitor | Evoked EMG nerve<br>locator/monitor | Evoked EMG nerve<br>locator/monitor |
| Intended Use | The Neurovision Nerve<br>Locator/Monitor is an<br>electronic device<br>consisting of a surgical<br>nerve stimulator and an<br>evoked EMG monitor<br>with integrated detecting<br>and warning<br>capability. This device is<br>intended for use in<br>surgical procedures<br>where motor nerves are | The INS-1 Intraoperative<br>Nerve Surveillance<br>System is intended to<br>provide intraoperative<br>electromyographic<br>(EMG) surveillance to<br>assist in the location and<br>evaluation of spinal<br>nerves during<br>percutaneous surgery of<br>the spine, by | The Neurovision<br>Nerve Locator<br>Monitor is an<br>electronic device<br>consisting of a<br>surgical nerve<br>stimulator and an<br>evoked EMG Monitor<br>with integrated<br>detecting or warning |

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Image /page/3/Picture/0 description: The image shows the logo for Neurovision Medical. The word "neurovision" is in bold, black letters on the top line. Underneath, there are two horizontal lines with a small, jagged line in the middle, followed by the word "MEDICAL" in bold, black letters.

## Traditional 510k – Neurovision Nerve Locator/Monitor Model NV006

| | at risk to assist the<br>surgeon in locating<br>these nerves. This<br>device is intended for<br>use only by qualified,<br>trained medical<br>practioners who perform<br>operative surgery and<br>fully understand that this<br>device is only and<br>adjuvant to proper<br>surgical technique and<br>good surgical judgment. | administration of low<br>amperage electrical<br>energy to tissues and<br>nerves at the operative<br>site, and EMG monitoring<br>of muscle groups<br>associated with those<br>nerves. The INS-1<br>System is designed for<br>use in conjunction with<br>the Nuvasive Guided<br>Spinal Arthroscopy<br>System to assist in<br>gaining controlled<br>percutaneous access to<br>the spinal nerve root,<br>foramina, intervertebral<br>disk, and surrounding<br>tissues of the spine via<br>uniportal or biportal<br>posterior or<br>posterolateral approach,<br>where anatomical<br>restrictions safely permit. | capability. The<br>device is intended to<br>assist the surgeon in<br>locating motor nerves<br>that are at risk in<br>surgical procedures. |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|
| Stimulation<br>Intensity | 150 microsecond<br>square pulse, 4 per<br>second, (0.1-5.0 mA, 10<br>steps); Maximum 42<br>VDC, 5 mA | 200 microsecond square<br>pulse, 4 per second,<br>0.4mA -12mA, Maximum<br>240 VDC | 150 microsecond<br>square pulse, 4 per<br>second, 0.1-5.0 mA<br>(Low) and 3.0-12 mA<br>(High) 10 steps;<br>Maximum 42 VDC,<br>12 mA |

## Performance Testing

Preclinical testing verified the design of this device and that all specified requirements were fulfilled

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Image /page/4/Picture/1 description: The image shows a logo for the Department of Health & Human Services. The logo features a stylized abstract symbol resembling an eagle or bird in flight, composed of three curved lines. The text "DEPARTMENT OF HEALTH &" is vertically oriented along the left side of the logo, with "HUMAN SERVICES" appearing below it.

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

SEP 3 0 2011

Re: K110140

Trade/Device Name: Nerve Locator Monitor (NV006) Regulation Number: 21 CFR 882.1870 Regulation Name: Evoked Response Electrical Stimulator Regulatory Class: Class II Product Code: GWF, ETN Dated: September 20, 2011 Received: September 22, 2011

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, forug 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/jability 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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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.html 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,
Debra Falls

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): K110140

Device Name: Neurovision Nerve Locator/Monitor Model NV006

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 or warning capability. The device is intended to assist the surgeon in locating motor nerves that are at risk in surgical procedures.

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.<br>(Per 21 CFR 801.109) | <div style="text-align:center;"><img alt="Prescription Use" height="20" src="prescription_use.png" width="20"/></div> |
|-------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|
|-------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|

Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)

Division of Ophthalmic, Neurological and Ear,
Nose and Throat Devices

| 510(k) Number | K110140 |
|---------------|---------|
|---------------|---------|

510(k) Number_