(115 days)
Not Found
No
The summary describes a device that provides visual stimulation and records electrical responses, but there is no mention of AI or ML being used for analysis, interpretation, or any other function.
No
The device is used to stimulate the eyes to record an electrical response from the brain (evoked potentials), which is a diagnostic purpose, not a therapeutic one. It helps in diagnosing conditions by measuring the brain's response to light stimuli.
Yes
The device "stimulate[s] the eyes to record an electrical response from the brain," which indicates it is used to obtain information about a patient's health status, classifying it as a diagnostic device.
No
The device description explicitly states it is "goggles" with "LEDs inside the goggles," indicating a physical hardware component that delivers the visual stimulus.
Based on the provided information, the LED Visual Stimulator Goggles are not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The LED Visual Stimulator Goggles directly interact with the patient's eyes by flashing light. They do not analyze any biological specimens taken from the patient.
- Intended Use: The intended use is to stimulate the eyes to record an electrical response from the brain, which is a physiological measurement, not an in vitro analysis.
The device is a medical device used for physiological testing, specifically evoked potentials, but it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
GWE
Device Description
LED Visual Stimulator Goggles are goggles that are used to stimulate the eyes to record an electrical response from the brain. LEDs inside the goggles flash light at the eye. An electrical signal from the brain in response to this stimulus is recorded by an evoked potential stimulator headbox.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's eyes
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained medical personnel in hospital and clinical settings
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
XLTEK Real Patient EP 8 [510(k) # K010092]
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 882.1890 Evoked response photic stimulator.
(a)
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.(b)
Classification. Class II (performance standards).
0
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
Director of R & D |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | XLTEK
2568 Bristol Circle
Oakville, Ontario
Canada, L6H 5S1 |
| Telephone: | (905) 829-5300 |
| Fax: | (905) 829-5304 |
| E-mail: | research@XLTEK.com |
| Common Names: | LED Visual Stimulator Goggles |
| Classification Name: | 21 CFR § 882.1890, Stimulator Photic Evoked
Response, 84 GWE, Class II |
| Predicate Devices: | XLTEK Real Patient EP 8 [510(k) # K010092] |
| Description: | LED Visual Stimulator Goggles are goggles that
are used to stimulate the eyes to record an
electrical response from the brain. LEDs inside
the goggles flash light at the eye. An electrical
signal from the brain in response to this stimulus
is recorded by an evoked potential stimulator
headbox. |
| Substantial Equivalence: | When used as an accessory with the Stim 1000
A/V [510(k) #K972157], the LED Visual
Stimulator Goggles are substantially equivalent
in terms of safety and effectiveness to the Grass-
Telefactor LED Goggles manufactured by Astro-
Med, Inc. |
| | Grass-Telefactor LED Goggles were designed
prior to the 1976 Medical Device Amendment to
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.
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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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Image /page/2/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure, composed of three curved lines that suggest wings or feathers. The overall design is simple and monochromatic.
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 (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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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Image /page/4/Picture/0 description: The image shows the word "XLTEK" in bold, black letters. To the left of the word is a graphic of several horizontal lines stacked on top of each other. The lines are also black and appear to be of varying lengths. The overall image has a simple, clean design.
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. |
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
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_