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 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.

AI/ML Overview

Here's a summary of the acceptance criteria and the study information for the Neurovision Nerve Locator/Monitor Model NV006, based on the provided text:

Acceptance Criteria and Device Performance

Feature/Criterion	Acceptance Criteria (from NV004/Predicate)	Reported Device Performance (NV006)
Indications for Use	Per 510(k) (K954601)	Same, plus addition of spinal procedures
Digital Display	N/A	Provides electrode impedance readings
Firmware	Assembly Language	Same
Logical Algorithm	Neurovision proactive nerve location algorithm	Same
Stim voltage limit	38 V	Same
Stimulation Output	Max 5mA, 5 steps, constant current	Max 5mA/12 mA, 10 steps, high range by separate cable (0.1mA to 12mA). Lowest setting 0.1mA conforms to ISO 60601-2-40.
Stim delivered audio	"Tic-tic" audio alert	Same
Stimulation Calibration	None	Accurate within 5% of delivered current
EMG	Variable gain	Same
Channels	One	Same
Electrode off alarm	4 beep alarm	Same
Impedance measure	>15 k fixed alert	Actual measurement with digital display
Audio out	Sounder	Speaker
Audio mode	Fixed alarms only	Alarms only, raw EMG only, 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 status data
Data collection	Digital PC oscilloscope	Dedicated digital EMGView oscilloscope software (K102861)
Cable Assembly	EMG and Stimulation (low)	Same, plus additional High-Stimulation cable
Stimulating Lead Wire	Reusable / user sterilizable wire, disposable sterile	Disposable sterile wire
Circuitry	Analog/digital	Same
Layout	Thru-hole components	Same, plus surface mount
Isolation	Per design	Improved physical isolation; shielding by Opto Isolators
High Stim LED	N/A	Activated when High Stim cable in use
Power	20 v AC Power Supply/Charger; not certified	12 V DC Power Supply/Charger; certified
Nerve Location Indication	Detection circuitry always active	Detection circuitry active only during stimulation. Helps prevent false alarms. (This is a change/improvement)
Laryngeal Surface electrode – accessory	Accessory sold separately (Cleared through K003745)	Cleared through K003745
Stimulating Hemostat – accessory	Accessory included with System (Cleared through K895676)	Cleared through K895676
Hydrogel Ground – accessory	Accessory sold separately (Cleared through K092744 and K110138)	Cleared through K092744 and K110138
Needle Ground Electrode – accessory	Accessory sold separately (Cleared through K091056)	Cleared through K091056

Study Information:

Sample size used for the test set and data provenance:
- The document states "Preclinical testing verified the design of this device and that all specified requirements were fulfilled." No specific details about the sample size of a test set (e.g., number of patients, cases, or data points) are provided.
- The provenance of the data (country of origin, retrospective or prospective) is not explicitly mentioned. Given the nature of a 510(k) for a device like a nerve monitor, most "preclinical testing" would likely involve bench testing, animal models, or potentially limited human use studies that are not described in detail here.
Number of experts used to establish the ground truth for the test set and their qualifications:
- This information is not provided in the document.
Adjudication method for the test set:
- This information is not provided in the document.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:
- No MRMC comparative effectiveness study is mentioned. The device is a nerve locator/monitor, not an AI-assisted diagnostic imaging device requiring human reader interpretation in the context of typical MRMC studies.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- The "Preclinical testing" mentioned implies standalone testing of the device's functionality. The document highlights various technical specifications and changes from the predicate device that would be subject to such testing (e.g., accuracy of delivered current, impedance measurement, alarm functions, stimulation output). However, no specific details of a formal "standalone" study are provided beyond the general statement.
The type of ground truth used:
- Given that the preclinical testing verified the design and requirements, the ground truth would likely be based on:
  - Engineering specifications and standards: Conformance to ISO 60601-2-40 for stimulation output, accuracy within 5% of delivered current, and other technical requirements.
  - Functional verification: The device's ability to accurately provide impedance readings, generate anticipated audio alerts, and stimulate within specified ranges.
  - Comparison to predicate device performance: Showing that the NV006 performs at least as well as the NV004 for existing functions and that new functions (like high-stim) meet their design intent.
The sample size for the training set:
- The device described is a medical instrument (hardware and embedded software) for nerve location and monitoring, not a machine learning or AI algorithm that typically has a "training set" in the conventional sense. The "logical algorithm" is described as the "Neurovision proactive nerve location algorithm," which is "Same" as the predicate device, implying it is a deterministic, rule-based algorithm rather than a learned model. Therefore, the concept of a "training set" as used for machine learning models does not apply here.
How the ground truth for the training set was established:
- As explained above, the concept of a "training set" for a machine learning model does not apply to this device based on the provided information.

