EYETRACKER/IDEAS

K070670 · S.A. Instrumentation Difra · GWN · Sep 18, 2007 · Neurology

Device Facts

• Record ID: K070670
• Device Name: EYETRACKER/IDEAS
• Applicant: S.A. Instrumentation Difra
• Product Code: GWN · Neurology
• Decision Date: Sep 18, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1460
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The device is intended to measure, record and display the movements of the eyeballs during their involuntary movements (nystagmus) and while testing the patient's vestibular function. The device is for prescription use only and it is intended for use by qualified medical personnel trained in the use of nystagmographs. This device provides no diagnoses nor does it provide diagnostic recommendations.

Device Story

PC-based nystagmograph system; measures, records, and displays eye movements. Inputs: video signals from goggles or electrical signals from surface electrodes. Processing: PC interface acquires data; software modules analyze and display eye movement patterns. Output: visual display of nystagmus/vestibular test data. Used in clinical settings by trained medical personnel. Provides objective data for clinician interpretation; does not provide automated diagnoses or recommendations. Benefits: facilitates assessment of vestibular function and involuntary eye movements.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technological comparison and bench testing/safety compliance (EN 60601-1, EN 60601-1-2).

Technological Characteristics

PC-based system; video goggles or surface electrodes; mains powered; integrated computer interface. Complies with EN 60601-1 (safety) and EN 60601-1-2 (EMC). Manufactured under ISO 9001:2000 and ISO 13485:2003 quality systems.

Indications for Use

Indicated for patients undergoing vestibular function testing or evaluation of involuntary eye movements (nystagmus). Intended for use by qualified medical personnel; prescription only. No specific age or gender restrictions provided.

Regulatory Classification

Identification

A nystagmograph is a device used to measure, record, or visually display the involuntary movements (nystagmus) of the eyeball.

Predicate Devices

• CHARTR ENG/VNG Diagnostic System (K991497)
• ENGPLUS (K010059)
• VISUAL EYES (K964325)
• ULMER (VNG) VIDEO NYSTAGMOGRAPH (K982103)
• I-PORTAL (K781268)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the word "DIFRA" next to a circular logo with a line going through the middle. The line has an arrow on each end, with one pointing to the left and the other pointing to the right. The logo and the word "DIFRA" are in black.

# 510(k) Summary

### Submitter Information:

| Name and Address: | S.A. INSTRUMENTATION DIFRA |
|----------------------|---------------------------------|
| | Rue de l'Eglise 84 |
| | Welkenraedt |
| | B-4840 |
| | Belgium |
| | Phone: [phone] |
| | Fax: [phone] |
| | Email: [e-mail] |
| | www.difra.be |
| Registration Number: | 9710334 |
| Contact Person: | Guido Pagnacco, Ph.D., US Agent |
| Summary Date: | July 5, 2007 |

#### Device Information:

Common/Usual Name: Trade/Proprietary Name: Regulation Number: Regulation Name: Regulatory Class: Product Code:

Nystagmographer (video or electrode) EyeTracker, IDEAS 882.1460 Nystagmograph II GWN

K070670

(Premarket Notification [510(k)] Number)

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-- DIFRA S.A./N.V.

Roe de l'église, 84 B 4840 WEKENRAD) • 161. 132 (0)67 89 80 80 • Filmeil mitoedra.ne • www.ditabe

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#### Substantial Equivalency:

The device is substantially equivalent to:

- the CHARTR ENG/VNG Diagnostic System (K991497) marketed by ICS 必 Medical Corporation
- * the ENGPLUS (K010059) marketed by Western System Research, Inc.
- * the VISUAL EYES (K964325) marketed by Micromedical Technologies, Inc.

For its ability to record torsional movements, the device is substantially equivalent to:

- the ULMER (VNG) VIDEO NYSTAGMOGRAPH (K982103) marketed by な Synapsys, Inc.
- the I-PORTAL, also known as I-PORTAL VNG, part of the NEURO-彩 OTOLOGIC TEST CENTER (K781268) marketed by Neuro Kinetics, Inc.

#### Description of the device:

The device is a PC-based system for measuring, recording and displaying the eve movements. Its components include video goggles or surface electrodes to record the eve movements, a PC interface to acquire the data, a series of software modules to display and analyze the data and various stimulation devices.

