(61 days)
Not Found
None
No
The summary provides no information about the device's internal workings, and the intended use is a standard photic stimulator for EEG, which typically does not involve AI/ML. There are no mentions of AI, ML, or related concepts.
No
The device is used for photic activation of the EEG, which is a diagnostic procedure to identify abnormalities, not to treat a condition.
No
The device is described as a "Photic Stimulator" intended for "photic activation of the EEG in visual evoked potentials." While it interacts with EEG, its primary stated purpose is stimulation ("activation"), not the interpretation or diagnosis of medical conditions based on the EEG data it helps to generate. It facilitates a diagnostic process rather than performing the diagnosis itself.
Unknown
The provided 510(k) summary is incomplete and lacks a device description, making it impossible to determine if the device is software-only. The intended use suggests a hardware component (photic stimulator), but without a description, this cannot be confirmed.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "The photic activation of the EEG in visual evoked potentials." This describes a procedure performed on a patient (in vivo), not a test performed on a sample taken from a patient (in vitro).
- Lack of IVD Indicators: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information based on the analysis of these samples.
- Mentioning any reagents, assays, or laboratory procedures.
Therefore, the Excel "Photic Stimulator" appears to be a device used for stimulating a patient's visual system to elicit a physiological response (EEG changes), which is a non-IVD application.
N/A
Intended Use / Indications for Use
Excel "Photic Stimulator" is intended The photic activation of the EEG in visual evoked potentials .
Product codes
GWE
Device Description
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Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name arranged in a circular fashion around a symbol. The symbol is a stylized representation of a human figure, with three lines forming the body and head. The overall design is simple and uses a black and white color scheme.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 4 1999
Mr. John R. Mumford President Excel Tech, Ltd. 2568 Bristol Circle Oakville, Ontario Canada L6H 5S1
Re: K991903
Trade Name: Excel Photic Stimulator Regulatory Class: II Product Code: GWE Dated: May 31, 1999 Received: June 4, 1999
Dear Mr. Mumford:
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 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 requirement, as set forth in the Quality System Regulation (OS) 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.
1
Page 2 -- Mr. John R. Mumford
This letter will allow you to begin marketing your device as described in your 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 vour device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D.
Director
Division of General and
Restorative Devices
Office of Device Evaluation
Center for Devices and
Radiological Health
Enclosure
2
تهالي والا 510(k) Number (if known): Photic stimulator model XLPS-1 Device Name: Indications For Use:
Excel "Photic Stimulator" is intended The photic activation of the EEG in visual evoked potentials .
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General Restorative Devices K991903
510(k) Number
Prescription Use (Per 21 CFR 801, 109) OR
Over-The-Counter Use
(Optional Formal 1-2-96)