NAVIGATOR PRO WITH AEP SOFTWARE (BIOMARK, ENOG, CHAMP)

K083371 · Natus Medical, Inc. · GWF · Dec 8, 2009 · Neurology

Device Facts

• Record ID: K083371
• Device Name: NAVIGATOR PRO WITH AEP SOFTWARE (BIOMARK, ENOG, CHAMP)
• Applicant: Natus Medical, Inc.
• Product Code: GWF · Neurology
• Decision Date: Dec 8, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1870
• Device Class: Class 2

Intended Use

The ENoG Protocol is a feature of the Navigator Pro with AEP Software Evoked Response System and is intended to record evoked responses upon presentation of sensory stimuli to the facial nerve. The product is indicated for use as an assessment tool to supplement the case history information, physical examination, imaging studies, and/or other sensory evaluations conducted by or on the order of the physician.

Device Story

The ENoG Protocol is a software feature for the Navigator Pro Evoked Response System. It facilitates Electroneuronography (ENoG) of facial nerves by automating a repeating stimulus-response cycle. Input consists of electrical potentials recorded via electrodes (cathode behind earlobe, anode in front, ground on forehead, recording at nasio-labial fold) following sensory stimulation. The system records and displays evoked responses for physician review. Used in clinical settings by qualified healthcare professionals, the device does not provide automated diagnosis; it serves as a data collection and display tool. Physicians review raw data and analysis to inform clinical decision-making regarding facial nerve function. Benefits include standardized, efficient data acquisition for nerve assessment.

Clinical Evidence

Bench testing only. The device underwent design verification and validation in accordance with internal procedures and FDA QSR Design Control specifications. Safety and effectiveness were established through Hazard/Risk analysis using Fault Tree Analysis (FTA) and risk assessment per ISO 14971:2007. No clinical trial data was required or presented for this software modification.

Technological Characteristics

Windows-based software application for the Navigator Pro hardware platform. Utilizes stimulus-response cycle for evoked potential recording. Electrode configuration: cathode behind earlobe, anode in front, forehead ground, recording at nasio-labial fold. Complies with ISO 9001, ISO 13485:2003, and ISO 14971:2007. Connectivity via standard hardware interfaces.

Indications for Use

Indicated for use as an assessment tool for facial nerve evaluation in patients undergoing sensory testing, to supplement clinical history, physical exams, and imaging.

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

• Bio-logic Master II Evoked Response System (K073626)
• Bio-logic Evoked Potential System (K031009)
• Stacked ABR for Navigator Pro (K030907)
• SmartEP (K070608)
• Bio-logic Portable Evoked Response System (K844992)

Reference Devices

• Digitimer (K051357)

Submission Summary (Full Text)

{0}------------------------------------------------

K08337/

K083371 Navigator Pro, AEP Software Modification - ENoG June 4, 2009 Page 1-1

# DEC - 8 2009

### Attachment 3

### 510(k) Summary

| Trade Name: | Navigator Pro, AEP Software Modification - ENOG |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Evoked Response Somatosensory Stimulator |
| Classification Name: | Stimulator, auditory, evoked response -21 CFR 882.1900. This device is<br>categorized as GWJ and is regulated as Class II. |
| Submitter Information: | Natus Medical Incorporated<br>One Bio-logic Plaza<br>Mundelein, 60060<br>Phone: [phone]<br>Fax: [phone] |
| Correspondent Information | Helen Chandler<br>Vantage Consulting International<br>1011 Bugle Ct.<br>Chapel Hill, NC 27516<br>Phone: [phone]<br>Fax: [phone] |
| Summary Prepared By: | Helen Chandler<br>Senior Consultant |
| Date Prepared: | June 5, 2009 |
| Predicate Devices: | K073626 Bio-logic Master II Evoked Response System<br>K031009 Bio-logic Evoked Potential System<br>K030907 Stacked ABR for Navigator Pro<br>K070608 SmartEP<br>K844992 Bio-logic Portable Evoked Response System |

#### Device Description

The ENoG Protocol is a feature of the Navigator Pro with AEP Software Evoked Response System; a Windows® based software application for use with the Navigator Pro hardware platform for the recording of evoked responses (i.e., electrical potentials) upon the presentation of sensory stimuli.

