XLTEK LED GOGGLES, MODEL LED-01

K011794 · Excel Tech. , Ltd. · GWE · Oct 1, 2001 · Neurology

Device Facts

• Record ID: K011794
• Device Name: XLTEK LED GOGGLES, MODEL LED-01
• Applicant: Excel Tech. , Ltd.
• Product Code: GWE · Neurology
• Decision Date: Oct 1, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1890
• Device Class: Class 2

Intended Use

The LED Visual Stimulator Goggles are intended to flash visible light into a patient's eyes. The LED Visual Stimulator Goggles are designed to be used in hospital and clinical settings by trained medical personnel.

Device Story

LED Visual Stimulator Goggles function as an accessory to an evoked potential stimulator headbox; device flashes visible light into patient eyes to elicit electrical brain response; recorded signals are used by clinicians to assess neurological function; used in hospital and clinical settings by trained medical personnel.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Goggles containing LEDs for light stimulation; designed for use with an evoked potential stimulator headbox; Class II device (21 CFR 882.1890, Product Code GWE).

Indications for Use

Indicated for use in hospital and clinical settings by trained medical personnel to flash visible light into a patient's eyes for the purpose of stimulating the eyes to record an electrical response from the brain.

Regulatory Classification

Identification

An evoked response photic stimulator is a device used to generate and display a shifting pattern or to apply a brief light stimulus to a patient's eye for use in evoked response measurements or for electroencephalogram (EEG) activation.

Predicate Devices

• XLTEK Real Patient EP 8 (K010092)
• Grass-Telefactor LED Goggles (pre-amendment/grandfathered)

Reference Devices

• Stim 1000 A/V (K972157)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the word "XLTEK" in a bold, sans-serif font. To the left of the word is a graphic consisting of three horizontal lines of varying lengths. The lines are stacked vertically, with the longest line at the top and the shortest at the bottom. The overall impression is of a modern, tech-oriented logo.

510(k) Notification for a New Device: LED Visual Stimulator Goggles Section E - 510(k) Summary

Ko11794

10P2

OCT - 1 2001 Section E - 510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in Fills Summary of 916 (1) Sussents of the SMDA 1990 and 21 CFR § 807.92.

| Name: | Cameron Mahon<br>Director of R & D |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | XLTEK<br>2568 Bristol Circle<br>Oakville, Ontario<br>Canada, L6H 5S1 |
| Telephone: | [phone] |
| Fax: | [phone] |
| E-mail: | [e-mail] |
| Common Names: | LED Visual Stimulator Goggles |
| Classification Name: | 21 CFR § 882.1890, Stimulator Photic Evoked<br>Response, 84 GWE, Class II |
| Predicate Devices: | XLTEK Real Patient EP 8 [510(k) # K010092] |
| Description: | LED Visual Stimulator Goggles are goggles that<br>are used to stimulate the eyes to record an<br>electrical response from the brain. LEDs inside<br>the goggles flash light at the eye. An electrical<br>signal from the brain in response to this stimulus<br>is recorded by an evoked potential stimulator<br>headbox. |
| Substantial Equivalence: | When used as an accessory with the Stim 1000<br>A/V [510(k) #K972157], the LED Visual<br>Stimulator Goggles are substantially equivalent<br>in terms of safety and effectiveness to the Grass-<br>Telefactor LED Goggles manufactured by Astro-<br>Med, Inc. |
| | Grass-Telefactor LED Goggles were designed<br>prior to the 1976 Medical Device Amendment to<br>the U.S. Food and Drug law, so were |

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Image /page/1/Picture/0 description: The image shows the logo for XLTEK, followed by the text "510(k) Notification for a New Device: LED Visual Stimulator Goggles". The last line of text says "Section E - 510(k) Summary". The text indicates that this is a notification for a new medical device, specifically LED visual stimulator goggles.

K011794

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"grandfathered" into being listed as "medical devices" in the U.S. The Grass-Telefactor LED Goggles that we are claiming substantial equivalence to have been listed in this way and thus do not have an FDA 510(k) or PMA listing.

## Indications for Use:

The LED Visual Stimulator Goggles are intended to flash visible light into a patient's eyes. The LED Visual Stimulator Goggles are designed to be used in hospital and clinical settings by trained medical personnel.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT - 1 2001

Mr. Cameron Mahon Vice President, Regulatory Affairs Excel Tech, Ltd. 2568 Bristol Circle Oakville, Ontario Canada L6H 5S1

Re: K011794

Trade/Device Name: LED Visual Stimulator Goggles Regulation Number: 882.1890 Regulatory Class: II Product Code: GWE Dated: August 7, 2001 Received: August 14, 2001

Dear Ms. Markez:

We have reviewed your Section 510(k) 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 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Cameron Mahon

This letter will allow you to begin marketing your device as described in your 510(k) premarket I natification. 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 and If you declie specific arin vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small mionhactor on your respond and Consumer Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrb/dsma/dsmamain.html".

Sincerely yours,

Susan Walk, MD

\$\xi\$

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) Notification for a New Device: LED Visual Stimulator Goggles Section D -- Statement of Indications for Use

## Section D - Statement of Indications for Uses -

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| 510(k) Number (if known): | K011794 |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | LED Visual Stimulator Goggles |
| Indications for Use: | The LED Visual Stimulator Goggles are intended to flash visible light into a patient's eyes. The LED Visual Stimulator Goggles are designed to be used in hospital and clinical settings by trained medical personnel. |

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OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use __ V (Per 21 CFR 801.109)

Over-The Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

**Division Sign Off**

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number_ < 011794