SLE EMG ELECTRODES AND ACCESSORIES

K981004 · Specialized Laboratory Equipment, Ltd. · IKT · Oct 21, 1998 · Physical Medicine

Device Facts

• Record ID: K981004
• Device Name: SLE EMG ELECTRODES AND ACCESSORIES
• Applicant: Specialized Laboratory Equipment, Ltd.
• Product Code: IKT · Physical Medicine
• Decision Date: Oct 21, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.1385
• Device Class: Class 2

Intended Use

SLE EMG Electrodes and Accessories are intended for use in recording muscle activity for electromyography applications.

Device Story

Device consists of various needle electrodes and accessories used for electromyography (EMG). Electrodes are inserted into muscle tissue to detect electrical activity; signals are transmitted to external EMG recording equipment. Used by clinicians in clinical settings to assess muscle function. Output provides electrical signal data for diagnostic evaluation of neuromuscular conditions.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technological characteristics and intended use compared to legally marketed predicate devices.

Technological Characteristics

Needle electrodes and accessories for EMG. Materials, design, and composition are identical to predicate devices. No active electronic components or software described.

Indications for Use

Indicated for use in recording muscle activity for electromyography applications. Patient population not specified.

Regulatory Classification

Identification

A diagnostic electromyograph needle electrode is a monopolar or bipolar needle intended to be inserted into muscle or nerve tissue to sense bioelectrical signals. The device is intended for medical purposes for use in connection with electromyography (recording the intrinsic electrical properties of skeletal muscle).

Predicate Devices

• Neuroline Disposable Concentric Needle Electrode, Medicotest A/S (K973529)
• Re-usable Concentric Needle, Chalgren (K953887)
• Re-usable Monopolar Needle, Ent., Inc. Chalgren Ent., Inc. (K953886)
• Needle Electrodes and Disposable Scalp Electrode, Dantec Medical, Inc. (K932059)
• Dantec Disposable Concentric Needle, Dantec Medical, Inc. (K931966)
• Disposable Monopolar Needle Electrode, Var Models, Chalgren (K912282)
• EMG Electrodes and Extension Cords, Nihon Koden, Inc. (K870795)

Submission Summary (Full Text)

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K 981004

SLE EMG Electrodes and Accessories

OCT 21 1998

## 510(K) SUMMARY

- A. Manufacturer: Specialised Laboratory Equipment 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

- B. Contact Information: Phone : [phone] 181 649 8570 FAX:
- C. Classification Name: Electrode, needle, diagnostic electromyograph Common/Usual Name: Electrode, needle electrode, etc.
- D. Classification Number: 89IKT

Proprietary Name:

- E. Substantial Equivalence: Neuroline Disposable Concentric Needle Electrode, Medicotest A/S (K973529), Re-usable Concentric Needle, Chalgren (K953887), Re-usable Monopolar Needle, Ent., Inc. Chalgren Ent., Inc. (K953886), Needle Electrodes and Disposable Scalp Electrode, Dantec Medical, Inc. (K932059), Dantec Disposable Concentric Needle, Dantec Medical, Inc. (K931966), Disposable Monopolar Needle Electrode, Var Models, Chalgren (K912282), and Ent., Inc. EMG Electrodes and

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Extension Cords, Nihon Koden, Inc. (K870795), and others.

- EMG Electrodes and Device Description: The SLE F. Accessories device consists of a variety of needle electrodes and accessories to be used in eletromyographic applications.
- The SLE EMG Electrodes and Accessories G. Intended Use: device is intended to be used in recording muscle activity for electromyography applications.
- Technological Characteristics: The design, materials, H. composition, packaging, and other chemical technological characteristics of the subject device are considered to be the same as the technological characteristics of the predicate devices.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 21 1998

Specialized Laboratory Equipment Limited Mr. Frank Ferguson Official Correspondent c/o Ferguson Medical 2581 California Park Drive, Suite 269 Chico, California 95928

Re: K981004 SLE EMG Electrodes and Accessories Trade Name: Regulatory Class: II Product Code: IKT July 6, 1998 Dated: Received: July 24, 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 Regulations, Title 21, Parts 800 to 895. substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory In addition, FDA may publish further announcements action. 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

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Page 2 - Mr. Frank Ferguson

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 requlation (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 requlation 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. Whitton, Ph. D.

Witten, Ph.D., M.D. Celia M. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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10(k) Number (If known): K 98/00 4 SLE EMG Electrodes and Accessories Pevice Name: Indications For Use:

> SLE EMG Electrodes and Accessories are intended for use in recording muscle activity for electromyography applications.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Division Sign Off

Division of General Restorative Devices
510(k) Number K981004

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rescription Use (Per 21 CFR 801.109)