FOCUS VNG/ENG TYPE 1068

K061791 · Gn Otometrics A/S · GWN · Jul 11, 2006 · Neurology

Device Facts

• Record ID: K061791
• Device Name: FOCUS VNG/ENG TYPE 1068
• Applicant: Gn Otometrics A/S
• Product Code: GWN · Neurology
• Decision Date: Jul 11, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1460
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The Focus VNG/ENG is a nystagmograph that is intended to measure, record, and display involuntary movements (nystagmus) of the eyeball.

Device Story

Focus VNG/ENG is a PC-based nystagmograph system; records and displays involuntary eyeball movements (nystagmus). System components include software modules, isolation transformer, external hardware platform, mains adapter, stimulation devices, and recording devices. Stimulation/recording devices connect to external hardware platform; platform connects to PC via USB cable. Used in clinical settings by healthcare professionals. Output allows clinicians to visualize and analyze nystagmus for diagnostic purposes.

Clinical Evidence

No clinical data provided; device is a replacement for existing technology type available and accepted in the market.

Technological Characteristics

PC-based system; external hardware platform; USB connectivity; mains powered. Complies with EN 60601-1, EN 60601-1-1, EN 60601-1-2, and EN 60601-2-40. Manufactured under ISO 9001:2000 and ISO 13485:2003.

Indications for Use

Indicated for measuring, recording, and displaying involuntary eyeball movements (nystagmus). Patient population not specified.

Regulatory Classification

Identification

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

Predicate Devices

• ICS Medical CHARTR ENG/VNG Diagnostic System (K991497)

Submission Summary (Full Text)

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K061791

JUL 1 1 2006

### 510(k) Summary of Safety and Effectiveness

## Submitter

| Name and address: | GN Otometrics A/S<br>Dybendalsvaenget 2<br>DK-2630 Taastrup<br>Denmark |
|-------------------|------------------------------------------------------------------------|
| Phone: | [phone] |
| Fax: | [phone] |
| Contact person: | Per Pape Thomsen |

Summary prepared: January 30, 2006

#### Device name

Common/Usual name: Trade/Proprietary name: Classification name:

Vestibular Testing System Focus VNG/ENG type 1068 Nystagmograph

### Predicate device

Focus VNG/ENG is similar to the product ICS Medical CHARTR ENG/VNG Diagnostic System (K991497) but differs in three ways: external hardware platform with USB interface, software and video goggles.

### Description

The Focus VNG/ENG is a PC-based system, which consist of software modules for installation on a PC, an isolation transformer, a hardware platform, a mains adapter, stimulation devices and recording devices.

The stimulation and recording devices are connected to the hardware platform, which is connected to the PC via a USB cable - no hardware installation inside the PC is required.

### Indications for Use

The Focus VNG/ENG is a nystagmograph that is intended to measure, record, and display involuntary movements (nystagmus) of the eyeball.

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## Technological Characteristics

| Device Specifications | Focus VNG/ENG | CHARTR ENG/VNG |
|-----------------------|-----------------------------------------------------------------------|------------------------------------------------------------|
| Safety compliance | EN 60601-1 | EN 60601-1 |
| Construction type | PC-based system with<br>external hardware platform<br>and peripherals | PC-based system with built-<br>in hardware and peripherals |
| Power source | Mains | Mains |
| Computer interface | USB cable connection | Integrated in computer |

## Safety

Focus VNG/ENG is designed to provide safety to the patient as well as the user and complies with:

- EN 60601-1:1990, UL 60601-1:2003, CAN/CSA-C22.2 NO 601.1-90:1990 . Medical Electrical Equipment. Part 1: General requirements for safety
- . EN 60601-1-1:2001: Medical Electrical Equipment. Part 1: Generel requirements for safety. 1. Collateral standard: Safety requirements for medical electrical systems
- EN 60601-1-2:2001 Medical Electrical Equipment. Part 1-2: Generel . requirements for safety - Collateral standard: Electromagnetic compatibility -Requirements and tests
- EN 60601-2-40:1998 Medical electrical equipment Part 2-40: Particular . requirements for the safety of electromyographs and evoked response equipment

Focus VNG/ENG is designed, developed and manufactured according to the following standards:

- ISO 9001:2000 Quality Management Systems -- Requirements .
- · ISO13485:2003 Quality management systems Requirements for regulatory purposes

### Effectiveness

The Focus VNG/ENG is a nystagmograph for replacement of an existing product of a technology type that is available and accepted in the market.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" arranged around the top half of the circle. Inside the circle is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

GN Otometrics A/S % Intertek Testing Services NA, Inc. Mr. Daniel W. Lehtonen Staff Engineer – Medical Devices 2307 East Aurora Road Unit B7 Twinsburg, Ohio 44087

JUL 1 1 2006

Re: K061791

Trade/Device Name: Focus VNG/ENG type 1068 Regulation Number: 882.1460 Regulation Name: Nystagmograph Regulation Class: II Product Code: GWN Dated: June 23, 2006 Received: June 26, 2006

Dear Mr. Lehtonen:

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 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.

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Page 2 - Mr. Daniel W. Lehtonen

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 Office of Compliance at [phone] . Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/industry/support/index.html.

Sincerely yours,

Barbara Aniceto

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

おすすめになってするというなんて

K061791 510(k) Number (if known):

Focus VNG/ENG type 1068 Device Name:

Indications For Use:

The Focus VNG/ENG is a nystagmograph that is intended to measure, record, and display involuntary movements (nystagmus) of the eyeball.

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)

Barbara Brehm
(Division Sign Off)

(Division Sig Division of General, Restorative, and Neurological Devices

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510(k) Number K061791