EXCEL PHOTIC STIMULATOR, MODEL (XLPS-1)

K991903 · Excel Tech. , Ltd. · GWE · Aug 4, 1999 · Neurology

Device Facts

• Record ID: K991903
• Device Name: EXCEL PHOTIC STIMULATOR, MODEL (XLPS-1)
• Applicant: Excel Tech. , Ltd.
• Product Code: GWE · Neurology
• Decision Date: Aug 4, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1890
• Device Class: Class 2

Intended Use

Excel "Photic Stimulator" is intended The photic activation of the EEG in visual evoked potentials .

Device Story

Excel Photic Stimulator (model XLPS-1) provides photic stimulation for EEG activation and visual evoked potential studies. Device used in clinical settings by trained healthcare professionals. Output consists of controlled light flashes to stimulate patient visual pathways; assists clinicians in diagnostic EEG/evoked potential assessment. Benefits include standardized visual stimulation for neurological evaluation.

Clinical Evidence

No clinical data provided; device cleared via 510(k) substantial equivalence pathway.

Technological Characteristics

Photic stimulator for EEG activation. Technical specifications, materials, and software details not provided in the document.

Indications for Use

Indicated for photic activation of the EEG in visual evoked potentials. Patient population not specified.

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.

Submission Summary (Full Text)

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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.

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## 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 [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" (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 [phone] or [phone] 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

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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 .

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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

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