The ENoG Protocol works on the basis of a repeating stimulus-response cycle. It is a convenience feature developed for the user to quickly set up testing for Electroneuronography evaluation of the facial nerves. The protocol utilizes the existing technology of the evoked response somatosensory function of the software. The evoked response from the patient is recorded through the use stimulus electrodes positioned near the mastoid, a cathode behind the earlobe, and an anode in front of the earlobe with the forehead as the ground.

{1}------------------------------------------------

#### Indications for Use

The ENoG Protocol is a feature of the Navigator Pro with AEP Software Evoked Response System and is intended to record evoked responses upon presentation of sensory stimuli to facial nerves. The product is indicated for use as an assessment tool to supplement the case history information, physical examination, imaging studies, and/or other sensory evaluations conducted by or on the order of the physician.

#### Technological Characteristics

The ENoG Protocol is a feature of the Navigator Pro with AEP Software Evoked Response System; a Windows® based software application using Evoked Response test which works on the basis of repeating a stimulus-response cycle. The evoked response is recorded through the use of two or more electrodes placed in the appropriate locations.

The technological characteristics of the ENoG Protocol feature are compared to the Bio-logic predicate devices and are summarized in the table below.

| Parameter for Comparison | Similarity or Difference |
|------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Protocol is set-up for stimulation of facial<br>nerves |
| Population | No differences |
| Hardware | Digitimer (K051357) |
| Computer Control Software | No differences |
| Patient Information and Tracking | No differences |
| Patient Connections (transducers & electrodes) | Stimulus electrodes positioned near the<br>mastoid, a cathode behind the earlobe, and an<br>anode in front of the earlobe with forehead as<br>the ground. Recording electrodes are placed at<br>the nasio-labial fold |
| Presentation Data/User Interface | No differences |
| Physical Characteristics | No differences |
| Safety Characteristics | No differences |
| Product Labeling | No differences |

#### Safety and Effectiveness Summary

Safety and effectiveness of the ENoG protocol feature have been established throughout the design and incorporation into the Navigator Pro with AEP Evoked Response System in accordance with the Bio-logic internal product development procedures, which are intended to meet ISO-9001, ISO 13485:2003 and FDA QSR Design Control specifications. A detailed Hazard/Risk analysis for the Evoked Potential family of products was performed using the Fault Tree Analysis (FTA) approach, and a detailed Risk Assessment for the AEP Software was written in accordance with ISO 14971:2007, Medical Devices - Application of Risk Management to Medical Devices. The ENoG protocol feature does not make any final decisions that result in any automatic forms of diagnosis or treatment. All program "results" require a

{2}------------------------------------------------

review by a physician or other qualified healthcare professional, and may be modified, overridden or deleted as determined by a qualified user. The program provides additional functionality to allow the qualified user to review all raw data collected and perform other data analyses to suit specific requirements.

#### Conclusions

The indications for use are consistent with the previously indicated predicate devices and in the applicable FDA classification regulation. Differences in technological characteristics from those of the cited predicate devices do not raise new issues of safety or effectiveness and are addressed in the submission.

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with outstretched wings, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle, indicating the department's name and national affiliation.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

Natus Medical, Incorporated Bio-logic, a Division of Natus % Ms. Nicohl Wilding One Bio-logic Plaza Mundelein, IL 60060

DEC - 8 2009

Re: K083371

Trade/Device Name: Navigator Pro, AEP Software Modification - ENoG Regulation Number: 21 CFR 882.1870 Regulation Name: Evoked Response Electrical Stimulator. Regulatory Class: Class II Product Code: GWF Dated: June 4, 2009 Received: June 9, 2009

Dear Ms. Wilding:

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.

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.

{4}------------------------------------------------

#### Page 2- Ms. Nicohl Wilding

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/Resourcesfor You/Industry/default.htm

Sincerely yours,

Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

## Indications for Use

510(k) Number (if known):

K083371

Device Name:

Navigator Pro, AEP Software Modification - ENoG

Indications For Use:

The ENoG Protocol is a feature of the Navigator Pro with AEP Software Evoked Response System and is intended to record evoked responses upon presentation of sensory stimuli to the facial nerve. The product is indicated for use as an assessment tool to supplement the case history information, physical examination, imaging studies, and/or other sensory evaluations conducted by or on the order of the physician.

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)

signature FOR M. MELKERSON

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K083371