EXCEL AV STIM 1000

K972157 · Excel Tech. , Ltd. · GWJ · Jan 30, 1998 · Neurology

Device Facts

• Record ID: K972157
• Device Name: EXCEL AV STIM 1000
• Applicant: Excel Tech. , Ltd.
• Product Code: GWJ · Neurology
• Decision Date: Jan 30, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1900
• Device Class: Class 2

Intended Use

AUDITORY TO PROVIDE VISUAL AND RECORDING FOR STIMULI EVOKED POTENTIAL S

Device Story

Excel AV Stim 1000 provides visual and auditory stimuli for evoked potential testing. Device facilitates clinical assessment of neural pathways by generating controlled sensory inputs. Used in clinical settings by healthcare professionals to elicit and record evoked potential responses. Output assists clinicians in diagnosing neurological conditions or monitoring sensory system integrity.

Clinical Evidence

No clinical data provided; substantial equivalence determination based on 510(k) regulatory review.

Technological Characteristics

Device provides visual and auditory stimuli for evoked potential recording. Technical specifications and materials not detailed in provided documentation.

Indications for Use

Indicated for providing visual and recording stimuli for evoked potentials.

Regulatory Classification

Identification

An evoked response auditory stimulator is a device that produces a sound stimulus for use in evoked response measurements or electroencephalogram activation.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

In 30 1998

Mr. John R. Mumford President Excel Tech. Ltd. 2892 Portland Drive Oakville, Ontario CANADA, L6H 5W8

K972157 Re: Trade Name: Excel AV Stim 1000 Regulatory Class: II Product Code: GWJ Dated: November 17, 1997 Received: November 19, 1997

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 requirements , as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) 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

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Page 2 - Mr. Mumford

devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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 your 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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K972157A'

Page

510(k) Number (if known):_K 972157 / Device Name:_£XLEL AV STIM 4000

Indications For Use:

AUDITORY TO PROVIDE VISUAL AND RECORDING FOR STIMULI

EVOKED POTENTIAL S

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

| Concurrence of CDRH, Office of Device Evaluation (ODE) |
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| (Division Sign-Off) | |
|---------------------------------------------------------------------|---------|
| Division of Dental, Infection Control, and General Hospital Devices | |
| 510(k) Number | K972157 |

| Prescription Use (Per 21 CFR 801.109) | OR Over-The-Counter Use |
|---------------------------------------|--------------------------|
| | (Optional Format 1-2-96) |

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