NEUROVISION SE (NERVEANA) by NEUROVISION MEDICAL PRODUCTS, INC.

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.

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.

AI/ML Overview

The provided text describes the EMGView Software, an accessory to the Neurovision Nerve Locator/Monitor. It focuses on the software's safety and efficacy as part of a 510(k) submission.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Stated Requirements)	Reported Device Performance
Primary Requirement: The EMGView software must not adversely affect the performance of the Nerveäna device.	"The EMGView software, being a read-only device accessory, does not affect the performance of the Nerveäna device."
Safety and Efficacy: The Nervous device with EMGView software is as safe and effective as the Nerveäna device alone in locating and monitoring motor nerves during surgery.	The text claims this equivalence is met because: - "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."
Clinical Use Conformance: The software's clinical use conforms to user needs.	"The software was validated by confirming that its clinical use conforms to user needs."
Requirements Verification: EMGView Software requirements were verified.	"The EMGView Software (v4.31, current version) requirements were verified using the Nerveana bench testing performance as a baseline."

Study Information:

The provided document describes a validation process rather than a detailed clinical study with specific statistical endpoints. The primary argument for safety and efficacy relies on the software being a "read-only device accessory" that does not interfere with the core function of the predicate device (Nerveäna Nerve Locator/Monitor).

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The document does not specify a sample size for a test set. The validation appears to be based on "bench testing performance" and "clinical use conformance" rather than a formal test set of patient data.
Data Provenance: Not applicable, as human patient data for a test set is not mentioned. The validation involves "bench testing performance" of the Nerveäna device as a baseline.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts

Number of Experts: Not applicable. The "ground truth" for the software's performance is tied to the baseline performance of the predicate device (Nerveäna) through bench testing.
Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable, as there is no mention of a formal test set with expert ground truth.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

MRMC Study: No, an MRMC comparative effectiveness study was not done or at least not described in this document. The focus is on the software being an accessory that doesn't alter the core device's performance, not on improving human reader performance with AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Standalone Performance: The EMGView software itself is a standalone software component in terms of its digital functions (displaying data, troubleshooting, digital backup, database). However, its "performance" is evaluated as an accessory to the Nerveäna device, which is a surgical device requiring human-in-the-loop operation. The document emphasizes that "No surgeon input is required for operation of the Nerveäna accessory," indicating the software's functions are automated, but it's not a standalone diagnostic AI.

7. The Type of Ground Truth Used

Ground Truth Type: The ground truth appears to be the established performance of the predicate device (Nerveäna) as determined by its existing "bench testing performance." The software's requirements were "verified" against this baseline. Its clinical use was "validated by confirming that its clinical use conforms to user needs," but the specific methodology for this conformance check is not detailed.

8. The Sample Size for the Training Set

Training Set Sample Size: The document does not mention a training set. This is not an AI/machine learning device in the modern sense that would typically involve a training set. It is an accessory software displaying data and providing additional features for an existing medical device.

9. How the Ground Truth for the Training Set Was Established

Ground Truth for Training Set: Not applicable, as there is no mention of a training set.

Summary

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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

نر

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: (866) 815-6999 Fax: (314) 310-4579

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:

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:

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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) withEMGView Software	Nerveäna (post 2006) K954601
Surgical NerveLocator/Monitor	Yes	Yes
Device dataoutput	Dedicated serial USB to PC	Dedicated serial USB to PC
Indications forUse	The Neurovision Nerve Locator/Monitor is anelectronic device consisting of a surgical nervestimulator and an evoked EMG monitor withintegrated detecting and warning capability.This device is intended for use in surgicalprocedures where motor nerves are at risk toassist the surgeon in locating these nerves.This device is intended for use only by qualified,trained medical practioners who performoperative surgery and who fully understand thatthis device is only an adjuvant to propersurgical technique and good surgical judgment.The EMGView software is an accessory to theNeurovision Nerve Locator/Monitor. When thededicated USB output of the EMG unit isconnected to a personal computer, the PC	The Neurovision Nerve Locator/Monitor is anelectronic device consisting of a surgical nervestimulator and an evoked EMG monitor withintegrated detecting and warning capability. Thisdevice is intended for use in surgical procedureswhere motor nerves are at risk to assist thesurgeon in locating these nerves. This device isintended for use only by qualified, trained medicalpractioners who perform operative surgery and who fully understand that this device is only anadjuvant to proper surgical technique and good surgical judgment.

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Image /page/2/Picture/0 description: The image shows handwritten text that appears to be a label or identifier. The text includes 'K102862' and 'P. 3 of 3', suggesting it might be a page number or a reference code within a larger document. The handwriting is clear, but the text is oriented diagonally in the image.

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 monitoringdata, troubleshooting data, real-time EMGwaveforms, and digital backup of all dataobtained during clinical use of the device. Thereal-time display of EMG waveforms is intendedto assist the surgeon with nerve integritymonitoring.
Software	Dedicated EMGView Program	N/A
EMG WaveformDisplay	PC Based Accessory	N/A
PC basedthreshold audioalarm	PC Based Accessory	N/A
Database andPlaybackcapability	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 (800) 638-2041 or (301) 796-7100 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:

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
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Regulation Number and Section

§ 874.1820 Surgical nerve stimulator/locator.

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