ICS MEDICAL MODEL VG-30 VIDEO GOGGLES

K013060 · Ics Medical · GWN · Dec 10, 2001 · Neurology

Device Facts

• Record ID: K013060
• Device Name: ICS MEDICAL MODEL VG-30 VIDEO GOGGLES
• Applicant: Ics Medical
• Product Code: GWN · Neurology
• Decision Date: Dec 10, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1460
• Device Class: Class 2

Intended Use

The ICS Medical Model VG-30 Video Goggles are intended to provide video signals of patient's eyes thus making it possible to observe, record, and measure eye movements during testing of vestibular function.

Device Story

The ICS Medical Model VG-30 Video Goggles consist of two cameras mounted in a housing worn on the patient's face. The device uses infrared (IR) illumination to capture video of the patient's eyes, enabling visualization in total darkness via a light-occluding cover. The goggles are used by clinicians during vestibular function testing. The device provides video signals that allow the clinician to observe, record, and measure eye movements. This facilitates the assessment of vestibular function, aiding in the diagnosis or evaluation of vestibular disorders.

Clinical Evidence

No clinical data. Substantial equivalence is based on design and material comparison to the predicate device.

Technological Characteristics

ABS plastic housing; polyvinyl chloride face cushion; neoprene rubber strap; polycarbonate mirrors. Features dual video cameras and 14 infrared LEDs (7 per eye). Provides horizontal and vertical image adjustment via mirror and camera positioning. Friction-fit light-occluding cover for dark-room testing. Weight: 18.5 oz.

Indications for Use

Indicated for patients undergoing vestibular function testing to observe, record, and measure eye movements.

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 Model VG-10 Goggles (K991497)

Submission Summary (Full Text)

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DEC 1 0 2001

## 510(k) SUMMARY

(847)-534-2150

(847)-534-2151

September 7, 2001

125 Commerce Drive Schaumburg, IL 60173-5329

ICS MEDICAL CORPORATION

Submitted by:

Telephone:

FAX:

Contact Person:

Date Summary Prepared:

Classification Name:

Description of Device:

Trade Name of Device:

Video goggle Common Name:

Accessory to: Nystagmograph, Class II, 21 CFR 882.146

Robert M. Simenson, Executive Vice President

ICS Medical Model VG-30 Video Goggie

KO13060

The ICS Medical Model VG-30 Video Goggle consists of two small video cameras mounted in a custom housing to be worn on the face of the patient to view the patients eyes. The goggles use infrared (IR) Illumination to allow the eyes to be viewed in total darkness, a feature produced by a cover that can be installed on the front of the goggle housing.

This device is intended to provide video signals of Intended Use: patient's eyes thus making it possible to observe, record, and measure eye movements during testing of vestibular function.

The Model VG-30 Video Goggles are substantially Substantial Equivalence: equivalent to the Model VG-10 Goggles cleared in 510(k): K991497.

Comparison of Similarities and Differences of Our New Medical Device to the Predicate Device:

| | ICS Video Goggle<br>(510K : K991497) | ICS Medical Model VG-30<br>Goggle |
|------------------------------------------------------------------------------|--------------------------------------|-----------------------------------|
| Housing Material | ABS Plastic | ABS Plastic |
| Face Cushion Material | Neoprene Rubber | Polyvinyl Chloride |
| Number of Light Emitting<br>Diodes (LED's) | 7 per eye ( Total: 14) | Identical |
| Mirror Adjustment Capability to<br>Center the Image | Yes | Yes |
| Horizontal Image Adjustment<br>Accomplished by Means of<br>Mirror Adjustment | Yes | Yes |

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| Vertical Image Adjustment<br>Accomplished by Adjusting<br>Cameras | Yes | Yes |
|-------------------------------------------------------------------|-----------------------|------------------------|
| Mirror Material | Polycarbonate plastic | Identical |
| Strap Material | Neoprene Rubber | Identical |
| Video Camera Adjustment<br>Capability | Yes | Yes |
| Friction Fit Light Occluding<br>Cover | Yes | Identical |
| Weight | Approximately 21 oz. | Approximately 18.5 oz. |

Please note that with the exception of the face cushion material both these goggles are virtually identical in design and materials.

The Model VG-30 Video Goggle is designed to meet the same safety standards as the predicate device, i.e. ICS Medical Model VG-10 Video Goggles.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 0 2001

Robert M. Simenson Executive Vice President ICS Medical Corporation 125 Commerce Drive Schaumburg, Illinois 60173-5329

Re: K013060

Trade Name: ICS Medical Model VG-30 Video Goggle Regulation Number: 882.1460 Regulation Name: Nystagmograph Regulatory Class: II Product Code: GWN Dated: September 7, 2001 Received: September 11, 2001

Dear Mr. Simenson:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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. Robert Simenson

This letter will allow you to begin marketing your device as described in your Section 510(k) I mo letter notification. The FDA finding of substantial equivalence of your device to a legally premated predicated. " 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of Compinates at [phone] Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the O wision 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/dsma/dsmamain.html

Sincerely yours,

Susan Walker

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Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K013060

ICS Medical Model VG - 30 Video Goggles Device Name:__________________________________________________________________________________________________________________________________________________________________

Indications For Use:

The ICS Medical Model VG-30 Video Goggles are intended to provide video signals of patient's eyes thus making it possible to observe, record, and measure eye movements during testing of vestibular function.

## (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) ·

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Optional Format 3-10-98)

Susan Walker

(Division Sign-Off) Division of General Pestorative and Neurological Devices

510(k) Number_KO13O60