SLE ELECTRODES AND ACCESSORIES

K980410 · Specialized Laboratory Equipment, Ltd. · GXY · Oct 22, 1998 · Neurology

Device Facts

• Record ID: K980410
• Device Name: SLE ELECTRODES AND ACCESSORIES
• Applicant: Specialized Laboratory Equipment, Ltd.
• Product Code: GXY · Neurology
• Decision Date: Oct 22, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1320
• Device Class: Class 2

Intended Use

SLE Electrodes and Accessories are intended to be used applied directly to a patient's skin to record physiological signals including applications in EEG, EMG, nerve conduction velocity, evoked potential, and electronystagmography.

Device Story

SLE Electrodes and Accessories are cutaneous surface electrodes applied directly to patient skin. Device functions as a passive interface to capture physiological signals for diagnostic procedures including EEG, EMG, nerve conduction velocity, evoked potential, and electronystagmography. Used in clinical settings by healthcare professionals to facilitate signal acquisition for diagnostic monitoring. Output consists of raw physiological electrical signals transmitted to external recording equipment. Benefits include non-invasive signal acquisition for neurological and muscular assessment.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Cutaneous surface electrode. Passive device; no internal energy source. Materials, composition, and design are stated to be identical to predicate devices. No software or active electronic components.

Indications for Use

Indicated for patients requiring physiological signal recording via skin-applied electrodes for EEG, EMG, nerve conduction velocity, evoked potential, and electronystagmography applications.

Regulatory Classification

Identification

A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.

Predicate Devices

• Electrode, PNS, NDM Corp. (K760213)
• Cutaneous Electrode, Medicotest, Inc. (K931430)
• Electrode, Cutaneous, Cadwell Laboratories, Inc. (K933801)

Submission Summary (Full Text)

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KC/804/C

## 510(K) SUMMARY

Specialised Laboratory Equipment A. Manufacturer: Limited Twin Bridges Business Park 232 Selsdon Road South Croydon Surrey CR2 6PL United Kingdom

Ferguson Medical Submitted By: Consultant to Specialised Laboratory Equipment Limited

- Phone: [phone] ਸ -Contact Information: 44 181 649 8570 FAX:
C. Classification Name: Electrode, cutaneous Common/Usual Name: Electrode, surface electrode, skin Burface electrode, electrode, etc.

SLE Electrodes and Accessories Proprietary Name:

- D. Classification Number: 80GXY
- E. Substantial Equivalence: Electrode, PNS, NDM Corp. (K760213), Cutaneous Electrode, Medicotest, Inc. (K931430), Electrode, Cutaneous, Cadwell Laboratories, Inc. (K933801), and others.
- P. Device Description: The SLE Electrodes and Accessories device is a cutaneous electrode.
- G. Intended Use: The SLE Electrodes and Accessories device is intended to be used in direct application the patient's skin to record physiological to signals including applications in EEG, EMG, nerve conduction velocity, evoked potential, and electronystagmography.
- Technological Characteristics: The design, materials, ਮ . composition, energy source, chemical and other technological characteristics of the subject device considered to be the same as the technological are characteristics of the predicatc devices.

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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of a stylized eagle or bird symbol, composed of three curved lines that suggest the shape of a bird's head and wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## OCT 2 2 1998

Mr. Frank Ferquson Official Correspondent Consultant for Specialized Laboratory Equipment Limited Ferquson Medical 2581 California Park Drive, Suite 269 Chico, California 95928

Re: K980410 SLE Electrodes and Accessories Trade Name: Requlatory Class: II Product Code: GXY Dated: July 3, 1998 Received: July 28, 1998

Dear Mr. Ferguson:

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 The general controls provisions of the Act 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 Requlations, Title 21, Parts 800 to 895. ਸ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (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. Frank Ferguson

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 gener 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 Radioloqical Health

Enclosure

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510(k) Number: K980410

Device Name: SLE Electrodes and Accessories

Indications For Use:

SLE Electrodes and Accessories are intended to be used applied directly to a patient's skin to record physiological signals including applications in EEG, EMG, nerve conduction velocity, evoked potential, and electronystagmography.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Pcolleto

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)