#### Intended use:

The device is intended to measure, record and display the movements of the eyeballs during their involuntary movements (nystagmus) and while testing the patient's vestibular function.

The device is for prescription use only and it is intended for use by qualified medical personnel trained in the use of nystagmographs. This device provides no diagnoses nor does it provide diagnostic recommendations.

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| Device<br>specifications | EYETRACKER<br>/ IDEAS | CHARTR<br>ENG/VNG | ENGPLUS | VISUAL<br>EYES | ULMER (VNG)<br>VIDEO<br>NYSTAGMOGRAPH | I-PORTAL,<br>(NEURO-<br>OTOLOGIC<br>TEST<br>CENTER) |
|--------------------------|-----------------------------------------------------------------|--------------------------------------------------------------------|--------------------------------------------------------------------------------|--------------------------------------------------------------------------------|--------------------------------------------------------------|--------------------------------------------------------------------------------|
| Safety<br>compliance | EN 60601-1 | EN 60601-1 | EN 60601-1 | EN 60601-1 | EN 60601-1 | EN 60601-1-2 |
| Type | Video / Electrode<br>based system | Video /<br>Electrode<br>based system | Electrode based<br>system | Video based<br>system | Video based<br>system | Video based<br>system |
| Construction<br>type | PC-based system<br>with built-in<br>hardware and<br>peripherals | PC-based<br>system with<br>built-in<br>hardware and<br>peripherals | PC-based<br>system with<br>external<br>hardware<br>platform and<br>peripherals | PC-based<br>system with<br>external<br>hardware<br>platform and<br>peripherals | PC-based system with<br>built-in hardware and<br>peripherals | PC-based<br>system with<br>external<br>hardware<br>platform and<br>peripherals |
| Power source | Mains | Mains | Mains | Mains | Mains | IEEE firewire<br>cable |
| Computer<br>interface | Integrated in<br>computer | Integrated in<br>computer | Serial or USB<br>connection | USB<br>connection | Integrated in computer | IEEE firewire<br>cable |

Technological Characteristics:

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### Safety:

The device is designed to provide safety to the patient as well as the user and complies with:

- * EN 60601-1:1990 Medical Electrical Equipment. Part 1: General requirements for safety
- * EN 60601-1-2:2001 Medical Electrical Equipment. Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility -Requirements and tests

The device is designed, developed and manufactured according to the following standards:

- な ISO 9001:2000 Quality Management Systems-Requirements
- * ISO13485:2003 Quality management Systems Requirements

The device satisfies all the requirements of the European Community Medical Device Directive MDD 93/42/EEC and bears the CE mark.

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Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized image of an eagle with its wings spread, composed of thick, black lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# SEP 1 8 2007

S.A. Instrumentation DIFRA % Vestibular Technologies, LLC Guido Pagnacco. Ph.D. 205 Co. Rd., 128A Suite 200 Cheyenne, WY 82007

Re: K070670

> Trade/Device Name: EyeTracker, IDEAS Regulation Number: 21 CFR 882.1460 Regulation Name: Nystagmograph Regulatory Class: Class II Product Code: GWN Dated: July 5, 2007 Received: July 6, 2007

Dear Dr. Pagnacco:

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 such 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); good manufacturing practice requirements as set

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Page 2 – Guido Pagnacco, Ph.D.

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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number [phone] or [phone] or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerelv vours.

Sincerely yours,

Mark A Milliman

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

Enclosure

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# Indications for Use

510(k) Number (if known): K070670

Device Name: EyeTracker, IDEAS

Indications For Use:

The device is intended to measure, record and display the movements of the eyeballs during their involuntary movements (nystagmus) and while testing the patient's vestibular function.

The device is for prescription use only and it is intended for use by qualified medical personnel trained in the use of nystagmographs. This device provides no diagnoses nor does it provide diagnostic recommendations.

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 IF NEEDED)

| Concurrence of CDRH Office of Device Evaluation (ODE) | |
|-------------------------------------------------------|--|
|-------------------------------------------------------|--|

Mark M
*K070670*
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices

| 510(k) Number | <i>K070670</i> |
|---------------|----------------|
| | Page 1 of ____ |