Summary

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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: 413-410-4579 christie@neurovisionmedical.com

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

Intended Use

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 spinalprocedures
Digital Display	N/A	Provides electrodeimpedance readings
Firmware	Assembly Language	Same
Logical Algorithm	Neurovision proactive nervelocation algorithm	Same
Stim voltage limit	38 v	Same
Stimulation output	Max 5mA, 5 steps, constantcurrent	Max 5mA/12 mA, 10 steps,high range by separate cable.Lowest setting 0.1mAconforms to ISO 60601-2-40
Stim delivered audio	"Tic-tic" audio alert	Same
Stimulation calibration	None	Accurate within 5% ofdelivered current
EMG	Variable gain	Same
Channels	One	Same
Electrode off	4 beep alarm	Same
Impedance measure	>15 k fixed alert	Actual measurement withdigital display
Audio out	Sounder	Speaker
Audio mode	Fixed alarms only	Alarms only, raw EMG only,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 andstatus data
Data collection	Digital PC oscilloscope	Dedicated digital EMGViewoscilloscope software(K102861)
Cable Assembly	EMG and Stimulation (low)	Same plus additional High-Stimulation cable
Stimulating Lead Wire	Reusable / user sterilizablewire, disposable sterile	Disposable sterile wire
Circuitry	Analog/digital	Same
Layout	Thru-hole components	Same plus surface mount
Isolation	Per design	Improved physical isolation;shielding by Opto Isolators
High Stim LED	N/A	Activated when High Stimcable in use
Power	20 v AC PowerSupply/Charger; notcertified	12 V DC PowerSupply/Charger; certified
Nerve Location Indication	Detection circuitry alwaysactive	Detection circuitry active onlyduring stimulation. Helpsprevent false alarms
Laryngeal Surface electrode-accessory	Accessory sold separately	Cleared through K003745
Stimulating Hemostat-accessory	Accessory included withSystem	Cleared through K895676
Hydrogel Ground-accessory	Accessory sold separately	Cleared through K092744and K110138
Needle Ground Electrode -accessory	Accessory sold separately	Cleared through K091056

. .

110140 p.2 of 4

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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 NerveLocator/MonitorSystem ModificationNV004 (K954601)	NuVasive INS-1(K002677)	Neurovision NerveLocator MonitorModel NV006
Description	Evoked EMG nervelocator/monitor	Evoked EMG nervelocator/monitor	Evoked EMG nervelocator/monitor
Intended Use	The Neurovision NerveLocator/Monitor is anelectronic deviceconsisting of a surgicalnerve stimulator and anevoked EMG monitorwith integrated detectingand warningcapability. This device isintended for use insurgical procedureswhere motor nerves are	The INS-1 IntraoperativeNerve SurveillanceSystem is intended toprovide intraoperativeelectromyographic(EMG) surveillance toassist in the location andevaluation of spinalnerves duringpercutaneous surgery ofthe spine, by	The NeurovisionNerve LocatorMonitor is anelectronic deviceconsisting of asurgical nervestimulator and anevoked EMG Monitorwith integrateddetecting or warning

110140 P-3 of 4

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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 thesurgeon in locatingthese nerves. Thisdevice is intended foruse only by qualified,trained medicalpractioners who performoperative surgery andfully understand that thisdevice is only andadjuvant to propersurgical technique andgood surgical judgment.	administration of lowamperage electricalenergy to tissues andnerves at the operativesite, and EMG monitoringof muscle groupsassociated with thosenerves. The INS-1System is designed foruse in conjunction withthe Nuvasive GuidedSpinal ArthroscopySystem to assist ingaining controlledpercutaneous access tothe spinal nerve root,foramina, intervertebraldisk, and surroundingtissues of the spine viauniportal or biportalposterior orposterolateral approach,where anatomicalrestrictions safely permit.	capability. Thedevice is intended toassist the surgeon inlocating motor nervesthat are at risk insurgical procedures.
StimulationIntensity	150 microsecondsquare pulse, 4 persecond, (0.1-5.0 mA, 10steps); Maximum 42VDC, 5 mA	200 microsecond squarepulse, 4 per second,0.4mA -12mA, Maximum240 VDC	150 microsecondsquare pulse, 4 persecond, 0.1-5.0 mA(Low) and 3.0-12 mA(High) 10 steps;Maximum 42 VDC,12 mA

Performance Testing

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

110140 p.48/4

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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 (800) 638-2041 or (301) 796-7100 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:

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.(Per 21 CFR 801.109)
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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
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510(k) Number_

Regulation Number and Section

§ 882.1870 Evoked response electrical stimulator.

(a)
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.(b)
Classification. Class II (performance standards).