(115 days)
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.
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.
The provided text is a 510(k) summary for the XLTEK LED Visual Stimulator Goggles. It primarily focuses on demonstrating substantial equivalence to a predicate device and does not contain information on acceptance criteria, specific study designs, or performance metrics in the way modern AI/software device submissions would.
Therefore, I cannot extract the requested information regarding:
- A table of acceptance criteria and reported device performance.
- Sample sizes, data provenance, number/qualifications of experts, or adjudication methods for a test set.
- Multi-reader multi-case (MRMC) comparative effectiveness study results or effect sizes.
- Standalone performance results.
- Sample size for the training set or how its ground truth was established.
Reasoning for Absence of Information:
The document describes a medical device (LED Visual Stimulator Goggles) by XLTEK, which was cleared in 2001. This device is a hardware accessory used for stimulating the eyes to record electrical responses from the brain.
The core of the submission (as evidenced by sections E and D of the 510(k) summary) is to demonstrate substantial equivalence to a predicate device, the Grass-Telefactor LED Goggles. The predicate device was "grandfathered" into being a medical device prior to the 1976 Medical Device Amendment, meaning it did not have an FDA 510(k) or PMA listing itself.
For devices demonstrating substantial equivalence to a pre-amendment device, the regulatory pathway generally does not involve extensive clinical trials or performance studies with acceptance criteria as would be required for a novel device or a software/AI device. The focus is on showing that the new device has the same intended use, technological characteristics, and safety/effectiveness profiles as the grandfathered predicate.
The document states: "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." This statement, along with the lack of detailed study descriptions, indicates that the approval was based on demonstrating equivalence, not on specific performance criteria derived from a controlled study with distinct test sets, expert ground truth, or adjudication as requested.
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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 MahonDirector of R & D |
|---|---|
| Address: | XLTEK2568 Bristol CircleOakville, OntarioCanada, 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 EvokedResponse, 84 GWE, Class II |
| Predicate Devices: | XLTEK Real Patient EP 8 [510(k) # K010092] |
| Description: | LED Visual Stimulator Goggles are goggles thatare used to stimulate the eyes to record anelectrical response from the brain. LEDs insidethe goggles flash light at the eye. An electricalsignal from the brain in response to this stimulusis recorded by an evoked potential stimulatorheadbox. |
| Substantial Equivalence: | When used as an accessory with the Stim 1000A/V [510(k) #K972157], the LED VisualStimulator Goggles are substantially equivalentin terms of safety and effectiveness to the Grass-Telefactor LED Goggles manufactured by Astro-Med, Inc. |
| Grass-Telefactor LED Goggles were designedprior to the 1976 Medical Device Amendment tothe 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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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
§ 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).